LEVOFLOXACIN IN 5% DEXTROSE INJECTION SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

LEVOFLOXACIN

Dostupné z:

STERIMAX INC

ATC kód:

J01MA12

INN (Medzinárodný Name):

LEVOFLOXACIN

Dávkovanie:

5MG

Forma lieku:

SOLUTION

Zloženie:

LEVOFLOXACIN 5MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

100ML/250ML

Typ predpisu:

Prescription

Terapeutické oblasti:

QUINOLONES

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2016-12-22

Súhrn charakteristických

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
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
6
1.2
Geriatrics
...................................................................................................................
6
2
CONTRAINDICATIONS
.................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE AND ADMINISTRATION
.................................................................................
7
4.1
Dosing Considerations
..............................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
......................................................... 7
4.4
Administration
..........................................................................................................
9
4.