Target species
Dogs (bitches).
Indications for use
Pregnant bitches: induction of abortion up to 45 days after mating.
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.
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.
Special precautions for use
Special precautions for safe use in the target species:
In the absence of available data, the veterinary medicinal product should be used with caution in dogs with chronic obstructive-airway disease and/or cardiovascular disease, particularly bacterial endocarditis.
Fatalities have been reported subsequent to off-label use in seriously ill bitches with uterine infections. A causal association is difficult to determine but is unlikely.
In up to 50 % of bitches, mating may not be followed by pregnancy. The possibility that a bitch may therefore be treated unnecessarily should be taken into account in evaluating the veterinary medicinal product risk-benefit ratio.
Bitches that remain pregnant despite treatment should be monitored, as viability of the puppies may be compromised and serious complications such as dystocia and uterine rupture could result from abortion failure.
Possible long-term effects of treatment have not been studied.
Owners should be advised to consult their veterinary surgeon if their dog shows the following signs after treatment with the veterinary medicinal product:
- purulent or haemorrhagic vaginal discharge
- prolonged vaginal discharge lasting over 3 weeks.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Nor-steroids are used in humans to induce abortion. Accidental injection may be a particular hazard to women who are pregnant, intending to become pregnant or whose pregnancy status is unknown. Care should be taken by the veterinary surgeon when handling the veterinary medicinal product and the person restraining the dog to avoid accidental injection. Pregnant women should administer the veterinary medicinal product with caution. This is an oil-based veterinary medicinal product that may cause prolonged local reactions at the site of injection. In case of accidental selfinjection, ingestion, spillage onto skin and/or eyes, seek medical advice immediately and show the package leaflet or the label to the physician.
Women of child-bearing age should avoid contact with the veterinary medicinal product or wear disposable plastic gloves when administering the veterinary medicinal product.
Adverse reactions (frequency and seriousness)
Dogs (bitches).
Very common (>1 animal / 10 animals treated):
Injection site inflammation1, Injection site pain2,3 Injection site oedema3, Injection site thickening3 Enlarged lymph node (localised)3 Anorexia, Depression Excitation Diarrhoea
Common (1 to 10 animals / 100 animals treated):
Modified haematological parameters (neutrophilia, neutropenia, thrombocytosis, elevated haematocrit, decreased haematocrit, lymphocytosis, lymphopenia)4 Modified biochemical parameters (elevated blood urea nitrogen (BUN), elevated creatinine, hyperchloraemia, hyperkalaemia, hypernatremia, elevated alanine aminotransferase (ALT), elevated serum alkaline phosphatase (SAP), elevated aspartate aminotransferase (AST))4 Uterine infection, Return to oestrus5 Vomiting
Rare (1 to 10 animals / 10,000 animals treated):
Hypersensitivity reaction Lack of efficacy7
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Injection site ulcer3
Undetermined frequency:
Physiological signs of parturition (foetal expulsion, vaginal discharge, reduced appetite, restlessness and mammary congestion)6
1At the injection site, size and intensity of the reaction depending on the volume of the veterinary medicinal product administered.
2During and shortly after injection.
3All local reactions are reversible and usually disappear within 28 days after injection.
4Changes are always transient and reversible.
5Early return to oestrus (oestrus interval shortened by 1 to 3 months).
6Accompanies abortion in bitches treated after 20 days of gestation.
7Which could lead to dystocia or uterine rupture and very rarely to fatal outcome.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Do not administer to pregnant bitches unless it is desirable to terminate the pregnancy.
Do not administer to bitches after the 45th day post mating.
Interaction with other medicinal products and other forms of interaction
In the absence of available data, a risk of drug interaction between aglepristone and ketoconazole, itraconazole and erythromycin may exist.
As aglepristone is an anti-glucocorticoid, it might reduce the effect of glucocorticoid treatment.
Possible interactions with other medicaments have not been studied.
Amounts to be administered and administration route
Subcutaneous use.
Administer 10 mg per kg of bodyweight of aglepristone, equivalent to 0.33 ml of veterinary medicinal product per kg of bodyweight, twice, 24 hours apart.
Weight of bitch
3kg
6kg
9kg
12kg
24kg
30kg
42kg
Volume of product
1ml
2ml
3ml
4ml
8ml
10ml
14ml
Severe local reactions can be avoided if the veterinary medicinal product is administered into the scruff of the neck. A light massage of the injection site is recommended.
In large bitches, it is recommended that a maximum of 5 ml is injected at any one site.
This veterinary medicinal product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry, sterile needle and syringe.
Following administration of the veterinary medicinal product to dogs, abortion (or resorption) occurs within 7 days.
The stopper can be safely punctured up to 10 times.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
The administration of 30 mg/kg, i.e. 3 times the recommended dose, in bitches showed no adverse effects, except local inflammatory reactions, related to the larger volumes injected.
Withdrawal periods
Not applicable