Land: Bretland
Tungumál: enska
Heimild: VMD (Veterinary Medicines Directorate)
Methadone Hydrochloride
Zoetis UK Limited
QN02AC90
Methadone Hydrochloride
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Neurological Agent analgesic
Authorized
2018-09-20
Unlimited Renewal: September 2023 AN: 01815/2023 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Methadyne 10 mg/ml solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substance: Methadone hydrochloride 10.0 mg Equivalent to Methadone 8.9 mg Excipient(s): Methyl parahydroxybenazoate (E218) 1.0 mg Propyl parahydroxybenzoate 0.2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection A clear colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES • Analgesia. • Premedication for general anaesthesia or neuroleptanalgesia in combination with a neuroleptic drug. 4.3 CONTRAINDICATIONS 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 monitored regularly to ensure sufficient efficacy for the desired duration of effect. Unlimited Renewal: September 2023 AN: 01815/2023 Page 2 of 7 Use of the product must be preceded by a thorough clinical examination. In cats, pupil dilation 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 regularly, including examinati Lestu allt skjalið