Land: Israel
Språk: engelsk
Kilde: Ministry of Health
OCLACITINIB MALEATE
ZOETIS ISRAEL HOLDING B.V., ISRAEL
FILM COATED TABLETS
OCLACITINIB MALEATE 5.4 MG
PER OS
Required
ZOETIS LLC (SUBSIDIARY OF ZOETIS INC), USA
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
2020-10-25
CONSUMER PACKAGE INSERT FOR A VETERINARY PREPARATION The format of this leaflet was determined by the Ministry of Health and its content was checked and approved The medicine is dispensed with a veterinarian’s prescription only For animal use only 1. NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE Apoquel 3.6 mg film-coated veterinary tablets Apoquel 5.4 mg film-coated veterinary tablets Apoquel 16 mg film-coated veterinary tablets 2. ACTIVE INGREDIENT Each film-coated tablet contains: Apoquel 3.6 mg veterinary tablets 3.6 mg oclacitinib (as oclacitinib maleate) Apoquel 5.4 mg veterinary tablets 5.4 mg oclacitinib (as oclacitinib maleate) Apoquel 16 mg veterinary tablets 16 mg oclacitinib (as oclacitinib maleate) The list of inactive ingredients is in section 13. 3. WHAT IS THE MEDICINE INTENDED FOR? Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. 4. CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active ingredient or to any of the ingredients of the preparation. Do not use in dogs under 12 months of age or that weigh less than 3 kg. Do not use in dogs that present i m m u n o s u p p r e s s i o n , s u c h a s hyperadrenocorticism, or if there is evidence of advanced malignant neoplasia, since the active ingredient has not been evaluated in these cases. 5. SIDE EFFECTS The common side effects observed up to day 16 in field studies are listed in the table. Side effects observed in atopic dermatitis study up to day 16 Side effects observed in pruritus study up to day 7 APOQUEL (n=152) Placebo (n=147) APOQUEL (n=216) Placebo (n=220) Diarrhea 4.6% 3.4% 2.3% 0.9% Vomiting 3.9% 4.1% 2.3% 1.8% Loss of appetite (anorexia) 2.6% 0% 1.4% 0% New cutaneous or subcutaneous lumps 2.6% 2.7% 1.0% 0% Lethargy 2.0% 1.4% 1.8% 1.4% Polydipsia 0.7% 1.4% 1.4% 0% After day 16, the following side effects have been observed: pustular dermatitis (pyoderma) and non-specified dermal lumps are very common effects. Otitis, vomiting, diarrhea, be Les hele dokumentet