Summary
- Main use
- Assists in hemostasis and vascular suturing
- Who uses it
- Adults · Children
- Adult dosage
- The dose and frequency of this drug should be determined based on the patient's clinical needs. In clinical trials, adult patients were administered doses ranging from 0.3mL to 12mL. The initial dose of the product for the selected anatomical site should be enough to completely cover the area, and it may be reapplied if necessary.
- Children's dosage
- For children over 2 years, up to 12mL can be used; for children under 2 years, up to 6mL can be used.
Ingredients
- Importer
- 한국존슨앤드존슨메디칼(주)
Efficacy & effects
Assists in hemostasis and vascular suturing
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This drug helps effectively stop bleeding in adult and pediatric patients during surgery when controlling bleeding through standard surgical techniques (suturing, ligation, or cautery, etc.) is difficult. It also assists in suturing during vascular surgery to reduce bleeding and enhance the safety of the procedure. This helps prevent complications due to bleeding and improves hemostasis to support patient recovery.
Dosage and Administration
Adult dosage
The dose and frequency of this drug should be determined based on the patient's clinical needs. In clinical trials, adult patients were administered doses ranging from 0.3mL to 12mL. The initial dose of the product for the selected anatomical site should be enough to completely cover the area, and it may be reapplied if necessary.
Children's dosage
For children over 2 years, up to 12mL can be used; for children under 2 years, up to 6mL can be used.
Precautions
This drug is made from human plasma and may contain infectious materials or viruses. Currently, there is no scientific method to completely eliminate this risk, so patients with hemophilia or those who are immune-compromised are recommended to receive vaccinations such as the Hepatitis A vaccine. The risk of infection should be regularly monitored by a physician while using this drug. This drug should only be used on wound surfaces and must never be administered intravenously. If injected intravascularly, serious complications such as thrombosis or embolism, which can be life-threatening, may occur. Patients with allergies or hypersensitivity to the components in this drug should not use it. Additionally, this drug should not be used for severe arterial bleeding. Rarely, allergic reactions such as hives, itching, difficulty breathing, or hypotension may occur while using this drug, and in severe cases, anaphylactic shock may develop. Those who use this drug repeatedly or are sensitive to its components may have a higher risk of such reactions. Care should be taken to avoid dangerous conditions such as thrombosis or disseminated intravascular coagulation (DIC) if mistakenly injected intravenously. Women who are pregnant or nursing should only use this drug if absolutely necessary because its safety has not been sufficiently established. This drug should not be mixed with other medications, and contact with antiseptics containing alcohol or iodine may lead to drug degradation, so caution is required. The wound area must be kept clean and dry before use, and applying the drug too thickly may reduce its effectiveness or impede wound healing. When storing, it must be kept frozen (-18 degrees Celsius or below) and after thawing, should not be refrozen and must be used within the specified period. It is important to protect areas of the body not being treated from contact with the drug when using this drug.
Side effects and when to seek care immediately
Serious side effects
Urticaria, generalized urticaria, angioedema, hypotension, wheezing, anaphylaxis, thromboembolism, disseminated intravascular coagulation (DIC), severe allergic reactions, difficulty breathing
Mild side effects
Burning and stinging at the application site, bronchospasm, chills, flushing, generalized urticaria, headache, rash, drowsiness, nausea, anxiety, tachycardia, chest tightness, paresthesia, vomiting, wheezing, antibodies to fibrin sealant/hemostatic agents, hyperglycemia, hyperkalemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypoproteinemia, anxiety, insomnia, headache, drowsiness, conjunctival irritation,
Not everyone experiences these, and they can vary from person to person.
Storage
This drug should be stored in a sealed container to avoid contact with air and must be kept at frozen temperatures below -18 degrees Celsius to maintain its freshness and efficacy.
Appearance and packaging
Appearance
A colorless or pale yellow frozen solution contained in a colorless transparent prefilled syringe, which, upon thawing, becomes a colorless or pale yellow liquid.
Package unit
1 kit/box [kit 2mL (1 fibrinogen prefilled syringe 1mL + 1 thrombin prefilled syringe 1mL)], 1 kit/box [kit 4mL (1 fibrinogen prefilled syringe 2mL + 1 thrombin prefilled syringe 2mL)], 1 kit/box [kit 6mL (1 fibrinogen prefilled syringe 3mL + 1 thrombin prefilled syringe 3mL)], 1 kit/box [kit 10mL (1 fibrinogen prefilled syringe 5mL + 1 thrombin prefilled syringe 5mL)]
Questions about this medicine
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For anything that needs medical judgment, consult a doctor or pharmacist.