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FLUAD TETRA 0.5ML SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE - Patient leaflet, side effects, dosage

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Patient leaflet - FLUAD TETRA 0.5ML SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

1. what fluad tetra is and what it is used for

Fluad Tetra is a vaccine against flu (influenza).

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 ofthe ingredients in the vaccine can cause flu.

Fluad Tetra is used to prevent flu in elderly adults of 65 years of age and older.

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 fluad tetra

You should not receive Fluad Tetra

  • – If you are allergic to

  • the active ingredients or any of the other ingredients of this medicine (listed in section 6)
  • egg or chicken proteins (such as ovalbumin), kanamycin and neomycin sulphate, formaldehyde, cetyltrimethy­lammonium bromide (CTAB) and hydrocortisone, which are trace residues from the manufacturing process.
  • – If you have had a severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.

Warnings and precautions

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

Comments:


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 Fluad 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 Fluad 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, Fluad Tetra may not fully protect all persons who are vaccinated.

Children

Fluad Tetra is not recommended for use in children.

Other medicines and Fluad 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.

Pregnancy and breast-feeding

This vaccine is for use in elderly adults 65 years and older. It is not to be used in women who are, or may be, pregnant or breast-feeding.

Driving and using machines

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

Fluad Tetra contains potassium and sodium

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 Fluad Tetra is given

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

Adults of 65 years of age and older:

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 in adults 65 years of age and older.

Mild side effects

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

  • Pain at injection site
  • Fatigue
  • Headache

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

  • Joint pain (arthralgia)
  • Muscular pain (myalgia)
  • Redness at injection site (erythema)
  • Hardening of the skin at injection site (induration)
  • Diarrhoea
  • Shivering
  • Nausea
  • Loss of appetite
  • Bruising at injection site (ecchymosis)
  • Flu-like symptoms

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

  • Vomiting
  • Fever (> 38°C)

Most side effects were mild or moderate and went away within 3 days of appearing.

Next to the above side effects, the following side effects occurred occasionally during general use of another vaccine similar to Fluad Tetra.

  • reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (thrombocytopenia); swelling of the glands in the neck, armpit or groin (lymphadenopathy)
  • swelling, pain and redness at the injection site extending to more than 10 cm and lasting more than one week (Injection site cellulitis-like reaction)
  • extensive swelling of injected limb lasting more than one week.
  • allergic reactions:
  • – sudden fall in blood pressure due to severe allergic reactions that in rare cases can lead to failure of the circulatory system to maintain adequate blood flow to the different organs (shock)

  • – swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema)

  • muscular weakness
  • pain on the nerve path (neuralgia), unusual feeling of touch, pain, heat and cold (paraesthesia), fits (convulsions), neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barre Syndrome)
  • skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash
  • severe skin rash (erythema multiforme)
  • blood vessel swelling that may cause skin rashes (vasculitis) and temporary kidney problems

Reporting of side effects

If you get any side effects, talk to your health care 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 website: . 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.

5. how to store fluad tetra

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

Store in a refrigerator (2 °C to 8 °C). Do not freeze. Discard if the vaccine has been frozen. Keep the pre-filled syringe in the outer carton in order to protect from light.

Do not use this medicine 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 your 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 Fluad Tetra contains

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

    per 0.5 ml dose

    A/Victoria/2570/2019 (H1N1)pdm09-like strain (A/Victoria/2570/2019 IVR-215)

    15 micrograms HA

    A/Cambodia/e0826360/2­020 (H3N2)-like strain (A/Cambodia/e0826360/2­020 IVR-224)

    15 micrograms HA

    B/Washington/02/2019-like strain (B/Victoria/705/2018 BVR-11)

    15 micrograms HA

    B/Phuket/3073/2013-like strain (B/Phuket/3073/2013 BVR-1B)

    15 micrograms HA

*propagated in fertilised hens’ eggs from healthy chicken flocks and adjuvanted with MF59C.1

**haemagglutinin

This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU recommendation for the 2021/2022 season.

  • – MF59C.1 is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines

to accelerate, improve and/or prolong the protective effects of the vaccine. MF59C.1 is an adjuvant that contains per 0.5 ml dose: squalene (9.75 mg), polysorbate 80 (1.175 mg), sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg) and citric acid (0.04 mg).

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

What Fluad Tetra looks like and contents of the pack

Fluad Tetra is a suspension for injection in a pre-filled (ready to use) syringe. Fluad Tetra is a milky-white suspension. A single syringe contains 0.5 ml of suspension for injection. Fluad Tetra is available in packs containing 1 or 10 pre-filled syringes with or without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Seqirus UK Ltd.

Point, 29 Market Street

Maidenhead SL6 8AA

United Kingdom

Manufacturer

Seqirus Vaccines Limited

Gaskill Road, Speke

L24 9GR Liverpool

United Kingdom

This leaflet was last revised in 07/2021.

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.

Gently shake before use. After shaking, the normal appearance of the vaccine is a milky white 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.

AIP007029A


When using a pre-filled syringe supplied without a needle, remove the tip cap from the syringe and then attach a suitable needle for administration. For Luer Lock syringes, remove the tip cap by unscrewing it in a counter-clockwise direction. Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks. Once the needle is locked in place, remove the needle protector and administer the vaccine.

AIP007029A FLUAD Leaflet NH21–22 QIV PFS 25G25 1×1 & 10X1 GB ROVI.indd 2

8/04/2021 1:41:31

PM

The drug is classified in the ATC tree:

Frequently Asked Questions

What is FLUAD TETRA used for?

FLUAD TETRA is a vaccine used to protect against influenza (the flu) caused by different strains of the virus.

How does FLUAD TETRA work?

FLUAD TETRA works by stimulating your immune system to produce antibodies against the flu viruses, helping protect you from infection.

Who should receive the FLUAD TETRA vaccine?

FLUAD TETRA is recommended for adults aged 65 and older, individuals with weakened immune systems, and those at high risk for flu complications.

Can FLUAD TETRA cause side effects?

Like all vaccines, FLUAD TETRA can cause side effects, such as soreness at the injection site, mild fever, or fatigue. These are usually temporary.

How often should I get vaccinated with FLUAD TETRA?

It is recommended to receive the FLUAD TETRA vaccine annually to ensure ongoing protection against the flu.

Is FLUAD TETRA safe during pregnancy?

Consult your healthcare provider regarding the use of FLUAD TETRA during pregnancy. Generally, it is considered safe for pregnant women at risk of influenza.

Can children receive FLUAD TETRA?

FLUAD TETRA is not typically recommended for children; check with your healthcare provider for appropriate flu vaccines for children.

Where can I get the FLUAD TETRA vaccine?

FLUAD TETRA can be obtained at clinics, pharmacies, and healthcare facilities that offer vaccinations.

How is FLUAD TETRA administered?

FLUAD TETRA is given as an injection into the muscle, usually in the upper arm.

What should I do if I miss my flu vaccine appointment?

If you miss your appointment, reschedule as soon as possible to ensure you receive your vaccination before flu season peaks.

Can I get the flu from the FLUAD TETRA vaccine?

No, you cannot get the flu from FLUAD TETRA as it contains inactivated viruses that cannot cause illness.

What should I do if I experience severe side effects after receiving FLUAD TETRA?

If you experience severe side effects such as difficulty breathing or swelling of the face, seek immediate medical attention.

How long does it take for FLUAD TETRA to become effective?

It usually takes about two weeks after vaccination for your body to develop sufficient protection against influenza.

Can I have the FLUAD TETRA vaccine if I have a cold or mild illness?

You should consult with your healthcare provider before getting vaccinated if you are currently experiencing an illness.

Are there any interactions between FLUAD TETRA and other medications?

Certain medications may affect vaccine efficacy. Always inform your doctor about any medications or allergies before vaccination.

Is there a specific time of year when I should get the FLUAD TETRA vaccine?

The best time to get vaccinated with FLUAD TETRA is in early fall before flu season starts; however, it can be given throughout the season.

How can I prepare for my vaccination with FLUAD TETRA?

Stay hydrated, wear loose clothing on vaccination day, and inform your healthcare provider of any health conditions or allergies.

What are my options if I'm allergic to components in FLUAD TETRA?

If you have allergies to components in traditional vaccines, discuss alternatives with your healthcare provider to ensure safety.

Can I have other vaccines at the same time as FLUAD TETRA?

Some vaccines can be given simultaneously with FLUAD TETRA; consult your healthcare provider for personalized advice.