IGIVNEX SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

IMMUNOGLOBULIN (HUMAN)

Tilgængelig fra:

GRIFOLS THERAPEUTICS LLC

ATC-kode:

J06BA02

INN (International Name):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dosering:

10G

Lægemiddelform:

SOLUTION

Sammensætning:

IMMUNOGLOBULIN (HUMAN) 10G

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

10/25/50/100/200ML

Recept type:

Schedule D

Terapeutisk område:

SERUMS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2012-02-03

Produktets egenskaber

_ _
Page 1 of 45
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
.........................................................