DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DAPTOMYCIN

Tilgjengelig fra:

JUNO PHARMACEUTICALS CORP.

ATC-kode:

J01XX09

INN (International Name):

DAPTOMYCIN

Dosering :

500MG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

DAPTOMYCIN 500MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

CYCLIC LIPOPEPTIDES

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-01-29

Preparatomtale

_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
...............