Χώρα: Σιγκαπούρη
Γλώσσα: Αγγλικά
Πηγή: HSA (Health Sciences Authority)
Olodaterol hydrochloride eqv olodaterol; Tiotropium bromide monohydrate eqv tiotropium
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
R03AL06
SOLUTION
Olodaterol hydrochloride eqv olodaterol 0.0025 mg/actuation; Tiotropium bromide monohydrate eqv tiotropium 0.0025 mg/actuation
RESPIRATORY (INHALATION)
Prescription Only
Boehringer Ingelheim Pharma GmbH & Co. KG
ACTIVE
2020-02-25
1. NAME OF THE MEDICINAL PRODUCT Spiolto® Respimat® re-usable solution for inhalation 2.5 microgram / 2.5 microgram 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The SPIOLTO RESPIMAT re-usable 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. (INN = tiotropium bromide) (INN= olodaterol) The delivered dose is the dose which is available for the patient after passing the mouthpiece. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Inhalation solution Clear, colourless, inhalation solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPIOLTO RESPIMAT re-usable is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose for adults 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). Elderly Elderly patients can use SPIOLTO RESPIMAT re-usable at the recommended dose. Hepatic impairment and renal impairment SPIOLTO RESPIMAT re-usable 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 re-usable at the recommended dose. There are no data available for use of olodaterol in patients with severe hepatic impairment. abcd Renal impairment Renally impaired patients can use SPIOLTO RESPIMAT re-usable at the recommended dose. SPIOLTO RESPIMAT re-usable contains tiotropium, which is a predominantly renally excreted drug. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min, see Specia Διαβάστε το πλήρες έγγραφο