Introduction

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

A stainless steel, spiral device covered with an inert elastomer incorporating 1.55 g progesterone.

Uses

Therapeutic

Synchronisation of oestrus in groups of cycling cows and heifers. To be used in combination with prostaglandin.

Management

Planned Breeding: By synchronising ovarian activity, PRID® enables beef cows, dairy cows, and heifers, to be inseminated at a predetermined fixed time without the need for oestrus detection. Thus, reducing the calving index and the number of cows culled.

Late Calvers

PRID® should not normally be used prior to 35 days post-partum. It can, however, be used from 21 days post-partum for late calvers in seasonally calving herds where, in healthy cows, early service is required.

Dosage and administration

Dosage: 1.55 g of progesterone / animal for 7 days.

Using a speculum, insert one device into the vagina of each cow or heifer to be inseminated, See ‘insertion' guidelines below. Take care not to damage the device; handle gently, especially during insertion. The device should be inserted intra-vaginally for 7 days. A prostaglandin injection such as 5 ml Enzaprost® (Dinoprost) should be performed at least 24 hours before removal of the device.

Disinfection procedure

It is recommended that one bucket is filled with a non-irritant disinfectant solution (e.g. chlorhexidine) diluted to manufacturer’s recommendations, and that another bucket is filled with clean water. Use the disinfectant for cleaning the speculum and rod after use in each animal and the clean water for a final rinse. As a further precaution cold sterilise the speculum between herds or use a separate speculum on each farm.

Insertion

Clean the vulva immediately prior to insertion using a suitable paper wipe. Lubricate the lip of the speculum inside and outside with a cetrimide cream.

When using speculums lubricate with cetrimide cream, the use of obstetrical lubricant may increase the loss rate.

USING PRID® WITH ORIGINAL SPECULUM

Load the device carefully into the bevelled end of the disinfected speculum, with the string clear of the opening. Insert the rod into the speculum.

Holding the speculum in one hand spread the lips of the vulva with the other and gently insert the loaded speculum into the vagina.

The slot on the speculum should be in the nine o’clock position for ease of insertion.

Still holding the speculum pointed slightly upwards, turn the speculum so that the slot is in the 12 o’clock position, then gently push it into the interior vaginal area, until it reaches the cervix.

Expel the device into the vagina by gently retracting the speculum over the rod, whilst holding the rod stationary.

Withdraw the speculum and rod, leaving the string extended from the vulva. Gently pull the string to straighten.

USING PRID® “GUN-TYPE” AND “QUICK-FIT” APPLICATOR

Gun type applicator

1. Hold the applicator by the handle and trigger.

2. Release the safety catch (handle onto top of the gun, above the rear handle) by raising it up away from the gun’s body.

3. Squeeze the trigger (most forward-facing handle on the underside of the gun) in order to draw back the retaining cover from the rear mounting pin.

4. Fit the rear hole (through which the string is attached) of the PRID® on to the rear pin, and then release the trigger, so that the retaining cover moves forward and holds the PRID® securely.

(If necessary, push the handle forward manually to secure the device).

5. Line up the two pins by turning the distal end of the applicator (can only rotate in one direction). Fit the hole at the front of the PRID® spiral onto the forward facing pin (i.e. located on the distal end of the applicator).

6. Whilst pressing your thumb on the forward pin, turn the distal end of the applicator to “wind up” the spiral.

7. Once the spiral has been fully wound up, reset the safety catch, and lightly lubricate the spiral and distal end of the applicator. Check that the string has not wound round the applicator.

8. Insert the applicator into the vagina. Once the applicator has reached the fundus of the vagina, release the safety catch and pull the trigger. This will release the spiral. The applicator and plastic cartridge are then gently withdrawn from the vagina, leaving the string extended from the vulva. Gently pull the string to straighten. Remove the empty plastic cartridge from the applicator and discard.

Quick-fit applicator

Fix the PRID® “Quick-fit” (which is supplied pre-rolled onto a plastic cartridge) onto the applicator gun by inserting the exposed metal rod of the gun into the device and fixing in place by gently rotating the gun clockwise to engage the two retaining lugs. Holding the applicator in one hand spread the lips of the vulva with the other, and gently insert the loaded applicator into the vagina. Then gently push it into the interior vaginal area, until it reaches the cervix. Firing the trigger on the device will release the PRID® into the vagina. The applicator and plastic cartridge are then gently withdrawn from the vagina, leaving the string extended from the vulva. Gently pull the string to straighten. Remove the empty plastic cartridge from the applicator and discard.

Removal

The device is intended for single use only.

Remove 7 days after insertion by gently pulling exposed string. If the string is not visible, the device may still be present. Insert a clean, gloved hand into the vagina and retract the device. This may be facilitated by using one hand in the rectum to move the coil towards the vulva. Occasionally a coil will be expelled by the animal.

Retention rates should be in the order of 98%. However, it may be lower in multiparous and large cows. Consequently, there may be an advantage in enlarging the device before manual insertion. One method is to bend in half (see figures 1 and 2). Another is to reverse roll (see figure 3 and 4). This is not possible with PRID® “Quick fit”.

Figure 1: If you bend the PRID® in the middle

Figure 2: The PRID® will be twice as wide

Figure 3: If you roll the PRID® back on itself

Figure 4: The PRID® will end up with a much greater diameter

Timing of insemination

It is recommended that animals are inseminated twice at 48 and 72 hours after removal of the device. If more practicable, animals may be inseminated only once 56 hours after removal. Animals which lose the coil during the 7-day treatment period should be inseminated/served at the next observed oestrus, or inject PGF2α if corpus luteum is present and the animal is non pregnant, or reinsert new device. Animals in oestrus more than 24 hours after the last insemination should be reinseminated normally. In herds where oestrus detection is impractical and pedigree registration of the calf is not required, a bull may be introduced 24 hours after fixed time AI.

Contra-indications, warnings, etc

Do not use in sexually immature heifers.

Do not use in females with abnormal genital tracts e.g. freemartins.

Do not use in animals with genital infections.

Do not use in pregnant cows.

Do not use in cows calved less than 35 days except when using at 21 days onwards for late calvers in seasonally calving herds where, in healthy cows, early service is required.

Do not use in cows and heifers in a poor nutritional state.

Gloves must be worn when handling the product both during insertion and removal.

Do not smoke when administering the product.

Withdrawal periods

Milk: Zero hours

Meat and offal: Zero days

The device should be removed before sending the animals to slaughter.

Keep out of the reach of children. For animal treatment only.

Pharmaceutical precautions

No special precautions for storage.

Legal category

POM-V

Packaging Quantities

Cartons containing 6 or 10 devices in polythene bags.

Not all pack sizes may be marketed.

Further information

A vaginal discharge commonly occurs; this clears spontaneously without treatment after the device is removed and has no effect on fertility.

A reduction in fertility to service or insemination in cows served early after calving may occur at the first oestrus after removal of the device. Nevertheless, the overall efficacy of the product, as evidenced by a significant shortening in the calving-to-conception interval, is unlikely to be affected.

Adequate nutrition is required to obtain good fertility results. This is particularly important when treating cows as early as 21 days after calving.

Avoid any unnecessary stress around the treatment period e.g. sudden dietary changes, vaccination, branding etc.

The insertion of PRID® into the vagina of normal cows and heifers should present no difficulty. If insertion is difficult, PRID® should not be used.

Animals should show no discomfort following insertion. In the event of an animal continuing to strain after insertion, remove the device and serve at the next oestrus.

Marketing authorisation number

Vm 15052/4009.