APO-DICLOFENAC OPHTHALMIC SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DICLOFENAC SODIUM

제공처:

APOTEX INC

ATC 코드:

S01BC03

INN (International Name):

DICLOFENAC

복용량:

0.1%

약제 형태:

SOLUTION

구성:

DICLOFENAC SODIUM 0.1%

관리 경로:

OPHTHALMIC

패키지 단위:

2.5/5/10ML FILL

처방전 유형:

Prescription

치료 영역:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

제품 요약:

Active ingredient group (AIG) number: 0114417004; AHFS:

승인 상태:

APPROVED

승인 날짜:

2015-05-12

제품 특성 요약

_APO-DICLOFENAC OPHTHALMIC (Diclofenac Sodium Ophthalmic Solution)_
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DICLOFENAC OPHTHALMIC
Diclofenac Sodium Ophthalmic Solution
Ophthalmic solution, 0.1% w/v for Topical use
Anti-inflammatory agents, non-steroids
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 12, 2015
Date of Revision:
SEP 18, 2023
Submission Control Number: 275184
_APO-DICLOFENAC OPHTHALMIC (Diclofenac Sodium Ophthalmic Solution)_
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
09/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2023
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 ...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS ...........................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.2
Recommended Dose and Dosage Adjustment
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4.4
Administration
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5
4.5
Missed Dose
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