DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DAPTOMYCIN

Tilgjengelig fra:

DR REDDY'S LABORATORIES LTD

ATC-kode:

J01XX09

INN (International Name):

DAPTOMYCIN

Dosering :

500MG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

DAPTOMYCIN 500MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

CYCLIC LIPOPEPTIDES

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2020-10-01

Preparatomtale

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DAPTOMYCIN FOR INJECTION
Lyophilized Powder for Solution
Daptomycin (350 mg / vial and 500 mg / vial)
For Intravenous Use Only
Antibacterial Agent
Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 India
Imported and Distributed by:
Dr. Reddy’s Laboratories Canada Inc.
Mississauga ON L4W 4Y1 Canada
Date of Initial Approval:
July 11, 2019
Date of Revision:
April 19, 2022
Submission Control No: 244532
2
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
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
........................................................................................
23
OVERDOSAGE
.....................................................................................................................
28
ACTION AND CLINICAL
PHARMACOLOGY..........................................................................
29
STORAGE AND STABILITY
..................................................................................................
35
SPECIAL HANDLING
INSTRUCTIONS..................................................................................
35
DOSAGE FORMS, COMPOSITION AND
PACKAGING.....................................................