Riik: Kanada
keel: inglise
Allikas: Health Canada
RIOCIGUAT
BAYER INC
C02KX05
RIOCIGUAT
1.5MG
TABLET
RIOCIGUAT 1.5MG
ORAL
42
Prescription
VASODILATING AGENTS
Active ingredient group (AIG) number: 0154770003; AHFS:
APPROVED
2013-09-19
_ _ _ _ _ADEMPAS (Riociguat Tablets) _ _Page 1 of 46_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ADEMPAS® riociguat (film-coated) tablet Tablet, 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg for oral use Professed standard Soluble Guanylate Cyclase (sGC) Stimulator Bayer Inc. 2920 Matheson Boulevard East Mississauga, Ontario L4W 5R6 http://www.bayer.ca Date of Initial Authorization: September 19, 2013 Date of Revision: October 13, 2022 Submission Control Number: 262975 © 2022, Bayer Inc. ® TM see www.bayer.ca/tm-mc All other trademarks are the property of their respective owners. _ _ _ _ _ _ _ADEMPAS (Riociguat Tablets) _ _Page 2 of 46_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 10/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES ............................................................................................. 2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................ 4 1 INDICATIONS...................................................................................................................... 4 1.1 Pediatrics ........................................................................................................................ 4 1.2 Geriatrics......................................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................... 4 4 DOSAGE AND ADMINISTRATION........................................................................................... 5 4.1 Dosing Considerations ....................................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ....................... Lugege kogu dokumenti