TEVA-AZATHIOPRINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

AZATHIOPRINE

Disponible des:

TEVA CANADA LIMITED

Codi ATC:

L04AX01

Designació comuna internacional (DCI):

AZATHIOPRINE

Dosis:

50MG

formulario farmacéutico:

TABLET

Composición:

AZATHIOPRINE 50MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

IMMUNOSUPPRESSIVE AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0101830001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

1997-11-14

Fitxa tècnica

TEVA-AZATHIOPRINE Product Monograph Page 1 of 35
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA–AZATHIOPRINE
Azathioprine Tablets
Tablets, 50 mg, Oral
USP
Immunosuppressive Agent
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Submission Control Number: 265113
Date of Initial Authorization:
November 14, 1997
Date of Revision:
November 23, 2022
TEVA-AZATHIOPRINE Product Monograph Page 2 of 35
RECENT MAJOR LABEL CHANGES
Not applicable.
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
........................................................................
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
4.2
Recommended Dose and Dosage
Adjustment……………………………………………………………
5
5
OVERDOSAGE
..................................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION A