BM Thrombin Freeze-dried Powder 5000 Units (Thrombin)

Adult dose

Spray, instill, or disperse the solution mixed with normal saline (thrombin at 50–1,000 units/mL) on the local bleeding site. For upper gastrointestinal bleeding, administer the appropriately buffered solution (thrombin at 200–400 units/mL) orally. Adjust according to the bleeding site and extent.

This drug must not be used as an injectable and great caution must be exercised to prevent it from entering the bloodstream even when used locally. If it mistakenly enters the bloodstream, serious issues such as blood clotting that could threaten life may occur, and severe allergic reactions such as anaphylaxis may also happen. Using this drug may result in abnormal laboratory test results related to blood clotting, and whilst rare, serious conditions like bleeding or thrombosis may occur. People with allergies to this drug or components derived from cattle should not use it. Additionally, patients who are taking other medications that control blood clotting should not use this drug. Patients with severely impaired liver function or reduced fibrinolytic activity in the blood, as well as women who are pregnant or may become pregnant, should be extremely cautious when using this drug. Rarely, severe shock symptoms such as difficulty breathing, cyanosis, and hypotension may occur when using this drug, so if any unusual symptoms arise, administration should be stopped immediately and appropriate treatment sought. Moreover, this drug can cause allergic reactions such as bleeding disorders, rashes, fever, urticaria, itching, and swelling; if such symptoms occur, use should be discontinued. Nausea, vomiting, and headaches may also appear. This drug should not be used in conjunction with specific clotting enhancers, anti-fibrinolytics, or aprotinin preparations as they can increase the risk of thrombosis. Additionally, iodine, hydrogen peroxide, alcohol, and substances containing heavy metals can reduce the effectiveness of this drug. Pregnant women should only use this drug if it is determined that the benefits of treatment outweigh the risks, as its safety during pregnancy is not well established. The safety of this drug has not been sufficiently confirmed in children or newborns, particularly low birth weight infants. When using it topically in solution, care must be taken to avoid entering the bloodstream, and it is advisable to adjust the stomach acidity before using it for treating gastric bleeding. This drug should be used immediately after preparation and must be handled with care as it is sensitive to acidity, alkalinity, heat, and heavy metal salts.

Serious side effects

• Urticaria
• swelling
• difficulty breathing
• hypotension
• abnormal bleeding
• shock
• anaphylactic reaction

Mild side effects

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

This drug should be stored in a sealed container to prevent exposure to air, maintaining a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Storing it this way can help maintain the drug's efficacy and safety.

Appearance

A white to pale yellow freeze-dried powder filled in a colorless transparent vial

Package unit

1 set/box[[1 vial (powder part 60.33mg) + 1 vial (attachment solution 5mL)]],1 set/box[[5 vials (powder part 60.33mg) + 5 vials (attachment solution 5mL)]],1 set/box[[20 vials (powder part 60.33mg) + 20 vials (attachment solution 5mL)]]