Oxytocin aniMedica

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxytocin

Available from:

aniMedica GmbH

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:

1999-10-01

Summary of Product characteristics

Health Products Regulatory Authority
23 December 2021
CRN00CMGK
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytocin aniMedica
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Oxytocin
10
I.U. (Voegtlin units)
EXCIPIENTS
Chlorobutanol hemihydrate
3.00
mg
Ethanol (96 %)
40.10
mg
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
Equine, Bovine, Porcine, Ovine, Caprine, Canine and Feline.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Oxytocin aniMedica is indicated for obstetric use (stimulation of
paturition, promotion of uterine involution and control of post
partum haemorrhage) and the treatment of agalactia in the mare, cow,
sow, ewe, goat, bitch and cat.
4.3 CONTRAINDICATIONS
Use in any form of obstructive dystocia.
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.
Health Products Regulatory Authority
23 December 2021
CRN00CMGK
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
When Oxytocin aniMedica 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.
Excessive doses of Oxytocin aniMedica may delay parturition by
producing uncoordinated uterine contractions which interfere
with the progress of the foetus especially in multiple pregnancies.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Pregnant women should avoid direct contact with the product. Care
should be taken to avoid accidental self-injection.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7 USE DURING PREGNANCY,