国: カナダ
言語: 英語
ソース: Health Canada
EZETIMIBE
RANBAXY PHARMACEUTICALS CANADA INC.
C10AX09
EZETIMIBE
10MG
TABLET
EZETIMIBE 10MG
ORAL
28/100/500
Prescription
CHOLESTEROL ABSORPTION INHIBITORS
Active ingredient group (AIG) number: 0149164001; AHFS:
APPROVED
2014-09-15
_ _ _Pr_ _RAN™-EZETIMIBE (Ezetimibe Tablets) Product Monograph _ _Page 1 of 30_ _ _ PRODUCT MONOGRAPH PR RAN ™ -EZETIMIBE Ezetimibe Tablets 10 mg Cholesterol Absorption Inhibitor Ranbaxy Pharmaceuticals Canada Inc., 2680 Matheson Blvd. E., Suite 200 Mississauga, Ontario L4W 0A5 Date of Preparation: January 16, 2014 SUBMISSION CONTROL NO: 158635 Trademark owned by Ranbaxy Laboratories Limited _ _ _Pr_ _RAN_ _™_ _-EZETIMIBE (Ezetimibe Tablets) Product Monograph _ _Page 2 of 30_ 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 ..................................................................................................11 DOSAGE AND ADMINISTRATION ..............................................................................13 OVERDOSAGE ................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ............................................................14 STORAGE AND STABILITY ..........................................................................................16 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................16 PART II: SCIENTIFIC INFORMATION ...............................................................................17 PHARMACEUTICAL INFORMATION ..........................................................................17 CLINICAL TRIALS 完全なドキュメントを読む