VEBIKED 50 UI/ML Roztwór do infuzji

Treść ulotki

1. VEBIKED 50 UI/ml Solution for Infusion
   1. What is VEBIKED and what is it used for
   2. What you need to know before using VEBIKED
   3. How to use VEBIKED
   4. Possible side effects
   5. How to store VEBIKED
   6. Contents of the pack and other information

VEBIKED 50 UI/ml Solution for Infusion

Human anti-hepatitis B immunoglobulin for intravenous use

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.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is VEBIKED and what is it used for

This medicine belongs to a pharmacotherapeutic group called immune sera and
immunoglobulins.
VEBIKED is a solution of human immunoglobulins (proteins that function as antibodies)
anti-hepatitis B for intravenous use and 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, in combination with antiviral therapy.
To rapidly provide antibodies against the hepatitis B virus in order to prevent
hepatitis B infection in the following cases:

• in case of accidental exposure in non-immunized subjects (i.e., in people who are not vaccinated against hepatitis B 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 becomes 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 VEBIKED

Do not use VEBIKED

• If you are allergic to human immunoglobulins or to any of the other ingredients of this medicine (listed in section 6). If you have antibodies directed against IgA-type immunoglobulins in your blood, as the administration of a product containing IgA may cause a severe allergic reaction.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using VEBIKED.
Occlusion of a blood vessel (thrombosis) has been associated with the administration of
normal intravenous immunoglobulin (IVIg).
Therefore, your doctor must act with particular caution when administering this medicine
if you have risk factors for thrombosis.
The levels of anti-HBs antibodies in your blood should be checked regularly.
Some adverse reactions may occur more frequently:

• if the infusion rate is high;
• if you have uncontrolled symptoms of untreated infections (e.g. fever) or symptoms of chronic inflammation;
• if you are receiving normal human immunoglobulins for the first time;
• in rare cases if the type of human immunoglobulin medicinal product has been changed, or if a long interval has passed since the previous infusion.
• In some conditions, immunoglobulins may increase the risk of myocardial infarction, stroke, pulmonary embolism or deep vein thrombosis as they increase theviscosity of the blood.Therefore, your doctor will be particularly careful in the following circumstances:
• if you are overweight,
• if you are elderly,
• if you suffer from diabetes,
• if you have high blood pressure (hypertension),
• if your blood volume is too low (hypovolemia),
• if you have or have had problems with blood vessels (vascular diseases),
• if you have an increased tendency to blood clotting (inherited or acquired thrombophilic disorders),
• if you suffer from thrombotic episodes,
• if you suffer from diseases that increase blood density (viscosity),
• if you have had a prolonged period of immobility,
• if you have or have had kidney problems or if you are taking medicines that can damage the kidneys (nephrotoxic medicines), as cases of acute renal failure have been reported. In case of kidney damage, your doctor will consider interrupting the treatment.
• You may be allergic (hypersensitive) to immunoglobulins (antibodies) without knowing it.This can happen even if you have received normal human immunoglobulins in the past and have tolerated previous administrations. This is particularly likely if you do not have IgA-type immunoglobulins (IgA deficiency with anti-IgA antibodies). In these rare cases, allergic (hypersensitivity) reactions such as a drop in blood pressure
  or shock may occur.

The recommended infusion rate in section 3 “ How to use VEBIKED” must be strictly
followed by the doctor; this is strongly recommended because some serious adverse
reactions to the medicine may be related to the infusion rate. In addition, you must be closely
monitored and carefully observed during the entire infusion period to detect the
appearance of any symptoms.
In case of adverse reactions, your doctor may decide to reduce the infusion rate or stop
the infusion. In addition, your doctor will decide the type of treatment required depending on the nature and
severity of the adverse effect.
VEBIKED contains small amounts of IgA. If you have IgA deficiency, you may be at risk of
developing anti-IgA antibodies and may develop anaphylactic reactions after the administration of
blood components containing IgA. Your doctor must assess the benefit of treatment with
VEBIKED against the potential risk of hypersensitivity reactions.
Human anti-hepatitis B immunoglobulins can rarely induce a drop in
blood pressure with anaphylactic reaction, even if you have tolerated previous treatments with
immunoglobulins.
If you suffer from renal failure, your doctor should consider interrupting treatment
with IVIg. Although cases of renal dysfunction and acute renal failure have been associated with the use of many IVIg-authorised products containing various excipients such as
sucrose, glucose and maltose, those containing sucrose as a stabiliser represent
a very high percentage of the total number. In patients at risk for acute renal failure
or thromboembolic adverse reactions, IVIg-based products must be
administered at the lowest practicable infusion rate and dose.
With immunoglobulin-based treatments, you may experience lung injury related to
treatment, called Transfusion Related Acute Lung Injury (TRALI). If you experience shortness of breath, or rapid breathing during the infusion or in the hours
following the infusion, immediately inform the doctor or nurse as emergency treatment may be
necessary.
Suspicion of allergic or anaphylactic reactions requires immediate interruption
of the injection. In case of shock, standard medical treatment for shock must be followed.
Tell your doctor if at least one of the above conditions applies to you. Your doctor
will take particular care when prescribing and administering VEBIKED.
Human intravenous immunoglobulin (IVIg) products may contain
blood group-specific antibodies that can rarely cause destruction of red blood cells
(hemolysis). For this reason, a form of anemia due to abnormal red blood cell breakdown (hemolytic anemia) may develop following IVIg therapy. Therefore, during treatment
with IVIg, you will be monitored for clinical signs and symptoms of hemolysis.
Blood tests
VEBIKED may interfere with some blood tests due to the temporary increase of various
antibodies that are passively transferred into your blood with the immunoglobulin infusion;
this increase in antibodies may cause some blood tests to have a result that
may not be correct. Passive transfer of antibodies against red blood cell antigens, e.g.
A, B, D (determining the blood group), may interfere with some serological tests for red blood cell antibodies, for example the direct antiglobulin test (Coombs' test).
Blood glucose tests
Some blood glucose measurement systems (e.g., those based on pyrroloquinoline quinone glucose dehydrogenase (GDH-PQQ) or the colorimetric glucose-oxidase method)
falsely recognize maltose (100 mg/ml) contained in VEBIKED as glucose. This
may result in falsely elevated blood glucose readings during the infusion and for a
period of approximately 15 hours after the end of the infusion and, consequently, in inappropriate insulin administration, causing a life-threatening or even fatal hypoglycemia.
In addition, real hypoglycemia may not be treated if the hypoglycemic state is
masked by falsely elevated glucose values. Consequently, during the administration
of VEBIKED or other parenteral products containing maltose, blood glucose measurement must be
performed using glucose-specific methods. The instructions for use of the blood glucose measurement system, including those of the test strips, must be carefully checked to establish whether
the system is appropriate for use in patients treated with parenteral products containing
maltose. If in doubt, contact the manufacturer of the measurement system to
determine the appropriateness of use in conjunction with parenteral products containing
maltose.
Viral safety
When medicines are prepared from human blood or plasma, certain measures are put in place to prevent the transmission of infections to patients.
These measures include:

• careful selection of blood and plasma donors to ensure that those potentially infected are excluded;
• testing of each donation and plasma pool to ensure that it does not contain infectious agents and/or viruses;
• the inclusion, during the manufacturing processes, of 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 totally 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 capacity.

It is strongly recommended that each time VEBIKED is administered, the name and lot
number of the product are recorded, in order to maintain traceability of the lot used.

Children
No specific measures or monitoring are required.

Other medicines and VEBIKED
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Human anti-hepatitis B immunoglobulins for intravenous use must not be mixed with
other medicinal products.
Live attenuated virus vaccines
VEBIKED 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 a period that can last up to 3
months. At least three months should elapse after the administration of VEBIKED before
proceeding with vaccination with live attenuated virus vaccines.
Human anti-hepatitis B immunoglobulins should be administered three or four weeks
after vaccination with live attenuated virus vaccines; if the administration of human anti-hepatitis B immunoglobulins is necessary within three or four weeks of
vaccination, revaccination should be done three months after the administration of
human anti-hepatitis B immunoglobulins.
Loop diuretics (a group of medicines that increase urine production)
Concomitant use of loop diuretics with VEBIKED should be avoided.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. The doctor will decide whether it is appropriate to use VEBIKED during pregnancy and breastfeeding.
• Clinical studies with VEBIKED have not been conducted in pregnant women. Human intravenous immunoglobulin products have been shown to cross the placenta increasingly during the third trimester. However, medicines containing antibodies have been used for years in pregnant women and have been shown not to be expected to have harmful effects on the course of pregnancy, the fetus or the newborn.
• If you are breastfeeding and are being treated with VEBIKED, the antibodies contained in the product may pass into breast milk. Therefore, your baby may be protected from some infections. Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected. Driving and using machines

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

VEBIKED contains sodium
This medicine contains up to a maximum of 39 mg of sodium (the main component of table
salt) per 10 ml vial and 195 mg of sodium per 50 ml vial.
This is equivalent to 1.9% and 9.7% of the recommended daily intake
of salt with the diet of an adult.

3. How to use VEBIKED

VEBIKED can only be administered in hospital or in clinics and nursing homes by doctors
or healthcare professionals.
The dosage and treatment regimen depend on the indication; the doctor will determine the dose and
treatment suitable for you.
At the beginning of the infusion, you will receive VEBIKED at the minimum infusion rate. If you tolerate
the applied rate well, your doctor may gradually increase the infusion rate.
For further instructions, please refer to the section “ The following information is intended

exclusively for doctors or healthcare professionals”.

If you use more VEBIKED than you should
The consequences of an overdose are unknown.
If you are given more VEBIKED than you should, protein overload may occur
in the fluids and the blood may become too thick (hyperviscous); this is particularly
evident in patients at risk, especially elderly patients or those with impaired cardiac or renal function.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

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). This side effect can in some cases progress to acute allergic reaction (anaphylactic shock): for example, itching, skin reactions, swelling of the lips, face and tongue, difficulty swallowing, difficulty breathing, fainting.
• Acute renal failure (for example, decreased or absent urine flow, fluid retention, shortness of breath).

The following side effects reported below may generally occur after treatment with intravenous immunoglobulin:

• chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate back pain have been reported occasionally;
• isolated cases of temporary reduction of red blood cells (reversible hemolytic anemia/hemolysis), especially in patients with blood groups A, B and AB and (rarely) hemolytic anemia requiring transfusion;
• a sudden drop in blood pressure has been reported rarely and, in some isolated cases, hypersensitivity reactions (anaphylactic shock) may occur, even when the patient has not presented reactions to previous administrations;
• rare cases of transient skin reactions have been observed;
• very rarely, thromboembolic events (blood clot formation) have been reported, which may cause myocardial infarction, stroke, pulmonary artery obstruction (pulmonary embolism) and deep vein thrombosis;
• cases of transient non-infectious meningitis (reversible aseptic meningitis);
• cases of increased creatinine levels in the blood and/or acute renal failure;
• cases of acute lung injury associated with transfusion (TRALI).

The following adverse events have been reported following the administration of VEBIKED subsequently to the marketing authorization of the medicine (the frequency cannot be estimated on the basis of available data):

• Headache
• Fast heartbeat (tachycardia)
• Low blood pressure (hypotension)
• Nausea
• Vomiting
• Skin reactions, redness (erythema), tingling, itching
• Joint pain (arthralgia)
• Fever
• Discomfort
• Chills

For information regarding safety with respect to transmissible agents, see section 2 “What you need to know before using VEBIKED”.

Additional side effects in children
No specific data are available on the paediatric 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 directly to the Italian Medicines Agency (AIFA) through its website: 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 VEBIKED

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.
Once the container is opened, the product must be administered immediately.
Do not use this medicine if you notice that the solution is cloudy or contains deposits or presents
a change in colour (see also “Description of the appearance of VEBIKED 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 VEBIKED contains
The active ingredient is human anti-hepatitis B immunoglobulin.

The IgG subclasses (immunoglobulins of type G) have the following distribution:
IgG 26.0 - 40.0 mg/ml
IgG 13.0 - 25.0 mg/ml
IgG 1.20 - 2.50 mg/ml
IgG 0.15 - 0.50 mg/ml
The maximum content of IgA is 0.05 mg/ml
Produced from human donor plasma.
The other components are maltose, sodium chloride and water for injections.

Description of the appearance of VEBIKED and contents of the pack
VEBIKED is a solution for infusion.
The solution appears as a clear or slightly opalescent, colorless or
pale yellow preparation.
Before administration, visually inspect the solution for the presence of
particles in suspension, corpuscles or chromatic alterations.
Do not use solutions that are cloudy or that present deposits.
VEBIKED 50 IU/ml solution for infusion: vial with 500 IU in 10 ml
VEBIKED 50 IU/ml solution for infusion: vial with 2500 IU in 50 ml + infusion set

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).

The following information is intended exclusively for doctors or healthcare professionals:
Instructions for correct use
Before use, bring the product to room or body temperature.
VEBIKED must be infused intravenously at an initial rate of 0.46 – 0.92 ml/kg/h
(for example for a patient of 65 kg at a rate of 10 - 20 drops per minute) for 20 - 30
minutes. In case of adverse reaction, the administration rate must be reduced or the
infusion stopped. If well tolerated, the administration rate may be gradually increased up to
a maximum of 1.85 ml/kg/h (for example for a patient of 65 kg at a rate of 40
drops/minute) for the remainder of the infusion.
Do not use solutions that are cloudy or that present deposits.
Reconstituted products must be visually checked for the presence of particles in
suspension or chromatic alterations before administration.
The solution appears as a clear or slightly opalescent, colorless or
pale yellow preparation.
Unused medicinal product and waste derived from such medicinal product must be disposed of in
accordance with local regulations.

Special precautions
Some adverse reactions to the product may be due to the infusion rate.
Potential complications can often be avoided by ensuring:

• that patients are not sensitive to normal human immunoglobulin by administering the product slowly at the beginning (with an infusion rate between 0.46 and 0.92 ml/kg/h);
• that patients are carefully monitored for any symptoms during the entire infusion period. In particular, patients who are receiving human normal immunoglobulin for the first time, patients who have changed the type of IVIg-based product, or patients for whom a long interval has elapsed since the previous infusion, must be monitored during the first infusion and for the first hour after the first infusion, to identify potential signs of adverse reactions. All other patients must be observed for at least 20 minutes after administration.

In all patients, the administration of IVIg requires:

• adequate hydration before the start of IVIg infusion;
• monitoring of urine volume;
• monitoring of serum creatinine levels;
• avoiding the concomitant use of loop diuretics. In case of adverse reaction, the administration rate must be reduced or the infusion must be stopped. The necessary treatment depends on the nature and severity of the adverse effect. In case of shock, standard medical treatment for shock must be performed.

Infusion reaction
Some adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, back pain, nausea and hypotension) may be related to the infusion rate.
The recommended infusion rate must be carefully followed. Patients
must be closely monitored and carefully observed for any symptoms during
the entire infusion period.
Adverse reactions may occur more frequently:

• in case of high infusion rate;
• in patients with hypo- or agammaglobulinemia with or without IgA deficiency.

Hypersensitivity
True hypersensitivity reactions are rare.
VEBIKED contains small amounts of IgA. Individuals who have an IgA deficiency may
develop antibodies against IgA and may have anaphylactic reactions after
administration of blood components containing IgA. The doctor must therefore assess the
benefit of treatment with VEBIKED against the potential risk of hypersensitivity reactions.
Rarely, human anti-hepatitis B immunoglobulins may induce a drop in
blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatments
with immunoglobulins.
Patients must be informed about the early signs of hypersensitivity reactions such as urticaria,
generalized urticaria, a feeling of tightness in the chest, wheezing, hypotension and anaphylaxis. The
treatment required depends on the nature and severity of the adverse reaction.
Suspicion of allergic or anaphylactic reactions requires immediate interruption
of the injection. In case of shock, standard medical treatment for shock must be followed.
Interference with serological tests
After injection of immunoglobulins, the transient increase of various passively transferred antibodies
in the patient's blood can give falsely positive results in serological tests.
Passive transfer of antibodies against erythrocyte antigens, e.g. A, B, D can interfere with
some serological analyses for red blood cell antibodies, for example the antiglobulin
test (Coombs' test).
Transmissible agents
Standard measures to prevent infections resulting from the use of medicinal products prepared from
human blood or plasma include the selection of donors, screening of individual donations
and plasma pools for specific infection markers and the inclusion of effective production steps for
virus inactivation/removal. However, when administering medicinal products prepared from human blood or plasma
the possibility of transmitting infectious agents cannot be totally excluded. This applies
also to viruses and other pathogens that are emerging or unknown.
The measures taken are considered effective for enveloped viruses such as the human immunodeficiency virus (HIV), the hepatitis B virus (HBV) and the hepatitis C virus (HCV) and
for the non-enveloped hepatitis A virus (HAV).
The measures taken have limited value against non-enveloped viruses such as the
parvovirus B19.
There is reassuring clinical experience regarding the absence of transmission of hepatitis A and
parvovirus B19 with immunoglobulins and it can be assumed that the antibody content makes an
important contribution to viral safety.
It is strongly recommended that each time VEBIKED is administered to a patient, the
product name and batch number are recorded, in order to maintain traceability between the
patient and the product batch.
Important information about the ingredients of VEBIKED
This medicine contains up to a maximum of 39 mg of sodium per 10 ml vial and 195
mg of sodium per 50 ml vial, equivalent to 1.9% and 9.7% respectively
of the recommended daily intake by the WHO, which corresponds to 2 g of sodium for an
adult.
This medicine contains up to a maximum of 91.9 mg of maltose per ml as an excipient.
Interference of maltose with blood glucose tests can lead to an overestimation of glucose values and, consequently, to inadequate insulin administration, which can cause a
life-threatening hypoglycemic state and patient death. In addition, cases of real hypoglycemia
may not be treated if the hypoglycemic state is masked by falsely elevated glucose values. See below for acute renal failure.

The following adverse reactions have been associated with the use of normal human immunoglobulins for

intravenous use (IVIg):
Thromboembolism
There is clinical evidence demonstrating a relationship between the administration of IVIg and thromboembolic events such as myocardial infarction, stroke (including stroke), pulmonary embolism and deep vein thrombosis, which are presumed to be related to a relative increase in blood viscosity due to a high influx of immunoglobulin in patients at risk.
Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with
pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus
and a history of vascular disease or thrombotic episodes, patients with acquired or congenital thrombophilic disorders, patients immobilized for a prolonged period, severely hypovolemic patients,
patients with diseases that increase blood viscosity).
In patients at risk for thromboembolic adverse reactions, IVIg-based products should be
administered at the minimum infusion rate and dose practicable.
Acute renal insufficiency
Cases of acute renal insufficiency have been reported in patients undergoing therapy with IVIg.
In most cases, risk factors such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant use of nephrotoxic drugs or age over 65 years have been identified.
Renal function should be monitored before administering IVIg, in particular in patients
with a potentially increased risk of developing acute renal insufficiency, and at adequate intervals
after administration.
In patients at risk of acute renal insufficiency, IVIg-based products should be
administered at the minimum infusion rate and dose practicable. In case of renal damage, it
should be considered to discontinue IVIg.
Although cases of renal dysfunction and acute renal insufficiency have been linked to
the use of many medicinal products authorized on the basis of IVIg containing various excipients such as
sucrose, glucose and maltose, those containing sucrose as a stabilizer represent
a very high percentage of the total number.
In at-risk patients, the use of IVIg-based products that do not
contain these excipients may be considered. VEBIKED contains maltose (see paragraph “ Information

important about the ingredients of VEBIKED”).
Aseptic meningitis syndrome (AMS)
Aseptic meningitis syndrome can occur in combination with IVIg treatment.
The syndrome generally begins after a period ranging from several hours to 2 days after treatment
with IVIg. Studies on cerebrospinal fluid often show positive pleocytosis up to several
thousands of cells per mm , especially granulocytes, and high protein levels, up to several
hundreds of mg/dl.
Patients presenting with such signs and symptoms should receive a complete neurological examination,
including CSF studies, to rule out other causes of meningitis.
Discontinuation of IVIg treatment has led to remission of AMS within a few days
without consequences.
Hemolytic anemia
Medicinal products based on IVIg contain blood group-specific antibodies that can
act as hemolysins and induce, in vivo, the binding of red blood cells with immunoglobulins, causing
a positive direct antiglobulin reaction (Coombs' test) and rarely, hemolysis. Following
IVIg therapy, hemolytic anemia due to increased red blood cell uptake may develop. Subjects receiving IVIg should be monitored for clinical signs and symptoms of
hemolysis.
Neutropenia/Leukopenia
A transient decrease in neutrophil count and/or episodes of neutropenia, sometimes severe, are
reported after treatment with IVIg. This usually occurs within a few hours or days
after administration of IVIg and resolves spontaneously within 7-14 days.
Acute lung injury associated with transfusion (TRALI)
Some cases of acute non-cardiogenic pulmonary edema (transfusion-related acute lung injury, TRALI) have been reported in patients receiving IVIg. TRALI is characterized by
severe hypoxia, dyspnea, tachypnea, cyanosis, fever and hypotension. Symptoms associated with TRALI
typically appear during the transfusion or within 6 hours of the transfusion, often within 1-2 hours.
Therefore, patients receiving IVIg should be monitored and the infusion with the product must be
immediately stopped if any pulmonary adverse reactions occur. TRALI is
a condition that can put the patient in life-threatening danger requiring immediate admission to
intensive care unit.
Pediatric population
No specific measures or monitoring are required.

Dosage recommendations
Posology
The dose and treatment regimen depend on the indication. The doses indicated below should be
understood as a guideline.
To prevent relapses of hepatitis B after liver transplantation due to liver failure
induced by hepatitis B.

Adults:

• 10,000 IU on the day of transplantation, peri-operatively; followed by 2,000-10,000 IU/day for 7 days, and as needed to maintain antibody levels above 100-150 IU/l in patients negative for HBV- DNA and above 500 IU/l in patients positive for HBV-DNA.

Paediatric population:
The dosage must be adjusted according to body surface area, based on 10,000 IU/1.73
m².
Hepatitis B immunoprophylaxis

• 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 newborns born to mothers carrying the hepatitis B virus, at birth or as soon as possible after birth: 30-100 IU/kg. In clinical practice, the intramuscular route of administration is preferred whenever repeated administrations are necessary to achieve seroconversion after vaccination. The administration of hepatitis B immunoglobulin may be repeated until seroconversion following vaccination.

In all these situations, vaccination against the hepatitis B virus is strongly recommended.
The first dose of vaccine and human anti-hepatitis B immunoglobulins can be injected on the
same day, but in different sites.
In subjects who have not shown an immune response after vaccination (anti-HBs antibodies not measurable) and for whom continuous prevention is necessary, the administration of 500 IU in adults and 8 IU/kg in children, every 2 months may be considered; it is considered that a protective antibody titer minimum is 10 mUI/ml.
The dose and dosage regimen for the use of human anti-hepatitis B immunoglobulins for intravenous use recommended in other official guidelines must also be considered.