Dorbene vet 1 mg/ml solution for injection for dogs and cats

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Medetomidine hydrochloride

Tilgjengelig fra:

Laboratorios SYVA, S.A.U

ATC-kode:

QN05CM91

INN (International Name):

Medetomidine hydrochloride

Dosering :

1 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cats, Dogs

Terapeutisk område:

medetomidine

Indikasjoner:

Neurological Preparations

Autorisasjon status:

Authorised

Autorisasjon dato:

2012-03-02

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dorbene vet 1 mg/ml solution for injection for dogs and cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
ACTIVE SUBSTANCE:
Medetomidine hydrochloride
1.0 mg
(equivalent to 0.85 mg medetomidine)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
1.0 mg
Propyl parahydroxybenzoate (E 216)
0.2 mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_In dogs and cats:_
Sedation to facilitate handling. Premedication prior to general
anaesthesia.
_In cats:_
In combination with ketamine for general anaesthesia for minor
surgical procedures of short duration.
4.3 CONTRAINDICATIONS
Do not use in animals with:
- Severe cardiovascular disease or respiratory diseases or impaired
liver or kidney function.
- Mechanical disturbances of the gastro-intestinal tract (torsio
ventriculi, incarcerations,
oesophageal obstructions).
- Diabetes mellitus.
- State of shock, emaciation or serious debilitation.
Do not use concomitantly with sympathomimetic amines.
Do not use in cases of known hypersensitivity to the active substance
or to any other excipients.
Do not use in animals with ocular problems where an increase in
intraocular pressure would be detrimental.
See also section 4.7
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