Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Medetomidine hydrochloride
Le Vet BV
QN05CM91
Medetomidine hydrochloride
1 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
medetomidine
Neurological Preparations
Authorised
2010-04-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Sedastart 1 mg/ml solution for injection for cats and dogs 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 0.2 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless, sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog and 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 gastrointestinal tract (torsio ventriculi, incarcerations, oesophagal obstructions). - pregnancy. - 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _ Read the complete document