Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Lecirelin acetate
FATRO S.p.A.
QH01CA92
Lecirelin acetate
25 microgram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Rabbits
lecirelin
Hormone
Authorised
2004-03-19
_DALMARELIN – VRA G.I.18_ _[Version 9,03/2022] corr. 11/2022_ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _DALMARELIN – VRA G.I.18_ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Dalmarelin 25 micrograms/ml solution for injection for cattle and rabbits (AT, BE, BG, CY, CZ, DE, DK, ES, FI, HR, HU, IE, IS, IT, LU, MT, NL, NO, PL, PT, RO, SI, SK) Reproréline 25 micrograms/ml solution for injection for cattle and rabbits (FR) Dalmarelin Vet 25 micrograms/ml solution for injection for cattle and rabbits (SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: lecirelin 25 µg (as lecirelin acetate) EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t benzyl alcohol (E1519) 20 mg glacial acetic acid (E 260) disodium phosphate dodecahydrate (E339ii) sodium chloride water for injections Clear, colourless solution, with no visible particles. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle (cows) and rabbits. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Cattle Treatment of follicular ovarian cysts. Cycle induction in early post-partum cows from day 14 post-partum. Induction of ovulation at the time of insemination in cases of short, silent heat or prolonged heat. Induction of ovulation in cycling cows in association with artificial insemination to optimise the time of ovulation. Induction and synchronisation of oestrus and ovulation in combination with prostaglandin F2α (PGF2α) or PGF2α analogue, with or without progesterone, as part of fixed time artificial insemination (FTAI) protocols. _DALMARELIN – VRA G.I.18_ Rabbits Induction of ovulation. Conception rate enhancement. 3.3 CONTRAINDICATIONS None. 3.4 SPECIAL WARNINGS The veterinary medicinal product should be administered to cows with normal ovaries at least 14 days after calving due to the absence of receptivity of the hypophysi Læs hele dokumentet