FloSeal Hemostatic Matrix

Adult dosage

Thrombin should be added to the gelatin matrix immediately before use. The thrombin solution should be mixed with the gelatin matrix and used within 8 hours. Apply this medication directly to the site where bleeding has started and hold it for 2 minutes. Use a sufficient amount to completely cover the damaged area of tissue and act promptly. Support the bleeding surface with a gauze sponge soaked in sterilized saline and secure it, then remove the gauze after approximately 2 minutes.

This medication should not be injected directly into blood vessels or used with excessive pressure. Using it in areas where blood flow is absent may lead to serious issues due to clot formation within blood vessels. This product contains thrombin extracted from human plasma, which presents a risk of contamination with viruses and other infectious agents. While multiple safety measures are taken during manufacturing, the risk of infection cannot be completely eliminated. Therefore, adequate consultation with a physician is required before using this product. This medication is used for hemostasis during surgical procedures involving bleeding and is not intended for preventive use. It should not be used in infected areas, and immediate treatment may be necessary if signs of infection appear. This product should not be used as a first-line treatment for coagulopathies, and applying it directly to blood vessels or tissues may be hazardous. Due to its gelatin component, it should not be used for sutures at skin incision sites and is contraindicated in patients taking specific medications. Patients with severe liver disease or blood coagulation issues may have an increased risk of thrombosis when using this product, and caution is required. Reported side effects among patients using this medication include anemia, atrial fibrillation, infection, bleeding, pneumonia, urinary tract infection, rash, hypotension, confusion, dural damage, ventricular fibrillation, arrhythmia, right heart failure, arterial thrombosis, fever, atelectasis, pleural effusion, myocardial infarction, soft tissue infection, pneumothorax, pain, cerebrovascular accident, hallucinations, paresthesia, bradycardia, abscess, diarrhea, urinary retention, suture breakdown, skin ulcer, transfusion reaction, cardiac arrest, pulmonary edema, low back pain, ventricular tachycardia, neuropathy, acute kidney injury. Gelatin-based hemostatic agents may cause infection or inflammation and pose a risk of neurological complications during brain or spinal surgery. Caution is advised when using this product in conjunction with adhesives that bond to bone as it may affect adhesive strength. Do not attempt to re-sterilize after use, and take care to avoid contact with solutions containing alcohol or iodine. When using on a bleeding site, be aware that the volume may expand by approximately 20%, which could impact surrounding tissues. Caution is required when using this medication in pregnant or lactating women and children, as its safety and efficacy have not been thoroughly verified in these populations. Use this product as soon as possible after opening, and do not blow air into the applicator tip to remove residual medication, and it is recommended not to cut the tip.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, severe allergic reactions, severe skin hypersensitivity reactions, respiratory issues, jaundice (yellowing of the skin or eyes), liver abnormalities, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, severe neurological symptoms, significantly decreased urine output, severe generalized swelling and hypertension, severe edema or urinary abnormalities, anaphylaxis.

Mild side effects

• Anemia
• atrial fibrillation
• infection
• bleeding
• pneumonia
• urinary tract infection
• rash
• hypotension
• confusion
• dural damage

This medication should be stored in a sealed container that prevents the ingress of air and should be kept at room temperature between 2 degrees and 25 degrees, ensuring it does not freeze. Proper storage will maintain the efficacy of the medication and allow for safe use.

Appearance

A kit consisting of a syringe containing a pale yellow to light brown powder, a vial containing a white to slightly yellow powder or brittle solid, and a syringe containing a colorless transparent solution.

Package unit

1 kit x 1