Iyeon Thrombin Lyophilized Powder 5000 Units

Adult dose

The solution, dissolved in physiological saline (as thrombin of 50–1,000 units/mL), is sprayed, instilled, or the powder is applied directly to the site of local bleeding. For upper gastrointestinal bleeding, the solution, dissolved with an appropriate buffering agent (as thrombin of 200–400 units/mL), is administered orally. Adjust according to the bleeding site and severity.

This medication should not be used as an injectable agent and extreme caution must be taken to avoid introducing the solution intravascularly when used locally. If it inadvertently enters the vascular system, it can cause blood clotting that threatens life and there is a risk of severe allergic reactions such as anaphylaxis. Additionally, this medication can cause abnormal blood coagulation test results, and while rare, serious bleeding or thrombosis may occur, requiring caution. This medication should not be administered to patients who have had allergic reactions to this drug or to components derived from cows or those who are taking other medications that affect blood coagulation. It should be used cautiously in patients with severe liver dysfunction or problems controlling coagulation in the blood, as well as in pregnant women or women who may become pregnant, as safety has not been established. During use, symptoms of shock such as dyspnea, cyanosis, and hypotension may occur rarely, so the patient's condition should be monitored closely, and if abnormal symptoms appear, administration should be stopped immediately and appropriate treatment should be commenced. Additionally, this medication may cause abnormal blood coagulation, bleeding, or allergic reactions (rash, fever, urticaria, itching, swelling), so if these symptoms occur, administration should be halted. Nausea, vomiting, and headaches may also occur as side effects. Co-administration with other coagulants, antifibrinolytics, or aprotinin products increases the risk of thrombosis, so it should not be used together. Furthermore, iodine, hydrogen peroxide, alcohol, and substances containing heavy metals may reduce the effectiveness of this medication. Patients taking cardiac glycosides should be cautious, as if this medication enters the vascular system, it may enhance effects due to calcium content. Pregnant women or women who may become pregnant should only use this medication when the benefits of treatment are deemed to outweigh the risks, as its safety has not been established. Care must be taken when using it in children, especially in low birth weight newborns or infants, as safety has not been fully confirmed. When used locally, care must be taken to ensure the medication does not enter the vascular system, and when treating gastrointestinal bleeding, it is advisable to use milk or phosphate-buffered saline to buffer the acidity within the stomach. It should be used as soon as possible after preparation, and if storage is necessary, it must be refrigerated; the solution is unstable to acids, bases, heat, and heavy metal salts, so care in handling is essential.

Serious side effects

• Urticaria
• swelling
• dyspnea
• shock symptoms (cyanosis, hypotension)

Mild side effects

• Rash
• fever
• itching
• nausea
• vomiting
• headache

This medication should be stored in a sealed container to prevent air or moisture from entering, and it is recommended to be kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication and allows for safe use.

Appearance

A colorless transparent vial containing a whitish lyophilized agent

Package unit

1 vial, 10 vials, 25 vials, 50 vials