Prospecto: Information for the User

BeriglobinaP

160 mg/ml injectable solution

Normal human immunoglobulin

1.What is Beriglobina P and what is it used for

2.What you need to know before starting to use Beriglobina P

3.How to use Beriglobina P

4.Possible adverse effects

5.Storage of Beriglobina P

6.Contents of the package and additional information

Beriglobina Pis a solution for injection under the skin (subcutaneous use) or into a muscle (intramuscular use). The solution contains normal human immunoglobulin, which is produced from human donor plasma.

Immunoglobulins are important components of the body's immune response system. They are produced by specialized cells in the body and act as inhibitors (antibodies) to foreign substances.

Normal human immunoglobulin contains mainly immunoglobulin G (IgG), which has a broad spectrum of antibodies against various infectious agents. Beriglobina P contains the antibodies of immunoglobulin G present in healthy populations. Appropriate doses of this preparation normalize the levels of immunoglobulin G that are below normal.

Beriglobina P is used for the following indicationsadministered bysubcutaneous (IgSC) route:

• Replacement therapy in adults, children, and adolescents (0-18 years) for:
• • Primary immunodeficiency syndromes with impaired antibody production.
  • Antibody deficiency (hypogammaglobulinemia) and recurrent bacterial infections in patients with chronic lymphocytic leukemia (CLL), in whom prophylactic antibiotics have not worked or are contraindicated.
  • Antibody deficiency (hypogammaglobulinemia) and recurrent bacterial infections in patients with multiple myeloma (MM).
  • Antibody deficiency (hypogammaglobulinemia) in patients before and after an allogeneic hematopoietic stem cell transplant (HSCT).

BeriglobinaP is used for the following indications administered by intramuscular (IgIM) route:

• Prophylaxis of Hepatitis A in adults, children, and adolescents (0-18 years):
• • Prophylaxis of pre-exposure preferably in combination with active vaccination, in unvaccinated individuals traveling within less than 2 weeks to areas at risk of hepatitis A.
  • Prophylaxis of post-exposure in unvaccinated individuals during the 2 weeks following exposure to the hepatitis A virus.

Active vaccination is recommended for long-term prophylaxis of Hepatitis A.

• Therapy of mucous membrane inflammation caused by radiation therapy (radiogenic mucositis).

The following sections contain information that you and your doctor should consider before applying BeriglobinaP.

Do not use Beriglobina P

• If you are allergic to the active ingredient or any of the excipients of this medication (see section 6. Subsection “Composition of Beriglobina P”). Inform your doctor if you are allergic to any medication or food.
• In a vein.
• In a muscle if you have severe thrombocytopenia or other bleeding disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Beriglobina P:

• • If Beriglobina P is accidentally administered in a vein, you may develop a severe allergic reaction (anaphylactic shock). This reaction is observed as a drop in blood pressure and difficulty breathing;
• If you receive human normal immunoglobulin for the first time;
• If you have received another medication to treat the same symptoms in the past;
• Or when it is not administered at regular intervals.

Hypersensitivity

Allergic reactions are rare. They can occur in cases of IgA deficiency with anti-IgA antibodies. In this case, you should be treated with caution. If subcutaneous IgG products remain the only option for you, you should be treated with Beriglobina P only under strict medical supervision.

Rarely, BERIGLOBINA P may induce a drop in blood pressure with anaphylactic reaction. This reaction can also occur if you tolerated previous treatments with human normal immunoglobulin.

Thromboembolism

With subcutaneous use of high doses of immunoglobulins for replacement therapy (e.g., primary immunodeficiency syndrome), there have been reports of blood clots (thromboembolic events). They can lead to heart attack (myocardial infarction), stroke, deep vein thrombosis, and pulmonary embolism. Please make sure you are well-hydrated before using immunoglobulins.

If you have any known risk factors for developing blood clots, such as:

• being an older person,
• having diabetes,
• having been bedridden for a long time,
• having or having had vascular problems (vascular diseases or obstruction of a vessel),
• having or having had kidney problems,
• having high blood pressure,
• having a disease that makes blood thicken,
• having a higher tendency to blood clotting (thrombophilia).

Inform your doctor or healthcare professional if you have at least one of the mentioned circumstances.

The first symptoms of thromboembolic events may be unexplained cough, shortness of breath, pain and swelling of a limb, numbness or weakness in an arm or leg or on one side of your face, sudden confusion or difficulty speaking or understanding, and chest pain. Contact your doctor immediately if you have any of these symptoms.

Asymptomatic Meningitis Syndrome (AMS)

Asymptomatic Meningitis Syndrome has been reported in association with subcutaneous immunoglobulin treatment; symptoms usually start within several hours to 2 days after treatment. Stopping immunoglobulin treatment may lead to the resolution of AMS within several days without sequelae.

The first symptoms of Asymptomatic Meningitis Syndrome may be severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting. Contact your doctor immediately if you have any of these symptoms.

Potential complications associated with subcutaneous administration are often preventable by:

• injecting the product slowly initially. The recommended infusion rate should be respected (10 ml/h);
• ensuring you are closely monitored for any adverse reaction during the entire infusion period, especially if:

• you are unfamiliar with human normal immunoglobulin,
• you receive human normal immunoglobulin for the first time,
• you come from an alternative product, or
• you do not receive it at regular intervals.

In these cases, you should be monitored during the first infusion and during the first hour after for potential adverse signs.

The rest of patients should be observed for at least 20 minutes after administration.

In case of suspected allergic or anaphylactic reaction, the administration should be stopped immediately. The required treatment depends on the nature and severity of the adverse effects. In case of shock, standard medical treatment should be followed.

Information on safety regarding infections

Beriglobina P is manufactured from human plasma (the liquid part of blood). When medications are made from blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These include:

• the careful selection of blood and plasma donors to ensure that high-risk donors are excluded,
• the analysis of each individual donation and plasma mixtures for signs of viruses and infections,
• the inclusion of steps in the production process of blood or plasma that can inactivate or eliminate viruses.

Despite these measures, when medications are prepared from blood or plasma, it cannot be ruled out that infectious agents may be transmitted. 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 non-enveloped viruses such as hepatitis A virus and parvovirus B19 (Sticker disease).

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections contained in this medication are protective.

It is strongly recommended that each time you receive a dose of Beriglobina P, the name and batch number of the medication be recorded to maintain a record of the batches used.

Children

The list of warnings and precautions applies to both adults and children.

Other medications and Beriglobina P

• Inform your doctor or pharmacist ifyou are using, have usedrecently or may have to use any other medication.
• Do not mix this medication with other medications, solvents, or diluents.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist beforeusing thismedication.
• The safety of this medication for use during human pregnancy has not been established.
• It has been shown that immunoglobulin products cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins indicates that no adverse effects on the course of pregnancy, the fetus, or the newborn are to be expected.
• Your doctor will decide whether it is appropriate for you to receive Beriglobina P if you are pregnant or breastfeeding.
• Immunoglobulins are excreted in breast milk and may contribute to protecting the newborn from certain infections.

Driving and operating machines

Your ability to drive and operate machines may be affected by some adverse effects associated with Beriglobina P. If you experience adverse effects during treatment, wait until they are resolved before driving or operating machines.

Beriglobina P contains sodium

Beriglobina P contains up to 110 mg (4.78 mmol) of sodium per dose (75 kgbody weight) if the maximum daily dose (11.25 g= 70.3 ml) is administered. You should be aware of this in the treatment of patients with low-sodium diets.

Other important information about Beriglobina P

Blood tests

After receiving Beriglobina P, the results of certain blood tests (serological tests) may be affected for a time. Inform your doctor about your treatment with Beriglobina P before any blood tests.

Replacement Therapy

The product must be administered subcutaneously.

Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will calculate the correct dose for you, taking into account your weight and response to treatment.

A loading dose of at least 1.3 to 3.1 ml/kg of body weight may be necessary. This dose can be divided over several days, with a maximum daily dose of 0.1 to 0.15 g/kg. After this, maintenance doses can be administered (approximately once a week) to reach a monthly accumulated dose of the order of 0.4 to 0.8 g per kg of body weight. Each individual dose can be injected in different anatomical sites.

Prophylaxis of Hepatitis A

The product is administered intramuscularly.

• Prophylaxis of pre-exposure in unvaccinated travelers who will travel in less than 2 weeks to areas at risk of Hepatitis A (short-term prophylaxis):

For stays in endemic areas for less than three months: 0.17 ml/kg of body weight (preferably administered in combination with active vaccination)

• Prophylaxis of post-exposure in unvaccinated individuals during the 2 weeks following exposure: 0.17 ml/kg of body weight.

Radiogenic Mucositis Therapy

The product is administered intramuscularly.

Initially 10 ml (1,600 mg), after 2 days 5 ml (800 mg), and after 2 days again 5 ml (800 mg). The treatment can be repeated as many times as necessary.

Children

The dose in children and adolescents (0-18 years) is not different from that of adults.

Administration Form

Depending on the indication, human normal immunoglobulin should be administered subcutaneously or intramuscularly.

The following applies to both administration modes:

• Beriglobina P is a ready-to-use solution (for more information on administration, see section 5 "Conservation of Beriglobina P" and section 6 subsection "Appearance of the product and contents of the package").

• Do not use solutions that are turbid or have sediments.

• The solution must be brought to room temperature or body temperature before use.

Subcutaneous Administration

Home subcutaneous infusion treatment should be initiated and supervised by a doctor experienced in the treatment of immunodeficiencies and in guiding patients for home treatment. Instructions will be given:

• on the use of a syringe controller,

• infusion techniques,

• maintenance of a treatment diary and

• recognition of and measures to be taken in case of severe adverse reactions.

Beriglobina P can be injected in sites such as the abdomen, thigh, upper arm, and lateral hip. It is recommended to use an initial administration rate of 10 ml/h/injection site. If well tolerated, the infusion rate can be gradually increased in each subsequent infusion. The maximum recommended rate is 22 ml/h/injection site. More than one injection site can be used simultaneously. The amount of product infused in a particular site varies. In infants and children, the infusion site can be changed every 5-15 ml. In adults, doses above 30 ml can be divided according to preference. There is no limit to the number of injection sites.

Your doctor will indicate how to dispose of unused product or waste material.

Intramuscular Administration

Intramuscular injection should be administered by a doctor or nurse.

If you have any questions about this medication, consult your doctor or pharmacist.

Using more Beriglobina P than you should

The consequences of overdose are unknown. However, if you have used

Beriglobina Pmore than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental administration, consult the Toxicological Information Service. Phone 91 562 04 20.

Missing a dose of Beriglobina P

• Consult your doctor or pharmacist immediately and follow their instructions.
• Do not administer a double dose to compensate for missed doses.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

With subcutaneous use of high doses of immunoglobulins for replacement therapy (for example, in primary immunodeficiency syndrome), blood clots (arterial and venous thromboembolic events) have been reported. Symptoms of these may include:

- Severe chest pain or pressure in the chest (heart attack).

- Weakness, paralysis, or numbness on one side of the body, loss of vision in one or both eyes, difficulty speaking (stroke).

- Cough, chest pain, rapid breathing, rapid heart rate (pulmonary embolism).

- Swelling, pain, redness of the leg (deep vein thrombosis).

If you have any of these conditions, please visit your doctor or emergency services immediately.

Allergic/anaphylactic reactions may occur, including difficulty breathing, low blood pressure, and skin reactions. In isolated cases, these reactions can cause severe allergic reactions (anaphylactic shock). This can happen even if you have previously tolerated administration with Beriglobina P or a similar product. If you experience any of the symptoms, stop your administration immediately and consult with your doctor urgently.

Circulatory disorders have been reported particularly if the product has been accidentally injected into a blood vessel. If this occurs, visit your doctor immediately.

Additionally, occasional adverse reactions such as dizziness, wheezing, fever, chills, general discomfort, headache, skin rash, and back pain have been reported. In isolated cases, some patients may also experience joint pain, vomiting, and nausea. Inform your doctor as soon as possible if you have experienced any of these adverse reactions.

Muscle pain at the injection site is very common; the following local reactions are common with subcutaneous administration and have been observed occasionally with intramuscular injection: swelling, redness, induration, local heat, itching, bruising, or hives. The frequency of these local reactions decreased very quickly during the first ten infusions, when patients became accustomed to this form of treatment. Urticaria at the injection site has been observed with intramuscular administration. Consult with your doctor when these reactions occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not use this medication after the expiration date that appears on the label and on the box after EXP.The expiration date is the last day of the month indicated.

• Store in refrigerator (between +2 °C and +8 °C) and store in the outer packaging to protect it from light. Do not freeze.
• The medication must be visually inspected before administration and should not be used if there is any change in its physical appearance (see also section 3 “Method of administration” and section 6 “Contents of the container and additional information”)
• Once the container is opened, its contents must be used immediately.
• Keep out of sight and reach of children.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines that you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Beriglobina P

Theactive principleis human normal immunoglobulin, 1 ml of solution contains: human protein

160 mg.

-Minimum 95% human immunoglobulin.

-Minimum 100 UI of hepatitis A antibodies.

The other components are glycine, sodium chloride, hydrochloric acid or sodium hydroxide (in small quantities to adjust the pH), and water for injection preparations.

Appearance of the product and contents of the packaging

Beriglobina P is a transparent solution for intramuscular or subcutaneous administration. The color may vary from transparent to pale yellow to light brown during the period of validity.

Packaging with 1 preloaded syringe of 2 ml.

Marketing Authorization Holder

CSL Behring, S.A.

c/ Tarragona 157, floor 18

08014 Barcelona (Spain)

Responsible for Manufacturing

CSL Behring GmbH

Emil-von-Behring-Str 76

Marburg (Germany)

Last review date of this leaflet:January 2021

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.