Země: Kanada
Jazyk: francouzština
Zdroj: Health Canada
OCLACITINIB (Acide d'oclacitinib malique)
ZOETIS CANADA INC
16MG
Comprimé
OCLACITINIB (Acide d'oclacitinib malique) 16MG
Orale
15G/50G
Prescription
Chiens
Numéro de groupe d'ingrédients actifs (GIA) :0155910003
APPROUVÉ
2014-07-09
Apoquel Labelling April 16, 2020 EXTENDED LABEL - 3.6 MG, 5.4 MG AND 16 MG TABLETS - 20 OR 100 COUNT BOTTLES Note that the net contents are interchangeable (there is one bottle size only for all strengths and count bottles). 3.6 MG STRENGTH Apoquel Labelling April 16, 2020 5.4 MG STRENGTH Apoquel Labelling April 16, 2020 16 MG STRENGTH Apoquel Labelling April 16, 2020 PACKAGE INSERT (part of the extended label and applicable to all strengths) DIN 02427885 DIN 02427893 DIN 02427907 APOQUEL TM oclacitinib tablets VETERINARY USE ONLY JANUS KINASE INHIBITOR FOR DOGS DESCRIPTION: APOQUEL TM (oclacitinib maleate) is a synthetic Janus Kinase inhibitor. The chemical name of the active ingredient in APOQUEL tablets is N-methyl[trans-4-(methyl-7H- pyrrolo[2,3-d]pyrimidin-4-ylamino) cyclohexyl]methanesulfonamide (2Z)-2-butenedioate. The chemical structure of oclacitinib maleate is: INDICATIONS: For the control of pruritus associated with allergic dermatitis and for the control of atopic dermatitis in dogs at least 12 months of age. DOSAGE AND ADMINISTRATION: The dose of APOQUEL tablets is 0.4 mg/kg to 0.6 mg oclacitinib /kg body weight, administered orally, twice daily for up to 14 days, and then administered once daily for maintenance therapy. APOQUEL tablets may be administered with or without food. DOSING CHART DOG BODY WEIGHT (KG) 3.6 MG TABLETS 5.4 MG TABLETS 16 MG TABLETS 3 – 4.4 0.5 4.5 – 5.9 0.5 6 – 8.9 1 9 – 13.4 1 13.5 – 19.9 0.5 20 – 26.9 2 27 – 39.9 1 40 – 54.9 1.5 55 – 80 2 Apoquel Labelling April 16, 2020 CONTRAINDICATIONS: APOQUEL tablets should not be given to dogs with known or suspected allergy or intolerance to oclacitinib maleate or any other components of this product. APOQUEL tablets are not for use in dogs less than 12 months of age (see ANIMAL SAFETY). APOQUEL tablets are not for use in dogs with serious infections, evidence of immune suppression or evidence of malignant neoplasia. APOQUEL tablets are not for use in breeding dogs, pregnant or lactating bitches. CAUTIONS: The safe us Přečtěte si celý dokument