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Xarelto ® 10s 10 mg film-coated tablets

$88.60

1312a867fa30

Description

The instruction for medical use of Xarelto ®â medicine the Trade name of Xarelto ® â Mezhdunarodnoye the unlicensed name Rivaroksaban Lekarstvennaya the Tablet form, film coated, 10 mg Structure One tablet contains active agent – the rivaroksaban micronized 10 mg, excipients: microcrystalline cellulose, sodium of a kroskarmelloz, gipromelloz 5sr (hydroksipropilmetiltsellyuloza of 2910), lactoses monohydrate, magnesium stearate, sodium lauryl sulfate, structure of a cover: gland (ІІІ) oxide red (E172), gipromelloza 15 sr (hydroksipropilmetiltsellyuloza of 2910), macrogoal 3350 (polyethyleneglycol (3350)), titan dioxide (E171). The description Round biconvex tablets of light-red color, film coated, with an engraving: on one party – a triangle with designation of a dosage (10), on another – a signature bayerovsky cross. Pharmacotherapeutic group the Drugs influencing a hemopoiesis and blood. Anticoagulants. Direct inhibitors Ha factor. Rivaroksaban. The ATX B01AF01 code the Pharmacological Pharmacokinetics Absorption properties and bioavailability Rivaroksaban is quickly soaked up, the maximum concentration (Smaks.) are reached in 2-4 hours after reception of a tablet. After intake absorption of a rivaroksaban almost full, and absolute bioavailability after reception of a dose of 10 mg high (80-100%) irrespective of meal. Meal does not influence PKK (the area under a curve concentration – time) or Smaks (maximum concentration) of a rivaroksaban in a dose of 10 mg. A pill rivaroksaban in a dose of 10 mg can be taken both together with food, and without food. The pharmacokinetics of a rivaroksaban has almost linear character at reception of a dose to 15 mg once a day. At higher doses the restriction of absorption of a rivaroksaban with decrease in its bioavailability and reduction in the rate of absorption in process of increase of a dose of drug is noted. These changes are more significant on an empty stomach, than at meal. The pharmacokinetics of a rivaroksaban is characterized by moderate individual variability, the individual variability (variation coefficient, %) is from 30% to 40%. Absorption of a rivaroksaban depends on the site of release of drug in digestive tract. It is reported about decrease in PKK and Cmax by 29% and 56%, respectively, at release of granules of a rivaroksaban in proximal department of a small intestine, in comparison with tablets. Further exposure decreases when drug is released in distal department of a small intestine or in the ascending department of a large intestine. Therefore it is necessary to avoid introduction of a rivaroksaban to distal department of a stomach as it can lead to decrease in absorption and as a result – to decrease in exposure of a rivaroksaban. The bioavailability (PKK and Cmax) was comparable for 20 mg of the rivaroksaban entered orally in the form of the crushed tablet mixed with apple puree or divorced in water and entered via the gastric tube with the subsequent intake of liquid food in comparison with reception of an integral tablet. Taking into account a pharmacokinetic profile of a rivaroksaban predictable, proportional to a dose, the value of bioavailability received in this research, most likely, is applicable also to lower doses of a rivaroksaban. Distribution In a human body bólshaya a part of a rivaroksaban (92-95%) contacts proteins of plasma which main connecting component is seralbumin. Distribution volume – average, Vss is about 50 l. Metabolism and removal About 2/3 of the accepted dose of a rivaroksaban is exposed to metabolic degradation and then is removed with urine and a stake in identical ratios. Remained 1/3 accepted doses it is removed in not changed look by means of direct renal excretion, mainly, due to active renal secretion. Metabolism of a rivaroksaban is carried out by isoenzymes of CYP3A4, CYP2J2 and mechanisms, not dependent on the system of P450 cytochrome. The main sites of biotransformation are the morfolinonovy group which is exposed to oxidizing degradation and the amide bridges which are exposed to hydrolysis. According to the data obtained by in vitro rivaroksaban also Bcrp (squirrel of resistance to a breast cancer) is substrate of proteins carriers R-gp (a glycoprotein P). Not changed rivaroksaban is the most important connection in human plasma, the significant or active circulating metabolites in plasma are absent. Rivaroksaban whose system clearance is about 10 l/h can be carried to medicinal substances with low clearance. After intravenous administration of a rivaroksaban in a dose of 1 mg the elimination half-life makes about 4.5 hours. After oral administration the removal depends on absorption speed. At removal of a rivaroksaban from plasma the terminal elimination half-life makes from 5 to 9 hours at young faces and from 11 to 13 hours at older persons. Separate populations of Paule At men and women of clinically significant distinctions of pharmacokinetics and a pharmacodynamics it is not revealed. Advanced age At elderly patients concentration of a rivaroksaban in plasma is higher, than at young patients, average PKK is about 1.5 times higher, than at young patients, mainly, owing to the reduced general (seeming) and renal clearance. Dose adjustment is not required. Various weight categories Too small or too big weight (& lt, 50 kg or & gt, 120 kg) only slightly affects concentration of a rivaroksaban in plasma (less than for 25%). Dose adjustment is not required. Interethnic distinctions of Clinically significant distinctions of pharmacokinetics and a pharmacodynamics of a rivaroksaban at patients of Caucasian, African American, Latin American, Japanese or Chinese ethnic origin it was not observed. The liver failure At patients with cirrhosis and a slight liver failure (class A on classification of Chayld-Pyyu) pharmacokinetics of a rivaroksaban differs slightly that is expressed by increase in PKK of a rivaroksaban on average by 1.2 times and is comparable to an indicator in control group of healthy faces. For patients with cirrhosis with a moderate liver failure (class B on classification of Chayld-Pyyu) average PKK of a rivaroksaban considerably increased by 2.3 times in comparison with healthy volunteers, free PKK raised by 2.6 times. At these patients the decrease in renal elimination of a rivaroksaban similar to that at patients with a moderate renal failure is also noted. Data at patients with a heavy liver failure are absent. At patients with a moderate liver failure the suppression of activity Ha of a factor was significant stronger (by 2.6 times), than healthy volunteers, had an identical lengthening of a prothrombin time and was 2.1 times. Patients with a moderate liver failure were more sensitive to a rivaroksaban that was expressed in higher pharmacokinetic and pharmakodinamichesky interrelation between concentration of a rivaroksaban and a prothrombin time. Ксарелто® it is contraindicated to patients with the liver diseases which are followed by a coagulopathy and risk of developing clinically significant bleeding including patients with cirrhosis of classes B and C on Chayld-Pyyu (see the section Contraindications). A renal failure At patients with a renal failure the increase in exposure of a rivaroksaban correlating with decrease in renal function according to indicators of clearance of creatinine was observed. At patients with easy (clearance of creatinine of 50-80 ml/min.), moderated (clearance of creatinine of 30-49 ml/min.) and heavy (clearance of creatinine of 15-29 ml/min.) the renal failure observed 1.4-, 1.5- and 1.6-fold increase in concentration of a rivaroksaban in plasma (PKK), respectively. The corresponding increase in pharmakodinamichesky effects was more expressed. At patients with a slight, moderate and heavy renal failure the general suppression of activity Ha of a factor of blood amplified in 1,5, 1,9 and 2 times, respectively, in comparison with healthy volunteers, at the corresponding lengthening of a prothrombin time in 1,3, 2,2 and 2.4 times, respectively. Given at patients with clearance of creatinine & lt, 15 ml/min. are absent. Owing to considerable linking with proteins of plasma of removal of a rivaroksaban by means of dialysis it is not expected. It is not recommended to use drug at patients with clearance of creatinine & lt, 15 ml/min. It is necessary to be careful at use of Xarelto ®® for patients with clearance of creatinine of 15-29 ml/min. (see the section Special Instructions). Pharmacokinetic data at patients At the patients receiving Xarelto ®® in a dose of 10 mg once a day for prevention VTE, average geometrical concentration (interval of forecasting of 90%) in 2-4 hours and about 24 hours after reception (that approximately reflects the maximum and minimum concentration calculated during the period between receptions) made 101 (7-273) and 14 (4-51) mkg/l, respectively. Pharmacokinetic / pharmakodinamicheskaya interrelation Pharmacokinetic / pharmakodinamicheskaya the interrelation between concentration of a rivaroksaban in blood plasma and several pharmakodinamichesky parameters (inhibition Ha of a factor, the prothrombin time (PT), AChTV, HepTest®) was investigated after administration of drug in the wide range of doses (5 – 30 mg 2 times a day). The interrelation of concentration of a rivaroksaban in blood plasma and activity of Xa of a factor is best described on model of Emaks. Data on PV in general were described better on linear model of pieces. Depending on reagent for definition of PV the biases of curves considerably differed. When using Neoplastin PT reagent initial PV made about 13 seconds, and a curve bias – about 3-4 seconds on 100 mkg/l. Results of the analysis of pharmacokinetics and a pharmacodynamics in clinical trials of II and III phase corresponded to data at healthy volunteers. Ha and PV at patients influenced initial level of a factor the surgical intervention resulting in differences in concentration of PV of a bias during the period between posleoperatsinny day and equilibrium concentration. The children’s age Safety and efficiency at children and teenagers is younger than 18 years is not established. A pharmacodynamics the action Mechanism Rivaroksaban – the high-selection direct inhibitor Ha a factor having high bioavailability at oral administration. The inhibition of Xa of a factor interrupts internal and external ways of a cascade of fibrillation that leads both formation of thrombin, and forming of blood clots to suppression. Rivaroksaban does not inhibit thrombin (the activated II factor) and does not influence thrombocytes. Pharmakodinamichesky effects of the Research at the person showed existence of dose-dependent suppression of activity Ha of a factor. Rivaroksaban has dose-dependent impact on a prothrombin time and closely correlates with concentration in plasma (r=0.98) if for the analysis Neoplastin® reagent is used. When using other reagents the results can differ. Instrument reading should be taken in seconds as INR (the international normalized relation) is calibrated and validizirovano only for coumarins and it cannot be applied to other anticoagulants. At patients to whom large orthopedic operations are performed 5/95 percentiles for a prothrombin (Neoplastin®) in 2-4 hours after reception of a tablet (i.e. during achievement of the maximum effect) vary from 13 to 25 seconds. Also rivaroksaban dozozavisimo increases the activated partial tromboplastinovy time (APTT) and result of HepTest®, however these parameters are not recommended to be used for assessment of pharmakodinamichesky effects of a rivaroksaban. During treatment of Xarelto ®â carrying out routine monitoring of parameters of fibrillation is not required. However at the clinical indication the level of a rivaroksaban can be measured by means of the calibrated quantitative test for activity of drug against Ha factor. Clinical performance and safety Prevention of a venous thrombembolia (VTE) at adult patients with the planned prosthetics of a hip or knee joint. Table 1: The results of efficiency and safety received in clinical trials of the III phase RECORD 1 RECORD 2 RECORD 3 Studied Population 4541 patients who were exposed to total endoprosthesis replacement of a hip joint of 2509 patients who were exposed to total endoprosthesis replacement of a hip joint 2531 patients who were exposed to total endoprosthesis replacement of a knee joint the Dosage and duration of treatment Rivarok-saban of 10 mg of 1 times a day 35 ± 4 days Enoksa-parin of 40 mg of 1 times a day 35 ± 4 days P Rivarok-saban of 10 mg of 1 times a day 35 ± 4 days Enoksa-parin of 40 mg of 1 times a day 35 ± 4 days P Rivarok-saban of 10 mg of 1 times a day 35 ± 4 days Enoksa-parin of 40 mg of 1 times a day 35 ± 4 days of P of All of cases of VTE 18 (1.1%) 58 (3.7%) & lt, 0.001 17 (2.0%) 81 (9.3%) & lt, 0.001 79 (9.6%) 166 (18.9%) & lt, 0.001 Frequency of cases of heavy VTE 4 (0.2%) 33 (2.0%) & lt, 0.001 6 (0.6%) 49 (5.1%) & lt, 0.001 9 (1.0%) 24 (2.6%) 0.01 Simptomnaya of VTE 6 (0.4%) 11 (0.7%) 3 (0.4%) 15 (1.7%) 8 (1.0%) 24 (2.7%) Massive bleedings 6 (0.3%) 2 (0.1%) 1 (0.1%) 1 (0.1%) 7 (0.6%) 6 (0.5%) the Analysis of the grouped results of tests of phase III confirm the data obtained in separate researches concerning decrease in total number of cases of VTE, cases of heavy VTE and simptomny VTE at reception of Xarelto ®â 10 mg in comparison with enoksapariny 40 mg once a day once a day. Results on efficiency and safety of research III of the phase Einstein Choice Studied Population of 3.396 Patients the Medical dose of Ксарелто® 20 mg of 1 Settl. Account, N=1.107 Ксарелто® 10 of mg of 1 Settl. Account, N=1.127 Acetylsalicylic acid of 100 mg 1 r / by days, N=1.131 the treatment Duration [interquartile range] of 349 [189-362] days of 353 [190-362] days of 350 [186-362] days the Simptomny recurrence of VTE 17 (1.5%)* 13 (1.2%) ** 50 (4.4%) the Simptomny recurrence of TELA 6 (0.5%) 6 (0.5%) 19 (1.7%) the Simptomny recurrence of TGV 9 (0.8%) 8 (0.7%) 30 (2.7%) Fatal TELA / death when TELA cannot exclude 2 (0.2%) 0 2 (0.2%) the Simptomny recurrence of VTE, IM, a stroke or a system embolism out of central nervous system 19 (1.7%) 18 (1.6%) 56 (5.0%) Big bleedings 6 (0.5%) 5 (0.4%) 3 (0.3%) Clinically significant small bleeding 30 (2.7) 22 (2.6) 20 (1.8) Simptomny recurrence of VTE or big bleeding (pure clinical advantage) 23 (1.2%) + 17 (1.5%) ++ 53 (4.7%) * p&lt, 0.001 (superiority) of Ксарелто® 20 mg r / days in comparison with acetylsalicylic acid of 100 mg r / days, the SHOUTING =0.34 (0.20-0.59) ** p&lt, 0.001 (superiority) of Ксарелто® 10 mg r / days in comparison with acetylsalicylic acid of 100 mg r / days, the SHOUTING =0.26 (0.14-0.47) + Ксарелто® 20 mg r / days in comparison with acetylsalicylic acid of 100 mg r / days, the SHOUTING =0.44 (0.2®7–0.71), p=0.0009 (nominally) ++ Xarelto ® of 10 mg r / days against acetylsalicylic acid of 100 mg r / days, the SHOUTING =0.32 (0.18-0.55), p&lt, 0.0001 (nominally) Indications – prevention of a venous thrombembolia (VTE) at adult patients with the planned prosthetics of a hip or knee joint continued prevention of a recurrence of a venous thrombembolia. – treatment of the deep vein thrombosis (DVT) and pulmonary embolism (TELA), and also prevention of repeated TGV and TELA at adults the Route of administration and doses the Route of administration For intake of Xarelto ®® it is possible to take a pill of 10 mg irrespective of meal. For patients who cannot swallow a tablet entirely the tablet Xarelto ® can be shattered and mixed with water or easy food, such as apple puree, just before reception and to accept orally. The shattered tablet Xarelto ® can be entered via the gastric tube. Before Xarelto ®’s use it is necessary to confirm existence of the probe in a stomach. The shattered tablet should be entered together with a small amount of water via the gastric tube then it needs to be washed with water (see the section Pharmacokinetics). A dosage Prevention of a venous thrombembolia (VTE) at adult patients with the planned prosthetics of a hip or knee joint. The recommended dose of drug makes 1 tablet Xarelto ®â 10 of mg of 1 times a day. The first dose should be accepted in 6-10 hours after operation, on condition of the reached hemostasis. Duration of treatment is defined by type
of big orthopedic operation and depends on individual risk of development of VTE at the patient. – After big a hip joint surgery the recommended duration of treatment is 5 weeks. – After big a knee joint surgery the recommended duration of treatment is 2 weeks. In case of the admission of a dose the patient should take immediately the pill Xarelto ®â and next day to continue reception of 1 times a day, as to the admission of a dose. Treatment of the deep vein thrombosis (DVT) and pulmonary embolism (TELA), and also prevention of repeated TGV and TELA at adults the Recommended dose of Xarelto ®® for initial treatment of sharp TGV or TELA makes 15 mg two times a day within the first 3 weeks, with the subsequent reception of Ксарелто® 20 mg for continuation of therapy and prevention of repeated TGV and TELA once a day. Short-term therapy (at least 3 months) should be considered at patients with TGV and TELA provoked by big tranzitorny risk factors (for example, recent extensive surgeries or an injury). Longer therapy should be considered at patients with provoked by TGV or TELA which are not connected with big tranzitorny risk factors, with unprovoked TGV or TELA or existence in the anamnesis of a recurrence of TGV or TELA. In the presence of indications to the prolonged prevention of a recurrence of TGV and TELA (after treatment of TGV or TELA within at least 6 months) the recommended dose makes 10 mg once a day. Patients with high risk of a recurrence of TGV or TELA, such as presence of the complicated associated diseases or a recurrence of TGV or TELA against the background of the prolonged therapy of Xarelto ®® in a preventive dose of 10 mg once a day, it is necessary to consider reception of a dose of Ксарелто® 20 mg once a day. Duration of treatment and a dose have to be selected individually – after careful assessment of advantage of treatment in relation to risk of bleeding (see the section Special Instructions). Duration the dosing Mode the General daily dose Treatment and prevention of repeated TGV and TELA C 1 for 21 days of 15 mg two times in day of 30 mg About 22 days and further 20 mg once a day 20 mg Prevention of repeated TGV and TELA After completion of therapy of TGV or TELA lasting at least 6 months 10 mg or 20 mg once a day 10 mg or 20 mg If reception of the next dose is missed at reception of a dose 15 mg two times a day (1-21 days of treatment), the patient has to accept immediately Xarelto ®® to provide receipt of a daily dose of 30 mg. For this purpose it is possible to take at the same time 2 pill Xarelto ®® in a dose of 15 mg. Next day it is necessary to continue regular administration of drug in a dose of 15 mg 2 times a day according to the recommended mode. In case of the admission of a dose at administration of drug of 1 times a day the patient should accept immediately Xarelto ®â and next day to continue treatment by reception of 1 times a day according to the recommended mode. It is not necessary to double the accepted dose for compensation of the dose which is passed earlier. Transition from antagonists of K (ABK) vitamin to Xarelto ®® At patients on treatment of TGV and TELA and on prevention of a recurrence of TGV and TELA reception of AVK should be stopped, and at decrease in MNO to ≤ 2.5 it is necessary to begin treatment of Xarelto ®®. Upon transition of patients from AVK to Xarelto ®®, after reception of Xarelto ®® of MNO value will be in a false manner raised. MNO is not suitable for determination of anticoagulating activity of Xarelto ®® and therefore it should not be used for this purpose (see. ‘Medicinal interactions’). Transition with Xarelto ®® on the antagonists of vitamin K (AVK) Exists the probability of insufficient anticoagulating effect upon transition with Xarelto ®® to AVK. In this regard it is necessary to provide continuous sufficient anticoagulating effect during any transition to other anticoagulant. It should be noted that Xarelto ®® can promote increase in MNO. Upon transition with Xarelto ®® to AVK, Xarelto ®® it is necessary to accept along with AVK until MNO does not reach an indicator ≥2.0. During the first two days of a transition period it is necessary to apply a standard initial dose of AVK with the subsequent purpose of a dose of AVK on the basis of definitions of MNO. During a concomitant use of Xarelto ®® and ABK, MHO it is necessary to define not earlier than in 24 hours after reception of the previous dose and before reception of the following dose of Xarelto ®®. After phase-out of Xarelto ®® reliable definition of MNO it is possible to carry out a minimum in 24 hours after reception of the last dose of drug (see the sections Medicinal Interactions and Pharmacokinetics). Transition from parenteral anticoagulants to Xarelto ®® For the patients receiving parenteral anticoagulants it is necessary to cancel parenteral anticoagulant, Xarelto ®® should be accepted in 0-2 hours until the following planned administration of parenteral drug (for example, low-molecular heparin) or at the time of the termination of continuous administration of parenteral drug (for example, intravenous administration of unfractionated heparin). Transition with Xarelto ®® to parenteral anticoagulants It is necessary to cancel Xarelto ®® and to enter the first dose of parenteral anticoagulant into the moment when the following dose of Xarelto ®® had to be accepted. Additional information on separate populations of patients the Renal failure Limited clinical data on use of Xarelto ®â for patients with a heavy renal failure (clearance of creatinine of 15-29 ml/min.) indicate substantial increase of levels of a rivaroksaban in plasma. In this regard it is necessary to apply with care Xarelto ®® in this group of patients. Use of Xarelto ®â is not recommended at patients with clearance of creatinine & lt, 15 ml/min. – For prevention of a venous thrombembolia (VTE) at adult patients with the planned prosthetics of a hip or knee joint are not required dose adjustment of Xarelto ®â from patients with a slight renal failure with clearance of creatinine of 50-80 ml/min. or a moderate renal failure with clearance of creatinine of 30-49 ml/min. – For treatment of the deep vein thrombosis (DVT) and a pulmonary embolism (TELA), and also prevention of repeated TGV and TELA is not required dose adjustment of Xarelto ®â from patients with a slight renal failure with clearance of creatinine of 50-80 ml/min. In a moderate renal failure (clearance of creatinine of 30-49 ml/min.) or from a heavy renal failure (clearance of creatinine of 15-29 ml/min.) the patients have to accept 15 mg two times a day within the first 3 weeks. Then the recommended dose makes 20 mg once a day. The dose decline from 20 mg up to 15 mg should be considered once a day once a day when the estimated risk of bleeding at the patient prevails over risk of repeated TGV and TELA. The recommendation of use of 15 mg is based on pharmacokinetic modeling once a day and not studied in clinical conditions at this state. At the recommended daily dose of drug of 10 mg of 1 times a day the dose adjustment of Xarelto ®â is not required. A liver failure Use of Xarelto ®â is contraindicated at patients with the liver diseases which are followed by a coagulopathy and risk of developing clinically significant bleeding including cirrhosis of the class B and C on classification of Chayld-Pyyu. Elderly patients of Nie it is required to dose adjustment. The body weight of Nie is required to dose adjustment. Paul Nie is required to dose adjustment. Children and teenagers Safety and efficiency of Xarelto ®â at children and teenagers are younger than 18 years is not established. Available data are absent. Therefore Xarelto ®â is not recommended to use for children and teenagers up to 18 years. Side effects the List of side reactions Summary data on the frequency of the side reactions registered when using Xarelto ®® are given below on classes of systems of bodies (MedDRA) and frequency. Side reactions are determined by frequency as: very frequent (≥ 1/10) frequent (from ≥1/100 to & lt, 1/10) infrequent (from ≥ 1/1000 to & lt, 1/100) rare (from ≥ 1/10000 to & lt, 1/1000) very rare (& lt, 1/10000) with an unknown frequency (frequency cannot be established on the available data) Often (from ≥1/100 to & lt, 1/10) – anemia (including the corresponding laboratory parameters) – dizziness, a headache – a hematopsia (including hemorrhage in a conjunctiva) – arterial hypotension, a hematoma – nasal bleeding, a pneumorrhagia – gingival bleeding, gastrointestinal bleeding (including rectal bleeding), pains in digestive tract and a stomach, dyspepsia, nausea, a constipation *, diarrhea, vomiting * – an itching (including infrequent cases of a generalized itching), rash, ecchymomas, skin and hypodermic hemorrhages – extremity pains * – bleeding from an urogenital path (including a hamaturia and a menorrhagia **), a renal failure (including increase in level of creatinine in blood, increase in level of urea in blood) * – fever *, peripheral hypostases, deterioration in overall health (including fatigue and an asthenia) – increase in level of transaminases – hemorrhages after the carried-out procedures (including postoperative anemia and bleeding from a wound), bruise, discharges from a wound * Infrequently (from ≥1/1000 to & lt, 1/100) – a thrombocytosis (including the raised number of thrombocytes) * – thrombocytopenia – allergic reaction, allergic dermatitis – intracerebral and intracraneal hemorrhages, a faint – tachycardia – dryness in a mouth – an abnormal liver function – urticaria – a hemarthrosis – feeling sick, including an indisposition – increase in levels of bilirubin, alkaline phosphatase *, lactate dehydrogenases (LDG) *, lipases *, amylases *, gamma glyutamiltransferazy (GGT *) in blood – a Quincke’s disease and allergic hypostasis (were observed during post-marketing experience in vremennóy interrelations with use of Xarelto ®®). Seldom (from ≥1/10000 to & lt, 1/1000) – jaundice – a cholestasia, hepatitis, including hepatocellular damage (were observed during post-marketing experience in vremennóy interrelations with use of Xarelto ®®). – hemorrhage in muscles – local hypostasis * – increase in level of the conjugated bilirubin (at the accompanying increase in an alanintrasferaza or without it) – a vascular pseudoaneurysm (it was observed as infrequent at prevention of aterotrombotichesky events at patients after a sharp coronary syndrome (after chrezkozhny intervention on coronary vessels)) Very seldom (& lt, 1/10000) – Stephens Johnson’s syndrome / a toxic epidermal necrolysis (were observed during post-marketing experience in temporary interrelation with use of Xarelto ®®). With an unknown frequency: – a compartment syndrome owing to bleeding – a renal failure / an acute renal failure owing to the bleeding sufficient for development of hypoperfusion * were observed at adult patients when performing prevention of VTE after endoprosthesis replacement of knee or coxofemoral joints ** were observed as very frequent at treatment of TGV, TELA and prevention of their recurrence at women at age & lt, 55 years the Description of some side reactions Considering the pharmacological mechanism of action Xarelto ®®, its use can be followed by the increased risk of the concealed or obvious hemorrhage from any bodies and fabrics which can lead to posthemorrhagic anemia. Signs, symptoms and weight (including a lethal outcome) vary depending on localization and severity or massiveness of bleeding and/or anemia (see the section (Treatment of bleedings). In clinical trials of bleeding from mucous membranes (for example, nasal, gingival
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