This product's status changed to Approval withdrawn on 2023.11.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Summary
- Main use
- Hemostatic adjunct effect when bleeding control is insufficient
- Who uses it
- Adults
- Adult dosage
- EVICEL is used according to the clinical needs of the patient as determined by the surgeon. The dosage varies based on the type of surgery, the size of the application area, the method and frequency of application, with a maximum of 4 mL for vascular surgeries and up to 10 mL for retroperitoneal or intra-abdominal surgeries. The initial dose should be sufficient to completely cover the application area, and can be reapplied as necessary. The method of application is either dripping or spraying.
Ingredients
- Importer
- 한국존슨앤드존슨메디칼(주)
Efficacy & effects
Hemostatic adjunct effect when bleeding control is insufficient
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This medicine helps effectively stop bleeding when bleeding during surgery cannot be adequately controlled by standard surgical methods, such as suturing, clipping, or cauterization. In other words, it aids in hemostasis in situations where controlling bleeding during surgery is difficult, thereby promoting patient safety. It is used to improve bleeding issues in such cases.
Dosage and Administration
Adult dosage
EVICEL is used according to the clinical needs of the patient as determined by the surgeon. The dosage varies based on the type of surgery, the size of the application area, the method and frequency of application, with a maximum of 4 mL for vascular surgeries and up to 10 mL for retroperitoneal or intra-abdominal surgeries. The initial dose should be sufficient to completely cover the application area, and can be reapplied as necessary. The method of application is either dripping or spraying.
Precautions
Since this medicine is made from human plasma, there may be a risk of viral or infectious agents that can be transmitted through blood, although rare. Therefore, patients with hemophilia or those with weakened immune systems should receive vaccinations, such as the hepatitis A vaccine, and should regularly check for infections after administration. This medicine should only be applied to wound surfaces, and administering it into blood vessels can lead to serious complications such as thrombosis or vascular embolism, so it must not be injected into blood vessels. Additionally, it should not be used in patients with allergies or hypersensitivity to any of its components. It is prohibited to use in a spray form during endoscopic procedures, and caution is necessary during laparoscopic surgeries. Patients with hemolytic anemia or hemorrhagic anemia, and those with compromised immune systems should be careful in using this medicine due to the risk of viral infection present in the product. Rarely, this medicine may cause allergic reactions, hives, shortness of breath, or hypotension, and in severe cases, it may progress to anaphylactic shock. Such reactions may be more pronounced in patients who are hypersensitive to the components or those using it repeatedly, so caution is recommended. If intravascular injection occurs accidentally, dangerous conditions such as thrombosis or disseminated intravascular coagulation (DIC) may arise, so utmost care is necessary. When this medicine is used with a nebulizer, the recommended pressure and distance must be maintained; otherwise, life-threatening air embolism may occur. As a drug derived from human blood, the risks of infections such as HIV or hepatitis viruses cannot be completely excluded, so the patient's condition must be closely monitored after use. Pregnant women or those who may become pregnant should use this drug only when the benefits of treatment outweigh the risks due to the potential risk of viral infections to the fetus. Nursing mothers should also only use this drug when absolutely necessary as sufficient safety has not been verified for its use during breastfeeding. This drug should not be mixed with other medications, and must be cleaned off any substances such as alcohol or disinfectants before use as it may degrade. For storage, it should be kept in a sealed container to avoid contact with air, and stored frozen at below -18 degrees Celsius. Doing so will maintain the drug's effectiveness and prevent degradation. Finally, it is essential to always document the manufacturing number and the patient's name for traceability when using this medicine, and to apply it safely following the recommended usage and devices.
Side effects and when to seek care immediately
Serious side effects
Angioedema, generalized urticaria, severe hypotension, chest tightness, wheezing, urticaria, bronchospasm, anaphylaxis, thromboembolism, disseminated intravascular coagulation (DIC), air or gas embolism, intra-abdominal abscess, graft thrombosis/occlusive adverse reactions
Mild side effects
Burning and tingling at the application site, headache, nausea, anxiety, tachycardia, a feeling of heaviness, vomiting, general fatigue, flushing
Not everyone experiences these, and they can vary from person to person.
Storage
This medicine should be stored in a sealed container to prevent contact with air and kept frozen at a temperature below -18 degrees Celsius. By doing this, the drug's effectiveness can be maintained and degradation can be prevented.
Appearance and packaging
Appearance
This medicine consists of a kit with two glass vials. Each vial contains an opaque frozen liquid that has a white to light yellow appearance, which turns into a colorless to light yellow clear liquid upon thawing.
Package unit
2 mL / kit, 4 mL / kit, 10 mL / kit
Questions about this medicine
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For anything that needs medical judgment, consult a doctor or pharmacist.