Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ANTITHROMBIN III (HUMAN)
GRIFOLS THERAPEUTICS LLC
B01AB02
ANTITHROMBIN
500UNIT
POWDER FOR SOLUTION
ANTITHROMBIN III (HUMAN) 500UNIT
INTRAVENOUS
100
Schedule D
DIRECT THROMBIN INHIBITORS
Active ingredient group (AIG) number: 0124256001; AHFS:
APPROVED
2012-01-30
_ _ Page 1 of 20 PRODUCT MONOGRAPH THROMBATE III Antithrombin III (Human) I.V. Injection, 500, IU Manufacturer’s Standard Anticoagulant 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 Submission Control No: 158117 Date of Approval: April 3, 2013 _ _ Page 2 of 20 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 DESCRIPTION....................................................................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................6 DRUG INTERACTIONS ....................................................................................................7 DOSAGE AND ADMINISTRATION ................................................................................8 ACTION AND CLINICAL PHARMACOLOGY ............................................................11 STORAGE AND STABILITY ..........................................................................................12 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................12 PART II: SCIENTIFIC INFORMATION ................................................................................14 PHARMACEUTICAL INFORMATION ..........................................................................14 CLINICAL TRIALS .................................................................. Přečtěte si celý dokument