TEVA-DICLOFENAC SUPPOSITORY
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
22-08-2016
이 제품에 대한 일부 문서는 현재 사용할 수 없습니다. 고객 서비스에 요청을 보내면 가능한 빨리 알려 드리겠습니다.
요청을 보내십시오.
요청을 보내십시오.
유효 성분:
DICLOFENAC SODIUM
제공처:
TEVA CANADA LIMITED
ATC 코드:
M01AB05
INN (국제 이름):
DICLOFENAC
복용량:
100MG
약제 형태:
SUPPOSITORY
구성:
DICLOFENAC SODIUM 100MG
관리 경로:
RECTAL
패키지 단위:
30
처방전 유형:
Prescription
치료 영역:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
제품 요약:
Active ingredient group (AIG) number: 0114417001; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2018-06-15
제품 특성 요약
Page 1 of 45
PRODUCT MONOGRAPH
Pr
TEVA-DICLOFENAC EC
Pr
TEVA-DICLOFENAC SR
Pr
TEVA-DICLOFENAC
(diclofenac sodium)
25 mg and 50 mg Enteric Coated Tablets, USP
75 mg and 100 mg Slow Release Tablets, Teva Standard
50 mg and 100 mg Suppositories, Teva Standard
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
August 15, 2016
Control no. 197101
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
4
CONTRAINDICATIONS
......................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................
6
ADVERSE REACTIONS
....................................................................................................
16
DRUG INTERACTIONS
.....................................................................................................
18
DOSAGE AND ADMINISTRATION
.................................................................................
22
OVERDOSAGE
...................................................................................................................
24
ACTION AND CLINICAL
PHARMACOLOGY................................................................
24
STORAGE AND STABILITY
.............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 27
PART II: SCIENTIFIC INFORMATION
...................................................................................
28
PHARMACEUTICAL INFORMATION
.......................................................................
전체 문서 읽기
