OESTRACTON 52.4 µG/ML SOLUTION FOR INJECTION FOR CATTLE, HORSES, PIGS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
06-06-2024
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Ingredient activ:
GONADORELIN(6-D-PHE)ACETATE
Disponibil de la:
VetCom-pharma Ltd
Codul ATC:
QH01CA01
INN (nume internaţional):
GONADORELIN(6-D-PHE)ACETATE
Dozare:
52.4 Microgram/ML
Forma farmaceutică:
Solution for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Bovine, Equine - Food, Porcine
Zonă Terapeutică:
Gonadorelin
Indicații terapeutice:
Hormone
Statutul autorizaţiei:
Authorised
Data de autorizare:
2013-11-08
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oestracton 52.4 µg/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 a 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, horse, pig
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:
- 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 for shortening of oestrus during infectious diseases and other relevant disorders.
-
Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/11/2013_
_CRN 7013381_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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