Uman Big

Package Leaflet: Information for the User

UMAN BIG 180 IU/ml Solution for Injection

Human Hepatitis B Immunoglobulin

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

Important information for patients.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Contents of the package leaflet:

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

1. What is UMAN BIG and what is it used for

UMAN BIG is a solution of human hepatitis B immunoglobulin. Immunoglobulins are blood proteins and are antibodies. UMAN BIG is used in the following therapies: prevention of hepatitis B virus recurrence after liver transplantation due to liver damage caused by hepatitis B virus, prevention of hepatitis B through immediate administration of antibodies that induce immunity in patients in the following cases: accidental exposure of non-immune individuals (i.e., individuals who have not been vaccinated against hepatitis B virus, including those whose vaccination has not been completed or whose status is unknown), in patients undergoing hemodialysis (i.e., patients with severe kidney failure requiring blood purification through so-called artificial kidneys) until the effectiveness of vaccination is achieved, in newborns born to mothers who are carriers of hepatitis B virus, and in individuals who do not respond to vaccination (i.e., individuals who do not have a immune response after vaccination) and those who require continuous prevention due to a constant risk of hepatitis B virus infection.

2. Important information before using UMAN BIG

When not to use UMAN BIG:

In individuals with immunoglobulin A (IgA) deficiency, antibodies against immunoglobulin A may develop in the blood. UMAN BIG contains a small amount of IgA, so these individuals may experience a severe allergic reaction. The doctor should weigh the benefits of using UMAN BIG against the potential risk of allergic reactions.

Warnings and precautions

Before starting treatment with UMAN BIG, discuss it with your doctor, pharmacist, or nurse. Ensure that UMAN BIG is not administered into the patient's blood vessel due to the risk of shock (acute circulatory failure). In carriers of hepatitis B surface antigen (HBsAg), administration of the medicine does not have an effect. Actual hypersensitivity reactions are rare. In rare cases, human hepatitis B immunoglobulin may cause a drop in blood pressure with an anaphylactic reaction (severe reaction with a drop in blood pressure, respiratory distress, fainting, sometimes fever, and skin reactions) even in patients who have previously tolerated human immunoglobulin treatment well. Suspected allergic or anaphylactic reaction requires immediate discontinuation of injection. In case of shock, follow the applicable medical standards for shock treatment. If any of the following symptoms occur: shortness of breath, pain, and swelling of the limb, loss of ability to move or feel a part of the body (focal neurological deficits), and chest pain, contact a doctor or the nearest hospital immediately, as these symptoms may indicate a progressing thrombotic event. The medicine contains 3.9 mg of sodium in 1 ml. Patients controlling sodium levels should take into account the amount of sodium in the diet depending on the required dose of the product. Medicines prepared from human blood or plasma are subject to certain procedures that are intended to prevent the transmission of infectious agents to treated patients. These procedures include: selection of blood and plasma donors, which aims to exclude donors who may be a source of infection, testing of plasma for the presence of infectious agents/viruses, and inclusion in the manufacturing process of methods that inactivate or remove viruses. Despite these precautionary measures, it cannot be completely excluded that the transmission of infectious agents through medicines prepared from human blood or plasma may occur. This also applies to unknown or newly discovered viruses and other types of infections. It is considered that the precautionary measures taken are effective against enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), as well as non-enveloped viruses, such as hepatitis A virus (HAV). These measures may have limited effectiveness against non-enveloped viruses, such as parvovirus B19. It has not been found that immunoglobulins can cause hepatitis A or parvovirus B19 infection, as the presence of antibodies may play a protective role against viral infections. It is strongly recommended that each time UMAN BIG is used, the name and batch number should be recorded in order to facilitate the identification of the medicine. Effect on laboratory tests If the patient has received UMAN BIG, before taking a blood test, inform the doctor or nurse about it. UMAN BIG may affect the results of some serological tests for the presence of antibodies against red blood cells.

Children and adolescents

There are no special precautions or monitoring recommended for children and adolescents.

UMAN BIG and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Do not mix UMAN BIG with other medicines. Live attenuated viral vaccines In the period of 3 months after administration of UMAN BIG, it may affect the immune response obtained after vaccination with live attenuated viral vaccines, such as measles, mumps, rubella, and chickenpox. After administration of UMAN BIG, a minimum of 3 months should be allowed to pass before vaccination with a live attenuated viral vaccine. After vaccination with live attenuated viral vaccines, human hepatitis B immunoglobulin should be administered within 3 to 4 weeks; in case of need for administration of human hepatitis B immunoglobulin within 3 to 4 weeks after vaccination, the vaccination should be repeated 3 months after administration of human hepatitis B immunoglobulin.

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. Pregnancy The safety of using this medicine in pregnant women has not been established in controlled clinical trials, and therefore, it should be administered with caution to pregnant women. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, the fetus, or the newborn are expected. Breastfeeding The safety of using UMAN BIG in breastfeeding women has not been established in controlled clinical trials, and therefore, it should be administered with caution to breastfeeding women. Immunoglobulins pass into human milk and may participate in protecting the newborn's body against pathogens penetrating through the mucous membrane. Fertility Clinical experience with immunoglobulins suggests that no harmful effects on fertility are expected.

Driving and using machines

UMAN BIG has no or negligible influence on the ability to drive and use machines. Patients who have experienced side effects during treatment should wait for them to resolve before driving or operating machines.

UMAN BIG contains sodium

This medicine contains up to 3.9 mg of sodium in a 1 ml vial and 11.7 mg of sodium in a 3 ml vial (sodium is a major component of common salt). This corresponds to 0.19% and 0.58% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use UMAN BIG

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. UMAN BIG should be administered intramuscularly. Before use, the medicine should be brought to room temperature or body temperature. Remove the protective strip from the rubber stopper and draw the solution into a syringe for injection. Change the needle and administer. After emptying the vial and filling the syringe, the medicine should be administered immediately. The solution is clear and colorless or pale yellow or pale brown. Do not use solutions that are cloudy or have sediment. If it is necessary to use a larger volume (>2 ml in children or >5 ml in adults), it is recommended to administer it in different parts of the body in divided doses. Any unused product or waste material should be disposed of in accordance with local regulations.

Dosage

The appropriate dose for the patient will be determined by the doctor. The following dosages are usually used: Prevention of hepatitis B virus recurrence after liver transplantation due to liver damage caused by hepatitis B virus: Adults: Recommended dosage: 2160 IU intramuscularly every 15 days after transplantation, not counting the first week after surgery. In case of long-term treatment, this dosage should be adjusted to maintain the concentration of antibodies against HBs antigen in serum above 100 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients. If necessary, consider concurrent use of appropriate antiviral drugs as standard prophylaxis against hepatitis B virus reinfection.

Use in children

There are no data on the use of UMAN BIG in children for the prevention of hepatitis B virus recurrence after liver transplantation due to liver damage caused by hepatitis B virus. Prevention of hepatitis B: Prevention of hepatitis B in case of accidental exposure in non-immune individuals: at least 500 IU, depending on the degree of exposure to infection, as soon as possible after exposure, preferably within 24-72 hours. Immunoprophylaxis of hepatitis B in patients undergoing hemodialysis: 8-12 IU/kg, up to a maximum of 500 IU, every 2 months until seroconversion (appearance of antibodies in serum) after vaccination. Prevention of hepatitis B in newborns whose mothers are carriers of hepatitis B virus, at birth or as soon as possible after birth: 30-100 IU/kg. Administration of human hepatitis B immunoglobulin may require repetition to achieve seroconversion after vaccination. In all these cases, vaccination against hepatitis B is highly recommended. The first dose of vaccination may be administered on the same day as human hepatitis B immunoglobulin, but in different parts of the body. In individuals who do not respond to vaccination (unmeasurable antibodies against hepatitis B virus) after vaccination and those who require continuous prophylaxis, administration of 500 IU every 2 months in adults and 8 IU/kg in children may be considered.

Overdose

There are no known consequences of overdose.

4. Possible side effects

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

If you experience any of the following side effects, contact a doctor or the nearest hospital immediately:

:

• Allergic reaction (hypersensitivity), anaphylactic shock (a severe, life-threatening allergic reaction). Symptoms of an allergic reaction/anaphylactic shock include itching, skin reactions, swelling of the lips, face, tongue, difficulty swallowing, difficulty breathing, fainting.

After administration of products containing human normal immunoglobulin for intramuscular injection, the following reactions may occur:

• Rarely, side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure, and back pain may occur;
• very rarely, human normal immunoglobulins may cause a sudden drop in blood pressure (hypotension) and, in single cases, hypersensitivity reactions (anaphylactic shock), even in patients without hypersensitivity after previous treatment;
• reactions at the injection site: pain, swelling, redness (erythema), induration, warmth, itching, rash, pruritus.

After the introduction of UMAN BIG to the market, the following side effects have been reported (frequency cannot be estimated from the available data):

• Headache
• Palpitations (tachycardia)
• Low blood pressure (hypotension)
• Nausea
• Vomiting
• Skin reactions: redness (erythema), itching, pruritus
• Joint pain
• Fever
• Malaise
• Chills
• At the injection site: pain, swelling, redness (erythema), induration, warmth, itching, rash, pruritus.

Information on viral safety, see section "2. Important information before using UMAN BIG".

Additional side effects in children

It is expected that the frequency, type, and severity of side effects in children are the same as in adults.

Reporting of side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides (Al. Jerozolimskie 181C, 02-222 Warsaw), phone: 22 4921301, fax: 22 4921309, e-mail: [email protected] By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store UMAN BIG

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month. Store in a refrigerator (2°C - 8°C). Store in the outer carton in order to protect from light. Do not freeze. Do not use this medicine if the solution is cloudy or sediment is visible (see also "What UMAN BIG looks like and contents of the pack" in section 6). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What UMAN BIG contains

The active substance of UMAN BIG is human hepatitis B immunoglobulin.

IgG subclass distribution: IgG1 63.7%, IgG2 31.8%, IgG3 3.3%, IgG4 1.2%. The maximum content of IgA is 300 micrograms/ml. Other ingredients of the medicine are glycine, sodium chloride, and water for injection.

What UMAN BIG looks like and contents of the pack

UMAN BIG is a solution for injection. The solution is clear and colorless or pale yellow or pale brown; during storage, it may show slight turbidity or a small sediment. UMAN BIG 180 IU solution for injection: vial of 180 IU in 1 ml UMAN BIG 540 IU solution for injection: vial of 540 IU in 3 ml

Marketing Authorisation Holder

Kedrion S.p.A. - Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca) Italy.

Manufacturer

Kedrion S.p.A. - S.S. 7 bis Km 19,5, S. Antimo (Napoli), Italy. This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information, please contact the representative of the Marketing Authorisation Holder: MB&S Medical Business and Science ul. Pilicka 4, 02-629 Warsaw email: [email protected] Date of last revision of the package leaflet:01/2023