Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

d-Cloprostenol

Disponibil de la:

SUPPORT PHARMA, S.L.

Codul ATC:

QG02AD90

INN (nume internaţional):

d-Cloprostenol

Dozare:

0.075 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Zonă Terapeutică:

cloprostenol

Statutul autorizaţiei:

Authorised

Data de autorizare:

2019-09-13

Caracteristicilor produsului

Health Products Regulatory Authority
13 September 2019
CRN000YPQ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and
horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
d-cloprostenol
​
0.075 mg
​
(equivalent to d-cloprostenol sodium ​
0.079 mg)
​
​
​
EXCIPIENTS:
​
​
chlorocresol
​
1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution, with no visible particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (cows), pigs (sows) and horses (mares).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for:
COWS:

​Synchronisation or induction of oestrus;

Induction of parturition after day 270 of gestation;

Treatment of ovarian dysfunction (persistent _corpus luteum_, luteal
cyst);

Treatment of clinical endometritis with the presence of a functional
_corpus luteum_ and pyometra;

Treatment of delayed uterine involution;

Induction of abortion up to day 150 of gestation;

Expulsion of mummified foetuses.
SOWS:

Induction of parturition after day 114 of gestation.
MARES:

Induction of luteolysis with a functional _corpus luteum_.
4.3 CONTRAINDICATIONS
Do not use in pregnant females, unless it is desirable to induce
parturition or induction of abortion.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not administer to animals with cardiovascular, respiratory or
gastrointestinal problems.
Health Products Regulatory Authority
13 September 2019
CRN000YPQ
Page 2 of 6
Do not administer to induce parturition in sows and cows with
suspected dystocia due to mechanical obstruction or if
problems are expected because of an abnormal position of the foetus.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The response of cows to the synchronization protocols is not
homogenous nor between th