Gonavet Veyx 50 micrograms/ml solution for injection for cattle, pigs and horses

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Gonadorelin (6-D-phenylalanine) acetate

Disponible desde:

Veyx-Pharma GmbH

Código ATC:

QH01CA01

Designación común internacional (DCI):

Gonadorelin (6-D-phenylalanine) acetate

Dosis:

50 microgram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle, Horses, Pigs

Área terapéutica:

gonadorelin

indicaciones terapéuticas:

Hormone

Estado de Autorización:

Authorised

Fecha de autorización:

2015-03-20

Ficha técnica

Health Products Regulatory Authority
08 May 2020
CRN00967D
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Gonavet Veyx 50 micrograms/ml solution for injection for cattle, pigs
and horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1.0 ml contains:
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​
​
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Gonadorelin [6-D-Phe]
​50
​micrograms (equivalent to 52.4 microgramsGonadorelin[6-D-Phe]
acetate)
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​
​
​
EXCIPIENTS:
​
​
​
Chlorocresol
​1
mg​
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​
​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (cows, heifers), pigs (sows, gilts), horses (mares)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Control and stimulation of reproduction in cattle and pigs. Treatment
of ovarian-related fertility disorders or dysfunctions in
cattle and horses.
Cattle (cows, heifers):

Ovulation induction in case of delayed ovulation due to LH-deficiency

Induction/synchronization of ovulation within the framework of systems
for timed inseminations

Stimulation of the ovaries during the puerperal period from day 12
post partum

Ovarian cysts (due to LH-deficiency)
Pigs (sows, gilts):

Induction/synchronization of ovulation within the framework of systems
for timed insemination and parturition
synchronization
Horses (mares):

Acyclia and anoestrus due to LH-deficiency
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 cases of known hypersensitivity to the active substance
or to any of the excipients.
Health Products Regulatory Authority
08 May 2020
CRN00967D
Page 2 of 5
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 act