Apovomin 1 mg/ml Solution for Injection for Dogs

Composition

Each ml contains:

Active substance:

Apomorphine 0.85 mg

(equivalent to apomorphine hydrochloride hemihydrate 1.00 mg)

Excipients:

Clear, colourless aqueous solution.

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Pharmacological properties

4.1 ATCvet code:

QN04BC07

4.2 Pharmacodynamics

Apomorphine is an aporphine derivative of the dibenzoquinoline class and a synthetic derivative of morphine with no analgesic, opiate or addictive properties. At low doses, apomorphine induces emesis by stimulation of the dopamine D2-receptors in the chemoreceptor trigger zone (CTZ).

Higher doses of apomorphine, however, may suppress vomiting by stimulating the µ receptors in the vomiting centre in the brain.

4.3 Pharmacokinetics

Absorption

After subcutaneous administration apomorphine is rapidly absorbed. Peak plasma concentration (Cmax) is 35.5 ± 7.46 ng/ml and is reached after about 13.5 ± 5.3 minutes.

Distribution

Apomorphine is very lipophilic and equilibrates rapidly between blood and tissue. Apomorphine binds extensively to plasma proteins in humans.

Metabolism

Apomorphine is extensively metabolised by the liver into-non-active metabolites.

Excretion

The metabolites and very little unchanged apomorphine (<2%) are excreted via the urine.

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Target species

Dogs.

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Indications

Induction of emesis.

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Dosage

For single subcutaneous use only.

0.1 mg of apomorphine hydrochloride hemihydrate per kg bodyweight (0.1 ml veterinary medicinal product per kg bodyweight).

To ensure a correct dosage, body weight should be determined as accurately as possible.

Do not use if the solution has turned green.

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Contraindications

Do not use in case of depression of the Central Nervous System (CNS).

Do not use in cases of ingestion of caustic agents (acids or alkalis), foamy products, volatile substances, organic solvents and non-blunt objects (e.g. glass).

Do not use in animals which are hypoxic, dyspnoeic, seizuring, in hyperexcitation, extremely weak, ataxic, comatose, lacking normal pharyngeal reflexes, or suffering other marked neurologic impairments that could lead to aspiration pneumonia. Do not use in cases of circulatory failure, shock and anaesthesia.

Do not use in animals which have been treated with Dopamine-Antagonists (Neuroleptics) in the past 24 hours.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Dogs:

Very common (>1 animal / 10 animals treated): Drowsiness a, Decreased appetite a, Hypersalivation a, Immediate pain upon injectiona, b

Common (1 to 10 animals / 100 animals treated): Dehydrationa, c, Tachycardia a, Bradycardia a

Undetermined frequency (cannot be estimated from the available data): Low blood pressure

a Transient and may be related to the physiological response to expulsive efforts

b Mild to moderate

c Slight

Multiple episodes of vomiting may be observed, and vomiting may occur up to several hours after the injection.

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.

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Warnings

Special precautions for safe use in the target species:

In dogs with known severe hepatic failure, the benefit-risk balance for use of the veterinary medicinal product should be considered by the veterinarian.

Before administering the veterinary medicinal product, consideration must be given to the time of the ingestion of the substance (in relation to gastric emptying times) and the suitability of inducing emesis based on the type of substance ingested (see also section 3.3).

Special precautions to be taken by the person administering the veterinary medicinal product to animals

This veterinary medicinal product may cause nausea and somnolence. In case of accidental self–injection, seek medical advice immediately and show the package leaflet or the label to the physician. DO NOT DRIVE, as sedation may occur. Apomorphine has been shown to have teratogenic effects in laboratory animals and is excreted in breast milk. Pregnant and breastfeeding women should avoid handling the veterinary medicinal product.

This veterinary medicinal product may cause hypersensitivity reactions. People with known hypersensitivity to apomorphine or to any of the excipients should avoid contact with the veterinary medical product.

If the veterinary medicinal product comes into contact with the skin or eyes, rinse immediately with water. Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

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.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation in dogs.

Pregnancy and lactation:

Apomorphine has been shown to have teratogenic effects in rabbits and foetotoxic effects in rats at doses higher than the recommended dose in dogs.

As apomorphine is excreted in breast milk, when used in lactating females, puppies should be monitored carefully for undesired effects.

Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

Neuroleptics with a dopaminergic antagonistic effect (e.g.: chlorpromazine, haloperidol), and anti-emetics (metoclopramide, domperidone) reduce or suppress the emesis induced by the administration of apomorphine.

The administration or the prior ingestion of opiates or barbiturates can induce additive CNS effects and respiratory depression with apomorphine.

Caution is advised when dogs are receiving other dopamine agonists, such as cabergoline, due to possible additive effects such as exacerbation or inhibition of vomiting.

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Overdose

Excessive doses of apomorphine may result in respiratory and/or cardiac depression, CNS stimulation (excitement, seizures, stereotypy) or depression, protracted vomiting, slight decrease in body temperature or rarely in restlessness, excitement or even convulsion.

At higher doses apomorphine may also suppress vomiting.

Naloxone may be used to reverse the CNS and respiratory effects of apomorphine. Anti-emetics such as metoclopramide and maropitant should be considered in case of protracted vomiting.

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Special warnings

Expulsive efforts with or without vomiting are likely to be seen from 3 to 4 minutes after the injection of the veterinary medicinal product and may last up to half an hour. If emesis is not induced following a single injection, do not repeat the injection as it will not be effective and may provoke clinical signs of overdose.

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Withdrawal period

Not applicable.

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Incompatibilities

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

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Immediate packaging

Clear Type I glass vials containing 5 ml, closed with a coated Type I bromobutyl rubber stopper and sealed with an aluminium cap. Each vial is packed into a cardboard box.

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Storage

Store in the original package in order to protect from light.

Store in a refrigerator (2°C – 8°C).

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Shelf life

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

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Disposal of unused product

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.

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Additional information

7 MARKETING AUTHORISATION NUMBER

Vm 50406/4012

8 DATE OF FIRST AUTHORISATION

15 December 2020

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

April 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.

Approved: 07 August 2025

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Registration holder

Dechra Regulatory B.V.

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