Land: Storbritannien
Språk: engelska
Källa: HMA (Heads of Medicines Agencies)
atipamezole hydrochloride 5 mg/ml
Laboratorios Syva SA
QV03AB90
Solution for injection
atipamezole
Cats Non Food, Dogs Non Food
2011-08-25
PART 1B SUMMARY OF PRODUCT CHARACTERISTICS, LABEL AND PACKAGE INSERT _ALZANE_ _Atipam ezole_ _ _ _ _ _5 mg/ml Solution for injection for dogs and cats _ _ _ 1 PART 1 B1 – SUMMARY OF PRODUCT CHARACTERISTICS _ALZANE_ _Atipam ezole_ _ _ _ _ _5 mg/ml Solution for injection for dogs and cats _ _ _ 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Alzane 5 mg/ml, solution for injection for dogs and cats (In Finland and Sweden: Alzane vet. 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 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 Dogs and cats. 4.2. INDICATIONS FOR US E, SPECIFYING THE TARGET SPECIES Atipamezole hydrochloride is a selective α2-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 or animals suffering from hepatic,renal or cardiac 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 t Läs hela dokumentet