Fragmin solution for intravenous and subcutaneous administration of 2500 IU syringes 0.2 ml 10 pcs
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Active ingredients
Dalteparin Sodium
Release form
Solution
Composition
0.2 ml dalteparin sodium 2500 IU (anti-Xa). Excipients: macrogol glyceryl ricinoleate (polyoxyethylated castor oil) - 522.396 mg, ethanol - 401.664 mg.
Pharmacological effect
Anticoagulant direct action. It is a low molecular weight heparin isolated in the process of controlled depolymerization (with nitrous acid) of sodium heparin from the mucous membrane of the small intestine of the pig and subjected to additional purification using ion-exchange chromatography. Consists of sulfated polysaccharide chains with an average molecular weight of 5,000 daltons. while 90% have a molecular weight of from 2000 to 9000 daltons. the degree of sulfation is from 2 to 2.5 per disaccharide. It binds plasma antithrombin, and therefore inhibits the activity of factor Xa and thrombin. The anticoagulant effect of dalparin sodium is primarily due to the inhibition of factor Xa. at the time of blood clotting affects slightly. Compared with heparin, it has a weak effect on platelet adhesion and, thus, has less effect on primary hemostasis.
Indications
- acute deep vein thrombosis. - pulmonary embolism . - prevention of blood coagulation in the extracorporeal circulation during hemodialysis or hemofiltration in patients with acute or chronic renal failure. - prevention of thrombosis during surgical interventions. - prevention of thromboembolic complications in patients with a therapeutic disease in the acute phase and limited mobility (including in conditions requiring bed rest). - unstable stenocardia and myocardial infarction (without a pathological Q wave on the ECG). - long-term treatment (up to 6 months) in order to prevent the recurrence of venous thrombosis and pulmonary thromboembolism in patients with oncological diseases.
Contraindications
- a history of or suspicion of immune thrombocytopenia (caused by heparin) - bleeding (clinically significant, for example, from the gastrointestinal tract against a background of gastric ulcer and / or duodenal ulcer, intracranial bleeding) - pronounced disorders of the blood coagulation system - septic endocarditis - recent injuries or surgical interventions on the central nervous system, organs of vision, hearing - hypersensitivity to the components of the drug - hypersensitivity to other low-molecular heparins and / or to heparin.Due to the increased risk of bleeding, Fragmin in high doses (used, for example, for the treatment of acute deep vein thrombosis, pulmonary embolism, unstable angina and myocardial infarction without an abnormal Q wave on an ECG) cannot be prescribed to patients undergoing spinal or epidural anesthesia, or other procedures involving lumbar puncture. With caution, especially in patients in the early postoperative period, Fragmin should be administered in high doses (for example, for the treatment of acute deep vein thrombosis, pulmonary embolism, unstable angina and myocardial infarction without a Q-wave on the ECG) should be used with caution in patients with increased risk development of bleeding, incl. patients with thrombocytopenia, impaired platelet function, severe hepatic or renal failure, uncontrolled arterial hypertension, hypertensive or diabetic retinopathy.
Use during pregnancy and lactation
When used in pregnant women, there was no adverse effect on the course of pregnancy, as well as on the health of the fetus and newborn. When using Fragmin during pregnancy, the risk of adverse effects on the fetus is assessed as low. However, since the possibility of adverse effects cannot be completely ruled out, Fragmin can only be assigned according to strict indications, when the intended benefit to the mother outweighs the potential risk. If necessary, the use of Fragmin during pregnancy should be monitored anticoagulant activity of the drug. In experimental studies revealed no teratogenic or fetotoxic effect of the drug. It is not established whether dalteparin sodium is excreted in breast milk.
Dosage and administration
Fragmin can not enter the / m! Treatment of acute deep vein thrombosis and pulmonary thromboembolism Fragmin is administered subcutaneously 1-2 times / day. You can immediately begin therapy with indirect anticoagulants (vitamin K antagonists). This combination therapy should be continued until the prothrombin index reaches a therapeutic level (usually not earlier than after 5 days). Patients can be treated on an outpatient basis in doses recommended for inpatient therapy. When administered once a day, a dose of 200 IU / kg body weight is injected sc.A single dose should not exceed 18,000 IU. Monitoring of the anticoagulant activity of the drug can not be carried out. With the introduction of 2 times / day, enter 100 IU / kg body weight n / a. Monitoring of the anticoagulant activity of the drug can not be carried out, but it should be borne in mind that this may be necessary in the treatment of certain groups of patients. The recommended maximum concentration of the drug in plasma should be 0.5-1 IU anti-Xa / ml. Prevention of blood coagulation in the extracorporeal circulation during hemodialysis or hemofiltration Fragmin administered IV. Patients with chronic renal failure or patients without the risk of bleeding, as a rule, require a slight correction of the dosing regimen, so in most cases there is no need for frequent monitoring of the level of anti-Xa. With the introduction of the recommended doses during hemodialysis, an anti-Xa activity level of 0.5–1 IU / ml is usually achieved. With a duration of hemodialysis or hemofiltration of not more than 4 hours, the drug is administered intravenously in streams of 30-40 IU / kg body weight, followed by intravenous drip injections at a rate of 10-15 IU / kg / h or once a streamer at a dose of 5000 IU. With a duration of hemodialysis or hemofiltration for more than 4 hours, a IV injection of the drug is administered in a dose-wise manner at a rate of 30-40 IU / kg, followed by IV drip injection at a rate of 10-15 IU / kg / h. When using Fragmin in patients with acute renal failure or in patients with a high risk of bleeding, the drug is administered in a jet at the rate of 5-10 IU / kg, followed by IV drip at a rate of 4-5 IU / kg / h. Emergency hemodialysis (for acute renal failure) requires more careful monitoring of the level of anti-Xa activity, since the range of therapeutic doses for such patients is much narrower than for patients on chronic hemodialysis. The recommended maximum level of anti-Xa activity in plasma should be in the range of 0.2-0.4 IU / ml. Prevention of thrombosis during surgery Fragmin injected s / c. Monitoring of anticoagulant activity is generally not required. When using the drug in recommended doses, Cmax in plasma ranges from 0.1 to 0.4 IU anti-Xa / ml.When performing an operation in general surgical practice in patients at risk of developing thromboembolic complications, the drug is injected s / c at a dose of 2500 IU 2 hours before the operation, then after the operation, 2500 IU / day (every morning) during the entire period the patient is on bed rest (usually 5-7 days). Patients with additional risk factors for the development of thromboembolic complications (including patients with malignant tumors) Fragmin should be used during the entire period while the patient is on bed rest (usually 5-7 days or more). At the same time, at the beginning of therapy the day before the operation, Fragmin is injected s / c in a dose of 5,000 IU in the evening before the operation, then after the operation, 5,000 IU each evening. At the beginning of therapy on the day of the operation, a sc / 2500 IU is administered 2 hours before the operation and 2500 IU after 8-12 hours, but not earlier than 4 hours after the end of the operation. then from the next day every morning at 5000 IU. When performing orthopedic surgeries (for example, for hip joint arthroplasty), Fragmin should be administered for up to 5 weeks after surgery, choosing one of the alternative dosing regimens. At the beginning of therapy, the drug is administered in a dose of 5000 IU p / c in the evening, on the eve of the operation, then 5000 IU each evening after the operation. At the beginning of therapy on the day of the operation, Fragmin is injected s / c at a dose of 2500 IU 2 hours before the operation and 2500 IU after 8-12 hours, but not earlier than 4 hours after the end of the operation. then from the next day every morning - 5000 IU. At the beginning of therapy after surgery, the drug is injected s / c at a dose of 2500 IU 4-8 hours after the operation, but not earlier than 4 hours after the end of the operation. then from the next day p / to 5000 IU / day. Prevention of thromboembolic complications in patients with a therapeutic disease in the acute phase and limited mobility (including in conditions requiring bed rest) Fragmin should be administered subcutaneous doses of 5000 IU 1 time / day, usually within 12-14 days or longer ( in patients with ongoing impaired mobility). Monitoring of anticoagulant activity is generally not required. Unstable stenocardia or myocardial infarction without a pathological Q wave on an ECG Monitoring of anticoagulant activity, as a rule, is not required, but it should be borne in mind that it may be required for the treatment of special groups of patients.The recommended Cmax of the drug in plasma should be 0.5-1 IU anti-Xa / ml (at the same time it is advisable to carry out therapy with acetylsalicylic acid in a dose of 75 to 325 mg / day). Fragmin is injected at a dose of 120 IU / kg body weight every 12 hours. The maximum dose should not exceed 10,000 IU / 12 hours. Therapy should be continued until the patient’s clinical condition is stable (usually at least 6 days) or longer (at the discretion of the doctor). Then it is recommended to switch to long-term therapy with Fragmin in a constant dose until revascularization (percutaneous intervention or coronary artery bypass surgery). The total duration of therapy should not exceed 45 days. The dose of Fragmin is selected taking into account the gender and body weight of the patient. Women with a body weight less than 80 kg and men with a body weight less than 70 kg, the drug should be injected s / to 5000 IU every 12 hours. Women with a body weight & # 8805. 80 kg and to men with a body weight & # 8805. 70 kg should be administered at 7,500 IU every 12 hours. Long-term treatment to prevent the recurrence of venous thrombosis in patients with oncological diseases for 1 month - prescribe a dose of 200 IU / kg body weight 1 time / day. The maximum daily dose is 18 000 ME. 2-6 months - n / a dose is administered at a dose of about 150 IU / kg body weight 1 time / day, using fixed dose syringes in accordance with Table 1. Table 1. Determination of the dose of the drug Fragmin depending on the body weight for the treatment period 2 -6 months. Body Weight (kg) Dose of Fragmin (ME) & # 8804. 56 7 500 57-68 10 000 69-82 12 500 83-98 15 000 & # 8805. 99 18 000 In cases of thrombocytopenia, which developed on the background of chemotherapy with platelet count less than 50 000 / μl, the use of Fragmin should be suspended until the number of platelets exceeds 50 000 / μl. For the platelet count from 50,000 / µl to 100,000 / µl, the dose of the drug should be reduced by 17-33% relative to the initial dose, depending on the patient’s body mass in accordance with Table 2. When the platelet count is restored to the level of & # 8805. 100 000 / μl of the drug should be prescribed in full dose. Table 2. Reduction of the dose of the drug Fragmin with thrombocytopenia 50 000 / μl-100 000 / μl Body weight (kg) Planned dose of Fragmin (ME) Reduced dose of Fragmin (ME) Reduction of the dose (%) & # 8804. 56 7 500 5 000 33 57-68 10 000 7 500 25 69-82 12 500 10 000 20 83-98 15 000 12 500 17 & # 8805. 99 18 000 15 000 17 In severe renal failure with creatinine levels more than 3 times higher than VGN, the dose of Fragmin should be adjusted to maintain the therapeutic level of anti-Xa IU / ml (range 0.5-1.5 IU / ml) , determined within 4-6 hours after drug administration.If the level of anti-Xa is lower or higher than the therapeutic range, the dose of Fragmin should be increased or decreased accordingly, and the measurement of anti-Xa should be repeated after the administration of 3-4 new doses. Dose adjustment should be carried out to achieve a therapeutic level of anti-Xa.
Side effects
Side effects are observed on average in 1% of patients. From the hemopoietic system and the blood coagulation system: bleeding, hematoma at the injection site, reversible non-immune thrombocytopenia, bleeding. in some cases, immune thrombocytopenia (with or without thrombotic complications). development of spinal or epidural hematoma, peritoneal and intracranial bleeding, some of which are fatal. On the part of the digestive system: a transient increase in liver transaminases (AST, ALT). Local reactions: pain at the injection site. in some cases - skin necrosis. Other: allergic reactions, in some cases - anaphylactic reactions.
special instructions
Side effects are observed on average in 1% of patients. From the hemopoietic system and the blood coagulation system: bleeding, hematoma at the injection site, reversible non-immune thrombocytopenia, bleeding. in some cases, immune thrombocytopenia (with or without thrombotic complications). development of spinal or epidural hematoma, peritoneal and intracranial bleeding, some of which are fatal. On the part of the digestive system: a transient increase in liver transaminases (AST, ALT). Local reactions: pain at the injection site. in some cases - skin necrosis. Other: allergic reactions, in some cases - anaphylactic reactions.