NERISONE OILY CREAM
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
26-01-2017
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Aktiva substanser:
DIFLUCORTOLONE VALERATE
Tillgänglig från:
GLAXOSMITHKLINE INC
ATC-kod:
D07AC06
INN (International namn):
DIFLUCORTOLONE
Dos:
0.1%
Läkemedelsform:
CREAM
Sammansättning:
DIFLUCORTOLONE VALERATE 0.1%
Administreringssätt:
TOPICAL
Enheter i paketet:
3G/30G/60G
Receptbelagda typ:
Prescription
Terapiområde:
ANTI-INFLAMMATORY AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0115864001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2016-09-30
Produktens egenskaper
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_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. _
_ _
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_Page 2 of 19_
TABLE OF CONTENTS
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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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