Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
ALBUMIN (HUMAN)
GRIFOLS THERAPEUTICS LLC
B05AA01
ALBUMIN
25%
SOLUTION
ALBUMIN (HUMAN) 25%
INTRAVENOUS
50ML/100ML
Schedule D
BLOOD DERIVATIVES
Active ingredient group (AIG) number: 0131452002; AHFS:
APPROVED
2005-07-11
_ _ Page 1 of 18 PRODUCT MONOGRAPH ALBUMIN (HUMAN) 25% SOLUTION, USP Albumin (Human) 25%, USP Intravenous Solution, 25% Manufacturer’s Standard Plasma Substitute/Blood Derivative Manufactured by: Grifols Therapeutics Inc 8368 U.S. 70 Bus. Hwy West Clayton, North Carolina 27520 U.S.A. Imported and Distributed by: Grifols Canada Ltd. 5060 Spectrum Way, Suite 405 Mississauga, Ontario L4W 5N5 Prepared for: Canadian Blood Services and/or Héma-Québec Submission Control No: 202697 Date of Approval: August 22, 2017 _ _ Page 2 of 18 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 DESCRIPTION....................................................................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................6 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS ....................................................................................................7 DRUG INTERACTIONS ....................................................................................................8 DOSAGE AND ADMINISTRATION ................................................................................8 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................11 STORAGE AND STABILITY ..........................................................................................11 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................11 PART II: SCIENTIFIC INFORMATION ....................... Perskaitykite visą dokumentą