Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Rifabutin 150mg
Pfizer New Zealand Limited
Rifabutin 150 mg
150 mg
Capsule
Active: Rifabutin 150mg
Blister pack, 30 capsules
Prescription
Prescription
Olon SpA
Mycobutin is indicated for infections caused by mycobacteria, such as M. tuberculosis, M. avium intracellulare complex (MAC) and other atypical mycobacteria. In infections caused by MAC and other atypical mycobacteria such as M. xenopi, Mycobutin has been shown to be effective for the treatment of both disseminated and localised disease, also in immunocompromised HIV positive patients. Mycobutin is also indicated for the prophylaxis of M. avium intracellulare complex (MAC) infections in immunodepressed patients with CD4 counts lower than or equal to 100/ml. In the treatment of tubercular disease, Mycobutin has been shown to be effective for the treatment of patients with chronic pulmonary tuberculosis, even if caused by multidrug-resistant M. tuberculosis strains. In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin therapy should always be given in combination with other antimycobacterial drugs not belonging to the family of rifamycins.
Package - Contents - Shelf Life: Blister pack, - 30 capsules - 24 months from date of manufacture stored at or below 25°C
1992-03-25
MYCOBUTIN ® 1 MYCOBUTIN ® CAPSULES _Rifabutin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before taking Mycobutin. This leaflet answers some common questions about Mycobutin. It does not contain all the available information and it does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Mycobutin against the expected benefits it will have for you. Ask your doctor if you have any concerns about taking this medicine. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT MYCOBUTIN IS USED FOR Mycobutin contains the active ingredient, rifabutin. It is an antibiotic, an agent used to kill certain types of germs, known as mycobacteria. Mycobutin is used in combination with other medicines to treat mycobacterial infections e.g. tuberculosis (TB) or Mycobacteria avium-intracellulare complex (MAC). It may also be used to prevent infections in patients with HIV disease. Your doctor, however, may prescribe Mycobutin for another purpose. Ask your doctor if you have any questions about why Mycobutin has been prescribed for you. Mycobutin can only be obtained on prescription from a doctor. BEFORE TAKING MYCOBUTIN Some information is provided below. However, always talk to your doctor if you have concerns or questions about your treatment. _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE MYCOBUTIN AND TALK TO YOUR DOCTOR OR PHARMACIST IF: • you are allergic to rifabutin or other rifamycin antibiotics (e.g. rifampicin) • you are allergic to any of the other ingredients listed at the end of this leaflet • the packaging is torn or shows signs of tampering Do not take Mycobutin capsules after the expiry date printed on the pack has passed. Do not give Mycobutin to children. Do not take Mycobutin capsules if you are taking treatments that include: • injections containing prolonged- release rilpivirine _BEFORE YOU TAKE MYCOBUTIN _ YOU SHOULD TELL YOUR DOCTOR IF YOU: • h Lugege kogu dokumenti
Version:pfdmycoc11023 Supercedes:pfdmycoc10920 Page 1 of 14 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ Mycobutin 150 mg capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule for oral administration contains 150 mg rifabutin. EXCIPIENT(S) WITH KNOWN EFFECT For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule Capsules are opaque, red-brown, hard gelatin Size No. 0 capsules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mycobutin is indicated for infections caused by mycobacteria, such as _M. tuberculosis, M. _ _avium intracellulare _ complex (MAC) and other atypical mycobacteria. In infections caused by MAC and other atypical mycobacteria such as _M. xenopi_ , Mycobutin has been shown to be effective for the treatment of both disseminated and localised disease, also in immunocompromised HIV positive patients. Mycobutin is also indicated for the prophylaxis of _M. avium intracellulare_ complex (MAC) infections in immunodepressed patients with CD4 counts lower than or equal to 100/mL. In the treatment of tubercular disease, Mycobutin has been shown to be effective for the treatment of patients with chronic pulmonary tuberculosis, even if caused by multidrug- resistant _M. tuberculosis_ strains. In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin therapy should always be given in combination with other antimycobacterial drugs not belonging to the family of rifamycins. _ _ 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Mycobutin can be administered as a single daily dose at any time independent of meals. _ADULTS _ Mycobutin as a single agent: Version:pfdmycoc11023 Supercedes:pfdmycoc10920 Page 2 of 14 - Prophylaxis of MAC infection in immunodepressed patients: 300 mg (2 capsules) per day. Mycobutin in combination regimens: - in non-tuberculosis mycobacterial disease: 450-600 mg (3 to 4 capsules) for up to 6 months after negative cultures are obtained. - in chronic, multidrug-resistant pulmonary tuberculosis: 300-450 mg (2 to Lugege kogu dokumenti