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, 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 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.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

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

¹ At the injection site, size and intensity of the reaction depending on the volume of the veterinary medicinal product administered.

² During and shortly after injection.

³ All local reactions are reversible and usually disappear within 28 days after injection.

⁴ Changes are always transient and reversible.

⁵ Early return to oestrus (oestrus interval shortened by 1 to 3 months).

⁶ Accompanies abortion in bitches treated after 20 days of gestation.

⁷ Which 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.

3.7 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 45^th day post mating.

3.8 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.

3.9 Administration routes and dosage

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	3 kg	6 kg	9 kg	12 kg	24 kg	30 kg	42 kg
Volume of veterinary medicinal product	1 ml	2 ml	3 ml	4 ml	8 ml	10 ml	14 ml

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.

3.10 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.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Not applicable.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QG03XB90.

4.2 Pharmacodynamics

Aglepristone is a synthetic steroid counteracting the effect of progesterone by competing with this hormone at the level of the uterine receptors, resulting in abortion (or resorption) within 7 days after administration.

Aglepristone does not modify progesterone, prostaglandins, oxytocin or cortisol plasma concentration within 24 hours after its administration but it induces a discharge of prolactin within 12 hours.

In vitro, the affinity of aglepristone for the progesterone receptors in the uterus of the dog is 3 times higher than that of progesterone.

The relative binding affinity of aglepristone to glucocorticoid receptors is similar to that of dexamethasone but aglepristone has antagonistic properties.

4.3 Pharmacokinetics

After 2 injections of 10 mg/kg/day at a 24-hour interval, the maximal concentration (about 280 ng/ml) is reached after 2.5 days. The mean residence time is around 6 days: this period includes the mean absorption time from the injection site.

After administration of a 10 mg/kg radio-labelled dose, the excretion of radioactivity is very slow. Only 60 % of the administered dose is excreted during the first 10 days and around 80 % over 24 days.

Excretion is essentially via the faeces (around 90 %).

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 28 days.

5.3 Special precautions for storage

Keep the vial in the outer carton in order to protect from light.

Should any apparent growth or discoloration occur, the veterinary medicinal product should be discarded.

5.4 Nature and composition of immediate packaging

Colourless vials (glass, type II) of 5 ml, 10 ml or 30 ml with bromobutyl stoppers and aluminium caps.

Presentations:

- cardboard box of 1 vial of 5 ml, 10 ml, 30 ml - cardboard box of 10 vials of 10 ml.

Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Virbac

7. MARKETING AUTHORISATION NUMBER

Vm 05653/5040

8. DATE OF FIRST AUTHORISATION

23 October 2001

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2025

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 30 January 2026