VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

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Active ingredient:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Available from:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC code:

N06AX16

INN (International Name):

VENLAFAXINE

Dosage:

37.5MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0131294002; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-08-16

Summary of Product characteristics

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_VENLAFAXINE XR (venlafaxine hydrochloride extended-release capsules)
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_Page 1 of 62_
PRODUCT MONOGRAPH
PR
VENLAFAXINE XR
(VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES)
37.5, 75 AND 150 MG
VENLAFAXINE (AS VENLAFAXINE HYDROCHLORIDE)
Professed Standard
ANTIDEPRESSANT/ANXIOLYTIC
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200 Date of Preparation: August 14,
2012
Mississauga, Ontario
Canada L4W 0A5
Submission Control No: 156578
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_VENLAFAXINE XR (venlafaxine hydrochloride extended-release capsules)
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_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
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
17
DRUG INTERACTIONS
.........................................................................................................
31
DOSAGE AND ADMINISTRATION
.....................................................................................
36
OVERDOSAGE
.......................................................................................................................
40
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 41
STORAGE AND STABILITY
.................................................................................................
45
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............
                                
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