DAPTOMYCIN FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DAPTOMYCIN

Fáanlegur frá:

PFIZER CANADA ULC

ATC númer:

J01XX09

INN (Alþjóðlegt nafn):

DAPTOMYCIN

Skammtar:

350MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

DAPTOMYCIN 350MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

1VIAL

Gerð lyfseðils:

Prescription

Lækningarsvæði:

CYCLIC LIPOPEPTIDES

Vörulýsing:

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

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2020-10-16

Vara einkenni

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