DOXORUBICIN SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DOXORUBICIN HYDROCHLORIDE

Предлага се от:

PFIZER CANADA ULC

АТС код:

L01DB01

INN (Международно Name):

DOXORUBICIN

дозиране:

2MG

Лекарствена форма:

SOLUTION

Композиция:

DOXORUBICIN HYDROCHLORIDE 2MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

5/25/100ML

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2013-08-16

Данни за продукта

_DOXORUBICIN (doxorubicin hydrochloride)_
_ _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DOXORUBICIN
doxorubicin hydrochloride injection
Solution, 2 mg/mL, for intravenous and intravesical use
Antineoplastic agent
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
AUG 16, 2013
Date of Revision:
NOV 25, 2022
Submission Control Number: 265420
© Pfizer Canada ULC 2022
_ _
_DOXORUBICIN (doxorubicin hydrochloride) - Product Monograph_
_ _
_Page 2 of 30_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female
and Male Potential
11/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations
11/2022
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
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
...............