Oxytocin Solution for Injection

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Oxytocin synthetic

Disponível em:

Eurovet Animal Health B.V.

Código ATC:

QH01BB02

DCI (Denominação Comum Internacional):

Oxytocin synthetic

Dosagem:

10 international unit(s)/millilitre

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Cats, Cattle, Dogs, Goats, Horses, Pigs, Sheep

Área terapêutica:

oxytocin

Indicações terapêuticas:

Hormone

Status de autorização:

Authorised

Data de autorização:

1990-10-01

Características técnicas

Health Products Regulatory Authority
05 April 2019
CRN008ZQJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytocin Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance:
Oxytocin (synthetic) 10 I.U.
Excipients:
Chlorobutanol hemihydrate (preservative) 4.75 mg
For a full list of excipients see 6.1
3 PHARMACEUTICAL FORM
Solution for injection.A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle, sheep, goats, pigs, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Uterine inertia, retention of the placenta, agalactia, prevention of
haemorrhages after caesarian section or after hard delivery.
4.3 CONTRAINDICATIONS
Do not use in cases of incomplete dilation of the cervix or any form
of obstructive dystocia.
Do not use in cases of hypersensitivity to the active substance or any
of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
When oxytocin is used as an aid to parturition, cervical dilation must
be confirmed prior to administration to prevent the risk of
foetal death and possible uterine rupture.
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 “letdown” or uterine
contractions.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If uterine hyperactivity occurs, oxytocin administration should be
discontinued immediately. Oxytocin should not be given
simultaneously by more than one route of administration.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Hypersensitivity reactions may rarely occur; avoid skin contact with
the solution.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Health Products Regulatory Authority
05 April 2019
CRN008ZQJ
Page 2 of 4
Hypersensitivity reactions sometimes occur.
4.7 USE DURING P