Medication info

STOPIHEMOSTATIC

Prescription medication
Ingredient · strength
Thrombin›Strength being verified
Manufacturer / importer
(주)한국비엠아이
Appearance
A kit consisting of BM Thrombin freeze-dried powder 5000 units (1 vial each of drug and diluent), collagen absorbable wound dressing, universal catheter cannula, syringe, and injection needle.
Packaging
1 kit/kit
Approval status
Active

MFDS item code 202008012 · Approved 2020.11.19

Summary

Main use
Hemostatic effect for bleeding (small blood vessels, capillaries)
Who uses it
Adults
Adult dosage
1. Thrombin freeze-dried powder 5000 units Dissolve the powder in saline to prepare a solution (50~1,000 units/mL of thrombin) and spray, instill, or apply the powder directly to the site of local bleeding. Adjust dosage according to the bleeding site and severity. 2. Collagen absorbable wound dressing - Cut to the appropriate size for the treatment area. - Up to 3 pieces can be used based on a 10x10cm standard, considering the patient's weight and total amount of gentamicin sulfate.

Ingredients

Manufacturer
(주)한국비엠아이

Efficacy & effects

Hemostatic effect for bleeding (small blood vessels, capillaries)

  • Bleeding from small blood vessels
  • capillary bleeding
  • organ bleeding
  • traumatic bleeding
  • surgical bleeding
  • wound contamination
View approved original text

Thrombin freeze-dried powder 5000 units is used to stop bleeding from small blood vessels, capillaries, and internal organ bleeding, for example, during trauma or surgery when conventional methods are difficult. The collagen absorbable wound dressing helps protect the surgical site or wound and prevents contamination, and it also contains the antibiotic gentamicin sulfate for infection prevention. The universal catheter cannula is used to safely inject drugs into the body cavity during surgery. The syringe and sterilized needle are sterile disposable tools needed for injecting drugs into the body. These products are used to stop bleeding, protect wounds, and aid safe drug administration, respectively.

Dosage and Administration

Adult dosage

1. Thrombin freeze-dried powder 5000 units Dissolve the powder in saline to prepare a solution (50~1,000 units/mL of thrombin) and spray, instill, or apply the powder directly to the site of local bleeding. Adjust dosage according to the bleeding site and severity. 2. Collagen absorbable wound dressing - Cut to the appropriate size for the treatment area. - Up to 3 pieces can be used based on a 10x10cm standard, considering the patient's weight and total amount of gentamicin sulfate.

Precautions

This drug is used topically to assist with blood coagulation. However, it must never be injected intravenously, subcutaneously, or intramuscularly. If it enters the bloodstream, it can cause serious complications due to coagulation. Patients who have had an allergic reaction to this drug or are taking specific pro-coagulants or anti-fibrinolytics should not use it. Caution is advised for patients with severe liver dysfunction or abnormal blood coagulation issues, as well as for pregnant women or women of childbearing potential. There may be rare but serious allergic reactions such as dyspnea or hypotension; therefore, symptoms should be carefully monitored. Additionally, this drug may affect blood coagulation, leading to bleeding or thrombosis, so use should be discontinued immediately if abnormal symptoms occur. This drug should not be used in combination with other coagulants or anti-fibrinolytics as it may increase the risk of thrombosis. When used in solution form, care must be taken to ensure it does not enter the bloodstream, and it should be used immediately after preparation. The safety for pregnant women or children has not been sufficiently confirmed, so it should be used cautiously only in special cases.

Side effects and when to seek care immediately

Serious side effects

Hives, swelling, dyspnea, hypotension, abnormal bleeding, shock symptoms, cyanosis, hypotension, neurotoxicity (dizziness, tinnitus, hearing loss), decreased urination, symptoms related to kidney impairment (renal failure)

Mild side effects

  • Rash
  • fever
  • itching
  • nausea
  • vomiting
  • headache
  • skin whitening
  • localized redness
  • flushing
  • inflammation
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  • allergic reactions

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a sealed container to protect it from air and is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy.

Appearance and packaging

Appearance

A kit consisting of BM Thrombin freeze-dried powder 5000 units (1 vial each of drug and diluent), collagen absorbable wound dressing, universal catheter cannula, syringe, and injection needle.

Package unit

1 kit/kit

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.