CILOXAN SOLUTION

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언어: 영어

출처: Health Canada

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제품 특성 요약 제품 특성 요약 (SPC)
22-05-2018

유효 성분:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

제공처:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC 코드:

S03AA07

INN (International Name):

CIPROFLOXACIN

복용량:

0.3%

약제 형태:

SOLUTION

구성:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3%

관리 경로:

OPHTHALMIC

패키지 단위:

5ML/10ML

처방전 유형:

Prescription

치료 영역:

ANTIBACTERIALS

제품 요약:

Active ingredient group (AIG) number: 0123207004; AHFS:

승인 상태:

APPROVED

승인 날짜:

2017-04-03

제품 특성 요약

                                _CILOXAN_
_®_
_ Product Monograph _
_ _
1
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CILOXAN
®
Ciprofloxacin Ophthalmic Solution, USP
0.3% w/v (as ciprofloxacin hydrochloride)
Antibacterial Agent
and
Pr
CILOXAN
®
Ciprofloxacin Ophthalmic Ointment, USP
0.3% w/w (as ciprofloxacin hydrochloride)
Antibacterial Agent
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Revision:
www.novartis.ca
May 22, 2018
Submission Control No.: 210590
CILOXAN and DROP-TAINER are registered trademarks.
_CILOXAN_
_®_
_ Product Monograph _
_ _
2
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
................................................................................11
DETAILED PHARMACOLOGY
.....................................................................................11
MICROBIOLOGY............
                                
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