Fragmin [Dalteparin Sodium]

For the treatment of acute deep vein thrombosis and pulmonary thromboembolism Fragmin injected s / c 1-2 times / day. In this case, you can immediately begin therapy with indirect anticoagulants. 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, the dose is 200 IU / kg body weight. A single dose should not exceed 18,000 IU. With the introduction of 2 times / day single dose of 100 IU / kg. Monitoring of the anticoagulant activity of the drug can not be carried out, but it should be borne in mind that this may be required 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.
For the prevention of blood coagulation in the extracorporeal circulation during hemodialysis or hemofiltration Fragmin injected into / in.
Patients with chronic renal failure or patients without a risk of bleeding in history as a rule, a slight correction of the dosing regimen is required, so there is no need for frequent monitoring of the anti-Xa level. With the introduction of the recommended doses during hemodialysis, an anti-Xa 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 streamed at 5000 IU. With the duration of hemodialysis or hemofiltration for more than 4 hours, it is carried out IV the jet injection of the drug at a dose of 30-40 IU / kg with the subsequent administration 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 intravenously in a jet at the rate of 5-10 IU / kg, followed by intravenous drip injections at a rate of 4-5 IU / kg / h. Emergency hemodialysis requires more careful monitoring of the level of anti-Xa activity, since the range of therapeutic doses for such patients is much narrower. The level of anti-Xa activity should be in the range of 0.2-0.4 IU / ml.
For the prevention of thrombosis during surgical interventions Fragmin SubQ. Monitoring of anticoagulant activity is usually 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 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 while 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. At the same time, at the beginning of therapy the day before the operation, Fragmin is injected s / c in a dose of 5000 IU in the evening before the operation, then after the operation, 5000 IU each evening. At the beginning of therapy on the day of the operation, subcutaneous diseases of 2500 IU are 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 operations (for example, in hip joint arthroplasty) Fragmin should be administered for up to 5 weeks after surgery, selecting one of the alternative dosing regimens. At the beginning of therapy on the evening before the operation, a single dose for sc infusion is 5000 IU, and the drug is administered on the evening before the operation and then every evening after the operation.At the start of therapy on the day of surgery, 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 at 5000 IU.
At the beginning of therapy after surgery the drug is injected s / c at a dose of 2500 IU after 4-8 h after surgery; then from the next day to 5000 IU / day.
With unstable angina or myocardial infarction without a pathological Q wave The recommended maximum plasma concentration of the drug should be 0.5-1 IU anti-Xa / ml (at the same time it is advisable to carry out therapy with acetylsalicylic acid at 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 clinical condition is stable (usually at least 6 days) or longer. (at the discretion of the doctor). Then it is recommended to switch to a long-term therapy with Fragmin in a constant dose until revascularization (percutaneous interventions or aorto-coronary 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 weighing less than 80 kg and men weighing less than 70 kg should be administered subcutaneous doses of 5,000 IU every 12 hours. Women weighing 80 kg or more and men weighing 70 kg or more should be administered 7500 IU. every 12 hours

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 excluded, Fragmin can only be prescribed for 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, no teratogenic or fetotoxic effect of the drug was detected.
It is not established whether dalteparin sodium is excreted in breast milk.

The drug can not be administered in / m!
When conducting neuroaxial anesthesia (epidural / spinal anesthesia) or when performing spinal puncture in patients who receive anticoagulant therapy or in whom it is planned to conduct anticoagulant therapy using low molecular weight heparins for the prevention of thromboembolic complications, there is an increased risk of developing spinal or epidural anesthesia for preventing thromboembolic complications, there is an increased risk of developing spinal or epidural anesthesia for the prevention of thromboembolic complications. a queue can lead to prolonged or permanent paralysis. The risk of such complications increases with the use of permanent epidural catheters for the introduction of analgesics or with the simultaneous use of drugs that affect hemostasis (NSAIDs, platelet function inhibitors, other anticoagulants). The risk also increases with injuries and repeated epidural or lumbar punctures. Such patients should be monitored for timely detection of pathological neurological symptoms. When a neurological pathology appears, it is shown that spinal cord decompression is urgent.
There are no clinical data on the use of Fragmin in pulmonary thromboembolism in patients with circulatory disorders, arterial hypotension or shock.
With rapid development during therapy with thrombocytopenia or with thrombocytopenia with platelet count less than 10,000 / μl, it is recommended to perform an in vitro test for anti-platelet antibodies in the presence of heparin or low molecular weight heparins. If the results of such an in vitro test turn out to be positive or doubtful, or if the testing has not been carried out at all, then Fragmin should be canceled.
In monitoring the anticoagulant activity of Fragmin, as a rule, there is no need. However, it should be carried out with the use of Fragmin in patients with a body weight below normal or obese, as well as with an increased risk of bleeding or thrombosis. Blood samples for the analysis of Fragmin's activity should be taken during the period when the maximum concentration of the drug in the blood plasma is reached (3-4 hours after s / c injection).
To determine the activity of anti-Xa, laboratory analyzes using a chromogenic substrate are the method of choice. Tests should not be used to determine activated partial thromboplastin time (APTT) and thrombin time, since these tests are relatively insensitive to the activity of dalteparin sodium. Increasing the dose of Fragmin in order to increase the APTT can lead to bleeding.
The units of action of Fragmin, unfractionated heparin and other low molecular weight heparins are not equivalent, therefore, when replacing one drug with another, it is necessary to correct the dosage regimen.
Use in pediatrics: Only limited information is available on the safety and efficacy of Fragmin in pediatric practice. When using Fragmin in children, it is necessary to control the level of anti-Xa activity.

Treatment: The anticoagulant effect of dalteparin sodium can be eliminated by administering protamine sulphate (an emergency treatment tool). 1 mg of protamine partially inhibited 100 ME of dalteparin sodium (and although there is a complete neutralization of the induced increase in clotting time, but from 25 to 50% of the anti-Xa activity of dalteparin sodium still persists).