INTELLI-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

Tersedia dari:

INTELLIPHARMACEUTICS CORP

Kode ATC:

N06AX23

INN (Nama Internasional):

DESVENLAFAXINE

Dosis:

100MG

Bentuk farmasi:

TABLET (EXTENDED-RELEASE)

Komposisi:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 100MG

Rute administrasi :

ORAL

Unit dalam paket:

14/100

Jenis Resep:

Prescription

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-02-14

Karakteristik produk

PRODUCT MONOGRAPH
PR INTELLI-DESVENLAFAXINE
desvenlafaxine extended-release tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate
monohydrate
)
Antidepressant
Intellipharmaceutics Corp.
30 Worcester Road
Toronto, Ontario
Date of Revision:
February 2, 2022
Canada, M9W 5X2
Submission
Control No: 257079
_________________________________________________________________________________________
_Intelli-Desvenlafaxine (desvenlafaxine succinate monohydrate) Product
Monograph _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFOR
M
ATION
..................................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................................3
INDICATIONS AND CLINICAL USE
..........................................................................................3
CONTRAINDICATIONS
.............................................................................................................4
WARNINGS AND PRECAUTIONS
..............................................................................................4
ADVERSE REACTIONS
...........................................................................................................
11
DRUG INTERACTIONS
...........................................................................................................
21
DOSAGE AND ADMINISTRATION
..........................................................................................
24
OVERDOSAGE
........................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
28
STORAGE AND STABILITY
....................................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................