DOXORUBICIN HYDROCHLORIDE FOR INJECTION USP POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DOXORUBICIN HYDROCHLORIDE

Tilgængelig fra:

PFIZER CANADA ULC

ATC-kode:

L01DB01

INN (International Name):

DOXORUBICIN

Dosering:

50MG

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

DOXORUBICIN HYDROCHLORIDE 50MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

25ML

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0110825003; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2007-06-05

Produktets egenskaber

_Pr_
_Doxorubicin Hydrochloride for Injection USP (doxorubicin
hydrochloride)_
_ _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DOXOrubicin Hydrochloride for Injection USP
Doxorubicin Hydrochloride for Injection
sterile powder for solution, 10 mg / vial, 50 mg / vial and 150 mg /
vial, for intravenous and intravesical
use
Antineoplastic agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
November 17, 1995
Date of Revision:
March 16, 2023
Submission Control Number: 268408
_ _
_Pr_
_Doxorubicin Hydrochloride for Injection USP (doxorubicin
hydrochloride)_
_ _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female
and Male Potential
03/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
03/2023
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
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.2
Recommended Dose and Dos