Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Mepivacaine hydrochloride
Richter Pharma AG
QN01BB03
Mepivacaine hydrochloride
20 milligram(s)/millilitre
Solution for injection
VPO: Veterinary Practitioner Only as defined in relevant national legislation
Horses
mepivacaine
Anaesthetic/Analgesic
Authorised
2018-01-05
Health Products Regulatory Authority 07 June 2018 CRN000YQY Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Mepidor 20 mg/ml solution for injection for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Mepivacaine hydrochloride 20 mg (equivalent to 17.4 mg Mepivacaine) 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 Horse 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Mepivacaine is indicated for intra-articular and epidural anaesthesia in horses. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to local anaesthetics belonging to the amide group, or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Aspirate prior to and during administration to avoid intra-vascular injection. The analgesic effect of mepivacaine, when used as part of a lameness investigation, Health Products Regulatory Authority 07 June 2018 CRN000YQY Page 2 of 5 begins to subside after 45-60 minutes. However, sufficient analgesia may persist to affect gait beyond two hours. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to mepivacaine or other local anaesthetics of the amide group should avoid contact with the veterinary medicinal product. This product may be an irritant to the skin and eyes. Avoid contact with the skin and eyes. Wash any splashes from skin and eyes immediately with plenty of water. Seek medical advice if irritation persists. Adverse effects on the foetus cannot be excluded. Pregnant women should avoid handling the product. Accidental self-injection may result in cardiorespiratory and/or CNS effects. Care should be taken to avoid accidental self-injection. In case of accidental self-inje Lees het volledige document