FLEBOGAMMA 5% SOLUTION
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
23-08-2017
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Senda beiðni.
Virkt innihaldsefni:
IMMUNOGLOBULIN (HUMAN)
Fáanlegur frá:
INSTITUTO GRIFOLS S.A.
ATC númer:
J06BA02
INN (Alþjóðlegt nafn):
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
Skammtar:
50MG
Lyfjaform:
SOLUTION
Samsetning:
IMMUNOGLOBULIN (HUMAN) 50MG
Stjórnsýsluleið:
INTRAVENOUS
Einingar í pakka:
10/50/100/200/400ML
Gerð lyfseðils:
Schedule D
Lækningarsvæði:
SERUMS
Vörulýsing:
Active ingredient group (AIG) number: 0106267002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2017-08-17
Vara einkenni
_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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