البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
OCLACITINIB MALEATE
ZOETIS ISRAEL HOLDING B.V., ISRAEL
FILM COATED TABLETS
OCLACITINIB MALEATE 16 MG
PER OS
Required
ZOETIS BELGIUM S.A.
Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
2021-11-30
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 اقرأ الوثيقة كاملة
1 Apoquel LPD 08.07.2021 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Apoquel 3.6 mg Veterinary film-coated tablets Apoquel 5.4 mg Veterinary film-coated tablets Apoquel 16 mg Veterinary film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each film-coated tablet contains: Apoquel 3.6 mg: 3.6 mg oclacitinib (as oclacitinib maleate) Apoquel 5.4 mg: 5.4 mg oclacitinib (as oclacitinib maleate) Apoquel 16 mg: 16 mg oclacitinib (as oclacitinib maleate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. White to off-white, oblong shaped film-coated tablets with a score-line on both sides and marked with the letters "AQ" and "S", "M" or "L" on both sides. The letters "S", "M" and "L" refer to the different strengths of tablets: "S" is on the 3.6 mg tablets, "M" on the 5.4 mg tablets, and "L" on the 16 mg tablets. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 12 months of age or less than 3 kg bodyweight. Do not use in dogs with evidence of immune suppression, such as hyperadrenocorticism, or with evidence of progressive malignant neoplasia as the active substance has not been evaluated in these cases. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 2 Apoquel LPD 08.07.2021 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals: Oclacitinib modulates the immune system and may increase susceptibility to infection and exacerbate neoplastic conditions. Dogs receiving Apoquel tablets should therefore be monitored for the development of infections and neoplasia. When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying اقرأ الوثيقة كاملة