产品特点
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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
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conducted using ultrasound. This examination should
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