FUCIDIN OINTMENT

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

SODIUM FUSIDATE

Disponible depuis:

DEXCEL LTD, ISRAEL

Code ATC:

D06AX

forme pharmaceutique:

OINTMENT

Composition:

SODIUM FUSIDATE 20 MG/G

Mode d'administration:

DERMAL

Type d'ordonnance:

Required

Fabriqué par:

LEO LABORATORIES LTD., IRELAND

Groupe thérapeutique:

OTHER ANTIBIOTICS FOR TOPICAL USE

indications thérapeutiques:

Local treatment of skin infections due to sensitive strains of staphylococcuos aureus

Date de l'autorisation:

2022-03-31

Résumé des caractéristiques du produit

FUCIDIN CREAM
FUCIDIN OINTMENT
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fucidin cream
Fucidin ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fucidin cream
Each gram of cream contains 20 mg fusidic acid.
Excipients with known effect: Contains Butylhydroxyanisole 0.04 mg/g,
Potassium Sorbate 2.7 mg/g and cetyl alcohol 111 mg/g.
For a full list of excipients, see section 6.1.
Fucidin ointment
Each gram of ointment contains: 20 mg sodium fusidate.
Excipients with known effect: Contains cetyl alcohol 4 mg/g, wool fat
(lanolin) 46 mg/g and butylhydroxytoluene
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Fucidin cream
Cream
A white cream.
Fucidin ointment
Ointment
Translucent, yellowish to white ointment
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local treatment of skin infections due to sensitive strains of
staphylococcus aureus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply three to four times daily or as required.
Less frequent application may be adequate for covered lesions.
Method of administration
Cutaneous use
4.3 CONTRAINDICATIONS
Known hypersensitivity to fusidic acid/sodium fusidate or to any of
the
excipients listed in section 6.1.
4.4 SPECIALS WARNINGS AND PRECAUTIONS FOR USE
1
Bacterial resistance among _Staphylococcus aureus_ has been reported
to
occur with the use of topical Fucidin
®
. As with all antibiotics, extended or
recurrent use of fusidic acid may increase the risk of developing
antibiotic
resistance.
Fucidin cream
Fucidin cream contains butylhydroxyanisole, potassium sorbate and
cetyl
alcohol. These excipients may cause local skin reactions (e.g. contact
dermatitis). In addition, butylhydroxyanisole may also cause
irritation to
the eyes and the mucous membranes. Fucidin
®
Cream should therefore be
used with care when applied in the proximity of the eyes.
_ _
Fucidin ointment
Fucidin
®
ointment contains cetyl alcohol and wool fat (lanolin). These
excipients may cause local skin reactions (e.g. contact dermatitis).
Fucidi