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Metacam Oral Suspension (Canada)

This page contains information on Metacam Oral Suspension for veterinary use.
The information provided typically includes the following:

Metacam Oral Suspension Indications
Warnings and cautions for Metacam Oral Suspension
Direction and dosage information for Metacam Oral Suspension

Metacam Oral Suspension

This treatment applies to the following species:

Dogs

Manufacturer: Boehringer

Veterinary Use Only

DIN 02237715

Composition

Each mL contains 1.5 mg meloxicam in a yellowish suspension with an odour of honey.

Presentation

Plastic squeeze dropper bottle containing either 10, 32, 100 or 180 mL.

A Metacam^® measuring syringe is also provided in the pack.

Metacam Oral Suspension Indications

Metacam^® is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam group for use in dogs. It acts by inhibition of prostaglandin synthesis and is indicated for the alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.

Dosage

Metacam^® Oral Suspension should be administered mixed with food. On the first day of treatment, a single dose of 0.2 mg meloxicam/kg body weight should be given. Treatment is to be continued once daily by oral administration (at 24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

Instructions For Use

Particular care should be given with regard to the accuracy of dosing. The suspension can be given using either the drop dispenser (for very small breeds) - which provides 0.05 mg meloxicam per drop - or the Metacam^® measuring syringe provided in the package. The syringe fits on to the bottle and has a kg-body weight scale designed for the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight). Thus twice the volume should be administered on the first day as the initial dose. Shake well before use. Please carefully follow the instructions of the veterinarian.

Dosing procedure using the measuring syringe:

Shake well!

1. pull The Plunger Back To The Approximate Volume Required

2. adjust Dosage Volume To The Corresponding Body Weight

twist The Bottle And The Syringe In Opposite Directions And Pull Apart

empty The Contents Of The Syringe Over The Feed

improvement Is Normally Seen Within 3-4 Days. Treatment Should Be Discontinued After 10 days At The Latest If No Improvement Is Apparent.

contraindications

Metacam^® should not be administered if gastric or intestinal ulceration or bleeding is suspected; if there is evidence of cardiac, hepatic or renal disease; or if there is evidence of a haemorrhagic disorder or individual hypersensitivity to the product. Do not administer concurrently, other steroidal or nonsteroidal anti-inflammatory drugs (NSAIDs), aminoglycoside antibiotics or anti-coagulant agents. Pre-treatment with other steroidal or nonsteroidal anti-inflammatory drugs (NSAIDs) may result in additional or increased effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment depending on the pharmacokinetic properties of the products used previously.

Metacam Oral Suspension Caution

Not approved for use in cats.

Metacam^® should not be administered to breeding, pregnant or lactating dogs. Do not exceed the stated dose. In case of overdosing, symptomatic treatment should be initiated.

Animals being treated with meloxicam should be monitored for the occurrence of side effects as susceptibility varies with the individual.

Adverse reactions reported with the NSAID class of drugs include gastrointestinal signs, renal and hepatic toxicity as well as hematological, neurological and dermatological abnormalities.

If gastrointestinal or other side effects occur, treatment should be discontinued.

As for all NSAIDs, use in any animal less than 6 weeks of age or in debilitated aged animals may involve additional risk. If use in such animals cannot be avoided, a reduced dosage and careful clinical management may be required.

Warning: Keep Out Of Reach Of Children.

Adverse Effects

The safety profile of meloxicam has been evaluated in well controlled target animal safety studies in the dog. Dogs treated with placebo, 1X, 3X and 5X label dosages were closely monitored over a 180 day (26 weeks) period. The study determined that there were no drug related adverse effects on clinical observations, normal body weight gain, food consumption, physical and ophthalmic examinations, clotting times, mucosal bleeding times or on a panel of clinical pathology parameters monitored throughout the study.

Postmarketing reports of suspected adverse drug reactions (SADRs) following field use of Metacam (meloxicam) have been monitored worldwide since 1995.

Based on case reports received under a voluntary reporting system by veterinarians or pet owners/caregivers, the most important affected body system was the gastrointestinal tract followed in decreasing order by central nervous system/behavioural signs, renal and dermatological system. Case reports often did not provide sufficient information to establish cause of the signs observed. In most cases, adverse effects were transient and disappeared after termination of treatment. In rare cases however, death has been associated with some of these adverse reactions. The following suspected adverse effects have been reported:

Gastrointestinal: Vomiting, diarrhea, inappetence, melena, hematemesis, ulceration.

Central Nervous System/Behavioural: Ataxia, personality change, seizures, sleepiness, hyperactivity, depression, trembling.

Renal: Elevated creatinine and BUN, acute renal failure.

Dermatologic: Pruritus, eczema, focal alopecia, moist dermatitis (hot spots).

Hypersensitivity: Urticaria, allergic dermatitis.

Hematologic: Immune mediated hemolytic anemia, immune mediated thrombocytopenia.

Hepatic: Elevated liver enzymes, jaundice.

Information For Pet Owners

Metacam^® (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID) and as with others in this group, side effects may occur in treated dogs. The most common adverse effects reported involve the gastrointestinal tract and usually occur within the first week of treatment. Typical symptoms include loss of appetite, vomiting, diarrhea, dark stools and depression. It is important in these situations to discontinue treatment and contact your veterinarian. In most cases, the side effects are transient and disappear after termination of treatment but in rare instances may be serious. Dogs undergoing prolonged treatment with Metacam^® should be monitored periodically. Consult your veterinarian.

Shake well before using.

Store at or below 25°C.

Boehringer Ingelheim (canada) Ltd., Burlington, Ontario L7l 5h4

601522L-03-0710

Nac No.

12300295

BOEHRINGER INGELHEIM (CANADA) LTD.
5180 SOUTH SERVICE ROAD, BURLINGTON, ON, L7L 5H4

Customer Care No.:		800-567-1885
Technical Services No.:		1-877-565-5501
Website:		www.boehringer-ingelheim.ca

Every effort has been made to ensure the accuracy of the Metacam Oral Suspension information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.