SANDOZ MOXIFLOXACIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

J01MA14

INN（国際名）:

MOXIFLOXACIN

投薬量:

400MG

医薬品形態:

TABLET

構図:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

投与経路:

ORAL

パッケージ内のユニット:

30

処方タイプ:

Prescription

治療領域:

QUINOLONES

製品概要:

Active ingredient group (AIG) number: 0142242001; AHFS:

認証ステータス:

APPROVED

承認日:

2015-11-04

製品の特徴

_Sandoz Moxifloxacin Page 1 of 60_
_ _
PRODUCT MONOGRAPH
PR
SANDOZ MOXIFLOXACIN
®
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
Antibacterial Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Revision:
May 29, 2020
Submission Control No: 238775
_Sandoz Moxifloxacin Page 2 of 60_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
...............................................................