Krajina: Holandsko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
ciclosporin 25 mg
NOVARTIS SA
QL04AA01
Capsule, soft
ciclosporin
Dogs
2007-07-26
ATOPICA 25 MG SPC. _[update of ADR section, January 2013 ] _ 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ATOPICA 25 mg soft capsules for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Ciclosporin 25.00 mg EXCIPIENT(S): -tocopherol (E-307) 0.25 mg Iron oxide black (E-172)0.105 mg Titanium dioxide (E-171) 2.12 mg Carminic acid (E-120) < 1.00 g For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule Blue-grey oval capsules bearing the following imprint: N_V_R 25 mg. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (weighing from 4 to 7.5 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 None. 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 2 allergies which cause dermatological signs (_e.g_. flea allergic dermatitis or food Prečítajte si celý dokument