NERISONE OILY CREAM

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
26-01-2017

유효 성분:

DIFLUCORTOLONE VALERATE

제공처:

GLAXOSMITHKLINE INC

ATC 코드:

D07AC06

INN (국제 이름):

DIFLUCORTOLONE

복용량:

0.1%

약제 형태:

CREAM

구성:

DIFLUCORTOLONE VALERATE 0.1%

관리 경로:

TOPICAL

패키지 단위:

3G/30G/60G

처방전 유형:

Prescription

치료 영역:

ANTI-INFLAMMATORY AGENTS

제품 요약:

Active ingredient group (AIG) number: 0115864001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2016-09-30

제품 특성 요약

                                _ _
_Page 1 of 19_
PRODUCT MONOGRAPH
PR
NERISONE
®
(DIFLUCORTOLONE VALERATE)
Oily Cream 0.1% w/w
GSK Standard
Topical Corticosteroid
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
January 26, 2017
Submission Control No: 200095
_©2017 GSK Inc., All Rights Reserved _
_NERISONE is a trademark of Bayer Schering Pharma Aktiengesellschaft,
used under license by GSK Inc. _
_ _
_ _
_Page 2 of 19_
TABLE OF CONTENTS
_ _
_ _
PAGE
PART I: HEALTH PROFESSIONAL
INFORMATION................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
...............................................................................................
8
DRUG INTERACTIONS
...............................................................................................
8
DOSAGE AND ADMINISTRATION
...........................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 10
STORAGE AND STABILITY
.....................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 11
PART II: SCIENTIFIC INFORMATION
........................................................................
13
PHARMACEUTICAL INFORMATION
.....................................................................
13
REFERENCES
.............................................................................................................
16
PART III: CONSUMER INFORMATION
......................................................................
17
_ _

                                
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