JAMP LEVOFLOXACIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

から入手可能:

JAMP PHARMA CORPORATION

ATCコード:

J01MA12

INN（国際名）:

LEVOFLOXACIN

投薬量:

250MG

医薬品形態:

TABLET

構図:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 250MG

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: 0131663003; AHFS:

認証ステータス:

APPROVED

承認日:

2020-11-24

製品の特徴

_JAMP Levofloxacin_
_Page 1 of 68_
PRODUCT MONOGRAPH
PR
JAMP LEVOFLOXACIN
Levofloxacin Tablets, USP
250 mg, 500 mg and 750 mg Levofloxacin
as Levofloxacin Hemihydrate
Antibacterial Agent
JAMP Pharma Corporation
Date of Approval: November 23, 2020
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Submission Control No: 232133
_JAMP Levofloxacin_
_Page 2 of 68_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................3
SUMMARY PRODUCT INFORMATION
..................................................................................3
INDICATIONS AND CLINICAL USE
........................................................................................3
CONTRAINDICATIONS
..........................................................................................................5
WARNINGS AND PRECAUTIONS
..........................................................................................5
ADVERSE REACTIONS
........................................................................................................
12
DRUG INTERACTIONS
........................................................................................................
16
DOSAGE AND ADMINISTRATION
........................................................................................
18
OVERDOSAGE
.....................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
21
STORAGE AND STABILITY
..................................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 25
PART II: SCIENTIFIC
INFORMATION......................................................................................
27
PHARMACEUTICAL INFORMATION
....................................................................................
27
CLINICAL TRIALS
...