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FLUCELVAX TETRA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

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How to use FLUCELVAX 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

Flucelvax Tetra injectable suspension in pre-filled syringe

Vaccine against influenza (surface antigen, inactivated, prepared in cell cultures)

Read all of this leaflet carefully before you start receiving 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

  1. What is Flucelvax Tetra and what is it used for
  2. What you need to know before you receive Flucelvax Tetra
  3. How Flucelvax Tetra is administered
  4. Possible side effects
  5. Storage of Flucelvax Tetra
  6. Contents of the pack and further information

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

Flucelvax Tetra is a vaccine against influenza. Flucelvax Tetra is prepared in cell cultures and therefore does not contain egg.

When a person receives 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.

Flucelvax Tetra is used to prevent influenza in adults and children from 2 years of age.

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

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 receive Flucelvax Tetra

You should not receive Flucelvax Tetra

If you are allergic to:

  • the active substances or any of the other components of this vaccine (listed in section 6).
  • beta-propiolactone, cetrimonium bromide, or polysorbate 80, which are residues from the manufacturing process that may be present in minimal amounts.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you receive Flucelvax Tetra.

BEFORE vaccination

  • your doctor or nurse will check that medical treatment and adequate supervision are readily available in the rare event of an anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty breathing, dizziness, weak and rapid pulse, and skin rash) after administration. This reaction can occur with Flucelvax Tetra, as with all injectable vaccines.
  • you should inform your doctor if you have an acute illness with fever. Your doctor may decide to postpone your vaccination until the fever has disappeared.
  • you should inform 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 Flucelvax Tetra").
  • you should inform 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 inform your doctor or nurse if you have fainted previously with any injection.

As with all vaccines, Flucelvax Tetra may not completely protect all people who are vaccinated.

Children under 2 years

This vaccine is not currently recommended in children under 2 years, as its safety and efficacy have not been established in this age group.

Other medicines and Flucelvax 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 recently received any other vaccine.

Flucelvax Tetra can be administered at the same time as other vaccines.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor. Influenza vaccines can be administered in any trimester of pregnancy.

Breastfeeding

The use of Flucelvax Tetra during breastfeeding has not been studied. No effect on breastfed infants is expected. Flucelvax Tetra can be administered during breastfeeding.

Driving and using machines

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

Flucelvax Tetra contains sodium and potassium

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

3. How Flucelvax Tetra is administered

Your doctor or nurse will administer Flucelvax Tetra as an injection into the muscle of the upper arm (deltoid muscle) or into the muscle of the upper and outer thigh in small children, depending on muscle size.

Adults and children from 2 years of age

A dose of 0.5 ml.

If your child is under 9 years of age and has never been vaccinated against influenza, a second dose should be administered after at least 4 weeks.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

The following side effects have been reported during clinical trials and during general use:

Very serious side effects

Consult your doctor or go to the emergency department of the nearest hospital immediately if you experience the following side effect - you may need urgent medical attention or hospitalization:

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

Serious side effects

Tell your doctor immediately if you experience any of the following side effects - you may need medical attention:

  • You feel weak, have difficulty moving, or experience numbness or tingling in your limbs. These can be symptoms of Guillain-Barré syndrome (GBS), an autoimmune disease caused by the body's immune system
  • Extensive swelling of the limb where the vaccine was injected

Other side effects

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

  • Pain at the injection site, bruising, redness, and swelling or hardness at the injection site
  • Headache
  • Muscle pain
  • Fatigue
  • Loss of appetite
  • Irritability (reported only in children from 2 to <6 years)< li>
  • Somnolence (reported only in children from 2 to <6 years)< li>

In elderly patients, the following were common: hardness or swelling at the injection site, headache, muscle pain, and fatigue.

Bruising at the injection site was common in adults, elderly, and children from 9 to <18 years.< p>

Headache was common in the elderly.

Loss of appetite was common in adults, elderly, and children from 9 to <18 years.< p>

Common (may affect up to 1 in 10 people)

  • Nausea, vomiting, diarrhea
  • Joint pain
  • Chills
  • Changes in eating habits (reported only in children from 2 to <6 years)< li>
  • Fever (> 38 °C)

Vomiting was uncommon in elderly patients

Fever was uncommon in adults and elderly

Frequency not known (cannot be estimated from the available data)

  • Paresthesia (tingling or numbness sensation)
  • Generalized skin reactions including itching, hives, or non-specific skin rash

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flucelvax Tetra

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

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

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the pre-filled syringe in the outer packaging to protect it from light.

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. Contents of the pack and further information

Composition of Flucelvax Tetra

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

Strain similar to A/Wisconsin/67/2022 (H1N1)pdm09 (A/Georgia/12/2022 CVR-167)

15 micrograms HA**

Strain similar to A/Massachusetts/18/2022 (H3N2) (A/Sydney/1304/2022, wild type)

15 micrograms HA**

Strain similar to B/Austria/1359417/2021 (Singapore/WUH4618/2021, wild type)

15 micrograms HA**

Strain similar to B/Phuket/3073/2013 (B/Singapore/INFTT-16-0610/2016, wild type)

15 micrograms HA**

per 0.5 ml dose

……………………………………….

  • propagated in Madin Darby Canine Kidney (MDCK) cells (a special cell culture in which the influenza virus grows)

** 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.

  • The other components are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections (see section 2: Flucelvax Tetra contains sodium and potassium).

Appearance and packaging of the product

Flucelvax Tetra is an injectable suspension (injection) in a pre-filled syringe (ready-to-use syringe).

Flucelvax Tetra is a transparent to slightly opalescent suspension.

Each individual syringe contains 0.5 ml of injectable suspension.

Flucelvax Tetra is available in packs of 1 pre-filled syringe with or without a needle or 10 pre-filled syringes with or without needles.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Seqirus Netherlands B.V.

Paasheuvelweg 28

1105BJ Amsterdam

Netherlands

You can request more information about this medicine from the local representative of the marketing authorization holder:

Seqirus Spain, S.L., Barcelona

Tel: 937 817 884

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/.

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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 before use. After shaking, the normal appearance of the vaccine is a transparent to slightly opalescent suspension.

The vaccine should be inspected visually for foreign particles or changes in color before administration. If foreign particles and/or any variation in physical appearance are observed, do not administer the vaccine.

Online doctors for FLUCELVAX TETRA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

Discuss questions about FLUCELVAX 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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€58
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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
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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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Frequently Asked Questions

Is a prescription required for FLUCELVAX TETRA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
FLUCELVAX 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 FLUCELVAX TETRA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
The active ingredient in FLUCELVAX 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 FLUCELVAX TETRA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
FLUCELVAX 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 FLUCELVAX 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 FLUCELVAX 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 FLUCELVAX 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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