Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Ciclosporin A
Virbac
QL04AD01
Ciclosporin A
Oral solution
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Anti Inflammatory immunosuppressive
Authorized
2014-04-03
Revised: January 2019 AN: 02461/2017 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cyclavance 100 mg/ml oral solution for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Ciclosporin 100 mg EXCIPIENT(S): All-rac- -tocopherol (E-307) 1.00 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear to slightly yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs, cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of chronic manifestations of atopic dermatitis in dogs. 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 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”). Do not use in dogs less than six months of age or less than 2 kg in weight. Do not use in cats infected with Feline Leukemia Virus (FeLV) or Feline Immunodeficiency Virus (FIV). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Revised: January 2019 AN: 02461/2017 Page 2 of 16 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 SPECIAL PRECAUTIONS FOR USE IN ANIMALS Clinical signs of atopic dermatitis in dogs and allergic dermatitis in cats such as pruritus and skin inflammation are not specific for these diseases. 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 Read the complete document