OXYTOCIN SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-01-2017
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Active ingredient:
OXYTOCIN
Available from:
Eurovet Animal Health B.V.
ATC code:
QH01BB02
INN (International Name):
OXYTOCIN
Dosage:
10 IU/ML
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Canine, Caprine, Equine - Food, Feline, Ovine, Porcine
Therapeutic area:
Oxytocin
Therapeutic indications:
Hormone
Authorization status:
Authorised
Authorization date:
1990-10-01
Summary of Product characteristics
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 23/12/2016_
_CRN 7025438_
_page number: 1_
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
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