Fosfomed 2’s granules 3g powder for oral solution
The instruction for medical use of PHOSPHOHONEY medicine the Trade name Phosphohoney the International unlicensed name Fosfomitsin Lekarstvennaya a form the Granulated powder for preparation of solution for intake, 3 g contains Structure of 1 sachet package: active agent – a fosfomitsina of a trometamol of 5.631 g (3.0 g of a fosfomitsin are equivalent), excipients: sucrose (crushed), orange essence, tangerine essence, silicon dioxide colloidal anhydrous, sodium saccharin. The description the Uniform granulated powder of white or almost white color with an orange and tangerine smell. Pharmacotherapeutic group Antimicrobial drugs for system use. Antibacterial drugs other. Fosfomitsin. The ATX J01XX01 code the Pharmacological Fosfomitsin’s Pharmacokinetics properties trometamol is quickly soaked up from digestive tract at intake. In an organism dissociates on fosfomitsin and trometamol. Trometamol has no antibacterial properties. The bioavailability of a single dose is from 34 to 65%. The maximum concentration in plasma is observed in 2-2.5 hours (tmax) after reception and makes 22-32 mg/l (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 reception of a single dose of Fosfomed 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 & lt, 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 Fosfomeda ingredient – a fosfomitsina trometamol – an antibiotic of a wide range, derivative phosphonic acid. Phosphohoney possesses bactericidal action. The mechanism of action is connected with suppression of the first stage of synthesis of a cell wall of bacteria. Being a structural analog of phosphoenol of pyruvate, enters competitive interaction with enzyme N – acetyl – glyukozamino – 3 – about-enolpiruvil-transferase 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 with other antibiotics (in vitro note synergism with amoxicillin, cefalexin, pipemidinovy acid). The antibacterial range of action of a fosfomitsin of a trometamol of in vitro includes the majority usual gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyt., Staphylococcus spp.) and gram-negative (E. coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.) activators. In vitro of a fosfomitsin trometamol reduces adhesion of a number of bacteria on an epithelium of urinary tract. Indications Phosphohoney is applied to treatment of the following infections caused by the pathogenic microorganisms sensitive to a fosfomitsin: – acute and uncomplicated infections of urinary tract – an asymptomatic 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 bag (3 g) once a day. Granules dissolve in 1/3 glasses of water. The drug is taken in 1 times a day on an empty stomach in 2 hours prior to or after a meal, preferably before going to bed, previously having emptied a bladder. The course of treatment makes 1 day. In more hard cases (the elderly patients recuring infections) accept 1 more bag in 24 hours. For the purpose of prevention of infection of urinary tract at surgical intervention and transurethral diagnostic procedures accept on 1 bag of Fosfomed in 3 hours prior to and in 24 hours after intervention. It is appointed to teenage girls from 12 years in a dose of 3 g once. In a renal failure reduce a dose and extend intervals between receptions. Side effects – it is frequent (& gt, 1/100 to & lt, 1/10) – – a vulvovaginitis – – a headache, dizziness – – diarrhea, nausea, dyspepsia – is rare (& gt, 1/1000 to & lt, 1/100) – – tachycardia – – paresthesias – – an abdominal pain, vomiting – – rash, urticaria, an itching – – an asthenia – is not known – – 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 12 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 Fosfomed’s absorption, drug needs to be used 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. Drug contains sucrose. Patients with hereditary intolerance of fructose, glyukozo-galaktozny malabsorption or sakharozo-izomaltazny insufficiency should not use this medicine. Pregnancy and the period of a lactation At pregnancy appoint drug only in case the expected advantage for mother exceeds 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 Considering side effects of medicine, it is necessary to be careful at control of motor transport and other potentially dangerous mechanisms Overdose Symptoms: vestibular dysfunction, hearing disorder, metal smack and general change of flavoring feelings, diarrhea. Treatment: intake of liquid inside for the purpose of increase in a diuresis. Symptomatic therapy. The form of release and packing On 8 g of drug place in a sachet packages. On 1 or 2 sachets packages together with the instruction for use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date! Prescription status According to the prescription the Producer/packer UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh., TURKEY Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul, Turkey Holder of the registration certificate UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh., TURKEY Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1B Zemin 4-5-6, Istanbul, Turkey
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 of TROKA-S PHARMA LLP (Republic of Kazakhstan) Republic of Kazakhstan, Almaty, Suyunbaya Avenue 222-b
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