Country: Ավստրիա
language: անգլերեն
source: 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
A. LABELLING PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nerfasin vet. 100 mg/ml, solution for injection for cattle and horses 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 Cattle: intramuscular. Horses: intravenous. The stopper should not be punctured more than 20 times. Number of punctures:................. Read the package leaflet before use. 8. WITHDRAWAL PERIOD Cattle: Meat and offal: 1 day Milk: zero hours Horses: Meat and offal: 1 day Milk: zero hours 9. SPECIAL WARNING(S), IF NECESSARY Accidental injection is dangerous – read the package leaflet before use. Accidental intake and contact with skin, eyes and mucous membranes is dangerous – read the package leaflet before use. 10. EXPIRY DATE EXP:Shelf life after first opening the immediate packaging: 28 days. Once broached/opened, use by….. 11. SPECIAL STORAGE CONDITIONS Do not refrigerate or freeze. 12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, read_full_document
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nerfasin vet. 100 mg/ml, solution for injection for cattle and horses (AT, BE, CZ, DK, EL, FI, FR, HU, IS, LU, NL, NO, PL, SE, and SK) Nerfasin 100 mg/ml, solution for injection for cattle and horses (ES, IE, IT, PT and UK) 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). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES HORSES: • Xylazine inhibits the normal intestinal motility. Therefore, it should only be used in hor read_full_document