País: Israel
Idioma: inglés
Fuente: Ministry of Health
CICLOSPORIN
EUROMAR LTD
SOLUTION (ORAL)
CICLOSPORIN 100 MG / 1 ML
PER OS
Required
ELANCO FRANCE S.A.S, FRANCE
Atopica 100 mg/ml oral solution for cats and dogs veterinary is indicated for:Symptomatic treatment of chronic allergic dermatitis in cats. Treatment of chronic manifestations of atopic dermatitis in dogs.
2021-10-19
PACKAGE LEAFLET FOR VETERINARY MEDICINAL PRODUCT This medicine is dispensed with a veterinarian's prescription only For veterinary use only 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Atopica 100 mg/ml oral solution for cats and dogs Veterinary 2. ACTIVE SUBSTANCE: Each ml contains 100 mg ciclosporin 3. WHAT IS THE MEDICINE INTENDED FOR Symptomatic treatment of chronic allergic dermatitis in cats. Treatment of chronic manifestations of atopic dermatitis in dogs. Therapeutic group: Selective immunosuppressant Allergic dermatitis and atopic dermatitis are common skin diseases in cats and dogs, respectively. They are caused by allergens such as house dust mites or pollens which stimulate an exaggerated immune response. The diseases are chronic and recurrent. Ciclosporin selectively acts on the immune cells involved in the allergic reaction. Ciclosporin reduces the inflammation and itching associated with allergic dermatitis. 4. CONTRAINDICATIONS Do not use in animals with 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 animals 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. Do not use in dogs less than six months of age or less than 2 kg in weight. 5. ADVERSE REACTIONS Cats: The most frequently observed undesirable effects are gastrointestinal disturbances such as vomiting and diarrhea. These effects are generally mild and transient and do not require cessation of the treatment. Other undesirable effects observed in clinical studies included: lethargy, anorexia, hypersalivation, weight loss and low levels of white blood cells. These effects generally resolve spontaneously after treatment is stopped or following a decrease in the dosing frequency. Side effects may be severe in individual animals. Dogs: The occurrence of adverse reactions is uncommon. The most frequently observed undesirable effects are Leer el documento completo
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Atopica 100 mg/ml oral solution for cats and dogs VETERINARY 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Ciclosporin 100 mg EXCIPIENT(S): α -tocopherol) 1.05 mg Ethanol, anhydrous 94.70 mg Propylene glycol 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 Dog (weighing more than 2 kg) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Symptomatic treatment of chronic allergic dermatitis in cats. Treatment of chronic manifestations of atopic dermatitis in dogs. 4.3 CONTRAINDICATIONS Do not use in animals with hypersensitivity to the active substance or to any of the excipients. Do not use in animals 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. Do not use in dogs less than six months of age or less than 2 kg in weight. 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 SPECIAL PRECAUTIONS FOR USE IN ANIMALS Clinical signs of atopic or allergic 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 or allergic dermatitis. A complete clinical examination should be performed before treatment. It Leer el documento completo