Dalteparin Sodium Injection

Dalteparin sodium is produced from heparin sodium prepared from porcine intestinal mucosa by controlled nitrous acid depolymerization. Its average relative molecular mass is 5000. The antithrombotic effect of dalteparin sodium is enhanced by the inhibition of coagulation factor Xa and thrombin through antithrombin. The ability of dalteparin sodium to enhance the inhibition of coagulation factor Xa is relatively greater than its ability to prolong the clotting time. The effect of dalteparin sodium on platelet function and platelet adhesion is smaller than that of heparin, so it has only a small effect on primary hemostasis. Nevertheless, some of the antithrombotic properties of dalteparin sodium are believed to be formed through the effect on the vascular wall or fibrinolytic system.

This medicine is an antithrombotic agent that contains dalteparin sodium (low molecular weight heparin sodium) and inactive ingredients such as sodium chloride or water for injection.

This product is a colorless or light yellow clear liquid.

Treatment of acute deep vein thrombosis. Prevention of coagulation in the extracorporeal circulation system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal insufficiency. Unstable coronary heart disease, such as unstable angina and non-Q-wave myocardial infarction. Prevention of thrombosis related to surgery.

If necessary, the activity of dalteparin sodium can be monitored by measuring anti-Xa. 1. Treatment of acute deep vein thrombosis. Dalteparin sodium can be injected subcutaneously once a day or twice a day. Once-daily dosage: 200 IU/kg body weight, subcutaneous injection twice a day, no need to monitor anticoagulant effect. The total daily amount should not exceed 18,000 IU. Twice-daily dosage: 100 IU/kg body weight, subcutaneous injection twice a day, this dose is suitable for patients with a higher risk of bleeding. Usually no monitoring is required during treatment, but functional anti-Xa determination can be performed. Blood samples are taken 3-4 hours after subcutaneous injection to measure the maximum blood drug concentration. The recommended blood drug concentration range is 0.5-1.0 IU anti-Xa/ml. Vitamin K antagonists can be taken orally immediately while using dalteparin sodium. Dalteparin sodium treatment should be continued until the level of prothrombin complex (factor II.VII.IX.X) drops to therapeutic levels. Usually, combined treatment requires at least 5 days. Prevention of coagulation during hemodialysis and hemofiltration. 2. Chronic renal failure, patients with no known risk of bleeding: Hemodialysis and hemofiltration no more than 4 hours: dose as follows or intravenous rapid injection of 5000 IU. Hemodialysis and hemofiltration more than 4 hours: intravenous rapid injection of 30-40 IU/kg body weight, followed by intravenous infusion of 10-15 IU/kg body weight per hour. Under normal circumstances, patients on long-term hemodialysis need to adjust the dose very rarely, and therefore the number of times the anti-Xa concentration is tested is also very small. The dose given usually keeps the plasma concentration within the range of 0.5-1.0 IU anti-Xa/ml. 3. Acute renal failure, patients with a high risk of bleeding: intravenous rapid injection of 5-10 IU/kg body weight, followed by intravenous infusion of 4-5 IU/kg body weight per hour. Patients on acute hemodialysis have short treatment intervals and should be fully monitored for anti-Xa. Plasma concentrations should be maintained within the range of 0.2-0.4 IU anti-Xa/ml. 4 Unstable coronary artery disease, such as unstable angina and non-Q-wave myocardial infarction. Subcutaneous injection of 120 IU/kg, twice a day. The maximum dose is 10,000 IU/12 hours. Treatment should be continued for at least 6 days, which can be extended if the doctor deems it necessary. It is recommended to use low-dose acetylsalicylic acid at the same time. 5 Prevention of surgery-related thrombosis: (1) Major surgery with the risk of thromboembolic complications: subcutaneous injection of 2500 IU 1-2 hours before surgery, and subcutaneous injection of 2500 IU every morning after surgery until the patient can move, which usually takes 5-7 days or longer. (2) Major surgery and orthopedic surgery with other risk factors: subcutaneous injection of 5000 IU in the evening before surgery, and subcutaneous injection of 5000 IU every night after surgery. Treatment must continue until the patient can move, which usually takes 5-7 days or longer. Alternatively, subcutaneous injection of 2500 IU 1-2 hours before surgery and subcutaneous injection of 2500 IU 8-12 hours after surgery can be performed. Then inject 5000 IU subcutaneously every morning.

Especially at high doses, it may cause bleeding. Common side effects reported are subcutaneous hematoma at the injection site. Rare thrombocytopenia, skin necrosis, allergic reactions and bleeding. Transient mild to moderate increases in liver transaminases (AST, ALT) have been observed. Allergic reactions are rare.

Hypersensitivity to this drug. Acute gastroduodenal ulcer and cerebral hemorrhage. Severe coagulation disorders. Septic endocarditis. Injury or surgery to the central nervous system, eyes and ears. Thrombocytopenic patients with positive results of in vitro platelet aggregation test when using dalteparin sodium. Concomitant use of local anesthesia in the treatment of acute deep vein thrombosis.

The simultaneous use of drugs that affect hemostasis, such as acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, vitamin K antagonists and dextran, may enhance the anticoagulant effect of this drug. Overdose of protamine can inhibit the anticoagulant effect caused by dalteparin sodium. The prolongation of clotting time caused by it can be completely offset, but the anti-Xa activity only offsets about 25-50%. Each 1 mg of protamine can inhibit the effect of 100 IU of anti-Xa dalteparin sodium. Protamine itself has an inhibitory effect on primary hemostasis, so it can only be used in emergency situations.

It can be stored at room temperature up to 30°C. Vials of Fragmin solution containing preservatives should be used within 14 days after the vial is first opened and should not be used after the expiration date.

0.2 ml: 2500 IU