AG-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

Dostupno od:

ANGITA PHARMA INC.

ATC koda:

N06AX23

INN (International ime):

DESVENLAFAXINE

Doziranje:

100MG

Farmaceutski oblik:

TABLET (EXTENDED-RELEASE)

Sastav:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 100MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2022-03-04

Svojstava lijeka

PRODUCT MONOGRAPH
Pr
AG-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 and 100 mg desvenlafaxine (as desvenlafaxine succinate monohydrate)
Antidepressant
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3
SUBMISSION CONTROL NO.: 260512
_AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph _
_Page 1 of 57_
Date of Revision:
February
28, 2022
_AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph_
_Page 2 of 57_
_ _
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
....................................................................................................
13
DRUG INTERACTIONS
....................................................................................................24
DOSAGE AND ADMINISTRATION
................................................................................28
OVERDOSAGE
...................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...............................................................33
STORAGE AND STABILITY
............................................................................................37
SPECIAL HANDLING INSTRUCTIONS
..........................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................37
PART II: SCIENTIFIC INFORMATION
..................................................................................