Eutoplasm (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Pharmstandard-UfaVITA OJSC (Russia)

ATC Code

B02BD02 (Blood coagulation factor VIII)

Active Substance

Human coagulation factor VIII

Human coagulation factor VIII (Ph.Eur. European Pharmacopoeia)

Dosage Forms

	Eutoplasm	Lyophilisate for preparation of solution for intravenous administration 500 IU
		Lyophilisate for preparation of solution for intravenous administration 1000 IU

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intravenous administration

500 IU – vials – cardboard packs /included with solvent: water for injections (vials) 10 ml, disposable syringe without needle/with needle, filter cannulas – 2 pcs., butterfly needle with extension tube, adhesive plaster, alcohol wipes-2 pcs./ – By prescription

Lyophilisate for preparation of solution for intravenous administration

1000 IU – vials – cardboard packs /included with solvent: water for injections (vials) 10 ml, disposable syringe without needle/with needle, filter cannulas – 2 pcs., butterfly needle with extension tube, adhesive plaster, alcohol wipes-2 pcs./ – By prescription

Clinical-Pharmacological Group

Blood coagulation factor VIII preparation

Pharmacotherapeutic Group

Hemostatic agents; vitamin K and other hemostatic agents; blood coagulation factors

Pharmacological Action

Hemostatic agent used in hemophilia A. Promotes the conversion of prothrombin to thrombin and the formation of a fibrin clot.

Pharmacokinetics

In patients with hemophilia A, the T_1/2 is 12 hours.

The activity of blood coagulation factor VIII decreases by 15% within 12 hours.

With an increase in temperature, the T_1/2 of blood coagulation factor VIII may decrease.

Indications

Prevention and treatment of bleeding in hemophilia A, acquired deficiency of blood coagulation factor VIII.

ICD codes

Dosage Regimen

Determine the dosage individually for each patient based on body weight and the required increase in plasma factor VIII activity.

Calculate the required dose using the formula: Dose (IU) = Body weight (kg) × Desired factor VIII increase (%) × 0.5.

For minor bleeding (e.g., early hemarthrosis, minor cuts), achieve a factor VIII level of 20-40% of normal. Administer a single dose; repeat every 12-24 hours if bleeding persists.

For moderate bleeding (e.g., muscle hematomas, dental extractions), achieve a factor VIII level of 30-60% of normal. Administer every 12-24 hours for 1-3 days or until adequate wound healing.

For major or life-threatening bleeding (e.g., major surgery, intracranial hemorrhage, trauma), achieve a factor VIII level of 80-100% of normal. Administer every 8-12 hours until the threat is resolved, then maintain levels at 30-50% for up to 14 days.

For surgical prophylaxis, achieve a factor VIII level of 80-100% pre-operatively. Maintain levels above 50% for the first 1-2 post-operative days and above 30% for up to 10-14 days until healing is complete.

For long-term prophylaxis in severe hemophilia, administer a dose of 20-40 IU/kg every 48 hours. Adjust the interval to every other day or three times weekly based on individual pharmacokinetics and clinical response.

Monitor plasma factor VIII activity levels regularly to verify the accuracy of the calculated dose and to guide subsequent dosing intervals.

Administer the reconstituted solution by slow intravenous injection or infusion. Do not mix with other infusion solutions.

Adverse Reactions

Allergic reactions possible chills, urticaria, fever; very rarely – anaphylactic reactions.

From the digestive system possible nausea, vomiting.

Other possible headache.

Contraindications

Hypersensitivity to human blood coagulation factor VIII.

Use in Pregnancy and Lactation

Data on the safety of using human blood coagulation factor VIII during pregnancy and lactation are not available.

Pediatric Use

Used in children according to indications.

Special Precautions

In patients receiving blood coagulation factor VIII, the development of antibodies to its protein is possible. In such cases, the effectiveness of therapy usually decreases and an increase in the dose of blood coagulation factor VIII may be required.

In severe hemophilia A, prophylactic use is possible.

When using drugs from human plasma or blood, the possibility of infection with infectious diseases cannot be completely excluded, despite modern methods of obtaining such medicines.

Drug Interactions

Danazol increases the activity of blood coagulation factor VIII.

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.