REFACTO® AF IV POWDER AND SOLVENT FOR INJECTION SOLUTION 1000 IU

Active ingredient: Each pre-filled syringe contains 1000 IU moroctocog alfa (recombinant coagulation factor VIII). It contains 250 IU/ml moroctocog alfa after reconstitution with 4 ml 0.9% sodium chloride solution for injection.

Excipient(s): Sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80 and sodium chloride, water for injection, hydrochloric acid, nitrogen gas. It contains sodium chloride and water for injection as solvents.

▼This drug is subject to additional monitoring. This triangle will enable rapid identification of new safety information. You can help by reporting any side effects that occur. To learn how to report side effects, see the end of Chapter 4.

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

REFACTO AF contains a protein known as clotting factor VIII, which helps your blood clot and stops bleeding. People with hemophilia A (congenital factor VIII deficiency) do not have enough factor VIII or it does not work properly. REFACTO AF is used to correct and prevent bleeding events, in emergency situations, and in cases where surgical intervention is required, to replace the temporarily missing clotting factor in Hemophilia A patients. REFACTO AF is produced in a laboratory environment with recombinant DNA technology, it is not obtained from the blood of people who donate blood (it is not plasma-derived factor VIII)..

REFACTO AF is presented as a ready-to-use syringe containing powder for injection in the upper compartment and solvent in the lower compartment. Each package contains 1 pre-filled syringe filled with 1000 IU moroctocog alfa powder and 4 ml solvent for reconstitution (9 mg/ml (0.9%) sodium chloride solution), 1 piston rod, 1 protective vented sterile cap, 1 sterile infusion set, 2 alcohol swabs, 1 patch, 1 gauze.

Instructions for proper use and dosage/frequency of administration

Please always use this medicine as your doctor told you. If you are not sure, consult your doctor or pharmacist.

Treatment with REFACTO AF should be initiated by a doctor experienced in treating patients with Haemophilia A. Your doctor will determine the dose of REFACTO AF you will receive. This dose and duration are based on your individual need for factor VIII replacement therapy. REFACTO AF is given by injection into a vein over a few minutes. Patients or their relatives can administer REFACTO AF injection after receiving appropriate training.

The dose and duration of treatment depend on the degree of factor VIII deficiency, the location and duration of bleeding, and the clinical condition of the patient. The applied doses should be adjusted according to the patient’s response to treatment. In the presence of an inhibitor (antibodies – the defense protein produced by the body against the allergenic substance), a higher dose or appropriate specific treatment may be required.

The amount to be administered and the frequency of application should always be adjusted according to clinical effectiveness in each patient.

Like all medicines, side effects may occur in people who are sensitive to the ingredients contained in REFACTO AF.

If any of the following occur, stop using REFACTO AF and IMMEDIATELY inform your doctor or go to the emergency department of your nearest hospital.

If severe, sudden allergic reactions (anaphylactic) occur, the injection should be stopped immediately. If you notice any of the early signs of allergic reactions listed below, inform your doctor immediately:

Severe symptoms, including difficulty breathing and (near) fainting, require immediate treatment.

Serious, sudden allergic (anaphylactic) reactions are uncommon (may affect up to 1 in 100 patients)

⚠️ Disclaimer: The information provided on this website is for informational purposes only and does not substitute professional medical advice. Always consult a healthcare provider before using any medication.