Země: Německo
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
detomidine hydrochloride 10 mg/ml
CP Pharma Handelsgesellschaft mbH
QN05CM90
Solution for injection
detomidine
Cattle, Horses
2011-09-30
1. NAME OF THE VETERINARY MEDICINAL PRODUCT CEPESEDAN 10 MG/ML, SOLUTION FOR INJECTION FOR HORSES AND CATTLE DE: Cepesedan RP 10 mg/ml, Solution for Injection for Horses and Cattle AT / BE / ES / FR / IE / IT / PT / UK: Medesedan 10 mg/ml, Solution for Injection for Horses and Cattle DK / FI / NO / SE: Cepesedan vet. 10 mg/ml, Solution for Injection for Horses and Cattle CZ / HU / LT / LV / NL / PL / SK: Cepesedan 10 mg/ml, Solution for Injection for Horses and Cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: _ACTIVE SUBSTANCE: _ Detomidine hydrochloride 10.0 mg (equivalent to 8.36 mg detomidine) _EXCIPIENTS: _ Methyl parahydroxybenzoate (E 218) 1.0 mg For a 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 Horse, cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the sedation and slight analgesia of horses and cattle, to facilitate physical examinations and treatments, such as minor surgical interventions. Detomidine can be used for: Examinations (e.g. endoscopy, rectal and gynaecological examinations, X-rays). Minor surgical procedures (e.g. treatment of wounds, dental treatment, tendon treatment, excision of skin tumours, teat treatment). Before treatment and medication (e.g. stomach tube, horse shoeing). For premedication prior to administration of injection Přečtěte si celý dokument