Active substancePolyhexanidePolyhexanide
Similar drugsTo uncover
  • Lavasept
    concentrate locally externally 
    B. Brown Medical AG     Germany
  • Dosage form: & nbspconcentrate for solution preparation for external and local use
    Composition:

    100 ml of the preparation contain:

    Active substance:

    Polyhexanide

    20.00 g

    (Polyhexanide 20% solution)

    97.98-103.19 g

    Excipients:

    Macrogol-4000

    1.00 g

    Hydrochloric acid 1 M solution

    0-1 ml

    Water for injections

    up to 100 ml

    pH

    5,0-7,0

    Description:Colorless transparent solution odorless.
    Pharmacotherapeutic group:Antiseptic
    ATX: & nbsp

    D.08.A.C   Biguanides and amidines

    D.08.A. C.05   Polyhexanide

    Pharmacodynamics:

    The active substance of the drug - polyhexanide (polyhexamethylene-biguanide hydrochloride) - is a polymeric derivative of biguanide. The bactericidal effect of the drug is due to the nonspecific affinity of polyhexanide against bacterial acid phospholipids, which leads to an increase in the permeability of cell membranes and the death of microorganisms.

    Polyhexanide has a wide spectrum of action: it is active both against fungi and bacteria such as Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae etc. In the presence of blood and a purulent discharge, the bactericidal and fungicidal effect weakens slightly.

    Pharmacokinetics:

    With local and external application is almost not absorbed.

    Indications:

    Treatment of infected wounds and superficial soft tissue damage.

    Washing of cavities of deep wounds of soft and hard tissues, including using drainage, intra-articular cavities.

    Treatment of burns and frostbites.

    Irrigation of the operating field in case of infection, in reconstructive operations, incl. at the transplantation of bone tissue, with arthroplasty of joints.

    Washing implants.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Operations on the brain, eyes, middle and inner ear.

    Washing of uninfected joints and cartilage.

    Washing of the abdominal and pleural cavities.

    Pregnancy, the period of breastfeeding.

    Children's age (up to 18 years).

    Carefully:

    At operations on intact cartilage tissues.

    Dosing and Administration:

    Outer and local. Lavasept can only be used diluted in a concentration of 0.1% or 0.2%.

    Preparation of 0.1% Lavasept solution (0.02% polyhexanide solution)

    To 1000 ml Ringer's solution without lactate or 0.9% solution of sodium chloride with a syringe add 1.0 ml of concentrate.

    Preparation of 0.2% Lavasept solution (0.04% polyhexanide solution)

    To 1000 ml of Ringer's solution without lactate or 0.9% solution of sodium chloride with syringe add 2.0 ml of concentrate.

    2 methods of preparation of a solution from a concentrate:

    - the required amount of concentrate with a sterile syringe is introduced into a container with a sterile solvent and mixed;

    - the necessary amount of concentrate is mixed with the solvent, poured into suitable containers and sterilized (at 121 ° C for 15 min).

    Divorced Lavasept is used for washing wounds, including using drainage, and also in the form of gauze napkins, richly moistened with a solution.

    At the beginning of treatment of superficial purulent wounds infected with gram-negative microflora, 0.2% Lavasept solution is usually used. For the subsequent treatment of wounds, their active washing, a 0.1% solution of the preparation is used.

    Duration of application

    Restrictions on the duration of use of the drug is not revealed.

    Side effects:

    Allergic reactions (hives, skin rashes), anaphylactic shock are possible.

    Overdose:

    Long-term use of Lavasept in very large quantities can cause systemic absorption of polyhexanide, which can cause generalized exanthema and fever. Symptoms disappear after removing the drug.

    Interaction:

    Drug interactions with other drugs are not known.

    The simultaneous use of Lavasept and other anionic agents may impair the antimicrobial activity of the drug.

    Special instructions:

    Lavasept is used only in a diluted form!

    The product is intended for external and local use only!

    Lavasept, like other antiseptics, in an experiment on animals, inhibited the growth of the cartilaginous tissue of embryos. With prolonged use, the drug may also damage intact cartilage. If the product gets on the damaged cartilage, the wound should be washed with Ringer's solution without lactate or with 0.9% sodium chloride solution. In case of accidental contact with the concentrate in the eyes or on the skin, they must be washed with a large amount of water.

    In case of an allergic reaction, the drug should be stopped immediately and symptomatic treatment should be given (blockers H1-histamine receptors). Storage at a temperature below 8 ° C can cause the formation of crystals that dissolve when the solution is heated to 60 ° C.

    The bottle with concentrate should not be stored for more than 6 weeks after opening, but not later than the expiry date.

    The Lavasept solution, ready for use, should be stored for 24 hours at a temperature of no higher than 25 ° C.

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

    Not found.

    Form release / dosage:

    Concentrate for solution preparation for external and local use, 20%.

    Packaging:

    By 2 ml or 5 ml in bottles of hydrolytic class 1 glass, sealed with rubber stoppers and aluminum caps with colorless plastic plugs that meet the requirements of the European Pharmacopoeia.

    100 ml in bottles of hydrolytic class 2 glass, sealed with rubber stoppers and aluminum caps, meeting the requirements of the European Pharmacopoeia.

    For 1 bottle of 2 ml, 5 ml or 100 ml with instructions for use in a cardboard pack.

    Storage conditions:

    Store at a temperature of 8 ° C to 25 ° C in a dark place.

    Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 of the year.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N016068 / 01
    Date of registration:03.12.2009 / 28.02.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:B. Brown Medical AGB. Brown Medical AG Germany
    Manufacturer: & nbsp
    Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company
    Information update date: & nbsp08.02.2018
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