CUBICIN RF POWDER FOR SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DAPTOMYCIN

Dostupné z:

CUBIST PHARMACEUTICALS LLC

ATC kód:

J01XX09

INN (Medzinárodný Name):

DAPTOMYCIN

Dávkovanie:

500MG

Forma lieku:

POWDER FOR SOLUTION

Zloženie:

DAPTOMYCIN 500MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

10ML

Typ predpisu:

Prescription

Terapeutické oblasti:

CYCLIC LIPOPEPTIDES

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2017-06-30

Súhrn charakteristických

_ _
_ _
_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
_ _
_ _
_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