Enzaprost Bovis 12.5 mg/ml solution for injection for cattle

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Dinoprost tromethamine

Commercializzato da:

Ceva Santé Animale

Codice ATC:

QG02AD01

INN (Nome Internazionale):

Dinoprost tromethamine

Dosaggio:

12.5 milligram(s)/millilitre

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapeutica:

dinoprost

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2020-12-04

Scheda tecnica

Health Products Regulatory Authority
04 December 2020
CRN008DL3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enzaprost Bovis 12.5 mg/ml solution for injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
​
​
Dinoprost (as dinoprost trometamol)
​12.5 mg
​
​
​
EXCIPIENTS:
​
​
Benzyl alcohol (E1519)
​16.5 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to pale brownish yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (heifers and cows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The veterinary medicinal product is used in the following indications:
- Induction of oestrus,
- Controlled breeding in normally-cycling dairy cows:
- oestrus synchronisation,
- ovulation synchronisation in combination with GnRH or GnRH analogues
as part of timed artificial insemination
protocols.
- Treatment of sub-oestrus or silent heat in cows which have a
functional corpus luteum,
- As supportive treatment of endometritis with the presence of
functional corpus luteum and pyometra,
- Induction of abortion,
- Induction of parturition, including cases with complications such as
hydrops amnii, etc,
- Expulsion of mummified foetuses.
4.3 CONTRAINDICATIONS
Do not use in animals suffering from either acute or sub-acute
disorders of the vascular system, gastro-intestinal tract or
respiratory system.
Do not use in pregnant cows unless abortion or parturition is
intended.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not administer by the intravenous route.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not administer more than 2 ml per single injection.
The veterinary medicinal product is ineffective when administered
prior to day 5 after ovulation in cattle.
Health Products Regulatory Authority
04 December 2020
CRN008DL3
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in