DORBENE VET 1 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
10-05-2024
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Senda beiðni.
Virkt innihaldsefni:
MEDETOMIDINE HYDROCHLORIDE
Fáanlegur frá:
Laboratorios Syva, S.A.U
ATC númer:
QN05CM91
INN (Alþjóðlegt nafn):
MEDETOMIDINE HYDROCHLORIDE
Skammtar:
1 Mg/Ml
Lyfjaform:
Solution for Injection
Gerð lyfseðils:
VPO-Vet.Practitioner Only
Meðferðarhópur:
Canine, Feline
Lækningarsvæði:
Medetomidine
Ábendingar:
Neurological Preparations
Leyfisstaða:
Authorised
Leyfisdagur:
2012-03-02
Vara einkenni
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
________________________________________________________________________________________________________________________
_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
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