Prolusyn 50 micrograms/ml Solution for Injection for Cattle

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Gonadorelin

Dostupné z:

Cyton AH Biosciences GmbH

ATC kód:

QH01CA01

INN (Medzinárodný Name):

Gonadorelin

Forma lieku:

Solution for injection

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Cattle

Terapeutické oblasti:

Hormone sex

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2020-04-08

Súhrn charakteristických

Revised: March 2021
AN: 01727/2020
Page 1 of 6
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 F2

(PGF2

) 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.
Revised: March 2021
AN: 01727/2020
Page 2 of 6
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.
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
exposure to GnRH
analogues in pregnant women or