ADEMPAS TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

RIOCIGUAT

Beszerezhető a:

BAYER INC

ATC-kód:

C02KX05

INN (nemzetközi neve):

RIOCIGUAT

Adagolás:

2.5MG

Gyógyszerészeti forma:

TABLET

Összetétel:

RIOCIGUAT 2.5MG

Az alkalmazás módja:

ORAL

db csomag:

42

Recept típusa:

Prescription

Terápiás terület:

VASODILATING AGENTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0154770005; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2013-09-19

Termékjellemzők

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_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.
_ _
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_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1
INDICATIONS......................................................................................................................
4
1.1 Pediatrics
........................................................................................................................
4
1.2
Geriatrics.........................................................................................................................
4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND
ADMINISTRATION...........................................................................................
5
4.1 Dosing Considerations
.......................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.......................