País: Canadá
Língua: inglês
Origem: Health Canada
EZETIMIBE
PRO DOC LIMITEE
C10AX09
EZETIMIBE
10MG
TABLET
EZETIMIBE 10MG
ORAL
30/100
Prescription
CHOLESTEROL ABSORPTION INHIBITORS
Active ingredient group (AIG) number: 0149164001; AHFS:
APPROVED
2018-01-10
_Ezetimibe _ _Page 1 of 28_ PRODUCT MONOGRAPH Pr EZETIMIBE Ezetimibe Tablets 10 mg ezetimibe Cholesterol Absorption Inhibitor Pro Doc Ltée 2925, boul. Industriel Laval, Quebec H7L 3W9 Date of Revision: January 10, 2018 Submission Control No.: 211911 _Ezetimibe _ _Page 2 of 28_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION........................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................... 7 DRUG INTERACTIONS ................................................................................................. 11 DOSAGE AND ADMINISTRATION ............................................................................. 12 OVERDOSAGE ................................................................................................................ 13 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 13 STORAGE AND STABILITY ......................................................................................... 15 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 15 PART II: SCIENTIFIC INFORMATION .............................................................................. 16 PHARMACEUTICAL INFORMATION ......................................................................... 16 CLINICAL TRIALS ......................................................................................................... 17 TOXICOLOGY ..................................................................................... Leia o documento completo