PRIVIGEN SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

IMMUNOGLOBULIN (HUMAN)

Доступна з:

CSL BEHRING CANADA INC

Код атс:

J06BA02

ІПН (Міжнародна Ім'я):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Дозування:

10%

Фармацевтична форма:

SOLUTION

Склад:

IMMUNOGLOBULIN (HUMAN) 10%

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

25ML/50ML/100ML/200ML/400ML/20G

Тип рецепту:

Schedule D

Терапевтична области:

SERUMS

Огляд продуктів:

Active ingredient group (AIG) number: 0106267005; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2008-01-10

Характеристики продукта

_ _
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_Privigen_
®
_, Immunoglobulin Intravenous (Human) _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PRIVIGEN
®
Intravenous Immunoglobulin (Human)
10%, Solution for infusion and Intravenous
Pharmacopeial
Passive Immunizing Agent
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
K1P 6L5
www.cslbehring.ca
Date of Initial Authorization:
JAN 9, 2008
Date of Revision:
OCT 14, 2022
Submission Control Number: 263839
_ _
_ _
_ _
_Privigen_
®
_, Immunoglobulin Intravenous (Human) _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
7 Warning and Precautions and 13 Pharmaceutical
Information
02/2022
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
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment..................................................