TEVA-GLATIRAMER ACETATE SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

GLATIRAMER ACETATE

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

L03AX13

INN (Nome Internazionale):

GLATIRAMER ACETATE

Dosaggio:

20MG

Forma farmaceutica:

SOLUTION

Composizione:

GLATIRAMER ACETATE 20MG

Via di somministrazione:

SUBCUTANEOUS

Confezione:

30

Tipo di ricetta:

Prescription

Area terapeutica:

Immunomodulatory Agents

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-06-19

Scheda tecnica

_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
......................................