Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Detomidine hydrochloride
Orion Corporation
QN05CM90
Detomidine hydrochloride
7.6 milligram(s)/millilitre
Oromucosal gel
POM: Prescription Only Medicine as defined in relevant national legislation
Horses
detomidine
Neurological Preparations
Authorised
2009-02-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DOMOSEDAN GEL 7.6 mg/ml oromucosal gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oromucosal gel Even, translucent, blue gel 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horse 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sedation to facilitate restraint for non-invasive veterinary procedures (e.g. passage of naso-gastric tube, radiography, rasping teeth) and minor husbandry procedures (e.g. clipping, shoeing). 4.3 CONTRAINDICATIONS Do not use in seriously ill animals with heart failure or impaired liver or kidney function. Do not use in conjunction with intravenous potentiated sulphonamides. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Unlike most other oral veterinary products, this product is not meant to be swallowed. Instead, it must be placed under the tongue of the horse. When the product is administered, the animal should be allowed to rest in a quiet place. Before any procedure is initiated, sedation should be allowed to fully develop (approximately 30 min). ACTIVE SUBSTANCE: Detomidine 6.4 mg/ml (equivalent to detomidine hydrochloride 7.6 mg/ml) EXCIPIENTS: Brilliant Blue FCF (E133) 0.032 mg/ml For a full list of excipients, see section 6.1 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_ _e_ _d_ _ _ _1_ _5_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _0_ _9_ _9_ _0_ _p_ _a_ সম্পূর্ণ নথি পড়ুন