Uman big

Patient Information Leaflet

UMAN BIG 180 IU/ml solution for injection
Human hepatitis B immunoglobulin
Please read all of this leaflet carefully before 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 further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It
• may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet Contents:

1. What UMAN BIG is and what it is used for
2. What you need to know before you use 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 UMAN BIG is and what it is used for

UMAN BIG is a solution containing human hepatitis B immunoglobulin. Immunoglobulins are blood proteins that act as antibodies.
UMAN BIG is used in the following treatments:
prevention of recurrence of hepatitis B after liver transplantation due to liver damage caused by hepatitis B virus;
prevention of hepatitis B by immediate administration of antibodies providing passive immunization in the following cases:
after accidental exposure of non-immunized individuals (i.e. individuals who have not been vaccinated against hepatitis B virus; including those whose vaccination has not been fully completed or whose immune status is unknown);
in patients undergoing haemodialysis (i.e. patients with severe kidney failure requiring blood purification through so-called artificial kidneys) until vaccine-induced immunity becomes effective;
in newborns born to mothers who are carriers of hepatitis B virus;
in individuals who do not respond to vaccination (i.e. in whom vaccination has not been effective) and in those who require continuous prophylaxis due to ongoing risk of hepatitis B virus infection.

2. Information before using UMAN BIG

When not to use UMAN BIG:

• if the patient is allergic to human immunoglobulins or to any of the other ingredients of this medicine (listed in section 6).

In patients with immunoglobulin A (IgA) deficiency, antibodies against IgA may develop in the blood. UMAN BIG contains a small amount of IgA; therefore, a severe allergic reaction may occur in these patients.
The physician should weigh the benefits of treatment with UMAN BIG against the potential risk of allergic reactions.

Warnings and precautions

Before starting treatment with UMAN BIG, discuss this with your doctor, pharmacist, or nurse.
Ensure that UMAN BIG is not administered intravascularly due to the risk of shock (acute circulatory failure).
Administration of the medicine provides no benefit in carriers of hepatitis B surface antigen (HBsAg).
True hypersensitivity reactions are rare.
In rare cases, human immunoglobulin for hepatitis B may cause hypotension with anaphylactic reaction (a rapid reaction with low blood pressure, breathing difficulties, fainting, sometimes fever and skin reactions), even in patients who previously tolerated immunoglobulin treatment well.
Suspicion of an allergic or anaphylactic-type reaction requires immediate discontinuation of the injection. In case of shock, treatment should follow current medical standards for shock management.
If any of the following symptoms occur—shortness of breath, pain and swelling in a limb, loss of ability to move or feel part of the body (focal neurological deficits), or 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 per 1 ml. Patients who are monitoring their sodium intake should consider the amount of sodium in their diet depending on the required dose of the product.

Medicines prepared from human blood or plasma undergo specific procedures intended to prevent transmission of infections to treated patients. These procedures include:

• selection of blood and plasma donors aimed at excluding donors who may be sources of infection;
• testing of plasma for the presence of infectious agents/viruses;
• inclusion of manufacturing steps that inactivate or remove viruses.

Despite these preventive measures, it cannot be completely excluded that medicines prepared from human blood or plasma may transmit infectious agents. This also applies to unknown or recently discovered viruses and other types of infections. The preventive measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), as well as against non-enveloped viruses such as hepatitis A virus (HAV). These measures may have limited effectiveness against non-enveloped viruses such as parvovirus B19. Immunoglobulins have not been shown to cause hepatitis A or parvovirus B19 infection, as the presence of antibodies may play an important protective role against viral infections.

It is strongly recommended that each time UMAN BIG is administered, the name and batch number of the medicine be recorded to allow identification of the product.

Effect on blood test results

If the patient has received UMAN BIG, inform the doctor or nurse before blood is drawn for testing.
UMAN BIG may affect the results of certain serological tests for antibodies against red blood cells.

Children and adolescents

No special precautions or monitoring requirements apply to children and adolescents.

UMAN BIG and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not mix UMAN BIG with other medicines.

Live attenuated viral vaccines

For a period of 3 months after administration of UMAN BIG, the medicine may affect the immune response to vaccines containing live attenuated viruses, such as rubella, mumps, measles, and varicella. After administration of UMAN BIG, at least a 3-month interval should be maintained before vaccination with live attenuated viral vaccines.
After vaccination with live attenuated viral vaccines, human immunoglobulin against hepatitis B virus should be administered within three to four weeks. If administration of human immunoglobulin against hepatitis B virus is required within three to four weeks after vaccination, revaccination should be performed three months after administration of the immunoglobulin.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 cautiously to pregnant women. Clinical experience with immunoglobulins suggests that no harmful effects on 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 cautiously to women who are breastfeeding.
Immunoglobulins pass into human milk and may contribute to protecting the newborn's body against pathogens entering through mucous membranes.

Fertility
Clinical experience with immunoglobulins suggests that no harmful effect on fertility is expected.

Driving and operating machinery
UMAN BIG has no effect or a negligible effect on the ability to drive and operate machinery. Patients who experience adverse reactions during treatment should wait until symptoms resolve before driving or operating machinery.

UMAN BIG contains sodium
This medicine contains 3.9 mg of sodium in a 1 ml vial and 11.7 mg of sodium in a 3 ml vial (sodium is the main component of table salt). This corresponds to 0.19% and 0.58% of the maximum recommended daily dietary sodium intake for adults.

3. How to use UMAN BIG

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician 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 using an
injection needle. Change the needle and administer the dose.
After emptying the vial and filling the syringe, the medicine should be administered immediately.
The solution is clear and colourless, pale yellow, or light brown. Do not use solutions that are
cloudy or contain sediment.
If a larger volume is required (>2 ml in children or >5 ml in adults), it is recommended to administer
the dose in divided amounts at different injection sites.
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 physician.
The usual dosage regimens are as follows:

Prevention of recurrent hepatitis B virus infection after liver transplantation due to liver damage caused by hepatitis B virus:
Adults:
Recommended dosage: 2160 IU intramuscularly every 15 days after transplantation, excluding the first
week post-operation. For long-term treatment, this dosage should be adjusted to maintain serum
antibody levels against HBs antigen above 100 IU/L in HBV-DNA negative patients and above
500 IU/L in HBV-DNA positive patients.
If necessary, concomitant use of appropriate antiviral agents should be considered as standard
prophylaxis against re-infection with hepatitis B virus.

Use in children
There is no data available on the use of UMAN BIG in children for the prevention of recurrent
hepatitis B virus infection after liver transplantation due to liver damage caused by hepatitis B virus.

Prevention of hepatitis B:
Prevention of hepatitis B virus infection following accidental exposure in non-immunized individuals:
At least 500 IU, depending on the degree of exposure to infection, administered 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) occurs after vaccination.

Prevention of hepatitis B in newborns of mothers who are hepatitis B virus carriers, at birth or as soon as possible thereafter:
30–100 IU/kg. Administration of human hepatitis B immunoglobulin may need to be repeated until
seroconversion occurs after vaccination.

In all the above cases, vaccination against hepatitis B virus is highly recommended. The first dose of
vaccine may be administered on the same day as human hepatitis B immunoglobulin, but at a different
injection site.

In individuals who do not show an immune response (undetectable antibodies against hepatitis B virus)
after vaccination, and in those requiring ongoing prophylaxis, administration of 500 IU every 2 months
in adults and 8 IU/kg in children may be considered.

Overdose of UMAN BIG
The consequences of overdose are unknown.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following adverse reactions, seek immediate medical
attention from a doctor or the nearest hospital:

• Allergic reaction (hypersensitivity), anaphylactic shock (a serious, potentially 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.

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

• Rarely, adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure, and moderate lower back pain may occur;
• Rarely, normal human immunoglobulins may cause a sudden drop in blood pressure (hypotension) and, in isolated cases, hypersensitivity reactions (anaphylactic shock), even in patients without prior hypersensitivity during previous treatments;
• Reactions at the injection site: pain, swelling, redness (erythema), induration, sensation of warmth, itching, rash, pruritus may occur commonly.

After the introduction of UMAN BIG to the market, the following adverse reactions have been reported following administration of the medicine (frequency cannot be determined from available data):

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

Information on viral safety, see section “2. Important information before using UMAN BIG”.
Additional adverse reactions in children
The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Al. Jerozolimskie 181C, 02-222 Warsaw), tel: 22 4921301, fax: 22 4921309, e-mail: [email protected]
Reporting adverse reactions allows for the collection of additional information on the safety of medicine use.

5. How to store UMAN BIG

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C).
Keep in the original outer cardboard packaging to protect from light.
Do not freeze.
Do not use this medicine if the solution is cloudy or if a precipitate 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 help protect the environment.

6. Contents of the package and other information

What UMAN BIG contains
The active substance in UMAN BIG is human immunoglobulin against hepatitis B virus.

IgG subclass distribution:
IgG 63.7%
IgG 31.8%
IgG 3.3%
IgG 1.2%
Maximum IgA content is 300 micrograms/ml.
Other components of the medicinal product are glycine, sodium chloride, water for injections.
What UMAN BIG looks like and contents of the pack
UMAN BIG is a solution for injection.
The solution is clear and colourless or slightly yellowish or slightly brownish; during storage it may
show slight opalescence or a small amount of sediment.
UMAN BIG 180 IU solution for injection: 1 ml vial containing 180 IU
UMAN BIG 540 IU solution for injection: 3 ml vial containing 540 IU
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
Pilicka 4, 02-629 Warsaw
email: [email protected]