OvuGel - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

OvuGel 0.1 mg/ml vaginal gel for sows for reproduction

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release :

Vetoquinol S.A.

Magny-Vernois

70200 LURE

France

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

OvuGel 0.1 mg/ml vaginal gel for sows for reproduction triptorelin

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

One ml contains:

Active substance:

Triptorelin (as triptorelin acetate) 0.1 mg

Excipients:

Sodium methyl parahydroxybenzoate

Sodium propyl parahydroxybenzoate

Thin clear to slightly hazy gel.

• 4. INDICATION(S)

For the synchronisation of ovulation in weaned sows to enable a single fixed-time artificial insemination.

• 5. CONTRAINDI­CATIONS

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use during pregnancy and/or lactation.

Do not use in sows with obvious reproductive tract abnormalities.

• 6. ADVERSE REACTIONS

None known.

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

  
  

Pigs (sow for reproduction)

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Each sow should receive a single 2 ml dose (equivalent to 0.2 mg) of the product intravaginally using a commercially available self-filling syringe with a draw-off needle, designed to deliver accurately doses of 2 ml and on which an intravaginal infusion tube can be plugged.

OvuGel should be administered intravaginally at approximately 96 hours after weaning.

Sows should be inseminated approximately 22 hours ± 2 hours following administration of the product using standard artificial insemination techniques.

The number of doses per vial will depends on the practices in the field, including the type of device and the regime of administration.

ADVICE ON CORRECT ADMINISTRATION

Follow directions carefully.

The product should be warmed to room temperature for 10 minutes prior to use.

Remove foil tab from top of the vial. Keep the vial in the upright position, invert the applicator over and push it onto vial.

Slowly compress and release the applicator handle causing the veterinary medicinal product to enter the infusion tube and another dose from the vial to refill the chamber. This allows also to displace any air in the infusion tube

Use a disposable protective sheath for each individual sow.

Gently and slowly insert the infusion tube into the vagina at a slight upper angle (to avoid entry into the urethra) until you encounter mild resistance (the cervix) and then withdraw the infusion tube approximately 1–3 cm.

Discharge the veterinary medicinal product dose into the vagina and remove the infusion tube from the vagina.

5-vagina

• 10. WITHDRAWAL PERIOD(S)

Meat and offal: Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store in a refrigerator (2°C – 8°C).

After first opening, do not store above 25°C.

Do not use this veterinary medicinal product after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.

Shelf life after first opening the container: 28 days

Special warnings for each target species :

The efficacy of the product has not been demonstrated in gilts (nulliparous sows), and the use of the product is therefore not recommended in these animals.

The response of sows to synchronisation protocols may be influenced by the physiological state at the time of treatment. Responses to treatment are not uniform either across herds or across individuals within herds.

Special precautions for use in animals :

The product should not be used in sows with reproductive tract abnormalities, infertility or general health disorders.

A reproduction safety study was conducted in sows after administration of 3 times the recommended dose of Ovugel and did not show any effect on reproduction performance nor on the piglets. However, safety of treatment in sows in subsequent reproductive cycles has not been demonstrated. Potential long-term effects of cyst occurrence cannot be excluded.

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

The product can cause eye irritation. People with known hypersensitivity to GnRH analogues or any of the excipients (including parabens) should avoid contact with the veterinary medicinal product.

Personal protective equipment consisting of overalls and gloves should be worn when handling the veterinary medicinal product.

Do not eat, drink or smoke while handling the veterinary medicinal product.

Avoid direct contact with skin or eyes, wash hands after handling the veterinary medicinal product.

In case of accidental contact with the eyes, rinse thoroughly and seek medical advice immediately.

In case of accidental skin contact, wash contaminated areas with soap and water.

Triptorelin can affect reproductive cycles in women and the effects of accidental exposure in pregnant women are unknown; therefore, it is recommended that pregnant women should not handle the veterinary medicinal product, and that women of child-bearing age should handle the veterinary medicinal product with caution.

Use during pregnancy and/or lactation :

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

Do not use during pregnancy and/or lactation.

Overdose (symptoms, emergency procedures, antidotes) :

Administration of the veterinary medicinal product in gilts and sows at doses up to 3X the recommended dose daily for 3 consecutive days showed the presence of luteal cysts in the ovaries, the maximal incidence being observed at 3 times the dose.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED <DD/MM/YYYY>

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION