PRO-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

זמין מ:

PRO DOC LIMITEE

קוד ATC:

N06AX23

INN (שם בינלאומי):

DESVENLAFAXINE

כמות:

50MG

טופס פרצבטיות:

TABLET (EXTENDED-RELEASE)

הרכב:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0152509001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2022-04-29

מאפייני מוצר

_PRO-DESVENLAFAXINE PRODUCT MONOGRAPH _
PAGE 1 OF 50
PRODUCT MONOGRAPH
PR
PRO-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate)
ANTIDEPRESSANT
DATE OF REVISION:
JAN 10, 2023
CONTROL NUMBER: 270605
PRO DOC LTÉE
2925 BOULEVARD INDUSTRIEL
LAVAL, QUEBEC
H7L 3W9
_PRO-DESVENLAFAXINE PRODUCT MONOGRAPH _
PAGE 2 OF 50
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
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
22
DOSAGE AND ADMINISTRATION
.....................................................................................
25
OVERDOSAGE
........................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
29
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL INFORM