SABRIL POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

VIGABATRIN

Disponibil de la:

LUNDBECK PHARMACEUTICALS LLC

Codul ATC:

N03AG04

INN (nume internaţional):

VIGABATRIN

Dozare:

500MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

VIGABATRIN 500MG

Calea de administrare:

ORAL

Unități în pachet:

50X500MG

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS ANTICONVULSANTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2000-09-01

Caracteristicilor produsului

_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