DOXORUBICIN HYDROCHLORIDE INJECTION SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

DOXORUBICIN HYDROCHLORIDE

Tillgänglig från:

TEVA CANADA LIMITED

ATC-kod:

L01DB01

INN (International namn):

DOXORUBICIN

Dos:

2MG

Läkemedelsform:

SOLUTION

Sammansättning:

DOXORUBICIN HYDROCHLORIDE 2MG

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

5/25/100ML

Receptbelagda typ:

Prescription

Terapiområde:

ANTINEOPLASTIC AGENTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2013-07-24

Produktens egenskaper

DOXORUBICIN HYDROCHLORIDE INJECTION
(
doxorubicin hydrochloride) Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR DOXORUBICIN HYDROCHLORIDE INJECTION
Doxorubicin Hydrochloride Injection
Solution, 2 mg/mL [10 mg (5 mL), 50 mg (25 mL) and 200 mg (100 mL)]
Vials, For Intravenous
and Intravesical Use
BP
Antineoplastic agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
July 24, 2013
Date of Revision:
February 21, 2023
Submission Control No: 267681
DOXORUBICIN HYDROCHLORIDE INJECTION
(
doxorubicin hydrochloride) Page 2 of 34
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential _ _
02/2023 _ _
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations _ _
02/2023 _ _
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I:
HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
........................................................................................................................
4
1.2
Geriatrics
.........................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................... 5
4
DOSAGE AND ADMINISTRATION
....................................................................................
6
4.2
Reco