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Today’s Valuable Cattle Deserve theToughest BRD Treatment Possible

*As reported by independent diagnostic laboratories data on file

Do not use in female dairy cattle 20 months of age or older because use in lactatingdairy cattle may cause milk residues. Not for use in cattle of breeding age. Do not ufor calves to be processed for veal. Please see Product Information Summary for FuProduct Information.

H E A D S U P T H E R A P Y

With the market where it is, this is no time to take risks. Protect the value of your calves with a sure thing: Nuflor

®

. Nuflor delivers long-acting, broad-spectrumcontrol in the sick pen or off the truck with an exceptionally high degree of bacterialsensitivity.* Only Nuflor offers this unique combination:

1 dose Sub-cutaneous

2 approved uses for BRD (high risk cattle or treatment)3 major bacterial causes of pneumonia4 full days of therapy

Don’t take risks with your valuable calves. Be sure with Nuflor. Nothing treats bovine respiratory disease quite like it.

See your veterinarian for more information.

www.nuflor.com www.mycattle.com

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F-24823113 PRODUCTNADA #141-063, Approved by FDA. INFORMATION

Injectable Solution 300 mg/mLFor Intramuscular and Subcutaneous Use inCattle Only.

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

DESCRIPTION: NUFLOR Injectable is a solutionof the synthetic antibiotic florfenicol. Each milliliterof sterile NUFLOR Injectable Solution contains300 mg of florfenicol, 250 mg n-methyl-2-pyrrolidone, 150 mg propylene glycol, andpolyethylene glycol q.s.

CLINICAL PHARMACOLOGY: The pharmacokineticdisposition of NUFLOR Injectable Solution wasevaluated in feeder calves following singleintramuscular administration at the recommendeddose of 20 mg/kg. NUFLOR Injectable Solution wasalso administered intravenously to the same cattlein order to calculate the volume of distribution,clearance, and percent bioavailability1 (Table 1).

TABLE 1. Pharmacokinetic Parameter Values forFlorfenicol Following IM Administration of 20 mg/kg

Body Weight to Feeder Calves (n=10).

Florfenicol was detectable in the serum of mostanimals through 60 hours after intramuscularadministration with a mean concentration of0.19 µ g/mL. The protein binding of florfenicolwas 12.7%, 13.2%, and 18.3% at serum concen- trations of 0.5, 3.0, and 16.0 µ g/mL, respectively.

MICROBIOLOGY: Florfenicol is a synthetic,broad-spectrum antibiotic active against manygram-negative and gram-positive bacteriaisolated from domestic animals. It is primarilybacteriostatic and acts by binding to the 50Sribosomal subunit and inhibiting bacterialprotein synthesis. In vitro and in vivo activity hasbeen demonstrated against commonly isolatedbacterial pathogens involved in bovine respiratorydisease (BRD) including Pasteurella haemolytica,Pasteurella multocida, and Haemophilus somnus,as well as against commonly isolated bacterialpathogens involved in bovine interdigital phlegmonincluding Fusobacterium necrophorum  andBacteroides melaninogenicus .

The minimum inhibitory concentrations (MICs)of florfenicol for BRD organisms were deter-

mined using isolates obtained from naturalinfections from 1990 to 1993. The MICs for inter-digital phlegmon organisms were determinedusing isolates obtained from natural infectionsfrom 1973 to 1997 (Table 2).

TABLE 2. MIC Values* of Florfenicol AgainstBacterial Isolates From Natural Infection of Cattle.

INDICATIONS: NUFLOR Injectable Solution is indi-cated for treatment of bovine respiratory disease(BRD) associated with Pasteurella haemolytica,Pasteurella multocida, and Haemophilus somnus ,and for the treatment of bovine interdigital phleg-mon (foot rot, acute interdigital necrobacillosis,infectious pododermatitis) associated withFusobacterium necrophorum and Bacteroides melaninogenicus . Also, it is indicated for thecontrol of respiratory disease in cattle at highrisk of developing BRD associated with

Pasteurella haemolytica, Pasteurella multocida,and Haemophilus somnus.

RESIDUE WARNINGS: Animals intendedfor human consumption must not beslaughtered within 28 days of the lastintramuscular treatment. Animals intend-ed for human consumption must not beslaughtered within 38 days of subcuta-neous treatment. Do not use in femaledairy cattle 20 months of age or older. Useof florfenicol in this class of cattle maycause milk residues. A withdrawal periodhas not been established in preruminatingcalves. Do not use in calves to be processedfor veal.

  WARNINGS: NOT FOR HUMAN USE. KEEP OUTOF REACH OF CHILDREN. This product containsmaterials that can be irritating to skin and eyes.Avoid direct contact with skin, eyes, and clothing.In case of accidental eye exposure, flush withwater for 15 minutes. In case of accidental skinexposure, wash with soap and water. Removecontaminated clothing. Consult a physician ifirritation persists. Accidental injection of thisproduct may cause local irritation. Consult aphysician immediately. The Material SafetyData Sheet (MSDS) contains more detailedoccupational safety information.

For customer service, adverse effects reporting,and/or a copy of the MSDS, call 1-800-211-3573.

CAUTION: Not for use in cattle of breeding age.

The effects of florfenicol on bovine reproductiveperformance, pregnancy, and lactation have notbeen determined. Intramuscular injection mayresult in local tissue reaction that persistsbeyond 28 days. This may result in trim loss ofedible tissue at slaughter. Tissue reaction atinjection sites other than the neck is likely to bemore severe.

ADVERSE EFFECTS: Inappetence, decreasedwater consumption, or diarrhea may occur transiently following treatment.

TOXICOLOGY: A 10X safety study was con-ducted in feeder calves. Two intramuscularinjections of 200 mg/kg were administered at a48-hour interval. The calves were monitored for14 days after the second dose. Marked anorexia,decreased water consumption, decreased body

weight, and increased serum enzymes wereobserved following dose administration. Theseeffects resolved by the end of the study.

A 1X, 3X, and 5X (20, 60, and 100 mg/kg) safetystudy was conducted in feeder calves for 3X theduration of treatment (6 injections at 48-hourintervals). Slight decrease in feed and waterconsumption was observed in the 1X dosegroup. Decreased feed and water consumption,body weight, urine pH, and increased serumenzymes were observed in the 3X and 5X dosegroups. Depression, soft stool consistency, anddehydration were also observed in some animals(most frequently at the 3X and 5X dose levels),primarily near the end of dosing.

A 43-day controlled study was conducted inhealthy cattle to evaluate effects of NUFLORInjectable Solution administered at the recom-mended dose on feed consumption. Although a  transient decrease in feed consumption wasobserved, NUFLOR Injectable Solution adminis-  tration had no long-term effect on body weight,rate of gain, or feed consumption.

DOSAGE AND ADMINISTRATION: For treatmentof bovine respiratory disease (BRD) and bovine

interdigital phlegmon (foot rot): NUFLOR InjectableSolution should be administered by intramuscularinjection to cattle at a dose rate of 20 mg/kg bodyweight (3 mL/100 lbs). A second dose should beadministered 48 hours later. Alternatively, NUFLORInjectable Solution can be administered by a sin-gle subcutaneous injection to cattle at a dose rateof 40 mg/kg body weight (6mL/100 lbs). Do notadminister more than 10 mL at each site. Theinjection should be given only in the neck.

NOTE: Intramuscular injection may result in local  tissue reaction that persists beyond 28 days.This may result in trim loss of edible tissue atslaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

For control of respiratory disease in cattle athigh-risk of developing BRD: NUFLOR InjectableSolution should be administered by a singlesubcutaneous injection to cattle at a dose rateof 40 mg/kg body weight (6 mL/100 lbs). Do notadminister more than 10 mL at each site. Theinjection should be given only in the neck.

Clinical improvement should be evident in most  treated subjects within 24 hours of initiation of  treatment. If a positive response is not notedwithin 72 hours of initiation of treatment, thediagnosis should be reevaluated.

STORAGE CONDITIONS: Store between 2°-30°C (36°-86°F). Refrigeration is not required. The solution is lightyellow to straw colored. Color does not affect potency.

HOW SUPPLIED: NUFLOR Injectable Solution ispackaged in 100 mL (NDC 0061-1116-04), 250 mL(NDC 0061-1116-05), and 500 mL (NDC 0061-1116-06) glass sterile multiple-dose vials.

REFERENCE: 1. Lobell RD, Varma KJ, et al.Pharmacokinetics of florfenicol following intra-venous and intramuscular doses to cattle.

J Vet Pharmacol Therap. 1994; 17:253-258.Made in Germany

Copyright © 1996, 1998, 1999,Schering-Plough Animal Health Corp.,

Union, NJ 07083

All rights reserved.

B-24B23113 Rev. 12/01 US 3025/1

TAKE TIME

(FLORFENICOL)

ParameterCMAX (µ g/mL)TMAX (hr)T 1/2, (hr)AUC (µ g•min/mL)Bioavailability (%)Vdss (L/kg)***Cl t (mL/min/kg)***

Median3.07*3.33

18.3**4242

78.50.773.75

Range1.43 - 5.600.75 - 8.008.30 - 44.0

3200 - 625059.3 - 1060.68 - 0.853.17 - 4.31

* harmonic mean

** mean value

*** following I.V. administration

CMAXMaximumserumconcentration

TMAXTimeatwhichCMAX isobserved

T 1 /2 Biological half-life

AUC Area under the curve

Vdss Volumeofdistributionatsteadystate

Cl t Total body clearance

RecommendedInjection Location

NUFLOR DOSAGE GUIDE

Do not injectmore than10 mL perinjection site

ANIMALWEIGHT

(lbs)

100200300400500600700800900

1000

IM NUFLORDOSAGE

3.0 mL/100 lbBody Weight

(mL)

3.06.09.0

12.015.018.021.024.027.030.0

SC NUFLORDOSAGE

6.0 mL/100 lbBody Weight

(mL)

6.012.018.024.030.036.042.048.054.060.0

Organism Isolate Numbers MIC50** (µ g/mL) MIC90** (µ g/mL)

Pasteurella haemolytica 398 0.50 1.00

Pasteurella multocida 350 0.50 0.50

Haemophilus somnus  66 0.25 0.50

Fusobacterium necrophorum  33 0.25 0.25

Bacteroides melaninogenicus  20 0.25 0.25

*The correlation between the in vitro susceptibility data (MIC values)and clinical response has not been determined.

**The minimum inhibitory concentration for 50% and 90% of the isolates.