Pevisone Cream

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ECONAZOLE NITRATE; TRIAMCINOLONE ACETONIDE

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

ECONAZOLE NITRATE; TRIAMCINOLONE ACETONIDE

Unit dalam pakej:

15 gm mcg/mL; 30gm mcg/mL; 15gm mcg/mL; 50gm mcg/mL; 30 gm mcg/mL; 50 gm mcg/mL

Dikeluarkan oleh:

JANSSEN PHARMACEUTICA N.V.

Risalah maklumat

PEVISONE
® CREAM
Econazole Nitrate/Triamcinolone Acetonide (10mg/1mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What PEVISONE
®
is used for
2.
How PEVISONE
®
works
3.
Before you use PEVISONE
®
4.
How to use PEVISONE
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of PEVISONE
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT PEVISONE
®
IS USED FOR
PEVISONE
®
is used for treatment of
fungal infections of the skin (problems
with itching and irritation).
HOW PEVISONE
®
WORKS
PEVISONE
®
is a combination product that
contains econazole nitrate (inhibits
proliferation of fungi) and triamcinolone
acetonide (a corticosteroid effective
against inflammation symptoms).
BEFORE YOU USE PEVISONE
®
-
_When you must not use it _
Do not use PEVISONE
®
:
•
if you are allergic (hypersensitive) to
econazole nitrate, triamcinolone
acetonide or to any of the other
ingredients in PEVISONE
®
.
•
if you suffer from rosacea (engorgement
and red skin on e.g. the nose) or skin
inflammations round the mouth (perioral
dermatitis).
•
if you have a certain type of skin disease
such as tuberculosis, varicella or herpes
simplex or other virus infections of the
skin.
•
on skin areas with a fresh vaccination
site.
-
_Before you start use it _
•
For external use only. Avoid getting
PEVISONE
®
in your eyes or mouth.
•
Discontinue treatment if you experience
reactions suggesting hypersensitivity or
chemical reaction.
•
You should avoid applying it to large
skin areas or damaged skin, use
occlusive skin dressings and prolonged
treatment since this could increase the
risk of adverse events.
•
Repeated and/or prolonged treatment
with corticosteroids (e.g. triamcinolone
acetonide) around the eyes can cause
cataracts (blurred vision), increased
pressure in the eyes or increased risk of
glaucoma (with symptoms such as
headache, nausea, visual impairment
and rainbow vision).
•
Prolonged external treatment with
corticosteroi

Ciri produk

PRODUCT NAME
PEVISONE
®
Cream
DOSAGE FORMS AND STRENGTHS
Cream. Each gram contains 10 mg econazole nitrate and 1 mg
triamcinolone acetonide.
For excipients, see
_List of Excipients_
.
PHARMACEUTICAL FORM
Soft white cream with faint odour.
CLINICAL INFORMATION
INDICATIONS
PEVISONE Cream in all its dosages is indicated for the treatment of
dermatomycoses
complicated by inflammatory and/or pruritic manifestations of skin
disorders.
DOSAGE AND ADMINISTRATION
DOSAGE
PEVISONE Cream should be applied to the affected area no more than 2
times daily, preferably
once in the morning and once in the evening. PEVISONE Cream should not
be applied with an
occlusive dressing, or to large skin areas of the body.
The duration of treatment with the PEVISONE Cream should be until the
inflammatory
symptoms subside but no longer than 2 weeks; after 2 weeks of therapy
with PEVISONE
Cream, continue therapy as needed with a preparation containing
econazole or econazole
nitrate alone.
ADMINISTRATION
Cream for topical application to the skin.
CONTRAINDICATIONS
PEVISONE Cream is contraindicated in individuals who have shown
hypersensitivity to any
of its ingredients.
Like any other dermatological preparation containing corticosteroids,
PEVISONE Cream is
contraindicated in specific skin conditions such as tuberculosis,
varicella, herpes simplex or other
viral infections of the skin, or fresh vaccination sites.
WARNINGS AND PRECAUTIONS
For external use only. PEVISONE Cream is not for ophthalmic or oral
use.
If a reaction suggesting hypersensitivity or chemical irritation
occurs, treatment should be
discontinued.
Corticosteroids applied to the skin can be absorbed in sufficient
amounts to produce systemic
effects, including adrenal suppression. Systemic absorption may be
increased by various factors
such as application over a large skin surface area, application to
damaged skin, application under
occlusive skin dressings and prolonged duration of therapy.
Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-indu