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

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

(+)- closprostenol sodium salt

Mevcut itibaren:

Industria Italiana Integratori Trei Spa

ATC kodu:

QG02AD90

INN (International Adı):

(+)- closprostenol sodium salt

Doz:

75 microgram(s)/millilitre

Farmasötik formu:

Solution for injection

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Cattle, Horses, Pigs

Terapötik alanı:

cloprostenol

Terapötik endikasyonlar:

Hormone

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2018-04-27

Ürün özellikleri

Health Products Regulatory Authority
02 May 2018
CRN000VD9
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sincrovet 75 micrograms/ml solution for injection for cattle, horses
and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
R(+)cloprostenol (as R(+)-cloprostenol sodium) 75 micrograms
EXCIPIENTS:
Chlorocresol (as preservative) 1000 micrograms
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:
Health Products Regulatory Authority
02 May 2018
CRN000VD9
Page 2 of 6
- 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