REBIF SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

INTERFERON BETA-1A

Boleh didapati daripada:

EMD SERONO, A DIVISION OF EMD INC., CANADA

Kod ATC:

L03AB07

INN (Nama Antarabangsa):

INTERFERON BETA-1A

Dos:

22MCG

Borang farmaseutikal:

SOLUTION

Komposisi:

INTERFERON BETA-1A 22MCG

Laluan pentadbiran:

SUBCUTANEOUS

Unit dalam pakej:

3X0.5ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

Immunomodulatory Agents

Ringkasan produk:

Active ingredient group (AIG) number: 0131806001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

1998-02-05

Ciri produk

REBIF
®
Product Monograph
Page 1
PRODUCT MONOGRAPH
PR
REBIF
®
(Interferon beta-1a Injection)
22 mcg/0.5 mL and 44 mcg/0.5 mL
Solution for Injection in Pre-filled Syringes
Multidose 22 mcg × 3 (66 mcg/1.5 mL)
Multidose 44 mcg × 3 (132 mcg/1.5 mL)
Solution for Injection in Pre-filled Cartridges
Immunomodulator
EMD SERONO, A DIVISION OF EMD INC., CANADA
2695 North Sheridan Way, Suite 200
Mississauga, Ontario, L5K 2N6
EMD Serono is a business of Merck KGaA, Darmstadt,
Germany
Date of Approval:
February 05, 1998
Date of Revision:
February 06, 2020
www.emdserono.ca
Submission Control No.: 225158
®
Registered trademark of Merck KGaA, Darmstadt, Germany
REBIF
®
Product Monograph
Page 2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
47
DOSAGE AND ADMINISTRATION
.............................................................................
47
OVERDOSAGE
...............................................................................................................
48
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 49
STORAGE AND STABILITY
................................................................................