Target species
Sheep (ewes).
Indications for use, specifying the target species
For the induction and synchronization of oestrus and ovulation in non-cycling ewes during seasonal anoestrus.
For the induction and synchronization of oestrus and ovulation in cycling and in non-cycling ewes for advancing the breeding season.
To be used in combination with eCG (equine chorionic gonadotrophin).
Contraindications
Do not use in sexually immature ewes or in females with abnormal genital tracts.
Do not use in animals presenting with infectious or non-infectious diseases of the genital tract.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
See section "Use during pregnancy, lactation or lay".
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
The efficacy and safety of the veterinary medicinal product has not been evaluated in ewes which are unwell, which have a BCS < 2 or ≥ 4, which have had complications during previous pregnancies or lambings, or which have lambed within the last 45 days. Use only according to the benefit/risk assessment by the responsible veterinarian.
Animals in poor condition, whether from illness, inadequate nutrition, or other factors, may respond poorly to treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Progesterone is a potent steroid hormone and may cause adverse effects on the reproductive system in cases of high or prolonged exposure.
As adverse effects on unborn children cannot be ruled out, pregnant women should avoid using this veterinary medicinal product.
The veterinary medicinal product may cause skin and eye irritation, as well as allergic skin rashes. Avoid accidental contact with the eyes. In case of accidental ocular exposure, flush the eyes thoroughly with water.
Persons administering the veterinary medicinal product should avoid contact with the silicone section; pregnant women should avoid using the veterinary medicinal product.
The device should be inserted using the product specific applicator. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product during insertion and removal.
Wash hands and exposed skin with soap and water after use.
Do not smoke, eat or drink while handling the veterinary medicinal product.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
Sheep:
Common (1 to 10 animals / 100 animals treated): | Application site irritation1, vaginal discharge1 (cloudy/yellow mucus) |
Uncommon (1 to 10 animals / 1,000 animals treated): | Vaginal discharge1 (dark red/brown mucus with fresh blood) |
1 typically resolve within 2 days of removal of the device without the need for treatment.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section ’Contact details’ of the package leaflet.
Use during pregnancy, lactation or lay
Do not use in pregnant ewes.
The safety of the veterinary medicinal product has not been established during lactation. During lactation use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known.
Amount(s) to be administered and administration route
Vaginal use.
0.35 g of progesterone (1 device) per animal for 12 days.
One device should be inserted into the vagina of each ewe to be treated. The vaginal insert should be left in position for 12 days followed by an injection of equine Chorionic Gonadotrophin (eCG, formerly known as PMSG) administered at device removal. The onset of oestrus occurs within 1-2 days after removal of the insert.
In a study of 11 Lacaune breed ewes, ovulation occurred between 42 and 58 hours following eCG injection, with the majority (73%) ovulating between 50 and 54 hours. In the case that artificial insemination and advanced breeding techniques (e.g. embryo transfer) are applied, the timing of ovulation should be taken into consideration for the selected technique for optimal results.
Administration
A device applicator should be used for administration, following the procedure described below:
1. Ensure that the applicator is clean and dipped in a non-irritant antiseptic solution before use.
2. Wearing sterile disposable plastic gloves, fold the arms of the device and load into the applicator. The arms of the device should protrude slightly from the end of the applicator. Care should be taken to avoid unnecessary or prolonged handling of the veterinary medicinal product to minimise transfer of the active substance to the operator's gloves.
3. Apply a small quantity of obstetrical lubricant to the end of the loaded applicator.
4. Lift the tail and clean the vulva and perineum.
5. Gently insert the applicator into the vagina, first in a vertical direction and then horizontally until some resistance is encountered.
6. Make sure the removal string is free, press the handle of the applicator and allow the barrel to move back towards the handle. This releases the arms of the device, which will then retain the device in the anterior vagina.
7. With the device correctly positioned, withdraw the applicator, leaving the removal string exiting from the vulva.
The applicator should be cleaned and disinfected before being used on another animal.
Removal
The device may be removed by gently pulling on the tail. On occasions the tail of the device 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. Approximately 1 in 10 devices may be lost by an animal. Withdrawal of the device should not require force. If any resistance is encountered a gloved finger 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.
The device is intended for single use only.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
Withdrawal period(s)
Meat and offal: zero days.
Milk: zero hours.