Land: Irland
Språk: engelska
Källa: HMA (Heads of Medicines Agencies)
Virbac S.A.
Solution for injection
Dogs Females
2011-05-18
Page 1 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Alizin 30 mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains: - active substance aglepristone………………………………….. 30 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear yellow oily solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (bitches). 4.2 INDICATION FOR USE, SPECIFYING THE TARGET SPECIES Pregnant bitches: induction of abortion up to 45 days after mating. 4.3 CONTRA-INDICATIONS Do not use in dogs with impaired hepatic or renal function, in diabetic animals or in dogs in poor health. DO NOT USE IN DOGS WITH EITHER MANIFEST OR LATENT HYPOADRENOCORTICISM (ADDISON’S DISEASE) OR IN DOGS WITH A GENETIC PREDISPOSITION TO HYPOADRENOCORTICISM. Do not use in dogs with known hypersensitivity to aglepristone or the veterinary medicinal product excipient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Rare cases of lack of efficacy (>0.01 % to < 0.1%) have been reported as part of the pharmacovigilance survey. To reduce the possibility of lack of expected efficacy, avoid the use of Alizin until after the end of oestrus and avoid new mating before the end of oestrus. In bitches confirmed pregnant, a partial abortion was observed in 5% of cases in field trials. A thorough clinical examination is always recommended in order to confirm that the uterus content is fully evacuated. Ideally, the examination should be Page 2 of 6 conducted using ultrasound. This examination should Läs hela dokumentet