Riik: Kreeka
keel: inglise
Allikas: HMA (Heads of Medicines Agencies)
atipamezole hydrochloride 5 mg/ml
Le Vet B.V
QV03AB90
Solution for injection
atipamezole
Cats, Dogs
2011-03-30
PART I B SUMMARY OF PRODUCT CHARACTERISTICS, LABEL AND PACK AGE INSERT SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Narcostop 5 mg/ml – Solution for Injection for Cats and Dogs (NL, AT, BE, CZ, EL, FR, HU, IS, IE, LU, PL, SK) Sedastop 5 mg/ml – Solution for Injection for Cats and Dogs (SE, NO, DK, ES, PT, IT, UK, FI) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: _ _ _Active substance: _ Atipamezole (as hydrochloride) 4.27 mg Equivalent to 5.0 mg of atipamezole hydrochloride _ _ _ _ _Excipients: _ Methyl parahydroxybenzoate (E 218) 1.0 mg _ _ For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A clear 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 indicated for reversal of the sedative effects and cardiovascular effects on circulation after use of alpha-2- agonists like medetomidine and dexmedetomidine in dogs and cats. 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. 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 Lugege kogu dokumenti