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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sedator, 1.0 mg/ml, solution for injection for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
_Active ingredients_
Medetomidine hydrochloride
1.00 mg
(equivalent to 0.85 mg medetomidine)
_FR: _
_Medetomidine (as hydrochloride) _
_ _
_ _
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_0.85 mg _
_(equivalent to 1.0 mg medetomidine hydrochloride) _
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_Excipients _
Methyl parahydroxybenzoate (E 218)
1.00 mg
Propyl parahydroxybenzoate (E 216)
0.20 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless sterile aqueous solution
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Dog, cat
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
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be detrimental.
See also section 4.7
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Medetomidine may not provide analgesia throughout the en
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