LEVOFLOXACIN IN 5% DEXTROSE INJECTION SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LEVOFLOXACIN

제공처:

PFIZER CANADA ULC

ATC 코드:

J01MA12

INN (국제 이름):

LEVOFLOXACIN

복용량:

5MG

약제 형태:

SOLUTION

구성:

LEVOFLOXACIN 5MG

관리 경로:

INTRAVENOUS

패키지 단위:

50/100/150ML

처방전 유형:

Prescription

치료 영역:

QUINOLONES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2009-10-21

제품 특성 요약

_LEVOFLOXACIN in 5% Dextrose Injection _
_Page 1 of 68 _
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
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
OCT 21, 2009
Date of Revision:
FEB 13, 2024
Submission Control Number: 279109
_ _
_LEVOFLOXACIN in 5% Dextrose Injection _
_Page 2 of 68 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
08/2022
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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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
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6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.4
Administration
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