SABRIL TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

VIGABATRIN

可用日期:

LUNDBECK PHARMACEUTICALS LLC

ATC代码:

N03AG04

INN（国际名称）:

VIGABATRIN

剂量:

500MG

药物剂型:

TABLET

组成:

VIGABATRIN 500MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

MISCELLANEOUS ANTICONVULSANTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2000-09-01

产品特点

_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