Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Ciclosporin A
Novartis Animal Health UK Ltd
QL04AD01
Ciclosporin A
Oral solution
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Anti Inflammatory immunosuppressive
Authorized
2011-09-16
Revised: August 2016 AN: 01505/2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Atopica 100 mg/ml oral solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Ciclosporin 100 mg EXCIPIENT(S): all-_rac_- -tocopherol (E-307) 1.05 mg Ethanol, anhydrous (E-1510) 94.70 mg Propylene glycol (E-1520) 94.70 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear, yellow to brownish liquid 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cat 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Symptomatic treatment of chronic allergic dermatitis in cats. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in cats infected with FeLV or FIV. Do not use in cats 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 Consideration should be given to the use of other measures and/or treatments to control moderate to severe pruritus when initiating therapy with ciclosporin. 4.5 SPECIAL PRECAUTIONS FOR USE Page 1 of 7 Revised: August 2016 AN: 01505/2015 SPECIAL PRECAUTIONS FOR USE IN ANIMALS Allergic dermatitis in cats can have various manifestations, including eosinophilic plaques, head and neck excoriation, symmetrical alopecia and/or miliary dermatitis. Clinical signs of allergic dermatitis such as pruritus and skin inflammation are not specific for this disease Read the complete document