SANDOGLOBULIN NF LIQUID SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMMUNOGLOBULIN (HUMAN)

Available from:

CSL BEHRING CANADA INC

ATC code:

J06BA02

INN (International Name):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dosage:

120G

Pharmaceutical form:

SOLUTION

Composition:

IMMUNOGLOBULIN (HUMAN) 120G

Administration route:

INTRAVENOUS

Units in package:

50ML/100ML

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

Active ingredient group (AIG) number: 0106267018; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-04-20

Summary of Product characteristics

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_Page 1 of 26 _
PRODUCT MONOGRAPH
SANDOGLOBULIN
® NF LIQUID
IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
12 % Solution for infusion
Passive Immunizing Agent
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
KIP 6L5
Date of Approval:
Date of Revision:
February 15, 2007
Submission Control No: 112481
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_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................................................................3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................3
DESCRIPTION
........................................................................................................................................................3
INDICATIONS
AND
CLINICAL
USE....................................................................................................................3
CONTRAINDICATIONS
........................................................................................................................................3
WARNINGS
AND
PRECAUTIONS
.......................................................................................................................4
ADVERSE
REACTIONS
.........................................................................................................................................7
DRUG
INTERACTIONS
.......................................................................................................................................11
DOSAGE
AND
ADMINISTRATION....................................................................................................................11
OVERDOSAGE
.....................................................................................................................................................13
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................13
STORAGE
AND
STABILITY
............................