DYFAZINE CREAM 1%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SILVER SULPHADIAZINE

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

SILVER SULPHADIAZINE

Unit dalam pakej:

250 gm mcg/mL; 500 gm mcg/mL; 50 gm mcg/mL

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

DYFAZINE CREAM 1%
Silver Sulphadiazine (1% w/w)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Dyfazine Cream is used for
2.
How Dyfazine Cream works
3.
Before you used Dyfazine Cream
4.
How to use Dyfazine Cream
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Dyfazine
Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DYFAZINE CREAM IS USED FOR
Indicated for the treatment and
prevention of wound infection and
prevention of sepsis (life threatening
response to infection) in people with
second and third degree burns.
HOW DYFAZINE CREAM WORKS
Silver Sulphadiazine has broad
antimicrobial activity against bacteria,
yeast and fungi.
BEFORE YOU USE DYFAZINE CREAM
-
_When you must not use it _
Do not use Dyfazine Cream in:
1.
Premature and newborn
babies
(less than 2 months old).
2.
Pregnancy
_Pregnancy and lactation _
It should be applied only in cases where
the burnt area covers more than 20% of
the total body surface or if the benefit
of Dyfazine for the burnt individual is
greater than the possible risk to the
foetus. It is not known whether
Dyfazine Cream is found in human
milk, therefore caution should be
exercised when used by nursing
mothers.
Safety and effectiveness in children
have not been established. Ask your
doctor or pharmacists for advice before
using Dyfazine Cream.
-
_Before you start to use it _
Tell your doctor or pharmacist if you
have:
1.
Hypersensitivity to silver
sulphadiazine or other
sulfonamides.
2.
Inborn deficiency of Glucose-6-
Phosphate Dehydrogenase (G6PD)
enzyme.
3.
Liver or kidney impairment
-
_Taking other medicines _
Tell your doctor if you are taking
topical proteolytic enzymes and any
other medicines, including that you buy
without a prescription from a pharmacy,
supermarket or health food shop.
HOW TO USE DYFAZINE CREAM
-
_How much to use _
Application
The burn wounds should be cleaned and
the cream applied over all the affected
areas to a depth of 3 – 5 mm. This
applicat

Ciri produk

DYFAZINE CREAM 1%
MAL19950334AZ
DESCRIPTION:
CREAM
Colour
:
White
Fragrance
:
Natural
CONTENT:
Silver Sulphadiazine
.................................................. 1% w/w
Preservative: Chlorocresol ........................................
0.1% w/w
PHARMACODYNAMICS:
Silver Sulphadiazine has broad antimicrobial activity against
Gram-positive and Gram-negative bacteria including Pseudomonas
aeruginosa, yeasts, and fungi. It has also been reported to be active
in vitro against herpes virus and Treponema pallidum. Silver
Sulphadiazine has a bactericidal action: in contrast to Sulphadiazine,
the Silver salt acts primarily on the cell membrane and cell
wall and its action is not antagonised by p-aminobenzoic acid.
Resistance to Silver Sulphadiazine has been reported.
PHARMACOKINETICS:
Silver Sulphadiazine is slowly metabolised in contact with wound
exudates. Up to about 10% of the Sulphadiazine may be
absorbed; concentrations in blood of 10 to 20 mcg/mL have been
reported although higher concentrations may be achieved
when extensive areas of the body are treated. Probably not more than
1% of the Silver content is absorbed.
INDICATIONS:
Second and third degree burns: Treatment and prophylaxis of wound
infection and prophylaxis of sepsis in patients with second
and third degree burns.
APPLICATION:
The burn wounds should be cleaned and the cream applied over all the
affected areas to a depth of 3-5 mm. This application is
best achieved with a sterile gloved hand and/or sterile spatula. Where
necessary, the cream should be reapplied to any area
from which it has been removed by patient’s activity.
CONTRAINDICATIONS:
Premature and newborn infants (less than 2 months old) because of the
possibility of kernicterus.
It is also not recommended in pregnancy.
It should be applied only in cases where the burnt area covers more
than 20% of the total body surface or if the benefit of
Dyfazine for the burnt patient is greater than the possible risk to
the foetus.
Pediatric use: Safety and effectiveness in children have not been
e