FANHDI I.V. LYOPHILIZED POWDER AND SOLVENT FOR PREPARING INJECTION SOLUTION 1500 I.U./15 mL

Active ingredient: Each vial 1500 I.U. Contains human coagulation factor VIII. Each 1 ml of the vial contains 100 I.U. Contains human coagulation factor VIII.

Excipients: Histidine, human albumin, arginine, water for injection.

▼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.

FANHDI, in each vial; 1500 I.U. It is offered as a lyophilized powder for injection, containing human coagulation factor VIII (I.U. stands for international unit and is the standard measure of effectiveness).

After dissolving the product in the appropriate amount of solvent (water for injection), each vial contains 100 I.U./mL human coagulation factor VIII.

FANHDI is in the group of drugs called clotting factors.

FANHDI is used to prevent and treat bleeding in patients with haemophilia A (congenital deficiency of a protein (factor FVIII) found in the blood and necessary for normal clotting).

Instructions for proper use and dosage/frequency of administration

The amount of FANHDI to be applied; It depends on various factors such as your weight, clinical condition, type and severity of bleeding. Your doctor will calculate the dose, frequency and intervals of administration of FANHDI to ensure the required levels of factor VIII in your blood.

Your doctor will determine the duration of treatment with FANHDI.

If you have not received adequate training about self-injection from your doctor or haemophilia nurse, you will be given full training before using FANHDI. Please reference all your educational materials or contact your local haemophilia center for further information.

Dissolve the product as stated at the end of the instructions for use (please see the illustrated explanations at the back of the instructions for use). Use the product as an intravenous injection. The application rate should be 3 mL per minute and should never exceed 10 mL per minute to avoid undesirable side effects.

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Side effects can be classified as follows:

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

If you have one of these, it means you have a serious allergy to this drug. You may need emergency medical attention or hospitalization.

Inhibitory antibodies may occur very commonly (in more than 1 in 10 patients) in children who have not been previously treated with Factor VIII drugs (see section USE FANHDI CAREFULLY in the following situations); However, in patients previously treated with Factor VIII (treatment lasting more than 150 days), the risk is uncommon (less than 1 in 100 patients). In this case, your or your child’s medicine may not have the desired effect and persistent bleeding may occur in you or your child. In this case, you should contact your doctor immediately.

⚠️ 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.