Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Gonadorelin (6-D-phenylalanine) acetate
Vetoquinol SA
QH01CA01
Gonadorelin (6-D-phenylalanine) acetate
52.4 microgram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Horses, Pigs
gonadorelin
Hormone
Authorised
2013-11-08
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 Preberite celoten dokument