Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxytocin

Available from:

Bela-Pharm GmbH & Co. KG

ATC code:

QH01BB02

INN (International Name):

Oxytocin

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, Goats, Horses, Pigs, Sheep

Therapeutic area:

oxytocin

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2014-02-21

Summary of Product characteristics

Health Products Regulatory Authority
04 February 2019
CRN000YLY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs,
Sheep, Goats, Dogs
and Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
1 ml contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Oxytocin
16.6​
​µg
​
(equivalent to 10 IU Oxytocin)
​
​
​
EXCIPIENTS:
​
​
​
Chlorobutanol hemihydrate
3.0​
mg​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses (mares), cattle (cows), pigs (sows), sheep (ewes), goats
(nanny), dogs (bitches)
and cats (queen)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In the mare, cow, sow, ewe, nanny, bitch and queen the product is
indicated for:

Obstetric use (stimulation of uterine contraction to facilitate
parturition in
the presence of a fully dilated cervix, promotion of involution of the
post
partum uterus, aid in the control of post partum haemorrhage).

Promotion of milk let-down in cases of agalactia.
4.3 CONTRAINDICATIONS
Do not use in cases of obstructive dystocia and/or in cases of
non-dilatation of the
uterine cervix.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Health Products Regulatory Authority
04 February 2019
CRN000YLY
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Adrenaline at physiological levels markedly reduces the effect of
Oxytocin on the
uterus or mammary gland. For this reason the animal should not be
frightened when
complete Oxytocin effect is desired to cause either milk let-down or
uterine
contractions.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
When the veterinary medicinal product is used as an aid in parturition
cervical
dilation must be confirmed prior to administration to prevent risk of
foetal death and
possible uterine rupture.
SPECIAL PRE