DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DAPTOMYCIN

Fáanlegur frá:

DR REDDY'S LABORATORIES LTD

ATC númer:

J01XX09

INN (Alþjóðlegt nafn):

DAPTOMYCIN

Skammtar:

350MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

DAPTOMYCIN 350MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-04-22

Vara einkenni

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