Nazione: Regno Unito
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
xylazine hydrochloride 23.31 mg/ml
Le Vet B.V
QN05CM92
Solution for injection
Xylazine
Cats Non Food, Cattle Food, Dogs Non Food, Horses Food
2012-02-22
Xylazine 20 mg/ml, solution for injection NL/V/0158/001-002/IB/002 Packaging, Labelling and Package Leaflet version 2012/10 page 1 of 16 A. LABELLING Xylazine 20 mg/ml, solution for injection NL/V/0158/001-002/IB/002 Packaging, Labelling and Package Leaflet version 2012/10 page 2 of 16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Xylasol 20 mg/ml, solution for injection for cattle, horses, dogs and cats (BE, ES, FR, HU, IE, IT, NL and UK) Xysol vet. 20 mg/ml, solution for injection for cattle, horses, dogs and cats (DK, FI, NO and SE) Xylavet 20 mg/ml, solution for injection for cattle, horses, dogs and cats (AT, DE) Xylazine (as hydrochloride) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per ml: ACTIVE SUBSTANCE: Xylazine (as hydrochloride) 20.0 mg (equivalent to 23.31 mg xylazine hydrochloride) EXCIPIENTS: Methyl parahydroxybenzoate (E218) 1.0 mg 3. PHARMACEUTICAL FORM Solution for injection. 4. PACKAGE SIZE Bottle 10 ml 25 ml 50 ml 5. TARGET SPECIES Cattle, horses, dogs and cats. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Xylazine 20 mg/ml, solution for injection NL/V/0158/001-002/IB/002 Packaging, Labelling and Package Leaflet version 2012/10 page 3 of 16 Cattle: intravenous, intramuscular. Horses: intravenous. Dogs: intramuscular. Cats: intramuscular, subcutaneous. The stopper should not be pu Leggi il documento completo
NL/V/0158/001-002/IB/002 Xylasol 20mg/ml Summary of Product Characteristics version 2012/ 10 page 1 of 9 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Xylasol 20 mg/ml, solution for injection for cattle, horses, dogs and cats (BE, ES, FR, HU, IE, IT, NL and UK) Xysol vet. 20 mg/ml, solution for injection for cattle, horses, dogs and cats (DK, FI, NO and SE) Xylavet 20 mg/ml, solution for injection for cattle, horses, dogs and cats (AT, DE) 2. QUALITATIVE AND QUANTITIVE COMPOSITION Per ml: ACTIVE SUBSTANCE: Xylazine (as hydrochloride) 20.0 mg (equivalent to 23.31 mg xylazine hydrochloride) EXCIPIENTS: Methyl parahydroxybenzoate (E218) 1.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses, dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sedation. Premedication in combination with an anaesthetic. 4.3 CONTRAINDICATIONS • Do not use in animals with gastrointestinal obstruction as the muscle relaxant properties of the drug appear to accentuate the effects of the obstruction and because of possible vomiting. • Do not use in animals with severe renal or hepatic impairment, respiratory dysfunction, cardiac abnormalities, hypotension and/or shock. • Do not use in diabetic animals. • Do not use in animals with a history of seizures. • Do not use in calves younger than 1 week of age, foals younger than 2 weeks or in puppies and kittens you Leggi il documento completo