DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DAPTOMYCIN

Disponible depuis:

JUNO PHARMACEUTICALS CORP.

Code ATC:

J01XX09

DCI (Dénomination commune internationale):

DAPTOMYCIN

Dosage:

500MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

DAPTOMYCIN 500MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

CYCLIC LIPOPEPTIDES

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2021-01-29

Résumé des caractéristiques du produit

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