Universal reference book for medicines
Product name: BATRAFEN ® (BATRAFEN ® )

Active substance: ciclopirox

Type: Antifungal medication for external use

Manufacturer: SANOFI-AVENTIS DEUTSCHLAND (Germany)
Composition, form of production and packaging
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Nail polish is 8% transparent.
1 g

cyclopyrox 80 mg

Excipients: copolymer of butylhydromaleate and methoxyethylene (50% solution in isopropanol), ethyl acetate, isopropanol.

3 g - vials of colorless glass (1) with a cover-brush - packs of cardboard.

6 g - vials of colorless glass (1) with a cover-brush - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Antifungal preparation of a wide spectrum of action.
It is active against Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum , Trichophyton tonsurans, Trichophyton quinckeanum, Trichophyton equinum, Trichophyton concentricum, Trichophyton epilans, Trichophyton ferrugineum, Trichophyton gallnae, Trichophyton Schoenleinii, Trichophyton soudanense, Trichophyton terrestre, Trichophyton violaceum, Microsporum canis, Microsporum gypseum , Microsporum audouinii, Microsporum langeroni, Microsporum nanum, Epidermophyton floccosum, Candida (Candida albicans, Candida tropicals, Candida krusei, Candida parapsilosis, Candida pseudotropicalis, Candida lipolytica, Candida quiliermondii, Candida brumpti, Candida utilis, Candida viswanathii), Cryptococcus neiformans, Histoplasma capsulatum, Sporotrichum schenkii, Torulopsis glabrata, Blastomyces dermatitidis, Paracoccidioides brasiliensis, Saccharomyces cerevisiae, Torula Bergeri, Aspergillus fumigalus, Aspergillus flavus, Aspergillus niger, Penicillium chrysogenum, P enicillium notatum, Absidia corymbifera, Mucor miehei, Paccilomyces varioti, Fusarium solani, Madurella grisca, Madurella mycetomi, Allescheria boydii, Cladosporium carrionii, Cladosporium trichoides, Philophora jeanselmei, Philophora pedrosoi, Philophora gougeroti, Hormodendrum dermatitidis, Pyrenochaeta romeroi, Leptosphacria senegalensis. The antifungal effect of cyclopyrox is based on inhibiting the entry into the cell and inducing the removal from the cell of the components necessary for its life. Has antibacterial action against Gram-positive and most Gram-negative pathogens. Suppress the development of mycoplasmas and trichomonads.
PHARMACOKINETICS

The values ​​of fungicidal concentrations in one-day application exceed the maximum plasma concentration by 20-30 times (maximum plasma concentration for dermatophytes, fungi of the genus Candida, mold and yeast-like fungi - 0.98-3.9 μg / ml, maximum plasma concentration for mycoplasma and Trichomonas

vaginalis - 7.8-31.3 μg / ml).

INDICATIONS

- fungal diseases of the nails.

DOSING MODE

Outwardly.
Before the first application of the drug Batrafen ® , nail polish, the maximum possible amount of the affected nail should be removed with scissors and the remaining nail plate should be sawed to create an uneven surface. The varnish is applied a thin layer on the affected nail once a day during the first month, during the second - 2 times a week, during the third - once a week. Once a week (for example, on Sunday), the varnish is removed with a conventional solvent or after a warm bath is scraped off, with the scissors again removing the growing affected part of the nail plate. If the varnish is damaged during the period between the application of varnish, then it is necessary to apply the varnish again only to those parts of the nail where the varnish is damaged.
The duration of treatment depends on the severity of the fungus nail plate, but the treatment period should not exceed 6 months.

SIDE EFFECT

Local reactions (rarely): itching, burning or irritation of the skin, flushing and flaking of the skin near the affected nail;
allergic reactions.
CONTRAINDICATIONS

- hypersensitivity to the components of the drug;

- In the absence of clinical experience, the use of Batrafen ® , nail polish, in children under 10 years old, as well as in women during pregnancy and lactation, is not shown.

PREGNANCY AND LACTATION

In the absence of clinical experience, the use of the drug during pregnancy and lactation is contraindicated.

APPLICATION FOR CHILDREN

In the absence of clinical experience, the use of the drug in children under 10 years is contraindicated.

SPECIAL INSTRUCTIONS

To prevent varnish drying, close the lid tightly after use.
To prevent the lid from sticking, avoid hitting the varnish on the thread. After opening the bottle, the drug can be used for 6 months under the storage conditions.
During treatment, it is not recommended to use cosmetic nail polish.
With prolonged external use of the drug sensitization phenomena are possible.
TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
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