Name:
Baneocin por. dnar. approx. 10g Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Expiration date from the date of manufacture2 years
Description:
of goods Powder for external use, finely dispersed, from white to yellowish Pharmacological action Combined antibacterial preparation for external use. Contains two antibiotics that have a bactericidal effect, neomycin and bacitracin. Bacitracin is a polypeptide antibiotic that inhibits bacterial cell wall synthesis. It is active against gram-positive (Streptococcus spp. / including ?-hemolytic streptococcus /, Staphylococcus spp.) and some gram-negative microorganisms. Bacitracin resistance rarely develops. Neomycin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis. Active against gram-positive and gram-negative bacteria. Through the use of a combination of these two antibiotics, a wide spectrum of action of the drug and synergism of action against a number of microorganisms, such as staphylococci, are achieved. Pharmacokinetics The active substances are usually not absorbed (even by damaged skin), however, their high concentrations are present in the skin. When applying the drug to large areas of skin lesions, the possibility of systemic absorption of the drug should be taken into account. Has good tissue tolerance; inactivation by biological products, blood and tissue components is not observed. Indications for use Infectious and inflammatory skin diseases caused by microorganisms sensitive to the drug: bacterial skin infections of limited prevalence, incl. weeping contagious impetigo, infected trophic ulcers of the lower extremities, infected eczema, bacterial diaper dermatitis, secondary bacterial infection in diseases caused by Herpes simplex, Varicella zoster (including infection of vesicles in chickenpox); prevention of umbilical infection in newborns; prevention of infection after surgical (dermatological) procedures: for additional treatment in the postoperative period (after tissue excision, cauterization, episiotomy, treatment of cracks, perineal rupture, weeping wounds and sutures). Use during pregnancy and lactation Use of Baneocin® during pregnancy and lactation possible after consultation with a doctor and only if the intended benefit to the mother outweighs the potential risk to the fetus or infant. It should be remembered that neomycin, like all antibiotics of the aminoglycoside group, can penetrate the placental barrier. With the systemic use of antibiotics of the aminoglycoside group in high doses, intrauterine hearing loss of the fetus has been described. Since the risk of toxic effects increases with a decrease in liver and / or kidney function, in patients with hepatic and / or renal insufficiency, blood and urine tests should be performed along with an audiometric study before and during therapy with Baneocin®. With the possible absorption of the active components of the drug Baneocin, it is necessary to monitor the possible appearance of signs of neuromuscular blockade, especially in patients with acidosis, 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 overgrowth of resistant microorganisms. If necessary, 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, prolonged use and deep skin lesions, you should first consult a doctor. With the development of allergic reactions and superinfection, the drug should be discontinued. Influence on the ability to drive vehicles and control mechanisms No special precautions are required. Precautions (Precautions) With caution, the drug should be prescribed to patients with impaired liver and / or kidney function, acidosis, myasthenia gravis, or other neuromuscular diseases. With caution, the drug should be prescribed to patients with impaired liver function. With caution, the drug should be prescribed to patients with impaired renal function. Contraindications extensive skin lesions (risk of developing an ototoxic effect accompanied by hearing loss); severe violations of the excretory function of the kidneys (due to heart or kidney failure) in patients with existing diseases of the cochleo-vestibular apparatus (if systemic absorption of the drug is possible); infections of the external auditory canal with perforation of the tympanic membranes; simultaneous use with antibiotics of the group of aminoglycosides of systemic action (risk of cumulative toxicity); hypersensitivity to bacitracin, neomycin or other aminoglycosides, auxiliary components of the drug. Do not use the drug for the treatment of eye infections. Dosage and administration For adults and children from the 1st day of life, the drug is applied in a thin layer to the affected areas 2-4 times / day; if necessary – under a bandage. The powder application area should not exceed 1% of the body surface area (which corresponds to the size of the patient’s palm). When applied topically, the dose of neomycin for adults and children and adolescents under the age of 18 years should not exceed 1 g / day (corresponding to 200 g of powder) for 7 days. Patients with impaired liver / kidney function and elderly patients do not require dose adjustment. Overdose When used at doses significantly higher than recommended, especially in the treatment of (neuro)trophic ulcers, nephro- and ototoxic reactions may occur due to the possible absorption of the active components of the Baneocin preparation. Side effectAccording to WHO, undesirable effects are classified according to the frequency of development as follows: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100 ), rarely (from? 10,000 to <1/1000), very rarely (<1/10,000), the frequency is unknown (according to the available data, it was not possible to establish the frequency of occurrence). Baneocin® is usually well tolerated when applied topically. On the part of the immune system: rarely - allergic reactions (if there is a history of allergic reactions to neomycin in 50% of cases, cross-allergy to other aminoglycosides may develop); the frequency is unknown - increased sensitivity to various substances, including neomycin (usually observed when used in the treatment of chronic dermatosis), in some cases, allergic reactions may look like a lack of effect from the therapy. From the side of the nervous system: the frequency is unknown - damage to the vestibular nerve, impaired neuromuscular conduction. On the part of the organ of hearing: the frequency is unknown - ototoxicity. On the part of the skin and subcutaneous tissues: rarely - allergic reactions manifesting in the form of contact dermatitis, an allergic reaction to neomycin; the frequency is unknown - allergic reactions in the form of redness and dryness of the skin, rash, itching (with prolonged use) may also be similar to the spread of primary foci or the lack of healing. May develop photosensitivity and phototoxic reactions (when exposed to the sun or exposure to UV radiation). From the urinary system: the frequency is unknown - nephrotoxicity. If these side effects occur or if any other side effects not specified in the instructions develop, the patient should immediately inform the doctor about this. Composition 1 g bacitracin (in the form of zinc bacitracin) 250 IU neomycin (in the form of neomycin sulfate) 5000 IU Excipients: lanolin, white soft paraffin. Interaction with other drugs With systemic absorption of the active components of the drug, the simultaneous use of cephalosporins or antibiotics of the aminoglycoside group may increase the likelihood of developing nephrotoxic reactions. With the simultaneous use of the drug Baneocin with ethacrynic acid or furosemide, the risk of developing oto- and nephrotoxic reactions increases. The absorption of the active components of the drug Baneocin while used with opioid analgesics, anesthetics and muscle relaxants may increase the risk of developing neuromuscular conduction disorders. Release formPowder for external use, finely dispersed, from white to yellowish. 1 g bacitracin (in the form of zinc bacitracin) 250 IU neomycin (in the form of neomycin sulfate) 5000 IU Excipients: sterilized powder base (corn starch containing no more than 2% magnesium oxide). 10 g - polyethylene cans (1) with a dispenser - packs of cardboard. Buy Baneocin powder for external use (250me+5000me)/1g 10g №1 one
INN | BACITRACIN+NEOMYCIN |
---|---|
The code | 81 782 |
Barcode | 9 002 260 024 919 |
Dosage | 250ME+5000ME |
Active substance | neomycin, bacitracin |
Manufacturer | Pharmaceutish Fabrik Montavit GmbH/Sandoz GmbH, Austria |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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