DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DAPTOMYCIN

から入手可能:

JUNO PHARMACEUTICALS CORP.

ATCコード:

J01XX09

INN（国際名）:

DAPTOMYCIN

投薬量:

500MG

医薬品形態:

POWDER FOR SOLUTION

構図:

DAPTOMYCIN 500MG

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:

CYCLIC LIPOPEPTIDES

製品概要:

Active ingredient group (AIG) number: 0152298001; AHFS:

認証ステータス:

APPROVED

承認日:

2021-01-29

製品の特徴

_Page 1 of 61 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DAPTOMYCIN FOR INJECTION
Sterile Lyophilized Powder for Solution, For Intravenous Use Only
500 mg / vial
Antibacterial Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Preparation:
January 28, 2021
Submission Control Number: 231178
_Page 2 of 61 _
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
..................................................................................................22
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE………………………………………………………………………….31
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 31
STORAGE AND STABILITY
.........................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 38
PART II: SCIENTIFIC INFORMATION
...............................................................................39
PHARMACEUTICAL INFORMATION
.........................................................................
39
CLINICAL TRIALS
..........................................................................................................40
DETAILED PHARMACOLOGY
...............