Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Progesterone
Syn Vet-Pharma Ireland Limited
QG03DA04
Progesterone
1.0 gram(s)
Vaginal delivery system
POM: Prescription Only Medicine as defined in relevant national legislation
progesterone
Authorised
2021-06-04
Health Products Regulatory Authority 04 June 2021 CRN00CF35 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DIB 1.0 g Vaginal Delivery System for Cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaginal delivery system contains: ACTIVE SUBSTANCE: Progesterone 1.0 g EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal delivery system. A white winged "V" shape device covered in progesterone-impregnated silicone, fitted with a green nylon tail to enable removal. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (cows and heifers). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the control of the oestrous cycle in cycling cows and heifers used in combination with prostaglandin F2α (PGF2α) or analogue, including synchronisation of oestrus, e.g. of donor and recipient animals for embryo transfer. For induction and synchronisation of oestrus in fixed time artificial insemination (FTAI) protocols: - In cycling cows and heifers: used in combination with PGF2α or analogue. - In cycling and non-cycling cows and heifers used in combination with Gonadotropin releasing hormone (GnRH) or analogue and PGF2α or analogue. - In non-cycling cows, used in combination with PGF2α or analogue and equine chorionic gonadotrophin (eCG). 4.3 CONTRAINDICATIONS Do not use in sexually immature heifers or in females with abnormal genital tracts e.g. freemartins. Do not use in animals presenting with infectious or non-infectious diseases of the genital tract. Do not use within the first 35 days after calving. Do not use in pregnant cattle. See section 4.7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The progesterone treatment alone, according to dosage regimen proposed, is not sufficient to induce oestrus and ovulation in all cycling females. Progesterone based breeding protocols are reproduction management tools and should not replace adequate feeding and general health management. The Read the complete document