Medicinal Products

FUSIDIC ACID BGR 2%

Generic drug Fucidine
Therapeutic class: Dermatology
Active ingredients: Fusidic acid
laboratory: Biogaran

Cream
15 g tube
All forms

Indication

Short-term treatment of the following superficial skin infections:

· Impetigo and impetigo dermatoses:

o in local treatment only in localized forms with small number of lesions,

o as an additional local treatment in combination with general antibiotic therapy adapted to the most extensive forms,

· Disinfection of cutaneomucous microbial deposits, in healthy carriers of staphylococci and after staphylococcal disease, including furunculosis.

See section 5.1 Pharmacodynamic properties for important information on clinical activity on different types of fucidic acid-sensitive microorganisms.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage FATTY ACID BGR 2% cream tube 15 g

Short-term treatment of the following superficial skin infections:

· Impetigo and impetigo dermatoses:

o in local treatment only in localized forms with small number of lesions,

o as an additional local treatment in combination with general antibiotic therapy adapted to the most extensive forms,

· Disinfection of cutaneomucous microbial deposits, in healthy carriers of staphylococci and after staphylococcal disease, including furunculosis.

See section 5.1 Pharmacodynamic properties for important information on clinical activity on different types of fucidic acid-sensitive microorganisms.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Against indications

Known hypersensitivity to fusidic acid or to any of the excipients.

Adverse effects Fusidic acid Bgr

Adverse reactions are classified by organ system class and frequency using the following convention: Very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000) <1/100), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000), not known (can not be estimated based on available data).

Skin and subcutaneous tissue disorders:

· Undetermined frequency: contact dermatitis, eczema.

Possibility of selection of strains resistant to the antibiotic used locally, which is detrimental to the oral use (later) of the same antibiotic. Nevertheless, most often, resistant strains in vivo become sensitive again after a short latency period.

Given the percutaneous absorption of the product, the treatment should not be used for more than one week or be applied to large areas, especially in infants (due to immature liver function), because possibility of hepatic side effects can not be totally ruled out.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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