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FLUAD TETRA Injectable Suspension in Pre-filled Syringe

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About the medicine

How to use FLUAD TETRA Injectable Suspension 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

Fluad Tetra, Prefilled Syringe Suspension for Injection

Influenza Vaccine (Surface Antigen, Inactivated, with Adjuvant)

This medicine is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Fluad Tetra and what is it used for
  2. What you need to know before you are given Fluad Tetra
  3. How Fluad Tetra is given
  4. Possible side effects
  5. Storage of Fluad Tetra
  6. Contents of the pack and other information

1. What is Fluad Tetra and what is it used for

Fluad Tetra is a vaccine against influenza.

When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection against the influenza virus. None of the components of the vaccine can cause influenza.

Fluad Tetra is used to prevent influenza in people aged 50 years and older.

The vaccine is directed against four strains of the influenza virus, following the recommendations of the World Health Organization for the 2024/2025 season.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you are given Fluad Tetra

You should not be given Fluad Tetra

  • if you are allergic to:
  • the active substances or any of the other ingredients of this medicine (listed in section 6).
  • egg or chicken proteins (such as ovalbumin), kanamycin, and neomycin sulfate, formaldehyde, cetyltrimethylammonium bromide (CTAB), and hydrocortisone, which are residues of the manufacturing process that may be present in minimal amounts.
  • If you have had a severe allergic reaction (e.g., anaphylaxis) to a previous influenza vaccine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given Fluad Tetra.

BEFOREvaccination

  • your doctor or nurse will check that medical treatment and adequate supervision are readily available in the rare event of an anaphylactic reaction (a severe allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) after administration. This reaction can occur with Fluad Tetra, as with all injectable vaccines.
  • you should tell your doctor if you have a disease with fever. Your doctor may decide to delay your vaccination until the fever has disappeared.
  • you should tell your doctor if your immune system is compromised or if you are receiving treatment that affects it, for example, cancer medication (chemotherapy) or corticosteroids (see section "Other medicines and Fluad Tetra").
  • you should tell your doctor if you have a bleeding problem or if you bruise easily.
  • you may faint after injection with a needle, or even before, so tell your doctor or nurse if you have fainted with any injection before.

As with all vaccines, Fluad Tetra may not fully protect all people who are vaccinated.

Children

Fluad Tetra is not recommended for use in children.

Other medicines and Fluad Tetra

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines, including those obtained without a prescription, or if you have received any other vaccine recently.

Pregnancy and breastfeeding

This vaccine is intended for adults aged 50 years and older. It should not be used in women who are or may be pregnant, or during breastfeeding.

Driving and using machines

Fluad Tetra has no or negligible influence on the ability to drive and use machines.

Fluad Tetra contains potassium and sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

This vaccine contains potassium, less than 1 mmol (39 mg) per dose; this is essentially "potassium-free".

3. How Fluad Tetra is given

Your doctor or nurse will give you Fluad Tetra as an injection into the muscle of the upper arm (deltoid muscle).

Adults aged 50 years and older:

A dose of 0.5 ml

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, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or go to the emergency department of your nearest hospital immediately if you get any of the following serious side effects, as you may need urgent medical attention or hospitalization:

  • Difficulty breathing, dizziness, weak and rapid pulse, and skin rash, which are symptoms of an anaphylactic reaction (a severe allergic reaction)

The following side effects have been reported during clinical trials in adults aged 50 years and older.

Very common (may affect more than 1 in 10 people):

  • Pain at the injection site
  • Fatigue
  • Headache
  • Joint pain (arthralgia)1
  • Muscle pain (myalgia)1

1 Reported as frequent in elderly subjects aged 65 years and older.

Common (may affect up to 1 in 10 people):

  • Redness at the injection site (erythema)
  • Hardening of the skin at the injection site (induration)
  • Diarrhea
  • Chills
  • Nausea
  • Loss of appetite
  • Bruising at the injection site (ecchymosis)
  • Flu-like symptoms2
  • Fever (≥38 °C)3

2 Reported in elderly subjects aged 65 years and older.

3 Reported as uncommon in elderly subjects aged 65 years and older.

Uncommon (may affect up to 1 in 100 people):

  • Vomiting
  • Swelling of the lymph nodes in the neck, armpit, or groin (lymphadenopathy)

Most side effects were mild or moderate and disappeared within 3 days of onset.

In addition to the side effects mentioned, the following side effects have occasionally occurred during general use of Fluad Tetra or a similar vaccine in elderly subjects aged 65 years and older.

  • decrease in the number of a certain type of particle in the blood called platelets; a low number of these can cause bruising or bleeding (thrombocytopenia)
  • swelling, pain, and redness at the injection site (reaction similar to cellulitis at the injection site)
  • extensive swelling of the limb where the medicine was injected, lasting more than one week.
  • general weakness or lack of energy (asthenia), feeling unwell (malaise)
  • fever (pyrexia)
  • muscle weakness
  • pain in the nerve pathway (neuralgia), unusual sensation of touch, pain, heat, and cold (paresthesia), seizures (convulsions), neurological disorders that can cause stiffness of the neck, confusion, numbness, pain, and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
  • skin reactions that can spread throughout the body, such as itching of the skin (pruritus, urticaria), redness of the skin (erythema), non-specific rash, severe skin rash (erythema multiforme)
  • more pronounced swelling of the head and neck, including the face, lips, tongue, throat, or any other part of the body (angioedema)
  • swelling of the blood vessels that can cause skin rashes (vasculitis) and temporary kidney problems
  • fainting, feeling of being about to faint (syncope, presyncope)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluad Tetra

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Discard if the vaccine has been frozen.

Keep the prefilled syringe in the outer packaging to protect it from light.

Do not use this vaccine after the expiry date which is stated on the label and on the carton after EXP/CAD. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Fluad Tetra

  • The active substances are surface antigens of the influenza virus (hemagglutinin and neuraminidase), inactivated, of the following strains*:

Per 0.5 ml dose

Strain similar to A/Victoria/4897/2022

(H1N1)pdm09

(A/Victoria/4897/2022 IVR-238)

15 micrograms HA**

Strain similar to A/Thailand/8/2022 (H3N2)

(A/Thailand/8/2022, IVR-237)

15 micrograms HA**

Strain similar to B/Austria/1359417/2021

(B/Austria/1359417/2021 BVR-26)

15 micrograms HA**

Strain similar to B/Phuket/3073/2013

(B/Phuket/3073/2013 BVR-1B)

15 micrograms HA**

*propagated in embryonated chicken eggs from healthy chicken flocks and adjuvanted with MF59C.1

**hemagglutinin

This vaccine complies with the recommendation of the World Health Organization (WHO) (northern hemisphere) and with the EU recommendation for the 2024/2025 season.

  • This vaccine includes MF59C.1 as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve, or prolong the protective effects of the vaccine. MF59C.1 is an adjuvant that contains per 0.5 ml dose: squalene (9.75 mg), polysorbate 80 (1.175 mg), sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg), and citric acid (0.04 mg).
  • The other ingredients are sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, and water for injections.

Appearance of Fluad Tetra and pack contents

Fluad Tetra is a suspension for injection in a prefilled syringe. Fluad Tetra is a white, cloudy suspension. One syringe contains 0.5 ml of suspension for injection. Fluad Tetra is available in packs containing 1 or 10 prefilled syringes with or without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands

For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Seqirus Netherlands B.V.

Nederland/Netherlands

Tel: +31 (0) 20 204 6900

Lietuva

Seqirus Netherlands B.V. Nyderlandai

Tel: +31 (0) 20 204 6900

Text in foreign language showing company name Seqirus Netherlands BV and phone number +31 (0) 20 204 6900

Luxembourg/Luxemburg

Seqirus Netherlands B.V. Netherlands

Tél/Tel: +31 (0) 20 204 6900

Ceská republika

Seqirus Netherlands B.V. Nizozemsko

Tel: +31 (0) 20 204 6900

Magyarország

Seqirus Netherlands B.V. Hollandia

Tel.: +31 (0) 20 204 6900

Danmark

Seqirus Netherlands B.V. Holland

Tlf: +31 (0) 20 204 6900

Malta

Seqirus Netherlands B.V. In-Netherlands

Tel: +31 (0) 20 204 6900

Deutschland

Seqirus GmbH Marburg

Tel: 0800/3601010

Nederland

Seqirus Netherlands B.V. Amsterdam

Tel: +31 (0) 20 204 6900

Eesti

Seqirus Netherlands B.V. Holland

Tel: +31 (0) 20 204 6900

Norge

Seqirus Netherlands B.V. Nederland

Tlf: +31 (0) 20 204 6900

Ελλάδα

WIN MEDICA Α.Ε.

Τηλ: +30 210 7488821

v

Österreich

Valneva Austria GmbH, Wien

Tel: +43 1 20620 2020

España

Seqirus Spain, S.L., Barcelona

Tel: 937 817 884

Polska

Seqirus Netherlands B.V. Holandia

Tel.: +31 (0) 20 204 6900

France

Seqirus Netherlands B.V. Netherlands

Tél: +31 (0) 20 204 6900

Portugal

Seqirus Netherlands B.V. Países Baixos

Tel: +31 (0) 20 204 6900

Hrvatska

Seqirus Netherlands B.V. Nizozemska

Tel: +31 (0) 20 204 6900

România

Seqirus Netherlands B.V. Olanda

Tel: +31 (0) 20 204 6900

Ireland

Seqirus UK Limited Maidenhead

Tel: +44 1628 641 500

Slovenija

Seqirus Netherlands B.V. Nizozemska

Tel: +31 (0) 20 204 6900

Ísland

Seqirus Netherlands B.V. Holland

Sími: +31 (0) 20 204 6900

Slovenská republika

Seqirus Netherlands B.V. Holandsko

Tel: +31 (0) 20 204 6900

Italia

Seqirus S.r.l. Siena

Tel: +39 0577 096400

Suomi/Finland

Seqirus Netherlands B.V. Alankomaat

Puh/Tel: +31 (0) 20 204 6900

Κύπρος

Seqirus Netherlands B.V. Ολλανδία

Τηλ: +31 (0) 20 204 6900

Sverige

Seqirus Netherlands B.V. Nederländerna

Tel: +31 (0) 20 204 6900

Latvija

Seqirus Netherlands B.V. Niderlande

Tel: +31 (0) 20 204 6900

Date of last revision of this leaflet: 07/2024

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

------------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Medical treatment and adequate supervision should always be readily available in case of an anaphylactic episode, which can rarely occur after vaccine administration.

Shake gently before use. After shaking, the normal appearance of the vaccine is a white, cloudy suspension.

The vaccine should be inspected visually for particulate matter and/or changes in physical appearance before administration. If particulate matter and/or changes in physical appearance are observed, do not administer the vaccine.

If a prefilled syringe is supplied without a needle, remove the protective cap from the tip of the syringe and attach a suitable needle for administration. For LuerLock syringes, remove the protective cap from the tip of the syringe by unscrewing it in an anticlockwise direction. Once the protective cap is removed, attach a needle to the syringe by screwing it in a clockwise direction until it is secure. When the needle is securely attached, remove the needle protector and administer the vaccine.

Online doctors for FLUAD TETRA Injectable Suspension in Pre-filled Syringe

Discuss questions about FLUAD TETRA Injectable Suspension in Pre-filled Syringe, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55
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Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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€80

Frequently Asked Questions

Is a prescription required for FLUAD TETRA Injectable Suspension in Pre-filled Syringe?
FLUAD TETRA Injectable Suspension 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 FLUAD TETRA Injectable Suspension in Pre-filled Syringe?
The active ingredient in FLUAD TETRA Injectable Suspension in Pre-filled Syringe is influenza, inactivated, split virus or surface antigen. This information helps identify medicines with the same composition but different brand names.
Who manufactures FLUAD TETRA Injectable Suspension in Pre-filled Syringe?
FLUAD TETRA Injectable Suspension in Pre-filled Syringe is manufactured by Seqirus Netherlands B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FLUAD TETRA Injectable Suspension 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 FLUAD TETRA Injectable Suspension 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 FLUAD TETRA Injectable Suspension in Pre-filled Syringe?
Other medicines with the same active substance (influenza, inactivated, split virus or surface antigen) include ADJUPANRIX 3.75 micrograms EMULSION AND SUSPENSION FOR INJECTABLE EMULSION, EFLUELDA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE, EFLUELDA TETRA Injectable Suspension in Pre-filled Syringe. 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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