Beryplast-P Combi Set 1mL

Adult use

The dosage of this drug is determined based on the area of the wound surface or the size of the defect, typically according to the surface area of the tissue requiring adhesion. 1 mL of the drug set for up to 8 cm², 3 mL of the drug set for up to 24 cm². Dosage instructions are as follows: 1) Solution Preparation: Remove from the refrigerator and allow to sit at room temperature (below 25°C) before opening the sterile blister pack and combining Combi Set I and II with the solvent and powder.

This drug is a product made from human plasma, and there is a potential risk of transmission of viruses or infectious agents that cannot be completely eliminated. Vaccinations, such as hepatitis A vaccine, are recommended for hemophilia patients or those with weakened immune systems, and regular checks for infection should be conducted after administration. This drug should not be used in patients with severe bleeding or allergies to milk protein and in cases where intravascular administration is required. It should only be used topically on the wound site, as unintentional intravascular administration may result in life-threatening thrombosis. We must take care not to damage tissues away from the injection site, and discontinue administration immediately if an allergic reaction occurs. This drug contains the milk protein Aprotinin, and the risk of allergic reactions may increase if the patient has a history of exposure to this ingredient, thus must be documented in the patient’s records. When used for the treatment of gastrointestinal bleeding via endoscopy, there is a risk of tissue damage and hematoma formation; therefore, immediate consultation with a doctor is necessary if symptoms such as abdominal pain, nausea, or vomiting occur. Acute allergic reactions such as rashes on the face, difficulty breathing, and hypotension have generally been reported, and repeated dosing may lead to anaphylactic reactions. When using this drug, care should be taken to ensure that it does not come into contact with other body parts apart from the treatment site, and additional hemostatic measures are required if severe bleeding occurs. As a product derived from human blood, the risk of viral infection cannot be entirely ruled out; therefore, precaution should be exercised, especially in pregnant women or immunocompromised patients regarding infectious risk. This drug should not be mixed with solutions containing alcohol, iodine, heavy metals, and it is safest not to mix it with other medications. Women during pregnancy or breastfeeding should only use this drug when the benefits are deemed greater than the risks, as its safety has not been sufficiently established. There are no reports of overdose, but it should only be used topically and intravenous administration must be strictly avoided. When storing, maintain refrigeration at temperatures between 2°C and 8°C and do not freeze; expired products must not be used. Any unused solution and syringes must be disposed of, and should be kept out of reach of children. Before using this drug, read the enclosed instructions thoroughly and use it safely according to the guidelines.

Serious side effects

Urticaria, hypotension, anaphylaxis, chest tightness (chest discomfort), difficulty breathing (bronchospasm, wheezing), thrombosis, shock, hematoma within the intestinal wall, pancreatitis

Mild side effects

• Nausea
• vomiting
• facial flushing
• hypotension
• local urticaria
• local edema
• wheezing
• low blood pressure
• abdominal pain
• nausea

This drug should be stored in a sealed container to prevent air ingress, and kept at refrigeration temperatures between 2°C and 8°C. Freezing may change the drug's composition, hence it should not be frozen. Additionally, it can be sensitive to light, so it is recommended to keep it in the original box to block light exposure while storing.

Appearance

1. Vial 1: A colorless vial containing a white freeze-dried substance, which becomes nearly colorless and a clear or slightly cloudy solution upon dissolving in Aprotinin solution. 2. Vial 2: Contains a colorless transparent liquid.

Package unit

1 set/box [2 freeze-dried vials + 2 liquid vials]