PROSOLVIN 7.5 MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-08-2016
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Active ingredient:
LUPROSTIOL
Available from:
Virbac S.A.
ATC code:
QG02AD91
INN (International Name):
LUPROSTIOL
Dosage:
7.5 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Equine - Food, Porcine
Therapeutic area:
Luprostiol
Therapeutic indications:
Hormone
Authorization status:
Authorised
Authorization date:
2008-11-28
Summary of Product characteristics
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:
Luprostiol
7.5 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 27/07/2016_
_CRN 7024260_
_page number: 1_
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
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