Overview

OvuGel is a veterinary medicine used to synchronise ovulation in weaned sows (sows whose piglets have been taken away) for reproduction to enable artificial insemination. Because ovulation occurs as a timed response to treatment with Ovugel, a timed insemination program can therefore be used to breed sows.

OvuGel contains the active substance triptorelin (as acetate), which is a synthetic analogue of gonadotropin releasing hormone (GnRH).

OvuGel is a vaginal gel, which should be given to sows into the vagina using an appropriate commercially available device, at 4 days (94 - 98 hours) after weaning.

The medicine can only be obtained with a prescription. For more information about using OvuGel, see the package leaflet or contact your veterinarian or pharmacist.

The active substance in OvuGel, triptorelin acetate, is a synthetic analogue of the naturally occurring gonadotropin releasing hormone (GnRH), which will stimulate ovulation in a sow once her piglets are weaned. Ovugel has to be given at a specified time point (i.e. approximately 96 hours) after the piglets have been weaned. This will then result in ovulation taking place approximately 22 hours later, and hence provide a fixed timepoint when artificial insemination can take place. 

OvuGel was first studied in a number of laboratory studies to establish the most effective dose and the best time points for the administration of OvuGel, and also the best time point to conduct the artificial insemination after the administration of OvuGel. Field studies in Europe and the USA then investigated the use of OvuGel (and subsequent insemination) in different sow breeds and in different pig husbandry practices across Europe.

Two main studies showed that OvuGel was effective in synchronising the time of ovulation when given 94-98 hours after weaning. In the first study in 708 weaned sows, the sows either received OvuGel followed by artificial insemination or only the standard insemination practice.  OvuGel led to similar fertility and reproduction performance as the standard insemination practice. 

The second study carried out in gilts (i.e. young female sows that have not yet been pregnant) did not support the effective use of OvuGel, and OvuGel is therefore not recommended in this animal population.

OvuGel was well-tolerated in studies without any side effects. 

OvuGel must not be used in sows with obvious reproductive tract abnormalities or which are pregnant or lactating. For the full list of restrictions with OvuGel, see the package leaflet.

OvuGel can cause eye irritation, and personal protective equipment should be worn when handling OvuGel. The active ingredient in OvuGel (triptorelin acetate) can affect reproductive cycles in women and the effects of accidental exposure in pregnant women are unknown.

Safety information has been included in the summary of product characteristics and the package leaflet for OvuGel, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.

The European Medicines Agency decided that OvuGel’s benefits are greater than its risks and it can be authorised for use in the EU.

Ovugel received a marketing authorisation valid throughout the EU on 10 November 2020. 

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Product information

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10/11/2020

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Product details

Name of medicine
OvuGel
Active substance
Triptorelin acetate
International non-proprietary name (INN) or common name
Triptorelin
Species
Pigs (sows for reproduction)
Anatomical therapeutic chemical veterinary (ATCvet) code
QH01CA97

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

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

Authorisation details

EMA product number
EMEA/V/C/005219
Marketing authorisation holder
Vetoquinol

Magny Vernois 70200
Lure
France

Opinion adopted
09/09/2020
Marketing authorisation issued
10/11/2020

Assessment history

Topics

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