País: Canadá
Idioma: inglés
Fuente: Health Canada
BUPROPION HYDROCHLORIDE
DOMINION PHARMACAL
N06AX12
BUPROPION
100MG
TABLET (EXTENDED-RELEASE)
BUPROPION HYDROCHLORIDE 100MG
ORAL
60
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0131140002; AHFS:
APPROVED
2009-11-30
PRODUCT MONOGRAPH PR DOM-BUPROPION SR Bupropion Hydrochloride Sustained Release Tablets, House Standard 100 mg and 150 mg Antidepressant DOMINION PHARMACAL Date of Revision: 6111 Royalmount Ave, Suite 100 February 13, 2014 Montréal, Québec H4P 2T4 Control number: 171397 _Product Monograph Dom-BUPROPION SR _ _Page 2 of 37 _ 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 ..................................................................................................... 10 DRUG INTERACTIONS ..................................................................................................... 15 DOSAGE AND ADMINISTRATION ................................................................................. 17 OVERDOSAGE ................................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ............................................................... 20 STORAGE AND STABILITY ............................................................................................. 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 24 PART II: SCIENTIFIC INFORMATION ........................................................................... 25 PHARMACEUTICAL INFORMATION ............................................................................. 25 CLINICAL TRIALS ............................................................................................................. 26 DETAIL Leer el documento completo