Alizin 30 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aglepristone

Available from:

Virbac S.A.

ATC code:

QG03XB90

INN (International Name):

Aglepristone

Dosage:

30 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

aglepristone

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2004-05-07

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alizin 30 mg/ml Solution for Injection for dogs
Alizin Vet 30 mg/ml Solution for Injection for dogs (DK, IS, NO, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Aglepristone……………………………30
mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _
Ethanol, anhydrous
Arachis oil, refined
Clear yellow oily solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs (bitches).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Pregnant bitches: induction of abortion up to 45 days after mating.
3.3
CONTRAINDICATIONS
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.
3.4
SPECIAL WARNINGS
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 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.
2
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in target species:
In the absence of available data, the veterinary medicinal product
should be used with caution in dogs
with
ch