TEVA-DICLOFENAC SUPPOSITORY
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
22-08-2016
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有效成分:
DICLOFENAC SODIUM
可用日期:
TEVA CANADA LIMITED
ATC代码:
M01AB05
INN（国际名称）:
DICLOFENAC
剂量:
100MG
药物剂型:
SUPPOSITORY
组成:
DICLOFENAC SODIUM 100MG
给药途径:
RECTAL
每包单位数:
30
处方类型:
Prescription
治疗领域:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
產品總結:
Active ingredient group (AIG) number: 0114417001; AHFS:
授权状态:
CANCELLED POST MARKET
授权日期:
2018-06-15
产品特点
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
.......................................................................
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