Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Methadone hydrochloride
Richter Pharma AG
QN02AC90
Methadone hydrochloride
10 milligram(s)/millilitre
Solution for injection
VPO: Veterinary Practitioner Only as defined in relevant national legislation
methadone
Authorised
2018-07-20
Health Products Regulatory Authority 27 July 2020 CRN009RFG Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Insistor 10 mg/ml solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCES: Methadone hydrochloride 10 mg (equivalent to 8.9 mg Methadone) EXCIPIENTS: Methyl parahydroxybenzoate (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. Clear colourless to slightly yellow 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 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. 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 examin Belgenin tamamını okuyun