FLEBOGAMMA 5% SOLUTION
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
23-08-2017
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Werkstoffen:
IMMUNOGLOBULIN (HUMAN)
Beschikbaar vanaf:
INSTITUTO GRIFOLS S.A.
ATC-code:
J06BA02
INN (Algemene Internationale Benaming):
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
Dosering:
50MG
farmaceutische vorm:
SOLUTION
Samenstelling:
IMMUNOGLOBULIN (HUMAN) 50MG
Toedieningsweg:
INTRAVENOUS
Eenheden in pakket:
10/50/100/200/400ML
Prescription-type:
Schedule D
Therapeutisch gebied:
SERUMS
Product samenvatting:
Active ingredient group (AIG) number: 0106267002; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2017-08-17
Productkenmerken
_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
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