Xylasol 100 mg/ml, oplossing voor injectie voor runderen en paarden

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

XYLAZINEHYDROCHLORIDE

Beschikbaar vanaf:

CP-Pharma Handelsgesellschaft mbH

ATC-code:

QN05CM92

INN (Algemene Internationale Benaming):

XYLAZINEHYDROCHLORIDE

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

XYLAZINEHYDROCHLORIDE 116,55 mg/ml,

Toedieningsweg:

Intraveneus gebruik, Intramusculair gebruik

Prescription-type:

Uitsluitend door dierenartsen te gebruiken

Therapeutische categorie:

Honden; Katten; Paarden; Runderen

Therapeutisch gebied:

Xylazine

Product samenvatting:

Wachttermijn: Paarden Melk 0 uur; Paarden Vlees 1 dagen; Runderen Melk 0 uur; Runderen Vlees 1 dagen

Autorisatie-status:

NL/V/0158/002

Autorisatie datum:

2012-04-10

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Xylasol 100 mg/ml, solution for injection for cattle and horses
(ES, HU, NL)
Xylavet 100 mg/ml, solution for injection for cattle and horses
(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 the 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 horses
with colic, that are not responsive to analgesics. The use of xylazine
should be avoided in
horses with caecal malfunction.
•
After treatment of horses with xylazine, the animals are reluctant to
walk, so whenever
possible the drug should be administered in the place where the
treatment/investigation is
going to take place.
•
Caution should be taken in the administration of the product to horses
susceptible to
laminitis.
•
Horses with airway disease or malfunction may d