Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
IMMUNOGLOBULIN (HUMAN)
GRIFOLS THERAPEUTICS LLC
J06BA02
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
10G
SOLUTION
IMMUNOGLOBULIN (HUMAN) 10G
INTRAVENOUS
10/25/50/100/200ML
Schedule D
SERUMS
Active ingredient group (AIG) number: 0106267015; AHFS:
APPROVED
2012-02-03
_ _ 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 ......................................................... Belgenin tamamını okuyun