SABRIL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VIGABATRIN

Available from:

LUNDBECK PHARMACEUTICALS LLC

ATC code:

N03AG04

INN (International Name):

VIGABATRIN

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

VIGABATRIN 500MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0125421003; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-09-01

Summary of Product characteristics

_Vigabatrin Product Monograph Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SABRIL®
vigabatrin
Tablets, 500 mg
Sachets, 500 mg
Antiepileptic
® Trademark of Lundbeck
Manufactured by:
Lundbeck
Six Parkway North
Deerfield, IL 60015
U.S.A.
Imported and distributed by:
Lundbeck Canada Inc., Saint-Laurent, QC H4S 0A9
Submission Control No: 244467
Date of Preparation:
October 6, 2009
Date of Revision:
February 9, 2021
TABLE OF CONTENTS
_ _
_Vigabatrin Product Monograph Page 2 of 44_
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................29
SPECIAL HANDLING INSTRUCTIONS
.......................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTI