PBF FUSIDIC ACID CREAM 2% ww

국가: 말레이시아

언어: 영어

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

유효 성분:

FUSIDIC ACID

제공처:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (International Name):

FUSIDIC ACID

패키지 단위:

5 gm

Manufactured by:

PANION & BF BIOTECH INC.

환자 정보 전단

"PBF" FUSIDIC ACID CREAM 2% W/W
Fusidic acid (20mg) 1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What “PBF” Fusidic Acid Cream is used for
2. How “PBF” Fusidic Acid Cream works
3. Before you use “PBF” Fusidic Acid Cream
4. How to use “PBF” Fusidic Acid Cream
5. While you are using it
6. Side effects
7. Storage and Disposal of “PBF” Fusidic Acid
Cream
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT “PBF”
FUSIDIC ACID CREAM IS USED
FOR
It is used as topical treatment for skin condi-
tions such as scaly skin patches, crusty or
blisters, boils, septic wound, or inflammation
on
hair
follicles,
larger
swelling,
painful
bumps under skin in the hair root, skin infec-
tion around the fingernails or toenails caused
by bacterial infection such as staphylococcus
or
streptococcus,
Propionibacterium
acnes,
Corynebacterium
minutissimum,
and
other
bacteria.
Fusidic
acid
cream
is
an
invisible,
non-
staining
preparation,
which
is
cosmetically
acceptable for treatment of face and scalp
infections.
HOW “PBF”
FUSIDIC ACID CREAM WORKS
The
active
ingredient
in
this
medicine
is
fusidic
acid.
Fusidic
acid
is
a
type
of
antibiotic
which
has
powerful
antibacterial
action that work against a number of gram-
positive bacteria. Fusidic acid is metabolized
in the liver and the metabolites are excreted
with the bile.
BEFORE YOU USE “PBF”
FUSIDIC ACID CREAM
_- When you must not use it _
Do not use “PBF” Fusidic Acid
Cream
if:-

you are allergic to fusidic acid or any of the
other
ingredients
in
“PBF”
Fusidic
Acid
Cream.
_- Before you start to use it _
Talk to your doctor or pharmacist before us-
ing “PBF” Fusidic Acid Cream. This cream
should be applied with care when used near
the eyes and must not enter the eyes.
_Pregnancy and breastfeeding _
You
should
check
with
your
doctor
or
pharmacist if you are pregnant or think you
may
be
pregnant,
planning
to
become
pregnant or if you are breastfeeding.
“PBF” Fusidic Ac

제품 특성 요약

"PBF" FUSIDIC ACID CREAM 2% W/W
ACTIVE INGREDIENT:
Each gram of "PBF" Fusidic Acid Cream 2% w/w contains 20mg Fusidic
Acid.
PRESERVATIVE(S):
Potassium Sorbate
Butylated Hydroxyanisole
Tocopherol Acetate
EXCIPIENTS:
Cetyl Alhochol
Propylene Glycol
Polysorbate 60/ Tween 60
White Petrolatum
Hydroxyethylcellulose
Butylated Hydroxyanisole
Purified Water
Tocopherol Acetate (Vitamin E)
Potassium Sorbate
Liquid Parafin
PRODUCT DESCRIPTION:
"PBF" Fusidic Acid Cream 2% w/w is a white to off-white cream.
PHARMACODYNAMICS:
Fusidic Acid is an antibiotic with powerful antibacterial activity
against a number of gram-positive
organisms. Staphylococci, including the strains resistant to
penicillin or to other antibiotics, are
particularly susceptible to Fusidic Acid. Besides pronounced
antibacterial activity against the
majority of organisms responsible for skin infections, "PBF" Fusidic
Acid Cream 2% w/w also
possesses unique ability for penetration to the focus of infection,
even when applied to intact
skin.
PHARMACOKINETICS:
The absorption of topical applicated Fucidin is about 2%. Fucidin is
bound reversibly to plasma
proteins, the binding being about 95%. Fucidin is metabolized in the
liver and metabolites are
excreted with the bile.
INDICATIONS:
"PBF" Fusidic Acid Cream 2% w/w is indicated for treatment of skin
infections caused by
staphylococci, streptococci, Propionibacterium acnes, Corynebacterium
minutissimum, and
other organisms sensitive to fusidic acid. The most important
indications being:
Impetigo
Boils
Carbuncles
Paronychia
Infected wounds
Sycosis barbae
Hidradenitis
Erythrasma
Folliculitis
"PBF"
Fusidic Acid
Cream
2%
w/w
is
an
invisible,
non-staining
preparation,
which
is
cosmetically acceptable for treatment of face and scalp infections.
RECOMMENDED DOSE:
"PBF" Fusidic Acid Cream 2% w/w is applied to the affected area 2-3
times daily, generally for a
period of 7 days, except in treatment of acne where therapy should be
extended for a longer
period according to the nature of this disease.
ROUTE OF ADMINISTRATION: