GAMMAGARD S/D SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-11-2021
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Active ingredient:
IMMUNOGLOBULIN (HUMAN)
Available from:
TAKEDA CANADA INC
ATC code:
J06BA02
INN (International Name):
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
Dosage:
5G
Pharmaceutical form:
SOLUTION
Composition:
IMMUNOGLOBULIN (HUMAN) 5G
Administration route:
INTRAVENOUS
Units in package:
1 VIAL OF POWDER AND 96 ML VIAL OF WATER
Prescription type:
Schedule D
Therapeutic area:
SERUMS
Product summary:
Active ingredient group (AIG) number: 0106267013; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-04-09
Summary of Product characteristics
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_Page 1 of 41_
PRODUCT MONOGRAPH
GAMMAGARD
® S/D, 5 G/VIAL & 10 G/VIAL
Immunoglobulin Intravenous (Human) [IGIV],
Solvent/Detergent-Treated (Freeze-Dried Concentrate)
Replacement Therapy for Immunodeficiencies
Takeda Canada Inc.
22 Adelaide Street West,
Suite 3800
Toronto Ontario M5H 4E3
GAMMAGARD
®
is a registered trademark of Baxalta Incorporated. Takeda
TM
and the Takeda
Logo
®
are trademarks of Takeda Pharmaceutical Company Limited, used under
license.
Submission Control No: 256697 Date of Approval: November 26, 2021
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
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