Land: Canada
Sprog: engelsk
Kilde: Health Canada
CARBAMAZEPINE
NOVARTIS PHARMACEUTICALS CANADA INC
N03AF01
CARBAMAZEPINE
200MG
TABLET (CHEWABLE)
CARBAMAZEPINE 200MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0108674001; AHFS:
CANCELLED POST MARKET
2017-09-26
_ _ _ _ _Page 1 of 46_ PRODUCT MONOGRAPH PR TEGRETOL ® (carbamazepine) Pr TEGRETOL ® Tablets, 200 mg Novartis Standard Pr TEGRETOL ® Chewtabs (Chewable Tablets), 100 mg and 200 mg Novartis Standard Pr TEGRETOL ® CR (Controlled-Release Tablets), 200 mg and 400 mg Novartis Standard Pr TEGRETOL ® Suspension, 100 mg/tsp (5 mL) Novartis Standard Anticonvulsant For Symptomatic Relief of Trigeminal Neuralgia Antimanic Novartis Pharmaceuticals Canada Inc. 385 Bouchard Blvd., Dorval, Quebec H9S 1A9 Date of Preparation: April 26, 1976 Date of Revision: May 4, 2018 Submission Control No: 213356 TEGRETOL is a registered trademark. _ _ _ _ _Page 2 of 46_ 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 ..................................................................................................16 DRUG INTERACTIONS ..................................................................................................20 DOSAGE AND ADMINISTRATION ..............................................................................25 OVERDOSAGE ................................................................................................................27 ACTION AND CLINICAL PHARMACOLOGY ............................................................28 STORAGE AND STABILITY ..........................................................................................30 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................30 PART II: SCIENTIFIC INFORMATION ................................... Læs hele dokumentet