Dalmaprost 0.075 mg/ml Solution for Injection for Cattle, Pigs and Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

d-Cloprostenol

Available from:

Support Pharma S.L.

ATC code:

QG02AD90

INN (International Name):

d-Cloprostenol

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

Prostaglandin

Authorization status:

Authorized

Authorization date:

2019-09-23

Summary of Product characteristics

Issued: September 2019
AN: 00298/2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and
horses (AT, BE,
BG, CY, CZ, DE, DK, EE, EL, ES, FR, HR, HU, IE, IS, IT, LT, LU, LV,
MT, NL, PL,
PT, RO, SI, SK, UK)
Dalmaprost vet 0.075 mg/ml solution for injection for cattle, pigs and
horses (FI, NO,
SE)
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:
Page 1 of 8
Issued: September 2019
AN: 00298/2018

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.
Do not administer to induce parturition in sows and cows with
suspected dystocia
due to mechanical obstruction or if problems are expected b