Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
RIFAMPICIN
Sandoz GmbH
300mg Milligram
Capsule
1997-07-05
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rimactane Capsules 300mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Rifampicin 300mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsules, hard 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of tuberculosis and certain other mycobacterial infections. _Non-mycobacterial infections:_ In these infections, e.g. staphylococcal infections, Rimactane should only be employed: _Prevention of meningococcal meningitis:_ Rimactane is also indicated for the chemoprophylaxis of meningococcal meningitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _For the management of tuberculosis and certain opportunistic mycobacterial infections_: Rimactane must always be given in association with other anti-tuberculosis drugs, to prevent emergence of resistant strains. _Use in Adults_: 450-600mg daily as a single dose (based on approximately 10mg per kg body weight). (Those patients 50kg (8 stone) and over should take 600mg rifampicin daily, whilst patients under 50kg should take 450mg). The following chemotherapeutic agents are employed today as combined therapy for tuberculosis: rifampicin (Rimactane) (RMP), isoniazid (INH), pyrazinamide (PZA), ethambutol (EMB), streptomycin (STM). - if the pathogens are resistant to the first-line antibiotics that normally prove effective, - if the pathogens are demonstrably sensitive to rifampicin, - if given in combination with other antibiotics/chemotherapeutic agents to which the pathogens are sensitive, - if a diagnosis of tuberculosis or leprosy has first been excluded. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/11/2006_ _CRN 2020999_ _page number: 1_ The dosages recommended Læs hele dokumentet