国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
d-Cloprostenol
SUPPORT PHARMA, S.L.
QG02AD90
d-Cloprostenol
0.075 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
cloprostenol
Authorised
2019-09-13
Health Products Regulatory Authority 13 September 2019 CRN000YPQ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: d-cloprostenol 0.075 mg (equivalent to d-cloprostenol sodium 0.079 mg) EXCIPIENTS: chlorocresol 1 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution, with no visible particles. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (cows), pigs (sows) and horses (mares). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for: COWS: Synchronisation or induction of oestrus; Induction of parturition after day 270 of gestation; Treatment of ovarian dysfunction (persistent _corpus luteum_, luteal cyst); Treatment of clinical endometritis with the presence of a functional _corpus luteum_ and pyometra; Treatment of delayed uterine involution; Induction of abortion up to day 150 of gestation; Expulsion of mummified foetuses. SOWS: Induction of parturition after day 114 of gestation. MARES: Induction of luteolysis with a functional _corpus luteum_. 4.3 CONTRAINDICATIONS Do not use in pregnant females, unless it is desirable to induce parturition or induction of abortion. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not administer to animals with cardiovascular, respiratory or gastrointestinal problems. Health Products Regulatory Authority 13 September 2019 CRN000YPQ Page 2 of 6 Do not administer to induce parturition in sows and cows with suspected dystocia due to mechanical obstruction or if problems are expected because of an abnormal position of the foetus. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The response of cows to the synchronization protocols is not homogenous nor between th 完全なドキュメントを読む