KEDHBS 180 IU/1 ML Roztwór do wstrzykiwań

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1. KEDHBs 180 IU/ml Injectable Solution, 540 IU/ 3 ml Injectable Solution, 1000 IU/3 ml Injectable Solution
   1. What is KEDHBs and what is it used for
   2. What you need to know before using KEDHBs
   3. How to use KEDHBs
   4. Possible side effects
   5. How to store KEDHBs
   6. Contents of the pack and other information

KEDHBs 180 IU/ml Injectable Solution, 540 IU/ 3 ml Injectable Solution, 1000 IU/3 ml Injectable Solution

Human anti-hepatitis B immunoglobulin

Read this leaflet carefully before you start to use 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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is KEDHBs and what is it used for

KEDHBs is a solution of human specific anti-hepatitis B immunoglobulins which are the
antibodies directed against the hepatitis B virus.
KEDHBs 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 via an artificial kidney), until vaccination has become effective;
• in the newborn of a mother 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 KEDHBs

Do not use KEDHBs

• If you are allergic to human immunoglobulins or to any of the other ingredients 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. KEDHBs contains small amounts of IgA and therefore severe allergic reactions may occur. The doctor must therefore assess the benefit of treatment with KEDHBs against the potential risk of allergic reactions.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using KEDHBs
Anyone administering KEDHBs 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.
Hypersensitivity
Severe 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 must
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, you should
immediately consult your doctor or the nearest hospital, as they may be symptoms of
an ongoing thrombotic event.
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 individuals 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 transmitting 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
for the non-enveloped hepatitis A virus (HAV).
The measures taken may have limited value against non-enveloped viruses such as the
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 KEDHBs, the name and lot
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 KEDHBs, inform
the nurse or doctor that you have taken this medicine.
KEDHBs 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 KEDHBs
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
KEDHBs must not be mixed with other medicinal products.
Live attenuated virus vaccines
KEDHBs 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 elapse after the administration of KEDHBs 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, 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, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The safety of this medicine during human pregnancy has not been established in controlled clinical
studies and therefore should be administered with caution in pregnant women.
Clinical experience with immunoglobulins suggests that no harmful effects
on the course of pregnancy, on the fetus and on the newborn are to be expected.

Breastfeeding
The safety of use of KEDHBs during breastfeeding has not been established in controlled clinical
studies and therefore 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
KEDHBs 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.

KEDHBs 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 and pre-filled syringe (main component of table salt).
This corresponds to 0.19% and 0.58% of the recommended daily maximum intake
with diet for an adult, respectively.

3. How to use KEDHBs

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
KEDHBs must be administered by intramuscular route.
The product must be brought to room or body temperature before use.

Vials: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.

Prefilled syringe:screw on the plunger rod and inject.
Caution: the injection must be carried out after ensuring that you have not penetrated a
blood vessel.
The solution is clear and colorless or pale yellow or light brown. Do not use solutions that
appear cloudy or with deposits.
If high doses are needed (> 2 ml for children or > 5 ml for adults), it is recommended to
administer them in divided doses at different injection sites.
Furthermore, if you suffer from severe thrombocytopenia and other coagulation disorders, KEDHBs must not
be administered by intramuscular route.

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

Adults
2000 IU every 15 days.
For long-term treatment, the dosage must be targeted at maintaining 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. 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
There are no data available on the use of KEDHBs in the pediatric population for the prophylaxis of
recidives 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.

Hepatitis B immunoprophylaxis in patients undergoing hemodialysis:
8-12 IU/kg up to a maximum of 500 IU, every 2 months until vaccination becomes
effective.

Prevention of hepatitis B in the newborn with a mother carrier of 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 becomes effective.
In all these situations, vaccination against hepatitis B is strongly recommended. The first
dose of the vaccine and human anti-hepatitis B immunoglobulins can be injected on the same
day, but at different sites.
If you have not shown an immune response after vaccination (anti-hepatitis B antibodies not
measurable) 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 KEDHBs than you should
The consequences of an overdose are unknown.

4. Possible side effects

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

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

• Allergic reactions (hypersensitivity), anaphylactic shock (severe allergic reaction, life-threatening). 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 adverse events have been reported following the administration of KEDHBs subsequently to the marketing authorization of the medicine (the frequency cannot be determined 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
• Feeling unwell
• Chills
• At the injection site: pain, swelling, erythema, hardening, heat, itching, rash, tingling

For information relating to safety with respect to transmissible agents, see section 2 “What you need to know before you use KEDHBs”.

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects via web: 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 KEDHBs

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 the
“ Description of the appearance of KEDHBs and contents of the pack” in section 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 KEDHBs 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 IgA content is 300 micrograms/ml.
Produced from human donor plasma.
The excipients are glycine, sodium chloride, water for injections.

Description of the appearance of KEDHBs and contents of the pack
KEDHBs is an injectable solution.
The solution may be colorless or pale yellow or light brown; during storage, slight opalescence or a small amount of suspended particles may
occur.
KEDHBs “180 IU/ 1 ml injectable solution” vial with 180 IU in 1 ml
KEDHBs “540 IU/ 3 ml injectable solution”: vial with 540 IU in 3 ml
KEDHBs “1000 IU/ 3 ml injectable solution": pre-filled syringe with 1000 IU in 3 ml

Marketing authorisation holder and manufacturer
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 leaflet was last approved on: