FUSIDIC ACID Cream (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Fusidic acid 20 mg/g cream.
Qualitative and quantitative composition
Each gram contains 20 mg fusidic acid. Excipient(s) with known effect: Butylhydroxyanisole 0.04 mg/gram, Cetyl alcohol 111.00 mg/gram and Potassium sorbate 2.70 mg/gram. For the full list of excipients, ...
Pharmaceutical form
Cream. White, homogenous cream.
Therapeutic indications
Treatment of non-severe, superficial, non-extensive, primary skin infections caused by microorganisms that are sensitive to fusidic acid, especially of infections caused by Staphylococcus (see section ...
Posology and method of administration
Posology Adults and children Uncovered lesions: apply gently three or four times daily. Covered lesions: less frequent applications may be adequate. Method of administration Cutaneous use.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance. Fusidic acid ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical fusidic acid 20mg/g cream can be used during pregnancy. ...
Effects on ability to drive and use machines
Fusidic acid 20mg/g cream has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting. Based on pooled data from clinical studies including 4754 ...
Overdose
Overdose is unlikely. Unless hypersensitivity to fusidic acid or any of the excipients exist, accidental ingestion of Fusidic acid 20mg/g cream is unlikely to cause any harm. The total quantity of fusidic ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antibiotics for topical use ATC code: D06AX01 Mechanism of action Fusidic acid belongs to a unique group of antibiotics, the fusidanes, which act to inhibit bacterial protein ...
Pharmacokinetic properties
Absorption 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 ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Butylhydroxyanisole (E320) Cetyl alcohol Glycerol 85% (E422) Liquid paraffin Potassium sorbate (E202) Polysorbate 60 (E435) White soft paraffin Hydrochloric acid for pH adjustment Purified water
Incompatibilities
Not applicable.
Shelf life
Unopened tube: 2 years. After opening of the tube: 4 weeks.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Aluminium tube with HDPE screw cap. Pack sizes: 15 gram and 30 gram. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom
Marketing authorization number(s)
PL 20046/0256
Date of first authorization / renewal of the authorization
20/01/2012 / 01/12/2015
Date of revision of the text
22/02/2018
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