Medication info

Hemopense Hemostatic (Thrombin)

Prescription medication
Ingredient · strength
Thrombin›Strength being verified
Manufacturer / importer
(주)한국비엠아이
Appearance
A colorless, transparent vial containing a white to light yellow freeze-dried powder, a colorless, transparent solvent vial containing a colorless, transparent liquid, and a colorless, transparent additive containing sodium cross-linked hyaluronate.
Packaging
1 kit/kit
Approval status
Active

MFDS item code 202400341 · Approved 2024.02.16

Summary

Main use
Effective hemostatic agent when bleeding control is not achievable.
Who uses it
Adults
Adult dosage
Thrombin should be mixed with sodium cross-linked hyaluronate gel in a prefilled syringe just before use. Important application steps: 1. Apply this medication directly to the site where bleeding has begun. 2. Carefully contact and secure this medication at the starting point of bleeding. 3. Use a sufficient amount to completely cover the damaged area of tissue. 4. Act promptly. 5. Ensure that the formed blood clot does not dislodge by always maintaining caution with the remaining amount of this medication.

Ingredients

Manufacturer
(주)한국비엠아이

Efficacy & effects

Effective hemostatic agent when bleeding control is not achievable.

  • Bleeding
View approved original text

This medication is used to effectively control bleeding during surgical procedures in various areas, particularly when bleeding cannot be controlled by ligation or conventional methods, excluding the eye.

Dosage and Administration

Adult dosage

Thrombin should be mixed with sodium cross-linked hyaluronate gel in a prefilled syringe just before use. Important application steps: 1. Apply this medication directly to the site where bleeding has begun. 2. Carefully contact and secure this medication at the starting point of bleeding. 3. Use a sufficient amount to completely cover the damaged area of tissue. 4. Act promptly. 5. Ensure that the formed blood clot does not dislodge by always maintaining caution with the remaining amount of this medication.

Precautions

This medication should not be administered intravenously or at sites of vascular occlusion, as coagulation in the blood vessel can lead to serious problems. It is used for hemostasis during surgery but should not replace common hemostatic methods. It should also not be used for preventive purposes. Do not use on infected areas, and if any signs of infection appear, additional surgery may be necessary. Contains components derived from cattle, which may occasionally cause serious adverse effects like coagulopathy, bleeding, or thrombosis. This medication is not suitable as a first-line treatment for patients with coagulation disorders. To reduce the risk of allergic reactions or thromboembolic events, it should not be used directly on blood vessels or tissues. It should not be administered to patients receiving other coagulation enhancers or antifibrinolytics, such as aprotinin products. Do not use in patients with severe arterial bleeding or for the treatment of ocular surgery sites, postpartum hemorrhage, or excessive menstruation. If allergic to components derived from cattle, do not use this medication. Use cautiously in patients with severely impaired liver function or in pregnant women. Rarely, symptoms of shock such as breathing difficulties, cyanosis, or hypotension may occur during use, so careful monitoring is necessary. If symptoms of hypersensitivity such as rash, urticaria, or pruritus occur, discontinue use immediately. Various side effects such as pain, rash, infection, and bleeding may occur at the surgical site, necessitating medical observation. This medication is for single use only and is not to be re-sterilized. The injection site must be thoroughly cleaned to avoid contamination with denaturing substances like alcohol or iodine, and any excess medication must be meticulously removed. When used in closed tissue spaces, it should be approached slowly, considering the drug's expansion properties. Safety when used with antibiotics has not been established, so caution is advised. In specific surgical fields, the safety and effectiveness of this medication have not been sufficiently validated. When storing, keep it out of reach of children and use it as soon as possible after opening. Administer the medication carefully following medical guidance, and report any unusual symptoms immediately for appropriate action.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • respiratory difficulties
  • drop in blood pressure
  • shock
  • severe allergic reactions
  • abnormal bleeding
  • coagulation disorders
  • thromboembolic events
  • urticaria
Show 2 more
  • edema
  • severe allergic reactions.

Mild side effects

  • Rash
  • fever
  • pruritus
  • headache
  • nausea
  • vomiting
  • constipation
  • dyspepsia
  • abdominal pain
  • diarrhea
Show 21 more
  • blood in stool
  • hemorrhoids
  • bowel obstruction
  • stomatitis
  • procedure-related pain
  • rash at incision site
  • postoperative discharge
  • postoperative erythema
  • skin tear
  • skin injury
  • tongue injury
  • dental fracture
  • chest discomfort
  • peripheral edema
  • facial edema
  • walking difficulties
  • pain at the injection site
  • swelling at the injection site
  • bleeding at the injection site
  • pain
  • hypotension.

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

Storage

Store this medication in a tightly sealed container to prevent the ingress of air or moisture, ideally at room temperature between 1°C and 30°C. Proper storage will maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

A colorless, transparent vial containing a white to light yellow freeze-dried powder, a colorless, transparent solvent vial containing a colorless, transparent liquid, and a colorless, transparent additive containing sodium cross-linked hyaluronate.

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.