Igantibe 200 IU/ml solution for injection
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Package leaflet: Information for the user
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, 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 only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Igantibe is and what it is used for
- Before you use Igantibe
- How to use Igantibe
- Possible side effects
- How to store Igantibe
- Further information
1. What Igantibe is and what it is used for
Each Igantibe package contains:
- One vial with an injectable solution of human anti-hepatitis B immunoglobulin, which contains antibodies against the hepatitis B virus.
This medicine belongs to the pharmacotherapeutic group known as immune sera and immunoglobulins.
The administration of Igantibe is indicated for:
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Hepatitis B immunoprophylaxis
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In case of accidental exposure in non-immunized individuals (including those with incomplete or unknown vaccination status).
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In patients undergoing hemodialysis, until vaccination becomes effective.
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In newborns of mothers who are carriers of the hepatitis B virus.
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In individuals who have not developed an immune response (non-detectable anti-hepatitis B antibodies) after vaccination and who require ongoing prevention due to continued risk of hepatitis B infection.
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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 HBV-DNA negative patients, in combination with nucleoside analogue therapy.
2. Before using 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
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Ensure that Igantibe is not administered into a blood vessel, due to the possibility of shock.
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Intramuscular administration of this medicine may cause pain and other discomfort at the injection site.
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If you are a carrier of HBsAg, you will not obtain any benefit from administering this product.
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True hypersensitivity reactions are uncommon.
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Igantibe contains a small amount of IgA. If you have IgA deficiency, you may develop anti-IgA antibodies and experience allergic reactions following administration of blood-derived products containing IgA. Your doctor should weigh the benefits of treatment with Igantibe against the potential risks of hypersensitivity reactions.
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Very rarely, human anti-hepatitis B immunoglobulin may cause a drop in blood pressure with an allergic reaction, even if you have previously tolerated treatment with human immunoglobulin.
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If you have a reaction to other antibodies, in rare cases you may be at risk of experiencing an allergic reaction.
Special safety precautions
When medicines derived from human plasma or blood are administered, 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, testing for specific markers of infection in individual donations and plasma pools, and inclusion of manufacturing steps designed to inactivate or remove viruses. Nevertheless, when human blood or plasma-derived medicines are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to emerging or unknown viruses and other types of infections.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as against the non-enveloped hepatitis A virus. However, the measures may have limited effectiveness against 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 the batch number administered, in order to maintain a record of the batches used.
Use of other medicines
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Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
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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
Inform the laboratory staff or your doctor that you have received this medicine if you undergo blood testing after receiving Igantibe. The levels of certain antibodies may be elevated.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
Inform your doctor if you are pregnant or breastfeeding. Your doctor will decide whether Igantibe can be used during pregnancy and breastfeeding.
Driving and use of machines
Igantibe has no influence on the ability to drive or operate machinery.
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 and is therefore 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 dose you should receive.
Follow these instructions unless your doctor has given you different ones.
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Hepatitis B immunoprophylaxis:
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Prevention of hepatitis B following accidental exposure in non-immunized individuals:
At least 500 IU, depending 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 seroconversion after vaccination.
- Prevention of hepatitis B in newborns of mothers carrying hepatitis B virus, at birth or as soon as possible after birth:
30–100 IU/kg. Administration of anti-hepatitis B immunoglobulin should be repeated until seroconversion after vaccination.
In all these situations, vaccination against hepatitis B virus is highly recommended. The first dose of the vaccine may be administered on the same day as human anti-hepatitis B immunoglobulin, but at different injection sites.
In individuals who did not develop an immune response (non-detectable anti-hepatitis B antibodies) after vaccination and who require ongoing prevention, administration of 500 IU in adults and 8 IU/kg in children every 2 months may be considered; a minimum protective antibody titer 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 hepatitis B virus reinfection in HBV-DNA negative patients in combination with nucleoside analogue treatment:
Dose required to maintain antibody levels above 100–150 IU/L in HBV-DNA negative patients. Administration of 2000 IU of Igantibe every 2 weeks has been shown to achieve these levels in adult patients.
For this indication, there are no data available regarding administration in children.
If a large volume is required (> 2 mL in children or > 5 mL in adults), it is recommended to administer the dose in divided amounts at different anatomical sites.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine must be administered at two different anatomical sites.
If intramuscular administration is contraindicated (e.g. coagulation disorders), patients should be treated with alternative medicines.
Igantibe must not be mixed with other medicines.
If you use more Igantibe than you should
If you have been administered more Igantibe than you should have, consult your doctor or pharmacist immediately.
The consequences of overdose are unknown.
In case of overdose or accidental administration, contact 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 adverse effects
Like all medicines, Igantibe may cause adverse effects, although not everyone experiences 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 previously experienced allergic reactions (hypersensitivity) during prior administrations.
Local reactions at the injection site: swelling, pain, redness, induration, local warmth, itching, bruising, and rash.
Since the product was marketed, only one adverse reaction has been reported to the manufacturer: an episode of facial flushing, excessive eye irrigation, and nausea.
Data from a clinical study indicate the following adverse event:
- Increase in levels of a liver enzyme (alanine aminotransferase or ALT)
Reporting of 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 leaflet. You may also report them directly through the Spanish System of Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Igantibe
Keep out of the reach and sight of children.
Do not use Igantibe after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C).
Must be brought to room temperature or body temperature before use.
The colour may vary from colourless to pale yellow or light brown. The solution should be clear or slightly opalescent, and a small amount of particles may appear during storage. Medicinal products in solution should be inspected visually before administration. Do not use Igantibe if the solution appears cloudy or contains sediments.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Additional Information
Composition of Igantibe
- The active substance is human anti-hepatitis B immunoglobulin.
Igantibe has an anti-hepatitis B antibody content of 200 IU/ml. The human protein content is 80 mg in 100 IU/0.5 ml vials, 480 mg in 600 IU/3 ml vials, and 800 mg in 1000 IU/5 ml vials, of which at least 95% is human immunoglobulin G.
- The other components are glycine, sodium chloride, and water for injections.
(See section 2. “Before using Igantibe” for more information on the components).
Nature of the product and contents of the container
Igantibe is an injectable solution. The solution is clear and ranges in color from pale yellow to light brown. A slight opalescence or a small amount of particles may appear during storage.
Presentations:
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 summary has been approved in
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/