Prosolvin 7.5 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Luprostiol

Available from:

Virbac S.A.

ATC code:

QG02AD91

INN (International Name):

Luprostiol

Dosage:

7.5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

luprostiol

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2008-11-28

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2019
CRN0094NK
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Prosolvin 7.5 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Luprostiol7.5 mg (0.75 % w/v)
EXCIPIENTS:
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs and horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Oestrus control:_cows and heifers treated during the luteal phase
will normally return to oestrus and ovulate 2-4 days after
treatment.In mares oestrus will normally occur within 5 days of
treatment followed by ovulation 2-4 days later.
_Oestrus synchronisation: _when a group of cows at different stages in
the oestrus cycle are to be synchronised, two injections of
Prosolvin will be required with an interval of 10-12 days between
injections.It is recommended that animals be
serviced/inseminated at the oestrus following treatment, i.e. at 72
hours after the second injection.If doubleinsemination is
preferred, this should take place at 72 and 96 hours after the second
injection.
_Treatment of sub-oestrus:_this condition is found in lactating cows
at the peak of production. Animals may have normal cyclical
ovarian activity, but may not show any outward signs of oestrus.Having
confirmed the presence of a corpus luteum, treatment
with Prosolvin will cause luteal regression followed by oestrus in 2-4
days.
_Induction of abortion: _Prosolvin can be used to induce abortion in
cattle and mares.Animals may be treated from 1 week and up
to 5 months after misalliance.Following luteal regression abortion
will usually occur within 7 days.In some cases, particularly
those later on the pregnancy, a second or third treatment may be
required.
_Induction of parturition:_in cattle Prosolvin may be used to initiate
labour after the 270th day of pregnancy.Calving may be
expected within 3 days of treatment. In pigs,