HIPRACIN 10IU/ML SYNTHETIC OXYTOCIN, SOLUTION FOR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-04-2024
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Active ingredient:
OXYTOCIN
Available from:
Laboratorios Hipra S.A.
ATC code:
QH01BB02
INN (International Name):
OXYTOCIN
Dosage:
10 International Unit
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Canine, Feline, Ovine, Porcine
Therapeutic area:
Oxytocin
Therapeutic indications:
Hormone
Authorization status:
Authorised
Authorization date:
2000-09-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007
(S.I. NO. 144 OF 2007)
VPA: 10846/002/001
Case No: 7003219
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to:
LABORATORIOS HIPRA S.A.
AVDA. LA SELVA 135, 17170 - AMER (GIRONA), SPAIN
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
HIPRACIN 10IU/ML SYNTHETIC OXYTOCIN, SOLUTION FOR INJECTION
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said Schedule.
The authorisation, unless previously revoked, shall continue in force from 11/09/2007.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 01/09/2007_
_CRN 7003219_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRACIN
10 IU/ml Synthetic Oxytocin, solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 pre
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