Šalis: Kanada
kalba: prancūzų
Šaltinis: Health Canada
Firocoxib
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
57MG
Comprimé
Firocoxib 57MG
Orale
15G/50G
Prescription
Chevaux
Numéro de groupe d'ingrédients actifs (GIA) :0152300001
APPROUVÉ
2020-06-30
BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC. PREVEQUINE™ (FIROCOXIB) /PROPOSED LABELING COMPONENTS BI Version-19JUN2020 21 DIN XXXXXXXX PR PREVEQUINE™ (FIROCOXIB) TABLETS FOR HORSES FOR VETERINARY USE ONLY DESCRIPTION: PrevEquine™ (firocoxib) tablets are round, beige to tan, half-scored tablets containing 57 mg of firocoxib. Firocoxib belongs to the coxib class of non-narcotic, non-steroidal anti-inflammatory drugs (NSAIDs). It is a white crystalline compound described chemically as 3 (cyclopropylmethoxy)-4-(4-methylsulfonyl)phenyl)-5, 5- dimethylfuranone. The empirical formula is C 17 H 20 O 5 S, and the molecular weight is336.4 g/mol. The structural formula is shown below: INDICATIONS: PrevEquine™ tablets are indicated for the control of pain and inflammation associated with osteoarthritis in horses. DOSAGE AND ADMINISTRATION: (Always provide the Client Information Sheet with the prescription). The recommended dosage of PrevEquine™ tablets is one 57 mg tablet administered orally to horses weighing 360 – 600 kg, once daily for up to 14 days. For ease of administration, PrevEquine™ tablets may be given with food. CONTRAINDICATIONS: Horses with a hypersensitivity to firocoxib should not receive PrevEquine™ tablets. CAUTIONS: Horses should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data before and periodically during administration of any NSAID. Clients should be advised to observe for signs of potential drug toxicity and should be given a Client Information Sheet with each prescription. See Information for Owner or Person Treating Horse section of this package insert. S O O O O O CH 3 BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC. PREVEQUINE™ (FIROCOXIB) /PROPOSED LABELING COMPONENTS BI Version-19JUN2020 22 Treatment with PrevEquine™ tablets should be terminated if signs such as inappetence, colic, abnormal feces, or lethargy are observed. As Perskaitykite visą dokumentą