Dorbene Vet 1 mg/ml Solution for Injection for Dogs and Cats

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Medetomidine Hydrochloride

Tersedia dari:

Laboratorios SYVA S.A.U

Kode ATC:

QN05CM91

INN (Nama Internasional):

Medetomidine Hydrochloride

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Cats, Dogs

Area terapi:

Neurological Agent sedative

Status otorisasi:

Authorized

Tanggal Otorisasi:

2007-12-06

Karakteristik produk

Revised: November 2012
AN: 01326/2011
Page 1 of 7
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.
Revised: November 2012
AN: 01326/2011
Page 2 of 7
Do not use in animals with ocular problems where an increase in
intraocular pressure
would be detrimental.
See also section 4.7
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 additional
analgesia for painful
procedures.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
A clinical examination should be carried out in all animals before the
use of veterinary
medicinal products for sedation and/or general anaesthesia. Higher
doses of
medetomidine should