Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
medetomidine hydrochloride 0.85 mg/ml
Vetpharma Animal Health S.L
QN05CM91
Solution for injection
Medetomidine
Cats, Dogs
2012-02-13
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Sededorm solution for injection for dogs and cats [FR] Sededorm 1 mg/ml solution for injection for dogs and cats [BE, DE, ES, HU, NL, PL, PT, UK] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Medetomidine hydrochloride ............................................ 1.0 mg (equivalent to medetomidine ............................................ 0.85 mg) Excipients: Methyl parahydroxybenzoate (E218) ................................ 1.0 mg Propyl parahydroxybenzoate .......................................... 0.2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and 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 in order to facilitate the restraint of animals during clinical examinations. - Premedication prior to general anaesthesia. 4.3. CONTRAINDICATIONS Do not use in animals with serious cardiovascular disease, respiratory disease or hepatic or renal disorders. Do not use in case of mechanical disorders of gastrointestinal tract (torsion of the stomach, imprisonment, obstruction of the oesophagus). Do not administer in conjunction with sympathomimetic amines. Do not use in case of known hypersensitivity to the active substance or to any of the excipients. Do not use in animals with diabetes mellitus. Do n Read the complete document