DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DAPTOMYCIN

Saatavilla:

JUNO PHARMACEUTICALS CORP.

ATC-koodi:

J01XX09

INN (Kansainvälinen yleisnimi):

DAPTOMYCIN

Annos:

500MG

Lääkemuoto:

POWDER FOR SOLUTION

Koostumus:

DAPTOMYCIN 500MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CYCLIC LIPOPEPTIDES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2021-01-29

Valmisteyhteenveto

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