TOPOTECAN HYDROCHLORIDE FOR INJECTION SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

TOPOTECAN (TOPOTECAN HYDROCHLORIDE)

から入手可能:

ACCORD HEALTHCARE INC

ATCコード:

L01CE01

INN（国際名）:

TOPOTECAN

投薬量:

1MG

医薬品形態:

SOLUTION

構図:

TOPOTECAN (TOPOTECAN HYDROCHLORIDE) 1MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

1ML/4ML

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

Active ingredient group (AIG) number: 0132984002; AHFS:

認証ステータス:

APPROVED

承認日:

2013-11-16

製品の特徴

_Product Monograph _
_–_
_ Topotecan Hydrochloride for Injection _
_Page 1 of 32_
PRODUCT MONOGRAPH
STERILE
PR
TOPOTECAN HYDROCHLORIDE FOR INJECTION
Lyophilized powder for Injection
Topotecan 4 mg / vial,
incorporated as the hydrochloride for reconstitution
Solution for injection
1mg / mL,
Topotecan (as Topotecan hydrochloride)
Antineoplastic Agent
Accord Healthcare Inc.
DATE OF REVISION:
3535 boul. St. Charles, suite 704 MAY 9, 2019
Kirkland, Quebec, Canada
H9H 5B9
Submission Control No: 227334
_Product Monograph _
_–_
_ Topotecan Hydrochloride for Injection Page 2 of 32_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
................................................................................
4
ADVERSE REACTIONS
..................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
...............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND STABILITY
........................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
......................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
....