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

ประเทศ: ไอร์แลนด์

ภาษา: อังกฤษ

แหล่งที่มา: HPRA (Health Products Regulatory Authority)

สารออกฤทธิ์:

D-cloprostenol sodium salt

มีจำหน่ายจาก:

aniMedica GmbH

รหัส ATC:

QG02AD90

INN (ชื่อสากล):

D-cloprostenol sodium salt

ปริมาณ:

75 microgram(s)/millilitre

แบบฟอร์มเภสัชกรรม:

Solution for injection

ประเภทใบสั่งยา:

POM: Prescription Only Medicine as defined in relevant national legislation

กลุ่มบำบัด:

Cattle, Horses, Pigs

พื้นที่บำบัด:

cloprostenol

ข้อบ่งชี้ในการรักษา:

Hormone

สถานะการอนุญาต:

Authorised

วันที่อนุญาต:

2009-10-09

สรุปลักษณะสินค้า

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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___