Country: Canada
Language: English
Source: Health Canada
IMMUNOGLOBULIN (HUMAN)
CSL BEHRING CANADA INC
J06BA02
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
120G
SOLUTION
IMMUNOGLOBULIN (HUMAN) 120G
INTRAVENOUS
50ML/100ML
Schedule D
SERUMS
Active ingredient group (AIG) number: 0106267018; AHFS:
CANCELLED POST MARKET
2010-04-20
_ _ _ _ _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 _ _ _ _ _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 ............................ Read the complete document