NERISONE OINTMENT

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DIFLUCORTOLONE VALERATE

Disponible des:

GLAXOSMITHKLINE INC

Codi ATC:

D07AC06

Designació comuna internacional (DCI):

DIFLUCORTOLONE

Dosis:

0.1%

formulario farmacéutico:

OINTMENT

Composición:

DIFLUCORTOLONE VALERATE 0.1%

Vía de administración:

TOPICAL

Unidades en paquete:

30G

tipo de receta:

Prescription

Área terapéutica:

ANTI-INFLAMMATORY AGENTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2015-11-03

Fitxa tècnica

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_Page 1 of 20_
PRODUCT MONOGRAPH
PR
NERISONE
®
(DIFLUCORTOLONE VALERATE)
Cream 0.1% w/w
Oily Cream 0.1% w/w
Ointment 0.1% w/w
THERAPEUTIC CLASSIFICATION
TOPICAL CORTICOSTEROID
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.stiefel.ca
Date of Revision:
October 29, 2014
Submission Control No: 175615
_©2014 GlaxoSmithKline Inc., All Rights Reserved _
_®NERISONE is a trade mark of Bayer Schering Pharma
Aktiengesellschaft. _
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_Page 2 of 20_
TABLE OF CONTENTS
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PAGE
PART I: HEALTH PROFESSIONAL
INFORMATION................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
...............................................................................................
8
DRUG INTERACTIONS
...............................................................................................
8
DOSAGE AND ADMINISTRATION
...........................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 11
STORAGE AND STABILITY
.....................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 12
PART II: SCIENTIFIC INFORMATION
........................................................................
13
PHARMACEUTICAL INFORMATION
.....................................................................
13
REFERENCES
.............................................................................................................
16
PART III: CONSUMER INFORMATION
............