Alizin 30 mg/ml Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Aglepristone

Available from:

Virbac

ATC code:

QG03XB90

INN (International Name):

Aglepristone

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Prostaglandin

Authorization status:

Authorized

Authorization date:

2001-10-23

Summary of Product characteristics

Revised: July 2022
Divergence from NI MA following AN: 00719/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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
Revised: July 2022
Divergence from NI MA following AN: 00719/2022
Page 2 of 6
confirm that the uterus content is fully evacuated. Ideally, the
examination should be
conducted using ultrasound. This examination should be performed 10
days after
treatment and at least 30 days after mating.
In case of partial abortion or no abortion, repeat treatment may be
recommended
10 days after treatment, between day 30 and day 45 after mating.
Surgery should
also be considered..
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR US