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PRODUCT MONOGRAPH
PRODUCT MONOGRAPH Pr WELLBUTRIN XL Bupropion Hydrochloride Extended-Release Tablets, USP 150 mg and 300 mg Antidepressant Name: Valeant Canada LP Address: 2150 St-Elzear Blvd. West Laval, QC, H7L 4A8 Date of Revision: March 20, 2017 Control Number: 200959 Page 1 of 45 Table of Contents Page PART I: HEALTH PROFESSIONAL INFORMATION .. 2 SUMMARY PRODUCT INFORMATION .. 2 INDICATIONS AND CLINICAL USE .. 2 CONTRAINDICATIONS .. 3 WARNINGS AND PRECAUTIONS.
PRODUCT MONOGRAPH Pr WELLBUTRIN ... incidence in clinical trials with doses of 450 mg/day was approximately 0.39% (2 of 537 subjects). There were no seizures in clinical trials where subjects (n=1638) were treated up to the maximum recommended dose of 300 mg/day. In post marketing data however, seizures have been observed across all doses and
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