Target species Cattle: cows and heifers. Indications for use, specifying the target species For the control of the œstrus cycle in cows and heifers including: -Synchronisation of œstrus including fixed time artificial insemination (FTAI) protocols. -Synchronisation of oestrus of donor and recipient animals for embryo transfer. To be used in combination with a prostaglandin (PGF2α or analogue) -Induction and synchronisation of œstrus in cycling and non cycling cattle including fixed time artificial insemination (FTAI) protocols. •In cycling cattle. To be used in combination with prostaglandin (PGF2α) or analogue. •In cycling and non-cycling cattle. To be used in combination with gonadotropin releasing hormone (GnRH) or analogue and PGF2α or analogue. •In non-cycling cattle. To be used in combination with PGF2α or analogue and equine chorionic gonadotrophin (eCG). Contraindications Do not use in sexually immature heifers or females with abnormal genital tracts e.g. freemartins. Do not use before 35 days have passed since previous calving. Do not use in animals suffering from infectious or non-infectious disease of the genital tract. Do not use in pregnant animals. See Use during pregnancy, lactation or lay. Special warnings for each target species The percentage of cows displaying oestrus within a given period following treatment is usually greater than in untreated cows and the subsequent luteal phase is of normal duration. However, the progesterone treatment alone, according to dosage regimen proposed, is not sufficient to induce oestrus and ovulation in all cycling females. In order to optimise the protocol, it is advisable to determine cycling ovarian activity before using the progesterone treatment. Animals in poor condition, whether from illness, inadequate nutrition, under unnecessary stress or other factors, may respond poorly to treatment. Special precautions for use Special precautions for use in animals It is recommended to wait a minimum of 35 days following parturition before starting the treatment with this product. Special precautions to be taken by the person administering the veterinary medicinal product to the animals Gloves must be worn when handling the veterinary medicinal product both during insertion and removal. Do not eat or drink when handling the veterinary medicinal product. Wash hands after use. Adverse reactions (frequency and seriousness) During the course of the seven day treatment, the device may induce a mild local reaction (i.e. inflammation of the vaginal wall). A clinical study carried out with 319 cows and heifers has demonstrated that 25% of animals presented ropy or cloudy vulvar secretions at the device removal. This local reaction disappears rapidly without any treatment between removal and insemination and does not affect fertility at inseminations nor pregnancy rates. Use during pregnancy, lactation or lay Can be used during lactation. Do not use before 35 days have passed since previous calving. Laboratory studies in rat and rabbit, after intramuscular or subcutaneous administrations, and at repeated high doses of progesterone, have produced evidence of foetotoxic effects. The use of the product is contraindicated in pregnant cattle. Interaction with other medicinal products and other forms of interaction None known.