Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg; ;
Janssen-Cilag (New Zealand) Ltd
Bedaquiline fumarate 120.89 mg (equivalent to bedaquiline 100 mg)
100 mg
Tablet
Active: Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Polysorbate 20
Prescription
Janssen Pharmaceutica NV
SIRTURO is indicated in adult (greater than or equal to 18 years) and pediatric patients (12 years to less than 18 years of age and weighing at least 30 kg) as part of combination therapy of pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis.
Package - Contents - Shelf Life: Blister pack, Alu/Alu - 24 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, HDPE - 188 tablets - 36 months from date of manufacture stored at or below 30°C protect from light
2015-05-15
1 SIRTURO (220729) ACMI New Zealand Consumer Medicine Information SIRTURO ® _BEDAQUILINE _ 100 mg tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using SIRTURO. This leaflet answers some common questions about SIRTURO. It does not contain all the available information. 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 using SIRTURO against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT SIRTURO IS USED FOR SIRTURO is used to treat tuberculosis (TB) that affects the lungs when the disease has become resistant to other antibiotics. This is called multi-drug resistant tuberculosis (MDR-TB). SIRTURO is used as part of combination therapy in adults and adolescents (12 years to less than 18 years of age and weighing at least 30 kg). SIRTURO is a type of antibiotic. Antibiotics are medicines that kill bacteria that cause disease. SIRTURO must always be taken together with other medicines for treating tuberculosis. Your doctor may have prescribed SIRTURO for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SIRTURO HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. 2 SIRTURO (220729) ACMI BEFORE YOU USE SIRTURO _ _ _ _ _WHEN YOU MUST NOT USE IT _ DO NOT TAKE SIRTURO IF: • you are allergic to bedaquiline, or any of the other ingredients listed at the end of this leaflet If you are not sure whether you should start using SIRTURO, talk to your doctor. _BEFORE YOU START TO USE IT _ Tell your doctor if you have: • heart problems including heart failure, slow heart rate, abnormal heart rhythm • a family history of a heart problem called “congenital long QT syndrome” • decreased thyroid gland function (hypothyroidism) • liver or kidney problems • human immunodeficiency v Läs hela dokumentet
14.220803 1 SIRTURO (221004) ADS SIRTURO ® BEDAQUILINE NEW ZEALAND DATA SHEET 1. PRODUCT NAME SIRTURO 100 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains bedaquiline fumarate equivalent to 100 mg of bedaquiline. Excipients with known effect: Each tablet contains 145 mg of lactose (as monohydrate). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Tablet. SIRTURO is supplied as an uncoated, white to almost white round biconvex tablet with debossing of "T" over "207" on one side and "100" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULT AND PEDIATRIC PATIENTS (12 YEARS TO LESS THAN 18 YEARS OF AGE) SIRTURO is indicated in adult (≥ 18 years) and pediatric patients (12 years to less than 18 years of age and weighing at least 30 kg) as part of combination therapy of pulmonary tuberculosis (TB) due to multi-drug resistant _Mycobacterium tuberculosis_. 4.2 DOSE AND METHOD OF ADMINISTRATION SIRTURO should only be administered as part of a multi-drug resistant tuberculosis (MDR-TB) regimen. It is recommended that SIRTURO is administered by directly observed therapy (DOT). MDR-TB is defined as _in vitro_ resistance of the patient’s isolate to at least isoniazid and rifampin. The prescribing physician should refer to international (e.g. WHO guidelines) and national/ local TB treatment guidelines for direction on selection and duration of use of companion drugs with SIRTURO. SIRTURO should only be used in combination with at least 3 drugs to which the patient’s isolate has been shown to be susceptible _in vitro_. If _in vitro_ drug susceptibility testing results are unavailable, treatment may be initiated with SIRTURO in combination with at least 4 other drugs to which the patient's isolate is likely to be susceptible. Throughout treatment with, and following the last intake of SIRTURO, patients should continue to take their companion drugs in accordance with international, national/local TB treatment guidelines and loca Läs hela dokumentet