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Sors: Health Canada
BUPROPION HYDROCHLORIDE
ODAN LABORATORIES LTD
N06AX12
BUPROPION
100MG
TABLET (EXTENDED-RELEASE)
BUPROPION HYDROCHLORIDE 100MG
ORAL
15G/50G
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0131140002; AHFS:
APPROVED
2021-05-14
_Pr_ _ODAN BUPROPION SR, Bupropion Hydrochloride_ Page 1 of 47 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ODAN BUPROPION SR Bupropion Hydrochloride Sustained-Release Tablets Tablets, 100 mg and 150 mg, Oral Mfr. Std. ANTIDEPRESSANT Odan Laboratories Ltd. Date of Initial Authorization: 325 Stillview Avenue June 19, 2006 Pointe Claire, Quebec H9R 2Y6 Date of Revision: August 18, 2022 Submission Control #: 262820 _Pr_ _ODAN BUPROPION SR, Bupropion Hydrochloride_ Page 2 of 47 RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 08/2022 7 WARNING AND PRECAUTIONS, Immune 08/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS .................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................ 4 1 INDICATIONS ................................................................................................................ 4 1.1 Pediatrics .............................................................................................................. 4 1.2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................ 5 4.1 Dosing Considerations .......................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ...................................................... 5 4.4 Administration ....................................................................................................... 6 4.5 Missed Dose ..................... Aqra d-dokument sħiħ