GAMMA ANTI-TETANUS GRIFOLS 250 I.U. PRE-FILLED SYRINGE SOLUTION FOR INJECTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gamma Anti-Tetanus Grifols 250 UI solution for injection in pre-filled syringe

Human anti-tetanus 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Gamma Anti-Tetanus Grifols is and what it is used for
2. Before you use Gamma Anti-Tetanus Grifols
3. How to use Gamma Anti-Tetanus Grifols
4. Possible side effects
5. Storage of Gamma Anti-Tetanus Grifols
6. Further information

1. What Gamma Anti-Tetanus Grifols is and what it is used for

It is presented as a solution for injection in a pre-filled syringe. Each pack of Gamma Anti-Tetanus Grifols contains a pre-filled syringe with human anti-tetanus immunoglobulin which are antibodies against tetanus toxin.

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

Administration of Gamma Anti-Tetanus Grifols is indicated in:

1. Post-exposure prophylaxis:

Immediate prevention after wounds that are likely to be contaminated with tetanus if you have not been adequately vaccinated, if your immunization status is not known with certainty, and if you have a severe deficiency in antibody production.

1. Clinical treatment of tetanus.

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

2. Before you use 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

• Make sure that Gamma Anti-Tetanus Grifols is not administered into a blood vessel, due to the possibility of shock.

• Allergic reactions may occur, although rarely.

• Gamma Anti-Tetanus Grifols 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 must weigh the benefits of treatment with Gamma Anti-Tetanus Grifols against the potential risks of hypersensitivity reactions.

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

• You should be under observation for at least 20 minutes after administration of the product.

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 being carriers of 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 Gamma Anti-Tetanus Grifols, they record the name of the medicine and batch number administered in order to maintain a record of the batches used.

Use of other medicines

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

• Effects on vaccines: Gamma Anti-Tetanus 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.

Effects on blood tests

Tell the analyst or your doctor that you have received this medicine if a blood test is performed after receiving Gamma Anti-Tetanus Grifols. 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 Gamma Anti-Tetanus Grifols can be used during pregnancy and breastfeeding.

Driving and using machines

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

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, so it is considered essentially "sodium-free".

3. How to use Gamma Anti-Tetanus Grifols

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

The wound should be cleaned before you are administered the intramuscular injection of Gamma Anti-Tetanus Grifols. In some cases, active immunization with tetanus vaccine should be started simultaneously, administering it in a different area of the body than the immunoglobulin, according to the following instructions:

• Minor and clean wounds

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

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

• Major or dirty wounds

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

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

The doctor will determine if a minor wound is likely to be contaminated.

Children and adults should receive the same dose.

• Prevention in case of wounds likely to be contaminated with tetanus:

• 250 UI unless the risk is considered extremely high.

• The dose may be increased to 500 UI in:

• infected wounds, when adequate surgical treatment cannot be performed within the next 24 hours.

• 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).

• Treatment of clinically manifested tetanus:

Single doses of 3000 to 6000 UI by intramuscular route in combination with other appropriate clinical therapies.

Gamma Anti-Tetanus Grifols should be administered by intramuscular route.

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

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

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

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

Gamma Anti-Tetanus Grifols should not be mixed with other medicines.

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

If you have been administered more Gamma Anti-Tetanus Grifols 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 Gamma Anti-Tetanus Grifols

Consult your doctor or pharmacist immediately and follow their instructions.

4. Possible side effects

Like all medicines, Gamma Anti-Tetanus Grifols can cause side effects, although not everybody gets them.

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

• Fever, skin rash, and chills may occur occasionally.

• 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 trials or post-marketing experience.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 which is stated on the carton after EXP. The expiry date is the last day of the month stated.

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 inspected visually before administration. Do not use Gamma Anti-Tetanus Grifols if you observe that the solution is turbid or has sediment.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Gamma Anti-Tetanus Grifols

• The active substance is:

Human anti-tetanus immunoglobulin 250 UI

(Human proteins 160 mg)

(Proportion of human immunoglobulin ≥ 95% IgG)

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

(See section 2. "Before you use Gamma Anti-Tetanus Grifols" for more information on components).

Appearance of the product and pack contents

Gamma Anti-Tetanus Grifols is a solution for injection in a pre-filled syringe. The solution is clear and pale yellow to light brown in color. During storage, a slight opalescence or a small amount of particles may appear.

Other presentations:

Gamma Anti-Tetanus Grifols 500 UI solution for injection in pre-filled syringe

Marketing authorization holder and manufacturer

Grifols Institute, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

This leaflet was approved in FEBRUARY 2011

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products.