Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
MELOXICAM
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
5MG
SOLUTION
MELOXICAM 5MG
INTRAVENOUS
15G/50G
Prescription
CATS; DOGS
Active ingredient group (AIG) number: 0131676002
APPROVED
2021-03-01
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC. METACAM ® 5 MG/ML (MELOXICAM) INJECTION /PROPOSED LABELING COMPONENTS BIAH Version 22Feb2023 Page 1 of 15 PACKAGE INSERT (ENGLISH) DIN 02240463 PR METACAM ® 0.5% INJECTION Meloxicam 5 mg/mL VETERINARY USE ONLY Sterile For Dogs and Cats DESCRIPTION: A clear, yellow solution containing 5 mg meloxicam per mL Ethanol (dehydrated) Ph.Eur. 150 mg/mL is the preservative. CLINICAL 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 antipyretic effects. Maximum plasma concentrations are obtained after approximately 1.5 hours (cats) to 2.5 hours (dogs) post subcutaneous injection. There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 L/kg. Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolized to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. Meloxicam is eliminated with a half-life of 15 hours (cat) and 24 hours (dog). Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine. INDICATIONS: Metacam ® 0.5% Injection is a nonsteroidal anti-inflammatory drug (NSAID) for use in dogs and cats. It is indicated for the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders in dogs and also for the control of perioperative pain following orthopedic and soft tissue surgery in dogs and cats. DOSAGE: MUSCULOSKELETAL DISORDERS: DOGS: Metacam ® 0.5% Injection should be given as a single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (0.4 mL per 10 kg body weight). The product Metacam Baca dokumen lengkapnya