Active substanceCyclopyroxCyclopyrox
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  • Dosage form: & nbspnail polish
    Composition:

    Composition per 1 g of the preparation:

    Active substance: cyclopyrox - 80 mg.

    Excipients: butilgidromaleata and metokietilena copolymer (50% solution in isopropanol), ethyl acetate, isopropanol.

    Description:

    Clear nail polish.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    D.01.A.E   Other antifungal agents for external use

    D.01.A.E.14   Cyclopyrox

    Pharmacodynamics:

    Antifungal preparation of a wide spectrum of action. Active against: Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton tonsurans, Trichophyton quinckeanum, Trichophyton equinum, Trichophyton concentricum, Trichophyton epiians, Trichophyton ferrugineum, Trichophyton gallnae, Trichophyton Schoenleinii, Trichophyton soudanense, Trichophyton terrestre, Trichophyton violaceuni, 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, Sporolrichum schenkii, Torulopsis glabrata, Blastomyces dermatitidis, Paracoccidioides brasiliensis, Saccharomyces ccrcvisiae, Torula Bergeri, Aspergillus fumigalus, Aspergillus flavus, Aspergillus niqer, Penicillium chrysogenum, Penicillium notatum, Absidia corymbifera, Mucor miehei, Paccilomyces varioti, Fusarium solani, Madurella grisca, Madurella mycetomi, Allescheria boydii, Cladosporium carrionii, Cladosporium trichoides, Philophora jeanselmei, Philophora pedrosoi, Philophora gougcroti, Hormodendrum dermatitidis, Pyrenochacta 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 vital activity.It has an antibacterial effect against gram-positive and most Gram-negative pathogens.

    Suppress the development of mycoplasmas and trichomonads.

    Pharmacokinetics:

    Values ​​fungicidal concentrations at one-day application exceed the maximum plasma concentration by 20-30 times (the maximum plasma concentration for dermatophytes, fungi of the genus Candida, molds and yeasts - 0.98 - 3.9 g / ml, the maximum plasma concentration for mycoplasma and Trichomonas vaginalis - 7.8-31.3 μg / ml).

    Indications:

    Fungal diseases of the nails.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Due to the lack of clinical experience with the drug Batrafen®, nail polish, children up to 10 years and in women during pregnancy and breastfeeding, not shown.

    Dosing and Administration:

    Outwardly. Before the first application Batrafen® preparation, nail polish should be removed with scissors maximum possible number of affected nail and nail file nadpilit remainder nail plate to create an uneven surface. Varnish applied in a thin layer to the affected nail 1 times a day during the first month, in the second - 2 times a week, during the third - 1 weekly.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 effects:

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

    Special instructions:

    To prevent varnish drying, close the lid tightly after use. To prevent the lid from adhering, avoid varnish getting 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.

    Form release / dosage:

    Nail polish 8%.

    Packaging:

    3 g or 6 g of the drug in a glass (type III), colorless transparent bottle, equipped with a screw cap with a brush for applying varnish. 1 bottle with instructions for use in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N014937 / 02
    Date of registration:24.03.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:Sanofi-Aventis Deutschland GmbHSanofi-Aventis Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp21.01.2017
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