البلد: أندونيسيا
اللغة: الإندونيسية
المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OLODATEROL
BOEHRINGER INGELHEIM INDONESIA - Indonesia
OLODATEROL
2,5 Mg
CAIRAN INHALASI
DUS, SINGLE REFILL PACK @ 1 CARTRIDGE
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG., GERMANY - Federal Republic of Germany
2020-02-24
PT. BOEHRINGER INGELHEIM INDONESIA 1 Medical & Regulatory Affairs CCDS 0270-05 No. 0270-05 23 Mar 2020 STRIVERDI RESPIMAT Olodaterol COMPOSITION The STRIVERDI ® RESPIMAT ® is a soft mist inhaler delivering olodaterol inhalation solution. The delivered dose is 2.5 microgram olodaterol per puff (2 puffs comprise one medicinal dose) and is equivalent to 2.7 microgram olodaterol hydrochloride. (INN = olodaterol) The delivered dose is the dose which is available for the patient after passing the mouthpiece. Excipients** Benzalkonium chloride, disodium edetate, water, purified, citric acid (anhydrous) INDICATIONS STRIVERDI ® RESPIMAT ® is indicated as long-term once daily maintenance bronchodilator treatment to improve lung function in patients with COPD. DOSAGE AND ADMINISTRATION The recommended dose for adults is 5 microgram olodaterol given as two puffs from the RESPIMAT once-daily at the same time of the day. Do not use STRIVERDI ® RESPIMAT ® more than two inhalations every 24 hours _(see Instructions for use)._ _ _ SPECIAL POPULATIONS Elderly Elderly patients can use STRIVERDI ® RESPIMAT ® at the recommended dose. Paediatric population COPD does not normally occur in children. The safety and effectiveness of STRIVERDI ® RESPIMAT ® in the pediatric population have not been established. Patients with hepatic insufficiency Patients with mild and morderate hepatic impairment can use STRIVERDI ® RESPIMAT ® at the recommended dose. There are no data available for use of STRIVERDI ® RESPIMAT ® in patients with servere hepatic impairment. Patients with renal insufficiency Renally impaired patients can use STRIVERDI ® RESPIMAT ® at the recommended dose. DISETUJUI OLEH BPOM: 03/06/2021 ID: EREG10036412000390 EREG10036412000391 PT. BOEHRINGER INGELHEIM INDONESIA 2 Medical & Regulatory Affairs CCDS 0270-05 INSTRUCTIONS FOR USE STRIVERDI RESPIMAT is intended for oral inhalation only. The STRIVERDI RESPIMAT cartridge is only intended for use with the STRIVERDI RESPIMAT inhaler. To ensure proper administr اقرأ الوثيقة كاملة