Tseal

Adult use

- The dosage and frequency of administration are determined based on the patient's condition. - It varies depending on the type of surgery, the area affected, the intended method of application, and the number of applications. - In clinical trials, individual doses typically ranged from 4 to 20 mL. However, in cases such as liver surgery or suturing of extensive burn areas, larger amounts may be necessary. - The initial treatment dose should be determined based on the anatomical structure and the area of the wound to be treated.

Child use

The safety and efficacy in children have not been established.

This medication is made from human plasma and cannot completely prevent viruses or infections transmitted through blood. It is especially advisable for patients with hemophilia or those with weakened immunity to receive vaccinations such as hepatitis vaccine. When using this medication, the physician must regularly check for signs of infection. Due to the risk of infection, this medication should only be used in minimal amounts when absolutely necessary. It should not be used alone for patients with extensive and rapid bleeding, and cannot replace skin sutures for closing surgical sites. It should not be administered to patients with allergies to this medication or its components. Injecting it into the bloodstream can lead to serious side effects such as thrombosis or embolism; hence it must never be administered intravenously. Patients with allergies or sensitivity to medications should use this medication with caution, and those who have previously used protamine components are recommended to take antihistamines. This medication can rarely cause allergic reactions such as venous swelling, itching, shortness of breath, hives, hypotension, nausea, rash, anxiety, tachycardia, vomiting, pruritus, erythema, sensory disturbances, hypotension, hematoma, paresthesia, chest tightness, pain, elevated temperature, limb pain, queasiness, treatment failure, procedural pain, seroma, blood and lymphatic abnormalities (increased fibrin degradation products), post-surgical wound infections, and edema. In particular, there is a risk of severe anaphylaxis (acute allergic reaction) in patients who have been sensitized to protamine or have used it multiple times. Improper administration into the bloodstream can lead to dangerous conditions such as thromboembolism or disseminated intravascular coagulation. This medication should be applied only to wound areas and must never be injected into the bloodstream, and care must be taken to avoid air embolism or tissue damage when using high-pressure gas to spray. The manufacturer's recommended pressure and distance should be observed during spraying, and blood pressure, pulse, oxygen saturation, etc. of the spray area should be closely monitored. Before using this medication, care should be taken to avoid contact of body parts other than the application site with this medication, and it should be confirmed that the product is completely thawed and properly mixed just before use. The safety of this medication for pregnant or breastfeeding women has not been sufficiently confirmed, so it should only be used when absolutely necessary. Applying it too thickly can reduce the drug's effectiveness and impede wound healing, so it should be applied thinly and any excess medication should be removed as much as possible. This medication must be stored frozen, and once thawed, it must not be refrozen or stored in a refrigerator. It should be stored protected from light until use, and must be used within the specified time after thawing.

Serious side effects

• Hives
• severe swelling (angioedema)
• chest tightness
• breathing difficulty
• wheezing
• respiratory distress
• hypotension
• anaphylactic reaction
• anaphylactic shock
• thromboembolism

Mild side effects

Burning and stinging at the administration site, bradycardia, generalized hives, headache, numbness, drowsiness, nausea, rash, anxiety, tachycardia, vomiting, itching, erythema, sensory disturbances, hypotension, hematomas, paresthesia, chest tightness, pain, elevated temperature, limb pain, queasiness, treatment failure, procedural pain, seromas, blood and lymphatic abnormalities (increased fibrin degradation products), post-surgical wound infections, edema

This medication is sensitive to light and should be kept in a container that does not allow light to enter. Additionally, it is important to store it frozen at or below -20 degrees Celsius to maintain its effectiveness.

Appearance

A pair of prefilled syringes with one end connected, containing a white to yellowish frozen solution.

Package unit

1 kit (2 mL)/box, 1 kit (4 mL)/box, 1 kit (10 mL)/box