מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
VIGABATRIN
LUNDBECK PHARMACEUTICALS LLC
N03AG04
VIGABATRIN
500MG
TABLET
VIGABATRIN 500MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0125421003; AHFS:
APPROVED
2000-09-01
_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 קרא את המסמך השלם