DAPTOMYCIN FOR INJECTION RF POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DAPTOMYCIN

Tilgængelig fra:

BAXTER CORPORATION

ATC-kode:

J01XX09

INN (International Name):

DAPTOMYCIN

Dosering:

500MG

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

DAPTOMYCIN 500MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

CYCLIC LIPOPEPTIDES

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2021-08-05

Produktets egenskaber

Page 1 of 66
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
P r
DAPTOMYCIN FOR INJECTION RF
Daptomycin for Injection
Lyophilized
Powder for Solution, For Intravenous Use Only
10 mL vial, Daptomycin 500 mg/vial
Sterile
Preservative Free, Single Dose Vials
Antibacterial Agent
Baxter Corporation
Date of Preparation: August 04, 2021
Mississauga, Ontario
L5N 0C2
Submission
Control Number: 227688
Baxter is a registered trademark of Baxter International Inc.
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...................................................................
3
SUMMARY PRODUCT
INFORMATION...................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................
5
ADVERSE
REACTIONS..........................................................................................................
11
DRUG INTERACTIONS
..........................................................................................................
22
DOSAGE AND ADMINISTRATION
........................................................................................
25
ACTION AND CLINICAL
PHARMACOLOGY........................................................................
32
STORAGE AND
STABILITY...................................................................................................
38
SPECIAL HANDLING
INSTRUCTIONS..................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 38
PART II: SCIENTIFIC INFORMATION
.....................................................................................
39
PHARMACEUTICAL I