Sedaxylan, 20 mg/ml solution for injection for dogs, cats, horses and cattle

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Xylazine Hydrochloride

Tilgjengelig fra:

Eurovet Animal Health B.V.

ATC-kode:

QN05CM92

INN (International Name):

Xylazine Hydrochloride

Dosering :

20 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cats, Cattle, Dogs, Horses

Terapeutisk område:

xylazine

Indikasjoner:

Neurological Preparations

Autorisasjon status:

Authorised

Autorisasjon dato:

2003-05-02

Preparatomtale

Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedaxylan, 20 mg/ml solution for injection for dogs, cats, horses and
cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 millilitre contains:
ACTIVE SUBSTANCE:
Xylazine (base) 20.0 mg
Equivalent to 23.32 mg xylazine hydrochloride
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218) 1.0 mg
Propyl parahydroxybenzoate 0.1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear and colourless.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats, horses and cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Sedation of dogs, cats, horses and cattle.
4.3 CONTRAINDICATIONS
Do not use in the later stages of pregnancy, see section 4.7
Do not use in animals with oesophageal obstruction, and torsion of the
stomach, 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 renal or hepatic impairment, respiratory
dysfunction, cardiac abnormalities, hypotension and/or
shock. Do not use in diabetic animals.
Do not use in calves younger than 1 week of age, foals younger than 2
weeks or in puppies and kittens younger than 6 weeks.
See also section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
​
DOGS AND CATS:

Xylazine inhibits the normal intestinal motility. This may make
xylazine sedation undesirable for upper
gastro-intestinal radiographs, because it promotes filling of the
stomach with gas and makes interpretation less
certain.

Brachycephalic dogs with air way disease or malfunction may develop
life-threatening dyspnoea
HORSES:

Xylazine inhibits the normal intestinal motility. Therefore, it should
only be used in horses with colic, that are not
Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 2 of 6
responsive to analgesics. The use of xylazine should be avoided in
horses with caecal malfun