Xylasol 100 mg/ml, solution for injection for cattle and horses
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
23-08-2013
Summary of Product characteristics
(SPC)
23-08-2013
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
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
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Summary of Product characteristics
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).
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