RIMSTAR 150/75/400 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-06-2024
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Active ingredient:
RIFAMPICIN ISONIAZID PYRAZINAMIDE ETHAMBUTOL DIHYDROCHLORIDE
Available from:
Sandoz GmbH
INN (International Name):
RIFAMPICIN ISONIAZID PYRAZINAMIDE ETHAMBUTOL DIHYDROCHLORIDE
Dosage:
150/75/400 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2013-03-05
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rimstar, film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide and 275 mg ethambutol hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
The tablet is brown, ovaloid and biconvex.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For initial treatment of tuberculosis according to World Health Organisation (WHO) guidelines.
Consideration should also be given to other official guidance on the appropriate use of anti- tuberculosis agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Rimstar should be administered under the supervision of a physician trained in the management of tuberculosis.
The recommended dose and dosage schedules for Rimstar are based on WHO guidelines:
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Fixed-dose-combination tablets for the treatment of tuberculosis; WHO/CDS/CPC/TB/99.267, 1999.
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The rationale for recommending fixed-dose combination tablets for treatment of tuberculosis; Bulletin of the
World Health Organisation, 2001, 79: 61-68.
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Informal Consultation on 4-drug Fixed-Dose Combination, Geneva 2001.
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Treatment of tuberculosis: Guidelines for national programmes; WHO/CDS/TB/2003.313, 2003.
These dose and dose schedules may differ from recommendations on the use of anti-tuberculosis agents given in other
official guidance.
Rimstar is a fixed combination product intended for use in the initial intensive phase of anti-tuberculous treatment.
Rimstar should be administered on a daily basis throughout the 2 month initial phase of treatment. When indicated,
other anti-tuberculous medicinal products such as streptomycin may be added in the initial phase of treatment.
Rimstar is a fixed combination product that shou
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