国家: 加拿大
语言: 英文
来源: Health Canada
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)
MYLAN PHARMACEUTICALS ULC
N06AX16
VENLAFAXINE
75MG
CAPSULE (EXTENDED RELEASE)
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG
ORAL
100/500
Prescription
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0131294001; AHFS:
CANCELLED POST MARKET
2018-02-07
PAGE 1 OF 62 PRODUCT MONOGRAPH PR MYLAN-VENLAFAXINE XR CAPSULES (VENLAFAXINE HYDROCHLORIDE) EXTENDED RELEASE CAPSULES (37.5 MG, 75 MG, AND 150 MG VENLAFAXINE AS VENLAFAXINE HYDROCHLORIDE) ANTIDEPRESSANT Mylan Pharmaceuticals ULC Date of Revision: 85 Advance Rd. May 17, 2018 Etobicoke, Ontario M8Z 2S6 Submission Control No.: 215657 PAGE 2 OF 62 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 ......................................................................................................... 16 DRUG INTERACTIONS ......................................................................................................... 29 DOSAGE AND ADMINISTRATION ..................................................................................... 36 OVERDOSAGE ....................................................................................................................... 39 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 41 STORAGE AND STABILITY ................................................................................................. 45 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 45 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 45 PART II: SCIENTIFIC INFORMATION .................................................................................... 47 PHARMACEUTICAL INFORMATION ....................... 阅读完整的文件