PATIENT INFORMATION LEAFLET

Igantibe 200 IU/ml injectable solution

Human anti-hepatitis B immunoglobulin

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Each package of Igantibe contains:

• A vial with injectable solution of human anti-hepatitis B immunoglobulin that contains antibodies against the hepatitis B virus.

This medication belongs to the pharmacotherapeutic group called immune sera and immunoglobulins.

The administration of Igantibe is indicated for:

• Immunoprophylaxis of hepatitis B

• Prevention, during the maintenance phase after one year of liver transplantation due to hepatitis B failure, of re-infection by hepatitis B virus in patients DNA-VHB negative, along with analog nucleoside treatment.

No use Igantibe

• If you are allergic (hypersensitive) to human immunoglobulins or any of the other components of Igantibe.

Tenga especial cuidado con Igantibe

• Ensure that Igantibe is not administered in a blood vessel, due to the possibility of shock.

• The intramuscular administration of this medication may cause pain and other discomforts at the injection site.

• If you are a carrier of AgHBs, no benefit is obtained by administering this product.

• True hypersensitivity reactions are infrequent.

• Igantibe contains a small amount of IgA. If you have IgA deficiency, you may develop anti-IgA antibodies and suffer allergic reactions after administration of blood-derived products containing IgA. Your doctor must weigh the benefits of treatment with Igantibe against the potential risks of hypersensitivity reactions.

• Infrequently, human anti-hepatitis B immunoglobulin may induce a drop in blood pressure with allergic reaction, even if you have previously tolerated treatment with human immunoglobulin.

• If you have an allergic reaction to other antibodies, in rare cases you may be at risk of an allergic reaction.

Precauciones especiales de seguridad

When administering human plasma or blood-derived medications, certain measures must be taken to prevent the transmission of infections to patients. These measures include a careful selection of donors to exclude those at risk of being carriers of infectious diseases, analysis of specific infection markers in individual donations and plasma mixtures, and inclusion of stages in the manufacturing process to eliminate/inactivate viruses. Despite this, when administering human blood or plasma-derived medications, the possibility of transmission of infectious agents cannot be entirely ruled out. This also applies to emerging or unknown viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and for non-enveloped hepatitis A virus. The measures taken may have limited value for non-enveloped viruses such as parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections, which are contained in the product, are protective.

It is highly recommended that each time healthcare personnel administer a dose of Igantibe, they record the name of the medication and batch number administered in order to maintain a record of the batches used.

Uso de otros medicamentos

• Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

• Effects on vaccines: Igantibe may reduce the effectiveness of certain types of vaccines such as measles, rubella, mumps, and varicella. You may need to wait 3 months before receiving these vaccines.

Efectos sobre los análisis de sangre

Inform the analyst or your doctor that you have received this medication, if a blood test is performed after receiving Igantibe. The level of some antibodies may increase.

Embarazo y lactancia

Consult your doctor or pharmacist before using any medication.

Inform your doctor if you are pregnant or breastfeeding. Your doctor will decide if Igantibe can be used during pregnancy and breastfeeding.

Conducción y uso de máquinas

The influence of Igantibe on the ability to drive and use machines is negligible.

Información importante sobre algunos de los componentes de Igantibe

Special warnings about components: This medication contains less than 23 mg (1 mmol) of sodium per dose, making it essentially "sodium-free".

This medication is intended for intramuscular administration and will be administered by a doctor or nursing staff.

The doctor will determine the adequate amount that should be received.

Follow these instructions unless your doctor has given you different instructions.

• Immunoprophylaxis of hepatitis B:

At least 500 IU, depending on the intensity of the exposure, as soon as possible after exposure, and preferably between 24 - 72 hours.

8 - 12 IU/kg with a maximum of 500 IU, every 2 months until seroconversion after vaccination.

30 - 100 IU/kg. The administration of hepatitis B immunoglobulin should be repeated until seroconversion after vaccination.

In all these situations, vaccination against the hepatitis B virus is highly recommended. The first dose of the vaccine can be administered on the same day as the human hepatitis B immunoglobulin, although in different sites.

In subjects who did not present an immune response (measurable anti-hepatitis B antibodies) after vaccination and who require continuous prevention, the administration of 500 IU in adults and 8 IU/kg in children every 2 months may be considered; the minimum protective antibody titre is considered to be 10 mUI/ml.

• Prevention, during the maintenance phase after one year of liver transplant due to hepatitis B failure, of re-infection by hepatitis B virus in patients ADN-VHB negative together with nucleoside analog treatment:

The necessary amount to maintain antibody levels above 100 - 150 IU/l in ADN-VHB negative patients. Administration of 2000 IU of Igantibe every 2 weeks has been shown to achieve those levels in adult patients.

No data are available for the administration in children for this indication.

If a high volume is required (> 2 ml in children or > 5 ml in adults), it is recommended to administer it in divided doses and in different anatomical regions.

When simultaneous vaccination is necessary, the immunoglobulin and vaccine should be administered in different anatomical regions.

If intramuscular administration is contraindicated (coagulation disorders), patients should be treated with other medications.

Igantibe should not be mixed with other medications.

If you use more Igantibe than you should

If you have been administered more Igantibe than you should, consult your doctor or pharmacist immediately.

No information is available on the consequences of an overdose.

In case of overdose or accidental administration, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to use Igantibe

Consult your doctor or pharmacist immediately and follow their instructions.

Like all medications, Igantibe may produce adverse effects, although not everyone will experience them.

Inform your doctor if you experience any of the following adverse reactions during or after the injection:

• Chills
• Fever
• Headache
• Nausea
• Vomiting
• Allergic reaction
• Joint pain
• Moderate back pain

Rare adverse effects:

• Sudden drop in blood pressure and, in isolated cases, anaphylactic shock, even if you have not experienced allergic reactions (hypersensitivity) in previous administrations.

Local reactions at the injection site: swelling, pain, redness, induration, local heat, itching, hematoma, and rash.

Since the product's commercialization, only one adverse reaction has been reported to the manufacturer, which was an episode of facial flushing, excessive eye irrigation, and nausea.

Data from a clinical study indicate the following adverse event:

• Increased levels of a liver enzyme (alanine aminotransferase or ALT)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Igantibe after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C).

It must be brought to room temperature or body temperature before use.

The color may vary from colorless to pale yellow to light brown. The solution must be clear or slightly opalescent and during storage, a small amount of particles may appear. Products in solution must be subject to visual inspection before administration. Do not use Igantibe if you observe that the solution is cloudy or has sediments.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines that you do not need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Igantibe

• The active principle is human anti-hepatitis B immunoglobulin.

Igantibe has an anti-hepatitis B antibody content of 200 UI/ml. The human protein content is 80 mg in 100 UI/0.5 ml ampoules, 480 mg in 600 UI/3 ml ampoules, and 800 mg in 1000 UI/5 ml ampoules, of which at least 95% is human immunoglobulin G.

• The other components are glycine, sodium chloride, and water for injectable preparations.

(See section 2. “Before using Igantibe” for more information on components).

Appearance of the product and contents of the package

Igantibe is an injectable solution. The solution is clear and pale yellow to light brown in color. During its storage, a slight opalescence or a small amount of particles may appear.

Presentations:

Igantibe 200 UI/ml

Ampoules of 100 UI in 0.5 ml solution

Ampoules of 600 UI in 3 ml solution

Ampoules of 1000 UI in 5 ml solution

Marketing authorization holder and manufacturer responsible

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This leaflet has been approved in

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/