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Microsoft word - metacam product label.doc

PRODUCT LABEL

METACAM® 20 MG/ML SOLUTION FOR INJECTION
Boehringer Ingelheim (Canada) Ltd.
Meloxicam 20 mg/mL
Burlington, Ontario L7L 5H4.
Veterinary Use Only
DIN 02330059
Nonsteroidal anti-inflammatory drug (NSAID) for cattle.
Each mL contains 20 mg meloxicam and 150 mg ethanol, as preservative.

Indications: As an aid in improving appetite and weight gains when administered at the onset of diarrhoea, in combination
with oral rehydration therapy, in calves over one week of age.
For relief of pain following de-budding of horn buds in calves less than 3 months of age.

Dosage and Administration: Single subcutaneous or intravenous injection of 0.5 mg meloxicam/kg body weight (2.5
mL/100 kg).

Contraindications: Do not use in breeding, lactating or pregnant animals. Do not use in bulls intended for breeding.
Do not use in animals suffering from gastrointestinal disorders such as irritation and hemorrhage, impaired hepatic, cardiac
or renal function and hemorrhagic disorders or where there is individual hypersensitivity to the product.
Do not administer concurrently with steroidal, other nonsteroidal anti-inflammatory drugs or with anti-coagulant agents.
Concomitant use of NSAID’s with aminoglycoside antimicrobials in very young animals may result in renal toxicity.

Cautions: Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of increased renal toxicity.
Use of anti-inflammatories in very young or debilitated animals may involve additional risk.
Transient, slight injection site swellings may occasionally be seen following subcutaneous injection and intravenous
injection.

Warnings: Treated animals must not be slaughtered for use in food for at least 20 days after the latest treatment with this
drug. Do not use in dairy cows 20 months of age or older. Do not use in calves to be processed for veal as a withdrawal
period has not been established for pre-ruminating calves. Keep out of reach of children.

Pharmacology: Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition
of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic and anti-pyretic properties. Meloxicam also has
anti-endotoxic properties because it has been shown to inhibit production of thromboxane B induced by E. coli endotoxin
administration in calves.

Toxicology: The acute oral toxicity (LD ) of meloxicam assessed in rats, mini-pigs, mice and rabbits was >80 mg/kg, 1600
mg/kg, 470 mg/kg and 320 mg/kg, respectively. Repeated dose toxicity studies in rats, mice and mini-pigs demonstrated
that the primary target organs for toxicity were the gastrointestinal tract (pyloric, duodenal and small intestine ulceration)
and kidneys (scarring, necrosis and pyelonephritis).

Adverse Reactions: In very rare cases, anaphylactoid reactions may occur and should be treated symptomatically.

Storage: Store at or below 25° C. Keep from freezing.
Boehringer Ingelheim (Canada) Ltd., Burlington, Ontario L7L 5H4.
40793/003
Presentation: 20 mL, 50 mL, and 100 mL.
NAC No.: 12300673

Source: http://metacamcattle.ca/wp-content/uploads/2013/03/Metacam-Product-Label.pdf