FUCIDIN Oral Suspension (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Fucidin 250 mg/5 ml Oral Suspension.
Qualitative and quantitative composition
Each 5 ml of Suspension contains 250 mg Fusidic Acid, Ph.Eur. (therapeutically equivalent to 175 mg Sodium Fusidate Ph.Eur.). Excipients with known effect: Glucose liquid 250 mg/1 ml suspension. Sorbitol ...
Pharmaceutical form
Suspension for oral administration. Cream coloured suspension with odour of banana.
Therapeutic indications
Fucidin is indicated in the treatment of all staphylococcal infections due to susceptible organisms such as: osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic ...
Posology and method of administration
Posology Each 5 ml of Fucidin Suspension is therapeutically equivalent to 175 mg of sodium fusidate owing to its lower oral bioavailability. Therefore the following dosages are recommended: Adults: 15 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use
Statins (HMG-CoA reductase inhibitors) and systemic Fucidin must not be co-administered. There have been reports of rhabdomyolysis (including fatalities) in patients receiving this combination (see section ...
Interaction with other medicinal products and other forms of interaction
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic Fucidin with statins. Co-administration of this combination may cause increased plasma concentrations ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited data (less than 300 pregnancy outcomes) from the use of fusidic acid in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to ...
Effects on ability to drive and use machines
Fucidin has no or negligible influence on the ability to drive or to 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. The most frequently reported undesirable effects of Fucidin ...
Overdose
Acute symptoms of overdose include gastrointestinal disturbances. Management should be directed towards alleviation of symptoms. Dialysis will not increase the clearance of fusidic acid. An overdose of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Steroid antibacterials ATC code: J01XC01 Fusidic acid and its salts are potent anti-staphylococcal agents with unusual ability to penetrate tissue. Bactericidal levels have been ...
Pharmacokinetic properties
Blood levels are cumulative, reaching concentrations of 50-100 mcg/ml after oral administration of 1.5 g daily for 3 to 4 days. Fucidin is excreted mainly in the bile, little or none being excreted in ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Acesulfame potassium Banana flavour Citric acid Disodium phosphate dihydrate Hydroxyethylcellulose Glucose liquid Methylcellulose Orange dry flavour Sodium benzoate (E211) Sorbitol (E420) Purified water ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Bottles of 50 ml.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK
Marketing authorization number(s)
PL 00043/5014R
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 November 1986 Date of latest renewal: 20 June 2003
Date of revision of the text
23 August 2018
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