Ország: Kanada
Nyelv: angol
Forrás: Health Canada
VALPROIC ACID (SODIUM VALPROATE)
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
N03AG01
VALPROIC ACID
50MG
SYRUP
VALPROIC ACID (SODIUM VALPROATE) 50MG
ORAL
450 ML
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0112996002; AHFS:
CANCELLED POST MARKET
2015-10-26
PRODUCT MONOGRAPH PR RATIO-VALPROIC Capsules and Oral Solution Capsules (250 mg) Oral solution (250 mg / 5 mL) USP Antiepileptic Ratiopharm Inc. Date of Revision: 17 800 Lapointe February 2, 2012 Mirabel, Quebec Canada J7J 1P3 Control No.: 152606 2 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 .............................................................................................. 19 DOSAGE AND ADMINISTRATION.......................................................................... 26 OVERDOSAGE ............................................................................................................ 28 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 29 STORAGE AND STABILITY...................................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................... 32 PART II: SCIENTIFIC INFORMATION............................................................................... 33 PHARMACEUTICAL INFORMATION...................................................................... 33 DETAILED PHARMACOLOGY................................................................................. 34 TOXICOLOGY ............................................................................................................. 34 REFERENCES ........................................................ Olvassa el a teljes dokumentumot