Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Mepivacaine hydrochloride
Dechra Regulatory B.V.
QN01BB03
Mepivacaine hydrochloride
20 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
mepivacaine
Authorised
2017-12-15
Health Products Regulatory Authority 07 January 2019 CRN008S6T Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Mepiblock 20 mg/ml solution for injection for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substance: Mepivacaine (as hydrochloride) 17.42 mg Equivalent to 20 mg of mepivacaine hydrochloride For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear, colourless solution, practically free from visible particles. 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. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None Health Products Regulatory Authority 07 January 2019 CRN008S6T Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Care should be taken to avoid intra-vascular injection, by aspiration prior to and during administration. The analgesic effect of mepivacaine, when used as part of a lameness investigation, begins to subside after 45-60 minutes. However, sufficient analgesia may persist to effect gait beyond two hours. Special precautions to be taken by the person administering the veterinary medicinal product to animals Care should be taken to avoid accidental self-injection. In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician. Adverse effects in the foetus cannot be excluded. Pregnant women should avoid handling the veterinary medicinal product. People with known hypersensitivity to mepivacaine or other local anaesthetics of the amide group should avoid contact with the veterinary medicinal product. The product may be irritant to the skin and e Read the complete document