IRINOTECAN HYDROCHLORIDE TRIHYDRATE INJECTION SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

IRINOTECAN HYDROCHLORIDE

Tillgänglig från:

SANDOZ CANADA INCORPORATED

ATC-kod:

L01CE02

INN (International namn):

IRINOTECAN

Dos:

20MG

Läkemedelsform:

SOLUTION

Sammansättning:

IRINOTECAN HYDROCHLORIDE 20MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

2ML/5ML

Receptbelagda typ:

Prescription

Terapiområde:

ANTINEOPLASTIC AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0132910001; AHFS:

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

2019-08-01

Produktens egenskaper

_Irinotecan Hydrochloride Trihydrate Injection _
_Page 1 of 60_
PRODUCT MONOGRAPH
PR
IRINOTECAN HYDROCHLORIDE TRIHYDRATE INJECTION
20 mg/mL
Professed
Antineoplastic Agent
Sandoz Canada Inc.
Date of Revision: March 29, 2019
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Submission Control No.: 225806
_Irinotecan Hydrochloride Trihydrate Injection _
_Page 2 of 60_
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
..........................................................................................................
11
DRUG
INTERACTIONS
..........................................................................................................
21
DOSAGE
AND
ADMINISTRATION
.......................................................................................
26
OVERDOSAGE
.........................................................................................................................
31
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
31
STORAGE
AND
STABILITY
..................................................................................................
34
SPECIAL
HANDLING
INSTRUCTIONS
................................................................................
34
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 34
PART II: SCIENTIFIC INFORMATION
......................................................................