ADEMPAS TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RIOCIGUAT

Disponibil de la:

BAYER INC

Codul ATC:

C02KX05

INN (nume internaţional):

RIOCIGUAT

Dozare:

2.5MG

Forma farmaceutică:

TABLET

Compoziție:

RIOCIGUAT 2.5MG

Calea de administrare:

ORAL

Unități în pachet:

42

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

VASODILATING AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-09-19

Caracteristicilor produsului

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