Active substancePovidone-iodinePovidone-iodine
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  • Dosage form: & nbspsolution for local and external use
    Composition:

    1 ml of the solution contains:

    active substance: Povidone-iodine 0.1 g;

    Excipients: glycerol, nonoxynol-9, citric acid, anhydrous, disodium hydrogenphosphate, sodium hydroxide 10% solution (w / v) for pH adjustment, purified water.

    Description:

    The solution is dark brown in color, free of suspended or sedimented particles.

    Pharmacotherapeutic group:Antiseptic
    ATX: & nbsp

    D.08.A.G.02   Povidone-iodine

    Pharmacodynamics:

    Antiseptic and disinfectant. When released from the complex with polyvinylpyrrolidone in contact with skin and mucous membranes, iodine forms with the proteins of the cells of iodine bacteria, coagulates them and causes the death of microorganisms. Has a rapid bactericidal effect on Gram-positive and Gram-negative bacteria (with the exception of M.tuberculosis). Effective against fungi, viruses, protozoa.

    Pharmacokinetics:

    With topical application, there is almost no reabsorption of iodine.

    Indications:

    - Treatment and prevention of wound infections in surgery, traumatology, combustiology, dentistry;

    - treatment of bacterial, fungal and viral skin infections, prevention of superinfection in dermatological practice;

    - treatment of pressure ulcers, trophic ulcers, diabetic foot;

    - disinfection of the skin and mucous patients in preparation for surgical interventions, invasive examinations (puncture, biopsy, injection, etc);

    - disinfection of the skin around drains, catheters, probes;

    - disinfection of the oral cavity during dental operations;

    - disinfection of the birth canal, with "small" gynecological surgeries (artificial termination of pregnancy, introduction of an intrauterine device (IUD), coagulation of erosion and polyp, etc.).

    Contraindications:

    - Hypersensitivity to iodine and other constituents of the drug;

    - thyroid dysfunction (hyperthyroidism) (see section "Special instructions");

    - adenoma of the thyroid gland;

    - herpetiform dermatitis of Dühring;

    - simultaneous application of radioactive iodine;

    - premature and newborn children.
    Carefully:

    Pregnancy and the period of breastfeeding, chronic renal failure.

    Application of Betadine® It is not recommended from the 3rd month of pregnancy and during lactation. If necessary, in these cases, treatment is possible under individual medical supervision.

    Dosing and Administration:

    For the treatment of skin and mucous membranes, they are used undiluted for lubrication, washing, or as a moist compress. For use in drainage systems, a 10% solution is diluted 10 to 100 times. The solution is prepared immediately before use, dilute solutions are not stored.

    Side effects:

    With frequent application on a large area of ​​the wound surface and mucous membranes, systemic reabsorption of iodine can occur, which can affect the tests of thyroid functional activity.

    Reactions of hypersensitivity to the drug, possibly allergic reaction (hyperemia, burning, itching, swelling, pain), which requires withdrawal of the drug.

    Interaction:

    Incompatible with other disinfectant and antiseptic agents, especially containing alkalis, enzymes and mercury.

    In the presence of blood, the bactericidal effect may decrease, but with an increase in the concentration of the solution, the bactericidal activity may be increased.

    Special instructions:

    In cases of thyroid dysfunction, the use of the drug is possible only under the strict supervision of a physician.

    The use of the drug in newborn babies is possible only if necessary, after examining the function of the thyroid gland.

    Care should be taken with regular application on damaged skin in patients with chronic renal failure.

    It should be ensured that there is no excess solution left under the patient.

    Do not heat before use.

    At the application site, a colored film is formed that persists until the release of the entire amount of active iodine, which means the drug ceases to function.

    Coloring on the skin and tissues is easily washed off with water.

    Do not use when biting insects, domestic and wild animals.

    Form release / dosage:

    Solution for local and external use, 10%.

    Packaging:

    For 30, 120 and 1000 ml of the drug in a bottle of green polyethylene, equipped with a dropper of colorless polyethylene and a screw cap made of white propylene with control of the first opening.

    Vials of 30 ml and 120 ml are placed in a cardboard box together with instructions for use.

    On a bottle of 1000 ml, two labels are glued and an instruction is attached, the bottle is not inserted into the cardboard bundle.

    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the product after the expiration date indicated on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N015282 / 03
    Date of registration:18.09.2008 / 25.08.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Egis Pharmaceutical Plant OJSCEgis Pharmaceutical Plant OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp24.01.2017
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