Страна: Канада
Язык: английский
Источник: Health Canada
DARIFENACIN (DARIFENACIN HYDROBROMIDE)
APOTEX INC
G04BD10
DARIFENACIN
15MG
TABLET (EXTENDED-RELEASE)
DARIFENACIN (DARIFENACIN HYDROBROMIDE) 15MG
ORAL
30/100
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0151554002; AHFS:
APPROVED
2016-08-23
_APO-DARIFENACIN Product Monograph_ Page 1 of 26 PRODUCT MONOGRAPH PR APO-DARIFENACIN DARIFENACIN EXTENDED RELEASE TABLETS 7.5 MG AND 15 MG DARIFENACIN (AS DARIFENACIN HYDROBROMIDE) Muscarinic M3 selective receptor antagonist APOTEX INC. DATE OF PREPARATION: 150 SIGNET DRIVE FEBRUARY 23, 2016 TORONTO, ONTARIO M9L 1T9 CONTROL NUMBER: 170837 _APO-DARIFENACIN Product Monograph_ Page 2 of 26 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 ...................................................................................................... 5 DRUG INTERACTIONS ....................................................................................................... 8 DOSAGE AND ADMINISTRATION ...................................................................................... 9 OVERDOSAGE ...................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ......................................................................10 STORAGE AND STABILITY................................................................................................13 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................13 PART II: SCIENTIFIC INFORMATION ....................................................................................14 PHARMACEUTICAL INFORMATION ..................................................................................14 CLINICAL TRIALS ....... Прочитать полный документ