DALMARELIN, 25 micrograms/ml, solution for injection for cattle and rabbits

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lecirelin acetate

Available from:

FATRO S.p.A.

ATC code:

QH01CA92

INN (International Name):

Lecirelin acetate

Dosage:

25 microgram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Rabbits

Therapeutic area:

lecirelin

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2004-03-19

Summary of Product characteristics

_DALMARELIN – VRA G.I.18_
_[Version 9,03/2022] corr. 11/2022_
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_DALMARELIN – VRA G.I.18_
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dalmarelin 25 micrograms/ml solution for injection for cattle and
rabbits (AT, BE, BG, CY, CZ, DE,
DK, ES, FI, HR, HU, IE, IS, IT, LU, MT, NL, NO, PL, PT, RO, SI, SK)
Reproréline 25 micrograms/ml solution for injection for cattle and
rabbits (FR)
Dalmarelin Vet 25 micrograms/ml solution for injection for cattle and
rabbits (SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
lecirelin 25 µg (as lecirelin acetate)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
benzyl alcohol (E1519)
20 mg
glacial acetic acid (E 260)
disodium phosphate dodecahydrate (E339ii)
sodium chloride
water for injections
Clear, colourless solution, with no visible particles.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (cows) and rabbits.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Cattle

Treatment of follicular ovarian cysts.

Cycle induction in early post-partum cows from day 14 post-partum.

Induction of ovulation at the time of insemination in cases of short,
silent heat or prolonged heat.

Induction of ovulation in cycling cows in association with artificial
insemination to optimise the
time of ovulation.

Induction and synchronisation of oestrus and ovulation in combination
with prostaglandin F2α
(PGF2α) or PGF2α analogue, with or without progesterone, as part of
fixed time artificial
insemination (FTAI) protocols.
_DALMARELIN – VRA G.I.18_
Rabbits

Induction of ovulation.

Conception rate enhancement.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
The veterinary medicinal product should be administered to cows with
normal ovaries at least 14 days
after calving due to the absence of receptivity of the hypophysi