SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

PRID1.55g progesterone releasing intra-vaginal device

2. COMPOSITION

Each spiral device contains:

Active ingredient:

Progesterone (micronised) 1.55 g

3. PHARMACEUTICAL FORM

Vaginal Delivery System.

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

4. CLINICAL PARTICULARS

4.1 Target species

Cattle - Cows and heifers.

4.2 Indications for use, specifying the target species

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, PRIDenables 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.

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 or vaginal discharge.

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

Do not use in pregnant cows.

4.4 Special warnings for each target species

Adequate nutrition is required to obtain good fertility results.

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

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.

It is recommended not to use PRID 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.

A reduction to service or insemination in cows served 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 of calving-to-conception interval, is unlikely to be affected.

Prostaglandins are contraindicated in pregnancy.

i. Special precautions for use in animals

Do not damage the device when loading the speculum. If device is damaged discard and replace with a fresh device. Insertion into the vagina of normal cows and heifers should present no difficulty. If insertion is difficult, the device should not be used.

ii. Special precautions to be taken by the person administering the product to animals:

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

Do not smoke, eat or drink when administering the product.

Wash hands after use

4.6 Adverse reactions (frequency and seriousness)

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

The product can be used during lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Since the levels of exogenous hormones in treated animals’ blood and tissues are within the ranges of the levels of endogenous hormones which occur at various times of the oestrus cycle, no interaction with other medications is to be expected.

Dosage: 1.55g 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 5ml 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 coldsterilise 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.

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”.

Bending in half
Figure 1 : If you bend the PRID in the middle	Figure 2: The PRID will be twice as wide

Reverse rolling
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 PGF_2αif corpus luteum and 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.

4.10 Overdose

As the product is a device which is inserted into the vagina, overdosage is not possible.

4.11 Withdrawal periods

Edible tissues from slaughtered animal (meat and offal) – zero days

Milk withdrawal period – zero hours.

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

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties:

ATC vet code:QG03DA04

Pharmacotherapeutic group: Sex hormones (progestogens)

PRID is a device which contains a naturally occurring hormone, progesterone. Progesterone interacts with specific intranuclear receptors and binds to specific DNA sequence on the genome. Progesterone subsequently initiates transcription of a specific set of genes, which is ultimately responsible for the translation of hormonal action into physiological events. Progesterone has a negative feedback action on the hypothalamo-pituitary axis, primarily on LH secretion. Progesterone prevents the hormonal surge from hypophysis (FSH and LH).

The release of progesterone during the treatment blocks the oestrous cycle of cyclical animals by acting as a corpus luteum. When the device is removed from the cow, the sudden drop in progesterone levels induces a new oestrous cycle.

For optimal synchronisation and fertility, a short period of progesterone administration, resulting in a healthy dominant follicle at oestrus, should be combined with the administration of a luteolytic agent (prostaglandin) 24h prior to the withdrawal of the progesterone device.

5.2 Pharmacokinetic properties:

Progesterone is rapidly absorbed by intravaginal route. Milk and blood progesterone levels are within the normal range of levels seen in untreated cows during the luteal phase of a normal oestrous cycle.

The released progesterone undergoes the same bio-transformation as endogenous progesterone.

Circulating progesterone is bound to proteins in blood. Progesterone binds to corticosteroid-binding globulin (CBG) and to albumin. Progesterone is accumulated in fatty tissue due to its lipophylic properties, and in tissues/organs containing progesterone receptors. The liver is the main site of progesterone metabolism.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Stannous Octoate

Silicone Fluid

Silicone Polymer

Steel strip treated with an adhesion promoter

Polyester cord

6.2 Incompatibilities

None known.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years

6.4 Special precautions for storage

No special precautions for storage.

6.5 Nature and composition of immediate packaging

Devices are packed individually in polyethylene bags for use with the original PRID speculum or are pre-rolled onto a plastic cartridge for use with the “Quick fit” applicator. These are then packed into cartons at the rate of 6 or 10 devices per carton.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused product or waste materials, if appropriate

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

7. MARKETING AUTHORISATION HOLDER:

CEVA Animal Health Limited

Unit 3

Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

8. MARKETING AUTHORISATION NUMBER

Vm15052/4009

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

25 April 1996 / 25 April 2006

10. DATE OF REVISION OF THE TEXT

Date:September 2011