DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DAPTOMYCIN

Tersedia dari:

DR REDDY'S LABORATORIES LTD

Kode ATC:

J01XX09

INN (Nama Internasional):

DAPTOMYCIN

Dosis:

350MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

DAPTOMYCIN 350MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0152298002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-04-22

Karakteristik produk

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.....................................................