Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
VALPROIC ACID
TEVA CANADA LIMITED
N03AG01
VALPROIC ACID
250MG
CAPSULE
VALPROIC ACID 250MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0112996001; AHFS:
CANCELLED POST MARKET
2018-05-02
PRODUCT MONOGRAPH PR NOVO-VALPROIC (Valproic Acid) 250 mg Capsules, USP Standard 500 mg Enteric Coated Capsules, Teva Standard Antiepileptic Teva Canada Limited Date of Preparation: 30 Novopharm Court June 19, 2014 Toronto, Ontario M1B 2K9 CONTROL NO.: 174447 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 ..................................................................................... 25 OVERDOSAGE ....................................................................................................................... 28 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 28 STORAGE AND STABILITY ................................................................................................. 31 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 31 PART II: SCIENTIFIC INFORMATION .................................................................................... 32 PHARMACEUTICAL INFORMATION ................................................................................. 32 CLINICAL TRIALS ................................................................................................................. 33 D Soma hati kamili