Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Cloprostenol sodium
Intervet Ireland Limited
QG02AD90
Cloprostenol sodium
0.25 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Horses
cloprostenol
Hormone
Authorised
2011-10-14
Health Products Regulatory Authority 02 July 2019 CRN0095GN Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Estrumate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: Cloprostenol (as cloprostenol sodium) 0.25 mg/ml EXCIPIENTS: Benzyl alcohol (E1519) 20.00 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses and ponies. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES As a synthetic prostaglandin analogue structurally related to Prostaglandin F 2a (PGF 2a ), for use in cattle and horses. Estrumate is a potent luteolytic agent. It causes functional and morphological regression of the corpus luteum (luteolysis) in cattle and horses followed by return to oestrus and normal ovulation. The recommended use in each target species is as follows: CATTLE: _Therapeutic indications:_ Suboestrus (or non detected oestrus - NDO) Induction of parturition Termination of normal pregnancy Termination of abnormal pregnancy Chronic endometritis (Pyometra) Ovarian luteal cysts _Controlled breeding in cattle_ HORSES: Induction of luteolysis following early foetal death and resorption. Termination of persistent dioestrus. Termination of psuedopregnancy. Treatment of lactation anoestrus. Establishing oestrus cycles in barren/maiden mares. As an aid to stud management. 4.3 CONTRAINDICATIONS Do not administer to pregnant animals unless the objective is to terminate the pregnancy. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Health Products Regulatory Authority 02 July 2019 CRN0095GN Page 2 of 4 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES CATTLE: Do not administer to pregnant animals unless the objective is to terminate pregnancy. For the termination of pregnancy, best results are obtained before day 100 of gestation. Results are less reliable between day 100 and 150 of gestation. If estrumate is adm Прочитать полный документ