Apovomin 3 mg/ml solution for injection for dogs

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Apomorphine hydrochloride hemihydrate

Disponible depuis:

Dechra Regulatory B.V.

Code ATC:

QN04BC07

DCI (Dénomination commune internationale):

Apomorphine hydrochloride hemihydrate

Dosage:

3 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

apomorphine

Statut de autorisation:

Authorised

Date de l'autorisation:

2018-03-16

Résumé des caractéristiques du produit

Health Products Regulatory Authority
01 March 2019
CRN000YX0
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Apovomin 3 mg/ml solution for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Apomorphine hydrochloride hemihydrate
3.00 mg
(equivalent to apomorphine
2.56 mg)
EXCIPIENTS:
Benzyl alcohol (E1519)
10 mg
Sodium metabisulfite (E223)
1.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Induction of emesis.
4.3 CONTRAINDICATIONS
Do not use in cats.
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 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 to 15 minutes after the injection of the product and may
last from 2 minutes to 2.5 hours. 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.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Health Products Regulatory Authority
01 March 2019
CRN000YX0
Page 2 of 4
In dogs with known severe hepatic failure, the benefit/risk balance
for use of the