Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - fluad

Document Subject

Generated Narrative: MedicinalProductDefinition mp2551c286e23d3921dbfab879452cee74

identifier: http://ema.europa.eu/identifier/EU/1/20/1433/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Fluad Tetra, suspension for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-2551c286e23d3921dbfab879452cee74

identifier: http://ema.europa.eu/identifier/EU/1/20/1433/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - fluad

Attesters

What is in this leaflet

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

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 of the ingredients in the vaccine can cause flu.

Fluad Tetra is used to prevent flu in adults 50 years of age and older.

The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2023/2024 season.

You should not receive Fluad Tetra

• if you are allergic to
  the active substances 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.

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 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 adults 50 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 .

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 50 years of age and older:

One dose of 0.5 ml

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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following serious 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)

The following side effects have been reported during clinical trials in adults 50 years of age and older.

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

• Pain at injection site
• Fatigue
• Headache
• Joint pain (arthralgia)1
• Muscular pain (myalgia)1 1 reported as Common in elderly subjects 65 years of age and older

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

• 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 symptoms2
• Fever ( 38 C)3 2 reported in elderly subjects 65 years of age and older 3 reported as Uncommon in elderly subjects 65 years of age and older

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

• Vomiting
• Swelling of the glands in the neck, armpit or groin (lymphadenopathy)

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 Fluad Tetra or a similar vaccine in elderly individuals 65 years of age and older.

• 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, pain and redness at the injection site (injection site cellulitis-like reaction)
• extensive swelling of injected limb lasting more than one week
• general weakness or lack of energy (asthenia), generally feeling unwell (malaise)
• fever (pyrexia)
• 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-Barr Syndrome)
• skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), skin redness (erythema), non-specific rash, severe skin rash (erythema multiforme)
• swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema)
• blood vessel swelling that may cause skin rashes (vasculitis) and temporary kidney problems
• fainting, feeling about to faint (syncope, presyncope)

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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/4897/2022 (H1N1)pdm09-like strain
(A/Victoria/4897/2022 IVR-238) 15 micrograms HA** A/Darwin/9/2021 (H3N2)-like strain
(A/Darwin/6/2021 IVR-227) 15 micrograms HA** B/Austria/1359417/2021-like strain (B/Austria/1359417/2021 BVR-26) 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 2023/2024 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 (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 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 and Manufacturer Seqirus Netherlands B.V. Paasheuvelweg 28,1105 BJ Amsterdam, Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Seqirus Netherlands B.V.Nederland/Netherlands Tel: +31 (0) 20 204 6
Seqirus Netherlands B.V.
.: +31 (0) 20 204 6 esk republika Seqirus Netherlands B.V. Nizozemsko Tel: +31 (0) 20 204 6Danmark Seqirus Netherlands B.V. Holland Tlf: +31 (0) 20 204 6Deutschland Seqirus GmbH Marburg Tel: 0800/3601Eesti Seqirus Netherlands B.V. Holland Tel: +31 (0) 20 204 6
WIN MEDICA . . : 210 7488Espa a Seqirus Spain, S.L., Barcelona Tel: 937 817 France Seqirus Netherlands B.V. Netherlands T l: +31 (0) 20 204 6Hrvatska Seqirus Netherlands B.V. Nizozemska Tel: +31 (0) 20 204 6Ireland Seqirus UK Limited Maidenhead Tel: +44 1628 641 sland Seqirus Netherlands B.V. Holland S mi: +31 (0) 20 204 6Italia Seqirus S.r.l. Siena Tel: +39 0577 096
Seqirus Netherlands B.V.
: +31 (0) 20 204 6Lietuva Seqirus Netherlands B.V. Nyderlandai Tel: +31 (0) 20 204 6Luxembourg/Luxemburg Seqirus Netherlands B.V. Netherlands T l/Tel: +31 (0) 20 204 6Magyarorsz g Seqirus Netherlands B.V. Hollandia Tel.: +31 (0) 20 204 6Malta Seqirus Netherlands B.V. In-Netherlands Tel: +31 (0) 20 204 6Nederland Seqirus Netherlands B.V. Amsterdam Tel: +31 (0) 20 204 6Norge Seqirus Netherlands B.V. Nederland Tlf: +31 (0) 20 204 6 sterreich Valneva Austria GmbH, Wien Tel: +43 1 20620 2Polska Seqirus Netherlands B.V. Holandia Tel.: +31 (0) 20 204 6Portugal Seqirus Netherlands B.V. Pa ses Baixos Tel: +31 (0) 20 204 6Rom nia Seqirus Netherlands B.V. Olanda Tel: +31 (0) 20 204 6Slovenija Seqirus Netherlands B.V. Nizozemska Tel: +31 (0) 20 204 6Slovensk republika Seqirus Netherlands B.V. Holandsko Tel: +31 (0) 20 204 6Suomi/Finland Seqirus Netherlands B.V. Alankomaat Puh/Tel: +31 (0) 20 204 6Sverige Seqirus Netherlands B.V. Nederl nderna Tel: +31 (0) 20 204 6Latvija Seqirus Netherlands B.V. N derlande Tel: +31 (0) 20 204 6This leaflet was last revised in {MM/YYYY}.

Other sources of information

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