Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Detomindine hydrochloride
Eurovet Animal Health B.V.
QN05CM90
Detomindine hydrochloride
10 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Horses
detomidine
Neurological Preparations
Authorised
2006-09-27
Health Products Regulatory Authority 25 June 2019 CRN0094HY Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Domidine 10 mg/ml solution for injection, for horses and cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: ACTIVE SUBSTANCES: Detomidine hydrochloride 10.0 mg this corresponds to 8.36 mg detomidine base 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. endoscopia, 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 or inhalation anaesthetics. 4.3 CONTRAINDICATIONS Do not use in animals with cardiac abnormalities or respiratory diseases. Do not use in animals with liver insufficiency or renal failure. Do not use in animals with general health problems (e.g. diabetes mellitus, dehydrated animals, shock or any other extraordinary stress conditions). Do not use in combination with butorphanol in horses suffering from colic. See also section 4.7 and 4.8. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Health Products Regulatory Authority 25 June 2019 CRN0094HY Page 2 of 5 As sedation begins, especially horses may start to sway and lower the head rapidly while they remain standing. Cattle and especially young cattle will try to lie down. To prevent injuries the location sho Olvassa el a teljes dokumentumot