The instruction for medical use of LEFT XYHONEY medicine the Trade name the Left xymedical International unlicensed name Levofloxacin Dosage Form of the Tablet, film coated, 500 mg Structure One tablet contains active agent – a levofloksatsin of 500 mg (in the form of a levofloksatsin of hemihydrate of 512.46 mg.) excipients: cellulose microcrystalline (PH 101), krospovidon, hydroksipropilmetiltsellyuloza of 6 cps, cellulose microcrystalline (PH 200), magnesium stearate, silicon dioxide colloidal anhydrous, titan dioxide (E171), iron oxide yellow (E172), iron oxide red (E172). The description of the Tablet of oblong shape, film coated light-peach color, with dividing risky on one party. Pharmacotherapeutic group Antibacterial drugs for system use. Antimicrobial drugs – derivatives of a hinolon. Ftorkhinolona. Levofloxacin. ATX J01MA12 code the Pharmacological Pharmacokinetics Later properties of intake levofloxacin is quickly and completely soaked up from the digestive tract (DT). The absolute bioavailability at oral administration of a levofloksatsin is 99%. Cmax is reached in 1–2 hours after reception. At a concomitant use with food time of achievement of Cmax slightly increases (by 1 h) and slightly Cmax (by 14%) therefore it is possible to appoint levofloxacin regardless of meal decreases. About 30 – 40% of a levofloksatsin contact protein of blood plasma. The average volume of distribution of a levofloksatsin is about 100 l after introduction of a single and repeated dose of 500 mg that indicates extensive distribution in body tissues. Levofloxacin gets into a mucous membrane of bronchial tubes, liquid of an epithelial vystilka, alveolar macrophages, tissue of lungs, skin (interstitial liquid), tissue of a prostate and urine. However levofloxacin badly gets into cerebrospinal fluid. Levofloxacin is almost completely metabolized, metabolites are dezmetil-levofloxacin and N-oxide of a levofloksatsin. These metabolites contain also lt, 5% of a dose of drug and are allocated with urine. Levofloxacin of a stereokhimicheska is stable and is not exposed to chiral inversion. After reception of a levofloksatsin inside drug is rather slowly removed from plasma (t/2: 6 – 8 h). It is removed generally by kidneys (& gt, 85% of the entered dose). The average seeming general clearance of a levofloksatsin after introduction of a single dose of 500 mg was 175 +/-29.2 ml/min. The pharmacokinetics of a levofloksatsin is linear in the range of doses from 50 to 1000 mg. Special groups of patients Patients with a renal failure the pharmacokinetics of a levofloksatsin is influenced by a renal failure. At depression of function of kidneys the drug removal by kidneys and renal clearance decreases, elimination half-life, as shown in the below-stated table increases. Pharmacokinetics in a renal failure after oral administration of a single dose of 500 mg. Clkp [ml/min.] & lt, 20 20 – 49 50 – 80 Clpoch. [ml/min.] of 13 26 57 t1/2 [ch] 35 27 9 Patients of advanced age does not exist considerable differences in pharmacokinetics of a levofloksatsin at patients of young and advanced age, except connected with differences in clearance of creatinine. A pharmacodynamics Levofloxacin (fluorine-2, metil-10-(1-piperazinit)-oxo-7H-piridol [1,2,3,-]-1.6-carboxyl acid) – synthetic antibacterial agent of group of ftorkhinolon. Has a wide range of antibacterial action. The fast bactericidal effect is provided with oppression levofloksatsiny bacterial DNK-girazy enzyme which belongs to type topoisomerases II. The volume structure of DNA of bacteria is as a result broken and their division is blocked. The range of activity of a levofloksatsin includes gram-positive and gram-negative bacteria, including nonfermentative bacteriums which often cause a nozokomialny infection and also atypical microorganisms, such as S. of pneumoniae, S. of trachomatis, M. pneumoniae, L. pneumophila, Ureaplasma. Besides, pylori such activators as mycobacteria, N. are sensitive to a levofloksatsin and anaerobe bacterias. Are sensitive to drug: gram-positive aerobes – Enterococcus faecalis, Staphylococcus aureus metitsillinchuvstvitelny, Staphylococcus haemolyticus metitsillinchuvstvitelny, Staphylococcus saprophyticus, Streptococci C, G, Streptococcus agalactiae, Streptococcus pneumoniae, including resistant to penicillin, Streptococcus pyogenes, gram-negative aerobes – Acinetobacter baumannii, Citrobacter freundii, Eikenella corrodens, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, including resistant to ampicillin, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis including producing α-lactamelements, Morganella morganii, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens, anaerobe bacterias – Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus, others – Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Mycoplasma pneumoniae. Are non-constantly sensitive to drug: gram-positive aerobes – Staphylococcus haemolyticus metitsillinrezistentny, gram-negative aerobes – Burkholderia cepacia, anaerobe bacterias – Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgaris, Clostridium difficile. To rezistentna drug: gram-positive aerobes – Staphylococcus aureus, metitsillinrezistentny. As well as other ftorkhinolona, levofloxacin it is not active concerning spirochetes. Indications the Infectious and inflammatory diseases caused by microorganisms, sensitive to drug: – acute sinusitis – lower respiratory tract infections: exacerbation of chronic bronchitis, extra hospital pneumonia – infections of skin and soft tissues For above-mentioned infections levofloxacin should be used, only when it is inexpedient to use the antibacterial medicines which are usually recommended for starting therapy of these infections. – the complicated infections of kidneys and urinary tract, including pyelonephritis – uncomplicated cystitis – chronic bacterial prostatitis – an inhalation anthrax: post-contact prevention and radical treatment accept the Route of administration and doses of the Tablet Levoksimeda 1-2 times a day. The dose depends on type and weight of an infection. Duration of treatment depends on the course of the disease and is no more than 14 days. Use of drug is recommended to be continued within 2-3 days after normalization of body temperature. Unacceptably independent interruption or early termination of drug treatment. The tablets Levoksimeda should be swallowed, without chewing, washing down with enough liquid. A pill can be taken both together with food, and in other time. For treatment the following mode of drug dosing is recommended to patients with normal or moderately reduced function of kidneys (clearance of creatinine & gt, 50 ml/min.): – acute sinusitis: on 500 mg of 1 times a day, the course of treatment makes 10-14 days, – exacerbation of chronic bronchitis: on 500 mg of 1 times a day, a course of treatment – 7 days, – extra hospital pneumonia: on 500 mg of 1 times a day, a course of treatment – 7-14 days, – uncomplicated cystitis: on 250 mg of 1 times a day, a course of treatment – 3 days, – the complicated infections of urinary tract and acute pyelonephritis: on 500 mg of 1 times a day, a course of treatment – 7-14 days, – chronic bacterial prostatitis: on 500 mg of 1 times a day, a course of treatment – 28 days, – uncomplicated infections of skin and soft tissues: on 500 mg 1-2 times a day, a course of treatment – 7-14 days. Dosing for patients with impaired renal function (clearance of creatinine & lt, 50 ml/min.) Clearance of creatinine the dosing Mode (depending on weight of an infection) 50–20 ml/min. the first dose of 250 mg following: 125 mg / 24 hour the first dose: 500 mg following: 250 mg / 24 hour the first dose: 500 mg following: 250 mg / 12 hour of 19-10 ml/min. the first dose: 250 mg following: 125 mg / 48 hours the first dose: 500 mg following: 125 mg / 24 hour the first dose: 500 mg following: 125 mg / 12 hour & lt, 10 ml/min., (and also at a hemodialysis and HAPD1) the first dose: 250 mg following: 125 mg / 48 hours the first dose: 500 mg following: 125 mg / 24 hour the first dose: 500 mg following: 125 mg / 24 1 After a hemodialysis or the chronic out-patient peritoneal dialysis (COPPD) additional doses are not necessary hour. Patients from the liver broken by function the Dose adjustment is not required as levofloxacin is not exposed to significant metabolism in a liver and is removed, mainly, by kidneys. Patients of advanced age Dose adjustment is not required from patients of advanced age, except for that which can be necessary in case of a renal failure (see the section “Special Instructions” “Tendinitis and a rupture of sinews” and ‘Lengthening of an interval of QT’). Children Levofloxacin is contraindicated to children and teenagers up to 18 years. It is necessary to take the drug Tablet Left Xyhoney, at least, two hours to or after administration of drugs containing iron, zinc salts, magnesium, aluminum, antacids or didanozin (only didanozin in a combination with aluminum or magnesium), sukralfat, because of possible reduction of absorption of a levofloksatsin. Side effects Side effects can be conditionally classified by occurrence frequency on the following groups: Very often (≥ 1/10), it is frequent (≥ 1/100, & lt, 1/10), infrequently (≥ 1/1.000, ≤ 1/100), is rare (≥ 1/10.000, ≤ 1/1.000), is very rare (≤ 1/10.000), it is unknown (it cannot be established on the available data). Often (≥1/100, & lt, 1/10) – insomnia, a headache, dizziness – nausea, vomiting, diarrhea – increase in level of liver enzymes for example, alaninaminotranspherases (ALT) and aspartate aminotransferases (nuclear heating plant), the alkaline phosphatase (AP), gamma glutamiltranspeptidazy (GGTP)) Infrequently (≥1/1000, & lt, 1/100) – a fungal infection, including Candida infection – resistance of a pathogen – a leukopenia, an eosinophilia – anorexia – concern – a condition of confusion of consciousness, hyperexcitability – drowsiness, a tremor, a dysgeusia – vertigo – an asthma – an abdominal pain, dyspepsia, a meteorism, a constipation – increase in level of bilirubin in blood – rash, an itching, urticaria, a hyperhidrosis – an arthralgia, myalgia – increase in level of creatinine in blood – an asthenia Seldom (≥1/10000, & lt, 1/1000) – thrombocytopenia, a neutropenia – a Quincke’s disease, hypersensitivity – the hypoglycemia, in particular at patients with diabetes is psychotic reactions (for example, with hallucinations, paranoia) – a depression, agitation – unusual dreams, nightmares – convulsions – paresthesia – a disorder of vision, such as illegibility – tinnitus – tachycardia, heartbeat – hypotension – diseases of sinews, including a tendinitis (for example, an Achilles tendon) – muscle weakness which can be of particular importance at patients, of patients a myasthenia gravis – an acute renal failure (for example, owing to interstitial nephrite) – the pyrexia Frequency is unknown – a pancytopenia, an agranulocytosis, hemolytic anemia – an acute anaphylaxis (anaphylactic and anaphylactoid reactions can sometimes arise even after introduction of the first dose of drug) – anaphylactoid shock (skin and mucous reactions can sometimes arise even after introduction of the first dose of drug) – a hyperglycemia – a hypoglycemic coma – psychotic disorders with the behavior constituting danger to the patient including suicide thinking or attempt of a suicide – peripheral touch neuropathy – peripheral sensomotor neuropathy – a parosmiya including an anosmia – dyskinesia, extrapyramidal disorder – an ageusia – a faint – benign intracranial hypertensia – temporary loss of sight – loss, a hearing disorder – ventricular tachycardia which can lead to cardiac arrest. – ventricular arrhythmia and torsade de pointes of ventricles (it is observed generally at the patients having risk factors of lengthening of an interval of QT), lengthening of an interval of QT on the ECG – a bronchospasm, an allergic pneumonitis – diarrhea – hemorrhagic, seldom or never can indicate presence of a coloenteritis, including pseudomembranous colitis, pancreatitis – jaundice and heavy injury of a liver, including cases of an acute liver failure with a lethal outcome, mainly, at patients with a serious basic disease, hepatitis – a toxic epidermal necrolysis, Stephens-Johnson’s syndrome, a polymorphic erythema, reaction of a photosensitization, a leykotsitoklastichesky vasculitis, stomatitis – the rhabdomyolysis, a rupture of sinews (for example, an Achilles tendon) – a rupture of ligaments, muscles – arthritis – pain (including a dorsodynia, breasts and extremities) Other undesirable effects which were connected with use of ftorkhinolon, include: – porphyria attacks at patients with a porphyria. Contraindications – hypersensitivity to a levofloksatsin or other hinolona and also other excipients – epilepsy – existence now or in the anamnesis of diseases of the sinews tied with use of ftorkhinolon – pregnancy and the period of a lactation – children’s and teenage age up to 18 years Medicinal interactions the Pharmacokinetics of a levofloksatsin did not change in clinically significant degree when a levofloksatsina it was applied together with the following medicines: calcium carbonate, digoxin, glibenclamide, ranitidine. Effect of other medicines on levofloxacin: Salts of iron, zinc, the antiacid drugs containing magnesium or aluminum didanozin Absorption of a levofloksatsin considerably decreases at use along with Levoksimeda of salts of iron, zinc, antiacid drugs containing magnesium or aluminum, or a didanozin (only the forms of a didanozin containing buffer substances with aluminum or magnesium). Simultaneous use of the ftorkhinolon and polyvitaminic drugs incorporating zinc reduces their absorption at oral administration. It is recommended not to take the drugs supporting two – or trivalent cations, such as salts of iron, zinc, the antiacid drugs containing magnesium or aluminum, or didanozin (only dosage forms containing buffer substances with aluminum or magnesium) in 2 hours prior to or in 2 hours after administration of drug. Salts of calcium render the minimum effect on absorption of a levofloksatsin at oral administration. Sukralfat Biodostupnost of a levofloksatsin considerably decreases at its use along with sukralfaty. If the patient needs to accept and sukralfat, and Left xyhoney, it is the best of all to accept sukralfat in 2 hours after administration of drug. Interaction of medicines with levofloksatsiny: Theophylline, fenbufen and non-steroidal anti-inflammatory drugs (NPVS) during clinical trial pharmacokinetic interactions of a levofloksatsin and theophylline were not revealed. However considerable reduction of the threshold of epileptic readiness at simultaneous use of the ftorkhinolon and theophylline, non-steroidal anti-inflammatory drugs or other medicines reducing a threshold of convulsive readiness can be observed. At use of drug along with fenbufeny the concentration of a levofloksatsin was about 13% higher. Probenetsid and Tsimetidin Levofloxacin should be applied with care together with the drugs affecting canalicular secretion such as probenetsid and Cimetidinum, especially at patients with renal failures. Other important information of the Research of clinical pharmacology showed that use of this drug together with the following medicines had no clinically significant impact on pharmacokinetics of a levofloksatsin: calcium carbonate, digoxin, glibenclamide, ranitidine. Action of a levofloksatsin on other medicines Cyclosporine Elimination half-life of cyclosporine increased by 33% at use together with levofloksatsiny. Antagonists of vitamin K It was reported about cases of increase in indicators of coagulative tests (PV/MNO) and/or developing of bleeding, perhaps, heavy, at the patients undergoing treatment using a combination of a levofloksatsin and the antagonist of vitamin K (for example, warfarin), Thus, it is necessary to carry out monitoring of results of coagulative tests at the patients undergoing treatment using antagonists of vitamin K. The medicines causing lengthening of an interval QT Levofloxacin, as well as other ftorkhinolona should be applied with care at patsy
the t taking the drugs causing lengthening of an interval of QT (for example, antiarrhythmic drugs of the class IA and III, tricyclic antidepressants, macroleads, neuroleptics). In researches of pharmacokinetic interactions levofloxacin did not affect theophylline pharmacokinetics (marker CYP1A2 substrate) that indicates that levofloxacin is not CYP1A2 inhibitor. Special instructions the probability that Methicillinum – resistant golden staphylococcus will also be resistant to ftorkhinolona, including levofloxacin Is high. Therefore, levofloxacin is not recommended to be applied at treatment of infections which were caused Methicillinum – resistant staphylococcus, or there are such suspicions if results of laboratory analyses did not confirm sensitivity of a microorganism to a levofloksatsin (and also if use of the antibacterial agents which are usually appointed at treatment of the infections caused Methicillinum – resistant staphylococcus, is considered inexpedient). The tendinitis and a rupture of sinews In rare instances can arise a tendinitis. Most often the Achilles tendon is surprised, the tendinitis can lead to a rupture of a sinew. The tendinitis and a rupture of a sinew, in certain cases bilateral, can arise during 48 h after an initiation of treatment levofloksatsiny, was also reported about cases of developing of these pathologies within several months after the treatment termination. Risk of developing a tendinitis and a rupture of sinews increases at patients 60 years, at the patients accepting daily doses of 1000 mg are more senior and also at reception of corticosteroids. The daily dose at patients of advanced age should be adjusted depending on clearance of creatinine. Therefore, it is necessary to conduct careful monitoring of such patients when assigning a levofloksatsin. At emergence of symptoms of a tendinitis all patients should see the attending physician. At suspicion of a tendinitis it is necessary to stop immediately use of a levofloksatsin and to begin the corresponding treatment of the injured sinew (for example, having provided it a sufficient immobilization). The disease caused by Clostridium difficile Diarrhea, especially heavy, persistent and/or with blood impurity in time or after treatment levofloksatsiny (including several weeks after completion of treatment), can be a symptom of the disease caused by Clostridium difficile. The diseases caused by Clostridium difficile can vary on severity from lungs to life-threatening, at the same time the most severe form is pseudomembranous colitis. Thus, it is important to mean this diagnosis if at patients the heavy diarrhea develops in time or after treatment using a levofloksatsin. At suspicion of the disease caused by Clostridium difficile it is necessary to stop immediately use of a levofloksatsin and to begin the corresponding treatment immediately. Use of antiperistaltic drugs in this clinical situation is contraindicated. The patients predisposed to developing of spasms of Hinolona can reduce a threshold of convulsive readiness and provoke spasms. Levofloxacin is contraindicated to the patients having epilepsy in the anamnesis and, as well as it is necessary to use other hinolona, this drug with extra care at the patients predisposed to developing of spasms or when performing the accompanying treatment by use of medicines which active agents (for example, theophylline) reduce a threshold of convulsive readiness. In case of developing of convulsive spasms it is necessary to stop treatment using a levofloksatsin. Patients with insufficiency glyukozo-6-fosfatdegidrogenazy At the patients having the hidden or obvious disturbances of activity glyukozo-6-fosfatdegidrogenazy the predisposition to hemolytic reactions when performing treatment can be observed by hinolonovy antibacterial drugs. Thus, in need of use of a levofloksatsin for such patients it is necessary to observe them regarding hemolysis emergence. Patients with a renal failure As levofloxacin is generally excreted by kidneys, at patients with disturbance of their function it is necessary to adjust a dose of a levofloksatsin. Reactions of hypersensitivity Levofloxacin can cause heavy and potentially lethal reactions of hypersensitivity, (for example, a Quincke’s disease up to an acute anaphylaxis) which sometimes arise after introduction of the first dose of drug. Patients should stop immediately treatment and to contact the attending physician or the emergency doctor for rendering the appropriate emergency aid. Heavy bullous reactions At use of a levofloksatsin it was reported about cases of emergence of heavy bullous skin reactions, such as Stephens-Johnson’s syndrome or a toxic epidermal necrolysis. Patients should recommend to contact immediately the attending physician at emergence of reactions on skin / mucous membranes before continuing treatment. A dysglycemia As well as at use of all hinolon, it was reported about emergence of disturbances of content of glucose in blood, including both hypo – and a hyperglycemia which were usually observed at the patients with diabetes undergoing the accompanying treatment using oral hypoglycemic drugs (for example, glibenclamide) or insulin. It was reported about cases of a hypoglycemic coma. At patients with diabetes it is recommended to watch carefully glucose level in blood. Prevention of a photosensitization It was reported about emergence of a photosensitization at use of a levofloksatsin. For prevention of development of a photosensitization it is not recommended to patients without need to be affected by strong solar or artificial UF of radiation (for example, UF a lamp, a sunbed), during treatment and during 48 h after its termination. The patients undergoing treatment using antagonists of vitamin K Because of possible increase in indicators of coagulative tests (PV/MNO) and/or developing of bleeding it is necessary to carry out monitoring of results of coagulative tests at the patients undergoing treatment using a combination of a levofloksatsin and the antagonist of vitamin K (for example, warfarin), at simultaneous use of these drugs. Psychotic reactions It was reported about cases of emergence of psychotic reactions at the patients receiving hinolona including levofloxacin. Seldom or never even after single use of a dose of a levofloksatsin, similar reactions progressed before the emergence of suicide thoughts and behavior constituting danger to the patient. In case of similar reactions it is necessary to stop reception of a levofloksatsin and to take the appropriate measures. Levofloxacin should be applied with care at patients with the loony or in the presence in the anamnesis of psychiatric diseases. Lengthening of an interval of QT of Ftorkhinolona, including levofloxacin, should be applied with care at patients who have known risk factors of lengthening of an interval of QT, such as: – a congenital syndrome of lengthening of an interval of QT – the accompanying use of the medicines causing lengthening of an interval of QT (for example, antiarrhythmic drugs of the class IA and III, tricyclic antidepressants, macroleads, neuroleptics) – not corrected disturbance of balance of electrolytes (for example, a hypopotassemia, a hypomagnesiemia) – heart diseases (for example, heart failure, a myocardial infarction, bradycardia). Patients of advanced age and women can be more sensitive to the drugs causing lengthening of an interval of QT. Therefore, ftorkhinolona including levofloxacin, it is necessary to apply with care at these groups of patients. Peripheral neuropathy It was reported about emergence at the patients receiving ftorkhinolona, including levofloxacin, peripheral touch neuropathy and peripheral sensomotor neuropathy which could develop pretty fast. At emergence of symptoms of neuropathy it is necessary to stop use of a levofloksatsin for prevention of development of irreversible disturbances. Disturbances from a liver and biliary tract It was reported about liver necrosis cases up to a liver failure with a lethal outcome at use of a levofloksatsin, mainly, at patients with a serious basic disease, for example, sepsis. Patients should recommend to stop treatment and to contact the attending physician at emergence of symptoms and symptoms of a disease of a liver, such as anorexia, jaundice, dark urine, itching and morbidity of a stomach. Aggravation a myasthenia gravis Ftorkhinolona, including levofloxacin, have the neuromuscular blocking activity and can strengthen muscle weakness at the patients suffering from a myasthenia gravis. Serious undesirable reactions, including cases of death and need for auxiliary artificial ventilation of the lungs which arose during post-marketing observation, were connected with use of ftorkhinolon for the patients suffering from a myasthenia gravis. It is not recommended to apply levofloxacin in the presence at the patient in the anamnesis of a myasthenia gravis. Disorders of vision During the developing of disorders of vision or manifestation of influence of administration of drug on eyes it is necessary to address the ophthalmologist immediately. Superinfection, especially for a long time, can lead Use of a levofloksatsin to the overgrowth of insensitive microorganisms. At emergence of superinfection during treatment it is necessary to take the appropriate measures. Influence on results of laboratory researches At the patients undergoing treatment using a levofloksatsin, the analysis on definition of opiates in urine can yield false positive results. Can be required to confirm results of analyses on presence of opiates with use of more specific method. Levofloxacin can suppress growth of Mycobacterium tuberculosis and, therefore, be the cause of false-negative results of bacteriological diagnosis of tuberculosis. Pregnancy Exists limited amount of data on use of a levofloksatsin for pregnant women. Preclinical trials, did not reveal direct or indirect harmful effects in terms of reproductive toxicity. However in the absence of clinical data and also because experimental data confirm risk of damage of a ftorkhinolonama of the cartilages bearing weight loading in the growing organism it is not necessary to apply levofloxacin at pregnant women. The lactation period Levofloxacin is contraindicated to women during breastfeeding. At the moment there is not enough information concerning discharge of a levofloksatsin with breast milk, however it is known that other ftorkhinolona are allocated with breast milk. In the absence of clinical data and also because experimental data confirm risk of damage of a ftorkhinolonama of the cartilages bearing weight loading in the growing organism it is not necessary to apply levofloxacin at women during breastfeeding. Fertility Levofloxacin did not cause disturbance of fertility or reproductive function in preclinical trials. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Some side effects, for example, dizziness, drowsiness, disorders of vision, can reduce ability of the patient to concentration of attention and speed of its reactions that can constitute danger in situations where such abilities are especially important (for example, when driving and working mechanisms). Overdose Symptoms: nausea, erosive damages of a mucous membrane of digestive tract, dizziness, confusion of consciousness, disturbance of consciousness and attacks of spasms, hallucinations, tremor, increase in an interval of QT. Treatment: Drug withdrawal, symptomatic treatment, the ECG monitoring for an exception of lengthening of an interval of QT. The hemodialysis, peritoneal dialysis are inefficient. There is no specific antidote. A release form On 7 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. To Store 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 the Producer “UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh.”, TURKEY (Bagdzhylar Ilchesi, Gyuneshli, Evren Makhallesi, Dzhami Yolu Dzhad. No. 50 K. 1В Zemin 4-5-6, Istanbul) “WORLD MEDICINE İLAÇ SAN. VE TIC. A.Ş.”, TURKEY (Bağcılar İlçesi, Güneşli, Evren Mahallesi, Cami Yolu Cad. No: 50 K. 1B of Zemin 4-5-6, İstanbul). Owner of the registration certificate “UORLD of ILACh DIGNITY MEDICINE. VE TIDZh. A.Sh.”, TURKEY the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products of RK, Almaty, Turksibsky district, Suyunbaya Ave., 222b Ph. / fax: 8 (7272) 529090 Address of the organization responsible for post-registration observation of safety of medicine, TROKA-S PHARMA LLP, Almaty, Suyunbaya Ave., 222b Cellular ph. +7 701 786 33 98, (24-hour access).
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