IDAMYCIN PFS SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

IDARUBICIN HYDROCHLORIDE

Доступна с:

PFIZER CANADA ULC

код АТС:

L01DB06

ИНН (Международная Имя):

IDARUBICIN

дозировка:

1MG

Фармацевтическая форма:

SOLUTION

состав:

IDARUBICIN HYDROCHLORIDE 1MG

Администрация маршрут:

INTRAVENOUS

Штук в упаковке:

5ML/10ML/20ML

Тип рецепта:

Prescription

Терапевтические области:

ANTINEOPLASTIC AGENTS

Обзор продуктов:

Active ingredient group (AIG) number: 0122755004; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2006-07-06

Характеристики продукта

_IDAMYCIN PFS (idarubicin hydrochloride injection) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
IDAMYCIN
® PFS
®
idarubicin hydrochloride injection
Preservative Free Solution, 1 mg/mL, intravenous injection
Antineoplastic Agent
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec, H9J 2M5
Date of Initial Authorization:
April 03, 1991
Date of Revision:
March 15, 2022
Submission Control Number: 258501
®
Idamycin is a registered trademark of Pfizer Italia S.r.L.
®
PFS is a registered trademark of Pfizer Inc.
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC, 2022
_ _
_IDAMYCIN PFS (idarubicin hydrochloride injection) _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Fertility; 7.1.1 Pregnant
Women, Women of childbearing potential / Contraception in
male and females; Patient Medication Information
03/2022
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
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...................................................................................5
4.1
Dosing Considerations
.............................................................