equipoise only cycle

The mechanism equipoise only cycle of action of equipoise only cycle Fondaparinux is a synthetic and selective inhibitor of activated factor . The antithrombotic activity of fondaparinux equipoise only cycle is the result of selective inhibition of Factor Xa, mediated by antithrombin . By selectively binding to AT III, fondaparinux equipoise only cycle potentiates cypionate for sale equipoise only cyclethe ability of the original AT III neutralize factor Xa. The neutralization of factor Xa interrupts the coagulation cascade and inhibits both thrombin formation and thrombus formation. Fondaparinux equipoise only cycle does not inactivate thrombin (activated factor Pa) and has no effect on platelets. Pharmacodynamics / pharmacokinetics of fondaparinux equipoise only cycle is determined by its concentration in the plasma, expressed in terms of anti-Xa-factor activity. To assess the calibration anti-Xa activity can be used only fondaparinux equipoise only cycle, it is not suitable for an international standard of heparin or low molecular weight heparins. This calibration is an expression of fondaparinux equipoise only cycle concentration in mg of fondaparinux calibration / liter.

Absorption
After subcutaneous administration of equipoise only cycle fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%). Following single subcutaneous administration of 2.5 mg fondaparinux equipoise only cycle young healthy volunteers maximum 4-chlorodehydromethyltestosterone plasma concentration (mean C max = 0.34 mg / L) was reached after 2 hours after dosing. Concentration in blood plasma constituting the above half the maximum concentration achieved within 25 minutes after administration.
In healthy elderly pharmacokinetics of fondaparinux equipoise only cycle is linear over a dose range 2.8 mg subcutaneously. With a single administration per day equilibrium concentration in plasma is reached after 3-4 days at a magnification of 1.3 times the values of C max and area under the curve “concentration-time» (AUC).
The mean pharmacokinetic parameters of fondaparinux equipoise only cycle in balance in patients undergoing substitutional hip surgery and drug treated “Arikstra” subcutaneously at a dose of 2.5 mg per day were C max– 0.39 mg / l (31%), t max – 2.8 hour (18%) and C min – 0.14 mg / l (56%). In elderly patients undergoing surgery for hip fracture, the equilibrium concentration of fondaparinux equipoise only cycle were: C max – 0.50 mg / l (32%), C min – 0.19 mg / l (58%).
In patients with symptoms of deep vein thrombosis and pulmonary embolism, treated with fondaparinux equipoise only cycle 5 mg (with a body weight less than 50 kg), 7.5 mg (with a body weight of 50 to 100 kg) and 10 mg (at a body weight of 100 kg) subcutaneously 1 once a day; Similar values were recorded the maximum and minimum equilibrium concentrations in plasma when selecting doses according to body weight in all categories. Maximum equilibrium concentration of the drug in plasma ranged from 1.20 mg / l to 1.26 mg / l. Average minimum equilibrium concentrations in the plasma of these patients ranged from 0.46 mg / l to 0.62 mg / l. Distribution In healthy volunteers fondaparinux equipoise only cycle by intravenous or subcutaneous administration, mainly distributed in the blood, and only to a small extent in the intercellular liquid, since the apparent volume of distribution at equilibrium and unstable state is 7-11 l. In vitro fondaparinux equipoise only cycle in high (not less than 94%) and specifically binds to antithrombin III (AT III). Binding of equipoise only cycle fondaparinux with other plasma proteins, including platelet factor IV of, or red blood cells is negligible. Metabolism In vivo metabolism of fondaparinux equipoise only cycle has not been studied, since most of the administered dose of the drug is excreted unchanged in the urine in patients with normal renal function. Elimination fondaparinux equipoise only cycle excreted by the kidneys unchanged. In healthy individuals 64 – 77% of a single dose of the drug administered subcutaneously or intravenously is excreted in urine within 72 hours. The half-life (T1 / 2) is about 17 hours in healthy young people, and about 21 hours – in elderly healthy subjects. In patients with normal renal function, the mean value of the clearance of fondaparinux equipoise only cycle was 7.82 ml / min.

Special groups of patients Patients with impaired kidney excretion of equipoise only cycle fondaparinux is slower in patients with renal insufficiency, since it is mainly excreted by the kidneys unchanged. In patients receiving prophylactic treatment after surgery for hip fracture or hip replacement, total clearance of fondaparinux equipoise only cycle 25% lower than with mild renal impairment (creatinine clearance of 50-80 ml / min), 40% below in patients with moderate renal impairment (creatinine clearance of 30-50 ml / min) and 55% lower in patients with severe renal impairment (creatinine clearance less than 30 mL / min) compared to patients with normal renal function. Appropriate final half-life of 29 hours in moderate and 72 h in severe forms of kidney failure. A similar relationship between the clearance of fondaparinux equipoise only cycle and the degree of severity of renal failure was observed in patients with deep vein thrombosis. Prevention of venous thromboembolic complications in the pharmacokinetic model used data on patients with a creatinine clearance of less than 23.5 ml / min, underwent surgery on the lower limbs and treated with fondaparinux equipoise only cycle. As a result of pharmacokinetic modeling, it was shown that the use of fondaparinux equipoise only cycle in patients with a creatinine clearance of 20 to 30 ml / min at a dose of 1.5 mg per day or 2.5 mg every other day corresponds to that in patients with mild to moderate severity of dysfunction renal (creatinine clearance 30-80 ml / min) receiving 2.5 mg per day. Due to the limitations of the currently available data, the drug “ARIXTRA” should not be used in patients with severe renal impairment. patients with hepatic impairment is believed that the concentration of free fondaparinux equipoise only cycle in plasma does not change with mild to moderate liver dysfunction, so on the basis of pharmacokinetics in the dose adjustment is not necessary. After a single subcutaneous injection of fondaparinux equipoise only cycle in patients with impaired liver function moderate (functional class in the classification of Child-Pugh), C max and AUC were down 22-39% compared with patients with normal liver function. Reduction of fondaparinux equipoise only cycle concentration in the plasma is attributable to reduced binding to antithrombin III due to reduced levels of this enzyme in the plasma of patients with impaired liver function, thereby increasing the excretion of equipoise only cycle by the kidneys fondaparinux. The pharmacokinetics of fondaparinux equipoise only cycle with severe hepatic impairment has not been studied. Children: Pharmacokinetic parameters of fondaparinux were described in the pharmacokinetic analysis based on blood sampling data from 24 children. Appointment once daily 0.1 mg / kg subcutaneously in children is based on a similar exposure of fondaparinux observed in adults when administered the recommended doses for the treatment of deep vein thrombosis and pulmonary embolism. Patients older Elimination of fondaparinux equipoise only cycle in patients over the age of 75 years slows. In a study of fondaparinux equipoise only cycle when administered at a dose of 2.5 mg as a prophylactic measure after surgery for hip fracture or hip replacement, total clearance of fondaparinux equipoise only cycle was about 25% less in patients over the age of 75 years compared to patients under the age of 65 years. A similar relationship between the clearance of fondaparinux equipoise only cycle and age was observed in patients with deep vein thrombosis. Sex When dose adjustment for body weight there was no difference between the sexes. Race Scheduled research pharmacokinetic differences have been conducted. However, tests carried out with the participation of healthy individuals of Asian origin (Japan) found no difference in the pharmacokinetic profile as compared with that in healthy individuals Caucasians. Similarly, no differences were observed in the clearance of fondaparinux equipoise only cycle patients between Caucasoid and Negroid races, which have borne orthopedic surgery. Body weight Patients with body weight below 50 kg total clearance of fondaparinux equipoise only cycle was reduced by approximately 30%.

testimony

 

  • Prevention of venous thromboembolic events in patients undergoing a “great” orthopedic surgery of the lower limbs, such as when:
    • hip fracture, including extended prophylaxis in the postoperative period;
    • replacement surgery of the knee joint;
    • of a hip replacement.
  • Prevention of venous thromboembolic events in patients undergoing abdominal surgery, the presence of risk factors for thromboembolic complications.
  • Prevention of venous thromboembolic events in patients with non-surgical profile of risk factors for these complications due to restricted mobility during the acute phase of the disease.
  • Treatment of deep vein thrombosis.
  • Treatment of pulmonary thromboembolism except hemodynamically unstable patients or patients who are in need of thrombolytic therapy or embolectomy.
  • Treatment of acute coronary syndrome, expressed as:
    • unstable angina or myocardial infarction without ST-segment elevation in patients who are not candidates emergency (within <120 mins) invasive treatment (percutaneous coronary revascularization), for the prevention of cardiovascular death, myocardial infarction, or refractory ischemia;
    • myocardial infarction with ST segment elevation in order to prevent death, reinfarction in patients receiving thrombolytic therapy or patients who initially received reperfusion therapy.
  • Treatment of acute symptomatic thrombosis of superficial veins of the lower limbs without concomitant deep-vein thrombosis.

Contraindications:

Hypersensitivity to fondaparinux equipoise only cycle or any other component of the drug.
The active clinically significant bleeding.
Acute bacterial endocarditis.
Severe renal impairment (creatinine clearance <20ml / min).

Carefully

We do not recommend the use of fondaparinux equipoise only cycle immediately prior to and during primary percutaneous coronary intervention (CHKB) in patients with myocardial infarction with ST-segment elevation.
Monotherapy fondaparinux equipoise only cycle is not recommended in patients with myocardial infarction without ST-segment elevation and ST-segment elevation at not primary CHKB; should evaluate the possibility of the combined purpose of unfractionated heparin. The available clinical data on the combined use of equipoise only cycle fondaparinux and unfractionated heparin during primary CHKB not limited. The product “Arixtra”, like other anticoagulants, should be used with caution in patients with increased risk of bleeding, ie, in such pathologies as congenital or acquired disorders of blood coagulation system in the form of bleeding, peptic ulcer and 12 duodenal ulcer in the acute stage and recently transferred intracranial hemorrhage, severe liver function, as well as soon after surgery on the brain or spine, or . ophthalmologic operations
For groups at high risk of bleeding against the use of anticoagulants include patients older than 75 years, patients weighing less than 50 kg, patients with moderate renal impairment (creatinine clearance less than 50 mL / min). In the appointment of “Arixtra” drug to patients referred to the risk, it is recommended to be careful.
In the treatment of unstable angina or myocardial infarction without ST segment elevation and myocardial infarction with ST-segment elevation Caution should be exercised with concomitant use of fondaparinux equipoise only cycle with other drugs that increase the risk bleeding (for example, inhibitors of GPIIb / IIIa or thrombolytics).

Pregnancy and lactation

Cumulative to date data on the use “Arixtra” of the drug in pregnant women are insufficient, and the drug “ARIXTRA” should not be given to pregnant women except in cases where the expected benefit outweighs the potential risk to the fetus. During the period of preparation “ARIXTRA” breastfeeding is not recommended.

Dosing and Administration

Mostly subcutaneous administration should be alternately left and right anterolateral surface of the anterior abdominal wall. To avoid the loss of the drug should not be prior to injection remove any air bubbles from the syringe. The needle should be introduced to the entire length perpendicular to the fold of skin, which is gripped between the thumb and forefinger; fold of skin is not is expanded throughout the administration.
The drug Arixtra is intended for use only under medical supervision. The patient is allowed to independently carry out subcutaneous injection only if the doctor considers it necessary, with a mandatory follow-up at the doctor and only after proper training techniques of subcutaneous injection. Intravenous administration (first dose only in patients with myocardial infarction with ST-segment elevation) drug Arixtra is found or directly into the catheter using the mini-containers with 0.9% equipoise only cycle chloride solution (25 ml or 50), wherein the pre-formulation is diluted. When using the drug Arixtra syringes in order to avoid the loss of the drug should not be prior to injection remove any air bubbles from the syringe. After injection of a sufficient amount catheter rinse solution of 0.9% to ensure delivery of the full dose of the drug.When administered using infusion mini-containers must be carried out within 1-2 minutes.

Adults

 

Prevention of venous thromboembolic complications Orthopedic and abdominal surgery The recommended dose of Arixtra is 2.5 mg of drug subcutaneously with 1 time a day after the operation. The initial dose is administered no earlier than six hours after the operation, provided a wealthy hemostasis. The course of treatment should last for a period of increased risk for venous thromboembolic complications, usually to transfer the patient to outpatient treatment, at least 5-9 days. Experience shows that in patients undergoing surgery for hip fracture, the duration of the period of increased risk for venous thromboembolic complications than 9 days after surgery. For such patients should be decided to extend the use of prophylactic drug Arixtra to 24 days. Patients with non-surgical profile presence of thromboembolic complications risk factors The recommended dose of the drug Arixtra is 2.5 mg subcutaneously once daily 1. The duration of treatment in this case ranges from 6 to 14 days. Thrombosis Treatment of deep vein thrombosis and pulmonary embolism recommended dose Arikstra preparation by subcutaneous injection one time per day is as follows: 5 mg for patients weighing less than 50 kg; 7.5 mg for patients with a body weight of 50-100 kg . 10 mg for patients weighing more than 100 kg Treatment should continue for at least 5 days and discontinued no earlier than would be possible on a full translation of adequate therapy with oral anticoagulants, ie when the values of international normalized ratio (MHO) from 2 to Z. Add to therapy with vitamin K antagonists are needed as soon as possible, usually within 72 hours. Usually duration of drug Arixtra is 5 to 9 days. Treatment of unstable angina or myocardial infarction without ST-segment elevation The recommended dose of the drug Arixtra is 2.5 mg subcutaneously once daily 1. Treatment should begin as soon as possible after diagnosis and continued for 8 days or until the patient’s discharge from the hospital, if it occurred earlier than 8 days. If the patient is supposed to conduct CHKB on the background of treatment with Arixtra, during CHKB be administered unfractionated heparin (UFH), according to standard practice in this hospital; thus it is necessary to consider the risk of bleeding, which is present in the patient, and that this risk level affects, including, and the time elapsed since the last dose Arikstra drug. Time resuming administration Arikstra after removal of the catheter should be determined on based on the clinical condition of the patient. In clinical studies, treatment with ARIXTRA resumed no earlier than 2 hours after catheter removal.In patients undergoing coronary artery bypass grafting (CABG), if possible, Arixtra drug is not administered within 24 hours before surgery. Introduction ARIXTRA drug may be resumed 48 hours after CABG.Treatment of myocardial infarction with ST-segment elevation recommended dose of the drug Arixtra is 2.5 mg 1 time per day. The first dose is injected, subsequent doses are administered subcutaneously. Treatment should begin as soon as possible after diagnosis and continued for 8 days or until the patient’s discharge from the hospital, if it occurred earlier than 8 days. If the patient is not supposed to conduct primary CHKB on the background of treatment with Arixtra, during CHKB UFH should be administered according to standard practice in this hospital; thus it is necessary to consider the risk of bleeding, which is available in a patient, and that this risk level affects, including, and the time elapsed since the last dose of drug. resuming administration Arikstra after catheter removal time should be determined on the basis of the clinical condition of the patient. In clinical studies, treatment with ARIXTRA resumed no earlier than 3 hours after catheter removal. In patients undergoing bypass surgery when possible Arikstra drug is not administered within 24 hours before surgery. The introduction of the drug may be restarted 48 hours after CABG. The treatment of thrombosis of superficial veinsrecommended dose of Arixtra is 2.5 mg of drug subcutaneously 1 time per day. Indications for use of the drug Arixtra 2.5 mg is an acute, symptomatic, isolated, spontaneous superficial vein thrombosis of the lower limbs, in which the extent of the affected area is not less than 5 cm, and the corresponding loss was documented on the basis of the results of ultrasound or other objective methods . Treatment should begin as soon as possible after diagnosis and after exclusion of concomitant DVT or superficial veins thrombosis length of not more than 3 cm from the anastomosis saphenofemoral. Patients with high risk for thromboembolic complications duration of treatment should be at least 30 and not more than 45 days. The patient is allowed to independently carry out subcutaneous injection only if the doctor considers it necessary, with a mandatory follow-up at the doctor and only after proper training techniques of subcutaneous injection.

atients requiring surgery or other invasive procedures.

  • Patients with thrombosis of the superficial veins requiring surgery or other invasive procedures, if possible, should not receive fondaparinux for at least 24 hours prior to surgery.
    Use of fondaparinux can at least resume after 6 hours after reconstitution hemostasis.

Special patient groups

Children
Use of the drug Arixtra is not recommended in children under the age of 17 years due to lack of efficacy and safety data. Elderly patients (over 75 years) drug Arixtra should be used with cautious in elderly patients, ie. In. With age is reduced renal function. In elderly patients undergoing surgery, you must strictly comply with the time the first dose of ARIXTRA drug. Patients with low body weight Prevention of venous thromboembolism and treatment of unstable angina or myocardial infarction with or without ST-segment elevation in patients weighing less than 50 kg have an increased risk bleeding. Speed excretion fondaparinux decreases with decreasing body weight. The drug Arixtra should be used with cautious in this group of patients. Thrombosis Treatment of superficial veins efficacy and safety of ARIXTRA drug in patients weighing less than 50 kg have not been studied, therefore its use in these patients is not recommended. Patients with impaired renal function Prophylaxis of venous thromboembolism Not ARIXTRA should be prescribed to patients with creatinine clearance less than 20 ml / min. If creatinine clearance is from 20 to 50 ml / min, the dose should be reduced to 1.5 mg once a day. In mild renal impairment (creatinine clearance greater than 50 mL / min) a dose reduction is needed. Treatment of unstable angina or myocardial infarction with or without ST segment elevation Use of the drug Arixtra is not recommended for use in patients with creatinine clearance less than 20 ml / min. No dose adjustment is required in patients with creatinine clearance 20 mL / min. The treatment of thrombosis of superficial veins should not be prescribed the drug Arixtra in patients with creatinine clearance less than 20 ml / min. If creatinine clearance is from 20 to 50 ml / min, the dose should be reduced to 1.5 mg once a day. In mild renal impairment (creatinine clearance greater than 50 mL / min) a dose reduction is required. The safety and efficacy of this drug in a dose of 1.5 mg have not been studied. Patients with hepatic impairment Prevention of venous thromboembolism and treatment of unstable angina or myocardial infarction with or without ST-segment elevation for patients with impaired mild to moderate liver function severity of the correction dose ARIXTRA is not required. Patients with severe hepatic insufficiency drug Arixtra should be used with caution, since the use of this drug in this patient group has not been studied. The treatment of thrombosis of superficial veins efficacy and safety of the drug Arixtra in patients with severe hepatic impairment have not been studied, so the use of the drug in this group of patients is not recommended.

Side effect

Adverse reactions shown below are listed in accordance with a lesion of organs and organ systems, and frequency of occurrence. The frequency is defined as follows: very common (≥1 / 10), commonly (≥1 / 100 and <1/10), uncommon (≥1 / 1000 and <1/100), rare (≥1 / 10,000 and . <1/1 000), very rare (<1/10 000)
These adverse events should be considered in surgical and therapeutic context, depending on the evidence. Infectious and parasitic diseases rare: infection of surgical wounds. Violations of the blood and lymphatic system often anemia, bleeding (various sites, including rare cases of intracranial and / or intracerebral and retroperitoneal hemorrhage and / or bleedings), purpura. Uncommon: thrombocytopenia, thrombocythemia, platelet abnormality, coagulation disorders. violations by the immune system rare: allergic reactions (including . very rare reports of angioedema, anaphylactoid and / or anaphylactic reactions) Violations of the metabolism and nutrition rare: hypokalaemia. Disorders of the nervous system Uncommon: headache. rare: anxiety, confusion, dizziness, spatial disorientation, drowsiness.Violations by vessels rare:. hypotension Disorders of the respiratory system, thorax and mediastinum rare: shortness of breath, cough. Violations of the gastrointestinal tract Uncommon: nausea, vomiting.rare: abdominal pain, dyspepsia, gastritis, constipation , diarrhea. Violations of the liver and biliary tract Uncommon: abnormal results of liver function tests, increased concentration of liver enzymes in the blood. rare: increased bilirubin concentration in the blood. Violations of the skin and subcutaneous tissue disorders Uncommon: rash, itching, discharge from the wound. General disorders and at the injection site Common: edema. Uncommon: fever, peripheral edema. rare: reaction at injection site, chest pain, pain in the lower extremities, fatigue, flushing of the face (flushing), syncope, genital edema.

Interaction with other drugs

Fondaparinux equipoise only cycle does not inhibit cytochrome P450 isozymes group (CYP1A2, CYP2A6, CYP2C9, CYP2C19 , CYP2D6, CYP2E1 , or CYP3A4) in vitro. Consequently, one should not expect drug interactions “Arikstra» in vivo with other drugs to suppress the level of metabolism mediated CYP system. Since fondaparinux equipoise only cycle binding to plasma proteins, except ATSH slightly, should not be expected interactions with other drugs at the level of competitive binding to plasma proteins. In clinical studies, fondaparinux equipoise only cycle has been shown that its co-administration with oral anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid), NSAIDs (piroxicam) and cardiac glycosides (digoxin), does not affect the pharmacokinetics or pharmacodynamics of fondaparinux equipoise only cycle. Fondaparinux equipoise only cycle does not affect the activity of warfarin, nor the bleeding time during treatment with acetylsalicylic acid or piroxicam, or on the pharmacokinetics and pharmacodynamics of digoxin at steady state.
In the absence of compatibility “ARIXTRA” solution of the drug data should not be mixed with other drugs .

Overdose

Symptoms
Doses “ARIXTRA is” in excess of the recommended can lead to increased risk of bleeding. Treatment of overdose complicated by bleeding, should lead to “ARIXTRA” elimination of the drug and to seek a primary cause. It is necessary to decide on the choice of method to start appropriate treatment, which may include surgical hemostasis, supplementation of blood loss, transfusion of fresh frozen plasma, plasmapheresis.

special instructions

 

The drug Arixtra is intended for subcutaneous and intravenous use. Do not administer intramuscularly! Bleeding Fondaparinux should be used with caution in patients at increased risk of bleeding due to inherited or acquired bleeding disorders (eg platelet count less than 50,000 / mm³), diseases of the gastrointestinal tract ulcerations in the active phase, recent myocardial intracranial hemorrhage or surgery on the brain, spinal cord or of the organs, as well as in specific groups of patients, as described below. It should not be used concurrently with fondaparinux for the prevention of venous thromboembolic events drugs, under the influence of which increases the risk of bleeding. Such drugs include dezirudin, fibrinolytic agents, receptor antagonists of glycoprotein IIb / IIIa of platelets, heparin, low molecular weight heparin or heparinoids. Can be carried out concomitant therapy with vitamin K antagonist, if necessary Other antiplatelet drugs (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. In case of emergency in the concomitant use of these drugs require careful monitoring of the patient. CHKB and the risk of blood clots in the guiding catheter is not recommended the use of fondaparinux immediately prior to and during the primary CHKB in patients with myocardial infarction with ST-segment elevation. Similarly, in patients with unstable angina or myocardial infarction without ST-segment elevation in life threatening situations, causing the need for urgent revascularization is not recommended fondaparinux CHKB before and during it. These are patients with refractory or recurrent angina associated with dynamic deviation of segment ST, heart failure, life threatening arrhythmias or haemodynamic instability. Monotherapy fondaparinux is not recommended in patients with unstable angina or myocardial infarction without ST-segment elevation and myocardial infarction with ST-segment elevation during the primary CHKB not due to an increased risk of blood clots in the guiding catheter. Therefore, in accordance with standard practice, the treatment should assess the possibility of combined purpose UFH. Thrombosis of the superficial veins should exclude concomitant deep vein thrombosis or thrombosis of superficial veins, where the lesion is localized for no more than 3 cm from the saphenofemoral anastomosis, as the use of Arixtra drug at a dose of 2 5 mg has not been studied in the presence of the above diagnoses. Efficacy and safety of fondaparinux 2.5 mg been studied in the following groups of patients: patients with thrombosis of the superficial veins after sclerotherapy or intravenous vein complications in patients with thrombosis of the superficial veins in a history of the previous 3 months, patients with a history of thromboembolic complications in previous 6 months, or patients with active malignant tumor. spinal / epidural anesthesia when using Arixtra drug concurrently with the spinal / epidural anesthesia or lumbar puncture, during the “big” orthopedic surgery can not exclude the possibility of epidural or spinal hematoma, which can result in long-term or permanent paralysis. The risk of these rare events may be increased with the use of permanent postoperative epidural catheters or simultaneous administration of other drugs that affect hemostasis. Elderly patients Elderly patients are more at risk of bleeding than the rest of the population.As kidney function generally decreases with age, in elderly patients fondaparinux excretion can be reduced, and thus, the exposure is increased. The drug Arixtra in elderly patients should be used with caution. Low body weight

Prevention of venous thromboembolic complications and treatment of unstable angina or myocardial infarction with or without ST-segment elevation

  • in patients weighing less than 50 kg are at increased risk of bleeding. The elimination rate of fondaparinux decreases with decreasing body weight. The drug Arixtra should be used with cautious in this group of patients.
  • Treatment of venous thrombosis surface
    no sufficient clinical data for use fondaparinux patients weighing less than 50 kg, so its use in such patients is not recommended.

Renal impairment
Fondaparinux is mainly excreted by the kidneys.

  • Prevention of venous thromboembolic events
    in patients with creatinine clearance less than 50 mL / min, increases the risk of bleeding and venous thromboembolic complications, therefore fondaparinux should be used with caution. There is insufficient clinical data on the use of fondaparinux in patients with creatinine clearance less than 30 ml / min.
  • Treatment of unstable angina or myocardial infarction with or without ST segment elevation
    There is limited clinical data on the use of fondaparinux in patients with unstable angina or myocardial infarction without ST segment elevation and myocardial infarction with ST segment elevation, and creatinine clearance in the range of 20-30 ml / min, therefore, the possibility of such patients is estimated in terms of the ratio of expected benefits to the possible risk.
  • Superficial vein thrombosis Treatment
    Fondaparinux is not recommended in patients with creatinine clearance less than 20 ml / min. In patients with a creatinine clearance in the range of 20-50 ml / min the dose should be reduced to 1.5 mg once a day. Efficacy and safety of a dose of 1.5 mg have not been studied.

Severe hepatic dysfunction

  • Prevention of venous thromboembolic complications and treatment of unstable angina or myocardial infarction with or without ST-segment elevation
    dose adjustment when used in this group of patients is not required. However, due to shortage of coagulation factors in patients with severe liver disease increases the risk of bleeding, so use the drug Arixtra in these patients with caution.

Treatment of thrombosis of superficial veins
do not have sufficient data on the use of fondaparinux in this group of patients. Therefore its use in this patient group is not recommended. Geparinindutsirovannaya thrombocytopenia drug Arixtra should be used with caution in patients with a history of thrombocytopenia geparinindutsirovannoy. So far not conducted special clinical studies on the efficacy and safety of the drug Arixtra in patients with geparinindutsirovannoy thrombocytopenia type II. Rare reports have been received of thrombocytopenia geparinindutsirovannoy development in patients treated with fondaparinux. Fondaparinux does not bind to the 4th platelet factor and has perekresnyh serum reactions in patients with geparinindutsirovannoy thrombocytopenia type II was no significant relationship between the use of the drug and the development geparinindutsirovannoy thrombocytopenia has been established. Latex allergy Base finished graduated syringe needle may contain dry natural latex, which potentially can cause allergic reactions in individuals with hypersensitivity to latex.

clenbuterol