Zepuning Recombinant Human Thrombin for Solution

1. Indications and Usage
Surgical Hemostasis: For adult patients where standard surgical hemostatic techniques (e.g., suturing, ligation, or electrocoagulation) are ineffective or not feasible, to promote hemostasis on surgical oozing surfaces or capillary and small venous bleeding.
2. Dosage and Administration
Route of Administration: For Local Topical Application ONLY. Intravenous, intramuscular, subcutaneous, or intradermal injection is STRICTLY PROHIBITED.
Recommended Dosage: The dosage depends on the size and number of bleeding surfaces and the method of application. It is typically reconstituted to a concentration of 1000 IU/mL.
Critical Administration Instructions:
Reconstitution: Reconstitute each vial with 5 mL of Sterile Normal Saline using aseptic technique. Gently swirl or invert until completely dissolved. Do not shake vigorously.
Application: The reconstituted solution can be sprayed directly onto the bleeding site or used to soak absorbable gelatin sponges, which are then placed on the bleeding area.
Stability: The solution must be used immediately. If not used immediately, it can be stored at 2-25°C for no longer than 4 hours.
3. Mechanism of Action
Fibrin Formation: It directly acts on the final step of the blood coagulation cascade, converting soluble fibrinogen into insoluble fibrin.
Hemostasis: This process leads to the rapid formation of a stable fibrin clot on the tissue surface, effectively stopping capillary and small venous bleeding.
4. Safety and Warnings
Thromboembolic Risk: If the drug accidentally enters the bloodstream, it carries a high risk of arterial and/or venous thrombosis.
Hypersensitivity: It is a recombinant protein product. It is contraindicated in patients with known hypersensitivity to the drug or Chinese Hamster Ovary (CHO) cell proteins.
Administration Error: Systemic absorption can lead to life-threatening embolic events. It must not be used for large-volume or arterial rapid bleeding.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypersensitivity reactions (including anaphylaxis) and local inflammation.
Clinical Research Highlights: Phase 3 clinical trials demonstrated that when applied with absorbable gelatin sponges, recombinant human thrombin significantly increased the hemostasis rate within 6 minutes compared to placebo in patients undergoing hepatic segmentectomy.
6. Drug Interactions
Chemical Incompatibility: The enzyme activity of thrombin can be degraded by acids, alkalis, and heavy metals. It should not be mixed with such substances.
Systemic Interactions: As it is administered locally and is designed not to enter the systemic circulation, significant systemic drug interactions are unlikely.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Recombinant Human Thrombin (produced in CHO cells). Excipients: Mannitol, sucrose, sodium chloride, calcium chloride.
Appearance: White or off-white loose cake or powder. Reconstituted solution should be a colorless, clear liquid or slightly milky.
Packaging: Single-use vial.
Storage: Store in the original carton at 2°C to 8°C. Do not freeze.