Xylasol 20 mg/ml, solution for injection for cattle, horses, dogs and cats
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
21-08-2013
Summary of Product characteristics
(SPC)
21-08-2013
Active ingredient:
xylazine hydrochloride 23.31 mg/ml
Available from:
Le Vet B.V
ATC code:
QN05CM92
Pharmaceutical form:
Solution for injection
Therapeutic group:
Xylazine
Therapeutic area:
Cats Non Food, Cattle Food, Dogs Non Food, Horses Food
Authorization date:
2012-02-22
Patient Information leaflet
Xylazine 20 mg/ml, solution for injection
NL/V/0158/001-002/IB/002
Packaging, Labelling
and Package Leaflet
version 2012/10
page 1 of 16
A. LABELLING
Xylazine 20 mg/ml, solution for injection
NL/V/0158/001-002/IB/002
Packaging, Labelling
and Package Leaflet
version 2012/10
page 2 of 16
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARTON BOX
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Xylasol 20
mg/ml, solution for injection for cattle, horses, dogs and cats
(BE, ES, FR, HU, IE, IT, NL and UK)
Xysol vet. 20
mg/ml, solution for injection for cattle, horses, dogs and cats
(DK, FI, NO and SE)
Xylavet 20
mg/ml, solution for injection for cattle, horses, dogs and cats
(AT, DE)
Xylazine (as hydrochloride)
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per ml:
ACTIVE SUBSTANCE:
Xylazine (as hydrochloride)
20.0 mg
(equivalent to 23.31 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, horses, dogs and cats.
6.
INDICATION(S)
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Xylazine 20 mg/ml, solution for injection
NL/V/0158/001-002/IB/002
Packaging, Labelling
and Package Leaflet
version 2012/10
page 3 of 16
Cattle: intravenous, intramuscular.
Horses: intravenous.
Dogs: intramuscular.
Cats: intramuscular, subcutaneous.
The stopper should not be pu
Read the complete document
Summary of Product characteristics
NL/V/0158/001-002/IB/002
Xylasol 20mg/ml Summary of Product Characteristics
version 2012/ 10
page 1 of 9
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Xylasol 20
mg/ml, solution for injection for cattle, horses, dogs and cats
(BE, ES, FR, HU, IE, IT, NL and UK)
Xysol vet. 20
mg/ml, solution for injection for cattle, horses, dogs and cats
(DK, FI, NO and SE)
Xylavet 20
mg/ml, solution for injection for cattle, horses, dogs and cats
(AT, DE)
2.
QUALITATIVE AND QUANTITIVE COMPOSITION
Per ml:
ACTIVE SUBSTANCE:
Xylazine (as hydrochloride)
20.0 mg
(equivalent to 23.31 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, horses, dogs and cats.
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 calves younger than 1
week of age, foals younger than 2 weeks or in
puppies and kittens you
Read the complete document
