APO-DICLO SR TABLET (EXTENDED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DICLOFENAC SODIUM

제공처:

APOTEX INC

ATC 코드:

M01AB05

INN (International Name):

DICLOFENAC

복용량:

75MG

약제 형태:

TABLET (EXTENDED-RELEASE)

구성:

DICLOFENAC SODIUM 75MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Prescription

치료 영역:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

제품 요약:

Active ingredient group (AIG) number: 0114417005; AHFS:

승인 상태:

DORMANT

승인 날짜:

2019-10-03

제품 특성 요약

_APO-DICLO and APO-DICLO SR diclofenac sodium Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DICLO
Diclofenac Sodium Delayed-Release Tablets
Delayed-Release Tablets, 25 mg and 50 mg, for oral use
USP
PR
APO-DICLO SR
Diclofenac Sodium Slow-Release Tablets
Slow Release Tablets, 75 mg and 100 mg, for oral use
Apotex Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
DEC 31, 1989
Date of Revision:
SEP 22, 2022
Submission Control Number: 260911
_APO-DICLO and APO-DICLO SR diclofenac sodium Page 2 of 52 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX- Risk in Pregnancy
09/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests,
_Pregnancy_
09/2022
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions_
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2022
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
...................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND
ADMINISTRATION......