REDDY-AZACITIDINE POWDER FOR SUSPENSION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

AZACITIDINE

제공처:

DR REDDY'S LABORATORIES LTD

ATC 코드:

L01BC07

INN (International Name):

AZACITIDINE

복용량:

100MG

약제 형태:

POWDER FOR SUSPENSION

구성:

AZACITIDINE 100MG

관리 경로:

SUBCUTANEOUS

패키지 단위:

30ML

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2023-06-27

제품 특성 요약

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