Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
HEPARIN SODIUM
PFIZER CANADA ULC
B01AB01
HEPARIN
5000UNIT
SOLUTION
HEPARIN SODIUM 5000UNIT
INTRAVENOUS
10ML/25X10ML
Ethical
HEPARINS
Active ingredient group (AIG) number: 0104596008; AHFS:
CANCELLED POST MARKET
2015-06-01
PRODUCT MONOGRAPH HEPARIN SODIUM INJECTION USP FOR INTRAVENOUS OR SUBCUTANEOUS USE 1000 USP UNITS PER ML (PRESERVATIVE FREE) 1000 USP UNITS PER ML 5 000 USP UNITS PER ML 10 000 USP UNITS PER ML ANTICOAGULANT Pfizer Canada Inc. 17300 Trans Canada Highway Kirkland, Quebec H9J 2M5 Control No.: 175574 Date of Revision: November 4, 2014 Date of Approval: December 16, 2014 _ _ Heparin Sodium Injection_ _USP _ _ Page 2 of 25_ _ Pfizer Canada Inc. TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION .....................................................................3 INDICATIONS AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS .................................................................................................4 WARNINGS AND PRECAUTIONS ...............................................................................4 ADVERSE REACTIONS ..................................................................................................9 DRUG INTERACTIONS ................................................................................................11 DOSAGE AND ADMINISTRATION ...........................................................................13 OVERDOSAGE ...............................................................................................................16 ACTIONS AND CLINICAL PHARMACOLOGY ......................................................17 STORAGE AND STABILITY........................................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................18 PART II: SCIENTIFIC INFORMATION ................................................................................20 PHARMACEUTICAL INFORMATION ......................................................................20 CLINICAL TRIALS ............................................................................. Aqra d-dokument sħiħ