Emedog
Active substance
ATC code
Species
Dog.
Indications
Induction of emesis.
Dose to be administered and administration route
Subcutaneous route only.
Single injection at a dosage of 0.1 mg of apomorphine/kg bodyweight (equivalent to 1 ampoule of 1 ml/10 kg BW).
To ensure a correct dosage, body weight should be determined as accurately as possible.
Adverse reactions
Dogs:
|
Very common (>1 animal / 10 animals treated): |
Drowsiness1 Decreased (or loss) appetite 1, increased salivation1 Immediate pain upon injection (mild to moderate)1 |
|
Common (1 to 10 animals / 100 animals treated): |
Dehydration (slight)1 Cardiac rhythm disorders 1,2 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Ataxia |
1These adverse events are transient and may be related to the physiological response to expulsive efforts.
2 Tachycardia followed by bradycardia.
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 section “contact details” of the package leaflet.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Emedog, 1 mg/ml, solution for injection for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
Active substance:
Apomorphine 1.0 mg
(equivalent to 1.17 mg of apomorphine hydrochloride hemihydrate)
Excipients:
Sodium metabisulfite (E223) 1.0 mg
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection.
Colourless or slightly yellow, clear liquid.
4. CLINICAL PARTICULARS
4.1 Target species
Dog.
4.2 Indications for use, specifying the target species
Induction of emesis.
4.3 Contraindications
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.
4.4 Special warnings for each target species
Expulsive efforts with or without vomiting are likely to be seen from 2 and 15 minutes after the injection of the veterinary medicinal 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 veterinary 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 (see section 4.10 “Overdose (symptoms, emergency procedures, antidotes), if necessary”).
4.5 Special precautions for use
i) Special precautions for use in animals
In dogs with known severe hepatic failure, the risk/benefit balance 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 on the suitability of inducing emesis based the type of substance ingested (see section 4.3 also).
ii) 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 or breast-feeding women should avoid handling the veterinary medicinal product.
This veterinary medicinal product may cause hypersensitivity reactions. People with known hypersensitivity to apomorphine or any of the excipients should avoid contact with the veterinary medicinal product.
If the veterinary medicinal product comes into contact with the skin or eyes, rinse immediately with water. Wash hands after use.
iii) Special precautions for the protection of the environment:
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Dogs:
|
Very common (>1 animal / 10 animals treated): |
Drowsiness1 Decreased (or loss) appetite 1, increased salivation1 Immediate pain upon injection (mild to moderate)1 |
|
Common (1 to 10 animals / 100 animals treated): |
Dehydration (slight)1 Cardiac rhythm disorders 1,2 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Ataxia |
1These adverse events are transient and may be related to the physiological response to expulsive efforts.
2 Tachycardia followed by bradycardia.
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 section “contact details” of the package leaflet.
4.7 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 in accordance with the benefit/risk assessment by the responsible veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
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.
4.9 Amount(s) to be administered and administration route
Subcutaneous route only.
Single injection at a dosage of 0.1 mg of apomorphine/kg bodyweight (equivalent to 1 ampoule of 1 ml/10 kg BW).
To ensure a correct dosage, body weight should be determined as accurately as possible.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
4.11 Withdrawal period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Dopamine agonists.
ATC Vet Code: QN04BC07
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic particulars
Absorption
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.
Distribution
Apomorphine is very lipophilic and equilibrates rapidly between blood and tissue.
Apomorphine binds extensively to plasma proteins.
Metabolism
Apomorphine is conjugated in the liver (glucuronidation and methylation) into nonactive metabolites.
Excretion
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 veterinary medicinal product is 25.9 ± 4.4 minutes.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium metabisulfite (E223)
Hydrochloric acid, concentrated (for pH adjustment) Water for injections
6.2 Major Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years. Shelf life after first opening the immediate packaging: Use immediately after opening.
6.4 Special precautions for storage
Store in the original package. Protect from light.
Any solution remaining in the ampoule following withdrawal of the required dose should be discarded.
6.5 Nature and composition of immediate packaging
Cardboard box of 5 colourless glass ampoules type I of 1 ml.
Cardboard box of 20 colourless glass ampoules type I of 1 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Domes Pharma
3 Rue Andre Citroën
63430 Pont-Du-Chateau France
8. MARKETING AUTHORISATION NUMBER
Vm 54982/5002
9. DATE OF FIRST AUTHORISATION
14 July 2015
10. DATE OF REVISION OF THE TEXT
May 2023
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
POM-V
Approved 26 May 2023
