REDDY-AZACITIDINE POWDER FOR SUSPENSION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AZACITIDINE

Tersedia dari:

DR REDDY'S LABORATORIES LTD

Kode ATC:

L01BC07

INN (Nama Internasional):

AZACITIDINE

Dosis:

100MG

Bentuk farmasi:

POWDER FOR SUSPENSION

Komposisi:

AZACITIDINE 100MG

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

30ML

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2023-06-27

Karakteristik produk

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
................................................