TEVA-GLATIRAMER ACETATE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GLATIRAMER ACETATE

Available from:

TEVA CANADA LIMITED

ATC code:

L03AX13

INN (International Name):

GLATIRAMER ACETATE

Dosage:

20MG

Pharmaceutical form:

SOLUTION

Composition:

GLATIRAMER ACETATE 20MG

Administration route:

SUBCUTANEOUS

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

Immunomodulatory Agents

Product summary:

Active ingredient group (AIG) number: 0132525001; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-06-19

Summary of Product characteristics

_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-GLATIRAMER ACETATE
glatiramer acetate injection
20 mg / mL and 40 mg / mL
Single-Use Pre-filled syringes for Subcutaneous Injection
Immunomodulator
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
CONTROL NUMBER: 254069
Date of Revision:
December 10, 2021
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
6 Warnings and Precautions
12/2021
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
3
1
INDICATIONS
.................................................................................................................
3
1.1
Pediatrics
.............................................................................................................
3
1.2
Geriatrics..............................................................................................................
3
2
CONTRAINDICATIONS
...................................................................................................
3
3
DOSAGE AND ADMINISTRATION
..................................................................................
3
3.1
Dosing Considerations
..........................................................................................
3
3.2
Recommended Dose and Dosage Adjustment
...................................................... 4
3.3
Administration.......................................................................................................
4
3.4
Missed
Dose.........................................................................................................
4
4
OVERDOSAGE
...............................................................................................................
4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
............................ 5
6
WARNINGS AND
PRECAUTIONS...................................................................................
5
6.1
Special Populations
......................................