País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Lidocaine hydrochloride
Bela-Pharm GmbH & Co. KG
QN01BB02
Lidocaine hydrochloride
20 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
lidocaine
Authorised
2018-07-06
Health Products Regulatory Authority 10 July 2018 CRN000VL5 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT LidoBel 20 mg/ml solution for injection for horses, dogs, and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: ACTIVE SUBSTANCE: Lidocaine hydrochloride: 20 mg (equivalent to Lidocaine: 16.23 mg) EXCIPIENTS: Methyl parahydroxybenzoate (E 218): 1.8 mg Propyl parahydroxybenzoate: 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 Horses, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For local/nerve block (regional infiltration) including field block anaesthesia. Superficial anaesthesia of mucous membranes. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipient. Do not use in cases of inflammatory tissue disorders at the site of application. Do not use in infected tissue. Do not use in new-born animals. Health Products Regulatory Authority 10 July 2018 CRN000VL5 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Do not administer by intravenous injection. Use with extreme care in animals with cardiac insufficiency, cardiac arrhythmia, hyperkalaemia, liver dysfunction, Diabetes mellitus, acidosis and neurological diseases. Exact dosing and appropriate injection technique must therefore be ensured. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. People with known hypersensitivity to lidocaine hydrochloride or any of the excipients should avoid contact with the veterinary medicinal product. 4.6 ADVERSE REACTIONS Llegiu el document complet