Genestran 75 micrograms/ml Solution for Injection for Cattle, Horses and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

d-Cloprostenol

Available from:

aniMedica GmbH

ATC code:

QG02AD90

INN (International Name):

d-Cloprostenol

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

Prostaglandin

Authorization status:

Authorized

Authorization date:

2008-11-27

Summary of Product characteristics

Revised: February 2017
AN: 01179/2016
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
2.
Genestran 75 micrograms/ml solution for injection for cattle, horses
and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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:
Revised: February 2017
AN: 01179/2016
Page 2 of 5
- 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.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
To reduce the risk of anaerobic infections, which might be related to
the pharmacolo