Land: Canada
Språk: engelsk
Kilde: Health Canada
HEPARIN SODIUM
PFIZER CANADA ULC
B01AB01
HEPARIN
1000UNIT
SOLUTION
HEPARIN SODIUM 1000UNIT
INTRAVENOUS
10ML/25X10ML
Ethical
HEPARINS
Active ingredient group (AIG) number: 0104596004; AHFS:
CANCELLED POST MARKET
2017-09-27
PRODUCT MONOGRAPH HEPARIN SODIUM INJECTION USP FOR INTRAVENOUS OR SUBCUTANEOUS USE 1000 USP UNITS PER ML 10 000 USP UNITS PER ML ANTICOAGULANT Pfizer Canada Inc. 17300 Trans Canada Highway Kirkland, Quebec H9J 2M5 Control No.: 193940 Date of Approval: August 10, 2016 _ _ _ _ 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 ...............................................................................................................17 ACTIONS AND CLINICAL PHARMACOLOGY ......................................................17 STORAGE AND STABILITY........................................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................19 PART II: SCIENTIFIC INFORMATION ................................................................................20 PHARMACEUTICAL INFORMATION ......................................................................20 CLINICAL TRIALS ........................................................................................................21 REFERENCES ......................................................... Les hele dokumentet