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Baneotsin 5000me + 250 IU / 1g 10g powder for external use




The instruction for medical use of Baneotsin Torgovoye medicine a name Baneotsin Mezhdunarodnoye the unlicensed name Is not present the Dosage form Powder for external use, 250 ME + 5000 ME/1 g the Structure of 1 g of powder contains active agents: bacitracin zinc of 0.0041667 g (250 ME corresponds) + 10% surplus of 0.0004166 g, Neomycinum sulfate of 0.0074626 g (5000 ME corresponds) + 10% surplus of 0.0007462 g excipient: powder basis of 0.9872079 g. The description Fine powder, from white till yellowish color. Pharmacotherapeutic group Antibacterial drugs and antimicrobial drugs for treatment of diseases of skin. Other antibacterial drugs for topical administration. The ATX D06AX code the Pharmacological Pharmacokinetics Baneotsin properties works locally in the place of use. If, nevertheless, absorption happened, elimination half-life of Neomycinum or bacitracin makes about 2 – 3 hours of serum. For separate active agents of the drug Baneotsin it is necessary to consider the following general pharmacokinetic features: Bacitracin is practically not soaked up by a mucous membrane and the uninjured skin, however is soaked up in open wounds. Neomycinum is soaked up by the uninjured skin only in limited degree. Neomycinum is quickly soaked up at loss of a keratinaceous layer (ulcers, wounds, burns, etc.) and also in cases of the inflamed or injured skin. Baneotsin’s pharmacodynamics is the combined antibacterial drug intended only for topical (external) administration. Baneotsin contains two antibacterial (possessing bactericidal action) substances – Neomycinum and bacitracin. It is effective at topical administration. Thanks to a combination of these two antibacterial substances the drug broad spectrum of activity is reached. Bacitracin first of all is active concerning gram-positive microorganisms, such as hemolytic streptococci, staphylococcus, a clostridium, a diphtheritic stick and a pale treponema and some gram-negative pathogenic microorganisms, such as Neysseriya and hemophilic stick. Baneotsin is also effective concerning actinomycetes and fuzobakteriya. Bacitracin resistance develops extremely seldom. Neomycinum is effective concerning gram-positive and gram-negative pathogenic microorganisms, such as Staphylococcus, Proteus, Enterobacter aerogenes, Klebsiella pneumoniae, Salmonella, shigella, Haemophilus influenzae, Pasteurella, Neisseria meningitidis, Vibrio cholerae, Bordetella pertussis, Bacillus anthracis, Corynebacterium diphtheriae, Streptococcus faecalis, Listeria monocytogenes, Escherichia coli, Mycobacterium tuberculosis. Leptospira interrogans (L. icterohaemorrhagicae) is also effective concerning Borrelia. The pyocyanic stick, nokardiya, fungi and viruses are not included. Baneotsin is well had. The fabric shipping is estimated as good, there is also no inactivation elements of secretion, blood or fabric. At extensive disturbances of integrity of integuments, it is necessary to consider an opportunity absorption of the drug Baneotsin and its possible consequences. Indications Baneotsin is effective in the infections caused by microorganisms sensitive to Neomycinum and/or bacitracin: – bacterial infections of skin of limited prevalence, including the bacterial complications of viral infections caused by Herpes simplex and Herpes zoster at vesicles of chicken pox, the becoming wet contagious impetigo, the infected trophic ulcers of the lower extremities infected varicose ulcers, consecutive infections in eczema, infections in burns – prevention of infections after the surgical (dermatological) procedures – as auxiliary therapy at treatment of contaminated wounds (for example, in external otitis, secondary infection of surgical hems) Baneotsin will be applied to additional treatment in the postoperative period (after excision and cauterization, treatment of cracks on skin, the becoming wet wounds and scars). The route of administration and dosage Baneotsin is intended only for topical (external) administration. Baneotsin apply with a thin layer on affected areas, use of a bandage is possible. Adults and children are more senior than 12 years: Baneotsin is applied from two to four times a day. At patients with burns which occupy more than 20% of a body surface Baneotsin should not be applied more often than once a day, especially in case of depression of function of kidneys as there can be an absorption of active agents. At topical administration the dose of Neomycinum should not exceed 1 g a day (there correspond 200 g of drug) no more than 7 days. At a repeated course the maximum dose has to be reduced twice. Not to apply Baneotsin on eyes. Side effects At prolonged use can arise allergic reactions, for example, reddening, dehydration and peeling of skin, rash and an itching. In comparison with healthy skin, the sensitization, as a rule, is supported by various substances, including Neomycinum, when using for treatment of a chronic dermatosis (for example, a stagnant dermatosis or chronic average otitis). Lack of the healing effect can be manifestation of allergic reaction. Allergic reactions proceed as contact eczema and are shown seldom. The allergy to Neomycinum is connected with a cross allergy to other aminoglikozidny antibiotics approximately in 50% of cases. At patients with extensive disturbances of integrity of integuments the absorption of the drug Baneotsin is possible and side effects in the form of defeat of vestibular and cochlear devices, a hearing disorder, nephrotoxic effect and neuromuscular blockade are observed. Contraindications – hypersensitivity to bacitracin and/or Neomycinum or to other aminoglikozidny antibiotics, excipients – extensive defeats of sites of skin (as absorption can cause development of the ototoksichesky effect which is followed by a hearing loss) – the significant disturbances of secretory function owing to a heart or renal failure at patients and already available defeats of vestibular and cochlear systems in cases if absorption of active agents of bacitracin and/or Neomycinum is possible – it is impossible to use in external acoustical pass at perforation drum pereponk Baneotsin is not applied to treatment of diseases of eyes. Medicinal interactions At system absorption the accompanying prescribing of cephalosporins or other antibiotics of an aminoglikozidny row can increase the probability of nephrotoxic reaction. Simultaneous use of diuretics, such as Acidum etacrynicum or furosemide, can also provoke from – and nephrotoxic effect. Absorption of the drug Baneotsin can exponentiate the phenomena of neuromuscular blockade at the patients receiving drugs, anesthetics and muscle relaxants. Special instructions It is impossible to allow hit of the drug Baneotsin in a mouth, especially at children. The uses of the drug Baneotsin given about safety in this dosage form children up to 12 years have not enough therefore use at this age group perhaps on doctor’s orders after careful assessment advantage/risk. When using in the doses significantly exceeding recommended owing to possible absorption of the drug Baneotsin it is necessary to pay special attention to the symptoms specifying on nefro-and/or ototoksichesky reactions. As the risk of toxic effects increases at depression of function of a liver and/or kidneys, at patients with a liver and/or renal failure it is necessary to carry out blood and urine count tests together with an audiometric research to and during therapy by the drug Baneotsin. At possible absorption (extensive disturbances of integrity of integuments) of the drug Baneotsin, it is necessary to monitor possible emergence of signs of neuromuscular blockade, especially at patients with acidosis, a heavy myasthenia or other neuromuscular diseases. At development of neuromuscular blockade, drugs of calcium or inhibitors of cholinesterase are shown (neostigmin). At long-term treatment attention has to be paid to the possible growth of steady microorganisms. Prolonged use of drug can lead to reproduction of strains of the bacteria and mushrooms resistant to Neomycinum. In such situations it is necessary to appoint the corresponding treatment. In case of development of the infections caused by bacteria insensitive to Neomycinum or mushrooms, it is necessary to perform the corresponding antibacterial or antifungal treatment. To patients at whom the allergy developed or superinfection the drug Baneotsin has to be cancelled. Pregnancy and the period of a lactation Use of the drug Baneotsin during pregnancy and a lactation is possible only when the expected advantage for mother does not exceed potential risk for the fruit/baby. As well as passes all aminoglikozidny antibiotics, Neomycinum through a placenta. At system use of high doses of aminoglycosides the pre-natal decrease in hearing at a fruit was described. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Does not know Overdose When using in the doses significantly exceeding recommended, owing to possible absorption of drug it is necessary to pay special attention to the symptoms specifying on nefro-and/or ototoksichesky reactions. The form of release and packing On 10 g of drug place in a container from polyethylene with a nominal volume of 25 ml. On 1 container together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store storage conditions in original packing, at a temperature not above 25 °C. To store out of children’s reach! 2 years not to use a period of storage after the expiry date specified on packing. Prescription status Without prescription of Producer/Upakovshchik Pharmatsoytishe Fabrik Montavit GmbH, Austria the Owner of the registration certificate of Sandoz GmbH, Austria of Biochemiestraße 10, 6250 Kundl, Austria the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of the products (goods) responsible for post-registration observation of safety of medicine Representative office of JSC Sandoz Pharmasyyutikals d. d. in Republic of Kazakhstan, Almaty, Luganskogo St. 96
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