PRID (Canada)

2. Attach the PRID to the applicator and twist to lock. (Note: it only fits one way)

3. Check that the string has not wound around the applicator. Lightly lubricate the device and the distal end of the applicator with a veterinary obstetrical lubricant.

4. Lift the cow’s tail. The exterior of the vulva should be washed with a disinfecting solution and dried.

5. Open the lips of the vulva and gently insert the loaded applicator into the animal's vagina, holding it by its handle. Advance the applicator, without forcing, into the fundus of the vagina.

6. Once the loaded applicator has reached the fundus of the vagina, raise the safety catch (B) and press on the handle (A); the PRID will be released.

7. Remove the applicator gently while keeping the handle pressed. The string attached to the PRID should be visible from the vulva. Shorten the string if necessary.

8. Twist and pull the disposable plastic tip to remove from the applicator.

Removal

1. Remove the device 7 days post insertion by gently pulling the exposed string.

2. If the string is not visible, the device may still be present. Insert a clean gloved hand into the vagina and retract. This may be facilitated by using one hand in the rectum to move the device towards the vulva. Occasionally, a device may be expelled by the animal.

NOTE: The expected retention rate is 92%. If loss rates exceed 8%, re-evaluate insertion technique.

Timing For Insemination

It is recommended that animals are inseminated at observed heat.

Animals which lose the PRID during the treatment period should be bred at next observed estrus.

Contraindications

Do not use in dairy cows with abnormal or infected reproductive tracts.

PRID Caution

- Safety and efficacy of this drug have not been evaluated in dairy heifers prior to first calving or in dairy cows less than 60 days post-partum.

- Contact a veterinarian if abnormal bloody discharge is observed during treatment.

- Do not reuse the device.

- Care must be taken when using the applicator so as not to damage the vagina.

- Do not use if the device is damaged or if the stainless steel inner spiral is exposed.

- Animals in poor condition resulting from illness or nutritional stress may not respond to this drug.

Adverse Effects

Mucopurulent discharge, as well as an offensive odor may be observed on the PRID at the time of removal. This is a result of mild irritation caused by the presence of the PRID and generally resolves prior to insemination.

Pivotal Target Animal Safety And Efficacy Studies

Efficacy

A multi-location field study was conducted to evaluate the efficacy of PRID to treat anestrus in dairy cows greater than 60 days post partum. Heifers were not included in this study. Holstein cows (n=410) which had not displayed signs of estrus and were greater than 60 days post partum were assigned to receive either PRID (n=218) or a placebo (device without progesterone) (n=192). Devices were inserted for 7 days. After 7 days, devices were removed and 500 µg of prostaglandin F2α was administered intramuscularly. Cows were detected in estrus by pedometry and inseminated at estrus according to the normal routine of the herd. Approximately 8% of animals lost the device during the 7 day treatment period. In animals retaining the device, 60.5% of PRID treated cows showed estrus within 5 days of device removal and prostaglandin injection, versus 38.0% in the placebo group. The median time from device insertion to insemination was 12 days for PRID treated cows, versus 23 days in cows treated with the placebo.

Safety

The effect of PRID on vaginal mucosal integrity and systemic inflammation were studied in 48 anestrus dairy cows greater than 60 days post partum. Heifers were not included in this study. Cows were randomly assigned to receive one of three treatments: 1) PRID (n=19); 2) placebo device without progesterone (n=16), and 3) control (no device) (n=13). Devices were inserted for 7 days and removed. Following device removal, a small amount of purulent debris on the PRID was observed in 26% (5 of 19) of cows. Copious amounts of purulent debris were observed on one PRID treated cow. A vaginoscopic exam did not indicate any evidence of mucosal damage after device removal. Bacteriological culture of the vagina revealed moderate growth of coliform, environmental Streptococcus, Staphylococcus sp. and other gram positive rod shaped organisms. These organisms are among the normal flora of the skin and feces of cattle. There was no significant difference in haptoglobin concentrations between treatment groups. Circulating lymphocyte concentrations in PRID treated cows were within normal reference intervals. In the field efficacy study, 34% of PRID treated animals had a small amount of mucopurulent discharge on the device when it was removed, while 8% had copious amounts of purulent debris.

Warning

KEEP OUT OF REACH OF CHILDREN.

Rubber gloves should be worn when handling the PRID.

Remove PRID before sending treated animals for slaughter.

Storage Conditions

Store at 15°C to 30°C in a dry place.

PRID^® is a registered trademark of Ceva Santé Animale

Vétoquinol N.-A. Inc., 2000 ch. Georges, Lavaltrie, QC, J5T 3S5 Canada

658019B

Nac No.