Synthadon 10 mg/ml solution for injection for cats and dogs

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Methadone hydrochloride

Disponible depuis:

Le Vet Beheer B.V.

Code ATC:

QN02AC52

DCI (Dénomination commune internationale):

Methadone hydrochloride

Dosage:

10 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Cats, Dogs

Domaine thérapeutique:

methadone, combinations excl. psycholeptics

indications thérapeutiques:

Miscellaneous

Statut de autorisation:

Authorised

Date de l'autorisation:

2014-10-10

Résumé des caractéristiques du produit

Health Products Regulatory Authority
09 July 2019
CRN008RMM
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Synthadon 10 mg/ml solution for injection for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Methadone hydrochloride
​
10 mg
​
equivalent to methadone
​
8.9 mg
​
EXCIPIENTS:
​
​
Methyl parahydroxybenzoate (E218)
​
1.0 mg
​
Propyl parahydroxybenzoate (E216)
​
0.2 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
A clear colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Analgesia in dogs and cats.
Premedication for general anaesthesia or neuroleptanalgesia in dogs
and cats in combination with a neuroleptic drug.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in animals with advanced respiratory failure.
Do not use in animals with severe liver and renal dysfunction.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Due to the variable individual response to methadone, animals should
be regularly monitored to ensure sufficient efficacy for
the desired effect duration. Use of the product must be preceded by a
thorough clinical examination. In cats pupil dilatation is
seen long after the analgesic effect has disappeared. It is therefore
not an adequate parameter to assess clinical efficacy of the
administered dose.
Greyhounds may require higher doses than other breeds to achieve
efficacious plasma levels.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Methadone may occasionally cause respiratory depression and as with
other opioid drugs, care should be taken when treating
animals with impaired respiratory function or animals that are
receiving drugs that can cause respiratory depression. To ensure
safe use of the product, treated animals should be monitored
r