Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
flugestone acetate 20 mg
Intervet Deutschland GmbH
QG03D
Vaginal sponge
GENITO URINARY SYSTEM AND SEX HORMONES
Sheep Females
2010-04-15
CHRONOGEST® CR I. SUMMARY OF THE DOSSIER B. Summary of Product Characteristics, label and package insert Registration file Intervet Pharma R&D Angers /November 2008/ REGDAT V3.0 B. 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 Each polyester polyurethane sponge contains ACTIVE SUBSTANCE(S) Flugestone acetate, 20 mg. LIST OF EXCIPIENTS Excipients qsp 1 sponge. 3. PHARMACEUTICAL FORM Vaginal sponge. White cylindrical polyester polyurethane foam equipped with string. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep (ewes and ewe-lambs). 4.2 INDICATIONS FOR USE 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 Please refer to section 4.7. and section 4.8. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE i) 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 fixed time artificial insemination at 55h following sponge removal. - The repeated use of sponges within one year has not been studied. CHRONOGEST® CR I. SUMMARY OF THE DOSSIER B. Summary of Product Characteristics, label and package insert Read the complete document