Oestracton 52.4 microgram/ml solution for injection for cattle, horses, pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gonadorelin (6-D-phenylalanine) acetate

Available from:

Vetoquinol SA

ATC code:

QH01CA01

INN (International Name):

Gonadorelin (6-D-phenylalanine) acetate

Dosage:

52.4 microgram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

gonadorelin

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2013-11-08

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2018
CRN008Q6S
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oestracton 52.4 microgram/ml solution for injection for cattle,
horses, pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
1 ml solution for injection contains:
​
​
​
Active Substance:
​
​
Gonadorelin[6-D-Phe]acetate
​52.4 µg
​
(corresponding to 50 µg Gonadorelin[6-D-Phe])
​
​
Excipients:
​
​
Methyl-4-hydroxybenzoate (E 218)
​1.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear colourless to brownish-yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (cows, heifers), horses (mares), pigs (sows, gilts)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Control and stimulation of reproduction and improvement of conception
rates in
cattle and pigs. Treatment of ovarian-related fertility disorders or
dysfunctions in
cattle and horses.
Cattle:
- Ovulation induction in case of delayed ovulation due to
LH-deficiency
- Ovulation synchronization following oestrus synchronisation
- Stimulation of the ovaries during the puerperal period from Day 12
post partum
- Ovarian cysts (due to LH-deficiency).
Horses:
- Acyclia and anoestrus due to LH-deficiency
- Ovulation induction (shortening of oestrus).
Pigs:
Health Products Regulatory Authority
15 November 2018
CRN008Q6S
Page 2 of 7
- Ovulation synchronization in association with a PMSG for timed
insemination as
part of a timed insemination-regime
4.3 CONTRAINDICATIONS
- Do not use in cows with a mature tertiary follicle ready to ovulate.
- Do not use during infectious diseases and other relevant health
disorders.
- Do not use in case of known hypersensitivity to the active substance
or to any of
the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
To maximise conception rates of cows to be treated with GnRH-PGF
2α
based
synchronization protocols, the ovarian status should be determined and
regular
cyclic ovarian activit