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

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Medetomidine hydrochloride

Доступно од:

Laboratorios SYVA, S.A.U

АТЦ код:

QN05CM91

INN (Међународно име):

Medetomidine hydrochloride

Дозирање:

1 milligram(s)/millilitre

Фармацеутски облик:

Solution for injection

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска група:

Cats, Dogs

Терапеутска област:

medetomidine

Терапеутске индикације:

Neurological Preparations

Статус ауторизације:

Authorised

Датум одобрења:

2012-03-02

Карактеристике производа

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
I
R
I
S
H
M
E
D
I
C
I
N
E
S
B
O
A
R
D
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_6_
_/_
_1_
_1_