BUPROPION HCL XL TABLET (EXTENDED-RELEASE)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

BUPROPION HYDROCHLORIDE

から入手可能:

BAUSCH HEALTH, CANADA INC.

ATCコード:

N06AX12

INN（国際名）:

BUPROPION

投薬量:

300MG

医薬品形態:

TABLET (EXTENDED-RELEASE)

構図:

BUPROPION HYDROCHLORIDE 300MG

投与経路:

ORAL

パッケージ内のユニット:

7/90

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTIDEPRESSANTS

製品概要:

Active ingredient group (AIG) number: 0131140004; AHFS:

認証ステータス:

APPROVED

承認日:

2021-09-16

製品の特徴

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BUPROPION HCL
XL
Bupropion Hydrochloride Extended-Release Tablets
Tablet (extended-release), 150 mg, 300 mg, For oral use
USP
Antidepressant
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Submission Control Number: 270781
Date
of Initial Authorization:
SEP 16, 2021
Date of Revision:
FEB 3, 2023
_ _
_Pr_
_BUPROPION HCL XL Product Monograph Page 2 of 59_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
01/2023
7 WARNING AND PRECAUTIONS
, Immune
01/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX………………………………………………………..…5
2
CONTRAINDICATIONS
................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..................................................... 5
4.4
Administration
............................................................................