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Dosage form: & nbsp

powder for external use

Composition:

1 g of powder contains:

Active substances: bacitracin (in the form of zinc bacitracin) - 250 ME; Neomycin (in the form of neomycin sulfate) - 5000 ME.

Excipients: powder base sterilized (corn starch, containing not more than 2% magnesium oxide).

Description:Fine powder of color from white to yellowish.
Pharmacotherapeutic group:Antibiotic, combined.
ATX: & nbsp
  • Other antibiotics for external use
  • Pharmacodynamics:

    Baneocin® is a combined antibacterial agent for topical application.

    Baneocin® contains two bactericidal antibiotics: neomycin and bacitracin.

    Bacitracin is a polypeptide antibiotic that inhibits the synthesis of the bacterial cell membrane.

    Neomycin is an antibiotic-aminoglycoside, which inhibits the synthesis of protein bacteria.

    Bacitracin is especially active against gram-positive microorganisms, such as beta-hemolytic streptococci, staphylococci and some gram-negative pathogens. Resistance to bacitracin is extremely rare.

    Neomycin is effective against gram-positive and gram-negative microorganisms. By using a combination of these two substances, a wide range of action is achieveddrug and synergism of action against a number of microorganisms, for example, staphylococci.

    Pharmacokinetics:

    The active substances, as a rule, are not absorbed (even damaged by the skin), nevertheless, their skin contains high concentrations.

    Baneocin® is well tolerated. Tissue tolerance is regarded as excellent, inactivation by biological products, blood and tissue components is not noted. If the drug is applied to extensive areas of skin lesions, the absorption of the drug and its effects should be taken into account (see "Side Effects", "Interaction with other medicines", "Contraindications" and "Special instructions").

    Indications:

    Baneocin® is indicated for use in infections caused by neomycin and / or bacitracin-sensitive microorganisms.

    - Bacterial skin infections of limited prevalence, for example: with wet contagious impetigo, infected trophic ulcers of the lower extremities, infected eczema, bacterial diaper dermatitis, bacterial complications (Herpes simplex and Herpes zoster, or varicella zoster vesicles).

    - Prevention of umbilical infection in newborns.

    - Preventing infection after surgical (dermatological) procedures: powder Baneocin® can be used for additional treatment in the postoperative period (after excision, cauterization, episiotomy, for the treatment of cracks in the skin, wiping wounds and sutures).

    Contraindications:

    Hypersensitivity to bacitracin and / or neomycin, or to other antibiotics of the aminoglycoside series.

    Do not use with extensive skin lesions, since absorption of the drug can cause an ototoxic effect, accompanied by hearing loss.

    Do not use in patients with severe impairment of the excretory function due to cardiac or renal insufficiency and already having lesions of the vestibular and cochlear systems in cases where absorption of the drug is possible. Do not use powder to treat the eyes.

    Carefully:

    With possible absorption (extensive violations of the integrity of the skin), it is necessary to monitor the possible appearance of signs of neuromuscular blockade, especially in patients with acidosis, severe myasthenia gravis or other neuromuscular diseases.With the development of neuromuscular blockade, calcium preparations or neostigmine are indicated.

    With prolonged use of the drug, it is necessary to monitor the possible excessive growth of resistant organisms. If this happens, appropriate treatment should be prescribed.

    Treatment with Baneocin® patients who have developed allergic reactions or superinfections should be discontinued.

    Pregnancy and lactation:

    The use of Baneocin® during pregnancy and breastfeeding is possible only after consulting a doctor if the intended benefit to the mother exceeds the potential risk to the fetus and infant.

    Dosing and Administration:

    Outwardly. Powder is applied a thin layer on the affected areas 2-4 times a day.

    In patients with burns that occupy more than 20% of the body surface, Baneocin® powder should not be used more than once a day, especially if the kidney function decreases, because the absorption of the active ingredient may occur.

    At local application, the dose of neomycin should not exceed 1 g per day (about 200 g of powder for external use) for 7 days.

    At the repeated course the maximum dose is not more than 100 g.

    Side effects:

    When applied topically to the skin, mucous membranes and wound surfaces, Baneocin® is usually well tolerated.

    In patients who have been using the drug for a long time, allergic reactions can develop in the form of redness and dryness of the skin, skin rashes and itching.

    Allergic reactions mainly occur according to the type of contact eczema and are rare. Approximately 50% of cases are associated with a cross-allergy to other aminoglycoside antibiotics.

    When treating patients with extensive damage to the skin, it is necessary to take into account the possibility of absorption of the drug and, consequently, the occurrence of complications such as lesions of the vestibular and cochlear apparatus, nephrotoxic effect and blockade of neuromuscular conduction.

    Interaction:

    If there is a systemic absorption, the concomitant use of cephalosporins or antibiotics of the aminoglycoside series may increase the likelihood of a nephrotoxic reaction.

    Simultaneous use with Baneocin® of such diuretics as ethacrynic acid or furosemide, can provoke oto- and nephrotoxic effect.

    Absorption of Baneocin® can potentiate the effects of blockade of neuromuscular conduction in patients receiving drugs, anesthetics and muscle relaxants.

    There were no incidents of incompatibility for bacitracin and neomycin.

    Special instructions:

    When used at doses significantly higher than those recommended, due to the possible absorption of Baneocin®, particular attention should be paid to symptoms indicating nephro- and / or ototoxic reactions.

    Since the risk of toxic effects increases with decreasing liver and / or kidney function, blood and urine tests should be performed in patients with hepatic and / or renal insufficiency together with audiometric testing before and during Baneocin® therapy.

    If Baneocin® absorption takes place, attention should be paid to the potential blockade of neuromuscular conduction, especially in patients with acidosis accompanied by severe myasthenia gravis (myasthenia gravis) or other neuromuscular diseases. With prolonged treatment, attention should be paid to the possible growth of resistant microorganisms. In such situations, appropriate treatment should be prescribed.

    In the case of the use of the drug in children, patients with impaired liver and kidney function, as well as with a large area of ​​the treated surface, long-term use and deep skin lesions, it is recommended to consult a doctor beforehand.

    Patients who developed an allergy or superinfection, the drug should be canceled.

    Form release / dosage:

    Powder for external use 250 ME / g + 5000 MU / g.

    Packaging:10 g powder for external use in polyethylene jars with polyethylene dispenser; 1 bank with instructions for medical use in a cardboard box.
    Storage conditions:

    In a place protected from light and moisture at a temperature below 25 ° C.

    Keep out of the reach of children.

    Shelf life:
    2 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N011271 / 02
    Date of registration:12.05.2011
    The owner of the registration certificate:Sandoz GmbHSandoz GmbH Austria
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp17.07.2012
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