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: June 2023 AN: 01276/2022 + 01304/2022 Page 1 of 7 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 mg EXCIPIENT(S): α-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 µg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule Blue-grey oblong soft capsules bearing the following imprint: NVR 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 any 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 “Special precautions for use” and “Interaction with other medicinal products and other forms of interaction”). Revised: June 2023 AN: 01276/2022 + 01304/2022 Page 2 of 7 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 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 infest Read the complete document