Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TIOTROPIUM BROMIDE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
TIOTROPIUM BROMIDE
3,124 MCG
CAIRAN INHALASI
DUS, SINGLE REFILL PACK @ 1 CARTRIDGE
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG., GERMANY - Federal Republic of Germany
2020-03-25
No. 0287-06 23 Mar 2020 SPIOLTO® RESPIMAT® Tiotropium/Olodaterol COMPOSITION The SPIOLTO RESPIMAT is a soft mist inhaler delivering tiotropium + olodaterol inhalation solution. The delivered dose is 2.5 microgram tiotropium and 2.5 microgram olodaterol per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 microgram tiotropium bromide monohydrate and 2.7 microgram olodaterol hydrochloride. The delivered dose is the dose which is available for the patient after passing the mouthpiece. Excipients: Benzalkonium chloride, disodium edetate, water, purified, 1 M hydrochloric acid (for pH adjustment) INDICATIONS SPIOLTO RESPIMAT is indicated for the second line treatment in patients with COPD when tiotropium or olodaterol alone does not provide adequate responses to reduce airflow obstruction, to improve quality of life and to reduce associated dyspnoea. DOSAGE AND ADMINISTRATION The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler. Two puffs from the Respimat inhaler comprise one medicinal dose. Adults The recommended dose is 5 microgram tiotropium and 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day (see Instructions for Use). The recommended dose should not be exceeded. Elderly population Elderly patients can use SPIOLTO RESPIMAT at the recommended dose. _Hepatic impairment and renal impairment _ SPIOLTO RESPIMAT contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver. Hepatic impairment Patients with mild and moderate hepatic impairment can use SPIOLTO RESPIMAT at the recommended dose. There are no data available for use of olodaterol in patients with severe hepatic impairment. Renal impairment Renally impaired patients can use SPIOLTO RESPIMAT at the recommended dose. SPIOLTO RESPIMAT contains tiotropium, which is a predominantly renally excreted drug. Therefore, DISETUJUI OLEH BPOM: 08/06/ Les hele dokumentet