Quadrivalent Influenza Vaccine Split Virion Inactivated High-Dose suspension for injection in pre-filled syringe

• 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 for you only. Do not pass it on to others.
• 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.

1. What Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose is and what it is used for
2. What you need to know before you use Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose
3. How to use Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose
4. Possible side effects
5. How to store Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose
6. Contents of the pack and other information

• if you are allergic to:
  • the active substances, or
  • any of the other ingredients of this vaccine (listed in Section 6), or
  • any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins) and formaldehyde.

Talk to your doctor, pharmacist or nurse before using QIV High-Dose.

You should tell your doctor before vaccination if you have:

• a poor immune response (immunodeficiency or taking medicines affecting the immune system),
• bleeding problem or bruising easily,
• experienced Guillain-Barré syndrome (GBS) (severe muscle weakness) after getting a flu vaccine.
• if you have an illness with a high or moderate temperature or an acute illness, the vaccination should be postponed until after you have recovered.

Your doctor will decide if you should receive the vaccine.

Fainting can occur following, or even before, any needle injection. Therefore tell your doctor or nurse if you fainted with a previous injection.

As with all vaccines, QIV High-Dose may not fully protect all persons who are vaccinated.

If, for any reason, you have a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.

This vaccine should not be used in children, it is only for use in adults aged 60 and older.

Tell your doctor or pharmacist if you are receiving, have recently received or might receive any other vaccines or any other medicines.

• If QIV High-Dose is to be given at the same time as other vaccines, the vaccines should always be administered by using separate limbs.
• It should be noted that the adverse reactions may be intensified by any co-administration.
• The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.

QIV High-Dose is only indicated for use in adults aged 60 years and older.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this vaccine. Your doctor/pharmacist will help you decide if you should receive QIV High-Dose.

QIV High-Dose has no or negligible influence on the ability to drive or use machines. However, if you are feeling unwell or dizzy it is not wise to drive.

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

Your doctor, pharmacist or nurse will administer the recommended dose of the vaccine as an injection into the muscle or under the skin.

See a doctor IMMEDIATELY if you experience:

• Severe allergic reactions:
  • that may lead to medical emergency with low blood pressure, shortness of breath, wheezing or trouble breathing, rapid heart rate and weak pulse, cold, clammy skin, dizziness, that may lead to collapse (anaphylaxis [including angioedema, i.e. swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body and which may cause difficulty in swallowing or breathing]).

See a doctor if you experience:

• Allergic reactions such as skin reactions that may spread throughout the body including itching, hives, rash.

These side effects are rare (may affect up to 1 in 1,000 people).

The below side effects were reported in adults 60 years of age and older.

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

• Reactions at the injection site: pain, redness (erythema)
• Generally feeling unwell (malaise), headache, muscular pain (myalgia)

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

• Reactions at the injection site: swelling, bruising, hardness (induration)
• Fever, chills (shivering)

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

• Reactions at the injection site: pruritus
• Fatigue, lethargy, feeling sick (nausea), vomiting, diarrhoea
• Cough, muscle weakness, indigestion (dyspepsia), inflammation of the throat (oropharyngeal pain)

Rare (may affect up to 1 in 1000 people):

• Abnormal lack of energy (asthenia), flushing, joint pain (arthralgia), dizziness, night sweats, rash, numbness or pins and needles sensation (paresthesia), inflammation of the nose (rhinorrhea), vertigo, excess of blood in the white of the eye (ocular hyperemia)
• Pain in extremities

Not known: frequency cannot be estimated from the available data

• 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)
• 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 and transverse myelitis, brachial neuritis, Guillain-Barré Syndrome), facial palsy (Bell’s palsy), vision disorders due to the optic nerves dysfunction (optic neuritis/neuropathy), fits (convulsions including febrile convulsions), fainting (syncope) shortly after vaccination
• Blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems, blood vessel opening (vasodilatation)
• Chest pain
• Wheezing, throat tightness, difficulty breathing (dyspnea).

Most side effects usually occurred within the 3 days following vaccination, and resolved within 3 days. The intensity of these side effects was mild to moderate.

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

• The active substances are: Influenza virus (inactivated, split) of the following strains*:

A/Victoria/4897/2022 (H1N1)pdm09-like strain

(A/Victoria/4897/2022, IVR-238).........60 micrograms HA**

A/Thailand/8/2022 (H3N2)-like strain

(A/California/122/2022, SAN-022)......60 micrograms HA**

B/Austria/1359417/2021-like strain

(B/Michigan/01/2021, wild type)........60 micrograms HA**

B/Phuket/3073/2013-like strain

(B/Phuket/3073/2013, wild type)........60 micrograms HA**

Per 0.7 ml dose

* propagated in embryonated chicken eggs

** haemagglutinin

This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2024/2025 season.

The other ingredients are: a buffer solution containing sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, water for injections and octoxinol-9.

Some components such as eggs (ovalbumin, chicken proteins) or formaldehyde may be present in very small amounts (see Section 2).

The vaccine, after shaking gently, is a colourless opalescent liquid.

QIV High-Dose is a 0.7 ml suspension for injection presented in a pre-filled syringe with or without needle (in box of 1, 5 or 10) or with safety needle (in box of 1 or 10).

Not all pack sizes may be marketed.

The Marketing Authorisation Holder is:

The Manufacturer is: