Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Alfaxalone
Jurox (UK) Limited
QN01AX05
Alfaxalone
10 milligram(s)/millilitre
Solution for injection
VPO: Veterinary Practitioner Only as defined in relevant national legislation
Cats, Dogs, Rabbits
alfaxalone
Neurological Preparations
Authorised
2018-04-27
Health Products Regulatory Authority 27 April 2018 CRN000VGT Page 1 of 10 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains: ACTIVE SUBSTANCE: Alfaxalone 10 mg EXCIPIENTS: Ethanol 150 mg Chlorocresol 1 mg Benzethonium 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, cats and pet rabbits 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES As an induction agent prior to inhalation anaesthesia in dogs, cats and pet rabbits. As a sole anaesthetic agent for the induction and maintenance of anaesthesia for the performance of examination or surgical procedures in dogs and cats. 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. Health Products Regulatory Authority 27 April 2018 CRN000VGT Page 2 of 10 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 (dogs and cats) and 16 weeks of age (rabbits) 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. In rabbits, oxygenation pr Lestu allt skjalið