LINEZOLID INJECTION SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

LINEZOLID

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

J01XX08

INN（国際名）:

LINEZOLID

投薬量:

2MG

医薬品形態:

SOLUTION

構図:

LINEZOLID 2MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

OXAZOLIDINONES

製品概要:

Active ingredient group (AIG) number: 0143501003; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2019-08-01

製品の特徴

_ _
_Linezolid Injection _
_Page 1 of 41_
PRODUCT MONOGRAPH
PR LINEZOLID INJECTION
Linezolid Injection
2 mg/mL, 300 mL bag
Antibacterial Agent
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Preparation:
May 16, 2018
Submission Control No: 215585
_ _
_Linezolid Injection _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 18
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........................................................................................................
25
DETAILED PHARMACOLOGY
.................................