ODAN BUPROPION SR 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:

ODAN LABORATORIES LTD

ATCコード:

N06AX12

INN（国際名）:

BUPROPION

投薬量:

100MG

医薬品形態:

TABLET (EXTENDED-RELEASE)

構図:

BUPROPION HYDROCHLORIDE 100MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTIDEPRESSANTS

製品概要:

Active ingredient group (AIG) number: 0131140002; AHFS:

認証ステータス:

APPROVED

承認日:

2021-05-14

製品の特徴

_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
.....................