REDDY-AZACITIDINE POWDER FOR SUSPENSION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

AZACITIDINE

Disponible des:

DR REDDY'S LABORATORIES LTD

Codi ATC:

L01BC07

Designació comuna internacional (DCI):

AZACITIDINE

Dosis:

100MG

formulario farmacéutico:

POWDER FOR SUSPENSION

Composición:

AZACITIDINE 100MG

Vía de administración:

SUBCUTANEOUS

Unidades en paquete:

30ML

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0152665001; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2023-06-27

Fitxa tècnica

1
PRODUCT MONOGRAPH
PR
REDDY-AZACITIDINE
Azacitidine for I
njecti
on
100 mg azacitidine per
vial
Antineoplastic
Agent
Pyrimidine
Analogue
DIN OWNER:
DR. REDDY’S LABORATORIES LIMITED
Bachupally–500 090 INDIA
IMPORTED BY:
DR. REDDY’S LABORATORIES CANADA INC.,
DATE OF REVISION:
2425 Matheson Blvd East, #754
November 26, 2018
Mississauga, ON L4W 5K4 CANADA
Submission Control No: 218731
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................................3
SUMMARY PRODUCT INFORMATION
....................................................................................3
INDICATIONS AND CLINICAL US
E
..........................................................................................3
CONTRAINDICATIONS...............................................................................................................3
WARNINGS AND
PRECAUTIONS..............................................................................................4
ADVERSE
REACTIONS................................................................................................................6
DRUG
INTERACTIONS
..............................................................................................................14
DOSAGE AND
ADMINISTRATION..........................................................................................15
OVERDOSAGE............................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
........................................................................19
STORAGE AND
STABILITY......................................................................................................21
SPECIAL HANDLING INSTRUCTIONS
...................................................................................22
DOSAGE FORMS, COMPOSITION AND
PACKAGING.........................................................22
PART II: SCIENTIFIC INFORMATION
................................................