Inflacam 1.0 mg Chewable Tablets for Dogs (Canada)

Company: Virbac

1.0 mg Chewable Tablets for Dogs DIN: 02480670

2.5 mg Chewable Tablets for Dogs DIN: 02480689

Veterinary Use Only

Inflacam 1.0 mg Chewable Tablets for Dogs Indications

INFLACAM^® Chewable Tablets for Dogs are 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 and Administration

Product can be given orally through: free selection from the palm of the hand; direct administration in the mouth; or as part of a treat or with food. Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day which can be given orally or alternatively using a meloxicam 5 mg/mL solution for injection.

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. Each tablet contains either 1.0 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg bodyweight dog, or a 25 kg bodyweight dog respectively. Chewable Tablets are scored and dosage should be calculated in half tablet increments. Improvement is normally seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no improvement is apparent.

Contraindications

Do not use in dogs less than 6 weeks or less than 5kg. INFLACAM Chewable Tablets 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.

Cautions: Not approved for use in cats. INFLACAM Chewable Tablets 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 debilitated aged animals may involve additional risk. If the use of INFLACAM Chewable Tablets in such animals cannot be avoided, a reduced dosage and careful clinical management may be required.

Warnings: 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 week 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 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: INFLACAM Chewable Tablets 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 Inflacam should be monitored periodically. Consult your veterinarian.

Storage

Store at 15 - 30°C. Store in the original package.

How Supplied

Cartons of 20 and 100 chewable tablets. Not all cartons may be marketed.

Manufactured by: Chanelle Pharmaceuticals Manufacturing Ltd, Loughrea, Co. Galway, Ireland

Imported and Distributed by: Virbac Canada Inc., 231 Shearson Crescent, Suite 209, Cambridge, ON, N1T 1J5.

1-800-338-3659

ca.virbac.com

10001 10002

© Virbac 2021. All rights reserved. INFLACAM is a registered trademark of Virbac S.A.

LB11461

CPN: 1177091.1