Medication info

Endostopy Hemostatic (Thrombin)

Prescription medication경구
Ingredient · strength
Thrombin›Strength being verified
Manufacturer / importer
(주)한국비엠아이
Appearance
A kit consisting of BM Thrombin freeze-dried powder 5000 units (main drug, solvent, each 1 vial) and a biocompatible material for tissue repair.
Packaging
1 kit/kit [BM Thrombin freeze-dried powder 5000 units main drug, solvent, accessory [biocompatible material for tissue repair (Endomucoup 20)]], 1 kit/kit [BM Thrombin freeze-dried powder 5000 units main drug, solvent, accessory [biocompatible material for tissue repair (Endomucoup 5)]], 1 kit/kit [BM Thrombin freeze-dried powder 5000 units main drug, solvent, accessory [biocompatible material for tissue repair (Endomucoup 20 x 2 vials)]].
Approval status
Active

MFDS item code 202107986 · Approved 2021.12.15

Summary

Main use
Hemostatic effect on bleeding (capillary, microvascular) and improvement in maintaining mucosal elevation.
Who takes it
Adults
Adult dose
Thrombin freeze-dried powder 5000 units is typically sprayed or instilled as a solution dissolved in saline (thrombin at 50-1,000 units/mL) at the local bleeding site, adjusting the amount based on the bleeding site and extent. The biocompatible material for tissue repair (sodium hyaluronate) dosage should be determined based on the area and size of the lesion, disinfect the area where the vial cap is removed and inject the required amount into the syringe.

Ingredients

Manufacturer
(주)한국비엠아이

Efficacy & effects

Hemostatic effect on bleeding (capillary, microvascular) and improvement in maintaining mucosal elevation.

  • Bleeding from small blood vessels
  • bleeding from capillaries
  • bleeding from solid organs
  • bleeding associated with trauma
  • bleeding during surgery.
View approved original text

Thrombin freeze-dried powder 5000 units is used mainly in situations where it is difficult to stop bleeding occurring in small blood vessels, capillaries, and solid organs. For example, it helps effectively stop bleeding that occurs during trauma or surgery. The biocompatible material for tissue repair is a colorless, transparent, viscous gel made from sodium hyaluronate, used to form and maintain mucosal elevation in the gastric tumor area during endoscopic mucosal resection. It is injected submucosally to aid in tissue repair and enhance therapeutic effects. Thus, thrombin freeze-dried powder is used to control bleeding, while the biocompatible material for tissue repair is used for tissue repair and therapy.

How to take

Adult dose

Thrombin freeze-dried powder 5000 units is typically sprayed or instilled as a solution dissolved in saline (thrombin at 50-1,000 units/mL) at the local bleeding site, adjusting the amount based on the bleeding site and extent. The biocompatible material for tissue repair (sodium hyaluronate) dosage should be determined based on the area and size of the lesion, disinfect the area where the vial cap is removed and inject the required amount into the syringe.

Precautions

This drug is a local agent that aids in blood coagulation and must never be injected. If it enters the bloodstream, it can cause coagulation that threatens life, so great caution is required. Also, it should not be used in individuals with a history of allergies to this drug or components derived from cattle. It should also be avoided in patients taking other medications that enhance or inhibit coagulation, as this can be dangerous. Patients with severe liver disease or blood coagulation disorders, as well as pregnant women or those who might become pregnant, need to be careful when using this drug. Occasionally, serious allergic reactions such as difficulty breathing or decreased blood pressure may occur during use, so the condition should be closely monitored. If skin reactions such as rash or itching occur, use should be stopped immediately. This drug may present a risk of thrombosis when used with certain other medications; hence, consultation with a healthcare provider is essential. Due to the uncertainty of safety, pregnant women should use it only cautiously when necessary. Safety in children and neonates has not been adequately confirmed, hence caution is warranted. Care must be taken not to allow the solution to enter the bloodstream during use, and it should be used immediately after preparation. Moreover, potency may decrease upon exposure to acidic or alkaline environments, heat, or heavy metals, so caution is required during storage and use. Patients with a tendency for bleeding during surgery or a history of hypersensitivity should be particularly cautious when using this drug and should monitor for bleeding afterward. Elderly patients may have reduced physiological functions, so caution is necessary. Women who are pregnant or breastfeeding should consider the risks and benefits of this drug thoroughly before use, and safety for children has not been established. There is limited clinical experience regarding overdose, thus the prescribed dosage must be strictly adhered to.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, difficulty breathing, shock symptoms (including hypotension, cyanosis), severe bleeding, thrombosis.

Mild side effects

  • Rash
  • fever
  • itching
  • nausea
  • vomiting
  • headache
  • pruritus
  • facial flushing.

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

Storage

This drug should be stored in a sealed container to prevent air or moisture from entering, and it should be safely stored at room temperature, between 1 and 30 degrees Celsius. Proper storage maintains the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

A kit consisting of BM Thrombin freeze-dried powder 5000 units (main drug, solvent, each 1 vial) and a biocompatible material for tissue repair.

Package unit

1 kit/kit [BM Thrombin freeze-dried powder 5000 units main drug, solvent, accessory [biocompatible material for tissue repair (Endomucoup 20)]], 1 kit/kit [BM Thrombin freeze-dried powder 5000 units main drug, solvent, accessory [biocompatible material for tissue repair (Endomucoup 5)]], 1 kit/kit [BM Thrombin freeze-dried powder 5000 units main drug, solvent, accessory [biocompatible material for tissue repair (Endomucoup 20 x 2 vials)]].

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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.

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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.