Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Alfaxalone
Jurox (Ireland) Limited
QN01AX05
Alfaxalone
10 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
alfaxalone
Authorised
2019-01-07
Health Products Regulatory Authority 01 October 2020 CRN009V7G Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Alfaxan Multidose 10 mg/ml solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH ML OF SOLUTION CONTAINS: ACTIVE SUBSTANCE: Alfaxalone 10 mg EXCIPIENTS: Ethanol 150 mg Chlorocresol 1 mg Benzathonium chloride 0.2 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES As an induction agent prior to inhalation anaesthesia. As a sole anaesthetic agent for the induction and maintenance of anaesthesia for the performance of examination or surgical procedures. 4.3 CONTRAINDICATIONS Do not use in combination with other intravenous anaesthetic agents. Do not use on animals with hypersensitivity to the active substance or any other excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The analgesic properties of alfaxalone are limited, therefore appropriate peri-operative analgesia should be provided in cases where procedures are anticipated to be painful. 4.5 SPECIAL PRECAUTIONS FOR USE (i) Special precautions for use in animals The safety of the veterinary medicinal product in animals less than 12 weeks of age has not been demonstrated. Transient post induction apnoea frequently occurs, particularly in dogs - see section 4.6 for details. In such cases, endotracheal intubation and oxygen supplementation should be employed. Facilities for intermittent positive pressure ventilation should be available. In order to minimise the possibility of apnoea, administer the veterinary medicinal product by slow intravenous injection and not as a rapid dose. The use of a preplaced catheter in dogs and cats is recommended as best practice for anaesthetic procedures. Health Products Regulatory Authority 0 Pročitajte cijeli dokument