INDUPART 75 micrograms /mL solution for injection for cattle, pigs and horses

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

D-cloprostenol sodium salt

Διαθέσιμο από:

Vetpharma Animal Health, S.L.

Φαρμακολογική κατηγορία (ATC):

QG02AD90

INN (Διεθνής Όνομα):

D-cloprostenol sodium salt

Δοσολογία:

75 microgram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle, Horses, Pigs

Θεραπευτική περιοχή:

cloprostenol

Θεραπευτικές ενδείξεις:

Hormone

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-08-15

Αρχείο Π.Χ.Π.

_[Version 9,03/2022]_
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
INDUPART 75 micrograms /mL solution for injection for cattle, pigs and
horses [
AT / BG / CZ / DE
/ ES / HU / LT / LV / PT / SK / RO / BE / IE / LU / NL]
INDUPART [
DK]
GANAPAR 75 micrograms /mL solution for injection for cattle, pigs and
horses
[PL / EE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
75 μg of D-cloprostenol as D-cloprostenol sodium
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
Chlorocresol
1.0 mg
Ethanol 96%
Sodium hydroxide (for pH adjustment)
Citric acid anhydrous (for pH adjustment)
Water for injections
Solution for injection. Clear colourless solution
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (cows), pigs (sows) and horses (mares).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Cattle:
•
Synchronisation or induction of oestrus
•
Induction of parturition;
•
Ovarian dysfunction (persistent
_corpus luteum_
, luteal cyst);
•
Endometritis/pyometra;
•
Delayed uterine involution;
•
Induction of abortion in the first half of pregnancy
•
Expulsion of mummified foetuses;
Pigs:
Induction of parturition.
Horses:
Induction of luteolysis in mares with a functional
_corpus luteum._
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in pregnant animals, unless it is desirable to induce
parturition or induction of abortion.
Do not administer intravenously.
Do not use in animals with cardiovascular, gastro-intestinal or
respiratory problems.
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.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target