OvuGel

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Triptorelin acetate

Available from:

Vetoquinol

ATC code:

QH01CA97

INN (International Name):

Triptorelin

Therapeutic group:

Pigs (sows for reproduction)

Therapeutic area:

Pituitary and hypothalamic hormones and analogues

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2020-11-10

Patient Information leaflet

14
B. PACKAGE LEAFLET
15
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
0.9 mg
Sodium propyl parahydroxybenzoate
0.1 mg
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.
16
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 re

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 PARTICULARS
4.1
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.
3
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