PRO-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

Land: Canada

Taal: Engels

Bron: Health Canada

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Productkenmerken Productkenmerken (SPC)
11-01-2023

Werkstoffen:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

Beschikbaar vanaf:

PRO DOC LIMITEE

ATC-code:

N06AX23

INN (Algemene Internationale Benaming):

DESVENLAFAXINE

Dosering:

100MG

farmaceutische vorm:

TABLET (EXTENDED-RELEASE)

Samenstelling:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 100MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Product samenvatting:

Active ingredient group (AIG) number: 0152509002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2022-04-29

Productkenmerken

                                _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
                                
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