Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
VALPROIC ACID (DIVALPROEX SODIUM)
MYLAN PHARMACEUTICALS ULC
N03AG01
VALPROIC ACID
250MG
TABLET (DELAYED-RELEASE)
VALPROIC ACID (DIVALPROEX SODIUM) 250MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0112996001; AHFS:
CANCELLED POST MARKET
2017-01-11
PRODUCT MONOGRAPH PR MYL-DIVALPROEX Divalproex Sodium Delayed-Release Tablets, USP 125 mg, 250 mg, 500 mg valproic acid (as divalproex sodium) Anticonvulsant Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Control Number: 197330 Date of Revision: September 08, 2016 _Page 2 of 47_ 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 ......................................................................................................... 21 DRUG INTERACTIONS ......................................................................................................... 29 DOSAGE AND ADMINISTRATION ..................................................................................... 37 OVERDOSAGE ....................................................................................................................... 40 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 40 STORAGE AND STABILITY ................................................................................................. 43 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 44 PART II: SCIENTIFIC INFORMATION ............................................................................... 45 PHARMACEUTICAL INFORMATION ................................................................................. 45 CLINICAL TRIALS ..................................................................................... Aqra d-dokument sħiħ