Nerfasin 100 mg/ml, solution for injection for cattle and horses
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
27-03-2013
Summary of Product characteristics
(SPC)
27-03-2013
Active ingredient:
xylazine hydrochloride 116.55 mg/ml
Available from:
Le Vet B.V
ATC code:
QN05CM92
Pharmaceutical form:
Solution for injection
Therapeutic group:
Xylazine
Therapeutic area:
Cattle Food, Horses Food
Authorization date:
2012-02-22
Patient Information leaflet
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,
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Summary of Product characteristics
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
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