Enzaprost 5 mg/ml Solution for injection for cattle and pig

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Dinoprost trometamol

Tilgjengelig fra:

Ceva Santé Animale

ATC-kode:

QG02AD01

INN (International Name):

Dinoprost trometamol

Dosering :

5 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle, Pigs

Terapeutisk område:

dinoprost

Indikasjoner:

Hormone

Autorisasjon status:

Authorised

Autorisasjon dato:

2004-07-30

Preparatomtale

Health Products Regulatory Authority
17 December 2020
CRN009ZLZ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enzaprost 5 mg/ml Solution for injection for cattle and pig
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each ml contains:
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​
​
​
​
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ACTIVE SUBSTANCE:
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​
​
Dinoprost (as trometamol)
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5
mg​
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EXCIPIENTS:
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Benzyl alcohol (E1519)
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16.5
mg​
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​
For the full list of excipients, see section 6.1.
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3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle: cows, heifers.
Pigs: sows, gilts.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for its luteolytic effects in cattle and
pigs.
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CATTLE
​
The luteolytic effect of the product can be exerted in following
therapeutic uses:
1. ​
Oestrus synchronisation.
​
2. Treatment of sub-oestrus or silent heat in cows which have a
functional corpus luteum, but do not express behavioural
oestrus.
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3. Induction of abortion until day 120 of pregnancy.
​
4. Induction of parturition.
​
5. For the aid in the treatment of chronic metritis or pyometra where
there is a functional or persistant corpus luteum.
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PIGS
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1. Induction of parturition from day 111 of pregnancy.
2. Post partum use: reduction of the weaning to oestrus interval (WOI)
and the weaning to fertile service interval (WFSI) in sows
with puerperal problems such as metritis in herds with reproductive
problems.
4.3 CONTRAINDICATIONS
Do not treat animals if they suffer from either acute or subacute
disorders of the vascular system, gastro-intestinal tract or
respiratory system.
Do not administer to pregnant animals, unless it is desirable to
induce parturition or interruption of pregnancy.
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
Health Products Regulatory Authority
17 December 2020
CRN009ZLZ
Page 2 of 5
4.4 SPECIAL WARNINGS FOR