Fragmin solution for i/v/s/c 2500IU 0.2ml syringe 10 pcs
Fragmin cannot be administered intramuscularly! Treatment of acute deep vein thrombosis and pulmonary embolism Fragmin is administered subcutaneously 1-2 times a day. In this case, you can immediately begin therapy with indirect anticoagulants (vitamin K antagonists). Combination therapy should be continued until the prothrombin index reaches a therapeutic value (usually this is noted no earlier than after 5 days). Treatment of patients on an outpatient basis can be carried out in the same doses that are recommended for treatment in a hospital setting.
When administered once a day - 200 IU/kg body weight s.c. A single daily dose should not exceed 18,000 IU. Monitoring of the anticoagulant activity of the drug is not necessary.
When administered 2 times a day - 100 IU/kg body weight subcutaneously 2 times a day. Monitoring of anticoagulant activity may not be necessary, but it should be borne in mind that it may be required when treating special groups of patients (see section "Special Instructions"). The recommended maximum concentration of the drug in blood plasma should be 0.5-1 IU anti-Xa/ml.
Prevention of blood coagulation in the extracorporeal circulation system during hemodialysis or hemofiltration
Fragmin should be administered intravenously, choosing a dosage regimen from those given below.
Patients with chronic renal failure, or patients without a risk of bleeding.
These patients usually require minor dosage adjustments and therefore there is no need for frequent monitoring of anti-Xa levels in most patients. When administered at recommended doses during hemodialysis, a plasma level of 0.5 to 1 IU anti-Xa/ml is usually achieved.
If the duration of hemodialysis or hemofiltration is no more than 4 hours - intravenous bolus 30-40 IU/kg body weight, followed by intravenous drip administration of 10-15 IU/kg/hour, or a single intravenous bolus at a dose of 5000 IU .
If the duration of hemodialysis or hemofiltration is more than 4 hours, 30-40 IU/kg body weight is administered intravenously, followed by intravenous drips of 10-15 IU/kg/hour.
Patients with acute renal failure, or patients at high risk of bleeding
IV jet administration of 5 - 10 IU/kg body weight, followed by IV drip administration of 4 - 5 IU/kg/hour. In patients undergoing hemodialysis for acute renal failure, the drug is characterized by a narrower therapeutic index than in patients on chronic hemodialysis (and therefore they require adequate monitoring of anti-Xa levels). The recommended maximum plasma level should be 0.2 - 0.4 IU anti-Xa/ml).
Prevention of thrombus formation during surgical interventions
Fragmin should be administered subcutaneously. Monitoring of anticoagulant activity is generally not required. When using the drug in recommended doses, maximum plasma concentrations range from 0.1 to 0.4 IU anti-Xa/ml.
When performing operations in general surgical practice - Patients at risk of developing thromboembolic complications - s/c 2500 IU 2 hours before surgery, then after surgery - s/c 2500 IU/day (every morning) for the entire period while the patient is in on bed rest (usually 5 - 7 days). - Patients with additional risk factors for the development of thromboembolic complications (for example, patients with malignant tumors) - Fragmin should be used for the entire period while the patient is on bed rest (usually 5-7 days or more). A. when starting prophylaxis the day before surgery: 5000 IU subcutaneously the evening before surgery, then 5000 IU subcutaneously every evening after surgery. b. when starting prophylaxis on the day of surgery: 2500 IU subcutaneously 2 hours before surgery and 2500 IU subcutaneously 8-12 hours later, but not earlier than 4 hours after the end of the operation. Then, from the next day, 5000 IU is administered s.c. every morning.
When performing orthopedic operations (for example, during hip replacement operations), Fragmin should be administered for up to 5 weeks after surgery, choosing one of the dosing regimens given below. A. when starting prophylaxis the day before surgery: 5000 IU subcutaneously the evening before surgery, then 5000 IU subcutaneously every evening after surgery. b. when starting prophylaxis on the day of surgery: 2500 IU subcutaneously 2 hours before surgery and 2500 IU subcutaneously 8 to 12 hours later, but not earlier than 4 hours after the end of the operation. Then from the next day every morning - 5000 IU subcutaneously. V. when starting prophylaxis after surgery: 2500 IU subcutaneously 4 to 8 hours after surgery, but not earlier than 4 hours after the end of the operation. Then from the next day, 5000 IU subcutaneously per 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 subcutaneously at 5000 IU once a day, usually for 12 - 14 days or longer (in patients with ongoing mobility restrictions). Monitoring of anticoagulant activity is generally not required.
Unstable angina and myocardial infarction (without Q wave on ECG) Monitoring of anticoagulant activity is usually not required, but it should be borne in mind that it may be required when treating special groups of patients (see section "Special instructions"). The recommended maximum concentration of the drug in plasma should be 0.5 - 1 IU anti-Xa/ml. Fragmin is administered subcutaneously at 120 IU/kg body weight every 12 hours. The maximum dose should not exceed 10,000 IU every 12 hours. At the same time, in the absence of contraindications, it is advisable to carry out therapy with acetylsalicylic acid in a dose of 75 to 325 mg/day. Therapy should be continued until the patient's clinical condition becomes stable (usually at least 6 days), or longer (at the discretion of the physician). Then it is recommended to switch to long-term therapy with Fragmin at a constant dose until revascularization (percutaneous interventions or coronary artery bypass grafting). 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 weighing less than 80 kg and men weighing less than 70 kg should be administered 5000 IU subcutaneously every 12 hours; - Women weighing 80 kg or more and men weighing 70 kg or more should be administered 7500 IU subcutaneously every 12 hours.
Long-term treatment to prevent recurrence of venous thromboembolism in patients with cancer: 1 month 200 IU/kg body weight subcutaneously once a day. A single daily dose should not exceed 18,000 IU. 2 – 6 months about 150 IU/kg body weight subcutaneously once a day, using syringes with a fixed dose (Table 1).
Table 1. Determination of the dose of Fragmin depending on body weight for a treatment period of 2 - 6 months.
Body weight, kg Dose of Fragmin, IU 99 18,000 Thrombocytopenia - in case of thrombocytopenia that developed during chemotherapy with a platelet count of 100,000/μl, the drug should be used in full dose.
Table 2. Reducing the dose of Fragmin for thrombocytopenia 50,000/µl - 100,000/µl.
Body weight, kg Planned dose of Fragmin, MEC Reduced dose of Fragmin Dose reduction, % 99 18,000 15,000 17 Renal failure - in case of renal failure with a serum creatinine concentration exceeding 3 times the upper limit of normal, the dose of Fragmin should be adjusted in such a way, to maintain a therapeutic anti-Xa level of 1 IU/mL (range 0.5 – 1.5 IU/mL), measured within 4 to 6 hours after dalteparin administration. If the anti-Xa level is below or above the therapeutic range, the dose of Fragmin should be increased or decreased accordingly, and the anti-Xa measurement should be repeated after 3-4 new doses. Dose adjustments should be made until therapeutic levels of anti-Xa are achieved.
Dalteparin sodium
International name of the medicinal substance:
Dalteparin sodium The list of drugs containing the active substance Dalteparin sodium is given after the description.
Pharmacological action:
Direct anticoagulant, binds to plasma antithrombin III, suppresses some coagulation factors, primarily factor Xa and thrombin, although it suppresses thrombin formation somewhat weaker than conventional heparin.
Has virtually no effect on blood clotting time. Has little effect on platelet adhesion (compared to heparin), etc. has less effect on primary hemostasis. It also has fibrinolytic, coronary dilation, hypolipidemic and immunosuppressive effects, and inhibits thrombokinase. The effect develops quickly and lasts 4-6 hours. Pharmacokinetics:
After subcutaneous injection, bioavailability is 90%. When administered intravenously, it practically does not bind to plasma proteins (less than 10%). It is metabolized in the RES of the liver and kidneys under the action of heparinase to form uroheparin. T1/2 after intravenous injection is 2 hours, after subcutaneous injection is 3-5 hours. It is excreted mainly by the kidneys. The rate of elimination in patients with uremia is reduced, T1/2 is 6-7 hours. Pharmacokinetic parameters do not depend on the dose.
Indications:
Acute deep vein thrombosis, pulmonary embolism, unstable angina, acute myocardial infarction (without Q wave on ECG).
Prevention of blood clotting in the extracorporeal circulatory system during long-term hemodialysis, prevention of thrombus formation during surgical interventions. Contraindications:
Hypersensitivity, hypocoagulation (of various origins), hemophilia;
erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase) with a tendency to bleeding; pulmonary tuberculosis, liver cirrhosis, nephrourolithiasis, renal and liver failure, septic endocarditis; injuries to the central nervous system, visual organs, surgical interventions on these organs, spinal and epidural punctures. With caution. Thrombocytopenia, thrombocytopathy. Side effects:
Bleeding (when used in high doses), thrombocytopenia, allergic reactions (urticaria, itching, rarely - anaphylactic shock);
osteoporosis, spontaneous fractures, increased activity of “liver” transaminases; alopecia, skin necrosis, hematomas at injection sites. Overdose. Symptoms: hemorrhagic syndrome. Treatment: administration of protamine (1 mg of protamine inhibits 100 IU of dalteparin). Interaction:
ASA, indomethacin and other NSAIDs, indirect anticoagulants, platelet aggregation inhibitors (including ticlopidine), thrombolytics (alteplase, streptokinase, urokinase), vitamin K antagonists, dipyridamole, dextran, phenylbutazone, sulfinpyrazone, tubular secretion blockers, ethacrynic acid, cytostatics (when administered intravenously) increase the anticoagulant effect (risk of bleeding);
antihistamines, cardiac glycosides, tetracyclines, ascorbic acid - reduce. Special instructions:
Use is only possible if factor Xa suppression activity is monitored using an anti-Xa assay using a chromogenic protein substrate.
Blood clotting time changes slightly. When the level of factor Xa suppression activity is more than 1.5 IU/ml, the risk of bleeding increases sharply. Safety of use during pregnancy and lactation has not been established. Preparations containing the active substance Dalteparin sodium:
Fragmin
The information provided in this section is intended for medical and pharmaceutical professionals and should not be used for self-medication. The information is provided for informational purposes only and cannot be considered official.
Fragmin solution for injection 5000IU 0.2ml syringe 10 pcs
Fragmin cannot be administered intramuscularly! Treatment of acute deep vein thrombosis and pulmonary embolism Fragmin is administered subcutaneously 1-2 times a day. In this case, you can immediately begin therapy with indirect anticoagulants (vitamin K antagonists). Combination therapy should be continued until the prothrombin index reaches a therapeutic value (usually this is noted no earlier than after 5 days). Treatment of patients on an outpatient basis can be carried out in the same doses that are recommended for treatment in a hospital setting.
When administered once a day - 200 IU/kg body weight s.c. A single daily dose should not exceed 18,000 IU. Monitoring of the anticoagulant activity of the drug is not necessary.
When administered 2 times a day - 100 IU/kg body weight subcutaneously 2 times a day. Monitoring of anticoagulant activity may not be necessary, but it should be borne in mind that it may be required when treating special groups of patients (see section "Special Instructions"). The recommended maximum concentration of the drug in blood plasma should be 0.5-1 IU anti-Xa/ml.
Prevention of blood coagulation in the extracorporeal circulation system during hemodialysis or hemofiltration
Fragmin should be administered intravenously, choosing a dosage regimen from those given below.
Patients with chronic renal failure, or patients without a risk of bleeding.
These patients usually require minor dosage adjustments and therefore there is no need for frequent monitoring of anti-Xa levels in most patients. When administered at recommended doses during hemodialysis, a plasma level of 0.5 to 1 IU anti-Xa/ml is usually achieved.
If the duration of hemodialysis or hemofiltration is no more than 4 hours - intravenous bolus 30-40 IU/kg body weight, followed by intravenous drip administration of 10-15 IU/kg/hour, or a single intravenous bolus at a dose of 5000 IU .
If the duration of hemodialysis or hemofiltration is more than 4 hours, 30-40 IU/kg body weight is administered intravenously, followed by intravenous drips of 10-15 IU/kg/hour.
Patients with acute renal failure, or patients at high risk of bleeding
IV jet administration of 5 - 10 IU/kg body weight, followed by IV drip administration of 4 - 5 IU/kg/hour. In patients undergoing hemodialysis for acute renal failure, the drug is characterized by a narrower therapeutic index than in patients on chronic hemodialysis (and therefore they require adequate monitoring of anti-Xa levels). The recommended maximum plasma level should be 0.2 - 0.4 IU anti-Xa/ml).
Prevention of thrombus formation during surgical interventions
Fragmin should be administered subcutaneously. Monitoring of anticoagulant activity is generally not required. When using the drug in recommended doses, maximum plasma concentrations range from 0.1 to 0.4 IU anti-Xa/ml.
When performing operations in general surgical practice - Patients at risk of developing thromboembolic complications - s/c 2500 IU 2 hours before surgery, then after surgery - s/c 2500 IU/day (every morning) for the entire period while the patient is in on bed rest (usually 5 - 7 days). - Patients with additional risk factors for the development of thromboembolic complications (for example, patients with malignant tumors) - Fragmin should be used for the entire period while the patient is on bed rest (usually 5-7 days or more). A. when starting prophylaxis the day before surgery: 5000 IU subcutaneously the evening before surgery, then 5000 IU subcutaneously every evening after surgery. b. when starting prophylaxis on the day of surgery: 2500 IU subcutaneously 2 hours before surgery and 2500 IU subcutaneously 8-12 hours later, but not earlier than 4 hours after the end of the operation. Then, from the next day, 5000 IU is administered s.c. every morning.
When performing orthopedic operations (for example, during hip replacement operations), Fragmin should be administered for up to 5 weeks after surgery, choosing one of the dosing regimens given below. A. when starting prophylaxis the day before surgery: 5000 IU subcutaneously the evening before surgery, then 5000 IU subcutaneously every evening after surgery. b. when starting prophylaxis on the day of surgery: 2500 IU subcutaneously 2 hours before surgery and 2500 IU subcutaneously 8 to 12 hours later, but not earlier than 4 hours after the end of the operation. Then from the next day every morning - 5000 IU subcutaneously. V. when starting prophylaxis after surgery: 2500 IU subcutaneously 4 to 8 hours after surgery, but not earlier than 4 hours after the end of the operation. Then from the next day, 5000 IU subcutaneously per 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 subcutaneously at 5000 IU once a day, usually for 12 - 14 days or longer (in patients with ongoing mobility restrictions). Monitoring of anticoagulant activity is generally not required.
Unstable angina and myocardial infarction (without Q wave on ECG) Monitoring of anticoagulant activity is usually not required, but it should be borne in mind that it may be required when treating special groups of patients (see section "Special instructions"). The recommended maximum concentration of the drug in plasma should be 0.5 - 1 IU anti-Xa/ml. Fragmin is administered subcutaneously at 120 IU/kg body weight every 12 hours. The maximum dose should not exceed 10,000 IU every 12 hours. At the same time, in the absence of contraindications, it is advisable to carry out therapy with acetylsalicylic acid in a dose of 75 to 325 mg/day. Therapy should be continued until the patient's clinical condition becomes stable (usually at least 6 days), or longer (at the discretion of the physician). Then it is recommended to switch to long-term therapy with Fragmin at a constant dose until revascularization (percutaneous interventions or coronary artery bypass grafting). 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 weighing less than 80 kg and men weighing less than 70 kg should be administered 5000 IU subcutaneously every 12 hours; - Women weighing 80 kg or more and men weighing 70 kg or more should be administered 7500 IU subcutaneously every 12 hours.
Long-term treatment to prevent recurrence of venous thromboembolism in patients with cancer: 1 month 200 IU/kg body weight subcutaneously once a day. A single daily dose should not exceed 18,000 IU. 2 – 6 months about 150 IU/kg body weight subcutaneously once a day, using syringes with a fixed dose (Table 1).
Table 1. Determination of the dose of Fragmin depending on body weight for a treatment period of 2 - 6 months.
Body weight, kg Dose of Fragmin, IU 99 18,000 Thrombocytopenia - in case of thrombocytopenia that developed during chemotherapy with a platelet count of 100,000/μl, the drug should be used in full dose.
Table 2. Reducing the dose of Fragmin for thrombocytopenia 50,000/µl - 100,000/µl.
Body weight, kg Planned dose of Fragmin, MEC Reduced dose of Fragmin Dose reduction, % 99 18,000 15,000 17 Renal failure - in case of renal failure with a serum creatinine concentration exceeding 3 times the upper limit of normal, the dose of Fragmin should be adjusted in such a way, to maintain a therapeutic anti-Xa level of 1 IU/mL (range 0.5 – 1.5 IU/mL), measured within 4 to 6 hours after dalteparin administration. If the anti-Xa level is below or above the therapeutic range, the dose of Fragmin should be increased or decreased accordingly, and the anti-Xa measurement should be repeated after 3-4 new doses. Dose adjustments should be made until therapeutic levels of anti-Xa are achieved.
