MYLAN-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Dostupné z:

MYLAN PHARMACEUTICALS ULC

ATC kód:

N06AX16

INN (Medzinárodný Name):

VENLAFAXINE

Dávkovanie:

37.5MG

Forma lieku:

CAPSULE (EXTENDED RELEASE)

Zloženie:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

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: 0131294002; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2018-02-07

Súhrn charakteristických

PAGE 1 OF 62
PRODUCT MONOGRAPH
PR
MYLAN-VENLAFAXINE XR CAPSULES
(VENLAFAXINE HYDROCHLORIDE)
EXTENDED RELEASE CAPSULES
(37.5 MG, 75 MG, AND 150 MG VENLAFAXINE AS VENLAFAXINE HYDROCHLORIDE)
ANTIDEPRESSANT
Mylan Pharmaceuticals ULC
Date of Revision:
85 Advance Rd.
May 17, 2018
Etobicoke, Ontario
M8Z 2S6
Submission Control No.: 215657
PAGE 2 OF 62
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
.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
29
DOSAGE AND ADMINISTRATION
.....................................................................................
36
OVERDOSAGE
.......................................................................................................................
39
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 41
STORAGE AND STABILITY
.................................................................................................
45
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 45
PART II: SCIENTIFIC INFORMATION
....................................................................................
47
PHARMACEUTICAL INFORMATION
.......................