DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DAPTOMYCIN

Tersedia dari:

ACCORD HEALTHCARE INC

Kode ATC:

J01XX09

INN (Nama Internasional):

DAPTOMYCIN

Dosis:

500MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

DAPTOMYCIN 500MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

CYCLIC LIPOPEPTIDES

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-10-01

Karakteristik produk

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