HYPOPHYSIN LA 35 MICROGRAM/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CARBETOCIN

Available from:

Veyx-Pharma GmbH

ATC code:

QH01BB03

INN (International Name):

CARBETOCIN

Dosage:

35 Microgram/ML

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Porcine

Therapeutic area:

Carbetocin

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2014-08-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Hypophysin LA 35 microgram/ml solution for injection for cattle and pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pig.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cow:
- Uterine atony during the puerperal period.
- Placental retention as a consequence of uterine atony.
- Initiation of milk ejection in stress-induced agalactia or in conditions requiring udder emptying.
Sow:
- Acceleration or restart of parturition after disruption of uterine contractions (uterine atony or inertia) .
following the expulsion of at least 1 piglet.
- Supportive therapy of mastitis-metritis-agalactia (MMA-) syndrome.
- Initiation of milk ejection.
- Shortening of total parturition duration as a component of synchronisation of parturition in sows. The product may be
applied to sows which have previously been administered an appropriate PGF
2
(e.g. cloprostenol) not prior to day
114 of pregnancy and have not started farrowing within 24 hours after the PGF
2
injection (day 1 of pregnancy is the
last day of insemination).
4.3 CONTRAINDICATIONS
Do not administer to accelerate parturition if cervix is not opened or if there is a mechanical cause for the delayed
parturition such as physical obstruction, positional and postural abnormalities, convulsive labour, threatened rupture of
uterus, uterine torsion, relative foetal oversize or deformities of the birth canal.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
1 ml contains:
_Active substance:_
Carbetocin
35.00 µg
_Excipients:_
Chlorocresol
1.00 mg
For the full list of excipients, see section 6.1.
HEALTH PRODU