Pays: Canada
Langue: anglais
Source: Health Canada
OXCARBAZEPINE
JAMP PHARMA CORPORATION
N03AF02
OXCARBAZEPINE
150MG
TABLET
OXCARBAZEPINE 150MG
ORAL
30/100/500
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0140461001; AHFS:
CANCELLED POST MARKET
2022-09-06
___________________________________________________________________________________________________________________ _ _Pr_ _JAMP-Oxcarbazepine _ _ _ _Page 1 of 53_ PRODUCT MONOGRAPH PR JAMP-OXCARBAZEPINE Oxcarbazepine Tablets 150 mg, 300 mg and 600 mg Manufacturer’s Standard Antiepileptic JAMP PHARMA CORPORATION 1380-203 NEWTON STREET BOUCHERVILLE, QUEBEC J4B-5H2 SUBMISSION CONTROL NO: 183866 Date of Preparation: May 1, 2015 ___________________________________________________________________________________________________________________ _ _Pr_ _JAMP-Oxcarbazepine _ _ _ _Page 2 of 53_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION....................................................... 3 SUMMARY PRODUCT INFORMATION................................................................................ 3 INDICATIONS AND CLINICAL USE...................................................................................... 3 CONTRAINDICATIONS........................................................................................................... 3 WARNINGS AND PRECAUTIONS.......................................................................................... 3 ADVERSE REACTIONS........................................................................................................... 14 DRUG INTERACTIONS............................................................................................................ 24 DOSAGE AND ADMINISTRATION........................................................................................ 26 OVERDOSAGE.......................................................................................................................... 29 ACTION AND CLINICAL PHARMACOLOGY...................................................................... 29 STORAGE AND STABILITY................................................................................................... 31 DOSAGE FORMS, COMPOSITION AND PACKAGING....................................................... 32 PART II: SCIENTIFIC INFORMATI Lire le document complet