UMAN 540 UI/3 ML Инъекционный раствор

Содержание инструкции

1. UMAN BIG 180 UI/ml injectable solution
   1. What is UMAN BIG and what is it used for
   2. What you need to know 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

UMAN BIG 180 UI/ml injectable solution

Human anti-hepatitis B immunoglobulin

Read this leaflet carefully before using this medicine as it contains important
information for you.

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

Contents of this leaflet:

• 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 is UMAN BIG and what is it used for

UMAN BIG is a solution of human anti-hepatitis B immunoglobulins. Immunoglobulins are proteins
in the blood and constitute antibodies.
UMAN BIG is used in the following therapies:

• to prevent relapses of hepatitis B after liver transplantation due to liver failure induced by the hepatitis B virus.
• to rapidly provide antibodies against the hepatitis B virus and therefore prevent hepatitis B in the following cases: in case of accidental exposure in non-immunized subjects (i.e. in people who are not vaccinated against the hepatitis B virus, including people who are not fully vaccinated or whose vaccination cycle is unknown). in patients undergoing hemodialysis (i.e. in patients with severe kidney failure who require blood purification through an artificial kidney), until vaccination has become effective. in newborns with mothers carrying the hepatitis B virus. in subjects who have not shown an immune response after vaccination (i.e. in people in whom vaccination has not become effective) and for whom continuous prevention is necessary due to the persistent risk of contracting hepatitis B.

2. What you need to know before using UMAN BIG

Do not use UMAN BIG

• If you are allergic to human immunoglobulins or to any of the other components of this medicine (listed in section 6).
• If you have an immunoglobulin A (IgA) deficiency, you may develop antibodies against immunoglobulin A in the blood. UMAN BIG contains small amounts of IgA and therefore serious allergic reactions may occur.

The doctor must therefore assess the benefit of treatment with UMAN BIG against the potential risk of
allergic reactions.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using UMAN BIG.
Anyone administering UMAN BIG must ensure that the product is not injected into a blood vessel;
this could cause an acute (or severe) crisis of the circulatory system, known as shock.
If you are an HBsAg carrier, there are no benefits to administering this product.
Serious allergic reactions are rare.
Rarely, anti-hepatitis B immunoglobulins can cause a sudden drop in blood pressure with respiratory distress, fainting, sometimes fever and skin reactions (anaphylactic reaction). This
can happen even if you have tolerated previous treatments with immunoglobulins.
If your doctor or anyone administering the medicine suspects an allergic or anaphylactic reaction,
they should immediately stop the injection. In case of shock, your doctor should follow the standard medical treatment for shock.
If you notice any of these symptoms: difficulty breathing, pain and swelling of a limb, loss of mobility or sensitivity in a part of the body (focal neurological deficits) and chest pain, immediately contact
your doctor or go to the nearest hospital, as they may be symptoms of an ongoing thrombotic event.
The product contains 3.9 mg of sodium per ml. This must be taken into consideration, based on the
total amount of product to be administered to you, if you are following a low-salt diet.
When medicines are prepared from human blood or plasma, specific measures are taken to
prevent the transmission of infections to patients.
These measures include:

• careful selection of blood and plasma donors to ensure that potentially infected donors are excluded;
• testing of donations to ensure the absence of infectious agents and/or viruses;
• the inclusion, during the manufacturing process, of certain steps capable of inactivating or removing viruses. Despite these measures, when administering medicines prepared from human blood or plasma, the possibility of transmission of infectious agents cannot be completely excluded. This also applies to viruses, or other types of infectious agents, emerging or unknown. The measures taken are considered effective for enveloped viruses such as the human immunodeficiency virus (HIV), the hepatitis B virus (HBV), the hepatitis C virus (HCV) and the non-enveloped hepatitis A virus (HAV). The measures taken may have limited value against non-enveloped viruses such as parvovirus B19. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, probably because the antibodies against these infections, which are contained in the product, have protective capabilities.

It is strongly recommended that each time you are administered UMAN BIG, the name and batch number
of the product are recorded, in order to maintain traceability of the batch used.
Effects on blood tests
If you are about to have a blood test after being administered UMAN BIG, tell the nurse or
doctor that you have taken this medicine.
UMAN BIG may interfere with some tests for red blood cell antibodies.

Children
No specific measures or monitoring are required for the pediatric population.

Other medicines and UMAN BIG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
UMAN BIG must not be mixed with other medicinal products.
Live attenuated virus vaccines
UMAN BIG may interfere with the development of an immune response to live attenuated virus vaccines, such as
those for rubella, mumps, measles and varicella. The administration of immunoglobulins may
alter the effectiveness of these vaccines for at least 3 months. At least three months must pass after the administration of UMAN
BIG before proceeding with vaccination with live attenuated virus vaccines.
3 or 4 weeks must pass after vaccination with live attenuated virus vaccines before
administering human anti-hepatitis B immunoglobulins. If the administration of
human anti-hepatitis B immunoglobulins is necessary within three or four weeks of vaccination, a
revaccination must be done three months after the administration of human anti-
hepatitis B immunoglobulins.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety of use of this medicine during human pregnancy has not been established in controlled clinical
studies and therefore it should be administered with caution in pregnant women.
Clinical experience with immunoglobulins suggests that no harmful effects on
the course of pregnancy, or on the fetus and newborn are to be expected.
Breastfeeding
The safety of use of UMAN BIG during breastfeeding has not been established in controlled clinical
studies and therefore it should be administered with caution in breastfeeding women.
Immunoglobulins are excreted in milk and may help protect the newborn from pathogens
that have a route of entry through the mucous membranes.
Fertility
Clinical experience with immunoglobulins suggests that no harmful effects on
fertility are to be expected.

Driving and operating machinery
UMAN BIG does not alter or negligibly alters the ability to drive vehicles and operate machinery.
Patients who experience adverse reactions during treatment should wait for their resolution before
driving vehicles or operating machinery.

UMAN BIG contains sodium
This medicine contains up to a maximum of 3.9 mg of sodium per 1 ml vial and 11.7 mg of
sodium per 3 ml vial (main component of table salt).
This corresponds to 0.19% and 0.58% respectively of the recommended daily intake
with the diet of an adult.

3. How to use UMAN BIG

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
UMAN BIG must be administered via intramuscular route.
The product must be brought to room or body temperature before use.
Remove the central protection from the rubber cap and aspirate the solution with a syringe for injection.
Replace the injection needle of the syringe and inject.
Once the solution has been aspirated from the container into the syringe, the medicine must be administered
immediately.
The solution is transparent and colorless or pale yellow or light brown. Do not use solutions that appear
cloudy or with deposits.
If high doses (> 2 ml for children or > 5 ml for adults) are necessary, it is recommended to
administer them in divided doses at different injection sites.
Unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations.

Dosage
The doctor will determine what dose is suitable for you.
The generally used doses are as follows:
To prevent relapses of hepatitis B after liver transplantation due to liver failure induced by
hepatitis B virus:

Adults
The suggested dosage is 2160 IU i.m. every 15 days in the post-transplant period excluding the first
week. This dosage must be modified in long-term treatment to ensure the
maintenance of serum levels of anti-HBsAg antibodies above the threshold of 100 IU/l in HBV-DNA
negative patients and above 500 IU/l in HBV-DNA positive patients.
The concomitant use of adequate virostatic agents should be considered, if appropriate, as
standard in the prophylaxis of re-infections with hepatitis B.

Use in children
No data are available on the use of UMAN BIG in the pediatric population for the prophylaxis of relapses
of hepatitis B virus infection after liver transplantation following liver failure caused by
hepatitis B.
To prevent hepatitis B in the following cases:

Prevention of hepatitis B in case of accidental exposure in non-immunized subjects:
at least 500 IU, based on the intensity of exposure, as soon as possible after exposure, and 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 vaccination has become effective.

Prevention of hepatitis B in the newborn with a mother carrying the hepatitis B virus, at birth or as soon as

possible after birth:
30-100 IU/kg. It may be necessary to repeat the administration of anti-hepatitis B immunoglobulins until
vaccination has become effective.
In all these situations, vaccination against hepatitis B virus is strongly recommended. The first
dose of the vaccine and human anti-hepatitis B immunoglobulins can be injected on the same day, but in
different sites.
If you have not shown an immune response after vaccination (non-measurable anti-hepatitis B antibodies) and if
continuous prevention is necessary, your doctor may consider administering 500 IU (in adults) and 8 IU/kg (in children) every 2 months.

If you use more UMAN BIG than you should
The consequences of an overdose of the product are unknown.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
manifest.

If you notice any of the following side effects, consult your doctor immediately or contact the nearest
hospital:

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

The side effects reported below may generally occur after treatment with
immunoglobulins administered intramuscularly:

• occasionally, adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate back pain may occur.
• normal human immunoglobulins can rarely cause a sudden drop in blood pressure (hypotension) and, in isolated cases, hypersensitivity reactions (anaphylactic shock), even when the patient has not shown hypersensitivity to previous administration.
• local reactions at the injection site: soreness, swelling, redness (erythema), hardening, local heat, itching, rash and tingling, may occur frequently.
• The following side effects have been reported following the administration of UMAN BIG after the medicine was placed on the market (frequency cannot be estimated based on available data):
• Headache
• Fast heartbeat (tachycardia)
• Lowering of blood pressure (hypotension)
• Nausea
• Vomiting
• Skin reactions, redness (erythema), tingling, itching
• Joint pain (Artralgia)
• Fever
• Discomfort
• Chills
• At the injection site: pain, swelling, erythema, hardening, heat, itching, rash, tingling

For information regarding safety with respect to transmissible agents, see section 2 “ What you must

know before using UMAN BIG”.

Additional side effects in children
The frequency, type and severity of adverse reactions are expected to be the same as in
the adult population.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly via the
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 label and the outer packaging.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store in the outer packaging to protect the medicine from light.
Do not freeze.
Do not use this medicine if you notice that the solution is cloudy or has deposits (see also “ Description

of the appearance of UMAN BIG and contents of the pack” in paragraph 6.).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What UMAN BIG contains
The active ingredient is human anti-hepatitis B immunoglobulins.

Distribution of IgG subclasses:
IgG 63.7 %
IgG 31.8 %
IgG 3.3 %
IgG 1.2 %
The maximum content of IgA is 300 micrograms/ml.
Produced from human donor plasma.
The other components are glycine, sodium chloride, water for injections.

Description of the appearance of UMAN BIG and contents of the pack
UMAN BIG is an injectable solution.
The solution may be colourless or pale yellow or light brown; during storage, slight opalescence or a small amount of particulate matter may
be present.
UMAN BIG 180 IU injectable solution: vial with 180 IU in 1 ml
UMAN BIG 540 IU injectable solution: vial with 540 IU in 3 ml

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

Manufacturer
Kedrion S.p.A. - S.S. 7 bis Km 19,5, S. Antimo (Napoli).

This medicinal product is authorised in the Member States of the European Economic Area with the following
names: