Flucelvax Tetra - patient leaflet, side effects, dosage

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

Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.

When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.

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

The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2021/2022 SEASON.

2. What you need to know before you receive Flucelvax Tetra

You should not receive Flucelvax Tetra:

If you are allergic to:

• the active ingredients or any of the other ingredients of this medicine (listed in section 6)
• beta-propiolactone, cetyltrimethy­lammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.

Warnings and precautions

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

BEFORE receiving the vaccine

• Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.
• You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.
• You should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).
• You should tell your doctor if you have a bleeding problem or bruise easily.
• Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.

As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.

Other medicines and Flucelvax 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.

Flucelvax Tetra may be given at the same time as other vaccines.

Pregnancy and breast-feeding

Pregnancy:

Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

Influenza vaccines may be given in any trimester of pregnancy.

Breast-feeding:

Use of Flucelvax Tetra during breast-feeding has not been studied. Flucelvax Tetra may be given during breast-feeding.

Driving and using machines

Flucelvax Tetra has no or negligible effect on your ability to drive and use machines.

Flucelvax Tetra contains sodium chloride and potassium chloride

This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.

This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free’.

• 3. How Flucelvax Tetra is given

Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).

Adults and children from 2 years of age:

One dose of 0.5 ml

4. Possible side effects

Like all medicines, this medicine 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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:

• Difficulty in breathing, dizziness, a weak and rapid pulse and 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:

• Extensive swelling of injected limb

Mild side effects

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

• Injection site pain, bruising, reddening and hardening or swelling at the site of the injection
• Headache
• Muscle pain
• Tiredness
• Loss of appetite
• Irritability (only reported in children from 2 to < 6 years)
• Sleepiness (only reported in children 2 to < 6 years)

Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly.

Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years.

Headache was common in the elderly.

Loss of appetite was common in adults, eldery and children 9 to < 18 years.

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

• Nausea, vomiting, diarrhoea
• Joint pain
• Shivering
• Change in eating habits (only reported in children from 2 to < 6 years)
• Fever (> 38°C)

Vomiting was uncommon in the elderly.

Fever was uncommon in adults and the elderly.

Not known (cannot be estimated from the available data):

• Numbness and tingling sensation
• Generalised skin reactions including itching, bumps on the skin or non-specific rash

Reporting of side effects

If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in* By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flucelvax Tetra

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

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

Keep the pre-filled syringe in the outer carton in order to protect from light.

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

Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Flucelvax Tetra contains

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

A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Washington/19/2020, wild type) 15 micrograms HA

A/Cambodia/e0826360/2­020 (H3N2)-like strain (A/Tasmania/503/2020, wild type) 15 micrograms HA

B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type) 15 micrograms HA

B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16–0610/2016, wild type) 15 micrograms HA

per 0.5 ml dose

• * propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in

which the influenza virus is grown);

• * * haemagglutinin

What Flucelvax Tetra looks like and contents of the pack

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

Flucelvax Tetra is a clear to slightly opalescent suspension.

A single syringe contains 0.5 ml of suspension for injection.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Seqirus Netherlands B.V.

Paasheuvelweg 28

1105BJ Amsterdam

Netherlands

Manufacturer

Seqirus Netherlands B.V.

Paasheuvelweg 28 1105BJ Amsterdam

Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

België/Belgiqu­e/Belgien Lietuva

Seqirus Netherlands B.V.Nederland/Net­herlands Seqirus Netherlands B.V. Nyderlandai

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

Efc^rapufl

Seqirus Netherlands B.V. HugepnaHgua

Tea.: +31 (0) 20 204 6900

Česká republika

Seqirus Netherlands B.V. Nizozemsko

Tel: +31 (0) 20 204 6900

Danmark

Seqirus Netherlands B.V. Holland

Tlf: +31 (0) 20 204 6900

Deutschland

Seqirus GmbH Marburg

Tel: 08003601010

Eesti

Seqirus Netherlands B.V. Holland

Tel: +31 (0) 20 204 6900

EZZáSa

Seqirus Netherlands B.V. OZZavóía

Tql: +31 (0) 20 204 6900

España

Seqirus Spain, S.L., Barcelona

Tel: 937 817 884

France

Seqirus Netherlands B.V. Netherlands

Tél: +31 (0) 20 204 6900

Hrvatska

Seqirus Netherlands B.V. Nizozemska

Tel: +31 (0) 20 204 6900

Ireland

Seqirus UK Limited Maidenhead

Tel: +44 1628 641 500

Ísland

Seqirus Netherlands B.V. Holland

Sími: +31 (0) 20 204 6900

Italia

Seqirus S.r.l. Siena

Tel: +39 0577 096400

Kúnpog

Seqirus Netherlands B.V. OZZavóía

Tql: +31 (0) 20 204 6900

Latvija

Seqirus Netherlands B.V. Niderlande

Tel: +31 (0) 20 204 6900

Luxembourg/Lu­xemburg

Seqirus Netherlands B.V. Netherlands

Tél/Tel: +31 (0) 20 204 6900

Magyarország

Seqirus Netherlands B.V. Hollandia

Tel.: +31 (0) 20 204 6900

Malta

Seqirus Netherlands B.V. In-Netherlands

Tel: +31 (0) 20 204 6900

Nederland

Seqirus Netherlands B.V. Amsterdam

Tel: +31 (0) 20 204 6900

Norge

Seqirus Netherlands B.V. Nederland

Tlf: +31 (0) 20 204 6900

Österreich

Valneva Austria GmbH, Wien

Tel: +43 1 20620

Polska

Seqirus Netherlands B.V. Holandia

Tel.: +31 (0) 20 204 6900

Portugal

Seqirus Netherlands B.V. Países Baixos

Tel: +31 (0) 20 204 6900

Romania

Seqirus Netherlands B.V. Olanda

Tel: +31 (0) 20 204 6900

Slovenija

Seqirus Netherlands B.V. Nizozemska

Tel: +31 (0) 20 204 6900

Slovenská republika

Seqirus Netherlands B.V. Holandsko

Tel: +31 (0) 20 204 6900

Suomi/Finland

Seqirus Netherlands B.V. Alankomaat

Puh/Tel: +31 (0) 20 204 6900

Sverige

Seqirus Netherlands B.V. Nederländerna

Tel: +31 (0) 20 204 6900

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

The following information is intended for healthcare professionals only:

Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

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

The vaccine should be visually inspected for particulate matter and discoloration prior to administration. In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.

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