Revised: September 2011
AN: 01095/2011
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PRID 1.55g progesterone releasing intra-vaginal device
2.
COMPOSITION
Each spiral device contains:
Active ingredient:
Progesterone (micronised)
3.
1.55 g
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, 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.
4.2
Contra-indications
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.
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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.
4.5
Special precautions for use
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.
4.7
Use during pregnancy and lactation
The product can be used during lactation.
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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.
4.9
Amounts to be administered and administration route
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 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.
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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.
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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
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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 2α if 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.
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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
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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
Vm 15052/4009
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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
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