FLEBOGAMMA 5% SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMMUNOGLOBULIN (HUMAN)

Available from:

INSTITUTO GRIFOLS S.A.

ATC code:

J06BA02

INN (International Name):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dosage:

50MG

Pharmaceutical form:

SOLUTION

Composition:

IMMUNOGLOBULIN (HUMAN) 50MG

Administration route:

INTRAVENOUS

Units in package:

10/50/100/200/400ML

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

Active ingredient group (AIG) number: 0106267002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-08-17

Summary of Product characteristics

_Page 1 of 28_
PRODUCT MONOGRAPH
FLEBOGAMMA
® 5%
Immune Globulin Intravenous (Human)
Solution for infusion, 50 mg/mL
Passive immunizing agent
Immune sera and immunoglobulins: immunoglobulins, normal human, for
intravascular
administration. ATC code: J06BA02
Manufactured by:
Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
E-08150 Barcelona
Spain
Imported and Distributed by:
Grifols Canada Ltd.
5060 Spectrum Way
Suite 405
Mississauga, Ontario
L4W 5N5
Date of Approval:
August 17, 2017
Submission Control No: 194291
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
......................................................................
15
DOSAGE FORMS, COMPOSITION AND PA