RIMACILLIN 500 Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
AMPICILLIN TRIHYDRATE
Available from:
Ranbaxy Ireland Limited
INN (International Name):
AMPICILLIN TRIHYDRATE
Dosage:
500 Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2010-09-10
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0408/001/002
Case No: 2055825
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
RANBAXY IRELAND LIMITED
SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
RIMACILLIN 500 MG HARD CAPSULES
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 30/09/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/09/2008_
_CRN 2055825_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rimacillin 500 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg ampicillin (as the trihydrate).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Size 0, hard, gelatin capsules with a scarlet body and a grey cap overprinted 'Rima 500'.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of infections due to organisms sensitive to Ampicillin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be taken orally.
ADULTS AND CHILDREN OVER 20KG BODY WEIGHT:
The usual dose is 250mg every six hours.
For treatment of severe infections, the dosag
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