Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Gonadorelin acetate
Syn Vet-Pharma Ireland Limited
QH01CA01
Gonadorelin acetate
50.0 microgram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
gonadorelin
Authorised
2020-05-15
Health Products Regulatory Authority 05 February 2021 CRN00C51K Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Prolusyn 50 micrograms/ml solution for injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Gonadorelin (as gonadorelin acetate) 50.0 micrograms EXCIPIENT: Benzyl alcohol (E1519) 9.0 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 F2α (PGF2α) or analogue with or without progesterone as part of Fixed Time Artificial Insemination (FTAI) protocols. Treatment of delayed ovulation. 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to the active substance or to any of the excipients. Do not use during infectious diseases and other relevant health disorders. 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, health status 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 05 February 2021 CRN00C51K Page 2 of 5 Special precautions to be taken by the person administering the veterinary medicinal product to animals Gonadorelin is a Gonadotropin Releasing Hormone (GnRH) analogue which stimulates the release of sex hormones. The effects of accidental Preberite celoten dokument