DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DAPTOMYCIN

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

J01XX09

INN (Nama Internasional):

DAPTOMYCIN

Dosis:

350MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

DAPTOMYCIN 350MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

1VIAL

Jenis Resep:

Prescription

Area terapi:

CYCLIC LIPOPEPTIDES

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2020-10-16

Karakteristik produk

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DAPTOMYCIN FOR INJECTION
Lyophilized Powder for Solution, For Intravenous Use Only
Daptomycin (350 mg/vial and 500 mg/vial)
Antibacterial Agent
Pfizer Canada ULC
17300 Trans-Canada highway
Kirkland, Québec
H9J 2M5
Submission Control Number: 176067, 211077,
219633, 227098
Date of Preparation:
May 3, 2019
_Product Monograph - Daptomycin for Injection _
_Page 2 of 68 _
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
..................................................................................................
21
DOSAGE AND ADMINISTRATION
..............................................................................
24
OVERDOSAGE
................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 31
STORAGE AND STABILITY
..........................................................................................
36
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 37
PART II: SCIENTIFIC INFORMATION
...............................................................................
38
PHARMACEUTICAL
INFORMATION.................................