DOXORUBICIN HYDROCHLORIDE INJECTION SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DOXORUBICIN HYDROCHLORIDE

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

L01DB01

INN (국제 이름):

DOXORUBICIN

복용량:

2MG

약제 형태:

SOLUTION

구성:

DOXORUBICIN HYDROCHLORIDE 2MG

관리 경로:

INTRAVENOUS

패키지 단위:

5/25/100ML

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0110825002; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2021-04-21

제품 특성 요약

_ _
_Doxorubicin Hydrochloride Injection _
_Page 1 of 46_
PRODUCT MONOGRAPH
PR
DOXORUBICIN HYDROCHLORIDE INJECTION
doxorubicin hydrochloride
2 mg/mL
10 mg (5 mL), 50 mg (25 mL) and 200 mg (100 mL) Vials
Manufacturer’s Standard
ANTINEOPLASTIC AGENT
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision: June 26, 2019
Submission Control No: 228706
_ _
_Doxorubicin Hydrochloride Injection _
_Page 2 of 46_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL INFORMATION
.........................................