Disuf Ointment 2% ww

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
23-10-2023
Ciri produk Ciri produk (SPC)
20-06-2018

Bahan aktif:

SODIUM FUSIDATE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

SODIUM FUSIDATE

Unit dalam pakej:

15gm mcg/mL

Dikeluarkan oleh:

HOVID BERHAD

Ciri produk

                                DESCRIPTION
Light yellow ointment.
COMPOSITION
Sodium fusidate (micronised) 2.0% w/w
PHARMACODYNAMICS
Fusidic acid is a steroidal 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.
PHARMACOKINETICS
_In vitro_ studies showed 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. Fusidic acid is excreted mainly in the bile with little
excreted in the urine.
INDICATIONS
DISUF
OINTMENT
is
indicated
for
the
treatment
of
skin
infections
caused
by
_staphylococci, _
_streptococci, _
_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.
CONTRAINDICATIONS
Infections caused by non-susceptible organisms. Patients with
hypersensitivity to any of the ingredients.
WARNINGS AND PRECAUTIONS
The sodium salt of fusidic acid has been shown to cause
conjunctival irritation.The ointment should not be used in or near
the eyes. Bacterial resistance has been reported to occur with
the use of fusidic acid applied topically. As with all topical
antibiotics, extended or recurrent application may increase the
risk of contact sensitization and the development of antibiotic
resistance.
PREGNANCY AND LACTATION
There is inadequate evidence of safety in human pregnancy.
Safety in nursing mothers has not been established.
MAIN SIDE / ADVERSE EFFECTS
Hypersensitivity reactions in the form of rashes and irritation
may occur after the topical administration of fusidates.
OVERDOSE
Not applicable.
DOSAGE AND ADMINISTRATION
For Topical Use
Apply 2
                                
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Dokumen dalam bahasa lain

Risalah maklumat Risalah maklumat Bahasa Melayu 23-10-2023

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