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FLUARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

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About the medicine

How to use FLUARIX SUSPENSION FOR INJECTION 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

Fluarix injectable suspension in pre-filled syringe

Influenza vaccine (trivalent, inactivated, split virion)

This package leaflet has been written to be read by the person receiving the vaccine. However, it may be read by someone else.

Read all of this leaflet carefully before you start receiving this vaccine,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.
  • This vaccine has been prescribed for you. Do not pass it on to others.
  • If you experience 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 Fluarix and what is it used for
  2. What you need to know before you receive Fluarix
  3. How Fluarix is administered
  4. Possible side effects
  5. Storage of Fluarix
  6. Contents of the pack and other information

1. What is Fluarix and what is it used for

Fluarix is a vaccine to prevent influenza in adults and children from 6 months of age.

Influenza is a disease of the upper respiratory tract and lungs caused by an influenza virus infection. The most common symptoms of influenza are: high fever, sore throat, cough, general aches, headache, weakness, and fatigue. Complications can occur, especially in very young, very old people, and those with low immunity to infections.

How does Fluarix work?

  • Fluarix contains killed viruses that cannot cause influenza.
  • Fluarix stimulates the body's immune system to produce antibodies against the specific viruses the vaccine is designed to protect against. This will help prevent the disease.
  • The vaccine is targeted against influenza viruses according to official recommendations.
  • As with all vaccines, it is possible that Fluarix may not completely protect all vaccinated individuals.
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 Fluarix

Do not receiveFluarix if:

  • you are allergic to the active substances or any of the other components of this vaccine (listed in section 6) or to any component that may be present in very small amounts, such as ovalbumin (an egg protein), hydrocortisone, gentamicin sulfate, formaldehyde, and sodium deoxycholate.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before receiving Fluarix if:

  • you have a severe infection with high fever. If this happens, vaccination may need to be postponed until you feel better. A minor infection, such as a cold, should not be a problem, but talk to your doctor, pharmacist, or nurse first.
  • you have a bleeding problem or bruise easily.

Fainting (syncope) can occur following, or even before, any injection, especially in adolescents. Tell your doctor, pharmacist, or nurse if you have fainted with a previous injection.

People with weakened immune systems, for example due to HIV infection or due to medicines that suppress the immune system, may not get the full benefit of Fluarix.

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist, or nurse before receiving Fluarix.

Other medicines and vaccines and Fluarix

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines or have recently received any other vaccine.

If Fluarix is to be given at the same time as other vaccines, a different injection site should be used for each type of vaccine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.

Driving and using machines

Some of the effects mentioned below in section 4 “Possible side effects” (e.g. fatigue or dizziness) may temporarily affect your ability to drive or use machines. Do not drive or use machines or tools if you do not feel well.

Fluarix contains sodium

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

Fluarix contains potassium

This medicine contains less than 39 mg (1 mmol) of potassium per dose, and is therefore considered to be “potassium-free”.

Fluarix contains polysorbate 80

This medicine does not contain more than 0.415 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergy to this substance.

3. How Fluarix is administered

Fluarix is given as a single injection of 0.5 ml into a muscle.

Use in children

Children under 9 years of age who have not been previously vaccinated against influenza will receive a second injection at least one month after the first. Make sure your child completes the vaccination course. This will maximize the protection provided by Fluarix.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

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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.

Talk to your doctor, pharmacist, or nurse if you want more information on the possible side effects of Fluarix.

Side effects reported during general use of Fluarix:

Serious side effects

Tell your doctor immediately if you notice any of the following serious side effects; you may need urgent medical treatment.

Rare:these may occur in up to 1 in 1,000 doses of the vaccine

  • Severe allergic reactions (anaphylactic reactions). These can be recognized by:
  • itchy rash on hands and feet
  • swelling of the eyes and face
  • difficulty breathing or swallowing
  • sudden drop in blood pressure and loss of consciousness.

These reactions usually occur within 15 minutes after vaccination. However, if you experience any of these symptoms, contact a doctor urgently.

Other side effects

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects.

Rare:these may occur in up to 1 in 1,000 doses of the vaccine

  • Nerve inflammation (neuritis), brain and spinal cord inflammation (encephalomyelitis), temporary nerve inflammation causing pain, weakness, and paralysis, called Guillain-Barré syndrome.
  • Skin reactions that can spread all over the body, including itching (pruritus, urticaria) and skin redness (erythema), rash.
  • Temporary inflammation of the glands in the neck, armpits, or groin (transient lymphadenopathy)
  • Flu-like symptoms, general feeling of being unwell.

Tell your doctor, pharmacist, or nurse if you notice any of the above side effects.

Side effects that occurred during clinical trials with Fluarix:

Side effects that occurred in children between 6 months and less than 6 years of age

Very common:these may occur in more than 1 in 10 doses of the vaccine

  • Lack of appetite.
  • Irritability.
  • Sleepiness.
  • Pain at the injection site.
  • Redness at the injection site.
  • Swelling at the injection site.

Common:these may occur in up to 1 in 10 doses of the vaccine

  • Nausea.
  • Vomiting.
  • Diarrhea.
  • Stomach pain.
  • Fever.

Side effects that occurred in children between 6 years and less than 18 years of age

Very common:these may occur in more than 1 in 10 doses of the vaccine

  • Headache.
  • Muscle pain.
  • Fatigue.
  • Pain at the injection site.
  • Redness at the injection site.
  • Swelling at the injection site.

Common:these may occur in up to 1 in 10 doses of the vaccine

  • Nausea.
  • Vomiting.
  • Diarrhea.
  • Stomach pain.
  • Joint pain.
  • Chills.
  • Fever.

Side effects that occurred in adults from 18 years of age

Very common:these may occur in more than 1 in 10 doses of the vaccine

  • Pain at the injection site.
  • Fatigue.
  • Headache.
  • Muscle pain.

Common:these may occur in up to 1 in 10 doses of the vaccine

  • Redness, swelling, or a hard lump at the injection site.
  • Chills.
  • Sweating.
  • Joint pain.
  • Nausea.
  • Vomiting.
  • Diarrhea.
  • Stomach pain.

Uncommon:these may occur in up to 1 in 100 doses of the vaccine

  • Fever.
  • Dizziness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluarix

  • Keep this vaccine 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 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.
  • Store in the outer carton to protect from light.
  • 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 Fluarix

The active substance is influenza virus (inactivated, split virion) of the following strains*:

Strain similar to A/Victoria/4897/2022 (H1N1)pdm09:

(IVR-238) derived from A/Victoria/4897/202215 micrograms of HA**

Strain similar to A/Croatia/10136RV/2023 (H3N2):

(X-425A) derived from A/Croatia/10136RV/202315 micrograms of HA**

Strain similar to B/Austria/1359417/2021:

(BVR-26) derived from B/Austria/1359417/202115 micrograms of HA**

per 0.5 ml dose

  • propagated in embryonated hens' eggs from healthy chicken flocks

** hemagglutinin

This vaccine complies with the World Health Organization (WHO) recommendation for the Northern Hemisphere and with the European Union recommendation for the 2025/2026 season.

The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, α-tocopherol hydrogen succinate, polysorbate 80, octoxinol 10, and water for injections

Appearance and pack contents

  • Fluarix is an injectable suspension in a pre-filled syringe.
  • Fluarix is a colorless, slightly opalescent liquid.
  • Fluarix is available in a pre-filled syringe with or without a separate needle; pack sizes of 1 and 10.
  • Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel.: +34 900 202 700

[email protected]

Manufacturer

GlaxoSmithKline Biologicals

Branch of SmithKline Beecham Pharma GmbH & Co. KG

Zirkusstrasse 40

01069 Dresden

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Member State

Name

Austria

Fluarix Trivalent

Belgium, Luxembourg

Alpharix

Spain, Finland, France, Italy, Norway, Netherlands, Poland, Portugal, Sweden

Fluarix

Germany, Greece

Influsplit

Date of last revision of this leaflet:07/2025

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Vaccines should be inspected visually for any foreign particles and/or changes in physical appearance before administration.

Before use, the vaccine should be shaken well to obtain a colorless, slightly opalescent liquid. Discard if the contents appear otherwise. Inject the entire contents of the syringe.

Instructions for the pre-filled syringe

Text that says

Vial stopper with large, bold text indicating the word

Transparent luer-lock adapter with internal thread visible and descriptive text above

Pre-filled syringe with retracted plunger and transparent protective cap with hook at the end

Hold the syringe by the body, not by the plunger.

Unscrew the syringe cap by twisting it counterclockwise.

Metal needle base with a sharpened end and a slightly textured cylindrical body

Hands holding an injection device with attached needle and arrows indicating rotation and push

To insert the needle, attach the base to the luer-lock adapter and twist it a quarter turn clockwise until it clicks.

Do not pull the plunger out of the syringe body. If this happens, do not administer the vaccine.

Disposal of waste

Disposal of unused medicinal products and all materials that have been in contact with them should be done in accordance with local regulations.

Online doctors for FLUARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Discuss questions about FLUARIX SUSPENSION FOR INJECTION 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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€55

Frequently Asked Questions

Is a prescription required for FLUARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE?
FLUARIX SUSPENSION FOR INJECTION 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 FLUARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE?
The active ingredient in FLUARIX SUSPENSION FOR INJECTION 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 FLUARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE?
FLUARIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE is manufactured by Glaxosmithkline S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FLUARIX SUSPENSION FOR INJECTION 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 FLUARIX SUSPENSION FOR INJECTION 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 FLUARIX SUSPENSION FOR INJECTION 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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