Ország: Kanada
Nyelv: angol
Forrás: Health Canada
VALPROIC ACID (DIVALPROEX SODIUM)
DOMINION PHARMACAL
N03AG01
VALPROIC ACID
125MG
TABLET (ENTERIC-COATED)
VALPROIC ACID (DIVALPROEX SODIUM) 125MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0112996004; AHFS:
APPROVED
2002-04-10
PRODUCT MONOGRAPH PR DOM-DIVALPROEX Divalproex Sodium Delayed-Release Tablets, USP 125 mg, 250 mg, 500 mg ANTIEPILEPTIC DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 Date of Revision: June 20, 2017 Submission Control No: 206234 _Dom-DIVALPROEX Product Monograph _ _Page 2 of 60_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................5 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................22 DRUG INTERACTIONS ..................................................................................................29 DOSAGE AND ADMINISTRATION ..............................................................................36 OVERDOSAGE ................................................................................................................39 ACTION AND CLINICAL PHARMACOLOGY ............................................................40 STORAGE AND STABILITY ..........................................................................................43 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................43 PART II: SCIENTIFIC INFORMATION ...............................................................................45 PHARMACEUTICAL INFORMATION ..........................................................................45 CLINICAL TRIALS ..........................................................................................................46 DETAILED PHARMACOLOGY ................................................ Olvassa el a teljes dokumentumot