Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
BUSERELIN (AS BUSERELIN ACETATE PH. EUR.)
T.P. Whelehan Son & Co. Ltd.,
QH01CA90
BUSERELIN (AS BUSERELIN ACETATE PH. EUR.)
0.004 Mg/Ml
Solution for Injection
POM
Bovine, Equine - Food, Rabbits
Buserelin
Hormone
Authorised
2008-09-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Busol 0.004 mg/ml solution for injection for cattle, horses, rabbits 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless liquid 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horse, rabbit 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES COW: Induction of ovulation in cows with a dominant follicle Synchronisation of oestrus and induction of ovulation Treatment of ovarian follicular cysts MARE: Induction of ovulation in oestrus mares Improvement of pregnancy rate RABBIT: Ovulation induction at post partum insemination Improvement of conception rate 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Treatment with a GnRH analogue is only symptomatic; the causes underlying a fertility disorder are not eliminated by this treatment. Each ml contains ACTIVE SUBSTANCE Buserelin (as Buserelin acetate) 0.004 mg/ml EXCIPIENT(S) Benzyl alcohol (E1519) 20.0 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_ _ _ _2_ _1_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _9_ _8_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Not applicable. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL P Lees het volledige document