DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DOXORUBICIN HYDROCHLORIDE

제공처:

PANDA PHARMACEUTICALS INC.

ATC 코드:

L01DB01

INN (국제 이름):

DOXORUBICIN

복용량:

50MG

약제 형태:

POWDER FOR SOLUTION

구성:

DOXORUBICIN HYDROCHLORIDE 50MG

관리 경로:

INTRAVENOUS

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0110825003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2017-08-16

제품 특성 요약

_Doxorubicin Hydrochloride for Injection USP _
_ _
_ _
_ _
_Page 1_
_ of 43_
_ _
PRODUCT MONOGRAPH
PR DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP 50 MG / VIAL
Sterile Powder for Solution - Intravenous
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
PANDA PHARMACEUTICALS INC.
35 Nixon Road Unit 10
Caledon, ON
L7E 1K1
Control # 195868
Date of Preparation: August 11, 2017
_Doxorubicin Hydrochloride for Injection USP _
_ _
_ _
_ _
_Page 2_
_ of 43_
_ _
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
................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
12
OVERDOSAGE
............................................................................................................
16
STORAGE AND STABILITY
.........................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 18
PART II: SCIENTIFIC INFORMATION
...........................................................................
18
PHARMACEUTICAL INFORMATION
...........................................................................
18
CLINICAL TRIALS
.........................