Gamma Anti-Tetanus Grifols 500 IU solution for injection in pre-filled syringe
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Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gamma Anti-Tétanos Grifols 500 IU solution for injection in a pre-filled syringe
Human tetanus immunoglobulin
Read the entire 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Gamma Anti-Tétanos Grifols is and what it is used for
- Before you use Gamma Anti-Tétanos Grifols
- How to use Gamma Anti-Tétanos Grifols
- Possible side effects
- How to store Gamma Anti-Tétanos Grifols
- Further information
1. What Gamma Anti-tetanus Grifols is and what it is used for
It is presented as an injectable solution in a pre-filled syringe. Each package of Gamma Anti-Tetanus Grifols contains a pre-filled syringe with human antitetanus immunoglobulin, which are antibodies against tetanus toxin.
This medicine belongs to the pharmacotherapeutic group called immune sera and immunoglobulins.
The administration of Gamma Anti-Tetanus Grifols is indicated for:
- Post-exposure prophylaxis:
Immediate prevention after wounds that may be contaminated with tetanus, if you have not been adequately vaccinated, if your immunization status is uncertain, or if you have severe deficiency in antibody production.
- Treatment of clinically manifested tetanus.
Active tetanus vaccination should always be administered concomitantly with antitetanus immunoglobulin, unless contraindicated or adequate vaccination is confirmed.
2. Before using Gamma Anti-Tetanus Grifols
Do not use Gamma Anti-Tetanus Grifols
- if you are allergic (hypersensitive) to human immunoglobulins or to any of the other components of Gamma Anti-Tetanus Grifols.
Take special care with Gamma Anti-Tetanus Grifols
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Ensure that Gamma Anti-Tetanus Grifols is not administered into a blood vessel, due to the risk of shock.
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Allergic reactions may occur, although infrequently.
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Gamma Anti-Tetanus Grifols contains a small amount of IgA. If you have IgA deficiency, you may develop antibodies against IgA and experience allergic reactions following administration of blood-derived products (hemoderivatives) containing IgA. Your doctor should weigh the benefits of treatment with Gamma Anti-Tetanus Grifols against the potential risks of hypersensitivity reactions.
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Human antitetanus immunoglobulin may, rarely, cause a drop in blood pressure accompanied by an allergic reaction, even if you have previously tolerated treatment with human immunoglobulin.
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You should remain under observation for at least 20 minutes after administration of the product.
Special safety precautions
When medicines derived from human plasma or blood are administered, certain measures must be taken to prevent transmission of infections to patients. These measures include careful selection of donors to exclude those at risk of carrying infectious diseases, testing of individual donations and pooled plasma for specific markers of infection, and inclusion of steps in the manufacturing process to inactivate or remove viruses. Nevertheless, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to emerging viruses or agents of unknown origin, 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, and also 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 a healthcare professional administers a dose of Gamma Anti-Tetanus Grifols, they record the name of the medicine and the batch number administered, in order to maintain traceability of the batches used.
Use of other medicines
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Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
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Effects on vaccines: Gamma Anti-Tetanus Grifols may reduce the effectiveness of certain types of vaccines, such as those against measles, rubella, mumps, and varicella. You may need to wait up to 3 months before receiving these vaccines. In the case of measles, you may need to wait up to 5 months before receiving the vaccine.
Effects on blood tests
Inform the laboratory staff or your doctor that you have received this medicine if you undergo blood testing after receiving Gamma Anti-Tetanus Grifols. 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 Gamma Anti-Tetanus Grifols can be used during pregnancy and breastfeeding.
Driving and using machines
Gamma Anti-Tetanus Grifols has no influence on the ability to drive or operate machinery.
Important information about some of the components of Gamma Anti-Tetanus Grifols
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 Gamma Anti-Tetanus Grifols
Follow these instructions unless your doctor has given you different ones.
The wound should be cleaned before you receive the intramuscular injection of Gamma Anti-Tetanus Grifols. In some cases, active immunization with tetanus vaccine should be initiated simultaneously, administered in a different body area than the immunoglobulin, according to the following instructions:
- Minor and clean wounds
If you have completed your tetanus vaccination series or received your last booster dose within the past 10 years, revaccination is not recommended, nor is the use of Gamma Anti-Tetanus Grifols.
If you have not completed your tetanus vaccination series, if your immunization status is unknown, or if more than 10 years have passed since your last booster, a vaccine dose is recommended. Administration of Gamma Anti-Tetanus Grifols is not necessary.
- Major or dirty wounds
If you have completed your tetanus vaccination series and also received your last booster dose within the past 5 years, revaccination is not necessary; however, if more than 5 years have passed since your last booster, a vaccine dose should be administered. In both cases, administration of Gamma Anti-Tetanus Grifols is not necessary.
If you have not completed your tetanus vaccination series or if your immunization status is unknown, in addition to the vaccine dose, Gamma Anti-Tetanus Grifols should be administered.
The physician will determine whether a minor wound is potentially contaminated.
Children and adults should receive the same dose.
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Prophylaxis in wounds susceptible to tetanus contamination:
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250 IU unless the risk is considered extremely high.
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the dose may be increased to 500 IU in:
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infected wounds when appropriate surgical treatment cannot be performed within the next 24 hours.
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penetrating or contaminated wounds with tissue destruction and lack of oxygen, as well as wounds caused by foreign bodies (e.g., bites, stings, or gunshot wounds).
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Treatment of clinically manifest tetanus:
Single doses of 3000 to 6000 IU by intramuscular route, in combination with other appropriate clinical therapies.
Gamma Anti-Tetanus Grifols must be administered by intramuscular route.
If a large volume is required (> 2 ml in children or > 5 ml in adults), administration in divided doses at different body sites is recommended.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine must be administered in different body regions.
For prophylaxis in wounds susceptible to tetanus contamination, if intramuscular administration is contraindicated (coagulation disorders), the injection may be given subcutaneously. However, it should be noted that there are no clinical efficacy data supporting subcutaneous administration.
For acute treatment of clinically manifest tetanus, if intramuscular administration is clinically inappropriate, an alternative intravenous product may be used if available.
Gamma Anti-Tetanus Grifols must not be mixed with other medicines.
If you use more Gamma Anti-Tetanus Grifols than you should
If you have been given more Gamma Anti-Tetanus Grifols than you should have, consult your doctor or pharmacist immediately.
The consequences of an overdose are not known.
In case of overdose or accidental administration, contact the Toxicology Information Service. Telephone: 91 562 04 20.
If you forget to use Gamma Anti-Tetanus Grifols
Consult your doctor or pharmacist immediately and follow their instructions.
4. Possible adverse effects
Like all medicines, Gamma Anti-Tétanos Grifols can produce adverse effects, although not everyone experiences them.
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Local pain and increased sensitivity at the injection site may occur.
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Occasionally, fever, skin rashes, and chills may appear.
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Rarely: nausea, vomiting, low blood pressure, tachycardia, and allergic or anaphylactic reactions, including shock.
There are no consistent data on the frequency of adverse reactions from clinical studies or post-marketing experience.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
5. Storage of Gamma Anti-Tetanus Grifols
Keep out of the reach and sight of children.
Do not use Gamma Anti-Tetanus Grifols after the expiry date stated on the container following 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. Products in solution should be visually inspected before administration. Do not use Gamma Anti-Tetanus Grifols if the solution appears cloudy or contains sediments.
Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Additional information
Composition of Gamma Anti-Tétanos Grifols
- The active substance is:
Human tetanus immunoglobulin 500 UI
(Human proteins 320 mg)
(Ratio of human immunoglobulin ≥ 95% IgG)
- The other components are glycine, sodium chloride, and water for injections.
(See section 2. “Before using Gamma Anti-Tétanos Grifols” for more information about the components).
Appearance of the product and contents of the container
Gamma Anti-Tétanos Grifols is an injectable solution in a pre-filled syringe. The solution is clear and ranges from pale yellow to light brown. During storage, slight opalescence or a small amount of particles may appear.
Other presentations:
Gamma Anti-Tétanos Grifols 250 UI solution for injection in pre-filled syringe
Marketing Authorization Holder and Manufacturer
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN
This summary has been approved in February 2011
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products.