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

• 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 (CTAB) and polysorbate 80, which are trace residues from the manufacturing process.
• if you have had a severe allergic reaction (e.g., anaphylaxis) to previous influenza vaccination.

Talk to your doctor, pharmacist or nurse before receiving Aujemflu.

BEFORE receiving this 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) after Aujemflu is given.
• You should tell your doctor or nurse if you are feeling nervous about the vaccination process or have ever fainted following an injection.
• You should tell your doctor or nurse if you have an acute illness which includes fever as a symptom. Your doctor may decide to delay your vaccination until your fever is gone. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
• You should tell your doctor or nurse if you have a bleeding problem, bruise easily or you use a medicine to prevent blood-clots.
• You should tell your doctor or nurse if your immune system is impaired, or if you are having treatment that affects the immune system, e.g., with medicine against cancer (chemotherapy) or corticosteriod medicines (see section “Other medicines and Aujemflu”).

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

Inflammation of large blood vessels (giant cell arteritis) has been reported after administration of influenza vaccines, including Aujemflu. This is a rare condition that may cause a severe headache, scalp tenderness, jaw pain or visual problems (see section 4, Possible side effects). If you experience any of these symptoms, seek immediate medical attention.

Aujemflu is not recommended for use in children.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before you are given this vaccine. Your doctor needs to assess the benefits and potential risks of giving you the vaccine.

Aujemflu has no or negligible effect on your ability to drive and use machines. However, some of the side effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect the ability to drive and use machines. Wait until these effects have worn off before driving and using machines.

This vaccine contains less than 1 mmol of sodium (23 mg) per dose, this means that it is essentially ‘sodium‑free’.

This vaccine contains less than 1 mmol of potassium (39 mg) per dose, this means that it is essentially ‘potassium-free’.

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

• Signs or symptoms of an allergic reaction (which may be severe) such as difficulty in breathing, dizziness, a weak and rapid pulse, skin rash
• Inflammation of large blood vessels which can cause symptoms such as severe headaches, pain or tenderness at the side of your head (temples) or on the scalp, jaw pain while eating or talking, vision problems (giant cell arteritis)

Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:

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

• Weakness of face muscles on one side of the face (Bell’s palsy)

Other side effects which may occur with Aujemflu include those listed below.

Adults 50 years of age and older

The following side effects have occurred with a similar vaccine in clinical studies in adults, including the elderly:

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

• Injection site pain
• Fatigue
• Headache
• Aching joints (arthralgia) and muscles (myalgia)

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

• Nausea
• Injection site hardness (induration) and bruising (ecchymosis)
• Fever

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

• Fainting (syncope)
• Dizziness
• Chills
• Injection site itching (pruritus)
• Injection site swelling

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

Elderly subjects, 65 years of age and older, generally reported fewer reactions compared to younger adults.

Unknown (Frequency cannot be estimated from the available data)

In addition to the side effects reported above from clinical studies, the following additional side effects have been reported with use of similar seasonal influenza vaccines:

• Temporary low blood platelet count which can result in bleeding or bruising (transient thrombocytopenia)
• Swollen lymph nodes (lymphadenopathy)
• Neurological disorders such as, severe stabbing or throbbing pain along one or more nerves (neuralgia), tingling (paraesthesia), inflammation of the nerves (neuritis), fits (convulsions), inflammation of the central nervous system (encephalomyelitis), a type of paralysis (Guillain-Barré syndrome), feeling about to faint (presyncope) and dizziness.
• Inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems (vasculitis)
• Generalised skin reactions including hives (urticaria), itchiness of the skin (pruritus), non-specific rash, severe skin rash (erythema multiforme), abnormal swelling of the skin, usually around the eyes, lips, tongue, hands or feet, due to an allergic reaction (angioedema), skin redness (erythema)
• Swelling, pain and redness at the injection site (injection site cellulitis-like reaction)
• Swelling of the lower legs or hands (peripheral swelling), extensive swelling of the vaccinated limb
• Pain in extremities, weakness of the muscles
• General weakness (asthenia), generally feeling unwell (malaise)

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 Yellow Card Scheme Website: 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.

• Active substance:

The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).

One dose (1.0 ml) of the vaccine contains 45 micrograms of haemagglutinin from the following influenza virus strains*:

A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022, CVR-167) 45 micrograms HA**

A/District of Columbia/27/2023 (H3N2)-like strain (A/Victoria/800/2024, CVR-289) 45 micrograms HA**

B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) 45 micrograms HA**

*propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown).

**haemagglutinin

• Adjuvant:

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 squalene, polysorbate 80, sorbitan trioleate, sodium citrate and citric acid.

• Other ingredients:

The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections, see section 2 Aujemflu contains sodium and potassium.

Aujemflu is a suspension for injection in a pre-filled syringe. It appears as a milky-white suspension.

It is provided in a ready-to-use syringe, containing a single dose (1.0 ml) for injection, in a pack of 1 or 10 pre-filled syringes, with or without needles.

Not all pack sizes are available.

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