IGIVNEX SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

IMMUNOGLOBULIN (HUMAN)

Sẵn có từ:

GRIFOLS THERAPEUTICS LLC

Mã ATC:

J06BA02

INN (Tên quốc tế):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Liều dùng:

10G

Dạng dược phẩm:

SOLUTION

Thành phần:

IMMUNOGLOBULIN (HUMAN) 10G

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

10/25/50/100/200ML

Loại thuốc theo toa:

Schedule D

Khu trị liệu:

SERUMS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2012-02-03

Đặc tính sản phẩm

_ _
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
.........................................................