Berinert 1500 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Berinert 1500 IU

Powder and solvent for solution for injection

Human C1 esterase inhibitor

Read this entire leaflet carefully before you start using this medicine, because 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 you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Berinert is and what it is used for

What is Berinert?

Berinert is presented as a powder and solvent. The prepared solution must be administered by intravenous injection.

Berinert is prepared from human plasma (the liquid portion of blood). The active substance is human C1 esterase inhibitor protein, derived from plasma.

What is Berinert used for?

Berinert is used for the treatment and preoperative prevention of hereditary angioedema type I and II (HAE, edema = swelling). Hereditary angioedema is a congenital disorder of the vascular system. It is not an allergic disease. HAE is caused by insufficient, absent, or defective synthesis of C1 esterase inhibitor, which is an important protein. The disease is characterized by the following symptoms:

• sudden swelling of hands and feet,
• sudden swelling of the face with a feeling of tightness,
• swelling of the eyelids and lips, possible swelling of the larynx (voice organ) leading to breathing difficulties,
• swelling of the tongue,
• colicky-type abdominal pain.

Generally, any part of the body may be affected.

2. What you need to know before using Berinert

The following sections contain information your doctor should consider before administering Berinert to you.

Do not use Berinert:

• If you are allergic to C1 esterase inhibitor protein or to any of the other components of this medicine (listed in section 6).

Inform your doctor or pharmacist if you are allergic to any medicines or foods.

Warnings and precautions

• If you have previously experienced allergic reactions to Berinert. You should take antihistamines and corticosteroids as prophylaxis, if advised by your doctor.
• In the event of allergic or anaphylactic reactions (severe allergic reaction causing serious breathing difficulties or dizziness), administration of Berinert must be stopped immediately (e.g., by stopping the injection).
• If you suffer from swelling of the larynx (laryngeal edema). You should be closely monitored and have emergency treatment readily available.
• When used for the treatment of indications and dosages for which the medicine has not been approved (e.g., Capillary Leak Syndrome, CLS). See section 4. "Possible side effects".

Your doctor will carefully weigh the benefits of treatment with Berinert against the risk of these complications.

Viral safety

When medicines derived from human blood or plasma are administered, certain measures must be taken to prevent the transmission of infections to patients. These measures include:

• careful selection of blood and plasma donors to exclude those at risk of carrying infectious diseases, and
• testing of individual donations and pooled plasma for specific markers of viruses and infections.

Manufacturers of these products also include steps in the processing of blood or plasma to remove or inactivate viruses. Despite these measures, the possibility of transmitting infectious agents cannot be completely ruled out when medicines derived from human blood or plasma are administered. This also applies to emerging or unknown viruses or other types of infections.

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

Your doctor may recommend vaccination against hepatitis A and B if you are receiving regular or repeated treatment with medicines derived from human plasma.

It is strongly recommended that each time Berinert is administered, the date of administration, batch number, and injected volume be recorded.

Use of Berinert with other medicines

• Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.
• Berinert must not be mixed with other medicines or diluents in the same syringe.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
• During pregnancy and breastfeeding, Berinert should only be used if clearly indicated.

Driving and use of machinery

No studies have been conducted on the effects on the ability to drive and use machinery.

Berinert contains sodium

Berinert contains less than 23 mg of sodium (1 mmol) per vial; this is essentially “sodium-free”.

3. How to use Berinert

Treatment should be initiated and supervised by a physician experienced in the treatment of C1 esterase inhibitor deficiency.

Dosage

Adults

Treatment of acute angioedema attacks:

20 IU per kilogram of body weight (20 IU/kg b.w.).

Preoperative prevention of angioedema attacks:

1000 IU administered 6 hours prior to a medical, dental, or surgical procedure.

Paediatric population

Treatment of acute angioedema attacks:

20 IU per kilogram of body weight (20 IU/kg b.w.).

Preoperative prevention of angioedema attacks:

15 to 30 IU per kilogram of body weight (15–30 IU/kg b.w.) administered 6 hours prior to a medical, dental, or surgical procedure. The dose should be selected based on clinical circumstances (e.g., type of procedure and disease severity).

If you use more Berinert than you should

Cases of overdose have not been reported.

Reconstitution and method of administration

Berinert is injected into a vein (intravenous administration), usually by your doctor or nurse. You or your caregiver may also inject Berinert, but only after receiving adequate training. If your doctor decides that you may treat yourself at home, you will be given detailed instructions. You will be provided with a diary in which to record each injection given at home, which you must bring with you each time you visit your doctor. You or your caregiver will be regularly reviewed to ensure that injections are being performed correctly over time.

General instructions

• The powder must be dissolved and withdrawn from the vial under aseptic conditions. Use the syringe provided with the product.
• The prepared solution should be transparent and clear to slightly opalescent. After filtering or transferring the solution (see below), the solution should be visually inspected to ensure it contains no particles and shows no discoloration before administration.
• Do not use the solution if it is visibly cloudy or contains particles or residues.
• Any unused portion of the medication or residual materials must be disposed of according to local regulations and in accordance with your doctor's instructions.

Reconstitution

Before opening any vial, allow the Berinert powder and solvent to reach room temperature. To achieve this, leave the vials at room temperature for approximately one hour, or hold them in your closed hands for several minutes. DO NOT expose the vials to direct heat. The vials must not be warmed to a temperature above body temperature (37°C).

Carefully remove the protective caps from the solvent vial and the powder vial. Clean the exposed rubber stoppers of both vials with an alcohol-impregnated wipe and allow them to dry. Now transfer the solvent to the powder vial using the provided administration system (Mix2Vial). Please follow the instructions below:

Transfer of the reconstituted solution to the syringe and administration

Administration

The solution must be administered by slow intravenous (i.v.) injection.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately

• if any adverse effect occurs, or
• if you notice any adverse effect not listed in this leaflet.

Adverse effects with Berinert are rare.

The following adverse effects have been observed rarely (may affect up to 1 in 1,000 people):

• There is an increased risk of blood clot formation during attempts at prophylactic or therapeutic treatment of Capillary Leak Syndrome (leakage of fluid from small blood vessels into tissues), for example, during or after cardiac surgery with extracorporeal circulation. See section 2. “Warnings and precautions”.

• Increased body temperature, as well as burning and itching at the injection site.

• Hypersensitivity or allergic reactions (for example, irregular heartbeat, rapid heartbeat, drop in blood pressure, skin redness, rash, breathing difficulties, headache, dizziness, feeling unwell).

In very rare cases (may affect up to 1 in 10,000 people), allergic reactions may progress to shock.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Berinert

• Keep this medicine out of the sight and reach of children.
• Do not use Berinert after the expiry date stated on the label and outer carton.
• Do not store above 30 °C.
• Do not freeze.
• Keep the vial in the outer packaging to protect it from light.
• Berinert does not contain preservatives; therefore, the prepared solution should preferably be used immediately.

If the prepared solution is not administered immediately, it must be used within 8 hours and should only be stored in the vial.

6. Contents of the pack and other information

Composition of Berinert

The active substance is:

Human C1 esterase inhibitor (1500 IU/vial; after reconstitution with 3 ml of water for injections, 500 IU/ml)

For further information, see Section “This information is intended for healthcare professionals only”.

Other components:

Glycine, sodium chloride, sodium citrate.

See the last paragraph of Section 2. "Berinert contains sodium".

Solvent: water for injections.

Appearance of the product and contents of the pack

Berinert is presented as a white powder and is supplied with water for injections as solvent.

The reconstituted solution should be clear and transparent to slightly opalescent.

Presentation

Carton containing 1500 IU includes:

1 vial with powder (1500 IU)

1 vial with 3 ml of water for injections

1 transfer device with filter 20/20

Administration set (inner box):

1 single-use 5 ml syringe

1 venipuncture set

2 alcohol wipes

1 dressing pad

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg (Germany)

For further information about this medicinal product, please contact 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 European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Berinert 1500 IE Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Austria

Berinert 1500 Belgium, Cyprus, Germany, Greece, Luxembourg, Poland, Portugal

Berinert 1500, 500 IU Powder and solvent for solution for injection Bulgaria

Berinert 1500 IU Czech Republic, Slovakia

Berinert Denmark, Italy

Berinert 1500 IU, infuusiokuiva-aine ja liuotin, liuosta varten Finland

Berinert 1500 UI, poudre et solvant pour solution injectable France

Berinert 1500 NE por és oldószer oldatos injekcióhoz Hungary

Berinert 1500 IU pulver og væske til injeksjons, oppløsning Norway

Berinert 1500, pulbere si solvent pentru solutie injectabila Romania

Berinert 1500 i.e. prašek in vehikel za raztopino za injiciranje Slovenia

Berinert 1500 UI Polvo y disolvente para solución inyectable Spain

Berinert 1500 IE, pulver och vätska till injektionsvätska, lösning Sweden

Berinert 1500 UI powder and solvent for solution for injection United Kingdom

Date of the latest revision of this leaflet: October 2021

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

QUALITATIVE AND QUANTITATIVE COMPOSITION

The potency of human C1 esterase inhibitor is expressed in International Units (IU), related to the current WHO standard for C1 esterase inhibitor products.