Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
D-cloprostenol sodium salt
aniMedica GmbH
QG02AD90
D-cloprostenol sodium salt
75 microgram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Horses, Pigs
cloprostenol
Hormone
Authorised
2009-10-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Genestran 75 micrograms/ml solution for injection for cattle, horses and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for Injection. A clear and odourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: - induction of luteolysis allowing resumption of oestrus and ovulation in cyclic females when used during dioestrus - synchronisation of oestrus (within 2 to 5 days) in groups of cyclic females treated simultaneously - treatment of suboestrus and uterine disorders related to a functioning or persistent corpus luteum (endometritis, pyometra) - treatment of ovarian luteal cysts - induction of abortion until day 150 of pregnancy - expulsion of mummified foetuses - induction of parturition (within the last two weeks of gestation). HORSES: - induction of luteolysis in mares with a functional corpus luteum. PIGS: - induction or synchronisation of farrowing (generally within 24 to 36 hours) from day 113 of pregnancy onwards (day 1 of pregnancy is the last day of natural or artificial insemination). 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with spastic respiratory or gastro-intestinal diseases. Do not use in pregnant animals, for which induction of abortion or parturition is not intended. Do not use for intravenous administration. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each ml contains: ACTIVE SUBSTANCE: micrograms R(+)-cloprostenol {as R(+)-cloprostenol sodium} 75 EXCIPIENTS: Chlorocresol (as preservative) 1000 For the 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document