DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DAPTOMYCIN

Dostępny od:

JUNO PHARMACEUTICALS CORP.

Kod ATC:

J01XX09

INN (International Nazwa):

DAPTOMYCIN

Dawkowanie:

500MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

DAPTOMYCIN 500MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

CYCLIC LIPOPEPTIDES

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2021-01-29

Charakterystyka produktu

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