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Uroseptiki 3g 1’s granules for oral solution




The instruction for medical use of Uroseptik Torgovoye medicine a name Uroseptik Mezhdunarodnoye the unlicensed name Fosfomitsin Lekarstvennaya the Granule form for preparation of solution for intake, 3 g Structure of 1 sachet contains active agent – a fosfomitsin trometamol 5.631 g (it is equivalent to a fosfomitsin of 3 g), excipients: glycine, sucralose, aerosil, povidone (PVP K 30), fragrance lemon (11028-71) Description of the Granule of white or almost white color. Pharmacotherapeutic group Antibacterial drugs other. Fosfomitsin. The ATX J01XX01 code the Pharmacological Fosfomitsin’s Pharmacokinetics properties trometamol is quickly soaked up from digestive tract at oral administration. In an organism dissociates on fosfomitsin and trometamol. Trometamol has no antibacterial properties. The bioavailability of a single oral dose of 3 g is from 34 to 65%. The maximum concentration in plasma is observed in 2-2.5 hours (tmax) after oral administration and makes 22-32 mkg/ml (Cmax). Plasma elimination half-life is equal to 4 hours. Fosfomitsina trometamol does not contact proteins of plasma, is not metabolized, mainly collects in urine. At oral administration of a single dose of 3 g in urine high concentration (from 1053 to 4415 mg/l) for 99% bactericidal for the majority of ordinary causative agents of infections of urinary tract is reached. The minimum inhibiting concentration of a fosfomitsin for these activators makes 128 mg/l. It is maintained in urine for 24-48 hours that assumes an odnodozny course of treatment. Fosfomitsin is brought by kidneys in not changed view with creation of high concentrations in urine to 90%. About 10% of the accepted dose are excreted with a stake in not changed look. At patients with moderate decrease in renal function (clearance of creatinine & gt, 80 ml/min.), including its physiological decrease at elderly people, elimination half-life of a fosfomitsin is a little extended, but concentration in urine remains at the therapeutic level. A pharmacodynamics Active Uroseptika ingredient – a fosfomitsina trometamol – an antibiotic of a broad spectrum of activity, derivative phosphonic acid. Uroseptik possesses the bactericidal action based on disturbance (at early stages) synthesis of a peptidoglikan of a cell wall of bacteria. Getting into a microbic cell on the systems of transport D-glucose-6-phosphate, drug it is irreversible enzyme inhibits UDF-N-atsetil-glyukozamino-3-enopiruvil-transferazu which catalyzes education reaction UDF-N-acetyl-3-O(1-carboxyvinyl) – a D-glycosamine from the fosfoyenolpiruvat and an UDF-N-atsetil-D-glyukozamina. Therefore there is specific, selective and irreversible inhibition of this enzyme that provides lack of cross resistance with other classes of antibiotics and a possibility of synergism to other antibiotics (in vitro note synergism with amoxicillin, cefalexin, pipemidinovy acid). Fosfomitsin is active concerning gram-positive aerobes – Staphylococcus aureus, Staphylococcus epidermidis (including some strains resistant to Methicillinum), Staphylococcus spp., Streptococcus pyogenes, Streptococcus spp. the viridans groups, streptococci of the groups C, F, G, Streptococcus pneumoniae, Enterococcus faecalis, Bacillus anthracis, gram-negative aerobes – Aeromonas hydrophila, Citrobacter spp., Campylobacter jejuni, Escherichia coli, Enterobacter spp. (are moderately sensitive), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca (are moderately sensitive), Morganella morganii (the majority of strains are moderately sensitive), Neisseria gonorrhoeae, Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri (are moderately sensitive), Pseudomonas aeruginosa, Serratia marcescens, Salmonella spp., Shigella spp., Vibrio spp. (are moderately sensitive), Yersinia enterocolitica and also some anaerobe bacterias – Actinomyces spp., Peptococcus spp., Peptostreptococcus spp., Fusobacterium spp., Veillonella spp., Clostridium perfringens and Prevotella spp are moderately sensitive. Enterococcus faecium, Acinetobacter spp., Legionella spp., Borrelia spp., Listeria monocytogenes, Mycobacterium spp., Bacteroides spp., the majority of intracellular activators are steady (Coxiella burnetii, Rickettsia spp., Chlamydia spp., Mycoplasma pneumoniae, Ureaplasma urealyticum). Secondary resistance of microorganisms to a fosfomitsin develops seldom. At a combination to beta lactams, ftorkhinolona, glycopeptides or aminoglycosides the significant synergism of antimicrobic action concerning a wide range of gram-positive and gram-negative aerobic bacteria is noted. Indications Uroseptik is applied to treatment of the following infections caused by the pathogenic microorganisms sensitive to a fosfomitsin: – acute and uncomplicated infections of urinary tract, such as acute bacterial cystitis, bad attacks of recurrent bacterial cystitis, a bacterial nonspecific urethritis – an asymptomatic massive bacteriuria – prevention of an infection of urinary tract when performing surgical interventions and diagnostic a research on lower parts of urinary tract (for example, the TOUR) the Adult appoint the Route of administration and doses on 1 sachet (3 g) once a day. Treatment duration – one day. Granules dissolve in 1/2 glasses of water and use right after preparation. Uroseptik apply once a day inside on an empty stomach in 2 hours prior to or after a meal, preferably before going to bed, previously having emptied a bladder. For the purpose of prevention of infection of urinary tract at surgical intervention, transurethral diagnostic procedures accept Uroseptik twice in the doses stated above: in 3 hours prior to intervention and in 24 hours after intervention. At advanced age and at more hard cases accept 1 more sachet in 24 hours. In a renal failure reduce a dose and extend intervals between introductions. Side effects Often (& gt, 1/100 to & lt, 1/10) – a vulvovaginitis – a headache, dizziness – diarrhea, nausea, dyspepsia Seldom (& gt, 1/1000 to & lt, 1/100) – tachycardia – paresthesias – an abdominal pain, vomiting – rash, urticaria, an itching – an asthenia does not know – an acute anaphylaxis, allergic reactions – hypotonia – asthma – a Quincke’s edema – pseudomembranous colitis of the Contraindication – hypersensitivity to any component of drug – a heavy renal failure (clearance of creatinine & lt, 10 ml/min.) – a hemodialysis – children’s age up to 18 years Medicinal interactions Simultaneous use of Metoclopramidum, antacids or salts of calcium causes considerable decrease therapeutic in effective concentration of a fosfomitsin in plasma and urine. As a result, these drugs have to be used at an interval of time (about 2 – 3 hours). Other drugs increasing gastrointestinal motility can cause similar effects. Special instructions the Concomitant use of food slows down Uroseptik’s absorption, drug it is necessary to use drug in 2 hours prior to or after a meal. At use of drug it is necessary to be guided by official recommendations about appropriate use of antibacterial drugs, in particular for prevention of development of resistance to antibiotics. The beginning of heavy and ultimate diarrhea in time or after treatment by antibiotics can be a symptom of the antibiotiko-associated colitis. Its most serious form is pseudomembranous colitis which treatment has to be begun immediately. In certain cases purpose of adequate therapy is required. Use of antiperistaltic drugs is a contraindication at this clinical picture. Children As experience of use of drug for children is limited because of its high dosage not suitable for children and teenagers with body weight less than 50 kg, Uroseptik should not be applied in this age group. Pregnancy and the period of a lactation This limited number of the studied pregnancies do not show undesirable impacts on pregnancy, a fruit or on health of the newborn. During pregnancy the drug should be taken, having compared the potential advantage for mother exceeding potential risk for a fruit. In need of prescribing of drug in the period of a lactation it is necessary to stop breastfeeding for the period of treatment. Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms the Overdose Symptoms does not influence: vestibular dysfunction, hearing disorder, metal smack and general change of flavoring feelings. Treatment: intake of liquid inside for the purpose of increase in a diuresis. Symptomatic therapy. The form of release and packing On 3 g of drug place in dual sachets from aluminum foil. On 1 sachet place in a cardboard box together with the instruction for use in the state and Russian languages. Storage conditions In the dry, protected from light place, at a temperature not over 25 ºС. To store out of children’s reach. 3 years not to apply a period of storage after the expiration date specified on packing Prescription status According to the prescription ARAFARMA GROUP, S.A. Producer, Spain the location Address: With / the Big-head Gabrielle de San Antonio of 6-10 19180 Marchamalo – Guadalajara Spain
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of EL company (EL company) LLP 050022, Almaty, Masangchi St., 98a, office 41

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