TOPOTECAN HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

TOPOTECAN (TOPOTECAN HYDROCHLORIDE)

Commercializzato da:

ACCORD HEALTHCARE INC

Codice ATC:

L01CE01

INN (Nome Internazionale):

TOPOTECAN

Dosaggio:

4MG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

TOPOTECAN (TOPOTECAN HYDROCHLORIDE) 4MG

Via di somministrazione:

INTRAVENOUS

Confezione:

5ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2018-04-06

Scheda tecnica

_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
....