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

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Methadone hydrochloride

Saadav alates:

Le Vet Beheer B.V.

ATC kood:

QN02AC52

INN (Rahvusvaheline Nimetus):

Methadone hydrochloride

Annus:

10 milligram(s)/millilitre

Ravimvorm:

Solution for injection

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Cats, Dogs

Terapeutiline ala:

methadone, combinations excl. psycholeptics

Näidustused:

Miscellaneous

Volitamisolek:

Authorised

Loa andmise kuupäev:

2014-10-10

Toote omadused

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