Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Atipamezole hydrochloride
CP-Pharma Handelsgesellschaft mbH
QV03AB90
Atipamezole hydrochloride
5 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
atipamezole
Neurological Preparations
Authorised
2008-04-25
Health Products Regulatory Authority 02 July 2019 CRN0095H5 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Revertor 5 mg/ml Solution for Injection for Dogs and Cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: ACTIVE SUBSTANCE: Atipamezole hydrochloride 5.0 mg (equivalent to 4.27 mg atipamezole) EXCIPIENT(S): Methyl parahydroxybenzoate 1.0 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Atipamezole hydrochloride is a selective a2-Antagonist and indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in dogs and cats. 4.3 CONTRAINDICATIONS Do not use in: - Breeding animals. - Animals suffering from liver- or renal diseases. See also section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS After administration of the product, the animals should be allowed to rest in a quiet place. During recovery time animals should not be left unattended. Make sure that the animal has regained a normal swallowing reflex before any food or drink is offered. Due to different dosing recommendations caution should be taken if using the product off-label in animals other than the target species. If other sedatives than medetomidine are given it must be kept in mind that the effects of those other agents may persist after reversal of (dex)medetomidine. Atipamezole does not reverse the effect of ketamine, which may cause Health Products Regulatory Authority 02 July 2019 CRN0095H5 Page 2 of 4 seizures in dogs and elicit cramps in cats when used alone. Do not use atipamezole earlier than 30-40 minutes after concomitant administration of ketamine. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Due to the poten Leggi il documento completo