Bioestrovet 0.250 mg/ml solution for injection for cattle

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Hent Produktets egenskaber (SPC)
12-06-2017

Aktiv bestanddel:

Cloprostenol

Tilgængelig fra:

Vetoquinol UK Limited

ATC-kode:

QG02AD90

INN (International Name):

Cloprostenol

Dosering:

0.250 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle

Terapeutisk område:

cloprostenol

Terapeutiske indikationer:

Hormone

Autorisation status:

Authorised

Autorisation dato:

2017-04-28

Produktets egenskaber

                                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
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 problems.
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 case of hypersensitivity to the active substance or to
any of the excipients.
Do not administer intravenously.
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.
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