CUBICIN POWDER FOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DAPTOMYCIN

Boleh didapati daripada:

CUBIST PHARMACEUTICALS LLC

Kod ATC:

J01XX09

INN (Nama Antarabangsa):

DAPTOMYCIN

Dos:

500MG

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

DAPTOMYCIN 500MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

10ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CYCLIC LIPOPEPTIDES

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2007-09-24

Ciri produk

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_Page 1 of 72_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CUBICIN
®
_/_CUBICIN
® RF
(Daptomycin for Injection)
Lyophilized Powder for Solution, For Intravenous Use Only
10 mL vial, 500 mg/vial
Antibacterial Agent
Cubist Pharmaceuticals LLC
Weystrasse 20
6000 Lucerne 6
Lucerne, Switzerland
IMPORTED AND DISTRIBUTED BY:
Sunovion Pharmaceuticals Canada Inc.
7025 Langer Drive
Mississauga ON
L5N 0E8
Date of Revision:
May 15, 2020
Submission Control Number:
235553
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_Page 2 of 72_
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
..................................................................................................24
DOSAGE AND ADMINISTRATION
..............................................................................27
ACTION AND CLINICAL PHARMACOLOGY
............................................................36
STORAGE AND STABILITY
..........................................................................................42
SPECIAL HANDLING INSTRUCTIONS
.......................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................43
PART II: SCIENTIFIC INFORMATION
...............................................................................44
PHARMACEUTICAL INFORMATION
..........................................................................44
CLINICAL TRI