MAR-MYCOPHENOLIC ACID TABLET (ENTERIC-COATED)

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)

Tillgänglig från:

MARCAN PHARMACEUTICALS INC

ATC-kod:

L04AA06

INN (International namn):

MYCOPHENOLIC ACID

Dos:

360MG

Läkemedelsform:

TABLET (ENTERIC-COATED)

Sammansättning:

MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM) 360MG

Administreringssätt:

ORAL

Enheter i paketet:

15G/50G

Receptbelagda typ:

Prescription

Terapiområde:

IMMUNOSUPPRESSIVE AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0150521002; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2021-01-27

Produktens egenskaper

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-MYCOPHENOLIC ACID
®
Mycophenolic Acid Delayed-release Tablets
Delayed-release tablets, 180 mg and 360 mg mycophenolic acid (as
mycophenolate sodium), Oral
USP
Immunosuppressant
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite # 112
Ottawa, ON K2E 1A2
Date of Initial Authorization:
JAN 25, 2021
Date of Revision: August 9, 2022
Submission Control Number: 262002
2
RECENT MAJOR LABEL CHANGES
None at the time of this authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................
4
1
INDICATIONS
.........................................................................................................................
4
1.1
Pediatrics
.....................................................................................................................
4
1.2
Geriatrics......................................................................................................................
4
2
CONTRAINDICATIONS
............................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................................
4
4
DOSAGE AND ADMINISTRATION
............................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................... 5
4.3
Reconstitution
..............................................................................................................
5
4.4
Administration..............................................................................................................
5
4.5
Missed
Dose........................