Country: Canada
Language: English
Source: Health Canada
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE); OLODATEROL (OLODATEROL HYDROCHLORIDE)
BOEHRINGER INGELHEIM (CANADA) LTD LTEE
R03AL06
OLODATEROL AND TIOTROPIUM BROMIDE
2.5MCG; 2.5MCG
SOLUTION
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 2.5MCG; OLODATEROL (OLODATEROL HYDROCHLORIDE) 2.5MCG
INHALATION
28/60 ACT
Prescription
ANTIMUSCARINICS ANTISPASMODICS
Active ingredient group (AIG) number: 0256970001; AHFS:
APPROVED
2015-05-28
_Inspiolto_ _®_ _ Respimat_ _ ®_ _ Product Monograph Page 1 of 50 _ PRODUCT MONOGRAPH PR INSPIOLTO ® RESPIMAT ® Tiotropium (as tiotropium bromide monohydrate) and Olodaterol (as olodaterol hydrochloride) Inhalation Solution 2.5 mcg/2.5 mcg per actuation INSPIOLTO ® RESPIMAT ® cartridge for use only with the INSPIOLTO ® RESPIMAT ® inhaler Bronchodilator Combination Long-Acting Muscarinic Antagonist (LAMA) and Long-Acting Beta 2 -Adrenergic Agonist (LABA) Boehringer Ingelheim (Canada) Ltd. 5180 South Service Road Burlington, Ontario L7L 5H4 Date of Revision: November 14, 2019 www.boehringer-ingelheim.ca Submission Control No: 223910 Inspiolto ® is a registered trademark of Boehringer Ingelheim International GmbH, used under license. Respimat ® is a registered trademark of Boehringer Ingelheim International GmbH, used under license. BICL #: 0287-04 _Inspiolto_ _®_ _ Respimat_ _ ®_ _ Product Monograph Page 2 of 50 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3 SUMMARY PRODUCT INFORMATION ..................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ............................................................................................... 4 WARNINGS AND PRECAUTIONS .............................................................................. 4 ADVERSE REACTIONS ................................................................................................ 9 DRUG INTERACTIONS .............................................................................................. 13 DOSAGE AND ADMINISTRATION ........................................................................... 15 OVERDOSAGE ............................................................................................................ 16 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 17 STORAGE AN Read the complete document