Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Ciclosporin
Le Vet Beheer B.V.
QL04AA01
Ciclosporin
50 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
ZZZ Ciclosporin
Miscellaneous
Authorised
2013-07-19
Health Products Regulatory Authority 16 October 2018 CRN000XW9 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Sporimune 50 mg/ml oral solution for cats and dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Ciclosporin 50mg EXCIPIENT(S): Ethanol, anhydrous (E-1510) 100mg all-rac-alfa-Tocopheryl acetate (E-307) 1.00mg 3 PHARMACEUTICAL FORM Oral solution. Colourless to yellowish oily solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog, cat. 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 any of the excipients. 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). Do not use in cats infected with FeLV or FIV. Health Products Regulatory Authority 16 October 2018 CRN000XW9 Page 2 of 10 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 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 this disease. 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 evaluated and eliminated where possible. It is good practice to treat Aqra d-dokument sħiħ