Disuf-B Cream

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
13-09-2023
Ciri produk Ciri produk (SPC)
15-11-2021

Bahan aktif:

BETAMETHASONE VALERATE; FUSIDIC ACID

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

BETAMETHASONE VALERATE; FUSIDIC ACID

Unit dalam pakej:

15gm mcg/mL

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DISUF-B CREAM
Fusidic Acid / Betamethasone valerate (2.0% w/w / 0.1% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Disuf-B Cream is used for
2.
How Disuf-B Cream works
3.
Before you use Disuf-B Cream
4.
How to use Disuf-B Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Disuf-
B Cream
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT DISUF-B CREAM IS USED FOR
Disuf-B Cream is used to treat
bacterial
skin
infection
and
inflammation.
HOW DISUF-B CREAM WORKS
Disuf-B
Cream
contains
two
active
ingredients
which
are
fusidic
acid,
an
antibiotic
and
betamethasone
valerate
from
steroid group.
Fusidic acid works by killing the
bacteria that cause infections and
betamethasone help to reduce any
swelling, redness or itchiness of
your skin.
BEFORE YOU USE DISUF-B CREAM
_-_
_ _
_ When you must not use it _
Do not use this medicine if:
•
You
are
allergic
(hypersensitive) to fusidic acid
or
betamethasone
valerate
or
any
other
ingredients
of
this
medicine
(listed
in
Product
Description).
•
You have red spotty rash around
your mouth or chin.
•
You have viral or fungal skin
infection.
•
You have acne-like breakouts
on face.
•
You
have
tuberculosis
of
the
skin (skin infection).
•
You have skin ulceration.
_-_
_ _
_Before you start to use it _
_Pregnancy and lactation _
•
Please consult your doctor or
pharmacist if you are pregnant,
planning
for
pregnancy
or
breast-feeding before using any
medicine.
•
Disuf-B
must
only
be
used
during pregnancy if the benefits
is more than the risks to the
fetus. However, topical steroid
should not be used extensively
in pregnancy.
_-_
_ _
_Taking other medicines _
•
Tell your doctor or pharmacist if
you
are
taking
any
other
medicines,
including
any
that
you buy without a prescription
from a pharmacy, supermarket
or health food shop.
HOW TO USE DISUF-B CREAM
_-_
_ _
_How much to use _
•
Wash
your
hands
before
and
after using this cream
•
Apply sparingly to the affe
                                
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Ciri produk

                                DESCRIPTION
White, opaque cream
COMPOSITION
Fusidic Acid (Micronised)
2.0% w/w
Betamethasone valerate equivalent to Betamethasone
0.1% w/w
ACTIONS AND PHARMACOLOGY
Fusidic acid is an antibiotic with a bacteriostatic or bactericidal
activity, mainly against Gram positive bacteria. Fusidic acid inhibits
bacterial protein synthesis although, in contrast to drugs such as the
macrolides or tetracyclines, it does not bind to the bacterial
ribosomes, but inhibits a factor necessary for translocation of
peptide subunits and elongation of the peptide chain. Betamethasone
valerate is a topical steroid with rapid effect in inflammatory
dermatoses. Even refractory conditions can often be treated
successfully.
PHARMACOKINETICS
_In vitro_ studies show that fusidic acid can penetrate intact human
skin. The degree of penetration depends on factors such as the
duration of exposure to fusidic acid and the condition of the skin.
Betamethasone can be absorbed when given locally.
INDICATIONS
Disuf-B Cream is indicated in inflammatory dermatoses where bacterial
infection is present or likely to occur. Inflammatory
dermatoses include atopic eczema, discoid eczema, stasis eczema,
seborrhoeic dermatitis, contact dermatitis, lichen simplex
chronicus, psoriasis, discoid lupus erythematosus.
CONTRAINDICATIONS
•
Topical corticosteroids are contraindicated in viral, tuberculous and
fungal skin infections, perioral dermatitis, acne rosacea and
ulcerative condition.
•
Patients with hypersensitivity to any of the ingredients.
WARNING / PRECAUTIONS
•
Long term continuous should be avoided.
•
Caution should be exercised when the product is used near the eye,
since topical steroid may cause glaucoma if the preparation
gets into the eye.
•
Steroid antibiotic combination should not be used for more than 7 days
in the absence of any clinical improvement.
PREGNANCY AND LACTATION
Topical steroids should not be used extensively in pregnancy as fetal
abnormalities have been observed in animals due to systemic
absorption.
DISUF-B CREAM
523
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