DOXORUBICIN HYDROCHLORIDE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOXORUBICIN HYDROCHLORIDE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

L01DB01

INN (International Name):

DOXORUBICIN

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

DOXORUBICIN HYDROCHLORIDE 2MG

Administration route:

INTRAVENOUS

Units in package:

5/25/100ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0110825002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-04-21

Summary of Product characteristics

_ _
_Doxorubicin Hydrochloride Injection _
_Page 1 of 46_
PRODUCT MONOGRAPH
PR
DOXORUBICIN HYDROCHLORIDE INJECTION
doxorubicin hydrochloride
2 mg/mL
10 mg (5 mL), 50 mg (25 mL) and 200 mg (100 mL) Vials
Manufacturer’s Standard
ANTINEOPLASTIC AGENT
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision: June 26, 2019
Submission Control No: 228706
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_Doxorubicin Hydrochloride Injection _
_Page 2 of 46_
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
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
......................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL INFORMATION
.........................................