PROSPECTO: INFORMATION FOR THE USER

Gamma Anti-Tétanos Grifols 250 UI injectable solution in pre-filled syringe

Human tetanus antitoxin

Read this prospectus carefully before starting to use the medication.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication 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 consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

It is presented as an injectable solution in a pre-filled syringe. Each package of Gamma Anti-Tétanos Grifols contains a pre-filled syringe with human antitetanus immunoglobulin that are antibodies against tetanus toxin.

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

The administration of Gamma Anti-Tétanos Grifols is indicated for:

1. Post-exposure prevention:

Immediate prevention after wounds susceptible to being contaminated with tetanus if you have not been adequately vaccinated, if your immunization status is not known with certainty, and if you have severe deficiency of antibody production.

1. Treatment of clinically manifested tetanus.

Active tetanus vaccination should always be administered together with antitetanus immunoglobulin unless there are contraindications or confirmation of adequate vaccination.

No use Gamma Anti-Tétanos Grifols

• If you are allergic (hypersensitive) to human immunoglobulins or to any of the other components of Gamma Anti-Tétanos Grifols.

Tenga especial cuidado con Gamma Anti-Tétanos Grifols

• Ensure that Gamma Anti-Tétanos Grifols is not administered through a blood vessel, due to the possibility of shock.

• Allergic reactions may occur, although infrequently.

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

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

• You must be observed for at least 20 minutes after administration of the product.

Precautions especiales de seguridad

When administering medications derived from human plasma or blood, certain measures must be taken to prevent the transmission of infections to patients. Such measures include a careful selection of donors to exclude those at risk of being carriers of infectious diseases, analysis of specific markers of infections in individual donations and plasma mixtures, as well as inclusion of stages in the manufacturing process to eliminate/inactivate viruses. Despite this, when administering medications derived from human blood or plasma, 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 contained in the product are protective.

It is highly recommended that each time healthcare personnel administer a dose of Gamma Anti-Tétanos Grifols, 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: Gamma Anti-Tétanos Grifols 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. In the case of measles, you may need to wait 5 months before receiving the vaccine.

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 Gamma Anti-Tétanos Grifols. 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 Gamma Anti-Tétanos Grifols can be used during pregnancy and breastfeeding.

Conducción y uso de máquinas

The influence of Gamma Anti-Tétanos Grifols on the ability to drive and use machines is nil.

Información importante sobre algunos de los componentes de Gamma Anti-Tétanos Grifols

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

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

The wound must be cleaned before administering the intramuscular injection of Gamma Anti-Tétanos Grifols. In some cases, active immunization with tetanus vaccine should be initiated simultaneously, administering this in a different area of the body from the immunoglobulin, in accordance with the following instructions:

• Minor and clean wounds

If you have completed your tetanus vaccination cycle or received your last booster dose within the last 10 years, it is not recommended to revaccinate or use Gamma Anti-Tétanos Grifols.

If you have not completed your tetanus vaccination cycle, or you are unsure of your immunization status, or more than 10 years have passed since your last booster, a dose of vaccine is recommended. It is not necessary to administer Gamma Anti-Tétanos Grifols.

• Major or dirty wounds

If you have completed your tetanus vaccination cycle and received your last booster dose within the last 5 years, it is not necessary to revaccinate; but if more than 5 years have passed since your last booster, a dose of vaccine is necessary. In both cases, it is not necessary to administer Gamma Anti-Tétanos Grifols.

If you have not completed your tetanus vaccination cycle, or if you are unsure of your immunization status, in addition to the dose of vaccine, Gamma Anti-Tétanos Grifols will be administered.

The doctor will determine if a minor wound is susceptible to contamination.

Children and adults should receive the same dose.

• Prevention in case of wounds susceptible to tetanus contamination:

• 250 UI unless the risk is considered extremely high.

• The dose may be increased to 500 UI in:

• Treatment of clinically manifested tetanus:

Single doses of 3000 to 6000 UI administered intramuscularly in combination with other appropriate clinical therapies.

Gamma Anti-Tétanos Grifols should be administered intramuscularly.

If you need a high volume (> 2 ml in children or > 5 ml in adults), it is recommended to administer it in fractional doses and in different regions of the body.

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

For prevention in case of wounds susceptible to tetanus contamination, if intramuscular administration is contraindicated (coagulation disorders), the injection may be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support subcutaneous administration.

For acute treatment of clinically manifested tetanus, if intramuscular administration is not clinically appropriate, an alternative intravenous product may be used if available.

Gamma Anti-Tétanos Grifols should not be mixed with other medications.

If you use more Gamma Anti-Tétanos Grifols than you should

If you have been administered more Gamma Anti-Tétanos Grifols than you should, consult your doctor or pharmacist immediately.

The consequences of an overdose are unknown.

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

If you forgot to use Gamma Anti-Tétanos Grifols

Consult your doctor or pharmacist immediately and follow their instructions.

Like all medications, Gamma Anti-Tétanos Grifols may produce adverse effects, although not all people will experience them.

• Local pain and increased sensitivity at the injection site may be observed.

• Fever, skin eruptions, and chills may occasionally appear.

• In rare instances: nausea, vomiting, low blood pressure, tachycardia, and allergic or anaphylactic reactions, including shock.

No consistent data on the frequency of adverse reactions are available from clinical studies or post-marketing experience.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Gamma Anti-Tetanus Grifols after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in a 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 Gamma Anti-Tetanus Grifols if you observe that the solution is turbid or presents sediments.

The disposal of unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations. Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition of Gamma Anti-Tétanos Grifols

• The active principle is:

Human antitetanus immunoglobulin 250 UI

(Human proteins 160 mg)

(Immunoglobulin human proportion ≥ 95% IgG)

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

(See section 2. “Before using Gamma Anti-Tétanos Grifols” for more information on components).

Aspect of the product and content of the package

Gamma Anti-Tétanos Grifols is an injectable solution in a pre-filled syringe. The solution is clear and pale yellow to light brown in color. During its conservation, a slight opalescence or a small amount of particles may appear.

Other presentations:

Gamma Anti-Tétanos Grifols 500 UI injectable solution in a pre-filled syringe

Holder of the marketing authorization and responsible for manufacturing

Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This prospectus was approved in FEBRUARY 2011

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices.