Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Butorphanol tartrate
aniMedica GmbH
QN02AF01
Butorphanol tartrate
10 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Horses
butorphanol
Neurological Preparations
Authorised
2010-10-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Morphasol 10 mg/ml solution for injection for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Butorphanol 10 mg (as Butorphanol tartrate 14.7 mg/ml) Excipients Benzethonium chloride 0.1 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 Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For short term relief of pain associated with colic of gastrointestinal tract origin. For information on the onset and duration of analgesia that can be expected following treatment, see section 5.1. For sedation in combination with certain 2-adrenoceptor agonists (see section 4.9). 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_ _9_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _9_ _6_ _4_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.3 CONTRAINDICATIONS _Butorphanol – as a sole agent and in any combination:_ Do not use in horses with a history of liver or kidney disease. Do not use in case of known hypersensitivity to the active substance or to any of the excipients. Do not use in cases of cerebral injury or organic brain lesions (e.g. lesions following cranial trauma) and in animals with obstructive respiratory diseases, heart dysfunction or spastic convulsions. _Butorphanol / detomidine hydrochloride combination_: The Przeczytaj cały dokument