Genestran 75 micrograms/ml solution for injection for cattle, horses and pigs

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Beli sekarang

Ciri produk Ciri produk (SPC)
12-06-2017
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
12-06-2017
DSU DSU (DSU)
06-06-2023

Bahan aktif:

D-cloprostenol sodium salt

Boleh didapati daripada:

aniMedica GmbH

Kod ATC:

QG02AD90

INN (Nama Antarabangsa):

D-cloprostenol sodium salt

Dos:

75 microgram(s)/millilitre

Borang farmaseutikal:

Solution for injection

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kumpulan terapeutik:

Cattle, Horses, Pigs

Kawasan terapeutik:

cloprostenol

Tanda-tanda terapeutik:

Hormone

Status kebenaran:

Authorised

Tarikh kebenaran:

2009-10-09

Ciri produk

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Genestran 75 micrograms/ml solution for injection for cattle, horses
and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear and odourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, horses and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
- induction of luteolysis allowing resumption of oestrus and ovulation
in cyclic females when used during dioestrus
- synchronisation of oestrus (within 2 to 5 days) in groups of cyclic
females treated simultaneously
- treatment of suboestrus and uterine disorders related to a
functioning or persistent corpus luteum (endometritis, pyometra)
- treatment of ovarian luteal cysts
- induction of abortion until day 150 of pregnancy
- expulsion of mummified foetuses
- induction of parturition (within the last two weeks of gestation).
HORSES:
- induction of luteolysis in mares with a functional corpus luteum.
PIGS:
- induction or synchronisation of farrowing (generally within 24 to 36
hours) from day 113 of pregnancy onwards (day 1
of pregnancy is the last day of natural or artificial insemination).
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in animals with spastic respiratory or gastro-intestinal
diseases.
Do not use in pregnant animals, for which induction of abortion or
parturition is not intended.
Do not use for intravenous administration.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
ACTIVE SUBSTANCE:
micrograms
R(+)-cloprostenol {as R(+)-cloprostenol sodium} 75
EXCIPIENTS:
Chlorocresol (as preservative)
1000
For the full list of excipients, see section 6.1
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