Bioestrovet 0.250 mg/ml solution for injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cloprostenol sodium

Available from:

Vetoquinol Ireland Limited

ATC code:

QG02AD90

INN (International Name):

Cloprostenol sodium

Dosage:

0.250 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

cloprostenol

Authorization status:

Authorised

Authorization date:

2017-04-28

Summary of Product characteristics

Health Products Regulatory Authority
26 November 2021
CRN00CCP7
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bioestrovet 0.250 mg/ml solution for injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Cloprostenol
0.250
mg
(equivalent to Cloprostenol Sodium)
0.263
mg
EXCIPIENTS:
Chlorocresol
1.00
mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (heifers, cows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle (heifers, cows):
- 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
4.3 CONTRAINDICATIONS
Do not administer to pregnant animals unless the objective is to
terminate the pregnancy.
Do not use in animals with cardiovascular, gastro-intestinal or
respiratory disturbances.
Do not administer to induce parturition in cattle with suspected
dystocia due to mechanical obstruction or if problems are
expected because of an abnormal position of the foetus.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not administer intravenously.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
There is a refractory period of four to five days after ovulation when
cattle are insensitive to the luteolytic effect of
prostaglandins.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In case of oestrus induction in cattle: from the 2nd day after
injection, adequate heat detection is necessary.
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