CELLCEPT I.V. POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE)

Tilgjengelig fra:

HOFFMANN-LA ROCHE LIMITED

ATC-kode:

L04AA06

INN (International Name):

MYCOPHENOLIC ACID

Dosering :

500MG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) 500MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

20 ML

Resept typen:

Prescription

Terapeutisk område:

IMMUNOSUPPRESSIVE AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0128158002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

1999-06-21

Preparatomtale

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_CELLCEPT® mycophenolate mofetil _
_Page 1 of 85_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CELLCEPT
®
mycophenolate mofetil
Capsules – 250 mg
Film-Coated Tablets – 500 mg
Powder for Oral Suspension – 200 mg/mL (when reconstituted)
PR
CELLCEPT
®
I.V.
mycophenolate mofetil for injection (as hydrochloride) – 500 mg/vial
Manufacturer’s Standard
Immunosuppressive Agent
Hoffmann-La Roche Ltd.
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
Date of Initial Authorization:
December 31, 1995
Date of Revision:
July 8, 2021
Submission Control Number: 248429
www.rochecanada.com
CellCept
®
is a registered trade-mark of Syntex Pharm AG, used under license
©
Copyright 1995-2021, Hoffmann-La Roche Limited.
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_Page 2 of 85_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune
06-2021
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
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
..........................................................................................................
5
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION...........................................................