GAMMAGARD S/D SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

IMMUNOGLOBULIN (HUMAN)

Tillgänglig från:

TAKEDA CANADA INC

ATC-kod:

J06BA02

INN (International namn):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dos:

10G

Läkemedelsform:

SOLUTION

Sammansättning:

IMMUNOGLOBULIN (HUMAN) 10G

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

1 VIAL OF POWDER AND 192 ML VIAL OF WATER

Receptbelagda typ:

Schedule D

Terapiområde:

SERUMS

Produktsammanfattning:

Active ingredient group (AIG) number: 0106267017; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2021-04-09

Produktens egenskaper

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_Page 1 of 41_
PRODUCT MONOGRAPH
GAMMAGARD
® S/D, 5 G/VIAL & 10 G/VIAL
Immunoglobulin Intravenous (Human) [IGIV],
Solvent/Detergent-Treated (Freeze-Dried Concentrate)
Replacement Therapy for Immunodeficiencies
Takeda Canada Inc.
22 Adelaide Street West,
Suite 3800
Toronto Ontario M5H 4E3
GAMMAGARD
®
is a registered trademark of Baxalta Incorporated. Takeda
TM
and the Takeda
Logo
®
are trademarks of Takeda Pharmaceutical Company Limited, used under
license.
Submission Control No: 256697 Date of Approval: November 26, 2021
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_Page 2 of 41_
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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION