Land: Kanada
Sprache: Englisch
Quelle: Health Canada
VALPROIC ACID (DIVALPROEX SODIUM)
SANIS HEALTH INC
N03AG01
VALPROIC ACID
500MG
TABLET (ENTERIC-COATED)
VALPROIC ACID (DIVALPROEX SODIUM) 500MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0112996003; AHFS:
APPROVED
2013-02-11
Page 1 of 49 PRODUCT MONOGRAPH Pr DIVALPROEX DIVALPROEX SODIUM ENTERIC-COATED TABLETS 125 MG, 250 MG AND 500 MG VALPROIC ACID (AS DIVALPROEX SODIUM) HOUSE STANDARD ANTIEPILEPTIC SANIS HEALTH INC. DATE OF REVISION: 333 CHAMPLAIN ST. SUITE 102 DIEPPE, NEW BRUNSWICK JUNE 16, 2014 E1A 1P2 CONTROL NUMBER: 174536 Page 2 of 49 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 .................................................................................................................... 16 DRUG INTERACTIONS ..................................................................................................................... 23 DOSAGE AND ADMINISTRATION .............................................................................................. 29 OVERDOSAGE ................................................................................................................................... 31 ACTION AND CLINICAL PHARMACOLOGY ............................................................................... 32 STORAGE AND STABILITY ............................................................................................................. 35 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................................ 35 PART II: SCIENTIFIC INFORMATION ........................................................................................... 36 PHARMACEUTICAL INFORMATION .................... Lesen Sie das vollständige Dokument