GAMMAGARD LIQUID SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMMUNOGLOBULIN (HUMAN)

Available from:

TAKEDA CANADA INC

ATC code:

J06BA02

INN (International Name):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dosage:

10%

Pharmaceutical form:

SOLUTION

Composition:

IMMUNOGLOBULIN (HUMAN) 10%

Administration route:

INTRAVENOUS

Units in package:

10/25/50/100/200/300ML

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2018-05-04

Summary of Product characteristics

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_Page 1 of 56_
PRODUCT MONOGRAPH
GAMMAGARD LIQUID
®
Immunoglobulin
Intravenous (Human), [IGIV] 10%
Solution
for infusion and 1 g/10 mL, 2.5 g/25 mL, 5 g/50 mL, 10 g/100 mL, 20
g/200 mL,
30 g/300mL
Pharmacopeial
Replacement Therapy for Immunodeficiencies
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Submission
Control No: 256703
Date of Initial Approval:
April 12, 2006
Date of Revision:
November 26, 2021
GAMMAGARD
®
and GAMMAGARD LIQUID
®
are registered trademarks of Baxalta
Incorporated. Takeda
TM
and the Takeda Logo
®
are trademarks of Takeda Pharmaceutical
Company Limited, used under license.
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_Page 2 of 56_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
DESCRIPTION
...........................................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................
4
CONTRAINDICATIONS
............................................................................................
5
WARNINGS AND PRECAUTIONS
............................................................................
6
ADVERSE
REACTIONS............................................................................................11
DRUG INTERACTIONS
............................................................................................15
DOSAGE AND ADMINISTRATION
.........................................................................16
OVERDOSAGE
.........................................................................................................18
ACTION AND CLINICAL
PHARMACOLOGY.........................................................18
STORAGE AND STABILITY
....................................................................................21
SPECIAL HANDLING INSTRUCTIONS
...............................................