País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Gonadorelin Diacetate Tetrahydrate
Ceva Santé Animale
QH01CA01
Gonadorelin Diacetate Tetrahydrate
50 microgram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
gonadorelin
Hormone
Authorised
2007-12-07
Health Products Regulatory Authority 12 April 2019 CRN008S2G Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ovarelin 50 ug/ml, solution for injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Composition for 1 ml:_ ACTIVE SUBSTANCE(S): QUANTITY: Gonadorelin (as diacetate tetrahydrate) 50.0 µg EXCIPIENT: Benzyl alcohol (E1519) 15.0 mg 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. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Induction and synchronisation of oestrus and ovulation in combination with prostaglandin F 2α (PGF 2α ) or analogue with or without progesterone as part of Fixed Time Artificial Insemination (FTAI) protocols. Treatment of delayed ovulation (repeat breeding). A repeat breeder cow or heifer is generally defined as an animal that has been inseminated at least 2 or often 3 times without becoming pregnant, despite having regular normal œstrus cycles (every 18 -24 days), normal œstrus behaviour and no clinical abnormalities of the reproductive tract. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The response of dairy cows to synchronisation protocols may be influenced by the physiological state at the time of treatment, which includes age of the cow, body condition and interval from calving. Responses to treatment are not uniform either across herds or across cows within herds. Where a period of progesterone treatment is included in the protocol, the percentage of cows displaying oestrus within a given period is usually greater than in untreated cows and the subsequent luteal phase is of normal duration. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Health Products Regulatory Authority 12 April 2019 CRN008S2G Page 2 of 5 Special precaution Leer el documento completo