Estrumate

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Cloprostenol sodium

Fáanlegur frá:

Intervet Ireland Limited

ATC númer:

QG02AD90

INN (Alþjóðlegt nafn):

Cloprostenol sodium

Skammtar:

0.25 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Cattle, Horses

Lækningarsvæði:

cloprostenol

Ábendingar:

Hormone

Leyfisstaða:

Authorised

Leyfisdagur:

2011-10-14

Vara einkenni

Health Products Regulatory Authority
02 July 2019
CRN0095GN
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Estrumate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Cloprostenol (as cloprostenol sodium)
0.25 mg/ml
EXCIPIENTS:
Benzyl alcohol (E1519)
20.00 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, horses and ponies.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As a synthetic prostaglandin analogue structurally related to
Prostaglandin F
2a
(PGF
2a
), for use in cattle and horses.
Estrumate is a potent luteolytic agent. It causes functional and
morphological regression of the corpus luteum (luteolysis) in
cattle and horses followed by return to oestrus and normal ovulation.
The recommended use in each target species is as follows:
CATTLE:
_Therapeutic indications:_
Suboestrus (or non detected oestrus - NDO)
Induction of parturition
Termination of normal pregnancy
Termination of abnormal pregnancy
Chronic endometritis (Pyometra)
Ovarian luteal cysts
_Controlled breeding in cattle_
HORSES:
Induction of luteolysis following early foetal death and resorption.
Termination of persistent dioestrus.
Termination of psuedopregnancy.
Treatment of lactation anoestrus.
Establishing oestrus cycles in barren/maiden mares.
As an aid to stud management.
4.3 CONTRAINDICATIONS
Do not administer to pregnant animals unless the objective is to
terminate the pregnancy.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Health Products Regulatory Authority
02 July 2019
CRN0095GN
Page 2 of 4
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
CATTLE:
Do not administer to pregnant animals unless the objective is to
terminate pregnancy.
For the termination of pregnancy, best results are obtained before day
100 of gestation. Results are less reliable between day
100 and 150 of gestation.
If estrumate is adm