国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
FLUGESTONE ACETATE
Intervet Ireland Limited
QG03D
FLUGESTONE ACETATE
20 Milligram
Sponge
POM
Ovine
PROGESTOGENS
Hormone
Authorised
1987-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Chronogest CR 20 mg controlled release vaginal sponge for sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Vaginal sponge White sponge with continuous Chronolone line forming a ring-like structure on the round surface of the sponge (5-7 rings per sponge). 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep (ewes, ewe lambs) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In ewes and ewe lambs, in combination with PMSG (Pregnant Mare Serum Gonadotrophin) - Induction and synchronization of oestrus and ovulation (non cycling ewes during seasonal anoestrus and ewe lambs) - Synchronization of oestrus and ovulation (cycling ewes and ewe-lambs). 4.3 CONTRAINDICATIONS The use in pregnant females is contraindicated. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The use of a vaginal applicator designed for ewes or ewe lambs is recommended to correctly insert sponges and to avoid vaginal injuries. EACH SPONGE CONTAINS: _Active substance:_ Flugestone acetate 20 mg For full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 05/08/2016_ _CRN 7024293_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The repeated treatment with the product combined with PMSG may trigger the appearance of PMSG antibodies in some ewes. This in turn may affect the time of ovulation and result in reduced fertility when combined with artificial insemination. The repeated use of sponges within one year has not been studied. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS - Direct contact with t 阅读完整的文件