Страна: Канада
Език: английски
Източник: Health Canada
EXEMESTANE
APOTEX INC
L02BG06
EXEMESTANE
25MG
TABLET
EXEMESTANE 25MG
ORAL
30
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0141702001; AHFS:
APPROVED
2014-02-04
Page 1 of 47 PRODUCT MONOGRAPH Pr APO-EXEMESTANE Exemestane Tablets, 25 mg Aromatase Inactivator; Anti-Tumour Agent APOTEX INC. DATE OF REVISION: MARCH 17, 2020 150 SIGNET DRIVE TORONTO, ONTARIO M9L 1T9 SUBMISSION CONTROL NO: 235772 Page 2 of 47 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 .................................................................................................................................. 8 DRUG INTERACTIONS ................................................................................................................................. 15 DOSAGE AND ADMINISTRATION ............................................................................................................. 15 OVERDOSAGE ............................................................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ........................................................................................... 16 STORAGE AND STABILITY ........................................................................................................................ 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................................................ 19 PART II: SCIENTIFIC INFORMATION ........................................................................... Прочетете целия документ