Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Ciclosporin A
Elanco Europe Ltd
QL04AD01
Ciclosporin A
Capsule, soft
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Anti Inflammatory immunosuppressive
Authorized
2003-10-06
Revised: September 2020 AN: 00839/2020 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ATOPICA 50 mg soft capsules for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Ciclosporin 50.00 mg EXCIPIENT(S): -tocopherol (E-307) 0.50 mg Titanium dioxide (E-171) 4.50 mg Carminic acid (E-120) < 1.00 μg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule Yellow-white oblong capsules bearing the following imprint: NVR 50 mg. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (weighing from 7.5 to 36 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”). Revised: September 2020 AN: 00839/2020 Page 2 of 7 4.4 SPECIAL WARNINGS 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 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 bacterial and fungal infections should be ruled out before treatment is started. It is good practice to treat flea infestations before and during treatment of atopic dermatitis. It is recommended to clear bacterial an Read the complete document