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company profi le

Med-Pharmex, Inc. was incorporated in 1983, with the purpose of manufacturing quality generic human and veterinary drug products.

The main strength of the company is its technical expertise in the areas of pharmaceutical manufacturing, formulation and research and

development. With this expertise, it was possible to develop specialized products for the pharmaceutical market and acquire approval

by the U.S. Food and Drug Administration.

To date, Med-Pharmex has specialized in the veterinary market. This includes products for companion animals, such as dogs, cats and horses, and food-producing animals such as cattle, swine and poultry.

Med-Pharmex, Inc. is represented by some of the largest veterinary distributors in the U.S. and has a complete national (U.S.) coverage in its

distribution. Internationally, Med-Pharmex, Inc. has a presence in several foreign countries.

The company is committed to continued development of newer products and to serve the veterinary community with a complete line of quality

generic products at a reasonable cost.

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table of contents

Betagen® Topical Spray .........................2-3Derma-Vet® Ointment ...................... 4-5Mometavet™

Otic Suspension ......... 6-7

Tri-Otic® Ointment ............................. 8-9Vet Beta•gen®

Otic Solution ............ 10-11

Miconosol® Lotion/Spray 1% ............. 12-13CEFTIFLEX® .................................... 14-15 Ivermectin Paste 1.87% ................. 16ButaVet™ Paste ................................ 17 Euthanasia-III Solution .................... 18Atropine Sulfate ............................ 19Dexpanthenol ................................ 19Dexamethasone Solution ............... 20Lidocaine ........................................ 20Thiamine ......................................... 21Vitamin C ........................................ 21Vitamin B-12 ................................... 22Lincosol Soluble Powder .................. 23Neosol•Oral .................................... 24Neosol Soluble Powder .................... 25Sulfasol Soluble Powder ................... 26Sulforal ............................................ 27Tetrasol Soluble Powder .................. 28-29Udder Balm .................................... 30C-M-P-K ......................................... 31Pect Plus ........................................ 31CONVEY® ......................................... 32Vet-o-lyte® ....................................... 33Nutri Lyte Powder + ..................... 33Med-Pharmex’s Calf Energy ....... 34Med-Pharmex’s Red Ribbon ....... 35KAO-PECTIN ................................... 36Bismuth Suspension .................... 36

Gentamicin Sulfate with Betamethasone Valerate

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Betagen® Topical Spray delivers a solid one-two punch with the unparalleled combination of two active ingredients.

Gentamicin a broad spectrum antibiotic with not less than 500 mcg

of gentamicin base per milligram.

Betamethasone a potent corticosteroid which provides

strong anti-inflammatory and antipruritic activity.

Betagen®

Topical Spray— clearly the product

of choice for treating infected

superficial lesions in dogs.

ANADA #200-188, Approved by FDA.

Betagen® Topical Spray(GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE)VeterinaryFor Topical Use in Dogs OnlyCAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION: Each mL contains: gentamicin sulfate equivalent to 0.57 mg gentamicin base, betamethasone valerate equivalent to 0.284 mg betamethasone, 163 mg isopropyl alcohol, propylene glycol, methylparaben and propylparaben as preservatives, purified water q.s. Hydrochloric acid may be added to adjust pH.

CHEMISTRY: Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture of sulfate salts of the antibiotics produced in this fermentation. The salts are weakly acidic and freely soluble in water.

Gentamicin sulfate contains not less than 500 micrograms of gentamicin base per milligram.

Betamethasone valerate is a synthetic glucocorticoid.

PHARMACOLOGY: Gentamicin, a broad-spectrum antibiotic, is a highly effective topical treatment for bacterial infections of the skin. In vitro, gentamicin is bactericidal against a wide variety of gram-positive and gram-negative bacteria isolated from domestic animals.1,2 Specifically, gentamicin is active against the following organisms isolated from canine skin: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positive and negative Proteus sp., Escherichia coli, Enterobacter sp., Staphylococcus sp., and Streptococcus sp.

Betamethasone valerate emerged from intensive research as the most promising of some 50 newly synthesized corticosteroids in the experimental model described by McKenzie3, et al. This human bioassay technique has been found reliable for evaluating the vasoconstrictor properties of new topical corticosteroids and is useful in predicting clinical efficacy.

Betamethasone valerate in veterinary medicine has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive infected superficial lesions in dogs.

WARNING: Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have produced cleft palate. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

INDICATIONS: For the treatment of infected superficial lesions in dogs caused by bacteria sensitive to gentamicin.

CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment with this product should be discontinued and appropriate therapy instituted.

DOSAGE AND ADMINISTRATION: Prior to treatment, remove excessive hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days.

Each depression of the sprayer head delivers 0.7 mL of Betagen® Topical Spray.

TOXICITY: Gentamicin sulfate with betamethasone valerate topical spray was well tolerated in an abraded skin study in dogs. No treatment-related toxicological changes in the skin were observed.

Systemic effects directly related to treatment were confined to histological changes in the adrenals, liver, and kidney and to organ-to-body weight ratios of adrenals. All were dose related, were typical for or not unexpected with corticosteroid therapy, and were considered reversible with cessation of treatment.

SIDE EFFECTS: Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs.

Cushing’s syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

PRECAUTIONS: Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to the use of this preparation. Use of topical antibiotics may permit overgrowth of non-susceptible bacteria, fungi, or yeasts. If this occurs, treatment should be instituted with other appropriate agents as indicated.

Administration of recommended dose beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely.

Avoid ingestion. Oral or parenteral use of corticosteroids, depending on dose, duration, and specific steroid may result in inhibition of endogenous steroid production following drug withdrawal.

In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

If ingestion should occur, patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gains, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

HOW SUPPLIED: Plastic spray bottle containing 60 mL, 120 mL or 240 mL of Betagen® Topical Spray.

Store upright between 2°C and 30°C (36°F and 86°F).

REFERENCES:1. Hennessey, PW, et al. In vitro activity of gentamicin against

bacteria isolated from domestic animals. Veterinary Medicine/Small Animal Clinician. November 1971; 1118-1122.

2. Bachmann, HJ, et al: Comparative in vitro activity of gentamicin and other antibiotics against bacteria isolated from clinical samples from dogs, cats, horses, and cattle. Veterinary Medicine/Small Animal Clinician. October 1975; 1218-1222.

3. McKenzie, HW and Atkinson, RM: Topical activities of betamethasone esters in man. Arch Derm. 1964; 19:741-746.

Med-Pharmex, Inc., Pomona, CA 91767April 1999

NET CONTENTS: NDC60 mL 54925-028-60120 mL 54925-028-12240 mL 54925-028-24

Betagen® Topical Spray

antibiotic Broad-spectrum antibiotic for effective treatment of canine bacterial skin disorders

2 3Available in 60 mL, 120 mL, and

240 mL plastic spray bottle.

C O M P A N I O N A N I M A L S

4

Nystatin

Neomycin Sulfate

ThiostreptonTriamcinolone

Acetonide

Through its four active ingredients, Derma-Vet® Ointment provides four basic therapeutic effects: anti-inflammatory, antipruritic, antifungal and antibacterial.

Derma-Vet® Ointment

antibiotic By virtue of its 4 active ingredients, the ointment provides 4 basic therapeutic effects: anti-inflammatory, antipruritic, antifungal and antibacterial

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There is some evidence that corticosteroids can be absorbed after topical application and cause systemic effects. Therefore, an animal receiving nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment therapy should be observed closely for signs such as polydipsia, polyuria, and increased weight gain. Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment is not generally recommended for the treatment of deep or puncture wounds or serious burns.

Sensitivity to neomycin may occur. If redness, irritation or swelling persists or increases, discontinue use. Do not use if pus is present since the drug may allow the infection to spread. Keep this and all medications out of the reach of children.

Avoid ingestion. Oral or parenteral use of corticosteroids (depending on dose, duration of use, and specific steroid) may result in inhibition of endogenous steroid production following drug withdrawal.

SIDE EFFECTS: SAP and SGPT (ALT) enzyme elevations, polydypsia/polyuria, vomiting, and diarrhea (occasionally bloody) have been observed following parenteral or systemic use of synthetic corticosteroids in dogs.

Cushing’s syndrome has been reported in association with prolonged or repeated steroid therapy in dogs.

Temporary hearing loss has been reported in conjunction with treatment of otitis with products containing corticosteroids. However, regression usually occurred following withdrawal of the drug. If hearing dysfunction is noted during the course of treatment with nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment, discontinue its use.

CAUTION: Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue the use of nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment.

DOSAGE AND ADMINISTRATION: Frequency of administration is dependent on the severity of the condition. For mild inflammations, application may range from once daily to once a week; for severe conditions nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment may be applied as often as two to three times daily, if necessary. Frequency of treatment may be decreased as improvement occurs.

Wear gloves during the administration of the ointment or wash hands immediately after application.

OTITIS: Clean ear canal of impacted cerumen. Inspect canal and remove any foreign bodies such as grass awns, ticks, etc. Instill three to five drops of nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment.

Preliminary use of a local anesthetic such as Proparacaine Hydrochloride Ophthalmic Solution may be advisable.

INFECTED ANAL GLANDS, CYSTIC AREAS, ETC: Drain gland or cyst and then fill with nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment.

OTHER DERMATOLOGIC DISORDERS: Clean affected areas, removing any encrusted discharge or exudate. Apply nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment sparingly in a thin film.

STORAGE: 240 mL. bottle. Do not store above 86°F. 7.5 mL, 15 mL, 30 mL tubes: Store at room temperature; avoid excessive heat (104°F).

Manufactured by Med-Pharmex, Inc., Pomona, CA 91767Revised October 1998

NET CONTENTS: NDC7.5 mL (1/4 fl. oz.) 54925-003-7515 mL (1/2 fl. oz.) 54925-003-1530 mL (1 fl. oz.) 54925-003-30240 mL (8 fl. oz.) 54925-003-40

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NADA #140-810, Approved by FDA.

Derma-Vet® OintmentNYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE OINTMENT

For Use Only in Dogs and Cats

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION: Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment in a non-irritating vehicle, a polyethylene and mineral oil gel base.

Shake well before using.Each mL contains:Nystatin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100,000 UnitsNeomycin Sulfate (equivalent to neomycin base) . . . . . 2.5 mg.Thiostrepton . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,500 UnitsTriamcinolone Acetonide . . . . . . . . . . . . . . . . . . . . . . . . 1.0 mg. In a polyethylene and mineral oil gel base.

Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment is supplied in tubes of 1/4 fl. oz. (7.5 mL.), 1/2 fl. oz. (15 mL.), and 1 fl. oz. (30 mL.), each with an elongated tip for easy application and in dispensing bottles of 8 fl. oz. (240 mL.). The preparation is intended for local therapy in a variety of cutaneous disorders of cats and dogs; it is especially useful in disorders caused, complicated or threatened by bacterial and/or candidal (monilial) infections.

ACTIONS: By virtue of its four active ingredients, the ointment provides four basic therapeutic effects: anti-inflammatory, antipruritic, antifungal and antibacterial. Triamcinolone acetonide is a potent synthetic corticosteroid providing rapid and prolonged symptomatic relief on topical administration. Inflammation, edema and pruritus promptly subside and lesions are permitted to heal. Nystatin is the first well tolerated anti-fungal antibiotic of dependable efficacy for the treatment of cutaneous infections caused by Candida albicans (monilia). Nystatin is fungistatic in vitro against a variety of yeast and yeast-like fungi including many fungi pathogenic to animals. No appreciable activity is exhibited against bacteria. Thiostrepton has a high order of activity against gram-positive organisms, including many which are resistant to other antibiotics; neomycin exerts antimicrobial action against a wide range of gram-positive and gram-negative bacteria. Together they provide comprehensive therapy against those organisms responsible for most superficial bacterial infections.

INDICATIONS: Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs, and in anal gland infections in dogs. The preparation is also indicated in the management of dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal (Candida albicans) infections. It is also of value in eczematous dermatitis; contact dermatitis and seborrheic dermatitis; and as an adjunct in the treatment of dermatitis due to parasitic infestation.

WARNING: Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta and metritis.

Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in the offspring. In dogs, other congenital anomalies have resulted; deformed forelegs, phocomelia, and anasarca.

PRECAUTIONS: Nystatin, neomycin sulfate, thiostrepton and triamcino-lone acetonide ointment is not intended for the treatment of deep ab-scesses or deep-seated infections such as inflammation of the lymphatic vessels. Parenteral antibiotic therapy is indicated in these infections.Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide ointment has been extremely well tolerated. Cutaneous reactions attributable to its use have been extremely rare. The occurrence of systemic reactions is rarely a problem with topical administration.

Combining four active ingredients to treat:

• acute and chronic ear infection

• interdigital cysts in cats and dogs

• anal gland infections in dogs

• moist or dry dermatologic disorders

characterized by inflammation from bacterial, and candidal infections, as well as from contact, eczematous, seborrheic and parasitic (ear mites) dermatitis.

Combining four active ingredients to treat:

• acute and chronic ear infection

• interdigital cysts in cats and dogs

• anal gland infections in dogs

• moist or dry dermatologic disorders

characterized by inflammation from bacterial, and candidal infections, as well as from contact, eczematous, seborrheic and parasitic (ear mites) dermatitis.


antibiotic

7


3mometasone

gentamicin

clotrimazole

Otic SuspensionEffective Triple Combination

antibacterial, anti-inflammatory, and antifungal treatment.


Mometavet™

(GENTAMICIN SULFATE, USP; MOMETASONE FUROATE ANHYDROUS; AND CLOTRIMAZOLE, USP, OTIC SUSPENSION)VETERINARYFor Otic Use in Dogs OnlyCAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.Keep this and all drugs out of the reach of children.DESCRIPTION Each gram of Mometavet™ Otic Suspension contains gentamicin sulfate, USP equivalent to 3 mg gentamicin base; mometasone furoate anhydrous equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oil-based system containing a plasticized hydrocarbon gel.PHARMACOLOGYGentamicin: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive bacteria. In vitro tests have determined that gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, gentamicin was shown to have a range of activity against the following organisms commonly isolated from infected canine ears: Pseudomonas spp. (including P. aeruginosa), coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.Mometasone: Mometasone furoate anhydrous is a synthetic adrenocorticoid characterized by a novel (2’) furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms. In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor and swelling.In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application. Gentamicin-Mometasone-Clotrimazole: By virtue of its three active ingredients, gentamicin, mometasone, and clotrimazole otic suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, gentamicin, mometasone, and clotrimazole otic suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Gentamicin, mometasone, and clotrimazole otic suspension reduced discomfort, redness, swelling, exudate, and odor.

INDICATIONS: Mometavet™ Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

WARNINGS: The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (e.g, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Mometavet Otic Suspension immediately and flush the ear canal thoroughly with a non-toxic solution.

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy. Field and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

PRECAUTIONS: Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.Administration of recommended doses of Mometavet™ Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of non-susceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

TOXICOLOGY Field and safety studies with gentamicin, mometasone, and clotrimazole otic suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS).

ADVERSE REACTIONSGentamicin: While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing’s syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.Mometavet™ Otic Suspension: In field studies following once daily treatment with gentamicin, mometasone, and clotrimazole otic suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with gentamicin, mometasone, and clotrimazole otic suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.

DOSAGE AND ADMINISTRATION The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (2 drops from the 215 g bottle) of Mometavet™ Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.

HOW SUPPLIED: Mometavet™ Otic Suspension is available in 7.5 g tubes and plastic bottles, 15 g tubes and plastic bottles, 30 g plastic bottles, and 215 g plastic bottles.Do not store above 25°C (77°F). Shake the bottles well before use.Med-Pharmex, Inc. Pomona, CA 91767-1861 Rev: May/2016

Product Information

NET CONTENTS: NDC 7.5 g 54925-087-44 15 g 54925-087-45 30 g 54925-087-46 215 g 54925-087-40

Mometavet™ Otic Suspension administered just ONCE a day for 7 consecutive

days provides an effective triple combination steroid, antibacterial and antifungal treatment

that work together to combat painful canine ear infections, reducing discomfort, redness, swelling, exudate, and odor.

Indicated for the treatment of acute and chronic infections associated with yeast (Malassezia

pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus

faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

Available in 7.5 g, 15 g, 30 g and 215 g Bottles

Now providing the economical alternative

6

™

Tri-Otic® Ointment

antibiotic Antibacterial, anti-inflammatory and antifungal combine to combat canine ear infections.

Tri-Otic® Ointment is an effective triple combination steroid, antibacterial and antifungal treatment that works together to combat painful canine ear infections. Indicated for the treatment of acute and chronic infections associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

3

Available in 7.5 g and 15 g Tubes, and 10 g, 15 g, 25 g and 215 g Bottles

Three active ingredients for antibacterial, anti-inflammatory and antifungal protection.

8

ANADA #200-229, Approved by FDA

Tri-Otic® OintmentGENTAMICIN SULFATE, USP BETAMETHASONE VALERATE, USP AND CLOTRIMAZOLE, USP OINTMENT

Veterinary

For Otic Use in Dogs Only


Keep this and all drugs out of the reach of children.

DESCRIPTION: Each gram of Tri-Otic® Ointment contains gentamicin sulfate, USP equivalent to 3 mg gentamicin base; betamethasone valerate, USP equivalent to 1 mg betamethasone; and 10 mg clotrimazole, USP in a mineral oil-based system containing a plasticized hydrocarbon gel.

PHARMACOLOGY:Gentamicin: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of pathogenic gram-negative and gram-positive bacteria. In vitro tests have determined that gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. Specifically, gentamicin is active against the following organisms commonly isolated from canine ears: Staphylococcus aureus, other Staphylococcus spp., Pseudomonas aeruginosa, Proteus spp., and Escherichia coli.

Betamethasone: Betamethasone valerate is a synthetic adrenocorticoid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticosteroid activity. Betamethasone valerate, the 17-valerate ester of betamethasone, has been shown to provide anti-inflammatory and anti-pruritic activity in the topical management of corticosteroid-responsive otitis externa. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes and yeasts. The primary action of clotrimazole is against dividing and growing organisms. In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp. and Malassezia pachydermatis (Pityrosporum canis). Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa infected with Malassezia pachydermatis, 1% clotrimazole in the Tri-Otic® Ointment vehicle was effective both microbiologically and clinically in terms of reduction of exudate odor and swelling. In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.

Tri-Otic® Ointment: By virtue of its three active ingredients, gentamicin-betamethasone-clotrimazole ointment has antibacterial, anti-inflammatory, and antifungal activity. In component efficacy studies, the compatibility and additive effect of each of the components were demonstrated. In clinical field trials, gentamicin-betamethasone-clotrimazole was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Gentamicin sulfate, USP Betamethasone valerate, USP and Clotrimazole, USP ointment reduced discomfort, redness, swelling, exudate, and odor, and exerted a strong antimicrobial effect.

INDICATIONS: Tri-Otic® Ointment is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

WARNINGS: The use of Tri-Otic® Ointment has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg. geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of gentamicin-betamethasone-clotrimazole ointment immediately and flush the ear canal thoroughly with a non-ototoxic solution. Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed

forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta and metritis.

PRECAUTIONS: Identification of infecting organisms should be made either by microscopic roll smear evaluation or by culture as appropriate. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation.

If overgrowth of nonsusceptible bacteria, fungi or yeasts occur, or if hypersensitivity develops, treatment should be discontinued and appropriate therapy instituted. Administration of recommended doses of Tri-Otic® Ointment beyond 7 days may result in delayed wound healing. Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects. Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.

TOXICOLOGY: Clinical and safety studies with Gentamicin sulfate, USP Betamethasone valerate, USP and Clotrimazole, USP ointment have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/SIDE EFFECTS).

SIDE EFFECTS:Gentamicin: While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear and renal toxicity.

Betamethasone: Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria have occurred following the use of parenteral or systemic synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs and cats.Cushing’s syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.

DOSAGE AND ADMINISTRATION: The external ear should be thoroughly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable non-irritating solutions. Excessive hair should be clipped from the treatment area. After verifying that the eardrum is intact, instill 4 drops (2 drops from the 215 g bottle) of gentamicin-betamethasone-clotrimazole ointment twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8 drops (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs or more. Therapy should continue for 7 consecutive days.

HOW SUPPLIED: Tri-Otic® Ointment is available in 7.5 gram and 15 gram tubes as well as in 10 gram, 15 gram, 25 gram and 215 gram plastic bottles.

Store between 2° and 25°C (36° and 77°F).

Shake well before use when using the 215 gram bottle.

Med-Pharmex, Inc., Pomona, CA 91767 January 2001

NET CONTENTS: NDC7.5 g Tube 54925-032-7515 g Tube 54925-032-1510 g Bottle 54925-032-1015 g Bottle 54925-032-4525 g Bottle 54925-032-25215 g Bottle 54925-032-40

9

betamethasone valerate

gentamicin sulfate

clotrimazole


antibioticBroad-spectrum antibiotic for effective treatment of canineotitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.

Gentamicin Sulfate with Betamethasone Valerate

Vet Beta•gen® Otic Solution

10

Available in 7.5 mL, 15 mL and 240 mL sizes.


For Use in Dogs and Cats Only.CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION: Vet Beta•gen® Otic Solution is packaged in a convenient plastic squeeze bottle for easy application. Each mL of Vet Beta•gen® Otic Solution contains gentamicin sulfate equivalent to 3 mg gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, 1.0 mg hydroxyethylcellulose, 2.5 mg glacial acetic acid, 200 mg purified water, 19% ethanol, 9.4 mg benzyl alcohol as preservative, 300 mg glycerin and pro-pylene glycol q.s.

CHEMISTRY: Gentamicin is a bactericidal antibiotic of the ami-noglycoside group derived from Micromonospora purpurea of the Actinomyces group. It is a powder, white to buff in color, basic in nature, readily soluble in water and highly stable in solution.

Betamethasone valerate is a synthetic corticosteroid derivative of prednisolone.

ACTION: Vet Beta•gen® Otic Solution combines the broad-spectrum activity of gentamicin sulfate with the anti-inflammatory and antipruritic activity of betamethasone valerate. In vitro antibacterial activity1 has shown that gentamicin is active against most gram-negative bacteria including Pseudomonas aeruginosa, indole-positive and negative proteus sp., Escherichia coli, Klebsiel-la pneumoniae, Aerobacter aerogenes, and Neisseria. Gentamicin is also active against strains of gram-positive bacteria including Staphylococcus species and some Streptococcus species.

Betamethasone valerate has emerged from intensive research as the most promising of some 50 newly synthesized corticosteroids in the experimental model described by McKenzie2 et al. This human bioassay technique has been found reliable for evaluating

the vasoconstrictor properties of new topical corticosteroids and is useful in predicting clinical efficacy.

Betamethasone valerate in human medicine has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive dermatoses. In the responsive cases, the local anti-inflammatory activity is sustained by the vasoconstrictor properties of the steroid.

TOXICITY STUDIES: Parenterally, no toxic effects were observed in rats given gentamicin sulfate 20 mg/kg/day for twenty-four days; in cats given 10 mg/kg/day for forty days. Gentamicin sulfate given to dogs at 6 mg/lb/day, 6 days weekly for three weeks, caused no detectable kidney damage. At higher doses, impairment of equilibrium and of renal function were observed in these species.

Subacute otic toxicity study in dogs showed Vet Beta•gen® Otic Solution to be well tolerated locally with no adverse systemic effects when administered 5 drops twice a day for 21 consecu-tive days.

Gentamicin sulfate solution in a 21-day subacute dermal toxicity study in dogs was shown to be well tolerated when applied topi-cally to abraded skin. There were no meaningful findings except a reduction in eosinophil count attributable to absorption of the corticosteroid component.

INDICATIONS: Vet Beta•gen® Otic Solution is indicated for the treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.

DOSAGE AND ADMINISTRATION: Duration of treatment will depend upon the severity of the condition and the response obtained. The duration of treatment and/or frequency of the dos-age may be reduced, but care should be taken not to discontinue therapy prematurely.

11

Otitis externa – The external ear and ear canal should be prop-erly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear. Instill 3 to 8 drops of Vet Beta•gen™ Otic Solution (approximately room temperature) into the ear canal twice daily for seven to fourteen days.

Superficial infected lesions – The lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. Apply a sufficient amount of Vet Beta•gen® Otic Solution to cover the treatment area twice daily for seven to fourteen days.

CONTRAINDICATIONS: If hypersensitivity to any of the compo-nents occurs, treatment with this product should be discontinued and appropriate therapy instituted.

Concomitant use of drugs known to induce ototoxicity should be avoided.

This preparation should not be used in conditions where cortico-steroids are contraindicated.

Do not administer parenteral corticosteroids during treatment withVet Beta•gen® Otic Solution.

PRECAUTIONS: The antibiotic sensitivity of the pathogenic organ-ism should be determined prior to the use of this preparation. Use of topical antibiotics occasionally allows overgrowth of non-susceptible bacteria, fungi, or yeasts. In these cases, treatment should be instituted with other appropriate agents as indicated.

Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocortico-steroid overdosage which include sodium retention, potassium loss, fluid retention, weight gains, polydipsia and/or polyuria. Prolonged use or overdosage may produce adverse immunosup-pressive effects.

Experimentally it has been demonstrated that corticosteroids, especially at high dosage levels, may result in delayed wound healing. An increase in the incidence of osteoporosis may be noted, mainly in the elderly, with prolonged use of these com-pounds. Their use in older dogs during the healing stages of bone fracture is not indicated for the reason listed above. Use of corticosteroids, depending on dose, duration, and specific steroid, may result in inhibition of endogenous steroid production follow-ing drug withdrawal. In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in unusually stressful situations.

CAUTION: Before instilling any medication into the ear, exam-ine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Vet Beta•gen® Otic Solution.

WARNING: Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when admin-istered during the last trimester of pregnancy and may pre-cipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids can induce cleft palates in offspring when given to pregnant ani-mals during the period of palate closure of the embryos. Other congenital anomalies including deformed forelegs, phocomelia,

and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

Avoid ingestion.

SIDE EFFECTS: Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria have occurred following the use of parenteral or systemic synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs and cats.

Cushing’s Syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

HOW SUPPLIED: Vet Beta•gen® Otic Solution, squeeze bottles of 7.5 mL, 15 mL, and 240 mL (8 fl oz.).

Store between 2°C and 25°C (36°F and 77°F).

REFERENCES: 1. Weinstein, M.J., Leudemann, G.M., Oden, E.M., and Wagman, G.H.: Gentamicin, a new broad-spectrum antibiotic complex. Antimicrobial Agents and Chemotherapy, 1963, pp. 1-7.2. McKenzie, A.W., and Atkinson, R.M.: Topical activities of betamethasone esters in man. Arch Derm. 1964; 19:741-746.

Manufactured by Med-Pharmex, Inc. Pomona, CA 91767May 1996

NET CONTENTS: NDC7.5 mL 54925-026-7515 mL 54925-026-15240 mL 54925-026-40



Miconosol® Lotion 1%(MICONAZOLE NITRATE)

Topical antifungal agent for dogs and cats

DESCRIPTION: MICONOSOL (miconazole nitrate) Lotion is a synthetic antifungal agent for use in dogs and cats. It contains: 1.15% miconazole nitrate (equivalent to 1% miconazole base by weight), polyethylene glycol 400 and ethyl alcohol 55%.

INDICATIONS: MICONOSOL (miconazole nitrate) Lotion is indicated for the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes.

PRECAUTIONS: In the event of sensitization or irritation due to MICONOSOL Lotion, treatment should be discontinued. Avoid contact with eyes, since irritation may result. Wash hands thoroughly after administration to avoid spread of fungal infection.

DOSAGE AND ADMINISTRATION: Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide, or by culture on an appropriate medium.

Apply a light covering of MICONOSOL (miconazole nitrate) Lotion to affected areas, once daily, for 2 to 4 weeks. Application is best accomplished using a gauze pad or cotton swab. Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. If no improvement is noticed within 2 weeks, diagnosis should be re-evaluated. Difficult cases may require treatment for 6 weeks.

General measures in regard to hygiene should be observed to control sources of infection or reinfection. Clipping of hair around and over the sites of infection should be done at the start of treatment and again as necessary.

HOW SUPPLIED: MICONOSOL (miconazole nitrate) Lotion in 60 mL containers.


August 1997

Med-Pharmex, Inc., Pomona, CA 91767

NET CONTENTS: NDC60 mL 54925-031-06

13

antifungal

S M A L L A N I M A L S

Safe and soothing treatment for fungal skin and ear infections

as well as ringworm

in dogs and cats.

Available in 60 mL lotion dropper bottle and 120 mL and

240 mL spray bottles

12

Miconazole Nitrate

Miconosol®

Lotion/Spray 1%

Effective treatment of fungal infections in dogs and cats caused by the three major dermatophytes


Miconosol® Spray 1%(MICONAZOLE NITRATE)

Topical antifungal agent for dogs and cats

DESCRIPTION: MICONOSOL (miconazole nitrate) Spray is a synthetic antifungal agent for use in dogs and cats. It contains: 1.15% miconazole nitrate (equivalent to 1% miconazole base by weight), polyethylene glycol 400 and ethyl alcohol 55%.

INDICATIONS: MICONOSOL (miconazole nitrate) Spray is indicated for the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes.

PRECAUTIONS: In the event of sensitization or irritation due to MICONOSOL Spray, treatment should be discontinued. Avoid contact with eyes, since irritation may result. Wash hands thoroughly after administration to avoid spread of fungal infection.

DOSAGE AND ADMINISTRATION: Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide, or by culture on an appropriate medium.

Spray affected areas from a distance of 2 to 4 inches to apply a light covering, once daily for 2 to 4 weeks. Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. If no improvement is noticed within 2 weeks, diagnosis should be re-evaluated. Difficult cases may require treatment for 6 weeks.

General measures in regard to hygiene should be observed to control sources of infection or reinfection. Clipping of hair around and over the sites of infection should be done at the start of treatment and again as necessary.

HOW SUPPLIED: MICONOSOL (miconazole nitrate) Spray in 120 mL and 240 mL containers.


August 1997

Med-Pharmex Inc., Pomona, CA 91767

NET CONTENTS: NDC120 mL 54925-031-12240 mL 54925-031-24



CEFTIFLEX®

(ceftiofur sodium sterile powder)For intramuscular and subcutaneous injection in cattle only. For intramuscular injection in swine, sheep, goats, and horses. For subcutaneous injection only in dogs. This product may be used in lactating dairy cattle, sheep, and goats.CAUTION: Federal USA law restricts this drug to use by or on the order of a licensed veterinarian.DESCRIPTIONCeftiflex® contains the sodium salt of ceftiofur which is a broad spectrum cephalosporin antibiotic active against gram-positive and gram-negative bacte-ria including β-lactamase-producing strains. Like other cephalosporins, ceftiofur is bactericidal in vitro, resulting from inhibition of cell wall synthesis.

Each mL of the reconstituted drug contains ceftiofur sodium equivalent to 50 mg ceftiofur. The pH was adjusted with sodium hydroxide and monobasic potassium phosphate.Shake thoroughly prior to use.Reconstitution of the sterile powder: Ceftiflex® should be reconstituted as follows:1 gram vial- Reconstitute with 20 mL Sterile Water for Injection. Each mL of the resulting solution contains ceftiofur sodium equivalent to 50 mg ceftiofur.4 gram vial- Reconstitute with 80 mL Sterile Water for Injection. Each mL of the resulting solution contains ceftiofur sodium equivalent to 50 mg ceftiofur.

INDICATIONSCattle Ceftiflex® is indicated for treatment of bovine respiratory disease (ship-ping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Ceftiofur Sodium Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.Swine Ceftiflex® is indicated for treatment/control of swine bacterial respira-tory disease (swine bacterial pneumonia) associated with Actinobacillus (Hae-mophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.Sheep Ceftiflex® is indicated for treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.Goat Ceftiflex® is indicated for treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.Horses Ceftiflex® is indicated for treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.Dogs Ceftiflex® is indicated for the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.

DOSAGE AND ADMINSTRATIONCattle Administer to cattle by intramuscular or subcutaneous injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner’s judgment of se-verity of disease (i.e., for respiratory disease, extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and /or loss of appetite; and for foot rot, extent of swelling, lesion and severity of lameness).Swine Administer to swine by intramuscular injection at the dosage of 1.36 to 2.27 mg ceftiofur per pound (3.0 to 5.0 mg/kg) of body weight (1 mL of reconsti-tuted sterile solution per 22 to 37 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days.Sheep Administer to sheep by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner’s judgment of severity of disease (i.e., extent of elevated body temperature, depressed physical appearance, increased respira-tory rate, coughing and/or loss of appetite).Goat Administer to goats by intramuscular injection at the dosage of 0.5 to 1.0 mg ceftiofur per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of three consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Selection of dosage (0.5 to 1.0 mg/lb) should be based on the practitioner’s judgment of severity of disease (i.e., extent of elevated body temperature, depressed physical appearance, increased respiratory rate, coughing and/or loss of appetite). Pharmacokinetic data indicate that elimination of the drug is more rapid in lactating does. For lactating does, the high end of the dose range is recommended.Horses Administer to horses by intramuscular injection at the dosage of 1.0 to 2.0 mg ceftiofur per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lbs body weight). A maximum of 10 mL may be administered per injection site. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared and should not exceed 10 days.Dogs Administer to dogs by subcutaneous injection at the dosage of 1.0 mg ceftiofur per pound (2.2 mg/kg) of body weight (0.1 mL reconstituted sterile solution per 5 lbs body weight). Treatment should be repeated at 24-hour intervals for 5-14 days.

15S M A L L A N I M A L S14

Reconstituted CEFTIFLEX® is to be administered to dogs by subcutaneous injec-tion. No vial closure should be entered more than 20 times. Therefore, only the 1 gram vial is approved for use in dogs.

CONTRAINDICATIONSAs with all drugs, the use of Ceftiflex® is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGSNOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN.Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth, and clothing.Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product.In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.The Safety Data Sheet contains more detailed occupational safety information. To obtain a Safety Data Sheet (SDS) please call 1-800-210-6419. To report any adverse event please call 1-800-210-6419.

PRECAUTIONS The effects of Ceftiflex® on the reproductive performance, pregnancy, and lactation of cattle, swine, sheep, and goats have not been determined.Cattle Following subcutaneous administration of ceftiofur sodium in the neck, small areas of discoloration at the site may persist beyond five days, potentially resulting in trim loss of edible tissues at slaughter.As with any parenteral injection, localized post-injection bacterial infections may result in abscess formation. Attention to hygienic procedures can minimize their occurrence.Swine The safety of Ceftiflex® has not been determined for swine intended for breeding.Horses The safety of Ceftiflex® has not been determined for horses intended for breeding. The administration of antimicrobials to horses under conditions of stress may be associated with acute diarrhea that could be fatal. If acute diarrhea is observed, discontinue use of this antimicrobial and initiate appropriate therapy.Dogs The safety of Ceftiflex® has not been determined for dogs intended for breeding, or pregnant dogs.

ADVERSE REACTIONS The use of CEFTIFLEX® may result in some sign of immediate and transient local pain to the animal.

STORAGE CONDITIONS Store unreconstituted product at controlled room temperature 20˚ to 25˚ C (68˚ to 77˚ F) [see USP].Store reconstituted product either in a refrigerator 2˚ to 8˚ C (36˚ to 46˚ F) for up to 7 days or at controlled room temperature 20˚ to 25˚ C (68˚ to 77˚ F) [see USP] for up to 12 hours. Protect from light. Color may vary from off-white to a tan color. Color does not affect potency.

ONE-TIME SALVAGE PROCEDURE FOR RECONSTITUTED PRODUCT At the end of the 7-day refrigeration or 12-hour room temperature storage period following reconstitution, any remaining reconstituted product may be frozen for up to 8 weeks without loss in potency or other chemical properties. This is a one-time only salvage procedure for the remaining product. To use this salvaged product at any time during the 8-week storage period, hold the vial under warm running water, gently swirling the container to accelerate thawing, or allow the frozen material to thaw at room temperature. Rapid freezing or thawing may result in vial breakage. Any product not used immediately upon thawing should be discarded.

NET CONTENTS: NDC1 gram vial 54925-082-014 gram vial 54925-082-04Revised May 2009

RESIDUE WARNINGS:Cattle: When used according to label indications, dosage and routes of administration, treated cattle must not be slaughtered for 4 days following the last treatment. When used according to label indications, dosage and routes of administration, a milk discard time is not required. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk.Swine: When used according to label indications, dosage and route of administration, treated pigs must not be slaughtered for 4 days following the last treatment. Use of dosages in excess of those indicated or by unapproved routes of administration may result in illegal residues in edible tissues.Sheep: Neither a pre-slaughter drug withdrawal interval nor a mild discard time is required when this product is used according to label indications, dosage, and route of administration. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk.Goats: Neither a pre-slaughter drug withdrawal interval nor a milk discard time is required when this product is used according to label indications, dosage, and route of administration. Use of dosages in excess of those indicated or by unapproved routes of administration, such as intramammary, may result in illegal residues in edible tissues and/or in milk.Horses: Do not use in horses intended for human consumption.

antibiotic Proven Formulation. Trusted Brand.

Ceftiflex®

Available in 1 gramand 4 gram vials.

Ceftiflex® contains the sodium salt of ceftiofur which is a broad spectrum cephalosporin antibiotic active against gram-positive and gram-negative bacteria including β-lactamase-producing strains. Like other cephalosporins, ceft-iofur is bactericidal in vitro, resulting from inhibition of cell wall synthesis.

Each mL of the reconstituted drug contains ceftiofur sodium equivalent to 50 mg ceftiofur. The pH was adjusted with sodium hydroxide and monobasic potassium phosphate.

Ceftiflex® Indications:• Cattle Ceftiflex® is indicated for treatment of bo-

vine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Ceftiofur Sodium Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododer-matitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

• Swine Ceftiflex® is indicated for treatment/control of swine bacterial respiratory disease (swine bacte-rial pneumonia) associated with Actinobacillus (Hae-mophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.

• Sheep Ceftiflex® is indicated for treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.

• Goat Ceftiflex® is indicated for treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.

• Horses Ceftiflex® is indicated for treatment of re-spiratory infections in horses associated with Strep-tococcus zooepidemicus.

• Dogs Ceftiflex® is indicated for the treatment of canine urinary tract infections associated with Esch-erichia coli and Proteus mirabilis.

(ceftiofur sodium sterile powder)

ivermectin

S M A L L A N I M A L S16

Anthelmintic and BoticideRemoves worms and bots with a single dose.

Ivermectin Paste 1.87%

Contents will treat up to 1250 lb body weight.


For Oral Use in Horses Only.Each Syringe Contains 0.21 oz (6.08 g) IVERMECTIN PASTENet Wt. 0.21 oz (6.08 g)

INDICATIONS: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Ivermectin Paste 1.87% provides effective treatment and control of the following parasites in horses.

Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp., including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) – Coronocyclus spp. including C. coronatus; C. labiatus and C. labratus; Cyathostomum spp., including C. catinatum and C. pateratum; Cylicocyclus spp. includ-ing C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Petrovinema poculatum; Small Strongyles – Fourth-stage larvae; Pinworms (adults and fourth-stage larvae) – Oxyuris equi; Ascarids (adults and third- and fourth-stage lar-vae) – Parascaris equorum; Hairworms (adults) –Trichostrongylus axei; Large-mouth Stomach Worms (adults) – Habronema muscae; Bots (oral and gastric stages) – Gasterophilus spp. including G. intes-tinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) – Dictyocaulus arnfieldi; Intestinal Threadworms (adults) – Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

DOSAGE AND ADMINISTRATION: This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight. (1) While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking. (2) Lock the ring in place by making a 1/4 turn to the right. (3) Make sure that the horse’s mouth contains no feed. (4) Remove the cover from the tip of the syringe. (5) Insert the syringe tip into the horse’s mouth at the space between the teeth. (6) Depress the plunger as far as it will go, depositing paste on the back of the tongue. (7) Immedi-ately raise the horse’s head for a few seconds after dosing.

PARASITE CONTROL PROGRAM: All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Consult

your veterinarian for a control program to meet your specific needs. Iver-mectin Paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.

PRODUCT ADVANTAGES: Broad-spectrum Control– Ivermectin Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Ivermectin Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.

ANIMAL SAFETY: Ivermectin Paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

WARNING: Do not use in horses intended for human consumption.

Not for use in humans. Keep this and all drugs out of reach of children.

Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a SDS, contact Med-Pharmex Incorporated at 909-593-7875

PRECAUTIONS: Ivermectin Paste has been formulated specifically for use in horses only. This product should not be used in other animal spe-cies as severe adverse reactions, including fatalities in dogs, may result.

Environmental Safety: Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

INFORMATION FOR HORSE OWNERS: Swelling and itching reactions after treatment with Ivermectin Paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp.) microfilariae. These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with Ivermectin Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).

NET CONTENTS: 6.08g NDC 54925-048-06

November 2012

17

anti-flammatory

Phenylbutazone Pastefor Horses

ButaVet®


For Veterinary Use OnlyFor Oral Use in Horses Only.Each syringe contains 20 g phenylbutazone.Each 3 mL marking on the plunger contains Phenylbutazone: 1 g. DESCRIPTION: ButaVet® Phenylbutazone Paste is a synthetic, non-hormonal anti-inflammatory, antipyretic compound useful in the management of inflammatory conditions. The apparent analgesic effect is probably related mainly to the compound’s anti-inflammatory properties. Chemically, Phenylbutazone Paste is 4-butyl-1, 2-diphenyl-3, 5-pyrazolidinedione. It is pyrazolone derivative, entirely unrelated to steroid hormones.

INDICATIONS: For the relief of inflammatory conditions associated with the musculosketal systems in horses.

CONTRAINDICATIONS: Use with caution in patients who have a history of drug allergy.

WARNING: Not for use in horses intended for food.

PRECAUTIONS: Stop medication at the first sign of gastrointestinal upset, jaundice, or blood dyscrasia. Authenticated cases of agranulocytosis associated with the drug have occurred in man; fatal reactions, though rare, have been reported in dogs after long-term therapy. To guard against this possibility, conduct routine blood counts at weekly intervals during the early phase therapy and at intervals of two weeks thereafter. Any significant fall in the total white blood cell count, relative decreases in granulocytes, or black or tarry stools should be regarded as a signal for immediate cessation of therapy and institution of appropriate counter-measures. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy is required.

ADMINISTRATION AND DOSAGE: Orally – 1 to 2 g of phenylbutazone per 500 lb. of body weight daily. Do not exceed 4 g daily.

When administering ButaVet® Phenylbutazone Paste, the oral cavity should be empty. Deposit paste on the back of tongue by depressing plunger that has been previously set to deliver the correct dose.

Guidelines to Successful Therapy: Use a relatively high dose for the first 48 hours, then reduce gradually to a

maintenance dose. Maintain lowest dose capable of producing desired clinical response. Response to ButaVet® Phenylbu-tazone Paste therapy is prompt, usually occurring within 24 hours. If no significant clinical effect is evident after five days, re-evaluate diagnosis and therapeutic approach.

Many chronic conditions will respond to ButaVet® Phenylbuta-zone Paste therapy, but discontinuance of treatment may result in recurrence of symptoms.

STORAGE: Store at 15°-30°C (59°-86°F)

HOW SUPPLIED: Syringes containing 20 g Phenylbutazone.

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Manufactured by: Med-Pharmex, Inc. Pomona, CA 91767-1861

Revised June 2012

NET CONTENTS: NDCNet Volume 60 mL 54925-088-60

ANADA #200-280

For Dogs Only.CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTIONA non-sterile solution containing pentobarbital sodium and phe-nytoin sodium as the active ingredients. Rhodamine B, a bluish-red fluorescent dye, is included in the formulation to help distinguish it from parenteral drugs intended for therapeutic use. Although the solution is not sterile, benzyl alcohol, a bacteriostat is included to retard the growth of microorganisms.

EACH mL CONTAINS: Active ingredients: 390 mg pento-barbital sodium (barbituric acid derivative), 50 mg phenytoin sodium; Inactive ingredients: 10% ethyl alcohol, 18% propylene glycol, 0.003688 mg rhodamine B, 2% benzyl alcohol (preservative), purified water qs. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

ACTIONS Euthanasia-III Solution contains two active ingredients which are chemically compatible but pharmacologically different. Each ingredient acts in such a manner so as to cause humane, pain-less and rapid euthanasia. Euthanasia is due to cerebral death in conjunction with respiratory arrest and circulatory collapse. Cerebral death occurs prior to cessation of cardiac activity.

When administered intravenously, pentobarbital sodium pro-duces rapid anesthetic action. There is a smooth and rapid onset of unconsciousness. At the lethal dose, there is depression of vital medullary respiratory and vasomotor centers.

When administered intravenously, phenytoin sodium produces toxic signs of cardiovascular collapse and/or central nervous system depression. Hypotension occurs when the drug is administered rapidly.

PHARMACODYNAMIC ACTIVITYThe sequence of events leading to humane, painless and rapid euthanasia following intravenous injection of Euthanasia-III Solution is similar to that following intravenous injection of pentobarbital sodium or other barbituric derivatives. Within seconds, unconsciousness is induced with simultaneous collapse of the dog. This stage rapidly progresses to deep anesthesia with concomitant reduction in the blood pressure. A few seconds later, breathing stops, due to depression of the medullary respiratory center; encephalographic activity becomes isoelectric, indicating cerebral death; and then cardiac activity ceases.

Phenytoin sodium exerts its effect during the deep anesthesia stage caused by the pentobarbital sodium. This ingredient, due to its cardiotoxic properties, hastens the stoppage of electrical activity in the heart.

INDICATIONSFor use in dogs for humane, painless and rapid euthanasia.

WARNINGFor canine euthanasia only. Must not be used for therapeutic purposes. Do not use in animals intended for food.

ENVIROMENTAL HAzARDThis product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws, to prevent consumption of carcass material by scavenging wildlife.

HUMAN WARNINGCaution should be exercised to avoid contact of the drug with open wounds or accidental self-inflicted injections. Keep out of reach of children. If eye contact, flush eyes with water and seek medical attention.

PRECAUTIONSEuthanasia may sometimes be delayed in dogs with severe cardiac or circulatory deficiencies. This may be explained by the impaired movement of the drug to its site of action. An occasional dog may elicit reflex responses manifested by motor movement; however, an unconscious animal does not experience pain, because the cerebral cortex is not functioning.

When restraint may cause the dog pain, injury or anxiety, or danger to the person making the injection, prior use of tranquilizing or immobilizing drugs may be necessary.

DOSAGE AND ADMINISTRATION Dosage: Dogs: 1 mL for each 10 pounds of body weight.Administration: Intravenous injection is preferred. Intracardiac injection may be made when intravenous injection is impractical, as in a very small dog, or in a comatose dog with impaired vascular functions. Good injection skill is necessary for intracardiac injection.

The calculated dose should be given in a single bolus injection.

For intravenous injection, a needle of sufficient gauge to ensure intravenous placement of the entire dose should be used. The use of a Luer-Lok® syringe is recommended to prevent accidental exposure to needle/syringe separation.

HOW SUPPLIED: Euthanasia-III Solution is available in 100-mL multiple-dose vials.

Manufactured by a non-sterilizing process.

STORAGE: Store between 15° and 30°C (59° and 86°F).

Med-Pharmex Inc., Pomona, CA 91767

NDC 54925-045-10October 2004

Euthanasia-III Solution

18

injectables

19

AtropineSulfate

(Atropine Sulfate Injection 1/120 Grain)CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

For Intravenous, Intramuscular or Subcutaneous Use

COMPOSITION: Each mL contains:Atropine Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . 0.54 mgSodium Chloride . . . . . . . . . . . . . . . . . . . . . . . . . . 9 mgBenzyl Alcohol (preservative) . . . . . . . . . . . . .1.5%Water for Injection . . . . . . . . . . . . . . . . . . . . . . . . q.s.

pH adjusted with sulfuric acid when necessary.

DOSAGE AND ADMINISTRATION: Dogs and Cats: Inject 1 mL for each 20 lbs. of body weight as a pre-anesthetic adjuvant or to reduce salivation, bronchial secretion or internal peristalsis associated with colic or diarrhea.

As an antidote for parasympathomimetic drugs, 1 mL for each 7.5 lbs. of body weight. It is suggested that 1/4 of the dosage be injected intravenous and the remainder intramuscular or subcutaneous.

WARNING: Poisonous alkaloid. Keep out of reach of children. Antidotes: warmth, emetics, cholinergics.

FOR ANIMAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

Store at room temperature between 15°- 30° C (59°- 86° F).

Net Contents: 100 mL Seterile Multiple Dose Vial

NDC 54925-063-10

Revised April 2008

Dexpanthenol(Dexpanthenol Injection)


COMPOSITION: Each mL contains:Dexpanthenol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 mgBenzyl Alcohol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1% w/vWater for Injection . . . . . . . . . . . . . . . . . . . . . . . . . q.s.Acetic Acid, Glacial, USP . . . . . . . . . . . . . . . . . . to adjust PH

INDICATIONS: For use as a nutritional source of dexpanthenol.

DOSAGE AND ADMINISTRATION: Dogs and Cats: 25 mg per 5 lbs. body weight intramuscularlyHorses: Initial dose 10 cc intravenously or intramuscularly.

PRECAUTION: Following the administration of succinylcholine chloride, a one-hour waiting period is advisable before initia-tion of dexpanthenol therapy.

CONTRAINDICATIONS: In therapy of colic resulting from administration of cholinergic type anthelmintics.




Net Contents: 100 mL NDC 54925-064-10

Revised April 2008

injectables

20

Lidocaine(Lidocaine Hydrochloride Injectable 2%)


COMPOSITION: Each mL of sterile aqueous solution contains:Lidocaine Hydrochloride ……….. .…… 2.0%Sodium Chloride ………….. . . . . . . . . .… 0.2%Potassium Phosphate Monobasic……… 0.2% Potassium Phosphate Dibasic ………… 0.2%Methylparaben …….. . . . . . . . . . . .……… 0.1%Water for Injection …….. . . . . . . .……… q.s.

INDICATIONS: Lidocaine is a potent local anesthetic for producing epidural and nerve conduction anesthesia.

CONTRAINDICATIONS: Lidocaine is contraindicated in animals with known hypersensitivity to the drug.

PRECAUTIONS: Lidocaine is usually well tolerated. Neverthe-less, as with all local anesthetics, untoward effects may occur due to hypersensitivity, faulty technique, overdosage and inadvertent intravascular or subarachnoid injection. In case of respiratory arrest, immediate resuscitation with oxygen is indicated.

DOSAGE AND ADMINISTRATION: Epidural Cattle and Horses – 5 to 15 mL. Dogs and Cats – 1 mL per 10 pounds of body weight.

Nerve Block Cattle and Horses – 5 to 20 mL.




Net Contents: NDC 100 mL 54925-073-10250 mL 54925-073-25

Revised April 2008

DexamethasoneSolution

RESIDUE WARNING:A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Sterile Multiple Dose Vial 2mg/mLANADA #200-456, Approved by FDA For Intravenous or Intramuscular Injection. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DOSAGE: Bovine – 5 to 20 mg Equine – 2.5 to 5 mg

COMPOSITION: Each mL contains:2 mg dexamethasone, 500 mg polyethylene glycol 400, 9 mg benzyl alcohol, 1.8 mg methylparaben, 0.2 mg propyl-paraben (as preservatives); 4.75% alcohol, hydrochloric acid and/or sodium hydroxide used to adjust pH to approximately 4.9, Water for Injection q.s.

Store between 20°C - 25°C (68°F - 77°F)Before using this drug read package insert for complete product information.



Net Contents: 100 mL NDC 54925-067-10

injectables

21

Thiamine(Thiamine Hydrochloride 200 or 500 mg/mL)


COMPOSITION: Each mL contains:Thiamine Hydrochloride ………….. . . . . . 200 mg / 500mgDisodium Edetate ………….. . . . . . . . . .…0.01% w/vBenzyl Alcohol ………….. . . . . . . . . . . .… 1.5% w/vWater for injection ………….. . . . . . . . . .… q.s. ph is adjusted with Hydrochloric Acid or Sodium Hydroxide

INDICATIONS: For use as a supplemental source of thiamine in dogs, cats, and horses.

DOSAGE AND ADMINISTRATION: For intramuscular use in dogs, cats, and horses. For the 200 mg/mL dosage may be repeated daily as needed.Horses – 0.25 mL per 100 lb body weight Dogs – 0.08 mL per 10 lb body weight up to 0.25 mL maximum Cats – 0.04 mL per 5 lb body weight up to 0.1 mL maximum.For the 500mg/mL as determined by the veterinarian.

WARNINGS: Anaphylactogenesis to parenteral Thiamine HCI has been reported. Administer slowly and with caution in doses over 0.25 mL (50 mg) for the 200mg/mL and 0.1mL for 500mg/mL




Do not use if precipitated.

Net Contents: NDC 200 mg/mL 100 mL 54925-058-10200 mg/mL 250 mL 54925-058-25500 mg/mL 100 mL 54925-059-10500 mg/mL 250 mL 54925-059-25

Revised October 2007

Vitamin C(Injectable Solution)


COMPOSITION: Each mL of sterile aqueous solution contains:Sodium Ascorbate ………….. . . . . . . . . .… 250 mgBenzyl Alcohol (preservative) ………….. . 1.5% v/vSodium Metabisulfite ………….. . . . . . . . . . 0.2% w/v

INDICATIONS: For use as a nutritive supplemental vitamin C in guinea pigs, primates, cattle, horses, sheep, swine, cats and dogs.

PRECAUTIONS: Since pressure may develop on long storage, precaution should be taken to release pressure before use. Storage under refrigeration will reduce possibility of pressure build-up.

DOSAGE AND ADMINISTRATION: Administer intramuscularly 1 to 10 mL, depending on condition, species, and body weight. Repeat daily or as indicated by desired response.




Do not use if precipitated.

Avoid exposure to light.

Net Contents: NDC 100 mL 54925-062-10250 mL 54925-062-25

Revised March 2008

injectables

injectables

22

Vitamin B-12CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

B-12 1000 mcg/mL / B-12 3000 mcg/mLand B-12 5000 mcg/mL VITAMIN B-12 1000 mcg/mLCOMPOSITION: Each mL of sterile aqueous solution contains:Cyanocobalamin (B-12) ………….. . . . . .1000 mcgSodium Chloride………….. . . . . . . . . . .… 9 mgBenzyl Alcohol ………….. . . . . . . . . . . . .…1.5 %Water for injection ………….. . . . . . . .… q.s.

VITAMIN B-12 3000 mcg/mLCOMPOSITION: Each mL of sterile aqueous solution contains:Cyanocobalamin (B-12) ………….. . . . . .3000 mcgSodium Chloride………….. . . . . . . . . . .… 9 mgBenzyl Alcohol ………….. . . . . . . . . . . . .…1.5 %Water for injection ………….. . . . . . . .… q.s.

INDICATIONS: For use as a supplemental nutritive source of Vitamin B12 in cattle, horses, sheep, swine, dogs and cats.

DOSAGE AND ADMINISTRATION: Inject subcutaneously or intramuscularly.Cattle, Horses, Sheep and Swine – 1 to 2 mL Dogs and Cats – 0.25 to 0.5 mLSuggested dosage may be repeated at 1 to 2 week intervals, as indicated by condition and response.

B-12 5000 mcg/mLCOMPOSITION: Each mL of sterile aqueous solution contains:Cyanocobalamin (B-12) ………….. . . . . .5000 mcgSodium Chloride………….. . . . . . . . . . .… 9 mgBenzyl Alcohol ………….. . . . . . . . . . . . .…1.5 %Water for injection ………….. . . . . . . .… q.s.

INDICATIONS: For use in Vitamin B12 deficiency associated with cobalt deficiency in cattle and sheep and for Vitamin B12 deficiency associated with inadequate Vitamin B12 intake or intestinal malabsorption in swine.

DOSAGE AND ADMINISTRATION: Inject subcutaneously or intramuscularly.Cattle and Sheep – 0.2 to 0.4 mL Swine – 0.1 to 0.4 mL Suggested dosage may be repeated at weekly intervals if necessary.



Store at room temperature between 15°- 30° C (59°- 86° F).Do not use if precipitated.Avoid exposure to light.Net Contents: NDC B-12 1000 mcg/mL 100 mL 54925-053-10B-12 3000 mcg/mL 100 mL 54925-054-10B-12 5000 mcg/mL 100 mL 54925-055-10

B-12 1000 mcg/mL 250 mL 54925-053-25B-12 3000 mcg/mL 250 mL 54925-054-25

Revised February 2008

(Cyanocobalamin Injectable Solution)

23

(Brand of Lincomycin Hydrochloride Soluble Powder)

Lincosol Soluble Powder


AVAILABLE IN 3 SIzES:32 oz. (0.907 Kg) Container, 1.41 oz (40 g) Packet, and 2.82 oz (80 g) Packet

SWINE: DIRECTIONS FOR USEINDICATIONS: Lincomycin Soluble Powder is indicated for the treatment of swine dysentery (bloody scours).DOSAGE: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per pound of body weight per day.TREATMENT PERIOD: The drug should be administered for a minimum of 5 consecutive days beyond disappearance of symptoms (bloody stools) up to maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin premix at 100 grams lincomycin per ton of complete feed as the sole ration according to label directions.ADMINISTRATION: One scoop (provided) of this powder will medicate 64 gallons of drinking water providing 250 mg/gallon. The 1.41 oz (40 g) packet will medicate 64 gallons of drinking water providing 250 mg/gallon. The 2.82 oz (80 g) packet will medicate 128 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per pound of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental tem-perature and humidity, each of which affects water consumption. For use in automatic water proportioners, prepare the stock solu-tion by dissolving one packet in one gallon of water: then adjust the proportioner to deliver 1 ounce of stock solution per gallon of drinking water.NOTE: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin premix at 40 grams lincomycin per ton of complete feed as the sole ration.

BROILER CHICKENS: DIRECTIONS FOR USEINDICATIONS: Lincosol Soluble Powder is indicated for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.DOSAGE: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water.TREATMENT PERIOD: Start medication as soon as the diagnosis of necrotic enteritis is determined. If improvement is not noted within 24 to 48 hours, consult a licensed veterinarian or veterinary diagnostic laboratory to determine diagnosis. The drug should be administered for 7 consecutive days.ADMINISTRATION: One scoop (provided) of this powder will medicate 250 gallons of drinking water providing 64 mg/gallon. The 1.41 oz (40 g) packet will medicate 250 gallons of drinking water providing 64 mg/gallon. The 2.82 oz (80 g)packet will medicate 500 gallons of drinking water providing 64 mg/gallon. NOTE: After water medication is discontinued, a recommended control program for necrotic enteritis consists of feeding lincomycin premix at 2 grams lincomycin per ton of complete feed.

CAUTIONS:1. Discard medicated drinking water if not used within 2 days.

Fresh stock solution should be prepared daily.2. If clinical signs of bloody scours (watery, mucoid or bloody

stools) have not improved during the first 6 days of medication, discontinue treatment and redetermine the diagnosis.

3. Occasionally, swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and /or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment.

4. Not for use in swine weighing more than 250 pounds.5. Do not allow rabbits, hamsters, guinea pigs, horses or ruminants

access to water containing lincomycin. Ingestion by these spe-cies may result in severe gastrointestinal effects.

6. Do not use the water treatment and the feed treatments simultaneously.

7. Not for use in layer and breeder chickens.WARNINGS:1. Do not slaughter swine for human consumption for 6 days

following last treatment.2. No drug withdrawal period is required before slaughter of

birds receiving Lincosol Soluble Powder at the approved level of 64 mg per gallon of drinking water.

3. Not for human use.

Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F)FOR ANIMAL USE ONLY.Restricted Drug — Use only as Directed (California)KEEP OUT OF REACH OF CHILDREN.Net Contents: NDC 40 g Packet 54925-037-0480 g Packet 54925-037-082 lb. Containers 54925-037-22

antibacterialOral Use in Swine and Broiler Chickens Only.


(Neomycin Oral Solution)Neosol•Oral


AVAILABLE IN 2 SIzES:1 Pint (473 mL) and 1 Gallon (3.785 L)FOR ORAL USE ONLY.

INDICATIONS: For the treatment and control of colibacillosis (bac-terial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep and goats.

For the control of mortality associated with Escherichia coli organ-isms susceptible to neomycin sulfate in growing turkeys.

DOSAGE AND ADMINISTRATION: Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg neomycin sulfate per pound of body weight in divided doses for a maximum of 14 days. Administer to turkeys at a dose rate of 10 mg neomycin sulfate per pound of body weight for 5 days.

DOSAGE SCHEDULE FOR TREATMENT OF COLIBACILLOSIS Pounds Amount of Neosol•Oral of Body Weight Solution Per Day in Divided Doses 25 lbs. 1.2 mL ( 1/4 teaspoonful) 50 lbs. 2.5 mL (1/2 teaspoonful) 100 lbs. 5.0 mL (1 teaspoonful) 300 lbs. 15 mL (1 tablespoonful) 591.5 lbs. 29.5 mL (1 fluid ounce)

Teaspoon = U.S. Standard MeasureNeosol•Oral Solution may be given undiluted or diluted with water.

Herd Treatment: Each 473 mL (1 Pint) will treat 9,464 pounds of body weight. Each 3.785 L (1 Gallon) will treat 75,700 pounds of body weight. Therefore estimate the total number of pounds of body weight of animals to be treated and administer 29.5 mL (1 fl. oz.) for each 591.5 lbs. The product should be added to the amount of drinking water estimated to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day.

Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix 5 mL (1 tsp.) in water or milk for each 100 lbs. of body weight. Administer daily either as a drench in divided dosages or in the drinking water to be consumed in 12-24 hours.

COMPOSITION: Each mL contains 200 mg of Neomycin Sulfate equivalent to 140 mg of neomycin base.

Precautions: To administer the stated dosage, the concentra-tion of neomycin required in medicated water must be adjusted to compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects water consumption.If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. If symptoms such as fever, depression or going off feed develop, oral neomycin is not indicated as the sole treatment since systemic levels of neomycin are not obtained due to poor absorption from the gastrointestinal tract.

Important: Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Animals not drinking or eating should be treated individually by drench.

RESIDUE WARNINGSDiscontinue treatment prior to slaughter as follows:

Turkeys – 0 dayCattle – 1 day Sheep – 2 daysSwine and Goats – 3 days

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Use of more than one product conta-ing neomycin or failure to follow withdrawal times may result in illegal drug residues.

Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F)FOR ANIMAL USE ONLY.Restricted Drug — Use only as Directed (California)KEEP OUT OF REACH OF CHILDREN.Net Contents: NDC 473 mL (pint) 54925-043-471 gallon 54925-043-11

antibacterial

25

(Neomycin Sulfate)Neosol Soluble Powder


AVAILABLE IN 2 SIzES:3.5 oz. (100g) Packet and 50 lb. (22.5 kg) Container

For Oral Use in Animals Only.Add to drinking water – Not for use in liquid supplements.

INDICATIONS: For the treatment and control of colibacillosis (bac-terial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep and goats.

Each 100 g packet contains: Neomycin Sulfate equivalent to 50 gm neomycin.

Contains per pound: Neomycin Sulfate equivalent to 227.5 gm neomycin.

DOSAGE AND ADMINISTRATION: Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg neomycin sulfate per pound of body weight in divided doses for a maximum of 14 days.

Herd Treatment: Each packet will treat 7,150 pounds of body weight. Therefore estimate the total number of pounds of body weight of animals to be treated and administer one (1) packet (or portion thereof) for each 7,150 pounds. The product should be added to the amount of drinking water estimated to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day.

Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1) level teaspoon in water or milk for each 160 pounds of body weight. Administer daily either as a drench in divided doses or in drinking water to be consumed in 12 - 24 hours.

Drinking Water: Swine – Use the number of packets indicated below in 256 gallons of water, or in two gallons of stock solution used in proportioner set to one ounce per gallon.

Pigs Body Weight Number of Neosol Packets 25 to 50 lbs. 2 packets 50 to 100 lbs. 3 packets Over 100 lbs. 4 packets

Caution: To administer the stated dosage, the concentration of neomycin required in medicated water must be adjusted to

antibacterial

WARNING:Discontinue treatment prior to slaughter as follows:

Cattle and Goats – 30 days Swine and Sheep – 20 days(Not to be used in veal calves)

Daily Schedule for Drinking Water:

SWINE One Tablespoon* of Neosol Soluble Powder added to water Weight of consumed in one day will treat each pig

50 pigs 10 pounds 20 pigs 25 pounds 10 pigs 50 pounds

CATTLE (Not to be used in veal calves) One Tablespoon* of Neosol Soluble Powder added to water or milk consumed in one Weight of day will treat each calf

10 calves 50 pounds 7 calves 75 pounds 4 calves 125 pounds

* Level Tablespoon = US Standard MeasureThe product should be added to the amount of drinking water estimated to be consumed in 12 - 24 hours. Provide medicated water as a sole source of water used each day until consumed, fol-lowed by non-medicated water as required. Fresh medicated water should be prepared each day. For a stock solution, add six level tablespoonfuls to one gallon water. Each pint of this stock solution will medicate 5 gallons of drinking water. For use in Automatic Proportioners delivering 2 ounces of stock solution per gallon of drinking water, dissolve 9 level tablespoonfuls in a gallon of water to make the stock solution.

KEEP CONTAINER TIGHTLY CLOSED.

Store in a dry place with controlled room temperature of 15˚ to 30˚C (59˚ to 86˚F). When storing partially used containers, securely close bags to prevent contents from caking.Restricted Drug — Use only as Directed (California)NOT FOR HUMAN USE.KEEP OUT OF REACH OF CHILDREN.Net Contents: NDC 3.5 oz. Packet 54925-036-3550 lb. Container 54925-036-50

compensate for variation in age and weight of animal, the nature and severity of disease signs, and environmental temperature and humidity, each of which affects water consumption. If symptoms persist after using this preparation for 2 or 3 days, consult a vet-erinarian. If symptoms such as fever, depression or going off feed develop, oral neomycin is not indicated as the sole treatment since systemic levels of neomycin are not obtained due to low absorption from the gastrointestinal tract.

Important: Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Animals not drinking or eating should be treated individually by drench.

26

(Brand of Sulfadimethoxine)Sulfasol Soluble Powder

CAUTION: Chickens and Turkeys – If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Cattle – During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, reevaluate diagnosis. Treatment should not be continued beyond 5 days.

WARNINGChickens and Turkeys – Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age.Cattle – Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in pre-ruminating calves.Do Not Use in Calves to be Processed for Veal.

Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F)Restricted Drug — Use only as Directed (California)NOT FOR HUMAN USE.KEEP OUT OF REACH OF CHILDREN.Net Contents: NDC 3.77 oz. Packet 54925-035-37

antibacterial

ANADA #200-238, Approved by FDA. Each packet contains: 3.34 oz. (94.6 g) sulfadimethoxine in the form of the soluble sodium salt and disodium edetate.

For Broiler and Replacement Chickens Only – Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.For Meat-producing Turkeys Only – Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.For Dairy Calves, Dairy Heifers, and Beef Cattle – Use for the treatment of shipping fever complex and bacterial pneumonia asso-ciated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.

DOSAGE AND ADMINISTRATION:

Species Concentration Use DirectionsChickens 0.05% Contents of packet to 50 gal. of waterTurkeys 0.025% Contents of packet to 100 gal. of waterAutomatic Proportioners: To make stock solution, add contents of 5 packets to two gallons of water for chickens and to four gallons of water for turkeys. Set proportioner to feed at a rate of 1 fl. oz. stock solution per gallon of water.Treatment Period: 6 consecutive days

DAIRY CALVES, DAIRY HEIFERS, AND BEEF CATTLEDosage: 25 mg/lb first day followed by 12.5 mg/lb/day for 4 days Sulfadimethoxine in Water Water Consumption Amount of (Summer)* (Winter)* Stock Solution 1 gal/100 lb 1 gal/150 lb for Cattle* body weight** body weight** 1 quart 10 gallons 7 gallonsFirst Day Add 2 quarts 20 gallons 14 gallons 1 gallon 40 gallons 28 gallons

1 quart 20 gallons 14 gallonsNext 4 Days Add 2 quarts 40 gallons 28 gallons 1 gallon 80 gallons 56 gallons

*Note: Make a cattle stock solution by adding one packet of Sulfadimethoxine Soluble Powder to 1 gallon of water.*Twenty fl. oz. of cattle stock solution will medicate 1-600 lb. animal initially or 2-600 lb. animals on maintenance dose. Contents of packet will medicate 6-600 lb. animals initially or 12-600 lb. animals on maintenance dose.**This dosage recommendation is based on a water consump-tion of 1 gallon per 100 lb. of body weight per day, the expected water consumption rate for summer. Water consumption during cold months (winter) may drop markedly (30%-40%). Accordingly, adjustments must be made in the dilution rates to compensate for this and insure proper drug intake.For treatment of individual cattle, Sulfadimethoxine Soluble Powder stock solution for cattle may be given as a drench.Treatment Period: 5 consecutive days

antibacterial

27

(Sulfadimethoxine)Sulforal

PROTECT FROM LIGHTStore at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) Restricted Drug — Use only as Directed (California)NOT FOR HUMAN USE.KEEP OUT OF REACH OF CHILDREN.

NDC 54925-034-11

WARNINGSChickens and Turkeys – Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age.Cattle – Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in pre-ruminating calves.Do Not Use in Calves to be Processed for Veal.

mg/lb/day. One fl oz will medicate one 150-lb initially and 1/2 fl oz will medicate one 150-lb on maintenance dose.

CAUTION: Store at room temperature; if freezing occurs, thaw before using. Protect from light; direct sunlight may cause discolor-ation. Freezing or discoloration does not affect potency. Prepare a fresh stock solution daily. Chickens and Turkeys – If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication.Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.Cattle – During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, reevaluate diagnosis. Treatment should not be continued beyond 5 days.

antibacterial

ANADA #200-251, Approved by FDA. 1 Gallon (3.8L) Sulforal Concentrated Solution 12.5%,3.75 g. sulfadimethoxine/fl.oz.Antibacterial for use in drinking waterFOR ORAL USE IN CHICKENS, TURKEYS, AND CATTLEBroiler and Replacement Chickens – Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.Meat-producing Turkeys – Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.Dairy Calves, Dairy Heifers, and Beef Cattle – Use for the treat-ment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

DOSAGE AND ADMINISTRATION: Chickens and TurkeysTreatment Period: 6 consecutive daysRecommended Concentration: Chickens – 0.05%; Turkeys – 0.025%Chickens Add 1 fl oz (30 mL) to 2 gallons of drinking water or 25 fl oz to 50 gallons of drinking water.Turkeys Add 1 fl oz (30 mL) to 4 gallons of drinking water or 25 fl oz to 100 gallons of drinking water.Automatic Proportioners* Stock Solution – To make 2 gallons of stock solution:Chickens Add 1 gallon of Sulforal Concentrated Solution 12.5% to 1 gallon of water.Turkeys Add 2 quarts of Sulforal Concentrated Solution 12.5% to 6 quarts of water.*Set proportioner to a feed rate of 1 fl. oz. of stock solution per gallon of water.

Dairy Calves, Dairy Heifers, and Beef CattleTreatment Period: 5 consecutive daysDosage: Initial dose of 25 mg/lb followed by four maintenance doses of 12.5 mg/lb/day.Summer Administration Dosage recommendations for summer are based on an estimated water intake of 1 gallon of water for every 100 lb of body weight per day.

Sulforal Concentrated Solution 12.5%Daily Drinking Water Supply Initial Dose Maintenance Dose 25 gallons 1 pt (16 fl oz) 1 cup (8 fl oz) 50 gallons 1 qt (32 fl oz) 1 pt (16 fl oz) 200 gallons 1 gal (128 fl oz) 2 qt (64 fl oz)

Winter Administration Dosage recommendations for winter are based on an estimated water intake of 1 gallon of water for every 150 lb of body weight per day.

Sulforal Concentrated Solution 12.5%Daily Drinking Water Supply Initial Dose Maintenance Dose 16 gallons 1 pt (16 fl oz) 1 cup (8 fl oz) 33 gallons 1 qt (32 fl oz) 1 pt (16 fl oz) 127 gallons 1 gal (128 fl oz) 2 qt (64 fl oz)

Individual Animal Treatment of Cattle: Sulforal Concentrated Solution 12.5% may be given as a drench. Administer using an initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5

28

(Tetracycline Hydrochloride Soluble Powder)

Tetrasol Soluble Powder


AVAILABLE IN 3 SIzES:5 oz (141.7 g) Packet – each packet containing 101.2 g of tetracycline hydrochloride.2 lbs. (907.2 g) and 5 lbs. (2.27 kg) Containers – each pound containing 324 g of tetracycline hydrochloride.

INDICATIONS: For use in the control and treatment of the following conditions in swine, calves and poultry.

SWINE AND CALVESINDICATIONS: Control and treatment of bacterial enteritis (scours) caused by Escherichia coli; bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp. and Klebsiella spp. sensitive to tetracycline hydrochloride.

RECOMMENDED DOSAGE LEVEL: Use soluble powder in the drinking water at a drug level of tetracycline hydrochloride per gal-lon to provide 10 mg/lb of body weight per day in divided doses.

DIRECTIONS FOR USE: Administer for 7-14 days. Medicate at first clinical signs of disease or when experience indicates the disease may be a problem.

GENERAL CAUTION: Prepare fresh solutions at least once a day. Solutions are not stable for more than 24 hours. Use as a sole source of tetracycline. Diagnosis should be reconsidered if improvement is not noticed within 3 days. The concentration of drug required in

DIRECTIONS FOR USE: Administer for 3-5 days.

CHICKENSINDICATIONS: Control of chronic respiratory disease (CRD) and air sac disease caused by Mycoplasma gallisepticum and Escherichia coli; infectious synovitis caused by Mycoplasma synoviae sensitive to tetracycline hydrochloride.

RECOMMENDED DOSAGE LEVEL: CRD and air sac disease: Use soluble powder in the drinking water at a drug level of 400-800 mg tetracycline hydrochloride per gallon. Infectious synovitis: Use soluble powder in the drinking water at a drug level of 200-400 mg tetracycline hydrochloride per gallon.

TURKEYS

WARNINGDo not slaughter birds for food within 4 days of treatment.CAUTION: Not for use in turkeys or chickens producing eggs for human consumption.Do not use for more than 14 consecutive days.

WARNINGSWINE – Do not slaughter animals for food purposes within 4 days of treatment.CALVES – Do not slaughter animals for food purposes within 5 days of treatment. A withdrawal period has not been estab-lished for this product in pre-ruminating calves.Do Not Use in Calves to be Processed for Veal.CAUTION: Do Not Use for more than 5 consecutive days.

antibacterial

INDICATIONS: Control of infectious synovitis caused by Mycoplasma synoviae; bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organ-isms sensitive to tetracycline hydrochloride.

RECOMMENDED DOSAGE LEVEL: Infectious sy-novitis: Use soluble powder in the drinking water at a drug level of 400 mg tetracycline hydrochloride per gallon. Bluecomb: Use soluble powder in the drinking water at a drug level of tetracycline hydrochloride per gallon to provide 25 mg/lb of body weight per day in divided doses.

29

T E T R A S O L ( C O N T . )

medicated water must be adequate to compensate for variations in the age and class of animals, feed consumption, and environmental temperature and humidity, each of which affects water consumption.

MIXING DIRECTIONSFOR SWINE, CALVES AND TURKEYS: Using 5 oz. Packet: 5 oz. dissolved in 1000 mL (approximately 34 fl. oz.) of warm water will provide a stock solution of 100 mg of tetracycline hydrochloride activity per mL. Using 2 lb. or 5 lb. Container: 2.52 oz. (two scoops) dissolved in 500 mL (approx. 17 fl. oz.) of warm water will provide a stock solu-tion of 100 mg of tetracycline hydrochloride activity per mL. FOR TURKEYS ONLY: This stock solution when metered at approxi-mately 1 oz. per gallon, will provide drinking water containing 2,957 mg of tetracycline hydrochloride activity per gallon. Using 5 oz. Packet: contents of packet are sufficient to deliver the recommended daily dosage levels as follows:

At 25 mg/lb of body weight – 4,048 total lbs of turkeys to be medicated.At 10 mg/lb of body weight – 10,120 total lbs of swine or calves to be medicated.Individual calf treatment – 5 mL (1 measuring teaspoonful) twice daily for each 100 lbs. of body weight administered as a drench or by dose syringe.

Using 2 lb. or 5 lb. Container: The contents of two scoops are sufficient to deliver the recommended daily dosage levels as follows:

At 25 mg/lb of body weight – 2,040 total lbs. of turkeys to be medicated.At 10 mg/lb of body weight – 5,100 total lbs. of swine or calves to be medicated.Individual calf treatment – 5 mL (1 measuring teaspoonful) twice daily for each 100 lbs. of body weight administered as a drench or by dose syringe.

FOR CHICKENS AND TURKEYS:Using 5 oz. Packet: To arrive at the recommended dosages, prepare stock solutions as follows:

200 mg/gallon – dissolve 1 packet (5 oz.) in 15,140 mL warm water (4 gallons)400 mg/gallon – dissolve 1 packet (5 oz.) in 7,570 mL warm water (2 gallon)800 mg/gallon – dissolve 1 packet (5 oz.) in 3,785 mL warm water (1 gallon)

These stock solutions should then be metered into drinking water at approximately 1 oz. per gallon. At 200-800 mg/gallon this packet will provide 126.5 to 506 gallons of medicated drinking water.Using 2 lb. or 5 lb. Container: To arrive at the recommended dosages, use contents of two scoops to prepare stock solutions as follows:

200 mg/gallon – dissolve 2 scoops (2.52 oz.) in 7,570 mL warm water (2 gallons)400 mg/gallon – dissolve 2 scoops (2.52 oz.) in 3,785 mL warm water (1 gallon)800 mg/gallon – dissolve 2 scoops (2.52 oz.) in 1,892 mL warm water (0.5 gallon)

These stock solutions should then be metered into drinking water at approximately 1 oz. per gallon. At 200-800 mg/gallon two scoops will provide 63.8 to 255 gallons of medicated drinking water.

SPECIAL DIRECTIONS FOR BABY CALVES AND BABY PIGS: Administer this product one hour before or two hours after feeding milk or milk replacers. Provide clean (unmedicated) drinking water at all times.

NOTE: When using a watering trough, this product is to be adminis-tered twice a day in the drinking water of swine, calves and poultry. One-half of the recommended daily dosage level of antibiotic is to be consumed during each administration period, thus providing the drug in divided doses.The contents of 2 lb. container will provide sufficient drug to treat 64,800 total pounds of swine or calves for a single day at the

recommended dosage level of 10 mg/lb of body weight in divided doses. Or the contents of this container will treat 25,920 lbs. of turkeys when supplied at 25 mg/lb or at 200-800 mg/gallon will provide 810 to 3,240 gallons of medicated drinking water for chickens or turkeys.The contents of 5 lb. container will provide sufficient drug to treat 162,000 total pounds of swine or calves for a single day at the recommended dosage level of 10 mg/lb of body weight in divided doses. Or the contents of this container will treat 64,800 lbs. of turkeys when supplied at 25 mg/lb or at 200-800 mg/gallon will provide 2,025 to 8,100 gallons of medicated drinking water for chickens or turkeys.Restricted Drug — Use only as Directed (California)FOR USE IN ANIMALS ONLY.KEEP OUT OF REACH OF CHILDREN.Net Contents: NDC 5 oz. Packet 54925-033-052 lb. Container 54925-033-025 lb. Container 54925-033-50


Emollient, AntisepticUdder Balm

Massage thoroughly and allow ointment to remain for full antiseptic and softening

effect on the udder.

ACTIVE INGREDIENT: 8 Hydroxyquinoline sulfate 0.3% in a petroleum, lanolin base.

INDICATIONS: For chapped teats, superficial scratches, abrasions, wind burn and sunburn.

DIRECTIONS: Apply Udder Balm thoroughly and allow a coating to remain on the surface. Wash af-fected udder and teats thoroughly before and after each milking to avoid contamination of milk. Dry with a clean cloth.

WARNING: This protective ointment helps to keep superficial tissue soft. If rash or irritation develops, discontinue use and consult veterinarian.


VETERINARY USE ONLY.

NET WEIGHT: NDC12 oz. 54925-057-124.5 lbs. (2.045 kg) 54925-057-45Revised October 2008

antiseptic

31

nutritional supplements

Dextrose Oral SolutionC-M-P-K

INDICATIONS: For use as a supplemental nutritive source of calcium, phosphorus, magnesium, potas-sium and dextrose in cattle.

DOSAGE AND ADMINISTRATION: Administer orally as a drench. The usual dose for adult cattle is 500 mL.

Each 500 mL contains: Calcium chemically equivalent to complex calcium borogluconate ................. 26%Dextrose .................................................... 15%Phosphorus ............................................... 6.0 g. (as sodium hypophosphite, H2O)Magnesium ..............................................2.76 g. (as magnesium chloride hexahydrate)Potassium ..............................................0.525 g. (as potassium chloride)Benzyl alcohol ............................................ 1.5%In a suitable base.

FOR VETERINARY USE ONLY.

USE ENTIRE CONTENTS.

Store at room temperature.

Net Contents: 500 mL

NDC 54925-066-50

Dietary Supplementfor Calves

Pect Plus

INGRDIENTS: PsylliumDextrose MonohydrateDried Apple PulpDried Potato Pulp

FEEDING DIRECTION: Mix about 50 gram Pect Plus into 2 liters of calf milk replacer or lukewarm water. Feed by teated bucket or by open pail twice a day.


USE ONLY AS DIRECTED.

Net Weight: 11 lbs.

NDC 54925-011-12

32

nutritional supplement

Nutritional Supplement for Young CalvesCONVEY ®

CONVEY ® provides supplemental electrolytes, dextrose and fluids when mixed with water and fed to calves.

CONTENTS: Psyllium Seed Husks, Dextrose Mono-hydrate, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Potassium Chloride, Citric Acid, Magnesium Hydroxide, FD&C Red No. 40–Alumi-num Lake.

FOR VETERINARY USE ONLY

DIRECTIONS: After mixing with water, feed CONVEY to young calves requiring supplemental electrolytes, dextrose and fluids. CONVEY is a short term supplement in place of usual diet. Since CONVEY™ is not a complete nutrition source, its use should not exceed the recommended feeding schedule.

GENERAL GUIDELINES: Feed CONVEY imme-diately after thorough mixing as the liquid may become too thick to be ingested by calves. To avoid absorption of moisture and caking, seal the CON-VEY bag and replace the bucket lid immediately after use. The 3rd feeding can be omitted if desired and 4th feeding used in its place, followed in 12 hours by usual diet.


Net Contents: 9.7 lbs. (4.4 kg)

NDC 54925-005-19

33


For Nutritional Supplement in Calves

Vet-o-lyte®

Contains: Dextrose anhydrous, sodium bicarbon-ate, sodium chloride, potassium chloride, magne-sium sulfate anhydrous.

FOR VETERINARY USE ONLYEach 80 grams of Vet-o-lyte provides: sodium, 134.0 mEq; potassium, 22.8 mEq; magnesium, 6.6 mEq; bicarbonate, 81.0 mEq; chloride, 75.8 mEq; dextrose, 68 grams.

Directions For Use: Preparation of Solution-Dissolve 80 grams (2 scoops) Vet-o-lyte in water and dissolve 240 grams (6 scoops) of Vet-o-lyte in water and dilute to a total volume of 3 quarts.

Dosage and Administration: Administer the solution by feeding or drench at a rate of 1 quart per 60 pounds of bodyweight 3-4 times daily for 2 days as the only source of oral fluids. The following 2 days the solution should be diluted 1:1 with milk replacer and given at feeding time.

Caution: Avoid exposure to excessive heat. Keep container tightly closed. Store in a dry place.

NOT FOR HUMAN USE.


Net Contents: 10 lbs.

NDC 54925-004-09

For Nutritional Supplement in Calves

Nutri LytePowder +

Ingredients: Dextrose, Salt, Potassium Chloride, Glycine, Citric Acid, Sodium Bicarbonate, Ascorbic Acid, Monosodium Phosphate, Magnesium Sulfate, Manganese Sulfate, Zinc Sulfate, Copper Sulfate, Vitamin A Acetate, Calcium Pantothenate, Xanthan Gum, Artificial color and flavor.

Directions: Mix 2 oz. in 2 quarts of clean water or 1 lb. in 4 gallons.

Caution: To prevent lumping keep the lid tightly closed. Store in cool place.

Net Contents: 25 lbs.

NDC 54925-008-25

Revised October 2008

34

medicated supplement

MED-PHARMEX’SCalf Energy Formula

Medicated

Type C Medicated Feed

For oral treatment and prevention of Bacterial Enteritis (Scours) in calves. Contains antibiot-ics, vitamins, and electrolytes with dextrose.INGREDIENTS: Dextrose, Whey, Magnesium Carbonate, Potassium Chloride, Salt, Choline Chlo-ride, Calcium Lactate, Niacin, Riboflavin, Vitamin B12 Supplement, Vitamin A Acetate, Vitamin D3, Calcium Pentothenate, Psyllium.ACTIVE DRUG INGREDIENTS: Oxytetracycline (from Quaternary Salt) equivalent toOxytetracycline HCI ................................. 3.0 g/lbNeomycin Sulfate .................................... 6.0 g/lbGUARANTEED ANALYSIS PER POUND:Crude Protein (minimum) ........................... 3.0 %Crude Fat (minimum) ................................. 0.1 %Crude Fiber (minimum) .............................. 1.0 %Vitamin A ................................800,000 USP unitsVitamin D3 ..............................200,000 USP unitsCholine Chloride ...................................5,000 mgVitamin B12 .............................................2.0 mgRiboflavin ................................................200 mgNiacin ..................................................2,000 mgCalcium Pentothenate ............................0.2174 gMagnesium Carbonate................................. 5.0 gPotassium Chloride ..................................... 6.0 gCalcium Lactate .......................................... 5.0 gSodium Chloride ....................................... 10.0 gRestricted Drug: Use only as directed.

FEEDING DIRECTIONS: Prevention: As an aid in the prevention of bacte-rial enteritis (scours) 1/2 ounce (approximately 1 tablespoon) per gallon of reconstituted milk or warm water.Treatment: One (1) ounce (approximately 2 tablespoons) per gallon of reconstituted milk or warm water.

Net Contents: 40 lbs. (18.15 kg)NDC 54925-039-40

WARNINGDo not slaughter treated animals to be used for food within 30 days following the last use of this product. Exceeding the highest recom-mended dosage level may result in antibiotic residues in edible portions of the animals be-yond the withdrawal time as stated.

35

MED-PHARMEX’SRED RIBBON

Nutritional Supplement in Calves


INGREDIENTS: Glucose, sodium bicarbonate, gly-cine, potassium chloride, sodium chloride, calcium hydroxide, magnesium sulfate, citric acid, ascorbic acid, and artificial coloring (FD & C Red no. 40).

EACH Oz. CONTAINS: Calcium, (Ca) maximum ............................ 0.30%Sodium, (Na) minimum ............................. 5.60%Potassium, (K) minimum ........................... 0.30%Calcium, (Ca) minimum ............................. 0.10%Magnesium, (Mg) minimum ........................ 0.05%

MIX AND FEED INSTRUCTIONS: Mix 2 scoops RED RIBBON with 2 qts. of 100°-110° F. water. Withdraw all milk products and free choice water. Discard any solution not consumed in 12 hours. Use in conjunction with appropri-ate scours treatment. For large quantities, mix 4 scoops per each gallon of water.

Store in cool, dry place.

Net Contents: 25 lbs. (11.36 Kg)

NDC 54925-022-25

DAY 1 DAY 2 DAY 3 DAY 4 DAY 5

2 qts. RED RIBBON 2 qts. RED RIBBON Mix 2 oz. Milk Replacer Mix Replacer 2 X Daily 1 qt. Milk Replacer into Milk Replacer 2 X Daily

2 qts. RED RIBBON 2 qts. RED RIBBON 2 qts. RED RIBBON Milk Replacer Milk Replacer 3 X Daily 2 X Daily + 1 qt. Milk Replacer 3rd Feeding 2 X Daily

2 qts. RED BIBBON 2 qts. RED RIBBON 2 qts. RED RIBBON 2 qts. RED RIBBON Milk Replacer 4 X Daily 3 X Daily 3 X Daily + 1 qt. Milk Replacer 4th Feeding 3rd Feeding 3rd Feeding 2 X Daily essential essential essential

36

anti-diarrheal

Anti-Diarrheal Liquid

KAO-PECTIN

COMPOSITION: Each fluid ounce contains:Kaolin (Colloidal) . . . . . . . . . . . . . . . . . . . . . . . . . . 19.44%Pectin (Citrus) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.44%in a palatable vehicle.

FOR VETERINARY USE ONLY

NOT FOR HUMAN USE

INDICATIONS: For oral administration as an aid in the treatment of non-infectious diarrhea in horses, cattle, dogs and cats.

SHAKE WELL BEFORE USE.

ADMINISTRATION: OralDOSAGE: May be repeated until condition improves.Horses, Cattle: 6 to 10 ounces every 2 to 3 hours.Colts, Calves: 3 to 4 ounces every 2 to 3 hours.Dogs, Cats: 1 to 3 tablespoons every 1 to 3 hours.

WARNING: If symptoms persist after using this product for 2 or 3 days, consult a veterinarian.


KEEP FROM FREEzING

Net Contents: One Gallon (3.785 L)

NDC 54925-006-11Revised April 2008

BismuthSuspension

Anti-Diarrheal LiquidFOR VETERINARY USE ONLYA palatable oral solution for use as an aid in the control of non-specific diarrhea.

USE ONLY AS DIRECTED CONTAINS: Bismuth Subsalicylate . . . . . . . . . . . . . . . . . . . . . . .1 .75%

SHAKE WELL BEFORE USE.

ADMINISTRATION: OralDOSAGE: May be repeated until condition improves.Horses, Cattle: 6 to 10 ounces every 2 to 3 hours.Foals, Calves: 3 to 4 ounces every 2 to 3 hours.Dogs, Cats: 1 to 3 tablespoons every 1 to 3 hours.

WARNING: If symptoms persist after using this product for 2 or 3 days, consult a veterinarian.


KEEP FROM FREEzING

Store at room temperature between 15˚ to 30˚C (59˚ to 86˚F)

Net Contents: One Gallon (3.785 L)

NDC 54925-014-11Revised June 2008

37

notes

2727 Thompson Creek Road • Pomona, CA 91767phone 909.593.7875 • 800.587.4306

fax 909.593.7862 • 800.210.6419www.medpharmex.com

product catalog - animal health international - home · 2019. 3. 13. · nada #140-810, approved by...

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