Emedog solution for injection contains 1 mg/ml apomorphine hydrochloride as a colourless or slightly yellow clear liquid.

Induction of emesis in dogs.

For subcutaneous administration only.

Single subcutaneous injection at a dosage of 0.1 mg of apomorphine/kg bodyweight (1 ampoule of 1 ml/10 kg BW).

Animal weight should be accurately determined to ensure the administration of the correct dose.

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

Do not use in cats and other species.

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

Do not use in animals which are hypoxic, dyspneic, 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 anesthesia.

Do not use in animals which are previously treated with Dopamine-Antagonists (Neuroleptics).

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

Minor adverse reactions may be observed:

- drowsiness (very common),

- modification of appetite (very common),

- increased salivation (very common),

- mild to moderate pain on injection (very common),

- slight dehydration (common).

- change in cardiac frequency (tachycardia followed by bradycardia) (common).

They are transient and may be related to the physiological response to expulsive efforts.

In addition, based on the post marketing experience, ataxia has been reported very rarely.

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

Expulsive efforts with or without vomiting are likely to be seen from 2 and 15 minutes after the injection of the product and may last from to 2 minutes to 2.5 hours (as observed in one clinical trial).

Some dogs may not respond to this medicinal product. 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 toxicity.

In dogs with known severe hepatic failure, the risk/benefit balance should be considered by the veterinarian.

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

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

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

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

Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

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

Wash hands after use.

If the product comes into contact with the skin, rinse immediately with plenty of water.

This 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 some laboratory species. Pregnant women should avoid handling the product.

Apomorphine is excreted in breast milk. Breast feeding women should avoid handling of the product.

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

Naloxone may be used to reverse the CNS and respiratory effects of apomorphine (but not cardiac side effects).

Maropitant (or dopamine receptor antagonists such as metoclopramide) should be considered in cases of protracted vomiting.

Store in the original package, protected from light.

Any solution remaining in the ampoule following withdrawal of the required dose should be discarded.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Cardboard box of:

5 colourless glass ampoules type I of 1 ml

20 colourless glass ampoules type I of 1 ml

Laboratoire TVM

57 rue des Bardines
63370 Lempdes
France

Neuroleptics (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 agonist like cabergoline due to possible additive effects such as exacerbation or inhibition of vomiting.

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

Maropitant or naloxone may be used to reverse the CNS and respiratory effects of apomorphine.

Dopamine antagonists such as metoclopramide should be considered in case of protracted vomiting.

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 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.

After subcutaneous administration apomorphine is rapidly absorbed. Peak plasma concentration (Cmax) is of 28.10 ± 7.58 ng/ml and is reached after about 20 minutes.

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

Apomorphine is conjugated in the liver (glucuronidation and methylation) into non-active metabolites.

Apomorphine is excreted in urine, mostly as the metabolites with some unchanged (<2%). It is also excreted in breast milk. The half-life of the product is 25.9 ± 4.4 minutes.

Vm 35079/4003