Trombin (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Ivanovo Regional Blood Transfusion Station SIH (Russia)

ATC Code

B02BD30 (Thrombin)

Active Substance

Thrombin (Rec.INN registered by WHO)

Dosage Form

Thrombin

Lyophilizate for preparation of solution for topical and external use 125 IU: amp. 10 pcs.

Dosage Form, Packaging, and Composition

125 IU – Ampoules with a volume of 10 ml (10) – cardboard packs.

Clinical-Pharmacological Group

Hemostatic agent for topical application

Pharmacotherapeutic Group

Topical hemostatic agent

Pharmacological Action

Hemostatic agent. Thrombin is a natural component of the blood coagulation system, formed in the body from prothrombin during the enzymatic activation of the latter by thromboplastin. It is obtained from donor plasma.

Indications

• Control of capillary bleeding from various tissues.
• Management of hemorrhage from bone cavities following surgical procedures.
• Treatment of gingival bleeding, particularly in patients with underlying hematologic conditions such as Werlhof’s disease, aplastic anemia, and hypoplastic anemia.
• Topical hemostasis for epistaxis (nosebleeds).

ICD codes

Dosage Regimen

Apply the reconstituted solution topically directly to the site of bleeding. Use as a spray, or by applying a sterile gauze or sponge soaked in the solution.

The frequency of application is determined by the surgeon or physician based on the clinical situation and the persistence of bleeding. Discontinue use once adequate hemostasis is achieved.

Adverse Reactions

Possible adverse effects include allergic reactions ranging from localized hypersensitivity to systemic manifestations.

There is a risk of secondary infection at the application site. Monitor the wound for signs of inflammation or infection.

Drug Interactions

Avoid concurrent topical use with anticoagulants (e.g., heparin) or antiplatelet agents, as this may antagonize the hemostatic effect.

Exercise caution when used in combination with other topical agents applied to the same site, as the potential for chemical or physical incompatibility exists.

Contraindications

• Known hypersensitivity to thrombin or any component of the formulation.
• Do not use in patients with a known history of severe systemic allergic reactions to products of human origin.
• Avoid direct introduction into large blood vessels or tissues with extensive, high-flow vascular networks due to the risk of life-threatening thrombosis.

Overdose

Excessive topical application is unlikely to cause systemic effects. The primary risk is related to the thrombogenic potential if the product enters the systemic circulation.

If accidental intravascular administration occurs, it may cause widespread, life-threatening thrombosis. Monitor for signs of thromboembolism and provide appropriate supportive and anticoagulant therapy.

Special Precautions

Intravenous and intramuscular administration is not allowed. Introduction into blood vessels can cause widespread thrombosis with a fatal outcome. The tampon soaked with thrombin should be removed from the wound carefully to avoid damaging the formed thrombi.

It is used as part of combined preparations for topical hemostasis.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.