Nazione: Regno Unito
Lingua: inglese
Fonte: VMD (Veterinary Medicines Directorate)
Atipamezole Hydrochloride
Eurovet Animal Health BV
QV03AB90
Atipamezole Hydrochloride
Expired
Issued: June 2011 AN: 00964/2010 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Revazol, 5.0 mg/ml, solution for injection for cats and dogs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active ingredients Atipamezole hydrochloride 5.0 mg (equivalent to 4.27 mg atipamezole base) Excipients Methyl parahydroxybenzoate (E 218) 1.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless sterile aqueous solution. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cats and dogs. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Atipamezole is indicated for the reversal of the sedative & analgesic effects of medetomidine or dexmedetomidine in dogs and cats. It also reverses all other effects of medetomidine or dexmedetomidine, such as cardiovascular and respiratory effects. 4.3. CONTRAINDICATIONS Not recommended for use in pregnant dogs and cats (see also 4.7). Concurrent use of drugs affecting the CNS is not recommended, apart from those in the SPC (see also 6.2). 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES When any combination of butorphanol or medetomidine or dexmedetomidine and ketamine have been used, atipamezole should not be used to reverse the effect in dogs. Page 1 of 5 Issued: June 2011 AN: 00964/2010 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Due to the potent pharmacological activity of atipamezole, skin contact with this product should be avoided and impervious gloves should be worn during administration. Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek immediate medical at Leggi il documento completo