מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Atipamezole hydrochloride
Eurovet Animal Health B.V.
QV03AB90
Atipamezole hydrochloride
5.0 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
atipamezole
Neurological Preparations
Authorised
2008-05-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Atipam, 5.0 mg/ml, solution for injection for cats and dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 hydrochloride is a selective 2-antagonist and indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in cats and dogs. 4.3 CONTRAINDICATIONS The product should not be used in: - Breeding animals - Animals suffering from liver- or renal diseases See also section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Make sure the animal has regained a normal swallowing reflex before any food or drink is offered. Each ml contains: Active ingredients Atipamezole hydrochloride (equivalent to 4.27 mg atipamezole base) 5.0 mg Excipients Methyl parahydroxybenzoate (E 218) 1.0 mg For a full list of excipients, see section 6.1. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _7_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _3_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _3_ _3_ _2_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _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 time animals should not be left unattended. Due to different dosing recommendations caution should be taken if using קרא את המסמך השלם