Active substanceEthanolEthanol
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  • Dosage form: & nbspsolution for external use and preparation of dosage forms
    Composition:

    A mixture of alcohol and water, containing 95% of ethyl alcohol by volume.

    Description:

    Transparent, colorless, mobile, volatile liquid with a characteristic alcohol smell.

    Pharmacotherapeutic group:antiseptic
    ATX: & nbsp

    D.08.A.X.08   Ethanol

    Pharmacodynamics:

    Antimicrobial, with local application has an antiseptic effect (denaturing proteins of microorganisms). It is active against gram-positive and gram-negative bacteria and viruses. Antiseptic activity increases with increasing ethanol concentration. For disinfecting the skin, a 70% solution is used, which penetrates more deeply into the deeper layers of the epidermis than 95%, which has a tanning effect on the skin and mucous membranes.

    With systemic application it has the ability to cause analgesia and general anesthesia.The cells of the central nervous system are most sensitive to ethanol, especially the cells of the cerebral cortex, affecting, ethanol causes a characteristic alcoholic excitement associated with the weakening of the processes of inhibition. Then comes the weakening of the processes of excitation in the cortex, the inhibition of the spinal cord and the medulla oblongata with suppression of the activity of the respiratory center.

    It is a solvent for a number of drugs, as well as an extractant for a number of substances contained in medicinal plant raw materials.

    Pharmacokinetics:

    Ethanol metabolismruled in the liver nri isof participationeriment CYP2E1, indof which he is the director.

    Indications:

    Used as an antiseptic and disinfectant, treatment initial stages of diseases: furuncle, panaritium, mastitis; treatment of the hands of the surgeon (the methods of Fürbringer, Alfred), the operating field (including those with heightened sensitivity to other antiseptics, in children and operations on areas with thin skin in adults - neck, face).

    Also used for conservation of biological material, the manufacture of medicinal forms for external use, tinctures, extracts.

    Contraindications:

    Hypersensitivity.

    Carefully:

    Pregnancy, lactation, children's age.

    Pregnancy and lactation:

    Special studies of the use of the drug during pregnancy and during breastfeeding were not carried out. During pregnancy and during breastfeeding, they are used only if the intended benefit to the mother exceeds the potential risk to the fetus and the baby

    External application of the drug in pregnant women, women during lactation and children should be short and limited to small areas of the skin.

    In external application, ethanol is partially absorbed through the skin and mucous membranes, and may have a resorptive general toxic effect (central nervous system depression), which should be taken into account when it is used in children. Data on the teratogenic effect are absent.

    Dosing and Administration:

    Outer in the form of lotions. To process the surgical field and pre-surgical disinfection of the hands of the surgeon, 70% solution is used, it is recommended to use a 40% solution for compresses and wipes (to avoid burns).95% solution must be diluted to the required concentrations and used according to indications.

    Drugs made on the basis of ethanol are used in accordance with the instructions for the medical use of these dosage forms.

    Side effects:

    Allergic reactions, skin burns, redness and soreness of the skin in the place of compresses.

    When applied externally, it is partially absorbed through the skin and mucous membranes and can exert a resorptive (general toxic) action (central nervous system depression).

    Overdose:When topical application in the recommended dose, the symptoms of an overdose were not noted.
    Interaction:

    At simultaneous application strengthens action of the preparations having oppressing influence on the central nervous system, cardiovascular system, the respiratory center.

    When ingested with drugs that have an inhibitory effect on the enzyme aldehyde dehydrogenase (which is involved in the metabolism of ethyl alcohol), the concentration of the metabolite of ethanol - acetaldehyde, causing blood flushes to the face, nausea, vomiting, general malaise, tachycardia, lowering blood pressure, increases.

    It is a solvent for a number of medicinal products, as well as an extractant for a number of substances contained in medicinal plant raw materials.

    Special instructions:

    Ethanol for external use is partially absorbed through the skin and mucous membranes, which should be taken into account when it is used in children and when driving a vehicle.

    Ethyl alcohol in a large container can be used for the preparation of dosage forms.

    Effect on the ability to drive transp. cf. and fur:

    Ethanol for external use is partially absorbed through the skin and mucous membranes, which should be taken into account when using it in the management of vehicles and other mechanisms.

    Form release / dosage:Solution for external use and preparation of medicinal forms, 95%.
    Packaging:

    For 50 or 100 ml in glass bottles with a screw neck of orange glass or in glass bottles with a screw neck of orange or colorless glass, sealed with aluminum caps with perforations or plastic caps screwed on.

    Vials are labeled with label paper or writing paper or self-adhesive labels.

    Each bottle, along with the instruction for use, is placed in a pack of cardboard for consumer packaging or paperboard chrome-ersatz coated or chrome-ersatz coated chalk.

    For 40 bottles of 100 ml or 70 bottles of 50 ml bottles with an equal number of instructions for use are placed in a box of cardboard or cardboard chrome-ersatz coated or chrome-ersatz coated chalk (for hospitals).

    For 40 bottles of 100 ml or 70 bottles of 50 ml bottles with an equal number of instructions for use are placed in a box of cardboard or cardboard chrome-ersatz coated or chromium-ersatz coated chalk (for the production departments of pharmacies).

    On the box (for hospitals), (for production departments of pharmacies) paste a label from paper label or writing or self-adhesive labels.

    By 1, 3, 5, 10, 21.5, 31.5 liters in polyethylene cans of low-density polyethylene (for hospitals).

    By 1, 3, 5, 10, 21,5, 31,5 l in polyethylene jerricans from low pressure polyethylene (for production departments of drugstores).

    On a canister (for hospitals), (for production departments of pharmacies) paste a label from paper label or writing or self-adhesive labels.

    On the canister (for hospitals), (for production departments of pharmacies) glue the instructions for use from paper label or writing or self-adhesive.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C, in a well-ukuporennoy container, away from fire.

    In a place inaccessible to children.

    Shelf life:

    5 years.

    Do not use after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002430
    Date of registration:16.01.2012
    The owner of the registration certificate:CONSTANTA-PHARM M, LLC CONSTANTA-PHARM M, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.10.2015
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