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Mupobel 15g of 2% cream for external use in a tube




The instruction for medical use of Mupobel Torgovoye medicine a name Mupobel Mezhdunarodnoye the unlicensed name Mupirotsin Lekarstvennaya a form Cream for external use of 2%, 15 g Structure of 1 g of cream contains active agent – a mupirotsin of calcium a dihydrate of 23.43 mg (it is equivalent to a mupirotsin of 20.00 mg) excipients: liquid paraffin, half-oxyethylene glycol 1000 monocetyl ether, alcohol stearyl, cetyl alcohol, phenoxyethanol, benzyl alcohol, the xanthane gum, water purified. The description the Uniform cream of soft consistence of white or whitish color free from foreign inclusions. Pharmacotherapeutic group Antibacterial drugs and antimicrobial drugs for treatment of diseases of skin. Antibacterial drugs for topical administration. Other antibacterial drugs for topical administration. Mupirotsin the ATX D06AX09 Code the Pharmacological Pharmacokinetics Absorption System Absorption properties of a mupirotsin through the uninjured skin is insignificant. Metabolism Mupirotsin is intended only for topical administration, in case of its absorption through the injured skin mupirotsin quickly is metabolized to an inactive metabolite – moniyevy acid. Penetration of a mupirotsin into deep layers of epidermis and dermas increases at traumatic injury of skin and when imposing occlusive bandages. Removal Mupirotsin is quickly brought out of an organism in the form of an inactive metabolite of moniyevy acid by means of the renal mechanism. A pharmacodynamics the action Mechanism Mupobel – the antibiotic of new generation received by fermentation of Pseudomonas fluorescens. Mupobel suppresses protein synthesis and RNA of bacteria by inhibition isoleucyl-transferastvorNK-sintetazy. When using drug in the minimum inhibiting concentration, Mupobel has bacteriostatic action, at increase in concentration – bactericidal. Thanks to this mechanism of action and chemical structure, the drug Mupobel has no cross resistance with other antibiotics and also there is an insignificant risk of development of resistance at use of drug according to recommendations. The following microorganisms are sensitive to the drug Mupobel: In vivo – Staphylococcus aureus (including Methicillinum – resistant strains) – S. epidermidis – β-hemolytic Streptococcus In vitro Gram-positive aerobes: – Staphylococcus aureus (including the strains producing beta lactamazu and Methicillinum – resistant strains) – Staphylococcus epidermidis (including the strains producing beta lactamazu and Methicillinum – resistant strains) Others a coagualase – negative staphylococcus (including Methicillinum – resistant strains) Streptococcus species Gram-negative aerobes: The drug Mupobel is active concerning gram-negative microorganisms, occasionally associated with skin infections: – Haemophilus influenzae – Neisseria gonorrhoeae – Neisseria meningitidis – Moraxella catarrhalis – Pasteurella multocida – Proteus mirabilis – Proteus vulgaris – Enterobacter cloacae – Enterobacter aerogenes – Citrobacter freundii – Bordetella pertussis Susceptible microorganisms: Staphylococcus aureus1 Staphylococcus epidermidis1 Koagulazo-negativnye stafilokokki1 Streptococcus species1 Haemophilus influenzae Neisseria gonorrhoeae Neisseria meningitidis Moraxella catarrhalis Pasteurella multocida. 1 Clinical performance was proved at use within the approved indications Irresponsive microorganisms of Corynebacterium species Enterobacteriaceae Gram-negative sticks of Micrococcus species Anaerobe bacterias the Mechanism of development of resistance the Low level of development of resistance of stafilokokk at the minimum inhibiting concentration of drug from 8 to 256 mkg/ml was revealed as a result of changes of the nature of an izoleytsil of a sintetaza of tRNK. The high level of development of resistance of stafilokokk at the minimum inhibiting concentration of drug of ≥512 mkg/ml is observed in connection with special structure of an izoleytsil of a sintetaza of tRNK. The considerable resistance of gram-negative microorganisms (Enterobacteriaceae) is connected with low degree of passability of drug in a bacterial cell. Indications Topical treatment of again infected traumatic damages of skin: – small wounds – embroidered wounds – grazes the Route of administration and doses a Small amount of cream is caused on the damaged site of skin with a thin layer by means of pure cotton wool or a gauze. The bandage can be applied to the processed site. It is impossible to put Mupobel together with other drugs in connection with possible dissolution of a mupirotsin and decrease in its stability that can result in insufficient antibacterial effect. After processing of skin it is necessary to wash up hands for removal of residues of cream. Any unused residues of drug after the end of treatment have to be destroyed. Adults/children / elderly patients Drug is applied 3 times a day. Treatment duration – up to 10 days, depending on the clinical response to the carried-out therapy. Patients with a renal failure of Dose adjustment it is not required. Patients with an abnormal liver function of Dose adjustment it is not required. Side effects the Undesirable phenomena given below are listed depending on anatomo-physiological classification and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1/10), it is frequent (≥1/100 and & lt, 1/10), infrequently (≥1/1,000 and & lt, 1/100), is rare (≥1/10,000 and & lt, 1/1,000), is very rare (& lt, 1/10,000, including separate cases), it is unknown (frequency cannot be determined on the basis of the available data). Categories of frequency were created on the basis of clinical trials of drug. Often – skin reactions of hypersensitivity It is very rare – system allergic reactions (generalized rash, a small tortoiseshell, vascular swelled) Contraindications – the known hypersensitivity to a mupirotsin or other components of drug – Medicinal interactions not to put intranasal and intraocular use along with other drugs. Special instructions In rare instances development of reaction of hypersensitivity or in the presence of serious local irritation, it is necessary to stop immediately carried-out therapy and to wash away drug with further transition to therapy by other drug for treatment of the existing infection. As well as in a case with other antibiotics, prolonged use of drug can lead to growth of insensitive flora. Cases of development of pseudomembranous colitis of various degrees of severity were revealed (from easy to life-threatening) when using antibacterial drugs. Thus, it is necessary to consider the possibility of this diagnosis at development in the patient of diarrhea in time or after use of antibiotics. Though the probability of developing of colitis at external use of a mupirotsin is extremely small, in case of presence of long or long diarrhea and spasms in a stomach, treatment Mupobel has to be immediately cancelled, and the patient is directed for further inspection. It is necessary to avoid contact with eyes. At hit in eyes it is necessary to wash carefully them with water before full removal of cream. In case of need intranasal use, use Mupobel in the form of nasal ointment. Pregnancy and the period of a lactation Fertility Data on influence on fertility at the person are absent. Pregnancy there Are no data on use of the drug Mupobel for pregnant women in this connection, drug is used only in case the potential advantage exceeds possible risk. The lactation Is not present data on penetration of drug into breast milk. If Mupobel is applied to treatment of nipple cracks, before feeding it is necessary to wash up carefully a breast for removal of residues of cream. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms the Side effects affecting ability of driving of vehicles and service of the mechanical equipment in the movement were not observed. The overdose Toxicity of the drug Mupobel is very low. In case of inadvertent administration of drug the symptomatic treatment is inside performed. The form of release and packing On 15 g of drug place in the aluminum tubas corked by a plastic cover. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of manufacturing firm. To Store storage conditions at a temperature not above 25 °C, in the dry, protected from light place. To store out of children’s reach! A period of storage 2 years not to apply after an expiration date Prescription status Without prescription Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer, Almaty, Shevchenko St. 162 E. The owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Phone number: (+7 727) 399-50-50 Fax number: (+7 727) 399-60-60
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