País: Canadá
Língua: inglês
Origem: Health Canada
CLOPIDOGREL (CLOPIDOGREL BISULFATE)
ABBOTT LABORATORIES, LIMITED
B01AC04
CLOPIDOGREL
75MG
TABLET
CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG
ORAL
100/500
Prescription
PLATELET AGGREGATION INHIBITORS
Active ingredient group (AIG) number: 0134440001; AHFS:
CANCELLED POST MARKET
2015-12-31
_ _ _Abbott-Clopidogrel Product Monograph _ _Page 1 of 52 _ _ _ _ _ PRODUCT MONOGRAPH PR ABBOTT-CLOPIDOGREL Clopidogrel Tablets USP 75 mg clopidogrel, as clopidogrel bisulfate Platelet Aggregation Inhibitor Abbott Laboratories, Limited 8401 Trans-Canada Highway Saint-Laurent, Quebec H4S 1Z1 Date of Revision: November 27, 2014 Submission Control No.: 179756 _ _ _Abbott-Clopidogrel Product Monograph _ _Page 2 of 52 _ 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 ....................................................................................................7 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................19 OVERDOSAGE ................................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY ............................................................20 STORAGE AND STABILITY ..........................................................................................24 SPECIAL HANDLING INSTRUCTIONS .......................................................................24 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................25 PART II: SCIENTIFIC INFORMATION ...............................................................................26 PHARMACEUTICAL INFORMATION ......................................................... Leia o documento completo