The instruction for medical use of Fosfomitsin-lf Torgovoye medicine a name Fosfomitsin-LF Mezhdunarodnoye the unlicensed name Fosfomitsin Lekarstvennaya a form Powder for preparation of solution for intake, 3 g Structure contains One package: active agent – fosfomitsin (in the form of a fosfomitsin of a trometamol) 3.0 g, excipients: calcium hydroxide, fragrance lemon, sodium saccharin, icing sugar. The description Powder from white till light yellow color with a lemon smell. Existence of the lumps which are breaking up when pressing is allowed. Pharmacotherapeutic group Antibacterial drugs other. Fosfomitsin. The ATX J01XX01 code the Pharmacological Pharmacokinetics Absorption Later properties of intake of a fosfomitsin trometamol is quickly soaked up in digestive tract, its absolute bioavailability is 50%. In an organism dissociates on fosfomitsin and trometamol. The last has no antibacterial properties. The bioavailability at single dose in 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 mg/l (Cmax). Plasma elimination half-life is equal to 4 hours. 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. The concomitant use with food slows down absorption, without affecting concentration of medicine in urine. Distribution Fosfomitsin does not contact proteins of plasma and mainly collects in urine. At oral administration of 3 g Fosfomitsin-LF in urine is reached high concentration from (1053 to 4415 mg/l), for 99% bactericidal for the majority of causative agents of infections of urinary tract. The minimum inhibiting concentration for these activators makes 128 mg/l. It is maintained in urine within 24-48 hours after intake of medicine that assumes an odnodozny course of treatment. Metabolism is not metabolized. Does not pass through a gemato-placental barrier. Removal Fosfomitsin is removed in not changed look, mainly by kidneys (90%), by glomerular filtration, and in smaller quantity (10% of total) is removed through intestines in an invariable look. A pharmacodynamics Active ingredient of Fosfomitsin-LF medicine – a fosfomitsin trometamol – an antibiotic of a broad spectrum of activity, derivative phosphonic acid. Possesses bactericidal action. The mechanism of action is connected with suppression of the first stage of synthesis of a peptidoglikan of a cell wall of bacteria. Being a structural analog of phosphoenol of pyruvate, enters competitive interaction with enzyme N-acetyl-glyukozamino-3-o-enolpiruvil-transferase, it is resulted by 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). Besides, in vitro of a fosfomitsin trometamol reduces adhesion of bacteria on an epithelium of urinary tract, reducing the probability of repeated infections. Has bactericidal effect on gram-positive (Enterococcus spp., Enterococcus faecalis, Staphylococcus aureus, Staphylococcus saprophyt., Staphylococcus spp.) and gram-negative (Escherichia coli, Citrobacter spp., Enterobacter spp., Klebsiella spp., Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas spp., Serratia spp.) the microorganisms causing infections of an urinogenital path. Indications Fosfomitsin-LF is applied to treatment of the following infections caused by the pathogenic microorganisms sensitive to a fosfomitsin: – acute and uncomplicated infections of lower parts of urinary tract – an asymptomatic bacteriuria – prevention of an infection of urinary tract when conducting surgical or diagnostic tests on lower parts of urinary tract the Route of administration and doses Fosfomitsin-LF carry out Reception on an empty stomach in 2 hours prior to or after a meal, preferably before going to bed, after bladder emptying. Contents of 1 package (3 g) should be dissolved in a glass of water and to accept solution immediately after preparation. At treatment of acute and uncomplicated infections of lower parts of urinary tract accept 1 Fosfomitsin-LF package once a day. Course of treatment 1 day. In more hard cases (the elderly patients recuring infections) accept 1 more package in 24 hours. For the purpose of prevention of an infection of urinary tract when holding the surgical or diagnostic procedures affecting lower parts of urinary tract accept 1 Fosfomitsin-LF package in 3 hours prior to the expected procedure, 1 more package in 24 hours after its carrying out. To apply strictly on doctor’s orders. Side effects Adverse effects are listed on the systems of an organism and on absolute frequency. Frequency is determined as: often (& gt, 1/100, & lt, 1/10), infrequently (& gt, 1/1000, & lt, 1/100), it is rare (& gt, 1/10000, & lt, 1/1000), frequency is unknown (it cannot be calculated on the available data). 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 a fosfomitsin to a trometamol or any component of drug – a heavy renal failure (clearance of creatinine & lt, 10 ml/min.) – carrying out a hemodialysis – children and teenagers with body weight less than 50 kg Medicinal interactions At simultaneous use with Metoclopramidum, antacids, calcium salts perhaps considerable decrease in concentration of a fosfomitsin in blood plasma and in urine. As a result, these drugs have to be used at an interval of time (about 2 – 3 hours). The similar effect can be caused by a concomitant use with the medicines increasing motility of digestive tract. Special instructions the Concomitant use with food can slow down absorption Fosfomitsin-LF therefore it is desirable to apply Fosfomitsin-LF on an empty stomach or in 2-3 hours 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. Use Fosfomitsin-LF can lead to emergence an antibiotic – the associated colitis (including pseudomembranous colitis). Therefore it is necessary to consider the probability of this diagnosis at patients when developing severe and ultimate diarrhea in time or after reception Fosfomitsin-LF. In case of confirmation of the diagnosis the necessary treatment has to be performed immediately. Use of the medicines inhibiting a vermicular movement is contraindicated at this clinical picture. When prescribing the drug Fosfomitsin-LF sick diabetes it is necessary to consider that icing sugar is its part. Children As experience of use of the drug Fosfomitsin-LF for children is limited because of its high dosage not suitable for children and teenagers with body weight less than 50 kg. Fosfomitsin-LF 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. At pregnancy, medicine is appointed only when the potential 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 vehicles or potentially dangerous mechanisms Considering side effects of drug it is worth being careful when driving or other potentially dangerous mechanisms. Overdose Symptoms: vestibular disturbances, deterioration in hearing, metal smack in a mouth and the general decrease in flavoring feelings. Treatment: symptomatic and maintenance therapy. Oral administration of a large amount of liquid is recommended to accelerate removal of medicine with urine. A form of release and packing On 8.0 g of powder in the package from the combined material (a paper/film polyethylene / aluminum foil / a film polyethylene) soldered from three or from four parties. On 1 or 2 packages together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. Storage conditions At a temperature not above 25 °C. To store out of children’s reach. Period of storage 3 years. Not to apply after an expiration date. Prescription status According to the prescription of Proizvoditel Romfarm Company of S.R. L., Otopen, Eroilor St., 1A, Romania ph. +40 21 208 9743, +40 21 208 97 42, fax: +40 21 266 49 38 Owner of the registration certificate of SOOO “Lekfarm”, Republic of Belarus, 223141, Logoysk, Minskaya St., 2a, ph. / fax: +375 1774 53 801 e-mail: email@example.com the Packer releasing quality control of SOOO “Lekfarm”, Republic of Belarus, 223141, Logoysk, Minskaya St., 2a, ph. / fax: +375 1774 53 801 e-mail: firstname.lastname@example.org the Address of the organization accepting claims from consumers on quality of a product in the territory of the Republic of Kazakhstan Representation of “ROMPHARM COMPANY” of S.R. L. (ROMFARM COMPANY of SRL) in Republic of Kazakhstan, 050013, Almaty, Boulevard Bukhar Zhyrau, 33, BC Zhe _ s, office 41, phone number: 8 (727) 247-07-85, fax: 8 (727) 376-35-88 The name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine Representation of “ROMPHARM COMPANY” of S.R. L. (ROMFARM COMPANY of SRL) in Republic of Kazakhstan, 050013, Almaty, Boulevard Bukhar Zhyrau, 33, BC Zhe _ s
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