Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ATIPAMEZOLE HYDROCHLORIDE
Laboratorios Syva, S.A.U
QV03AB90
ATIPAMEZOLE HYDROCHLORIDE
5 Mg/Ml
Solution for Injection
POM
Canine, Feline
Atipamezole
Neurological Preparations
Authorised
2011-10-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Alzane 5 mg/ml, solution for injection for dogs and cats 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 the 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 Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Atipamezole hydrochloride is a selective 2-antagonist and indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in dogs and cats. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance or to any of the excipients. Do not use in breeding animals or animals suffering from hepatic, renal or cardiac diseases. See also section 4.7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 26/06/2015_ _CRN 7019138_ _page number: 1_ 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 animals should not be left unattended. Make sure the animal has regained a normal swallowing reflex before any food or drink is offered. Due to different dosing recommendations caution should be taken using the product off label in animals other than the target species. If sedatives other than medetomidine or dexmedetomidine are given, it must be kept in mind that the effects of those other ag Prečítajte si celý dokument