Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
bedaquiline fumarate
Janssen-Cilag International NV
J04AK05
bedaquiline
Antimycobacterials
Tuberculosis, Multidrug-Resistant
Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 21
Authorised
2014-03-05
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SIRTURO 20 MG TABLETS bedaquiline This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What SIRTURO is and what it is used for 2. What you need to know before you take SIRTURO 3. How to take SIRTURO 4. Possible side effects 5. How to store SIRTURO 6. Contents of the pack and other information 1. WHAT SIRTURO IS AND WHAT IT IS USED FOR SIRTURO contains the active substance bedaquiline. SIRTURO is a type of antibiotic. Antibiotics are medicines that kill bacteria that cause disease. SIRTURO is used to treat tuberculosis that affects the lungs when the disease has become resistant to other antibiotics. This is called multi-drug resistant pulmonary tuberculosis. SIRTURO must always be taken together with other medicines for treating tuberculosis. It is used in adults and children (5 years and over, who weigh at least 15 kg). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIRTURO DO NOT TAKE SIRTURO if you are allergic to bedaquiline or any of the other ingredients of this medicine (listed in section 6). Do not take SIRTURO if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking SIRTURO. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking SIR Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT SIRTURO 20 mg tablets SIRTURO 100 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SIRTURO 20 mg tablets Each tablet contains bedaquiline fumarate equivalent to 20 mg of bedaquiline. SIRTURO 100 mg tablets Each tablet contains bedaquiline fumarate equivalent to 100 mg of bedaquiline. Excipient with known effect Each tablet contains 145 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM SIRTURO 20 mg tablets Tablet. Uncoated, white to almost white oblong tablet (12.0 mm long x 5.7 mm wide), with score line on both sides, debossed with “2” and “0” on one side and plain on other side. The tablet can be divided into equal doses. SIRTURO 100 mg tablets Tablet. Uncoated, white to almost white round biconvex tablet, 11 mm in diameter, with debossing of "T" over "207" on one side and "100" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with SIRTURO should be initiated and monitored by a physician experienced in the management of multi-drug resistant _Mycobacterium tuberculosis_. 3 Consideration should be given to WHO guidelines when selecting the appropriate combination regimen. Only use SI Lesen Sie das vollständige Dokument