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GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe

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About the medicine

How to use GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gamma Anti-Tetanus Grifols 500 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 medicine 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 may 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. Treatment of clinically manifested tetanus.

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

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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 should weigh the benefit 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 different 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, revaccination and use of Gamma Anti-Tetanus Grifols are not recommended.

If you have not completed your tetanus vaccination cycle, or your immunization status is unknown, or 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, revaccination is not necessary; 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 your immunization status is unknown, in addition to the vaccine dose, Gamma Anti-Tetanus Grifols will be administered.

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

Children and adults should receive the same dose.

  • Prevention in case of wounds susceptible to being 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 large 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 susceptible to being 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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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 expiration date stated on the packaging after EXP. The expiration 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 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 will 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 the packaging and medicines you no longer need. This will help protect the environment.

6. Further information

Composition of Gamma Anti-Tetanus Grifols

  • The active substance is:

Human anti-tetanus immunoglobulin 500 UI

(Human proteins 320 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 packaging content

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 250 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.

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
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  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
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  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
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  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
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Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
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During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Марта Регеро Капілья

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

  • allergic rhinitis, seasonal allergies, and perennial allergy symptoms;
  • allergic conditions in adults and children;
  • bronchial asthma and allergy-related respiratory symptoms;
  • urticaria (acute and chronic) and angioedema;
  • food allergies and reactions to foods, additives, or medications;
  • atopic dermatitis, allergic rashes, and persistent itching;
  • unexplained or recurrent allergic reactions;
  • interpretation of laboratory tests, allergy testing, and immunology results;
  • immune system concerns, frequent infections, and reduced immune response;
  • ongoing medical follow-up and treatment adjustment.
Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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Frequently Asked Questions

Is a prescription required for GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe?
GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe?
The active ingredient in GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe is tetanus immunoglobulin. This information helps identify medicines with the same composition but different brand names.
How much does GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe cost in pharmacies?
The average pharmacy price for GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe is around 32.78 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe?
GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe is manufactured by Instituto Grifols S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to GAMMA ANTI-TETANUS GRIFOLS 500 I.U. Injectable Solution in Pre-filled Syringe?
Other medicines with the same active substance (tetanus immunoglobulin) include GAMMA ANTI-TETANUS GRIFOLS 250 I.U. PRE-FILLED SYRINGE SOLUTION FOR INJECTION, HEPATECT 50 IU/ml SOLUTION FOR INFUSION, HYPERRAB 300 IU/mL INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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