Ichor Fibroseal 1.0ml Fibrin Sealant Kit

Ichor Fibroseal 1.0ml Fibrin Sealant Kit contains human fibrinogen and human thrombin, acting as a biological adhesive to support hemostasis and tissue sealing during surgical procedures.

Benefits

This kit helps control bleeding by speeding up blood clotting, preventing excessive blood loss, and enhancing the healing process. It forms a stable fibrin clot at the application site, mimicking the body's natural clotting mechanism. The sealant is a fully resorbable biological matrix that may also contribute to reducing post-operative pain and bleeding.

Uses and Indications

• As an adjunct to hemostasis in surgical procedures where standard techniques are ineffective or impractical.
• For tissue sealing, gluing, and supporting wound healing.
• Commonly used in cardiovascular, general, and reconstructive surgeries.
• Managing diffuse bleedings and sealing vascular prostheses.
• Fixation of skin grafts and flaps, and gluing of peripheral nerves.
• Sealing suture lines to prevent leakage of intestinal anastomoses.

The Ichor Fibroseal 1.0ml Fibrin Sealant Kit contains:

• Lyophilized Human Fibrinogen Concentrate (1 mL contains Fibrinogen Clottable protein: not less than 40 mg).
• Lyophilized Human Thrombin 500 (1 mL of preparation contains Thrombin 500 IU).
• Calcium Chloride solution, 40 mmol/L.
• Sterile Water for Injection I.P.
• Application device kit.

Dosage and Administration

Ichor Fibroseal 1.0ml Fibrin Sealant Kit is applied by a healthcare professional during surgery. The required dose depends on the size of the surface to be sealed or coated. As a guideline for gluing surfaces, one kit (1.0ml Fibrinogen solution plus 1.0ml Thrombin preparation) is typically sufficient for an area of at least 10 cm². When applied by spray, the same quantity can cover an area of 25 cm² to 100 cm². The two components are mixed during or immediately before application. The Fibrinogen and Thrombin solutions must be used within 4 hours after reconstitution. The sealant should be applied as a thin layer, and the sealed parts held in position for at least three to five minutes to ensure firm adhesion.

Storage and Disposal

• Store between 2°C and 8°C (Refrigerated).
• Protect from light and moisture.
• Do not refrigerate or freeze after reconstitution.
• Keep out of reach of children.

Precautions and Safety

• Ichor Fibroseal must not be injected intravascularly, as this carries a risk of anaphylactic reactions and life-threatening thromboembolic events.
• Avoid injection into the nasal mucosa.
• This product is contraindicated in patients with known hypersensitivity to any of its constituents.
• It is not indicated for the treatment of massive and brisk arterial or venous bleeding.
• As this medicine is made from donated human blood, there is a theoretical, albeit small, risk of transmitting infectious agents, despite testing.
• Air or gas embolism may occur when administered via a spray device if high pressure settings are improperly used.
• Avoid contact with solutions containing alcohol, iodine, or heavy metals on the wound area, as these may interfere with the product's performance.

Side Effects and Risks

• Seek immediate medical attention if you experience signs of an allergic reaction, such as hives, itching, swelling in the face or hands, chest tightness, trouble breathing, or anaphylaxis.
• Other serious side effects may include chest pain, coughing up blood, sudden numbness or weakness, severe headache, problems with vision, speech, or walking, or unusual bleeding or bruising.
• Less serious side effects reported include fever, nausea, or vomiting.
• This medicine may cause blood clots.
• Other reported side effects include slow heart rate, low blood pressure, graft infection, and swelling of extremities.

Disclaimer

Use this medicine only under the prescription and guidance of a qualified doctor or pharmacist.