AG-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:

ANGITA PHARMA INC.

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:

2018-06-28

製品の特徴

_AG-_
_MOXIFLOXACIN _
_Page 1 of 70 _
PRODUCT MONOGRAPH
PR
AG
-
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
Antibacterial Agent
Date
of
Revision:
August 03, 2022
Manufactured
by:
Angita
Pharma
Inc.
1310 rue Nobel
Boucherville,Québec
J4B
5H3
Canada
SUBMISSION
CONTROL
NO:
265857
_AG-_
_MOXIFLOXACIN _
_Page 2 of 70 _
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
...........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 31
PART II: SCIENTIFIC INFORMATION
.................................................................................
32
PHARMACEUTICAL
INFORMATION
............................................................................
32
CLINICAL TRIALS
...