País: Alemania
Idioma: inglés
Fuente: HMA (Heads of Medicines Agencies)
xylazine hydrochloride 116.55 mg/ml
Le Vet B.V
QN05CM92
Solution for injection
Xylazine
Cattle Food, Horses Food
2012-02-22
Xylazine 100 mg/ml, solution for injection NL/V/0158/001-002/IB/002 Packaging, Labelling and Package Leaflet version 2012/10 page 1 of 14 A. LABELLING Xylazine 100 mg/ml, solution for injection NL/V/0158/001-002/IB/002 Packaging, Labelling and Package Leaflet version 2012/10 page 2 of 14 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Xylasol 100 mg/ml, solution for injection for cattle and horses (BE, ES, FR, HU, IE, IT, NL and UK) Xysol vet. 100 mg/ml, solution for injection for cattle and horses (DK, FI, NO and SE) Xylavet 100 mg/ml, solution for injection for cattle and horses (AT, DE) Xylazine (as hydrochloride) 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per ml: ACTIVE SUBSTANCE: Xylazine (as hydrochloride) 100.0 mg (equivalent to 116.55 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 (≥ 200 kg) and horses. 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Xylazine 100 mg/ml, solution for injection NL/V/0158/001-002/IB/002 Packaging, Labelling and Package Leaflet version 2012/10 page 3 of 14 Cattle: intramuscular. Horses: intravenous. The stopper should not be punctured more than 20 times. Number of punctures:................. Read the package leaflet Leer el documento completo
NL/V/0158/001-002/IB/002 Xylasol 100mg/ml Summary of Product Characteristics version 2012/ 10 page 1 of 7 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Xylasol 100 mg/ml, solution for injection for cattle and horses (BE, ES, FR, HU, IE, IT, NL and UK) Xysol vet. 100 mg/ml, solution for injection for cattle and horses (DK, FI, NO and SE) Xylavet 100 mg/ml, solution for injection for cattle and horses (AT, DE) 2. QUALITATIVE AND QUANTITIVE COMPOSITION Per ml: ACTIVE SUBSTANCE: Xylazine (as hydrochloride) 100.0 mg (equivalent to 116.55 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 (≥ 200 kg) and horses. 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 cattle weighing less than 200 kg bodyweight. Do not use in foals younger than 2 weeks. • Do not use during the last stage of pregnancy (danger of premature birth), except at parturition (see section 4.7). Leer el documento completo