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Country of origin : Taiwan

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dalteparin sodium

Injection 2500 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Taiwan
GMP approvals
PICS
Manufacturer #20530
With the rapid improvement of pharmaceutical technology and the approaching aging society, they focus on the development of innovative healthcare technology for Acute and Critical Care and Anti-aging and Preventive Medicine. The company has passed US FDA, Japan PMDA, and PIC/S GMP inspections through specific approaches to total quality management.

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DALTEPARIN SODIUM

Dalteparin Sodium is low molecular weight heparin. It is used in the prevention and treatment of deep vein thrombosis and pulmonary embolism, with the objective to reduce the risk of a stroke or heart attack. Dalteparin works as an anticoagulant or a blood thinner, heparin used to prevent ischemic complications in unstable angina and non-Q-wave myocardial infarction, and is concurrently administered with aspirin therapy. Its actions potentiate the activity of antithrombin III. This inhibits the formation of both Factor Xa and thrombin. It is normally administered by self-injection. In patients with malignancy and acute venous thromboembolism (VTE), it has been proven more effective than warfarin in reducing the risk of recurrence of embolic events. Dalteparin Sodium is marketed as Fragmin among others. In May 2019, the U.S. Food and Drug Administration (FDA) approved Fragmin injection to reduce the recurrence of symptomatic VTE in pediatric patients one month of age and older

DOSAGE AND ADMINISTRATION

Dalteparin Sodium is sold as an injection in international units (IU). The usual recommended adult dose for Prophylaxis of Ischemic Complications In Unstable Angina And Non-Q-Wave Myocardial Infarction is 120 IU per kilo of body weight, not to exceed 10,000 IU, subcutaneously, once every 12 hours with concurrent oral aspirin dose of 75 to 165 mg once daily, as aspirin therapy. The normal duration of the therapy is 5 to 8 days or till the patient is clinically stable. When being administered as a subcutaneous injection, the patient should be sitting or lying down and injected deep. Usually, it is injected in a U-shape area around the navel, the upper outer thigh, or on the upper outer quadrangle of the buttock and the site of injection changed each day. If the area around the stomach and thigh is full, the in can be injected into the thumb and forefinger by lifting up a fold of skin while giving the injection and the entire length of the needle inserted at a 45 to 90-degree angle.

The price of Dalteparin Sodium

In the USA, the consumers have to pay USD 275 for a supply of 2 milliliters, of the subcutaneous solution with 2500 IU equal to 0.2 mL. In India, the 7500 IU injection costs around USD 6.16, and the the10000 IU costs around USD 7.17.

How does it work?

Dalteparin Sodium is heparin of the low molecular weight class. It has antithrombotic properties which act by enhancing the inhibition of Factor Xa and thrombin by antithrombin. Dalteparin potentiates the inhibition of coagulation Factor Xa preferentially. But it can only affect the activated partial thromboplastin time slightly.

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