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Country of origin : Mexico

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streptokinase

Ampoules, injection 1500000 IU , 75000 IU

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Mexico
GMP approvals
COFEPRIS
Manufacturer #18736
It was founded in the 2000s. The main aim of the position itself in the market as a company dedicated to the research, development, manufacturing, marketing, and distribution of new generation specialized generic and biosimilar medicines.

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Streptokinase

Streptokinase is a thrombolytic medication and enzyme that breaks down clots in patients suffering from myocardial infarction, pulmonary embolism and arterial thromboembolism. It has been found effective in lysis of objectively Pulmonary Embolism, involving obstruction of blood flow to a lobe or multiple segments with or without unstable hemodynamics, for the lysis of objectively diagnosed acute, Deep Vein Thrombosis, such as those involving the popliteal and more proximal vessels. It is also indicated for the lysis of Arterial Thrombosis or Embolism. Streptokinase is sold under the brand name Streptase amongst others. William S. Tillett discovered Streptokinase in 1933. Initially, it was used to treat fibrinous pleural exudates, hemothorax and tuberculous meningitis. Several companies like Novartis AG and Novochem have filed various patents for different formulations. Due to its efficacy, this medicine has found a place on World Health Organization's List of Essential Medicines. Please note that kind medicine is no longer commercially available in the United States.

Forms and dosage:

A health care professional only administers streptokinase through an injection. The usual adult dose for treating Acute Evolving Transmural Myocardial Infarction is 1,500,000 IU through an IV infusion within 60 mins. If you get an Intracoronary infusion, the usual adult dose is 140,000 IU by bolus followed by 2,000 IU per min for 60 min. In the treatment of Pulmonary Embolism, the usual adult dose is 250,000 IU every 30 min. In the cases of concurrent DVT the same dose is given for 72 hours. In the treatment of Deep Vein Thrombosis 250,000 IU every 30 min or 100,000 IU every hour for 72 hours. And in the treatment of Arterial Thrombosis or Embolism, the usual adult dose is 250,000 IU every 30min or 100,000 IU per hour for 24-72 hours.

The price of Streptokinase:

Streptokinase is no longer sold in the US or EU. In India, the consumers have to pay approximately US$34 for an injection of 1,500,000UI. The medicine is relatively inexpensive in the rest of the developing world.

How does it Streptokinase work?

Streptokinase is a fibrinolytic. With a human plasminogen, Streptokinase hydrolytically activates unbound plasminogen by activating through bond cleavage to produce plasmin. Blood produces Plasmin in the blood to break down fibrin. Fibrin is the major constituent of blood thrombi. Unwanted blood clots, for example, in pulmonary embolism, are controlled by extra production of plasmin thereby dissolving clots once they have fulfilled their purpose of stopping bleeding.

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