Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ciclosporin
Novartis Animal Health UK Ltd
QL04AA01
100 Milligram
Capsules, Soft
Canine
Miscellaneous
Authorised
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT ATOPICA 100 mg soft capsules for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Ciclosporin 100.00 mg EXCIPIENT(S): -tocopherol (E-307) 1.00 mg Iron oxide black (E-172) 0.285 mg Titanium dioxide (E-171) 5.73 mg Carminic acid (E-120) < 1.00 ug For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule Blue-grey oblong capsules bearing the following imprint: NVR and 100 mg. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (weighing from 15 to 55 kg) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of chronic manifestations of atopic dermatitis in dogs. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to ciclosporin or one of the excipients. For all capsule strengths, do not use in dogs less than six months of age or less than 2 kg in weight. Do not use in cases with a history of malignant disorders or progressive malignant disorders. Do not vaccinate with a live vaccine during treatment or within a two-week interval before or after treatment. (see also sections 4.5 “Special precautions for use” and 4.8 “Interaction with other medicinal products”). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 02/05/2013_ _CRN 7013759_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Clinical signs of atopic dermatitis such as pruritus and skin inflammation are not specific for this disease and therefore other causes of dermatitis such as ectoparasitic infestations, other allergies which cause dermatological signs (_e.g_. flea allergic dermatitis or food allergy) or ba Read the complete document