IGANTIBE 200 IU/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Igantibe 200 IU/ml solution for injection

Human hepatitis B immunoglobulin

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Igantibe and what is it used for
2. Before you use Igantibe
3. How to use Igantibe
4. Possible side effects
5. Storing Igantibe
6. Further information

1. What is Igantibe and what is it used for

Each vial of Igantibe contains:

• A vial with a solution for injection of human hepatitis B immunoglobulin containing antibodies against the hepatitis B virus.

This medicine belongs to a group of medicines called immune sera and immunoglobulins.

The administration of Igantibe is indicated in:

• Hepatitis B immunoprophylaxis

• In case of accidental exposure in non-immunized subjects (including individuals whose vaccination is incomplete or unknown).

• In patients undergoing hemodialysis, until vaccination becomes effective.

• In newborns of mothers carrying the hepatitis B virus.

• In subjects who did not present an immune response (unmeasurable anti-hepatitis B antibodies) after vaccination and who require continuous prevention due to the ongoing risk of being infected with hepatitis B.

• Prevention, during the maintenance phase after one year of liver transplantation due to liver failure caused by hepatitis B, of reinfection with hepatitis B virus in patients who are HBV-DNA negative, along with nucleoside analog treatment.

2. Before you use Igantibe

Do not use Igantibe

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

Take special care with Igantibe

• Make sure Igantibe is not administered into a blood vessel, due to the possibility of shock.

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

• If you are a carrier of HBsAg, there is no benefit in administering this product.

• True hypersensitivity reactions are rare.

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

• Rarely, human hepatitis B immunoglobulin may cause a drop in blood pressure with an allergic reaction, even if you have previously tolerated treatment with human immunoglobulin.

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

Special precautions for safety

When administering medicines derived from human plasma or blood, certain measures must be taken to prevent infections from being transmitted to patients. These measures include careful selection of donors to exclude those at risk of carrying infectious diseases, analysis of specific infection markers in individual donations and plasma pools, as well as inclusion of stages in the manufacturing process to eliminate/inactivate viruses. Despite this, when administering medicines derived from human blood or plasma, the possibility of transmitting infectious agents cannot be entirely excluded. 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 the 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 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 medicine and batch number administered in order to maintain a record of the batches used.

Using other medicines

• Tell your doctor or pharmacist if you are using or have recently used any other medicines, 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.

Effects on blood tests

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines

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

Important information about some of the components of Igantibe

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

3. How to use Igantibe

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

Your doctor will determine the appropriate amount to be administered.

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

• Hepatitis B immunoprophylaxis:

• Prevention of hepatitis B in case of accidental exposure in non-immunized subjects:

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

• Hepatitis B immunoprophylaxis in patients undergoing hemodialysis:

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

• Prevention of hepatitis B in newborns of mothers carrying the hepatitis B virus, at birth or as soon as possible after birth:

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 (unmeasurable 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 mIU/ml.

• Prevention, during the maintenance phase after one year of liver transplantation due to liver failure caused by hepatitis B, of reinfection with hepatitis B virus in patients who are HBV-DNA negative, along with nucleoside analog treatment:

As necessary to maintain antibody levels above 100 - 150 IU/l in HBV-DNA negative patients. The administration of 2000 IU of Igantibe every 2 weeks has been shown to achieve these levels in adult patients.

There are no data on the administration of this indication in children.

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

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

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

Igantibe should not be mixed with other medicines.

If you use more Igantibe than you should

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

The consequences of an overdose are not known.

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

If you forget to use Igantibe

Consult your doctor or pharmacist immediately and follow their instructions.

4. Possible side effects

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

Tell your doctor if you experience any of the following side effects during or after the injection:

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

Rare side effects:

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

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

Since the marketing of the product, only one adverse reaction has been reported to the manufacturer, which was an episode of flushing of the face, excessive irrigation of the eyes, and nausea.

Data from a clinical study indicate the following adverse event:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Igantibe

Keep out of the reach and sight of children.

Do not use Igantibe after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

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

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

The color may vary from colorless to pale yellow to light brown. The solution should be clear or slightly opalescent, and during storage, a small amount of particles may appear. Products in solution should be visually inspected before administration. Do not use Igantibe if you observe that the solution is turbid or contains sediment.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Further information

Composition of Igantibe

• The active substance is human hepatitis B immunoglobulin.

Igantibe has a content of anti-hepatitis B antibodies of 200 IU/ml. The content of human proteins is 80 mg in vials of 100 IU/0.5 ml, 480 mg in vials of 600 IU/3 ml, and 800 mg in vials of 1000 IU/5 ml, of which at least 95% is human immunoglobulin G.

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

(See section 2. "Before you use Igantibe" for more information on components).

Appearance and packaging of the product

Igantibe is a solution for injection. The solution is clear and has a pale yellow to light brown color. During storage, it may become slightly opalescent or contain a small amount of particles.

Presentation:

Igantibe 200 IU/ml

Vials of 100 IU in 0.5 ml solution

Vials of 600 IU in 3 ml solution

Vials of 1000 IU in 5 ml solution

Marketing authorization holder and manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This leaflet was approved in

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/