DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DAPTOMYCIN

MAH:

ACCORD HEALTHCARE INC

ATC_code:

J01XX09

INN:

DAPTOMYCIN

dosage:

500MG

pharmaceutical_form:

POWDER FOR SOLUTION

composition:

DAPTOMYCIN 500MG

administration_route:

INTRAVENOUS

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

CYCLIC LIPOPEPTIDES

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2020-10-01

SPC

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DAPTOMYCIN FOR INJECTION
Lyophilized Powder for Solution, For Intravenous Use Only
500 mg/vial
Antibacterial Agent
Accord Healthcare Inc.
3535 boul. St-Charles, Suite 704
Kirkland, Quebec
H9H 5B9
Date of Revision:
August 31, 2020
Submission Control Number:
242602
_Page 2 of 60_
_Product Monograph of Daptomycin for Injection _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 27
STORAGE AND STABILITY
.........................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETA