COMPOSITION

In each device:

Progesterone…….……………………………….……… 1.55 g

Excipients……….….…………q.s….………….…………    14 g

ADMINISTRATION AND DOSAGE

Cows and heifers: Vaginal use. 1.55 g of progesterone/animal for 7 days.

Judgment on the protocol to be used should be made by the veterinarian responsible for treatment, on the basis of the treatment objectives of the individual herd or cow.

The following protocols could be used:

• For synchronisation of œstrus (including synchronisation of œstrus of donor and recipients animal for embryo transfer).
• For the induction and synchronisation of œstrus for Fixed Time Artificial Insemination (FTAI).

ADVICE ON CORRECT ADMINISTRATION

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. The end of the device tail should be outside of the applicator. Lightly lubricate the distal end of the applicator with an obstetrical lubricant.

Lift the tail and clean the vulva and perineum.

Gently insert the applicator into the vagina, first in a vertical direction and then horizontally until some resistance is encountered.

Make sure the removal tail is free, press the handle of the applicator and pull it out, leaving the removal tail hanging from the vulva.

Removal:

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

The device is intended for single use only.

CONTRA-INDICATIONS

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.

ADVERSE REACTIONS

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.

PRECAUTIONS

Special warnings for each target species:

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.

Use during pregnancy or lactation or lay:

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.

WITHDRAWAL PERIOD

Cattle:

- Meat and offals:  zero days.

- Milk: zero hours.

PRESENTATION

Box (10 devices with each device in one pack)

STORAGE

Store at room temperature.

Keep out of reach of children.

FOR ANIMAL TREATMENT ONLY