Luteoplan 0.25 mg/ml solution for injection for cattle and horses

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Cloprostenol sodium

Beschikbaar vanaf:

Syn Vet-Pharma Ireland Limited

ATC-code:

QG02AD90

INN (Algemene Internationale Benaming):

Cloprostenol sodium

farmaceutische vorm:

Solution for injection

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

cloprostenol

Autorisatie datum:

2023-10-13

Productkenmerken

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Luteoplan 0.25 mg/ml solution for injection for cattle and horses.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each ml contains:
Cloprostenol
0.25 mg
(as cloprostenol sodium
0.263 mg)
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/ml
Citric acid
Sodium hydroxide (for pH adjustment)
Ethanol, anhydrous
Water for injections
Clear, colourless solution for injection.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (heifers and cows) and horses (mares).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Cattle (heifers, cows):
- Synchronisation or induction of oestrus;
- Treatment of ovarian dysfunction (persistent corpus luteum, luteal
cyst);
- Treatment of uterine disorders related to a functioning or
persistent corpus luteum (endometritis,
pyometra);
- Induction of abortion until day 150 of pregnancy;
- Expulsion of mummified foetuses;
- Induction of parturition
Horses (mares):
Induction of luteolysis with a functional corpus luteum
3.3
CONTRAINDICATIONS
Do not use in pregnant animals unless the objective is to induce
parturition or abortion. Do not use in
animals with cardiovascular, gastro-intestinal or respiratory
problems.
Do not administer to induce parturition in cattle with suspected
dystocia due to mechanical obstruction
or if problems are expected because of an abnormal position of the
foetus.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
2
Do not administer intravenously.
3.4
SPECIAL WARNINGS
There is a refractory period of four to five days after ovulation when
cattle and horses are insensitive
to the luteolytic effect of prostaglandins.
Cattle:
For the induction of abortion, best results are obtained before day
100 of gestation. Results are less
reliable between day 100 and 150 of gestation.
In case of oestrus induction in cattl