País: Canadá
Idioma: inglés
Fuente: Health Canada
OXCARBAZEPINE
NOVOPHARM LIMITED
N03AF02
OXCARBAZEPINE
150MG
TABLET
OXCARBAZEPINE 150MG
ORAL
50/100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0140461001; AHFS:
CANCELLED PRE MARKET
2018-07-24
_ _ _ _ PRODUCT MONOGRAPH PR NOVO-OXCARBAZEPINE (Oxcarbazepine) 150 mg, 300 mg and 600 mg Tablets Antiepileptic Novopharm Limited DATE OF PREPARATION: 30 Novopharm Court MAY 30, 2008 Toronto, Ontario M1B 2K9 CONTROL NUMBER: 109545 _ _ _ _ _Page 2_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION......................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS......................................................................................... 4 ADVERSE REACTIONS......................................................................................................... 11 DRUG INTERACTIONS ......................................................................................................... 19 DOSAGE AND ADMINISTRATION..................................................................................... 21 OVERDOSAGE ....................................................................................................................... 24 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 25 STORAGE AND STABILITY................................................................................................. 27 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 27 PART II: SCIENTIFIC INFORMATION ............................................................................... 28 PHARMACEUTICAL INFORMATION................................................................................. 28 CLINICAL TRIALS................................................................................................................. 29 DETAILED PHARMACOLOGY............ Leer el documento completo