CIDR OVIS is presented as a “T” shaped device consisting of progesterone impregnated silicone rubber elastomer skin moulded over an inert nylon spine. Each device contains 0.35 g progesterone.

For the induction and synchronisation of oestrus and ovulation in non-cycling ewes during seasonal anoestrus.

For the induction and synchronisation of oestrus and ovulation in cycling and in non-cycling ewes for advancing the breeding season.

To be used in combination with eCG.

0.35 g of progesterone 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.

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 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.

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.

Do not use in pregnant ewes.

Do not use in ewes with abnormal or immature genital tracts, or with genital infections.

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.

Local irritation and discharge of cloudy/yellow mucus are common (more than 1 but less than 10 animals in 100 animals displaying adverse reactions during the course of one treatment) and discharge of dark red/brown mucus or mucus with fresh blood is uncommon (more than 1 but less than 10 animals in 1,000 animals). However, these signs typically resolve within 2 days of removal of the device without the need for treatment.

Meat and offal: zero days.

Milk: zero hours.

Progesterone is a potent steroid hormone and may cause adverse effects on the reproductive system in cases of high or prolonged exposure.

Adverse effects on unborn children cannot be ruled out.

The product may cause skin and eye irritation, as well as allergic skin rashes.

Those administering the product should avoid contact with the silicone section; pregnant women should avoid using the product completely.

Wear gloves when administering and disposing of the product. Insert the device using the applicator.

Wash hands and exposed skin with soap and water after use.

Do not smoke, eat or drink while handling the product.

Do not store above 30°C.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Keep out of the sight and reach of children.

For animal treatment only.

CIDR OVIS is supplied in heat-sealed low density polyethylene sachets containing 20 devices.

Not applicable.

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.

The safety of the veterinary medicinal product has not been established during lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

The pharmacokinetic profile of progesterone when administered as a single device was characterised by a maximum concentration (Cmax) in plasma of up to 5.9 ng/ml achieved post-dosing. Peak concentrations were followed by a decline in systemic exposure to a steady state of approximately 2 ng/ml. After removal of the device, circulating blood levels of progesterone fall precipitously within 2-4 hours reaching baseline levels by 12 hours.

Vm 42058/4206