PAIN RELIEVER & SLEEP AID TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
30-09-2020
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有效成分:
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
可用日期:
APOTEX INC
ATC代码:
M01AE57
INN（国际名称）:
NAPROXEN AND DIPHENHYDRAMINE
剂量:
25MG; 220MG
药物剂型:
TABLET
组成:
DIPHENHYDRAMINE HYDROCHLORIDE 25MG; NAPROXEN SODIUM 220MG
给药途径:
ORAL
每包单位数:
100
处方类型:
OTC
治疗领域:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
產品總結:
Active ingredient group (AIG) number: 0257270001; AHFS:
授权状态:
APPROVED
授权日期:
2020-10-08
产品特点
Page 1 of 47
PRODUCT MONOGRAPH
PAIN RELIEVER & SLEEP AID
Naproxen Sodium 220 mg and Diphenhydramine Hydrochloride 25mg Tablets
Apotex Inc.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Preparation:
September 30, 2020
Control No. 230683
Page 2 of 47
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
SUMMARY PRODUCT INFORMATION
.................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................
3
WARNINGS AND PRECAUTIONS
...........................................................................................................
4
ADVERSE REACTIONS
.............................................................................................................................
7
DRUG INTERACTIONS
...........................................................................................................................
12
DOSAGE AND ADMINISTRATION
.......................................................................................................
14
OVERDOSAGE...........................................................................................................................................
15
ACTION AND CLINICAL
PHARMACOLOGY......................................................................................
15
STORAGE AND STABILITY
...................................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
18
PART II: SCIENTIFIC INFORMATION
.............................................................................................
20
PHARMACEUTICAL INFORMATION
........
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