REPIDOSE READY PULSE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
OXFENDAZOLE
Available from:
Schering Plough Limited
ATC code:
QP52AC02
Dosage:
1250 Milligram
Pharmaceutical form:
Bolus
Therapeutic group:
Endoparasiticide
Therapeutic area:
Bovine
Authorization date:
1999-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA: 10277/015/001
Case No: 7006165
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
SCHERING PLOUGH LIMITED
SHIRE PARK, WELWYN GARDEN CITY, HERTFORDSHIRE AL7 1TW, UNITED KINGDOM
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:
REPIDOSE READY PULSE
The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in
the Schedule.
The authorisation,unless revoked, shall continue in force from 30/09/2009.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/06/2010_
_CRN 7006165_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Repidose Ready Pulse
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Pulsatile release, intraruminal device.
Each tablet is a blue annular tablet with a slight bevel on the outside-edge.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle weighing between 100 kg and 400 kg.
Each tablet contains:
Active Substance
Oxfendazole
1250 mg
Excipients
Indigo Carmine (F.D. & C Blue No. 2) Aluminium Lake (E132)
20 mg
For a full list of excipients, see section 6.1
Bolus contains
7 tablets as
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