Vilate 500

PATIENT INFORMATION LEAFLET: USER INFORMATION

Wilate500,500 IU VWF / 500 IU FVIII, powder and solvent for solution for injection
for injection
Wilate 1000, 1000 IU VWF / 1000 IU FVIII, powder and solvent for solution for injection
Human von Willebrand factor / human factor VIII

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Wilate and what is it used for
• 2. Important information before using Wilate
• 3. How to use Wilate
• 4. Possible side effects
• 5. How to store Wilate
• 6. Contents of the pack and other information

1. What is Wilate and what is it used for

Wilate belongs to a group of medicines called clotting factors and contains human von Willebrand factor (VWF) and factor VIII. These two proteins are involved in blood clotting.
Von Willebrand disease
Wilate is used to treat and prevent bleeding in patients with von Willebrand disease (VWD), which is essentially a group of related diseases. VWD is a clotting disorder in which bleeding can last longer than expected. This is due to either the lack of von Willebrand factor in the blood or its malfunction.
Hemophilia A
Wilate is used to treat and prevent bleeding in patients with hemophilia A. This is a condition in which bleeding is prolonged. It is due to a congenital lack of factor VIII in the blood.

2. Important information before using Wilate

When not to use Wilate

• 6).

Warnings and precautions

Before starting treatment with Wilate, discuss it with your doctor or pharmacist.

• Wilate, like any medicine made from human blood (containing proteins) and injected into a vessel (administered intravenously), may cause allergic reactions. Pay attention to early signs of allergic reactions (hypersensitivity) such as: hives, skin rash, feeling of chest tightness, wheezing, low blood pressure, or anaphylaxis (when any or all of these symptoms occur suddenly and are severe). If these symptoms occur, stop using the medicine and contact your doctor immediately.
• In the case of medicines made from human blood or plasma, appropriate methods are used to prevent the transmission of infections to patients. These include: strict selection of blood and plasma donors to eliminate carriers of infections, testing of individual donations and plasma pools for specific viral/infection markers, as well as the inclusion of virus inactivation or removal methods in the production process. Despite this, when administering medicines obtained from human blood or plasma, it is not possible to completely rule out the transmission of an infectious agent. This applies to both known and new emerging viruses and other types of infections. The methods used are considered effective against enveloped viruses such as: human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as against the non-enveloped hepatitis A virus. The methods used may have limited effectiveness against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be hazardous to pregnant women (fetal infection) and to patients with immune system disorders or patients with certain types of anemia (e.g., sickle cell anemia or conditions of abnormal red blood cell destruction). It is strongly recommended that when administering Wilate to a patient, the product name and batch number should be recorded in order to maintain a record of the batches used. Vaccinations against hepatitis A and B may be recommended by your doctor in the case of regular or repeated use of plasma-derived factor VIII and von Willebrand factor. Von Willebrand disease (VWD)
• See section 4 (von Willebrand disease (VWD)) for information on side effects related to the treatment of von Willebrand disease. Hemophilia A

The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII-containing medicines. These inhibitors, especially at high levels, can disrupt proper treatment, and the patient will be closely monitored for the development of these inhibitors. If the patient's bleeding is not properly controlled with Wilate, they should immediately tell their doctor.

• See section 4 (Hemophilia A) for information on side effects related to the treatment of hemophilia A.

Wilate and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No interactions between Wilate and other medicines have been found. However, you should inform your doctor about any other medicines you are taking (including those available without a prescription).
Do not mix Wilate with other medicines during injection.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Wilate contains sodium

This medicine contains up to 58.7 mg of sodium (the main component of common salt) per vial of 500 IU of von Willebrand factor and factor VIII, and up to 117.3 mg of sodium per vial of 1000 IU of von Willebrand factor and factor VIII per vial. This corresponds to 2.94% and 5.87%, respectively, of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Wilate

Wilate should be injected into a vessel (administered intravenously) after dissolution in the supplied solvent. Treatment should be initiated under medical supervision.

Dosage

The dose and frequency of administration should be determined by your doctor individually for each patient. Always use Wilate as directed by your doctor. Consult your doctor or pharmacist if you have any doubts.

Overdose of Wilate

No symptoms of overdose of human von Willebrand factor or factor VIII have been observed. However, do not exceed the recommended dose.

Missed dose of Wilate

Do not take a double dose to make up for a missed dose.
Consult your doctor or pharmacist if you have any other questions about using the product.

4. Possible side effects

Like all medicines, Wilate can cause side effects, although not everybody gets them.

• Although not very common, allergic reactions or hypersensitivity have been observed. They may include: burning and stinging at the injection site, chills, flushing, headache, rash (hives), low blood pressure (hypotension), feeling of fatigue (lethargy), nausea, anxiety, rapid heartbeat (tachycardia), feeling of chest tightness, tingling, vomiting, wheezing, sudden swelling of various parts of the body (angioedema). Tell your doctor if you experience any of these symptoms. Stop using Wilate and contact your doctor immediately if you experience symptoms of angioedema, such as: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing
• Fever has also been observed, although this is not very common.
• Abdominal pain, back pain, chest pain, cough, and dizziness may also occur, but the frequency of these side effects is unknown.
• In very rarecases, hypersensitivity may lead to severe allergic reactions called anaphylaxis (when any or all of the above symptoms occur suddenly or are severe), including anaphylactic shock. In the case of anaphylactic shock, appropriate medical treatment should be administered.

Hemophilia A

• In the case of previously untreated patients with factor VIII-containing medicines, inhibitor antibodies (see section 2) may develop very frequently (more than 1 in 10 patients). However, in patients who have previously been treated with factor VIII (more than 150 days of treatment), the risk is not very common(less than 1 in 100 patients). If this happens, the patient's medicines may stop working properly, and they may experience persistent bleeding. If this happens, contact your doctor immediately. Inhibitors may increase the risk of allergic reactions (anaphylactic shock). If allergic reactions occur, tests for inhibitors should be performed.

Not very common:may affect up to 1 in 100 users
Rare:may affect up to 1 in 1,000 users
Very rare:may affect up to 1 in 10,000 users
There is not enough data to recommend the use of Wilate in previously untreated patients.
Experience with the treatment of children under 6 years of age with Wilate is limited.
Information on protection against viral factors, see section 2 (Warnings and precautions).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly (see below for details). By reporting side effects, you can help provide more information on the safety of this medicine.
Department for the Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl

5. How to store Wilate

Keep the medicine out of the sight and reach of children.
Store the powder and solvent in the refrigerator (2°C - 8°C).
Do not freeze.
Store the vials in the outer packaging to protect from light.
Do not use Wilate after the expiry date stated on the label.
The product can be stored at room temperature (below 25°C) for a period of 2 months. In this case, the expiry date of the product expires at the end of the second month after the product was first removed from the refrigerator. The new expiry date should be written on the outer packaging by the patient.
The powder should be dissolved immediately before injection. The stability of the prepared solution has been demonstrated for 4 hours at room temperature. However, to avoid microbial contamination, the prepared solution should be used immediately and is only suitable for single use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Wilate contains

The active substances are human von Willebrand factor and human factor VIII.
Other ingredients: Sodium chloride, Glycine, Sucrose, Sodium citrate, and Calcium chloride.
Solvent: water for injections with 0.1% Polysorbate 80.

What Wilate looks like and contents of the pack

Lyophilized powder: white or pale yellow powder or a lump.
Solution after dissolution: should be clear or slightly opalescent.
Wilate is supplied as a powder and solvent for solution for injection.
It is available in 2 pack sizes:

• Wilate 500, 500 IU VWF and 500 IU FVIII, is available as a powder and solvent for solution for injection containing nominally 500 IU of human von Willebrand factor and 500 IU of human factor VIII in a vial. The product contains approximately 100 IU of human von Willebrand factor and 100 IU of human factor VIII after dissolution in 5 ml of water for injections with 0.1% Polysorbate 80 (solvent)

The product contains nominally 500 IU of human von Willebrand factor and 500 IU of human factor VIII in a vial.

• Wilate 1000, 1000 IU VWF and 1000 IU FVIII, is available as a powder and solvent for solution for injection containing nominally 1000 IU of human von Willebrand factor and 1000 IU of human factor VIII in a vial. The product contains approximately 100 IU of human von Willebrand factor and 100 IU of human factor VIII after dissolution in 10 ml of water for injections with 0.1% Polysorbate 80 (solvent)

Contents of the pack

1 vial of lyophilized powder
1 vial of solvent
1 package with equipment for intravenous injection (1 transfer set, 1 infusion set, 1 single-use syringe)
2 alcohol swabs

Marketing authorization holder and manufacturer

Octapharma (IP) SPRL
65 Allée de la Recherche
1070 Anderlecht
Belgium
To obtain more detailed information on this medicinal product, please contact the local representative of the marketing authorization holder.
Octapharma Poland Sp. z o.o.
39a Domaniewska Street
02-672 Warsaw
Poland
phone +48 22 489 52 28
fax +48 22 489 52 29

Manufacturer

Octapharma Pharmazeutika
Produktionsges.m.b.H.
Oberlaaerstr. 235
A-1100 Vienna
Austria

Date of approval of the leaflet: 03/2021

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia, Spain, United Kingdom: Wilate 500/ Wilate 1000
Finland, Norway, Sweden: Wilate
Denmark: Wilnativ
France: Eqwilate 500/ Eqwilate 1000

Home use instructions

• Read all instructions carefully and follow them!
• Do not use the Wilate product after the expiry date stated on the label.
• During the procedure described below, maintain aseptic conditions!
• Before administration, visually inspect the prepared solution for particulate matter or discoloration.
• The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain particles.
• Use the prepared solution immediately to prevent microbial contamination.
• Only use the provided injection set. Using other injection/infusion equipment may cause additional risks and treatment failure.

Instructions for preparing the solution:

• 1. Do not use the product directly from the refrigerator. Leave the solvent and powder in closed vials until they reach room temperature.
• 2. Remove the caps from both vials and clean the rubber stoppers with one of the provided alcohol swabs.
• 3. The transfer set is shown in Fig. 1. Place the vial of solvent on a flat surface and hold it firmly. Take the transfer set and turn it upside down. Place the blue part of the transfer set on top of the vial of solvent and press firmly until it clicks (Fig. 2 + 3). Do not twist during connection.

Fig. 1
Fig. 2
Fig. 3

• 4.Place the vial of powder on a flat surface and hold it firmly.

Take the vial of solvent with the attached transfer set and turn it upside down. Place the white part of the transfer set on top of the vial of powder and press firmly until it clicks (Fig. 4). Do not twist during connection. The solvent flows automatically into the vial of powder.

• 5.With both vials still connected, gently rotate the vial of powder until the product is dissolved. Dissolution is complete in less than 10 minutes at room temperature. A slight foam may form during preparation. Unscrew the transfer set into two parts (Fig. 5). The foam will disappear.

Discard the empty vial of solvent along with the blue part of the transfer set.

Instructions for injection:

As a precaution, check your pulse before and during injection. If your heart rate increases significantly, reduce the injection rate or pause the administration for a short time.

• 1. Connect the syringe to the white part of the transfer set. Turn the vial upside down and draw the solution into the syringe (Fig. 6). The solution in the syringe should be clear or slightly opalescent. After transferring the solution, hold the syringe plunger firmly (holding it down) and remove the syringe from the transfer set (Fig. 7).

Discard the empty vial of solvent along with the white part of the transfer set.

• 2. Clean the selected injection site with one of the provided alcohol swabs.

• 3. Connect the provided infusion set to the syringe.
• 4. Insert the needle into the selected vein. If a tourniquet is used to make the vein visible, release it before starting the injection of Wilate. Blood must not enter the syringe due to the risk of fibrin clot formation.
• 5. Inject the solution slowly into the vein, no faster than 2-3 ml per minute. If more than one vial of Wilate powder is used for one treatment cycle, it is possible to reuse the same needle and syringe. The transfer set is for single use only.

Dispose of any unused solution or used materials in accordance with local regulations.
Do not mix or inject (using the same infusion set) Wilate with other medicinal products.
Only administer using the provided infusion set. Using other injection or infusion equipment may cause additional risks and treatment failure (von Willebrand factor and factor VIII may adsorb to the inner surface of some infusion sets).