Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
BEDAQUILINE AS FUMARATE
J-C HEALTH CARE LTD
J04AK05
TABLETS
BEDAQUILINE AS FUMARATE 100 MG
PER OS
Required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
BEDAQUILINE
SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
2019-10-28
1 1. NAME OF THE MEDICINAL PRODUCT SIRTURO 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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 Tablet. 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 patients 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_ . SIRTURO should be used in combination with at least three medicinal products to which the patient’s isolate has been shown to be susceptible _in vitro_ . If _in vitro_ testing results are unavailable, treatment may be initiated with SIRTURO in combination with at least four medicinal products to which the patient's isolate is likely to be susceptible. Consideration should be given to WHO guidelines when selecting the appropriate combination regimen. Treatment with the other agents in the regimen should continue after completion of treatment with SIRTURO. Refer to the Summary of Product Characteristics of the medicinal products used in combination with SIRTURO for their specific dosing recommendations. It is recommended that SIRTURO is administered by directly observed therapy (DOT). 2 Posology The recommended dosage is: • Weeks 1-2: 400 mg (4 tablets of 100 mg) ONCE DAILY • Weeks 3-24: 200 mg (2 tablets of 100 mg) THREE Прочитайте повний документ
1 1. NAME OF THE MEDICINAL PRODUCT SIRTURO 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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 Tablet. 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 SIRTURO is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients 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_ . SIRTURO should be used in combination with at least three medicinal products to which the patient’s isolate has been shown to be susceptible _in vitro_ . If _in vitro_ testing results are unavailable, treatment may be initiated with SIRTURO in combination with at least four medicinal products to which the patient's isolate is likely to be susceptible. Consideration should be given to WHO guidelines when selecting the appropriate combination regimen. Treatment with the other agents in the regimen should continue after completion of treatment with SIRTURO. Refer to the Summary of Product Characteristics of the medicinal products used in combination with SIRTURO for their specific dosing recommendations. It is recommended that SIRTURO is administered by directly observed therapy (DOT). Posology The recommended dosage is: • Weeks 1-2: 400 mg (4 tablets of 100 mg) once daily • Weeks 3-24: 200 mg (2 tablets of 100 mg) three times per week (with Прочитайте повний документ