RIVA-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Dostupné z:

LABORATOIRE RIVA INC.

ATC kód:

N06AX16

INN (Medzinárodný Name):

VENLAFAXINE

Dávkovanie:

75MG

Forma lieku:

CAPSULE (EXTENDED RELEASE)

Zloženie:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG

Spôsob podávania:

ORAL

Počet v balení:

100/500

Typ predpisu:

Prescription

Terapeutické oblasti:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0131294001; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2019-11-08

Súhrn charakteristických

_RIVA-VENLAFAXINE XR - Product Monograph _
_Page 1 of 71 _
PRODUCT MONOGRAPH
PR
RIVA-VENLAFAXINE XR
(venlafaxine hydrochloride extended release capsules)
venlafaxine (as venlafaxine hydrochloride)
USP
37.5 mg, 75 mg and 150 mg
Antidepressant / Anxiolytic
www.labriva.com
Submission Control No.: 240095
J7C 3V4
Blainville, Québec
660
Boul.
Industriel
LABORATOIRE RIVA INC.
July 8,
2020
Date of Revision:
_RIVA-VENLAFAXINE XR - Product Monograph _
_Page 2 of 71 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT
INFORMATION.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
5
WARNINGS AND PRECAUTIONS
..................................................................................
6
ADVERSE REACTIONS
..................................................................................................
20
DRUG INTERACTIONS
..................................................................................................
37
DOSAGE AND ADMINISTRATION
..............................................................................
44
OVERDOSAGE
.................................................................................................................
48
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 49
STORAGE AND STABILITY
..........................................................................................
52
SPECIAL HANDLING INSTRUCTIONS
........................................................................
53
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 53
PART II: SCIENTIFIC INFORMATION
................................................................................
54
PHARMACEUTICAL INFORM