DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DAPTOMYCIN

Disponibil de la:

ACCORD HEALTHCARE INC

Codul ATC:

J01XX09

INN (nume internaţional):

DAPTOMYCIN

Dozare:

500MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

DAPTOMYCIN 500MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CYCLIC LIPOPEPTIDES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-10-01

Caracteristicilor produsului

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