Flenox Enoxaparin solution for injections 4000IU/0.4ml syr. №10

Flenox Enoxaparin solution for injections 4000IU/0.4ml syr. №10

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Composition active ingredient: sodium enoxaparin 1 ml of 10,000 anti-XA IU, equivalent to 100 mg of enoxaparin sodium 2000 anti-XA IU/0.2 ml, equivalent to enoxaparin sodium 20 mg 4000 anti-XA IU/0.4 ml, equivalent to enoxaparin sodium 40 mg 6000 anti-XA IU/0.6 ml, equivalent to enoxaparin sodium 60 mg 8000 anti-XA IU/0.8 ml, equivalent to enoxaparin sodium 80 mg excipients: water for injection. Dosage form The solution for injection. Basic physico-chemical properties: transparent colorless or light yellow liquid. Pharmacological group Antithrombotic agents. The group of heparin. Enoxaparin. Code ATH V01A v05. Pharmacological properties Pharmacodynamics. Enoxaparin is a low molecular weight heparin (HMG), which is separated by the antithrombotic and anticoagulant activity of standard heparin. It has higher anti-XA activity than anti-IIA, and antithrombin activity (for enoxaparin, the ratio is 3.6). When used in preventive doses, enoxaparin does not have a significant effect on APTT (activated partial thromboplastin time). When using therapeutic doses of the drug aPTT may be prolonged and in 1,5-2,2 times greater than the control time of maximal activity. This extension reflects the residual antithrombin activity. Treatment of acute myocardial infarction with ST segment elevation in combination with thrombolytic agent in patients who undergo further coronary angioplasty, as well as in patients who do not undergo this procedure. A large multicenter clinical study, 20479 patients with acute myocardial infarction with ST-segment elevation, after they have received fibrinolytic therapy were randomized divided into groups to receive or enoxaparin in the form of a bolus injection of 3,000 anti-XA IU, followed immediately subcutaneously injected dose of 100 anti-XA IU/kg, then held subcutaneous injection of 100 anti-XA IU/kg every 12:00, or for administration of intravenous unfractionated heparin in the form of a bolus injection of 60 IU/kg (maximum 4000 IU/kg) with subsequent continuous infusion at a dose of, which was adjusted according to the activated partial thromboplastin time. Subcutaneous injections of enoxaparin were carried out before discharge from hospital or no more than 8 days (in 75% of cases - at least 6 days). Half of the patients receiving heparin, the drug was administered for at least 48 hours (in 89.5% of cases ? 36 hours). All patients also received acetylsalicylic acid for at least 30 days. The dose of enoxaparin for patients aged ?75 was corrected 0.75 mg/kg (75 anti-Ha IU/kg) in the form of a subcutaneous injection every 12:00 without initial bolus injection. In the course of the study, 4716 (23%) patients underwent coronary angioplasty on the background of antithrombotic therapy with the use of disguised studied drugs. Patients did not receive additional doses, if since the last subcutaneous injection of enoxaparin to inflate the balloon passed less than 8:00, or received bolus intravenous injection of enoxaparin at a dose of 0.3 mg/kg (30 anti-Ha ME/kg), if since the last subcutaneous injection of enoxaparin to inflate the balloon passed more than 8:00. Enoxaparin made it possible to significantly reduce the frequency of events that correspond to primary endpoints (combined end point, including a recurrence of myocardial infarction and mortality for any reason that occurred during the 30-day follow-up period after inclusion in the study: 9.9% in the enoxaparin group compared with 12% in the group of non - fractionated heparin (reduction of relative risk-17% (p<0.001)). The recurrence rate of myocardial infarction was significantly lower in the enoxaparin group (3.4% compared to 5%, p<0.001, relative risk reduction - 31%). Mortality was lower in the enoxaparin group, but the difference between the groups was not statistically significant (6.9% compared to 7.5%, p = 0.11). The advantage of enoxaparin in terms of the primary end point of the indicator was unconditional regardless of the subgroup (age, gender, localization of myocardial infarction, diabetes or myocardial infarction in history, the type of prescribed thrombolytic and the period between the appearance of the first clinical signs and the beginning of treatment). Enoxaparin showed a significant advantage over non-fractionated heparin in terms of primary efficacy in both patients who underwent coronary angioplasty in the 30-day period after inclusion in the study (10.8% compared with 13.9%, 23% reduction in relative risk) and patients who did not undergo coronary angioplasty (9.7% compared with 11.4% reduction in relative risk by 15%). The incidence of massive bleeding before the 30th day was significantly higher in the enoxaparin group (2.1%) compared with the heparin group (1.4%). The incidence of gastrointestinal bleeding was higher in the enoxaparin group (0.5%) than in the heparin group (0.1%), whereas the incidence of intracranial hemorrhage in both groups was the same (0.8% in the case of enoxaparin compared to 0.7% in the case of heparin). The analysis of the combined criteria by which clinical benefit was determined showed a statistically significant advantage (p<0.0001) of enoxaparin over unfractionated heparin: reduction of the relative risk by 14% in favor of enoxaparin (11% compared to 12.8%) for the combined criteria that included death, recurrence of myocardial infarction and severe bleeding (time criteria) until the 30th day, and 17% (10.1% compared with 12.2%) for the combined criteria that, recurrence of myocardial infarction and intracranial hemorrhage until the 30th day. Pharmacokinetics. Pharmacokinetic parameters of the drug are evaluated by changes in anti-Ha and anti - IIA activity in blood plasma over time in the recommended dose ranges. Bioavailability. With subcutaneous injection enoxaparin is absorbed rapidly and almost completely (nearly 100%). The maximum activity in the blood plasma between the 3rd and fourth hours after administration. This maximum activity (expressed in anti-Ha ME) is 0.18 ± 0.04 (after the introduction of 2000 anti-ha ME), 0.43 ± 0.11 (after the introduction of 4000 anti-Ha ME) and 1.01 ± 0.14 (after the introduction of 10,000 anti-Ha ME). Bolus intravenous injection of 30 mg (0.3 ml 3000 anti-Ha IU) with subsequent subcutaneous injections of 1 mg/kg (100 anti-Ha IU/kg) every 12:00 leads to the achievement of the first maximum concentration of the anti-factor ha, is 1.16 IU/ml (n = 16), and the average area under the pharmacokinetic curve corresponding to 88% of the equilibrium level. The equilibrium state is achieved on the second day of treatment. In the recommended dose range, the pharmacokinetics of enoxaparin is linear. The differences in performance between the individual patient and the patients are very small. After repeated subcutaneous administration to healthy volunteers, 40 mg (0.4 ml 4000 anti-XA IU) once a day the equilibrium condition was reached on the 2nd day, the average activity of enoxaparin was almost 15% higher than that observed after a single dose. Stable levels of enoxaparin activity are quite predictable with the introduction of single doses. After repeated subcutaneous administration of 1 mg/kg (100 anti-XA IU/kg) two times a day the equilibrium condition was reached in the period between the third and fourth day, the average AIS was 65% higher than that observed after a single dose, and maximum and minimum anti-XA activity was 1.2 and 0.52 of anti-XA IU/ml, respectively. According to the indicators of pharmacokinetics enoxaparin sodium this difference in achieving equilibrium is also expected for the therapeutic dose range. Anti - Ha activity in plasma after subcutaneous administration is almost 10 times lower than anti-IIA activity. The mean maximum anti-IIA activity is observed approximately 3-4 hours after drug administration, reaching 0,13 anti-XA IU/ml after repeated doses of 1 mg/kg (100 anti-XA IU/kg) twice a day . Distribution. The volume of distribution of sodium enoxaparin on anti-Ha activity is about 5 liters and almost corresponds to the volume of circulating blood. Metabolism. Metabolism enoxaparin occurs mainly in the liver (by desulfurization and depolymerization). Conclusion. After subcutaneous injection the half-life for anti-XA activity of low molecular weight heparins is longer compared to the rate in the unfractionated heparin. The removal of enoxaparin Monophase, the half-life is about 4: 00 after a single subcutaneous injection and almost 7: 00 with the introduction of repeated doses. For low molecular weight heparins characterized by a more rapid decline of anti-IIA activity in plasma compared to anti-XA activity. Enoxaparin and its metabolites are excreted in the urine (unsaturated mechanism), as well as with the bile. Renal clearance of substances with anti-Ha activity is 10% of the administered dose, and the total renal excretion of active and inactive metabolites - 40% of the dose. High-risk groups Patients of advanced age. Since in this age group there is a physiological decline in kidney function, elimination is slower. This does not affect the dosage or the input mode for prophylactic treatment. In patients aged 75 years, it is very important to systematically monitor kidney function with Cocroft formula before starting treatment with HMG. Patients with mild to moderate renal failure (creatinine clearance> 30 ml/min). In some cases, it may be useful to monitor the anti-Ha activity in order to exclude the possibility of overdose if enoxaparin is used in therapeutic doses. Indications Prevention of venous thromboembolism in surgical interventions accompanied by moderate and high thrombogenic risk; prevention of deep vein thrombosis in patients who are on bed rest due to acute therapeutic diseases: heart failure of III or IV grade according to NYHA classification, acute respiratory failure, acute infectious or rheumatic disease, in the presence of at least another risk factor for venous thromboembolism ; prevention of thrombosis in the extracorporeal circuit of blood circulation during hemodialysis (the procedure lasts about 4:00 on average) treatment of diagnosed deep vein thrombosis, which is accompanied or not accompanied by pulmonary embolism and has no severe clinical symptoms, except pulmonary thromboembolism, which requires treatment with thrombolytic agent or surgery treatment of unstable angina and acute myocardial infarction without q tooth in combination with acetylsalicylic acid treatment of acute myocardial infarction with St-segment elevation/elevation in combination with thrombolytic agent in patients who may be further using coronary angioplasty, as well as in patients who do not undergo this procedure. Contraindications For doses 2000 anti-XA IU/0.2 ml, equivalent to enoxaparin sodium 20 mg 4000 anti-XA IU/0.4 ml, equivalent to enoxaparin sodium 40 mg 6000 anti-XA IU/0.6 ml, equivalent to enoxaparin sodium 60 mg 8000 anti-XA IU/0.8 ml, equivalent to enoxaparin sodium 80 mg This drug should not be used in such cases hypersensitivity to enoxaparin, heparin or its derivatives, including other low molecular weight heparins; a history of severe heparin-induced thrombocytopenia (hit) type II caused by the use of unfractionated or low molecular weight heparin (see section "peculiarities of use»); hemorrhagic manifestations or a tendency to bleeding due to violation of hemostasis (except for this contraindication may be disseminated intravascular coagulation syndrome, if it is not associated with the treatment of heparin (see section " Features of application»); organic organ lesions with the probability of bleeding clinically significant active bleeding; active ulcer of the stomach or duodenum; patients receiving heparin for treatment rather than for prevention, local-regional anesthesia for scheduled surgical procedures is not applicable. For doses 2000 anti-XA IU/0.2 ml, equivalent to enoxaparin sodium 20 mg 4000 anti-XA IU/0.4 ml, equivalent to enoxaparin sodium 40 mg This medicine is generally not recommended in such cases severe renal insufficiency (creatinine clearance about 30 ml/min according to the formula of Cockroft-Gault, see section "peculiarities of use»); in the first 24 hours after intracerebral hemorrhage. In addition, it is advisable not to prescribe this drug in prophylactic doses to patients over 65 years of age in combination with such drugs (see section " Interaction with other drugs and other types of interactions »): 1. Acetylsalicylic acid in analgesic, antipyretic and anti-inflammatory doses. 2. NSAIDs (NSAID) (systemic use). 3. Dextran 40 (parenteral introduction). For doses 6000 anti-XA IU/0.6 ml, equivalent to enoxaparin sodium 60 mg 8000 anti-XA IU/0.8 ml, equivalent to enoxaparin sodium 80 mg This medicine is generally not recommended in such cases Intracerebral hemorrhage. Due to the lack of appropriate data, the drug is not used in patients with severe renal insufficiency (creatinine clearance, calculated by the formula of Cocroft, 30 ml/min), except for patients on dialysis. Patients with severe renal insufficiency should be prescribed unfractionated heparin. In order to calculate the Cocroft formula, it is necessary to have the data of the last measurement of the patient's body weight (see section "Features of application"). Spinal or epidural anesthesia should not be used in any case in patients treated with HMG. It is not recommended to use the drug in the following cases: acute extensive ischemic brain stroke with or without loss of consciousness. If the stroke is caused by embolism, in the first 72 hours after the stroke enoxaparin can not be used; the effectiveness of therapeutic doses of NMG is still not determined, regardless of the cause, the magnitude of the lesion or the severity of clinical manifestations of brain infarction acute infectious endocarditis (except for some heart disease caused by embolism) renal insufficiency of mild or moderate severity (creatinine clearance 30-60 ml/min). In addition, this drug is generally not recommended in combination with such agents (see "Interactions with other medicinal products and other forms of interaction»): 1. Acetylsalicylic acid in analgesic, antipyretic and anti-inflammatory doses. 2. NSAIDs (NSAID) (systemic use). 3. Dextran 40 (parenteral application). Interaction with other medicinal products and other forms of interaction. Certain drugs or therapeutic classes may contribute to the development of hyperkalemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II inhibitors, non-steroidal anti-inflammatory agents, heparin (low molecular or unfractionated heparin), ciclosporin and tacrolimus, trimethoprim. The development of hyperkalemia may depend on related risk factors. The risk of its occurrence increases if the above drugs are used simultaneously. Elderly patients (over 65 years). Undesirable combinations. With acetylsalicylic acid in analgesic, antipyretic and anti-inflammatory doses (and similar to other salicylates): increased risk of bleeding (suppression of platelet function by salicylates and lesions of the digestive tract mucosa). You should use antipyretics, analgesics that are not related to salicylates (eg, paracetamol). With NSAIDs, including ketorolak (systemic use) : increased risk of bleeding (inhibition of NSAIDs platelet function and destruction of the digestive tract mucosa). If it is impossible to avoid simultaneous use, a thorough clinical control should be carried out. C dextran 40 (parenteral use) : increased risk of bleeding (depression of 40 functions of platelets with dextran). Combinations that require action . Oral anticoagulants : increased anticoagulant effect. When replacing heparin with oral anticoagulant, clinical observation should be strengthened. Combinations to be considered . With thrombocyte aggregation inhibitors (other than acetylsalicylic acid, analgesic, antipyretic and anti-inflammatory doses of NSAIDs): abciximab, acetylsalicylic acid in antiplatelet doses in cardiological and neurological indications, beraprost, Clopidrogel, eptifibatide, iloprost, tiklopidin, tirofiban : increased risk of bleeding. Patients under the age of 65 years. Combinations to be considered. The combined use of drugs that affect different phases of hemostasis increases the risk of bleeding. Therefore, regardless of the age of the patient should be continuous monitoring of the clinical picture and, if necessary, perform laboratory tests, when prescribed prophylactic doses of LMWH simultaneously with oral anticoagulants, inhibitors of platelet aggregation ( abciximab, NSAIDs, acetylsalicylic acid at any dose, Clopidrogel, systemic corticosteroids , eptifibatide, iloprost, tiklopidin, tirofiban ), and thrombolytic drugs. Application features The drug is not allowed to be injected intramuscularly. Low molecular weight heparins are not interchangeable medications, since they differ in molecular mass, specific activity values against factor XA, dosing. It is necessary to pay attention and observe the specific methods of application recommended for each of the drugs of low molecular weight heparins. Precautions for use. Bleeding. As with anticoagulants, bleeding may occur (see section "Adverse reactions"). In case of bleeding, you should establish its cause and begin appropriate treatment. Kidney function. Before starting treatment with low molecular weight heparin, it is very important to evaluate kidney function, especially in patients aged 75 years, by determining creatinine clearance using Cocroft formula and the latest indicators of body weight measurement. In male patients: creatinine clearance (140 - age) ? body weight/0.814 ? serum creatinine, where age is expressed in years, body weight - in kg, and serum creatinine-in µmol/L. For patients, this formula should be corrected by multiplying the result by 0.85. If serum creatinine is expressed in mg/ml, the resulting value must be multiplied by a factor of 8.8. The use of HMG in therapeutic doses is contraindicated in patients with diagnosed severe renal failure (creatinine clearance of about 30 ml/min) (see section "Contraindications"). Suppression of aldosterone secretion. Heparin can suppress the secretion of aldosterone by the adrenal glands, especially in patients with diabetes, chronic renal failure, pre-existing metabolic acidosis, high levels of potassium in the blood plasma, as well as in patients taking potassium preparations. The risk of hyperkalemia increases with the duration of therapy, but is usually the opposite. In patients with an increased risk of this complication, the level of potassium in the blood plasma should be measured before treatment with heparin and regularly monitored in the future, especially if the treatment is prolonged for more than 7 days. The laboratory parameters. Control the number of platelets. Heparin-induced thrombocytopenia (hit). There is a risk of serious, sometimes thrombogenic, heparin-induced thrombocytopenia (which was also observed in the application of non - fractional heparin and rarely - in the application of NMH) immune origin-type II GIT (see section "Adverse reactions"). Due to the presence of such a risk, it is necessary to determine the number of platelets regardless of the therapeutic indications and dose applied. Determination of the number of platelets should be carried out before the introduction of the drug or no later than 24 hours after the start of treatment, and then twice a week during the entire period of treatment. If the need for long-term treatment is confirmed in some special cases (for example, in knee surgery, in the II and III trimesters of pregnancy in a woman at risk (see Section "Application during pregnancy or lactation"), an analysis should be carried out on the number of platelets twice a week during the first month of treatment (high-risk period) and once a week before the termination of treatment. You should suspect the occurrence of gits if the number of platelets does not exceed 150,000/mm3 and/or if there is a decrease in the number of platelets by 30-50% compared with the previous blood test. GIT develops mainly from the 5th to the 21st day after the start of treatment with heparin (most often occurs approximately on the 10th day). However, patients with heparin thrombocytopenia history of this complication may occur much earlier. Isolated cases were also observed after the 21st day of treatment. You should try to identify patients with such a history through a detailed survey before starting treatment. In addition, the risk of recurrence in the re-use of heparin has been observed for many years, and sometimes remains forever (see section "Contraindications"). In all cases of GIT is an urgent condition that requires consultation with a specialist. Any significant reduction in platelet count (30-50% compared to the initial values) is a warning signal, even if the rate has not reached a critical level. If there is a decrease in the number of platelets, in all cases, the following measures should be taken: 1) instant replay for counting the number of platelets for the confirmation; 2) discontinuation of treatment with heparin , if the results confirm a decrease in the number of platelets or even indicate an increase, if no other obvious reason for this is found. For carrying out the test for platelet aggregation of IP vitro and immunological examination, the blood sample must be placed in a test tube with citrate solution. However, in such circumstances, the immediate action to be taken is not based on the results of a platelet aggregation test for IP vitro or an immunological study, which is difficult to carry out, since there are only a few specialized laboratories that can conduct such tests, and their results can be obtained at best only in a few hours. However, these studies are necessary, as they can help diagnose such a complication, since the risk of thrombosis in the continuation of treatment with heparin is very high; 3) prevention or treatment of thromboembolic complications associated with hit. If continued anticoagulation therapy is very important, heparin should be replaced by antithrombotic agent refers to a chemical group, for example, sodium danaparoid or hirudin is assigned in a therapeutic or prophylactic doses individually for each patient. The transition to oral anticoagulants can be carried out only after the number of platelets has returned to normal, since there is a risk of worsening the course of thrombosis when using oral anticoagulants. Replacement of heparin with oral anticoagulants. Should be more intensive clinical monitoring and laboratory tests (prothrombin time, expressed using the international normalized ratio (MCHS) or to control the effects caused by oral anticoagulants. Since there is a certain period of time until the oral anticoagulant reaches its maximum action, it is necessary to continue the introduction of heparin in a constant dose as long as necessary to MOE in two consecutive tests remained within the necessary therapeutic limits. Monitoring of anti-factor activity. Most clinical studies that showed the efficacy of HMG were conducted using doses calculated based on the patient's body weight and without special monitoring of laboratory parameters, so the usefulness of laboratory studies to assess the effectiveness of HMG has not yet been determined. However, monitoring of anti-XA activity can be useful to reduce the risk of bleeding in certain clinical situations, which are most often associated with the risk of overdose. These situations mainly relate to therapeutic indications for the use of HMG and occur due to the dose administered to patients with: mild to moderate renal failure (creatinine clearance - approximately 30-60 ml/min, calculated by the formula of Cocroft). Since HMG is primarily excreted in the urine, unlike standard unfractionated heparin, an overdose may occur in the case of any renal failure. Severe renal failure is a contraindication to the use of HMG in therapeutic doses (see section " Contraindications»); significant deviations of body weight from the norm (very low body weight and even cachexia, obesity); the bleedings of unknown aetiology. By contrast, monitoring of laboratory parameters is not recommended when applying prophylactic doses, if NMG is used in accordance with the therapeutic recommendations (in particular regarding the duration of treatment) or during hemodialysis. To identify the possible cumulation of heparin when administered again, it is recommended, if necessary, to conduct blood sampling at the time of the highest activity of the drug (based on available data), that is, approximately 4:00 after the third injection, if the drug is administered in the form of subcutaneous Dr ' injections 2 times a day. The question of repeated studies of anti-Ha activity in order to determine the levels of heparin in the blood, for example, every 2 or 3 days, should be decided individually, depending on the results of the previous study. Consideration should also be given to adjusting the dose of HMG. Anti-XA activity is observed, depends on the type of LMWH and dosing regimens. According to the information based on the existing data, the mean value (± standard deviation), which was observed 4: 00 after the 7th injection of enoxaparin at a dose of 100 anti-Ha ME/kg/injection twice a day, was 1,2 ± 0,17 anti-Ha ME/ml. This is an average value was calculated in clinical trials, during which the study of anti-XA activity was carried out chromogenic (amidolytic) method. Control of activated partial thromboplastin time (APTT). Some NMG cause a moderate increase in APTT. Since the clinical significance of this test has not been established, there is no need to monitor the treatment taking it into account. Spinal/epidural anesthesia in patients receiving prophylactic treatment with LMWH. As with other anticoagulants, LMWH, when used during spinal/epidural anesthesia rare cases can cause bruising of the spinal cord and prolonged or permanent paralysis. The risk of spinal hematoma is higher in the case of epidural anesthesia with catheter compared with spinal anesthesia. The risk of these rare events may increase with prolonged postoperative use of epidural catheters. If the doctor decides on the appointment of anticoagulants on the background of epidural/spinal anesthesia, it is necessary to observe extreme vigilance and carry out regular monitoring to identify any signs and symptoms of neurological disorders, such as pain in the midline of the back, impaired sensory and motor function (numbness or weakness in lower limbs), bowel dysfunction and/or bladder. Patients should be instructed about the need to immediately inform your doctor on experiencing any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, urgent diagnostic and therapeutic interventions, including interventions for spinal cord decompression, should be initiated. If preoperative treatment of HMG is necessary (patients bedridden for a long time, trauma) and if the benefit of local/regional spinal anesthesia has been carefully weighed, patients who received prior to the operation of HMG injection may behave as anesthesia, provided that between the injection of heparin and spinal anesthesia has passed at least 12:00. It is recommended to carefully monitor the neurological status of the patient, bearing in mind the risk of spinal cord hematoma. Almost all patients can start preventive treatment of NMG 6-8 hours after anesthesia or removal of the catheter, with the control of neurological status. Should be particularly careful in case of simultaneous treatment with other drugs that can affect the hemostatic system (in particular, NSAID, acetylsalicylic acid). Situations that are accompanied by a certain risk. Monitoring of the treatment should be improved in the following cases: liver failure peptic ulcer disease of the gastrointestinal tract or any other organic lesion with the probability of bleeding vascular chorioretinal diseases; after surgery on the brain and/or spinal cord; lumbar (lumbar) puncture, as there is a risk of internal cerebrospinal bleeding, if possible, the puncture should be postponed; while taking other drugs that affect hemostasis (see section"Interaction with other drugs and other types of interactions"). Although all concentrations of various low molecular weight heparins are expressed in international units (IU) of anti-Xa activity, their effectiveness is not only related to their anti-Xa activity. Replacing one dosage regimen for HMG with another can be dangerous, as each regimen has been tested in special clinical studies. Therefore, great caution and compliance with the instructions for the use of each drug. Reservations. The risk of bleeding. Recommended dosing regimens (dosage and duration of treatment) should be followed. Failure to follow these guidelines may result in the occurrence of bleeding, especially in patients from high risk groups (elderly patients, patients with renal insufficiency). Cases of serious bleeding were observed: in elderly patients, including due to age-related impairment of kidney function in patients with renal insufficiency, if body weight exceeds 40 kg; if the therapy is carried out longer than the recommended period of treatment, which is 10 days in case of non-compliance with therapeutic recommendations, in particular regarding the duration of treatment and correction of therapeutic doses, taking into account body weight at simultaneous reception of other medicines (see "Interaction with other medicinal means and other types of interactions "). Enoxaparin injection, as with any other anticoagulant, should be used with caution for conditions for which you possess increased the likelihood of bleeding, such as hemostatic disorders, the presence of peptic ulcer disease in anamnesis, recent ischemic stroke, uncontrolled arterial hypertension, diabetic retinopathy , recent neurosurgery or ophthalmic surgery. In any case, it is necessary to carefully monitor the condition of elderly patients and/or patients with renal insufficiency, as well as if the treatment lasts more than 10 days. Analysis for the definition of anti-Ha activity in some cases may be useful to identify the cumulation of the drug (see section "features"). The risk of heparin - induced thrombocytopenia (hit). If the patient receives NMG (in therapeutic or prophylactic doses), there will be thromboembolic complications: deterioration of thrombosis, treatment of which is carried out; phlebitis; pulmonary embolism; acute ischemia of the lower extremities; or even a myocardial infarction or ischemic stroke, you should always remember about the likelihood of appearance:

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