MYLAN-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:

MYLAN PHARMACEUTICALS ULC

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:

100

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:

CANCELLED PRE MARKET

承認日:

2017-01-11

製品の特徴

_ _
_ _
_Page 1 of 61_
PRODUCT MONOGRAPH
Pr
MYLAN-MOXIFLOXACIN
Moxifloxacin Hydrochloride Tablets
400 mg Moxifloxacin (as Moxifloxacin Hydrochloride)
Antibacterial Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
November 15, 2016
Submission Control No: 199712
_ _
_ _
_Page 2 of 61_
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
.................................................................................................
12
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
.........................................................................................................
31
DETAILED PHARMACOLOGY
....................................................................................
40
MICROBIOLOGY
.......................................................