Alizin 30 mg/ml Solution for Injection

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Aglepristone

Dostępny od:

Virbac

Kod ATC:

QG03XB90

INN (International Nazwa):

Aglepristone

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Dogs

Dziedzina terapeutyczna:

Prostaglandin

Status autoryzacji:

Authorized

Data autoryzacji:

2001-10-23

Charakterystyka produktu

Revised: August 2023
AN: 00719/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alizin 30 mg/ml Solution for Injection for dogs
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,
Revised: August 2023
AN: 00719/2022
Page 2 of 7
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.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in target species:
In the absence of available data, the veterinary med