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

Pharmacy Guide

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

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Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre‐filled syringe

What it is and what it is used for

for

3.

Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is a vaccine for use in individuals 6 months of age and older, intended to be given in the context of outbreaks of zoonotic influenza (coming from birds) to prevent flu caused by H5 subtype influenza A viruses. Zoonotic influenza viruses occasionally infect humans, and can cause disease ranging from mild upper respiratory infection (fever and cough) to rapid progression to severe pneumonia, acute respiratory distress syndrome, shock and even death. Human infections are primarily caused by contact with infected animals, but do not spread easily between people. Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is intended also to be given when there is anticipation of a possible pandemic due to the same or a similar strain. When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. 2.

What you need to know before you take it

e Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8

You should not receive Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8: if you have previously had a sudden life-threatening allergic reaction to any ingredient of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 (listed in section 6) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics), hydrocortisone or cetyltrimethylammonium bromide (CTAB). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 2

Warnings and precautions Talk to your doctor or nurse before having this vaccine •

if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and chicken protein, ovalbumin, formaldehyde, hydrocortisone, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6. Further information).

•

if you have a severe infection with a high temperature (over 38°C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8.

•

if you are having immunosuppressive therapy, e.g. corticosteroid treatment or chemotherapy for cancer, or if you have any condition which makes you prone to infections (immunodeficiency conditions)

•

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. Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 may not fully protect everyone who is vaccinated, especially elderly subjects and those with weakened immune systems, such as HIV patients, or those with underlying long term medical problems, such as diabetes, lung disease or heart problems. Tell your doctor if you have a weak immune system or an underlying long term medical problem. In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed. Other medicines and Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or have recently received any other vaccine. Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 can be given at the same time as non-adjuvanted seasonal influenza vaccines. There is no information on administration of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 with non-influenza vaccines. If administration of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 with other vaccines can not be avoided, the vaccines should be injected into separate limbs. In such cases, you should be aware that the side effects may be more intense. Children Vaccination is currently not recommended in children less than 6 months of age. 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 receiving this vaccine. Your doctor needs to assess the benefits and potential risks of giving you the vaccine. Driving and using machines Some effects mentioned under section 4. "Possible side effects" may affect the ability to drive or use machines. 3

Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 contains sodium and potassium. Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium-free. 3.

How to take it

Your doctor or nurse will administer the vaccine in accordance with official recommendations. A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle) or upper thigh, depending on the muscle mass. The vaccine should never be given into a vein. Two doses of 0.5 ml will be given with an interval of at least 3 weeks. There is limited experience in elderly over 70 years of age. If you have any further questions on the use of this medicinal product, ask your doctor or nurse. 4.

Possible side effects

Like all medicines, Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 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 side effect – you may need urgent medical attention or hospitalisation:

  • difficulty in breathing, wheezing, swelling of the throat, dizziness, a weak and rapid pulse, decreased blood pressure and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction) The side effects listed below have occurred with a vaccine similar to Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 in clinical studies in adults: Very common (affects more than 1 user in 10): • At the site of injection: pain/tenderness, hardening of the skin, redness, swelling • Aching muscles • Headache • Fatigue • Generally feeling unwell • Shivering Common (affects 1 to 10 users in 100): • Aching joints • Injection site bleeding and bruising • Fever (uncommon in individuals over 60 years of age) • Sweating • Nausea • Diarrhoea • Vomiting • Loss of appetite Uncommon (affects 1 to 10 users in 1000) • Hives (urticaria)

4

These side effects are usually mild and disappear within 3 days without treatment. If they persist, CONSULT YOUR DOCTOR. The side effects listed below have occurred with a vaccine similar to Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 in clinical studies in children: 6 months to less than 3 years of age Very common (affects more than 1 user in 10):

  • At the site of injection: tenderness, redness, hardening of the skin, swelling, bruising
  • Change in eating habits
  • Diarrhoea
  • Vomiting
  • Sweating and unusual sweating
  • Sleepiness
  • Iritability
  • Unusual crying
  • Fever (≥38° C) Common (affects 1 to 10 users in 100):
  • Injection site bleeding
  • Shivering 3 years to less than 18 years of age Very common (affects more than 1 user in 10):
  • At the site of injection: pain, redness, hardening of the skin, swelling, bruising
  • Headache
  • Diarrhoea
  • Nausea
  • Sweating
  • Muscle soreness
  • Feeling generally unwell
  • Fatigue
  • Shivering
  • Fever (≥38° C)*
  • Reported as common in the 9 to <18 year old population Common (affects 1 to 10 users in 100):
  • Vomiting
  • Aching joints
  • Loss of appetite Undesirable effects in patients with underlying long term medical problems such as diabetes, lung disease or heart problems and weakened immune systems (immunocompromised) such as HIV patients Very common (affects more than 1 user in 10): Nausea, aching joints, diarrhoea and loss of appetite Common (affects 1 to 10 users in 100): Vomiting Other rare side effects observed after routine use: The additional side effects listed below have occurred in the days or weeks after vaccination with another vaccine similar vaccine. These side effects may occur with Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8. •

Generalised skin reactions including 5

• • •

Itching Rash or swelling of the skin and mucous membranes Angioedema (abnormal swelling of the skin, usually around the eyes, lips, tongue, hands or feet, due to an allergic reaction)

•

Disorders of the gut such as abdominal pain

•

Neurological disorders such as • Severe stabbing or throbbing pain along one or more nerves • Tingling • Fits • Neuritis (inflammation of nerves) • Syncope or presyncope (fainting or feeling about to faint) • Dizziness, drowsiness

•

Swollen lymph nodes, palpitations (irregular or forceful heartbeat), tachycardia (faster than normal heart beat), weakness, pain in the extremities, cough and asthenia (unusual weakness).

In addition, side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and not-adjuvanted vaccines given routinely every year to prevent seasonal flu. These side effects may occur with Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8. • • • • • •

Low blood platelet count which can result in bleeding or bruising Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) Erythema multiforme (type of allergic skin reaction that occurs in response to medications, infections, or illness) Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome Swelling, pain and redness at the injection site (injection site cellulitis-like reaction) Extensive swelling of injected limb

Reporting of side effects If you get any side effects, talk to your doctor 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

Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8

Keep this vaccine out of the sight and reach of children. Do not use Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 after the expiry date which is stated on the carton and the label. The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light. Do not throw 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

6.

Contents of the pack and other information

What Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 contains –

Active Substance: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b) 7.5 micrograms** per 0.5 ml dose * **

propagated in fertilised hens' eggs from healthy chicken flocks expressed in microgram haemagglutinin.

–

Adjuvant MF59C.1: The vaccine contains per 0.5 ml 9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate.

–

Other ingredients: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.

What Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 looks like and contents of the pack Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is a suspension for injection in a pre-filled syringe. The suspension is a milky-white liquid. It is provided in a ready-to-use pre-filled syringe, containing a single dose of 0.5 ml for injection. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Seqirus UK Ltd Point, 29 Market Street Maidenhead SL6 8AA UK Manufacturer Seqirus Vaccines Ltd Gaskill Road, Speke, Liverpool L24 9GR UK Seqirus Netherlands B.V. Paasheuvelweg 28 1105BJ Amsterdam Netherlands This leaflet was last revised in 10/2024

7

Frequently asked questions about Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre‐filled syringe

How do I take Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre‐filled syringe?

Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus 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 Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre‐filled syringe?

The active substance in Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre‐filled syringe is influenza vaccine (surface antigen, inactivated).

Are there equivalent medicines to Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre‐filled syringe?

Medicines with the same active substance, strength and form include: Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1, Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe, Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus 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 Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus 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: influenza vaccine (surface antigen, inactivated)
  • 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: Influenza vaccine (surface antigen, inactivated) (5 medicines)
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

Active immunisation against H5 subtype of Influenza A virus in individuals 6 months of age and above.

Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 should be used in accordance with official recommendations.

4.2. Posology and method of administration

Posology

Two doses (0.5 ml each), at least 21 days apart.

Data on a third dose (booster) administered 6 months after the first dose are limited (see sections 4.8 and 5.1).

In the event of an officially declared influenza pandemic due to A/H5 virus, individuals previously vaccinated with one or two doses of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 that contained haemagglutinin (HA) antigen derived from a different clade of the same influenza subtype as the influenza pandemic strain may receive a single dose of adjuvanted H5 pandemic vaccine instead of two doses that are required in previously unvaccinated individuals (see section 5.1).

Paediatric population

No data are available in children aged less than 6 months.

Elderly

There is limited experience in elderly over 70 years of age (see section 5.1).

Method of administration

The vaccine is administered by intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older individuals

The vaccine should under no circumstances be administered intravascularly or intradermally.

4.3. Contraindications

History of an anaphylactic (i.e. life‑threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide) of this 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 product should be clearly recorded.

Hypersensitivity and anaphylaxis

Caution is needed when administrating this vaccine to individuals with a known hypersensitivity to the active substance, to any of the excipients listed in section 6.1 and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide).

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Concurrent illness

Immunisation should be postponed in patients with febrile illness until the fever is resolved.

Anxiety-related reactions

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from fainting.

Immunocompromised individuals

Immunocompromised individuals, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced immune response to active immunisation.

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..

Protection against influenza

There is no immune correlate of protection established for influenza A/H5 strains.

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

Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of Zoonotic Influenza Vaccine H5N1. However, the degree of protection that may be elicited to H5N1 strains of other clades is unknown (see section 5.1).

There are no safety, immunogenicity or efficacy data to support interchangeability of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 with other H5 monovalent vaccines.

Excipients with known effect

Sodium

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium free'

Potassium

This vaccine contains potassium, less than 1 mmol (39 mg) per dose, that is to say essentially 'potassium-free'.

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

Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 may be co‑administered with non‑adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs.

There are no data on co‑administration of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 with other vaccines. If co‑administration with another vaccine is considered, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

4.6. Fertility, pregnancy and lactation

Pregnancy

No data are available regarding the use of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 during pregnancy.

Limited data obtained from women who became pregnant during the course of clinical trials with Zoonotic Influenza Vaccine H5N1 or similar pandemic H1N1 vaccines adjuvanted with MF59C.1 were insufficient to inform vaccine-associated risks in pregnancy.

However, it is estimated that during the 2009 H1N1 pandemic more than 90,000 women were vaccinated during pregnancy with an H1N1 pandemic vaccine similar to zoonotic influenza vaccine H5N1 which contains the same amount of adjuvant MF59C.1 as Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8.

Post-marketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of H1N1 vaccine exposure on pregnancy.

In addition, two large observational studies designed to assess the safety of H1N1 vaccine exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10,000 vaccinated pregnant women and their offspring compared with unvaccinated controls.

Since Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is expected not to be used in an emergency situation, its administration during pregnancy might be deferred as a precautionary approach.

Healthcare providers need to assess the benefit and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.

Breast‑feeding

There are no data regarding the use of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 during breast‑feeding.

The potential benefits to the mother and risks to the infant should be considered before administering Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 during breast‑feeding.

Fertility

There are no data concerning human fertility with Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8. A study in rabbits did not indicate reproductive or developmental toxicity of Zoonotic influenza Vaccine H5N1 (see section 5.3). Male fertility has not been assessed in animals.

4.7. Effects on ability to drive and use machines

Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or operate machinery.

4.8. Undesirable effects

Summary of the safety profile

The safety of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is inferred from safety data of the zoonotic influenza H5N1 vaccine (7.5 or 15 micrograms haemagglutinin, HA) containing either the A/turkey/Turkey/1/2005 or the A/Vietnam/1194/2004 strain, which has been evaluated in nine clinical trials in healthy subjects involving 5055 adults, elderly and children. There were 4041 adults subjects 18 to 60 years of age, 540 elderly subjects 61 years of age and above. In the paediatric population, there were 214 subjects 6 to 35 months of age, 167 subjects 3 to 8 years of age and 93 subjects 9 to 17 years of age.

The overall safety profile was similar across the adult, elderly and paediatric populations.

Irrespective of antigen dose or age group, most local and systemic adverse reactions after administration were of short duration, with onset close to the time of vaccination, and were mild or moderate in severity. The majority of these reactions usually disappeared within 3 days without treatment. Across all trials, there was a general trend towards decreased reports of local adverse reactions after the second vaccination compared with the first.

In adults 18 to 60 years, the most frequently reported (≥ 10%) adverse reactions were injection site pain (59%), myalgia (34%), headache (26%), injection site redness (24%), fatigue (24%), injection site induration (21%), injection site swelling (15%), chills (13%) and malaise (13%).

In elderly subjects (≥ 61 years), the most frequently reported (≥ 10%) adverse reactions were injection site pain (35%), myalgia (24%), injection site redness (17%), headache (16%), chills (12%), fatigue (10%) and malaise (10%).

In children and adolescents 3 to 17 years of age, the most frequently reported (≥10%) adverse reactions were injection site pain (95%), headache (61%), myalgia (60%), fatigue (41%), injection site redness (60%), injection site induration (34%), injection site swelling (34%), malaise (32%), nausea (25%), sweating (18%), chills (19%), diarrhoea (18%) and injection site ecchymosis (16%).

In infants and children 6 to 35 months of age, the most frequently reported (≥10%) adverse reactions were injection site redness (62%), irritability (57%), tenderness (55%), unusual crying (48%), sleepiness (45%), injection site induration (38%), injection site swelling (37%) change in eating habits (36%), diarrhoea (34%), fever (27%), injection site ecchymosis (19%), vomiting (10%), sweating, (10%) and unusual sweating (10%).

Tabulated list of adverse reactions

The solicited and unsolicited adverse reactions reported after any vaccination doses (i.e. first, second or booster) across subjects age, are listed according to the following MedDRA frequency convention and system organ class:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).

MedDRA System Organ class

Very common

(≥1/10)

Common

(≥1/100 to <1/10)

Uncommon

(≥1/1,000 to <1/100)

Rare

(≥1/10,000 to <1/1,000)

Immune system disorders

Anaphylaxis

Metabolism and nutrition disorders

Change in eating habits1

Loss of appetite

Nervous system disorders

Headache

Gastrointestinal disorders

Nausea2, Diarrhoea2, Vomiting2

Skin and subcutaneous tissue disorders

Sweating2, Unusual sweating1

Urticaria

Musculoskeletal and connective tissue disorders

Myalgia

Arthralgia

General disorders and administration site conditions

Injection site swelling, pain, tenderness1, induration, redness, ecchymosis2, Fatigue, Malaise, Chills/Shivering, Sleepiness1, Irritability1, Unusual crying1, Fever3

Injection site haemorrhage

1 Reported only in paediatric subjects 6-35 months

2 Reported as Common in adults (18-60 years) and elderly (≥ 61 years)

3 Reported as Very common only in paediatric subjects 6 months-8 years. Reported as Common in adolescents and adults 9 60 years of age and Uncommon in eldery (≥ 61 years)

Clinical trials in special populations

Adverse reactions in special populations have been evaluated in two clinical trials, V87_25 and V87_26, involving adult (18-60 years) and elderly (≥ 61 years) subjects who were either healthy or with underlying medical conditions or immunosuppressive conditions.

Across studies V87_25 and V87_26, the safety of the H5N1 A/turkey/Turkey/1/2005 vaccine in healthy adult and elderly subjects was consistent with existing safety data from previous clinical trials. However, in immunocompromised subjects 18 to 60 years of age, slightly higher rates of nausea (13.0%) were reported. In addition, higher rates of arthralgia (up to 23.3%) were reported in both adult and elderly subjects, who were immunocompromised or with underlying medical conditions.

The following solicited adverse reactions were additionally collected in these two studies and reported with the following frequencies irrespective of age or health status: diarrhoea (up to 11.9%), loss of appetite (up to 10.9%) and vomiting (up to 1.7%). In both studies, subjects with underlying medical and immunosuppressive conditions reported higher frequencies of diarrhoea, loss of appetite and vomiting compared to healthy subjects (irrespective of age).

Post‑marketing surveillance

No post‑marketing experience exists for Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8.

In addition to the adverse events listed from clinical studies, the following adverse events were reported from post-marketing surveillance with an H1N1 pandemic vaccine (licensed for use from 6 months of age during the 2009 influenza pandemic, and containing the same MF59 adjuvant and manufactured with the same process as Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8).

Blood and lymphatic system disorders

Lymphadenopathy.

Immune system disorders

Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.

Nervous system disorders

Dizziness, somnolence, syncope, presyncope, neuralgia, paraesthesia, convulsions and neuritis.

Cardiac disorders

Palpitation, tachycardia.

Respiratory , thoracic and mediastinal disorders

Cough.

Gastrointestinal disorders

Abdominal pain.

Skin and subcutaneous tissue disorders

Generalised skin reactions including pruritus, non‑specific rash, angioedema.

Muscoskeletal and connective tissue disorders

Muscular weakness, pain in extremities.

General disorders and administration site conditions

Asthenia.

The following additional adverse events were reported from post‑marketing surveillance with seasonal non‑adjuvanted trivalent vaccines in all age groups and a seasonal trivalent MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older:

Blood and lymphatic system disorders

Thrombocytopenia (in some cases reversible platelet counts less than 5000 mm3).

Nervous system disorders

Neurological disorders, such as encephalomyelitis and Guillain Barré syndrome.

Vascular disorders

Vasculitis with transient renal involvement.

Skin and subcutaneous tissue disorders

Erythema multiforme.

General disorders and administration site conditions

Extensive swelling of injected limb lasting more than one week, injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week).

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

No case of overdose has been reported.

💬 Ask about this leaflet

Ask anything about Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus 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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