Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Methadone hydrochloride
Le Vet Beheer B.V.
QN02AC52
Methadone hydrochloride
10 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
methadone, combinations excl. psycholeptics
Miscellaneous
Authorised
2014-10-10
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 Прочитайте повний документ