Prolusyn 50 micrograms/ml solution for injection for cattle

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Gonadorelin acetate

Verfügbar ab:

Syn Vet-Pharma Ireland Limited

ATC-Code:

QH01CA01

INN (Internationale Bezeichnung):

Gonadorelin acetate

Dosierung:

50.0 microgram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

gonadorelin

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2020-05-15

Fachinformation

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