Beriate 500 IU powder and solvent for solution for injection and for infusion

Package Leaflet: Information for the User

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Beriate 500 IU powder and solvent for injectable solution and for infusion

Human coagulation Factor VIII

Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects mentioned are not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Beriate is and what it is used for

Beriate is a medicine used to treat and prevent bleeding episodes in patients with haemophilia A (classical haemophilia). Haemophilia A is an inherited bleeding disorder caused by a deficiency of a clotting protein called factor VIII. Beriate contains human coagulation factor VIII as its active substance. It works by replacing the missing factor VIII, thereby helping the blood to clot and controlling bleeding.

What is Beriate

Beriate is supplied as a powder, together with the solvent. The solution obtained must be administered into a vein, either by injection or by infusion.

Beriate is derived from human plasma (which is the liquid part of the blood) and contains human coagulation factor VIII. It is used to prevent or stop bleeding episodes caused by a deficiency of factor VIII (haemophilia A) in the blood. It may also be used in the treatment of acquired factor VIII deficiency.

What Beriate is used for

Factor VIII is involved in blood coagulation. A lack of factor VIII means that blood does not clot as quickly as it should, resulting in an increased tendency to bleed. Beriate provides factor VIII, thereby temporarily restoring normal blood coagulation mechanisms.

2. What you need to know before using Beriate

The following paragraphs contain information that you and your doctor should consider before using Beriate.

Do not use Beriate

• If you are allergic (hypersensitive) to human coagulation factor VIII or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Traceability

It is strongly recommended that each time Beriate is administered, you record the administration date, batch number, and injected volume in your treatment diary.

Consult your doctor or pharmacist before starting to use Beriate

• Allergic-type hypersensitivity reactions may occur. Your doctor should inform you about the early symptoms of hypersensitivity reactions, including rash, generalized hives, chest tightness, difficulty breathing, drop in blood pressure, and anaphylaxis (a severe allergic reaction causing serious breathing problems or dizziness). If these symptoms occur, you must stop administering the medicine immediately and contact your doctor.
• The development of inhibitors (antibodies) is a known complication that may occur during treatment with any factor VIII-containing medicine. These inhibitors, especially in large amounts, may prevent the treatment from working properly, so you and your child will be closely monitored for the development of such inhibitors. If your bleeding or your child's bleeding is not being controlled with Beriate, consult your doctor immediately.
• If you have heart disease or are at risk of developing it, inform your doctor or pharmacist.
• If a central venous access device (CVAD) is required for the administration of Beriate, your doctor should consider the risk of catheter-related complications, including local infections, bacterial infections (bacteremia), and blood clots (thrombosis) at the catheter insertion site.

Your doctor will carefully assess the benefit of treatment with Beriate against the risk of these complications.

Viral safety

When medicines derived from human blood or plasma are administered, certain measures are taken to prevent transmission of infections to patients. This includes careful selection of blood and plasma donors to exclude those who may pose a risk of transmitting infections, and testing of each donor and plasma pools for signs of viruses/infections. Manufacturers of these products also include steps in the production process that can inactivate or remove viruses and other pathogens. Nevertheless, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to emerging or unknown viruses and other pathogens.

These procedures are considered effective against enveloped viruses such as human immunodeficiency virus (HIV, AIDS virus), hepatitis B virus, and hepatitis C virus (liver inflammation), as well as against non-enveloped viruses such as hepatitis A virus and parvovirus B19.

Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly or repeatedly receive human plasma-derived products (e.g., factor VIII).

It is strongly recommended that each time Beriate is administered, you record the administration date, batch number, and injected volume in your treatment diary.

Other medicines and Beriate

• Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
• Beriate must not be mixed with other medicines, diluents, or solvents except those recommended by the manufacturer (see section 6).

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
• During pregnancy and breastfeeding, Beriate should only be used if clearly indicated.
• There is no information available regarding fertility.

Driving and using machines

Beriate does not affect the ability to drive vehicles or operate machinery.

Beriate contains sodium

Beriate 500 IU contains less than 1 mmol of sodium (23 mg) per vial; therefore, it is essentially “sodium-free.”

3. How to use Beriate

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Treatment of haemophilia A should be initiated under the supervision of a physician experienced in the treatment of this type of disorder.

Dosage

The factor VIII dose you require and the duration of treatment depend on several factors, such as your body weight, the severity of your condition, the location and extent of bleeding, or the need to prevent bleeding during surgery or a medical procedure.

If you have been instructed to use Beriate at home, your doctor will ensure that you receive proper instructions on how to inject the product and how much product to use.

Follow the instructions given by your doctor or the nurses at your haemophilia treatment centre.

Use in children and adolescents

The dose is calculated based on body weight and is determined in the same way as for adults.

If you use more Beriate than you should

Symptoms of overdose with factor VIII have not been reported.

If you forget to use Beriate

Take the next dose immediately and continue at regular intervals as directed by your doctor. Do not take a double dose to make up for missed doses.

Reconstitution and administration

General instructions:

• The powder must be mixed (reconstituted) with the solvent (liquid) and withdrawn from the vial under aseptic conditions.
• The reconstituted solution should be clear or slightly opalescent, meaning it may shimmer when held up to light. Occasionally, flakes or particles may appear in the vial. The filter included in the Mix2Vial removes these particles. This filtration does not affect dose calculations. After filtration and transfer of the reconstituted product to the syringe (see below), and before administration, the solution should be visually inspected for small particles and discoloration. Do not use solutions that appear cloudy or contain flakes or particles in the syringe.
• Once the product has been transferred to the syringe, it must be used immediately. Do not store the product in the syringe.
• Any unused product and waste materials should be properly disposed of according to local requirements and as instructed by your doctor.

Reconstitution:

Allow the Beriate vials (vial with powder and vial with liquid), without opening them, to reach room temperature. This can be done by leaving the vials at room temperature for 1 hour or by holding them in the hands for a few minutes. DO NOT expose the vials to direct heat. Vials must not be heated above body temperature (37 °C).

Carefully remove the protective caps from the vials containing the powder and the solvent, and clean the exposed portion of the stoppers with an alcohol-impregnated wipe. Allow the vials to dry before opening the Mix2Vial container, and follow the instructions below.

Application and removal:

Use the venous puncture equipment supplied with the product. Insert the needle into the vein. Allow blood to enter until it reaches the end of the tube. Attach the syringe to the threaded, locking end of the venous puncture equipment. Slowly inject the reconstituted solution into the vein, following your doctor's instructions. The injection or infusion rate must not exceed 2 mL per minute. Take care to avoid blood entering the syringe containing the product.

When a large volume needs to be administered, infusion is an option to consider. The reconstituted product should be transferred to an authorized infusion system. Infusion must be performed according to your doctor's instructions.

Monitor yourself for any adverse reactions that may occur immediately. If you experience any adverse reaction related to the administration of Beriate, the injection or infusion must be stopped (see also section 2).

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If any of the following adverse effects occur, consult your doctor immediately or go to the Emergency Department or hemophilia center at your nearest hospital:

• Symptoms of angioedema

• swelling of the face, tongue, or pharynx,

• difficulty swallowing,

• hives and difficulty breathing.

These adverse effects have been observed very rarely (may affect up to 1 in 10,000 people), and in some cases may lead to severe allergic reactions (anaphylaxis), including shock.

• Loss of effect (bleeding does not stop). In children who have not previously received treatment with factor VIII-containing medicines, inhibitor antibodies may develop very frequently (more than 1 in 10 patients); however, in patients who have previously received factor VIII treatment (more than 150 days of treatment), the risk is uncommon (less than 1 in 100 patients). If this occurs, the medicines you or your child are taking may no longer work properly, and you or your child may experience persistent bleeding. In this case, contact your doctor immediately.

Other adverse effects are:

• Allergic reactions (hypersensitivity), which may include:

• burning sensation and itching at the site where the product was injected or infused.

• chills, flushing, generalized skin rash, papules.

• headache.

• drop in blood pressure, restlessness, faster heartbeat, chest tightness, difficulty breathing.

• drowsiness (lethargy).

• nausea, vomiting.

• tingling.

These adverse effects have been observed very rarely, but in some cases they may progress to severe allergic reactions (anaphylaxis), including shock.

• Fever has been observed on very rare occasions.

Adverse effects in children and adolescents

The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Beriate

Do not use this medicine after the expiry date stated on the label and on the carton. The expiry date refers to the last day of the month indicated.

• Store in a refrigerator (between 2 °C and 8 °C).
• During its shelf life, Beriate may be stored at room temperature (up to 25 °C) for a maximum period of 1 month. This period of storage at room temperature should be recorded in your treatment diary to ensure compliance with the 1-month limit.
• Beriate does not contain preservatives; therefore, the reconstituted product should preferably be used immediately.
• If the reconstituted product is not administered immediately, storage in the vial at room temperature must not exceed 8 hours. Once transferred to a syringe, the product must be used immediately.
• Do not freeze.
• Keep the vial in the original packaging to protect it from light.

Keep out of sight and reach of children.

6. Contents of the pack and other information

Composition of Beriate

The active substance is:

Beriate is presented as a powder (containing nominally 500 IU of human coagulation factor VIII per vial) and a liquid (solvent). The reconstituted solution is administered either by injection or by infusion.

Beriate 500 IU is reconstituted with 5 ml of water for injections and contains approximately 100 IU/ml of human coagulation factor VIII.

The other components are:

Glycine, calcium chloride, sodium hydroxide (in small amounts) to adjust pH, sucrose and sodium chloride.

Solvent: water for injections 5 ml.

Appearance of the product and contents of the pack

Beriate is a white powder and is supplied with the corresponding water for injections.

The reconstituted solution should be clear or slightly opalescent, meaning it may shimmer when held up to the light, but must not contain particles.

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Presentations

Box containing 500 IU comprising:

• 1 vial with powder
• 1 vial with 5 ml of water for injections
• 1 transfer device with 20/20 filter

Administration set (inner box):

• 1 single-use 5 ml syringe
• 1 venipuncture set
• 2 alcohol-impregnated wipes
• 1 non-sterile dressing

Marketing Authorization Holder and Manufacturing Responsible

CSL Behring GmbH
Emil-von-Behring-Straße 76
35041 Marburg, Germany

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

CSL Behring, S.A.
C/ Tarragona 157, 18th floor
08014 Barcelona
Spain

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

Austria:
Beriate 100 I.E./ml Powder and solvent for solution for injection or infusion (500 I.E., 1000 I.E.)
Beriate 200 I.E./ml Powder and solvent for solution for injection or infusion (2000 I.E.)

Bulgaria:
Beriate 500 IU Powder and solvent for solution for injection or infusion
Beriate 1000 IU Powder and solvent for solution for injection or infusion
Beriate 2000 IU Powder and solvent for solution for injection or infusion

Croatia:
Beriate 500 IU prašak i otapalo za otopinu za injekciju ili infuziju
Beriate 1000 IU prašak i otapalo za otopinu za injekciju ili infuziju
Beriate 2000 IU prašak i otapalo za otopinu za injekciju ili infuziju

Czech Republic:
Beriate 500 IU, Beriate 1000 IU, Beriate 2000 IU

Estonia:
Beriate

Germany:
Beriate 500, Beriate 1000, Beriate 2000

Hungary:
Presentations of Beriate 500 and 1000:
BERIATE 100 NE/ml por és oldószer oldatos injekcióhoz vagy infúzióhoz
Presentation 2000:
BERIATE 200 NE/ml por és oldószer oldatos injekcióhoz vagy infúzióhoz

Italy:
Beriate

Latvia:
Beriate 500 SV pulveris un škidinātājs injekciju vai infūziju šķīduma pagatavošanai
Beriate 1000 SV pulveris un škidinātājs injekciju vai infūziju šķīduma pagatavošanai
Beriate 2000 SV pulveris un škidinātājs injekciju vai infūziju šķīduma pagatavošanai

Lithuania:
Beriate 500 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui
Beriate 1000 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui
Beriate 2000 TV milteliai ir tirpiklis injekciniam ar infuziniam tirpalui

Portugal:
Beriate

Romania:
Beriate 500 pulbere si solvent pentru solutie injectabila/perfuzabila
Beriate 1000 pulbere si solvent pentru solutie injectabila/perfuzabila
Beriate 2000 pulbere si solvent pentru solutie injectabila/perfuzabila

Spain:
Beriate 500 UI powder and solvent for injectable solution and for perfusion
Beriate 1000 UI powder and solvent for injectable solution and for perfusion

Slovakia:
Beriate 500 IU
Beriate 1000 IU
Beriate 2000 IU

Slovenia:
Beriate 500 i.e. prašek in vehikel za raztopino za injiciranje/infundiranje
Beriate 1000 i.e. prašek in vehikel za raztopino za injiciranje/infundiranje
Beriate 2000 i.e. prašek in vehikel za raztopino za injiciranje/infundiranje

Date of the most recent review of this summary: March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

This information is intended for healthcare professionals only

Dosage and Administration

Monitoring of treatment

During treatment, it is recommended to adequately monitor factor VIII levels to determine the required dose and the frequency of repeated infusions. Individual patient response to factor VIII may vary, showing different half-lives and recovery rates. Doses based on body weight may require adjustment in patients with low or high body weight. In the specific case of major surgical procedures, accurate monitoring of replacement therapy using coagulation tests (plasma factor VIII activity) is essential.

Patients should be monitored for the development of factor VIII inhibitors. See also section 2.

The number of factor VIII units administered is expressed in International Units (IU), relative to the current World Health Organization (WHO) standard for factor VIII concentrates. Plasma factor VIII activity is expressed as a percentage (relative to normal human plasma) or preferably in IU (relative to an international standard for factor VIII in plasma).

The activity of one IU of factor VIII is equivalent to the amount of factor VIII contained in 1 ml of normal human plasma.

On-demand treatment

The calculation of the required factor VIII dose is based on the empirical observation that 1 IU of factor VIII per kg of body weight increases plasma factor VIII activity by approximately 2% (2 IU/dL) above baseline. The required dose can be determined using the following formula:

Required units = body weight (kg) × desired increase in factor VIII [% or IU/dL] × 0.5

The amount administered and the frequency of administration should always be determined according to the observed clinical efficacy in each individual case.

In the following bleeding episodes, factor VIII activity should not fall below the indicated plasma activity level (expressed as % of normal or IU/dL) during the corresponding period. The following table may be used as a dosing guideline for bleeding episodes and surgery.

Prophylaxis

For long-term prophylaxis of bleeding episodes in patients with severe hemophilia A, the usual dose is 20 to 40 IU of factor VIII/kg body weight administered every 2 to 3 days. In some cases, especially in younger patients, it may be necessary to shorten the administration intervals or use higher doses.

Pediatric population

Dosing in pediatric patients is based on body weight and therefore generally follows the same guidelines as those used for adults. The frequency of administration should always be adjusted according to the clinical efficacy required in each individual case. Some experience exists in the treatment of children under 6 years of age.

Information on the pharmacological properties of von Willebrand factor

In addition to its protective role for factor VIII, von Willebrand factor facilitates platelet adhesion at sites of vascular injury and plays a role in platelet aggregation.