GAMMAGARD S/D POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMMUNOGLOBULIN (HUMAN)

Available from:

BAXALTA CANADA CORPORATION

ATC code:

J06BA02

INN (International Name):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dosage:

2.5G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

IMMUNOGLOBULIN (HUMAN) 2.5G

Administration route:

INTRAVENOUS

Units in package:

FREEZE-DRIED CONCENTRATE

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

Active ingredient group (AIG) number: 0106267012; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2015-05-12

Summary of Product characteristics

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_Page 1 of 42_
PRODUCT MONOGRAPH
GAMMAGARD S/D, 5 G/VIAL & 10 G/VIAL
Immune Globulin Intravenous (Human) [IGIV],
Solvent/Detergent-Treated (Freeze-Dried Concentrate)
Replacement Therapy for Immunodeficiencies
BAXALTA CANADA CORPORATION
7125 Mississauga Road
Mississauga, Ontario
CANADA, L5N 0C2
Date of Revision:
August 19, 2015
Submission Control No: 182618 Date of Approval: November 2, 2015
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_Page 2 of 42_
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
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
................................