DORBENE VET 1 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MEDETOMIDINE HYDROCHLORIDE

Available from:

Laboratorios Syva, S.A.U

ATC code:

QN05CM91

INN (International Name):

MEDETOMIDINE HYDROCHLORIDE

Dosage:

1 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

VPO-Vet.Practitioner Only

Therapeutic group:

Canine, Feline

Therapeutic area:

Medetomidine

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2012-03-02

Summary of Product characteristics

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
IRISH MEDICINES BOARD
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_Date Printed 16/11/2012_
_CRN 7011667_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Medetomidine may not provide analgesia throughout the entire period of sedation, therefore consideration should be
given to providing addition