Fluarix Tetra

Leaflet accompanying the packaging: information for the user

Fluarix Tetra, suspension for injection in a pre-filled syringe

The flu vaccine (split virion, inactivated)
The content of this leaflet has been formulated on the assumption that it will be read by the person receiving the vaccine. However, since this vaccine may be administered to adults and children, it is possible that the content of the leaflet will be reviewed by a parent or guardian of the child.

You should carefully read the content of the leaflet before using the vaccine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This vaccine has been prescribed for a specific person. It should not be given to others.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Fluarix Tetra vaccine and what is it used for
• 2. Important information before using Fluarix Tetra vaccine
• 3. How to use Fluarix Tetra vaccine
• 4. Possible side effects
• 5. How to store Fluarix Tetra vaccine
• 6. Contents of the pack and other information

1. What is Fluarix Tetra vaccine and what is it used for

Fluarix Tetra is a vaccine. The vaccine helps protect vaccinated individuals against flu, which is particularly important for people who are at high risk of post-flu complications.
The use of Fluarix Tetra vaccine should be based on local recommendations.
After administration of Fluarix Tetra vaccine, the immune system of the vaccinated person (the body's natural defense system) will produce its own protection against the disease (antibodies). None of the components of the vaccine cause flu.
Flu is a disease that can spread quickly. It is caused by different strains of the virus, which can change every year. Therefore, annual vaccination may be necessary. The greatest risk of getting flu is during the cold months of the year, between October and March. In the case of people who have not been vaccinated in the fall, it is recommended to consider vaccination at a later time (until spring), as the risk of flu infection still exists. The doctor will inform you when the vaccination should be performed. Fluarix Tetra protects against four strains of the virus that are included in it.
The protective effect of the vaccine starts from about 2 to 3 weeks after vaccination.
The incubation period of flu is several days, so if exposure to the flu virus occurs just before or just after vaccination, it may lead to illness despite receiving the vaccine.
The vaccine does not protect against the common cold, even though some of its symptoms are the same as those of flu.

2. Important information before using Fluarix Tetra vaccine

You should inform your doctor or pharmacist if any of the following statements apply to the person who is to receive Fluarix Tetra vaccine. If additional explanations are needed, you should ask your doctor or pharmacist.

When not to use Fluarix Tetra vaccine:

• If the patient is allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6) or to any ingredient that may be present in very small amounts, such as egg protein (egg albumin or chicken protein), formaldehyde, gentamicin sulfate, or sodium desoxycholate.
• If the patient has a disease with high fever or acute infection, vaccination should be postponed until the patient feels better.

Warnings and precautions:

Before administering Fluarix Tetra vaccine, you should consult a doctor:

• If the patient has impaired immune response (due to immunodeficiency or taking medications that affect the immune system),
• If the patient is scheduled to have a blood test within a few days after vaccination, as false-positive blood test results have been observed in people who have been recently vaccinated,
• If the patient has bleeding disorders or a tendency to bruise.

The doctor will decide whether the patient can be vaccinated.
After or even before administration of each injection vaccine, fainting (especially in adolescents) may occur. In this regard, you should inform your doctor or nurse if the patient has ever fainted during injection.
As with any vaccine, Fluarix Tetra may not fully protect all vaccinated individuals.

Fluarix Tetra vaccine and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Fluarix Tetra can be administered at the same time as other vaccines, but each vaccine should be administered in a different limb.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this vaccine.
Your doctor or pharmacist will decide whether you can receive Fluarix Tetra vaccine. You should consult your doctor or pharmacist before using this vaccine.

Driving and using machines

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

Fluarix Tetra contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, so it can be considered sodium-free.

Fluarix Tetra contains potassium

This medicinal product contains less than 1 mmol of potassium (39 mg) per dose, so it can be considered potassium-free.

3. How to use Fluarix Tetra vaccine

Dosage

Adults receive one dose of 0.5 ml.
Use in children:
Children from 6 months of age receive one dose of 0.5 ml.
Children under 9 years of age who have not been previously vaccinated against flu should receive a second dose at least 4 weeks after the first dose.

How to administer the vaccine

The doctor will administer the appropriate dose of the vaccine by intramuscular injection.
If you have any additional questions about using the vaccine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
In clinical trials, the following side effects have been observed.
Side effects that occurred in children aged 6 to 36 months
Very common(may occur more often than 1 in 10 doses of the vaccine): loss of appetite, irritability, sleepiness, pain and/or redness at the injection site.
Common(may occur no more often than 1 in 10 doses of the vaccine): fever, swelling at the injection site.
Side effects that occurred in children aged 3 to 6 years
Very common(may occur more often than 1 in 10 doses of the vaccine): pain and/or redness and/or swelling at the injection site, irritability.
Common(may occur no more often than 1 in 10 doses of the vaccine): loss of appetite, sleepiness, fever.
Uncommon(may occur no more often than 1 in 100 doses of the vaccine): rash, itching at the injection site.
Side effects that occurred in children aged 6 to 18 years
Very common(may occur more often than 1 in 10 doses of the vaccine): muscle pain, pain and/or redness and/or swelling at the injection site, fatigue.
Common(may occur no more often than 1 in 10 doses of the vaccine): nausea, diarrhea, vomiting, abdominal pain, headache, joint pain, chills, fever.
Uncommon(may occur no more often than 1 in 100 doses of the vaccine): rash, itching at the injection site.
Side effects that occurred in adults aged 18 years and older
Very common(may occur more often than 1 in 10 doses of the vaccine): pain at the injection site, fatigue, muscle pain (myalgia).
Common(may occur no more often than 1 in 10 doses of the vaccine): headache, nausea, diarrhea, vomiting, abdominal pain, joint pain (arthralgia), fever, chills, redness and/or swelling at the injection site.
Uncommon(may occur no more often than 1 in 100 doses of the vaccine): bruising, itching around the injection site, dizziness.
Aside from the above, side effects that occurred during clinical trials in patients aged 3 years and older who received Fluarix (trivalent vaccine) included:
Common(may occur no more often than 1 in 10 doses of the vaccine): induration around the injection site, sweating.
The above reactions usually resolve within 1-2 days without additional treatment.
Aside from the above side effects, the following side effects have been reported after using Fluarix and Fluarix Tetra vaccines.
Rare(may occur no more often than 1 in 1,000 doses of the vaccine):

• allergic reactions:
• leading to conditions requiring emergency medical attention due to circulatory failure, leading to reduced blood flow to various organs (shock),
• swelling, particularly visible on the face and neck, including the face, mouth, tongue, throat, or other parts of the body (angioedema);
• skin reactions that can spread throughout the body, such as itching (pruritus, urticaria) and redness (erythema),
• neurological changes that can result in 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 (encephalitis and meningitis, neuritis, Guillain-Barré syndrome),
• temporary swelling of the cervical, axillary, or inguinal lymph nodes (transient lymphadenopathy),
• flu-like symptoms, general malaise.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluarix Tetra vaccine

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the month.
The abbreviation "Lot" means the batch number of the product.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fluarix Tetra contains:

The active substance is:split, inactivated flu virus from the following strains*:

A/Victoria/4897/2022 (H1N1)pdm09–like strain (A/Victoria/4897/2022, IVR-238)

15 micrograms of HA**

A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022, IVR-237)

15 micrograms of HA**

B/Austria/1359417/2021–like strain (B/Austria/1359417/2021, BVR-26)

15 micrograms of HA**

B/Phuket/3073/2013–like strain (B/Phuket/3073/2013, wild-type strain)

15 micrograms of HA**

in a 0.5 ml dose
* grown in chicken embryos from healthy flocks
** hemagglutinin
This vaccine is in line with the recommendations of the World Health Organization (WHO) (for the Northern Hemisphere) and the European Union for the 2024/2025 season.
Other ingredients of the vaccine are: sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, α-tocopheryl hydrogen succinate, polysorbate 80, octoxynol 10, and water for injections.

What Fluarix Tetra looks like and contents of the pack

Fluarix Tetra is a suspension for injection in a pre-filled syringe.
Fluarix Tetra is available in a 1-dose pre-filled syringe, with needles attached to the packaging or without needles, in packs of 1 and 10.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Manufacturer:

GlaxoSmithKline Biologicals S.A.
GlaxoSmithKline Biologicals
Rue de l’Institut 89
SmithKline Beecham Pharma GmbH&Co. KG
1330 Rixensart
Zirkusstrasse 40
Belgium
01069 Dresden
Germany

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

Date of last revision of the leaflet: July 2024

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
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Information intended for healthcare professionals only:
As with all injectable vaccines, it is necessary to ensure the possibility of proper immediate treatment and adequate medical care in case of anaphylactic reactions after vaccination.
Vaccination should be performed intramuscularly.
Fluarix Tetra should not be administered intravascularly under any circumstances.
Fluarix Tetra can be administered at the same time as other vaccines. Vaccination should be performed in separate limbs.
Before administration, the vaccine should reach room temperature.
The vaccine should be shaken before use. The vaccine should be visually inspected before administration.
Instructions for the pre-filled syringe

You should hold the pre-filled syringe by the body, not by the plunger.
Luer Lock adapter
You should remove the needle cap from the pre-filled syringe by twisting it in the opposite direction to the arrow.
Plunger
Body
Needle cap

You should attach the needle to the pre-filled syringe by screwing the needle cap onto the Luer Lock adapter (Luer Lock Adaptor, LLA) and twisting it a quarter turn in the direction of the arrow until you feel the needle click into place.
You should not pull the plunger out of the body of the pre-filled syringe. If this happens, you should not administer the vaccine.
Needle cap
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.