국가: 이스라엘
언어: 영어
출처: Ministry of Health
RIFABUTIN
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J04AB04
CAPSULES
RIFABUTIN 150 MG
PER OS
Required
PFIZER ITALIA S.R.L, ITALY
RIFABUTIN
RIFABUTIN
For the treatment of chronic tuberculosis where there is evidence of acid fast bacteria resistant to rifampicin or to two other alternative drugs. For the treatment of infections caused by MAC or other atypical mycobacteria where there is evidence of resistant bacteria as above. For the treatment of infections caused by MAC or other atypical mycobacteria in AIDS patients in all cases not subject to the above restrictions. For prevention of MAC infections in AIDS patients whose CD4 counts lower or eqval to 200/mm3
2016-07-31
Mycobutin, PIL, CC 070623 1 2020-0059555 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only MYCOBUTIN ® CAPSULES EACH CAPSULE CONTAINS: RIFABUTIN 150 MG Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. WHAT DO I NEED TO KNOW ABOUT THE MEDICINE? This medicine may cause changes to the colour of the skin, urine and body secretions to red- orange. These changes are nothing to worry about. Please note that the medicine may permanently alter the colour of contact lenses. 1. WHAT IS THIS MEDICINE INTENDED FOR? • In combination with additional medicines for treatment of infections caused by mycobacteria. • Prophylactic treatment for _Mycobacterium avium complex_ (MAC) infection in immunocompromised patients. THERAPEUTIC GROUP: An ansamycin antibiotic for the treatment of tuberculosis. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (listed in section 6) or to other medicines for the treatment of tuberculosis. • You are pregnant or breast-feeding. • Do not use in children under 12 years of age. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH MYCOBUTIN, TELL YOUR DOCTOR IF: • You suffer or have suffered in the past from problems with liver or kidney/urinary tract function. _ _ • You are taking oral contraceptives. This medicine may adversely affect the efficiency of oral contraceptives, and therefore you 전체 문서 읽기
Mycobutin ,LPD, CC 281223 Page 1 of 12 2023-0085644 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Mycobutin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150.0 mg rifabutin. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Hard capsule. Opaque, red-brown, Size N°. 0 hard gelatin capsules. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Mycobutin is indicated for: • the treatment of chronic tuberculosis where there is evidence of acid fast bacteria resistant to rifampicin or to two other alternative drugs. • the treatment of infections caused by MAC or other atypical mycobacteria where there is evidence of resistant bacteria as above. • treatment of infections caused by MAC or other atypical mycobacteria in AIDS patients in all cases not subject to the above restrictions. • prevention of MAC infections in AIDS patients whose CD4 counts lower or eqval to 200/mm 3 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Mycobutin is generally administered as a single, daily, oral dose at any time independently of meals. Adults Mycobutin as a single agent: • prophylaxis of MAC infection in immunodepressed patients: 300 mg (2 capsules). Mycobutin in combination regimens: • Non-tuberculous mycobacterial disease: 450-600 mg (3 to 4 capsules) for up to 6 months after negative cultures are obtained. • MAC treatment: when Mycobutin is given in association with clarithromycin, the dosage of Mycobutin should be reduced to 300 mg after the first month of treatment (see Section Mycobutin ,LPD, CC 281223 Page 2 of 12 2023-0085644 4.4, Special Warnings and Special Precautions For Use, and Section 4.5, Interactions with Other Medications & Other Forms of Interactions) • Pulmonary tuberculosis: 150 mg daily (1 capsule), for 6-9 months, or for at least 6 months after negative cultures are obtained. This dosage should be increased to 300-450 mg/day in patients previously treated with antituberculous drugs. In accordance with the commonly accepted criteria for t 전체 문서 읽기