HIPRACIN10 IU/ml Synthetic Oxytocin, solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxytocin synthetic

Available from:

Laboratorios Hipra S.A.

ATC code:

QH01BB02

INN (International Name):

Oxytocin synthetic

Dosage:

10 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Cattle, Dogs, Pigs, Sheep

Therapeutic area:

oxytocin

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2000-09-01

Summary of Product characteristics

Health Products Regulatory Authority
20 June 2019
CRN0094NJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRACIN10 IU/ml Synthetic Oxytocin, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Synthetic Oxytocin
10 IU/ml
EXCIPIENTS:
Chlorobutanol hemihydrate
5 mg/ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sows, Ewes, Cows, Bitches, and Queens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In general, for all target species:
Stimulation of uterine contractions to facilitate parturition in the
presence of a fully dilated cervix.
To promote involution of the post-parturient uterus and thus aid the
passage of retained placenta.
To help control post-partum haemorrhage.
Promotion of milk let-down in cases of agalactia and as a co-adjuvant
in antibiotic treatment of mastitis.
4.3 CONTRAINDICATIONS
Do not use in females with obstructive dystochia, pelvic-foetal
disproportion or with any other mechanical obstruction.
Do not use in animals with cardiovascular problems.
To prevent the risk of foetal death and possible uterine rupture, do
not use to induce parturition if cervical dilatation is not
confirmed.
Do not use in sows with normal parturition.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Adrenaline at physiological levels markedly reduces the effect of
oxytocin on the uterus and mammary gland. For this reason
the animal should not be stressed when complete oxytocin effect is
desired to cause either milk let-down or uterine
contractions.
4.5 SPECIAL PRECAUTIONS FOR USE
Health Products Regulatory Authority
20 June 2019
CRN0094NJ
Page 2 of 4
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The intravenous injection must be given by slow intravenous infusion.
A low initial dose is recommended and should only be increased if no
effect is observed.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PROD