TOPOTECAN HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TOPOTECAN (TOPOTECAN HYDROCHLORIDE)

Available from:

ACCORD HEALTHCARE INC

ATC code:

L01CE01

INN (International Name):

TOPOTECAN

Dosage:

4MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

TOPOTECAN (TOPOTECAN HYDROCHLORIDE) 4MG

Administration route:

INTRAVENOUS

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0132984001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-04-06

Summary of Product characteristics

_Product Monograph _
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_ 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 _
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_ 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
....