SUPEMTEK TETRA Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Supemtek Tetra injectable solution

Influenza vaccine (tetralent, recombinant, prepared in cell culture)

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you are vaccinated 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 to you, do not pass it on to others.
• 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 Supemtek Tetra and what is it used for
2. What you need to know before you start using Supemtek Tetra
3. How to use Supemtek Tetra
4. Possible side effects
5. Storage of Supemtek Tetra
6. Contents of the pack and other information

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

Supemtek Tetra is a vaccine for adults and children from 9 years of age. This vaccine helps protect you against influenza virus. Supemtek Tetra does not contain egg due to the technology used to produce it.

How Supemtek Tetra works

When a person receives Supemtek Tetra, the body's natural defenses (the immune system) produce protection against the influenza virus. None of the vaccine components can cause influenza.

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

When to administer the influenza vaccine

Influenza can spread very quickly.

• It is caused by different types of influenza viruses that can change every year. That's why you may need to be vaccinated every year.
• The risk of getting influenza increases during the cold months between October and March.
• If you did not get vaccinated in the fall, it is still a good idea to get vaccinated even in the spring, since you are at risk of getting influenza until then.

Your doctor will recommend the best time for you to get vaccinated.

2. What you need to know before you start using Supemtek Tetra

Do not use Supemtek Tetraif you are allergic to:

• the active substances or any of the other ingredients of this vaccine (listed in section 6).
• octylphenol ethoxylate, in trace residual amounts from the manufacturing process.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Supemtek Tetra.

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

Before receiving the vaccine, tell your doctor, nurse, or pharmacist if:

• you have an acute illnessassociated with fever. It may be necessary to delay vaccination until the fever has disappeared.
• you have a weakened immune system(immunodeficiency or are taking medicines that affect the immune system, such as cancer medicines (chemotherapy) or medicines with corticosteroids).
• you have bleeding problemsor bruise easily.
• you have faintedafter an injection before. Fainting can occur after or even before an injection.

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

Other medicines and Supemtek Tetra

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

Supemtek Tetra can be administered at the same time as other vaccines using separate limbs.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before using this vaccine. Your doctor/pharmacist will help you decide if you should receive Supemtek Tetra.

Driving and using machines

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

Supemtek Tetra contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per dose unit, which is essentially "sodium-free".

3. How to use Supemtek Tetra

Your doctor, nurse, or pharmacist will administer Supemtek Tetra as an injection into the upper arm (deltoid muscle).

Adults and children from 9 years of age:

A dose of 0.5 ml.

4. Possible side effects

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

Severe allergic reactions

Immediatelycontact your doctor or healthcare professional or go immediately to the emergency department of the nearest hospital if you have an allergic reaction, as it can be life-threatening.

Symptoms include:

• difficulty breathing, shortness of breath
• swelling of the face, lips, throat, or tongue
• cool, clammy skin
• palpitations
• dizziness, weakness, fainting
• skin rash or itching

The following adverse reactions have been reported with Supemtek Tetra:

Other side effects

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

• pain at the injection site
• fatigue
• headache
• muscle pain and joint pain

Muscle pain and joint pain are common in adults 50 years of age and older.

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

• feeling sick (nausea)
• redness, swelling, hardness, and bruising at the injection site
• fever, chills

Fever is rare in adults 50 years of age and older.

Bruising is reported in children/adolescents 9 to 17 years of age.

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

• diarrhea, vomiting, abdominal discomfort, and decreased appetite
• itching, skin irritation, skin rash
• flu-like symptoms
• asthma, cough, mouth and throat pain
• itching at the injection site

Itching is rare in adults 50 years of age and older.

Neither skin irritation nor skin rash has been reported in adults 50 years of age and older.

Flu-like symptoms have not been reported in adults 18 to 49 years of age.

Vomiting, decreased appetite, abdominal discomfort, and asthma have not been reported in adults 18 years of age and older.

Rare (may affect up to 1 in 1,000 people):

• dizziness
• hives

Neither dizziness nor hives has been reported in adults 18 to 49 years of age.

Dizziness is uncommon in children/adolescents 9 to 17 years of age.

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

• neurological disorders that can cause stiff neck, confusion, numbness, pain, and weakness in the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (Guillain-Barré syndrome).

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 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 Supemtek 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.

Store the pre-filled 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 carton after EXP.

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 other information

Composition of Supemtek Tetra

One dose (0.5 ml) contains:

The active substances are hemagglutinin proteins (HA) of the influenza virus of the following strains*:

Strain similar to A/XXXXXX (H1N1) 45 micrograms HA

Strain similar to A/XXXXXX (H3N2) 45 micrograms HA

Strain similar to B/XXXXXX 45 micrograms HA

Strain similar to B/XXXXXX 45 micrograms HA

• Produced by recombinant DNA technology using a baculovirus expression system in a stable insect cell line derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda.

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

The other ingredients are: polysorbate 20 (E432), sodium chloride, sodium phosphate monobasic, sodium phosphate dibasic, water for injections (see section 2).

Appearance and packaging of the product

Supemtek Tetra is an injectable solution in a pre-filled syringe (ready-to-use syringe).

Supemtek Tetra is a clear and colorless solution, essentially free from visible particles.

A single syringe contains 0.5 ml of injectable solution.

Supemtek Tetra is available in packs containing 1, 5, or 10 pre-filled syringes without a needle or with a separate needle.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly, France

Manufacturer

Sanofi Winthrop Industrie

Voie de l’Institut - Parc Industriel d'Incarville

B P 101

27100 Val de Reuil

France

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

Date of last revision of this leaflet:MM/AAAA

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 appropriate supervision should be available in case of an anaphylactic episode following administration of the vaccine.

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