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.
Amounts to be administered and administration route
Vaginal use.
1.55 g of progesterone / animal for 7 days.
Judgment on the protocol to be used should be made by the veterinarian responsible for treatment, on the basis of the treatment objectives of the individual herd or cow. The following protocols could be used.
For synchronisation of oestrus (including synchronisation of oestrus of donor and recipients animal for embryo transfer):
•Insert the device for 7 days.
•Inject a prostaglandin (PGF2α) or analogue 24 hours prior to device removal
•Removal of the device
•In animals that respond to treatment the onset of oestrus generally occurs within 1-3 days after removal of the device. Cows should be inseminated within 12 hours of first observed oestrus.
For the induction and synchronisation of oestrus for Fixed Time Artificial Insemination (FTAI):
The following FTAI protocols have been commonly reported in the literature:
In cycling cattle:
•Insert the device for 7 days.
•Inject a prostaglandin (PGF2α) or analogue 24 hours prior to device removal
•Removal of the device
•Animals should be inseminated 56 hours after removal of the device.
In cycling and non-cycling cattle (including recipient cows):
•Insert the device for 7 days.
•Inject GnRH or analogue at the device insertion.
•Inject a prostaglandin (PGF2α) or analogue 24 hours prior to device removal
•Animals should be inseminated 56 hours after removal of the device, or
•Inject GnRH or analogue 36 hours after device removal and FTAI 16 to 20 hours later.
Or in alternative,
•Insert the device for 7 days
•Inject GnRH or analogue at the device insertion
•At device removal inject prostaglandin (PGF2α) or analogue
•Inject GnRH or analogue 56 hours after removal of the device
•Animals should be inseminated 16 to 20 hours later
In non-cycling cattle:
•Insert the device for 7 days
•Inject a prostaglandin (PGF2α) or analogue 24 hours prior to device removal
•Inject eCG at the time of the device removal
•Animals should be inseminated 56 hours after removal of the device.
Device application information:
Using an applicator, insert one device into the vagina of the animal. The intravaginal device should stay in place for 7 days. The device is intended for single use only.
Applicator method of use and Insertion:
A device applicator should be used for administration, following the procedure described below:
1Clean and disinfect the applicator in a non-irritant antiseptic solution before use.
2Fold the device and load into the applicator. The end of the device tail should be outside of the applicator. Care should be taken to avoid unnecessary or prolonged handling of the product to minimise transfer of the active substance to the operator's gloves.
3Apply a small quantity of obstetrical lubricant to the end of the loaded applicator.
4Lift the tail and clean the vulva and perineum.
5Gently insert the applicator into the vagina, first in a vertical direction and then horizontally until some resistance is encountered.
6Make sure the removal tail is free, press the handle of the applicator and pull it out, leaving the removal tail hanging from the vulva.
7Clean and disinfect the applicator after use and before use on another animal.
Removal:
Remove 7 days after insertion by gently pulling on the removal tail. On occasions the tail may not be visible from the outside of the animal, in such cases it may be located in the posterior vagina using a gloved finger. Withdrawal of the device should not require force. If any resistance is encountered a gloved hand should be used to ease removal.
If there is any difficulty in removal from the animal beyond that itemised above veterinary advice must be sought.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal periods
Meat and offal: zero days
Milk: zero days