Država: Austrija
Jezik: engleski
Izvor: 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, Pročitajte cijeli dokument
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 Pročitajte cijeli dokument