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Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Aujemflu suspension for injection in pre-filled syringe

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Adjuvanted trivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures) may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Adjuvanted trivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Aujemflu is a vaccine against flu (influenza) for adults 50 years of age and older. 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. Aujemflu contains an adjuvant (a substance which is intended to boost your immune system's response to the vaccine). The vaccine is prepared in cell culture and, therefore, is egg-free. The vaccine targets three strains of influenza virus following the recommendations by the World Health Organisation for the 2025/2026 Season. 2.

What you need to know before you take it

e Aujemflu

You should not receive Aujemflu: 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.

1

Warnings and precautions 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. Children Aujemflu is not recommended for use in children. Other medicines and Aujemflu 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. Pregnancy and breast-feeding 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. Driving and using machines 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. Aujemflu contains sodium and potassium 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'. 3.

How to take it

Your doctor, nurse or pharmacist administers the vaccine in accordance with official recommendations. 2

Adults 50 years of age and older: One dose (1.0 ml) of the vaccine will be injected into the upper arm (deltoid muscle). 4.

Possible side effects

Like all medicines, Aujemflu can cause side effects, although not everybody gets them. Very serious side effects 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)

Serious side effects 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 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.

3

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), nonspecific 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)

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 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. 5.

How to store it

Aujemflu

Keep this vaccine out of the sight and reach of children. Do not use Aujemflu after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Discard if the vaccine has been frozen. Keep the prefilled syringe in the original carton in order to protect from light. 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 to protect the environment. 6.

Contents of the pack and other information

What Aujemflu contains Active substance: The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).

4

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) HA**

45 micrograms

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. What Aujemflu looks like and contents of the pack 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. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Seqirus UK Limited Point, 29 Market Street Maidenhead, SL6 8AA United Kingdom Manufacturer Seqirus Vaccines Ltd Gaskill Road, Speke, Liverpool L24 9GR United Kingdom This leaflet was last revised in 05/2026 —————————————————————————————-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.

5

Gently shake before use. After shaking, the normal appearance of Aujemflu 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. To use the pre-filled syringe without a needle supplied with a Luer Lock system, 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. Use a sterile needle of the appropriate size for intramuscular injection. Once the needle is locked in place, remove the needle protector and administer the vaccine.

6

Frequently asked questions about Aujemflu suspension for injection in pre-filled syringe

How do I take Aujemflu suspension for injection in pre-filled syringe?

Aujemflu suspension for injection in pre-filled syringe comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Aujemflu suspension for injection in pre-filled syringe?

The active substance in Aujemflu suspension for injection in pre-filled syringe is adjuvanted trivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures).

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Aujemflu suspension for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Aujemflu suspension for injection in pre-filled syringe without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

  • Source: electronic medicines compendium (emc), Datapharm
  • Active substance: adjuvanted trivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
  • Official document: view the original leaflet on emc →
Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Adjuvanted trivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Prophylaxis of influenza in adults 50 years of age and older.

Aujemflu should be used in accordance with official recommendations.

4.2. Posology and method of administration

Posology

One 1.0 ml dose.

Paediatric population

Safety and efficacy of Aujemflu in children from birth to less than 18 years has not been established. No data are available.

Method of administration

For intramuscular injection only.

The preferred injection site is the deltoid muscle of the upper arm.

The vaccine must not be injected intravascularly, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.

For instructions on handling and disposal, see section 6.6.

4.3. Contraindications

Hypersensitivity to the active substances, to any components of the adjuvant, to any excipients listed in section 6.1, or to possible trace residues such as beta-propiolactone, cetyltrimethylammonium bromide and polysorbate 80.

A severe allergic reaction (e.g., anaphylaxis) to a previous dose of an influenza vaccine.

4.4. Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded.

Hypersensitivity and anaphylaxis

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

Concurrent illness

Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. However, the presence of a minor infection and/or low-grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

Anxiety-related reactions

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.

Immunocompromised patients

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza.

Limitations of vaccine effectiveness

A protective immune response may not be elicited in all vaccine recipients.

Giant cell arteritis

Giant cell arteritis (GCA) is a rare condition and has been reported in temporal relation with influenza vaccination, including two case reports after administration of Aujemflu in a clinical trial (see section 4.8). Healthcare professionals should be alert to the clinical signs and symptoms suggestive of GCA such as a severe headache, scalp tenderness, jaw pain or visual disturbances and advise vaccine recipients, especially those at increased risk of GCA (older adults, women and individuals with polymyalgia rheumatica), to seek immediate medical attention if they experience such symptoms.

Excipients with known effect

Sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose, this means it is essentially 'sodium-free'.

Potassium

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

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. If Aujemflu is given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered to separate limbs. It should be noted that adverse reactions may be intensified.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of Aujemflu in pregnant women.

There have been no reproductive and developmental toxicology studies with Aujemflu. Reproductive and developmental toxicology data from cell-based trivalent influenza vaccine (TIVc) and MF59 do not predict an increased risk of developmental abnormalities.

Breast‑feeding

Aujemflu has not been evaluated during breast-feeding. The vaccine is not expected to be excreted in human milk and no effects on the breastfed newborn/infant are anticipated.

Fertility

No human fertility data are available. Animal data, with cell-based trivalent influenza vaccine (TIVc) and MF59, have not shown effects on female fertility. Male fertility has not been assessed in animals.

4.7. Effects on ability to drive and use machines

Aujemflu has no or negligible influence on the ability to drive and use machines. However, some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery.

4.8. Undesirable effects

Summary of the safety profile

Data with aQIVc, a quadrivalent formulation of Aujemflu, are relevant to Aujemflu because both vaccines are manufactured using the same process and have overlapping compositions.

The most commonly reported (≥10%) adverse reactions reported in adults 50 to 64 years of age following administration of aQIVc were injection site pain (54%), fatigue (38%), headache (27%), myalgia (21%) and arthralgia (20%).

The most commonly reported (≥10%) adverse reactions reported in adults 65 years of age and older following administration of aQIVc were injection site pain (38%), fatigue (28%), headache (17%), arthralgia (14%) and myalgia (13%)

Most solicited reactions were reported as mild or moderate in intensity and resolved within the first 3 days after vaccination.

Tabulated list of adverse reactions

The frequencies of adverse reactions are based on a clinical study (V201_03) in which 3282 adults 50 years of age and older received aQIVc.

The adverse reactions are listed according to the following MedDRA frequency convention and system organ class: Very common (≥1/10); Common (≥1/100 to <1/10); Rare (≥1/10 000 to <1/1 000).

Table 1: Adverse reactions reported in adults 50 years of age and older

MedDRA system organ class

Very common

(≥1/10)

Common

(≥1/100 to <1/10)

Rare

(≥1/10 000 to <1/1 000)

Nervous system disorders

Headache

Dizzinessa, Bell's palsya, syncope

Vascular disorders

Giant cell arteritisa

Gastrointestinal disorders

Nausea

Musculoskeletal and connective tissue disorders

Arthralgia, myalgia

General disorders and administration site conditions

Injection site pain, fatigue

Injection site induration, injection site erythema, fever

Chillsa, injection site pruritusa, injection site swelling

a unsolicited adverse reaction reported within 29 days of vaccination.

Description of selected adverse reactions

Giant cell arteritis

In the Phase 3 study V201_03, one serious case of giant cell arteritis (GCA) was reported in an elderly female study participant on Day 5 after vaccination with aQIVc, and one non-serious case of a relapse of GCA was reported in an elderly female participant with a known history of GCA on Day 2 after vaccination with aQIVc.

Elderly population

Elderly individuals 65 years and older generally reported fewer solicited local and systemic reactions compared to younger adults.

Adverse reactions from post-marketing experience

There is no post-marketing experience following administration of Aujemflu. However, the following post-marketing adverse events have been reported after use of seasonal influenza vaccines that are made using the same cell-based manufacturing process or contain the same MF59 adjuvant as Aujemflu (Table 2).

Table 2: Post-marketing experience reported after use of similar influenza vaccines

MedDRA system organ class

Adverse reaction1

Blood and lymphatic system disorders

Thrombocytopenia (some cases were severe with platelet counts less than 5,000 per mm3), lymphadenopathy

Immune system disorders

Allergic reactions including anaphylactic shock (in rare cases), anaphylaxis

Nervous system disorders

Encephalomyelitis, Guillain-Barré Syndrome, convulsions, neuritis, neuralgia, paraesthesia, presyncope

Vascular disorders

Vasculitis which may be associated with transient renal involvement

Skin and subcutaneous tissue disorders

Generalised skin reactions including erythema multiforme, urticaria, pruritus or non-specific rash, erythema, angioedema

Musculoskeletal and connective tissue disorders:

Muscular weakness, pain in extremity

General disorders and administration site conditions

Extensive swelling of injected limb, injection site cellulitis-like reaction, peripheral swelling, asthenia, malaise

1 Frequency not known (cannot be estimated from the available data)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9. Overdose

There is insufficient experience on overdose with Aujemflu. In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Adjuvanted trivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures). The products below do not contain exactly the same set of active substances — they are not direct substitutes.

  • BCG VACCINE prescription partial — not the same combinationVACCIN BCG · injection / infusion

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

  • Onko BCG 100BCG vaccinum 100 mg

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Aujemflu suspension for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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