Land: Portugal
Taal: Engels
Bron: HMA (Heads of Medicines Agencies)
methadone hydrochloride 10 mg/ml
Eurovet Animal Health
QN02AC52
Solution for injection
methadone, combinations excl. psycholeptics
Cats, Dogs
2011-02-23
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Comfortan 10 mg/ml, solution for injection for dogs and cats Spain, Italy, Portugal: Semfortan 10 mg/ml, solution for injection for dogs and cats France: Comfortan, solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE : Methadone 8.9 mg equivalent to methadone hydrochloride 10 mg EXCIPIENT(S): Methyl parahydroxybenzoate (E218) 1.0 mg Propyl parahydroxybenzoate (E216) 0.2 mg For a 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 CONTRA-INDICATIONS Do not use in known 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 ma Lees het volledige document