OCUFLOX SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
15-08-2022

유효 성분:

OFLOXACIN

제공처:

ABBVIE CORPORATION

ATC 코드:

S01AE01

INN (국제 이름):

OFLOXACIN

복용량:

0.3%

약제 형태:

SOLUTION

구성:

OFLOXACIN 0.3%

관리 경로:

OPHTHALMIC

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

ANTIBACTERIALS

제품 요약:

Active ingredient group (AIG) number: 0122759007; AHFS:

승인 상태:

APPROVED

승인 날짜:

2022-08-16

제품 특성 요약

                                _ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OCUFLOX®
Ofloxacin ophthalmic solution
Solution, 0.3% w/v, for ophthalmic use
USP
Antibacterial Agent (ATC code: S01AE01)
Submission Control Number: 266079
Date of Initial Authorization:
NOV
25,
1994
Date of Revision:
AUG 15, 2022
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
_OCUFLOX_
_(ofloxacin) Page 1 of 20_
_ _ RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
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
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
.........................................................................................................
5
4.5
Missed Dose
.....................................................................................................
                                
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