Ülke: Hollanda
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
medetomidine hydrochloride 1 µg/ml
Eurovet Animal Health
QN05CM91
Injection
Medetomidine
Cats, Dogs
2011-10-27
_ _ 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) _ _ _ _ _ _ _ _0.85 mg _ _(equivalent to 1.0 mg medetomidine hydrochloride) _ _ _ _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 _ _ be detrimental. See also section 4.7 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES Medetomidine may not provide analgesia throughout the en Belgenin tamamını okuyun