Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
BUPROPION HYDROCHLORIDE
BAUSCH HEALTH, CANADA INC.
N06AX12
BUPROPION
150MG
TABLET (EXTENDED-RELEASE)
BUPROPION HYDROCHLORIDE 150MG
ORAL
15G/50G
Prescription
MISCELLANEOUS ANTIDEPRESSANTS
Active ingredient group (AIG) number: 0131140003; AHFS:
APPROVED
2001-07-04
_Pr_ _ZYBAN _ _®_ _, Bupropion Hydrochloride _ _ _ _Page 1 of 53 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ZYBAN ® Bupropion Hydrochloride Extended-Release Tablets, 150 mg, for oral use Mfr. Std. Smoking Cessation Aid Bausch Health, Canada Inc. Date of initial Authorization: 2150 St-Elzear Blvd. West July 30, 1998 Laval, Quebec H7L 4A8 Date of Revision: December 5, 2023 Control #: 276730 ZYBAN ® is a registered trademark of the GlaxoSmithKline Groups and is used under license by Bausch Health, Canada Inc. _ _ _ _ _Pr_ _ZYBAN_ _®_ _, Bupropion Hydrochloride _ _ Page 2 of 53 _ _ _ RECENT MAJOR LABEL CHANGES 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 12/2021 4.1 Dosing Considerations 12/2023 7 WARNINGS AND PRECAUTIONS, Cardiovascular 12/2023 7 WARNING AND PRECAUTIONS, Immune 12/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ......................................................................................................... 2 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 .................. Διαβάστε το πλήρες έγγραφο