Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
D-cloprostenol sodium salt
Vetpharma Animal Health, S.L.
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
2014-08-15
_[Version 9,03/2022]_ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT INDUPART 75 micrograms /mL solution for injection for cattle, pigs and horses [ AT / BG / CZ / DE / ES / HU / LT / LV / PT / SK / RO / BE / IE / LU / NL] INDUPART [ DK] GANAPAR 75 micrograms /mL solution for injection for cattle, pigs and horses [PL / EE] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: 75 μg of D-cloprostenol as D-cloprostenol sodium EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t Chlorocresol 1.0 mg Ethanol 96% Sodium hydroxide (for pH adjustment) Citric acid anhydrous (for pH adjustment) Water for injections Solution for injection. Clear colourless solution 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle (cows), pigs (sows) and horses (mares). 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Cattle: • Synchronisation or induction of oestrus • Induction of parturition; • Ovarian dysfunction (persistent _corpus luteum_ , luteal cyst); • Endometritis/pyometra; • Delayed uterine involution; • Induction of abortion in the first half of pregnancy • Expulsion of mummified foetuses; Pigs: Induction of parturition. Horses: Induction of luteolysis in mares with a functional _corpus luteum._ 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant animals, unless it is desirable to induce parturition or induction of abortion. Do not administer intravenously. Do not use in animals with cardiovascular, gastro-intestinal or respiratory problems. 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. 3.4 SPECIAL WARNINGS None. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target Aqra d-dokument sħiħ