OvuGel - summary of medicine characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

OvuGel 0.1 mg/ml vaginal gel for sows for reproduction

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance :

Triptorelin (as triptorelin acetate)           0.1 mg

Excipients :

Sodium methyl parahydroxybenzoate      0.9 mg

Sodium propyl parahydroxybenzoate       0.1 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Vaginal gel.

Thin clear to slightly hazy gel.

4. CLINICAL PARTICULARS4.1 Target species

Pig (sow for reproduction)

• 4.2 Indications for use, specifying the target species

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

4.3 Contraindications

Do not use in cases 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.

• 4.4 Special warnings for each target species

The efficacy of OvuGel has not been demonstrated in gilts (nulliparous sows), and the use of the veterinary medicinal 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.

• 4.5 Special precautions for use

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.

• 4.6 Adverse reactions (frequency and seriousness)

None known.

• 4.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

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

• 4.8 Interaction with other veterinary medicinal products and other forms of interaction

No data available.

• 4.9 Amounts to be administered and administration route

For vaginal use.

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 administrated intravaginally at 96 hours ± 2 hours after weaning.

Sows should be inseminated approximately 22 hours ± 2 hours following administration of the veterinary medicinal product.

• 1. Allow the vial to warm to room temperature for a minimum of 10 minutes.

• 2. \                                 ­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.

6-rectum

7-cervix

8-uterine horn

9-ovaries

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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

• 4.11 Withdrawal period(s)

Meat and offal: Zero days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Gonadotropin releasing hormones. ATC vet code: QH01CA97

5.1 Pharmacodynamic properties

Triptorelin is a synthetic analogue of GnRH.

GnRH is synthesised in and secreted from the hypothalamus and targets the anterior pituitary gland where it stimulates the release of luteinizing hormone (LH) and follicle stimulating hormone (FSH). These in turn stimulate the production of sex steroids and gametogenesis (ovulation). The hypothalamic release of GnRH is controlled by biofeedback from the circulating sex steroid hormones.

The mode of action of triptorelin is the same as for natural GnRH. GnRH interacts with its plasma membrane bound gonadotropin releasing hormone receptors expressed on the pituitary gonadotrope cells. This in turn activates the mobilisation of calcium and via a G-protein, the activation of a phospholipase C-type enzyme. The subsequent accumulation of calcium activates calmodulin, which appears to mediate the release of gonadotropins.

In sows, 48 hours after the intravaginal application of 0.2 mg of triptorelin, ovulation was observed in 78 to 81% of animals.

The expected secondary pharmacodynamics effects following chronic parenteral administration are pituitary desensitisation followed by gonadal suppression resulting in reduction of serum sex steroids. This has been observed following use in human medicine.

• 5.2 Pharmacoki­netic particulars

In the target animal, blood levels of triptorelin were substantially higher after intravenous administration, than those following intravaginal administration. Quantifiable levels were detectable after 12 hours following intravenous administration in comparison to 6 hours following intravaginal administration.

AUClast values in sows indicated that the exposure to triptorelin was 13 x lower after intravaginal administration relative to intravenous administration of the same dose. Less than 7.45% of the triptorelin dose was absorbed through the vaginal mucosa following administration of 0.2 mg of triptorelin in the form of the veterinary medicinal product.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Sodium methyl parahydroxybenzoate

Sodium propyl parahydroxybenzoate

Sodium Chloride

L-Methionine

Sodium Citrate

Citric Acid anhydrous

Methylcellulose

Purified Water

6.2 Major 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 packaging: 28 days.

6.4 Special precautions for storage

Store in a refrigerator (2°C – 8°C).

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

• 6.5 Nature and composition of immediate packaging

A multidose 50 ml type I amber glass vial closed with a bromobutyl rubber stopper and an aluminium seal.

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

7. MARKETING AUTHORISATION HOLDER

Vetoquinol S.A.

Magny-Vernois

70200 LURE

France

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/20/260/001

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: DD/MM/YYYY