Flucelvax Tetra - suspension for injection in pre-filled syringe

Read all of this leaflet carefully before you receive 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

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 vaccinations can be used at any stage of pregnancy.

Breast-feeding:

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

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

What Flucelvax Tetra contains

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

A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type) 15 micrograms HA**

A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, 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

This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2020/2021 season.

The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.

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 pre-filled syringes with or without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer