IGIVNEX SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IMMUNOGLOBULIN (HUMAN)

Tersedia dari:

GRIFOLS THERAPEUTICS LLC

Kode ATC:

J06BA02

INN (Nama Internasional):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dosis:

10G

Bentuk farmasi:

SOLUTION

Komposisi:

IMMUNOGLOBULIN (HUMAN) 10G

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

10/25/50/100/200ML

Jenis Resep:

Schedule D

Area terapi:

SERUMS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2012-02-03

Karakteristik produk

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PRODUCT MONOGRAPH
IGIVNEX®
Immune Globulin Intravenous (Human), 10%
_Manufactured by Chromatography _
Injectable Solution
Passive Immunizing Agent
Manufactured by:
Grifols Therapeutics Inc.
8368 US 70 Bus. Hwy West
Clayton, NC 27520
Distributed and Imported by:
Grifols Canada Ltd.
5060 Spectrum Way
Suite 405
Mississauga, Ontario
L4W 5N5 CANADA
Prepared for:
Canadian Blood Services
and/or
Héma-Québec
DATE OF APPROVAL:
July 12, 2017
SUBMISSION CONTROL NO: 205015
_ _
Page 2 of 45
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
.............................................24
PART II: SCIENTIFIC INFORMATION
.........................................................