SOLUTION FOR INJECTION FOR CATTLE AND PIGS

Emdocam® 20mg/ml injection. Presentation: A clear yellow solution for injection containing 20mg/ml meloxicam and 150mg/ml ethanol (as preservative). Indications. Cattle: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. Pigs: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy. Dosage and administration. Cattle: Single subcutaneous or intravenous injection at a dosage of 0.5mg meloxicam/kg body weight (i.e. 2.5ml/100kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. Pigs: Single intramuscular injection at a dosage of 0.4mg meloxicam/kg body weight (i.e. 2.0ml/100kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours. Contra-indications: Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substance or to any of the excipients. For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age. Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents. Adverse reactions: In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies. In very rare cases anaphylactoid reactions may occur and should be treated symptomatically. Special warnings: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity. Overdose: In case of overdose, symptomatic treatment should be initiated. Withdrawal periods: Cattle: meat and offal: 15 days; milk: 5 days. Pigs: meat and offal: 5 days. User warnings: Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal Anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Pharmaceutical precautions: Keep out of the reach and sight of children. This veterinary medicinal product does not require any special storage conditions. Shelf-life after first opening the container: 28 days. Do not use after the expiry date stated on the carton and vial after EXP. Avoid introduction of contamination during use. Do not broach the vial more than 50 times. Disposal: Any unused medicines or waste materials should not be disposed of via waste water or household waste but in accordance with local requirements. These measures should help to protect the environment. Keep the container in the outer carton. Marketing authorisation numbers: EU/2/11/128/001, EU/2/11/128/002. Legal category: UK: POM-V . IE: POM. Prescription Only Medicine.

Further information is available from: ® Registered trademark of EMDOKA bvba, Belgium.

1. Salamon E. et al., Effects of meloxicam on thromboxane levels in calves with experimentally induced endotoxaemia. Cattle Practice (2000) 8, 1. 2. Friton G. et al., Clinical efficacy of meloxicam (Metacam®) in lactating cows with acute mastitis. Proc. XX11 World Buiatrics Congress (2002) 427-259. 3. Friton G.M. et al., Long-term effects of meloxicam in the treatment of respiratory disease in fattening cattle. Veterinary Record (2005) 156, 809-811. 4. Bardella I. et al., Effects in treatment of respiratory diseases of calves with a non-steroidal anti-inflammatory drug (NSAID). Proc. XX11 World Buiatrics Congress (2002) 140-189.5. Schmidt H. et al., Effekte der zusatzlichen Gabe von Metacam® (meloxicam) auf den Krankheitsverlauf bei Rindern mit akuten Atemwegserkrankungen. Praktischer Tierarzt (2000) 81:3, 240-244. 6. McDougall S. et al., Effect of treatment with the non-steroidal anti-inflammatory meloxicam on milk production, somatic cell count, probability of re-treatment and culling of dairy cows with mild clinical mastitis. J. Dairy Science (2009) 92: 4421-4431. 7. Todd D.R. et al., An evaluation of meloxicam (Metacam®) as an adjunctive therapy for calves with neonatal calf diarrhoea complex (2007) J. Animal Sci; 85, (Suppl 1): 369.

• Improved efficacy used adjunctively.

• Analgesic, anti-inflammatory, anti-endotoxic and anti-pyretic.

• Long-acting - up to 3 days.

• Low volume dose: 2.5ml/100kg in cattle IV or SC, 2.0ml/100kg in pigs IM.

• A high quality product from Animalcare.

• Cost effective.

Withdrawal: Cattle: meat and offal: 15 days; milk: 5 days. Pigs: meat and offal: 5 days.

Use medicines responsibly (www.noah.co.uk/responsible/index.htm).

Emdocam® 20mg/ml Solution for Injection

Size 50ml 100ml

Product code XVD220 XVD222

Also licensed in horses - see datasheet.

Choose Emdocam® for pigs

Indications include:

•Non-infectious locomotive disorders.

•Adjunctive therapy with an antibiotic in puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).

Single intramuscular (IM) injection

0.4mg/kg - 2.0ml/100kg bodyweight

Can repeat dose after 24 hours

Choose Emdocam® for Calf Scour

Double blinded, controlled study 7

Meloxicam, administered as a single SC injection (0.5mg/kg bw) improved the outcome and reduced morbidity in 28 neonatal calves with non-specific diarrhoea compared with 28 given a placebo solution. All were given electrolytes.

NSAIDs as asupportive therapy:

• Can improve calf well-being.

• Reduce morbidity and improve outcome.

Common sign in neonatal dairy calves:

•Multifactorial disease involving management and infective factors.

•Often complicated by signs of systemic disease such as fever, inappetance and lethargy.

OUTCOME: Meloxicam improved daily feed and water intake, aided greater average bodyweight gain and helped calves wean earlier.

II/EMD/09/11/1

Animalcare Ltd Common Road Dunnington York YO19 5RU UK

t: +44 (0) 1904 487687 f: +44 (0) 1904 487611

e: office@animalcare.co.uk i: (UK) www.animalcare.co.uk (Ireland:) www.animalcare.ie

LONG-ACTING NSAID TREATMENT THAT...

meloxicam

emdocam®

WHY CHOOSE EMDOCAM®?

meloxicam

emdocam®

...MAKES YOUR MONEY RUN FURTHER

Meloxicam-proven efficacy

•A non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. – Disrupts the inflammatory cascade by inhibiting prostaglandin synthesis. – Analgesic and anti-inflammatory effects.

• A potent and preferential inhibitor of COX-2. – COX-1 sparing.

• Meloxicam is tried and trusted and is one of the most widely used NSAIDs in animals in Europe.

Choose Emdocam® (meloxicam 20mg/ml)

Cattle: Single intravenous (IV)or subcutaneous (SC) injection

0.5mg/kg - 2.5ml/100kg bodyweight

Long-acting - from a single administration

•Anti-endotoxic, anti-pyretic and anti-inflammatory.

For up to 3 days.1,2

PROVENEFFICACY

AFFORDABLEPRICE

Low volume dose

Choose Emdocam® for BRD

On the farm

Long-term, blinded, controlled field study 3

200 fattening cattle with clinical signs of BRD and rectal temperature 40OC were randomly divided into 2 equal groups. One group received meloxicam administered as a single SC injection (0.5mg/kg bw) plus an antibiotic, the other the same antibiotic (plus isotonic saline).

Leading to areduced daily

liveweight gain.

Bovine Respiratory Disease(BRD) can cause:

• A marked inflammatory response.

• An increase in rectal temperature (pyrexia > 39.5OC).

• Permanent lung damage.

Leading to an improved clinical efficacy and daily liveweight gain compared to antibiotics alone -e.g. oxytetracycline,3 florfenicol 4

and tilmicosin.5

Early use of meloxicam in conjunction with antibiotics:

• Reduces lung consolidation.

• Reduces pyrexia and pain, especially in young calves.

• Improves feed intake and calf demeanour.

IMPROVEDLIVEWEIGHT

GAIN INCATTLE

OUTCOME: Meloxicam plus an antibiotic significantly reduced theextent of lung lesions, improved mean liveweight gain and carcaseweight in comparison with animals treated with an antibiotic alone.

Choose Emdocam® for Clinical Mastitis

On the farm

Large scale, double blinded study 6

Controlled trial in New Zealand incows with farmer diagnosed, mild clinical mastitis, in 15 herds duringthe first 200 days of lactation.

361 cows received a single 250mg SC injection of meloxicam, 366 were injected with a control vehicle. Allwere treated with an antibiotic.

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7 14 21Days after treatment

Impact of meloxicam on Somatic Cell CountMean SCC/ml post treatment. meloxicam vs control

Geo

met

ric m

ean

SCC

/ml (

x100

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MOREEFFECTIVE

THAN USINGANTIBIOTICS

ALONE

Anti-inflammatory treatment will:

•Relieve local and systemic inflammation.

• Return the udder to a normal condition.

• Reduce the PMN response.

Bovine mastitis triggers:

•Immune response of varying degrees.

•An influx of white cells, predominantly polymorphonuclear leucocytes (PMNs).

•E.coli can trigger rapid inflammatory response and result in a hard, hot, swollen quarter.

– On occasion it can result in death.

OUTCOME: “Addition of an NSAID (meloxicam) toantibiotic therapy ... resulting in a lower SomaticCell Count and a reduced risk of removal (culling)”.