GAMUNEX SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMMUNOGLOBULIN (HUMAN)

Available from:

GRIFOLS THERAPEUTICS LLC

ATC code:

J06BA02

INN (International Name):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dosage:

10G

Pharmaceutical form:

SOLUTION

Composition:

IMMUNOGLOBULIN (HUMAN) 10G

Administration route:

INTRAVENOUS

Units in package:

25/50/100/200ML

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

Active ingredient group (AIG) number: 0106267015; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-02-02

Summary of Product characteristics

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Page 1 of 42
PRODUCT MONOGRAPH
GAMUNEX

Immune Globulin Intravenous (Human), 10%
Manufactured by Chromatography
Injectable Solution
Passive Immunizing Agent
Manufactured by:
Grifols Therapeutics Inc.
8368 U.S. 70 Bus. Hwy West
Clayton, North Carolina
27520
U.S.A.
Imported and Distributed by:
Grifols Canada Ltd.
5060 Spectrum Way
Suite 405
Mississauga, Ontario
L4W 5N5
Date of Approval:
January 26, 2016
Control # 188678
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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
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
5
WARNINGS AND
PRECAUTIONS..................................................................................
6
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
..................................................................................................
16
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 21
STORAGE AND
STABILITY..........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 23
PART II: SCIENTIFIC INFORMATION
................................................................................
24
PHARMACEUTICAL INFOR