LEVOFLOXACIN IN 5% DEXTROSE INJECTION SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LEVOFLOXACIN

Boleh didapati daripada:

STERIMAX INC

Kod ATC:

J01MA12

INN (Nama Antarabangsa):

LEVOFLOXACIN

Dos:

5MG

Borang farmaseutikal:

SOLUTION

Komposisi:

LEVOFLOXACIN 5MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

100ML/250ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

QUINOLONES

Ringkasan produk:

Active ingredient group (AIG) number: 0131663001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2016-12-22

Ciri produk

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LEVOFLOXACIN IN 5% DEXTROSE INJECTION
Levofloxacin
5 mg / mL Sterile solution for intravenous infusion
Antibacterial Agent
J01MA12 Levofloxacin
Submission Control Number: 270610
SteriMax Inc.
2770 Portland Drive
Oakville, ON
L6H 6R4
Date of Initial Authorization:
December 22, 2016
Date of Revision:
May 16, 2023
_LEVOFLOXACIN IN 5% DEXTROSE INJECTION Page 2 of 75_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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6
1.2
Geriatrics
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6
2
CONTRAINDICATIONS
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6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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7
4.1
Dosing Considerations
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7
4.2
Recommended Dose and Dosage Adjustment
......................................................... 7
4.4
Administration
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9
4.