Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
oclacitinib maleate
Zoetis Belgium SA
QD11AH90
oclacitinib maleate
Dogs
Agents for dermatitis, excluding corticosteroids
- Treatment of pruritus associated with allergic dermatitis in dogs.- Treatment of clinical manifestations of atopic dermatitis in dogs.
Revision: 8
Authorised
2013-09-12
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: APOQUEL 3.6 MG FILM-COATED TABLETS FOR DOGS APOQUEL 5.4 MG FILM-COATED TABLETS FOR DOGS APOQUEL 16 MG FILM-COATED TABLETS FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Pfizer Italia S.R.L. Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALY or Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs oclacitinib 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each film-coated tablet contains 3.6 mg, 5.4 mg or 16 mg oclacitinib (as oclacitinib maleate). 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. INDICATION(S) Treatment of pruritus associated with allergic dermatitis in dogs. Treatment of clinical manifestations of atopic dermatitis in dogs. 30 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to oclacitinib 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 hyperadrenocorticisim or with evidence of progressive malignant neoplasia as the active substance has not been evaluated in these cases. 6. ADVERSE REACTIONS The common adverse reactions seen up to day 16 of the field trials are listed in the following table: Adverse reactions observed in atopic dermatitis study up to day 16 Ad Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs 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 Treatment of pruritus associated with allergic dermatitis in dogs. Treatment of clinical manifestations of atopic dermatitis in dogs. 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. 3 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 underly Lue koko asiakirja