FOR ANIMAL USE ONLY

PRID^® DELTA

Reg. No. G4037 Act 36/1947

Vaginal delivery system

PRID^® DELTA is a vaginal delivery system used for the controlled breeding of cows and heifers, including synchronisation of oestrus in cycling cows and heifers, and induction and synchronisation of oestrus in non-cycling cows.

STORAGE

PRID^® DELTA is stable for three years in the original packaging, if stored under the recommended storage conditions.

Shelf-life of the PRID^® DELTA after first opening the sachet of 10 devices: 12 months.

Store in a cool, dry place below 25˚ C.

COMPOSITION

One PRID^® DELTA intra-vaginal device contains:

Progesterone                 1,55 g

Excipients q.s.p.             1 vaginal delivery system of 14 g

WARNINGS

• Withdrawal time for meat and offal: 0 days.
• Withdrawal time for milk: 0 days.
• Each device is for once-off administration only and cannot be used a second time.
• Do not use in pregnant animals.
• Do not use in sexually immature heifers.
• Do not use before 35 days have passed since previous calving.
• Do not use in animals suffering from infectious or non-infectious diseases of the uro-genital tract.
• During the treatment course of 7 days, a local reaction of the vaginal wall may be induced, resulting in a mild, transparent secretion from the vagina. On removal of the device, 66 % of treated animals may present with a vulvular secretion, suggesting a mild local reaction. These local reactions disappear rapidly without any treatment between insertion and insemination, and do not impair the pregnancy rates.
• During the treatment meat, offal and milk can be delivered for human consumption.
• Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.
• Keep out of reach of children, uninformed persons and pets.

PRECAUTIONS

Special precautions for use in the target species:

• Use only as directed.
• Not for use in animals with abnormal vaginas.
• The progesterone treatment alone, according to the dosage regimen proposed, is not sufficient to induce oestrus and ovulation in all cycling females.
• In order to optimize the treatment protocol, it is advisable to determine cycling ovarian activity before using progesterone treatment.

Special precautions for operator:

• Gloves must be worn during both the insertion and removal the PRID^® DELTA intra-vaginal device.
• Do not eat, drink or smoke while handling the product.
• Wash hands thoroughly after use.

DIRECTIONS FOR USE: USE ONLY AS DIRECTED.

For intra-vaginal administration only.

Each device is for once-off administration only and cannot be used a second time.

Dosage:

1,55 g of progesterone per animal for 7 days ie one PRID^® DELTA intra-vaginal device as follows:

In cycling cattle: this device has to be used in combination with a prostaglandin, injected 24 hours prior to removal of the device.

In non-cycling cattle: a prostaglandin injection must be administered 24 hours prior to removal of the device and an injection of eCG (equine Chorionic Gonadotropin) must be administered at the time of removal of the device.

Insertion of the device:

Use an applicator to insert one device into the vagina of each animal.

Before each application, the applicator must be cleaned and disinfected with a suitable non-irritant antiseptic.

Fit the PRID^® DELTA intra-vaginal device into the applicator. Bend the device before inserting in the applicator. Ensure the string is in the appropriate slot.

Lubricate the extremity of the applicator with a suitable veterinary obstetrical disinfectant cream.

Clean the vulva immediately prior to insertion of the device using a suitable paper wipe.

Holding the applicator in one hand, spread the lips of the vulva with the other hand and gently insert the applicator into the vagina. Then gently push it into the anterior vaginal area, until it reaches the cervix.

Release the device from the applicator into the vagina by pressing on the handle of the applicator. Remove the applicator and leave the device string extended out of the vulva.

Before each application, the applicator must be cleaned and disinfected with a suitable non-irritant antiseptic.

Removal of the device:

Remove 7 days after insertion by gently pulling on the exposed string.

Timing of insemination:

Animals should be inseminated 56 hours after removal of the device.

PRESENTATION

The whitish triangular devices are packaged in metallized polyester or polyethylene sachets.

There are two shapes of sachets:

Triangular sachet for individual packaging.

Rectangular sachet for packaging of ten devices.

The string attached to the device is of polyester.

Pack sizes are as follows:                                                                      

• Cardboard box containing 10 sachets of 1 device.
• Cardboard box containing 25 sachets of 1 device.
• Cardboard box containing 1 applicator and 25 sachets of 1 device.
• Cardboard box containing 50 sachets of 1 device.
• Cardboard box containing 1 applicator and 50 sachets of 1 device.
• Polyethylene box containing 50 sachets of 1 device.
• Sachet containing 10 devices.

REGISTRATION HOLDER

Ceva Animal Health (Pty) Ltd.

(Reg. No. 1973/016009/07)

Cnr 16^th and Douglas Roads

Randjespark

1685

Tel. 011 312 4088

Fax. 011 312 4092

Website: www.ceva.co.za