SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Prid delta 1.55 g vaginal delivery system for cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each delivery system contains:

Active substance:

1.55 g of progesterone

Excipients:

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Vaginal delivery system.

Whitish triangular device with a double 50 cm cord attached.

4. CLINICAL PARTICULARS

Cattle: cows and heifers.

For the control of the œstrus cycle in cows and heifers including:

- Synchronisation of œstrus in cycling cattle. To be used in combination with a prostaglandin (PGF2).

- Induction and synchronisation of œstrus in non cycling cattle. To be used in combination with a prostaglandin and equine chorionic gonadotrophin (eCG, in the past called PMSG).

Do not use in sexually immature heifers or females with abnormal genital tracts e.g. freemartins.

Do not use before 35 days have passed since previous calving.

Do not use in animals suffering from infectious or non-infectious disease of the genital tract.

Do not use in pregnant animals. See section 4.7.

The percentage of cows displaying oestrus within a given period following treatment is usually greater than in untreated cows and the subsequent luteal phase is of normal duration. However, the progesterone treatment alone, according to dosage regimen proposed, is not sufficient to induce oestrus and ovulation in all cycling females.

In order to optimise the protocol, it is advisable to determine cycling ovarian activity before using the progesterone treatment.

Animals in poor condition, whether from illness, inadequate nutrition, under unnecessary stress or other factors, may respond poorly to treatment.

Special precautions for use in animals

It is recommended to wait a minimum of 35 days following parturition before starting the treatment with this product.

Special precautions to be taken by the person administering the veterinary medicinal product to the animals

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

Do not eat or drink when handling the veterinary medicinal product.

Wash hands after use.

During the course of the seven day treatment, the device may induce a mild local reaction (i.e. inflammation of the vaginal wall). A clinical study carried out with 319 cows and heifers has demonstrated that 25% of animals presented ropy or cloudy vulvar secretions at the device removal. This local reaction disappears rapidly without any treatment between removal and insemination and does not affect fertility at inseminations nor pregnancy rates.

Can be used during lactation.

Do not use before 35 days have passed since previous calving.

Laboratory studies in rat and rabbit, after intramuscular or subcutaneous administrations, and at repeated high doses of progesterone, have produced evidence of foetotoxic effects. The use of the product is contra indicated in pregnant cattle.

None known.

Vaginal use.

1.55 g of progesterone / animal for 7 days.

Using an applicator, insert one device into the vagina of the animal. The intravaginal device should stay in place for 7 days.

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

In non cycling cattle, an injection of a prostaglandin must be done 24 hours prior to removal of the device and an injection of eCG at the time of removal.

Disinfection procedure:

The applicator must be cleaned and disinfected in a non-irritating antiseptic solution before and after use and between each animal.

Applicator method of use and Insertion:

Bend the device before inserting in the applicator. Ensure the string is in the appropriate slot.

Lightly lubricate the distal end of the applicator with an obstetrical lubricant.

Clean the animal’s vulva before gently inserting the applicator in the vagina.

Once the applicator has reached the fundus of the vagina, press on the handle to release the device.

Remove the applicator gently and ensure the string is outside the vulva. Shorten the string according to animal’s size if necessary.

Removal:

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.

The device is intended for single use only.

Not applicable.

Meat and offal: zero days

Milk: zero days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Sex hormones (progestogens).

ATC Vet code: QG03DA04.

5.1 Pharmacodynamic properties

Progesterone interacts with specific intranuclear receptors and binds to specific DNA sequence on the genome and then, 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 GnRH and consequently on LH secretion. Progesterone prevents the hormonal surge from hypophysis (FSH and LH) and so suppresses oestrus and ovulation. At removal progesterone falls dramatically in 1 hour allowing follicular maturation, oestrus and ovulation in a narrow window.

5.2 Pharmacokinetic particulars

Progesterone is rapidly absorbed by intravaginal route. 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. Liver is the main site of progesterone metabolism. Progesterone has a half-life of 3 hours, a Cmax of 5µg/L and a Tmax of 9h. The principal route of excretion is the faeces and the secondary route is the urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

EthylVinylAcetate

Polyamide

Polyester string

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate sachet: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Material of the primary container

Polyester/ polyethylene triangular or rectangular sachet.

Pack sizes

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 100 sachets of 1 device

Cardboard box containing 1 applicator and 50 sachets of 1 device

Polyethylene box containing 50 sachets of 1 device

Polyethylene box containing 1 applicator and 50 sachets of 1 device

Sachet containing 10 devices

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

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

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

Vm15052/4047

15 October 2010

October 2015

Approved: 13 October 2015