Zoonotic influenza vaccine Seqirus

Package leaflet: Information for the user

Zoonotic Influenza Vaccine Seqirus, injectable suspension in pre-filled syringe.

Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted)
Please read this leaflet carefully before you are given this vaccine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What Zoonotic Influenza Vaccine Seqirus is and what it is used for
2. What you need to know before receiving Zoonotic Influenza Vaccine Seqirus
3. How Zoonotic Influenza Vaccine Seqirus is administered
4. Possible side effects
5. How to store Zoonotic Influenza Vaccine Seqirus
6. Contents of the pack and other information

1. What Zoonotic Influenza Vaccine Seqirus is and what it is used for

Zoonotic Influenza Vaccine Seqirus is a vaccine for individuals aged 6 months and older, intended to be administered during epidemics caused by zoonotic influenza viruses (transmitted from birds), to prevent influenza caused by influenza A subtype H5 viruses.
Zoonotic influenza viruses occasionally infect humans and can cause illnesses ranging from mild upper respiratory tract infections (fever and cough) to rapid progression to severe lung infection, acute respiratory distress syndrome, shock, and even death. Human infections are primarily due to contact with infected animals, but these viruses do not spread easily from person to person.
Zoonotic Influenza Vaccine Seqirus is also intended for administration when a possible pandemic caused by the same viral strain contained in the vaccine or by a similar strain is anticipated.
After administration of the vaccine, the immune system (the body's natural defence system) produces its own defences (antibodies) against the disease. None of the components of the vaccine can cause influenza.

2. What you should know before receiving Zoonotic Influenza Vaccine Seqirus

Do not receive Zoonotic Influenza Vaccine Seqirus

• if you have previously had a sudden, life-threatening allergic reaction to any component of Zoonotic Influenza Vaccine Seqirus (listed in section 6) or to any component that may be present as trace amounts, such as egg or chicken proteins, ovalbumin, formaldehyde, kanamycin and neomycin sulfate (antibiotics), hydrocortisone or cetyltrimethylammonium bromide (CTAB). Signs of an allergic reaction may include itchy rash, difficulty breathing, or swelling of the face or tongue. However, during a pandemic influenza outbreak, it may be advisable to receive Zoonotic Influenza Vaccine Seqirus, provided that appropriate medical care is immediately available in case an allergic reaction occurs.

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

• if you have any allergic reaction to any component of the vaccine, egg or chicken proteins, ovalbumin, formaldehyde, kanamycin and neomycin sulfate (antibiotics), hydrocortisone or cetyltrimethylammonium bromide (CTAB) (see section 6, "Other information");
• if you have a severe infection accompanied by fever (above 38°C). In such cases, vaccination is usually postponed until you feel better. Minor infections such as the common cold generally do not pose a problem; your doctor or nurse will advise you whether you can receive Zoonotic Influenza Vaccine Seqirus;
• if you have bleeding disorders or bruise easily.

Fainting may occur following, or even before, any injection with a needle. Therefore,
inform your doctor or nurse if you have previously fainted after an injection.
Zoonotic Influenza Vaccine Seqirus may not fully protect all vaccinated individuals,
particularly elderly people and those with weakened immune systems, such as HIV patients,
or those with long-term underlying medical conditions such as diabetes, lung disease, or
heart problems. Inform your doctor if your immune system is weakened or if you have a
long-term underlying medical condition.
INFORM YOUR DOCTOR OR NURSE IN THESE CASES, as vaccination may not be recommended or may need to be postponed.

Children
Children under 6 months of age
Currently, vaccination is not recommended in this age group.

Other medicines and Zoonotic Influenza Vaccine Seqirus
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription, or if you have recently received another vaccine.
If administration of Zoonotic Influenza Vaccine Seqirus together with other vaccines cannot be avoided, the vaccines should be injected in separate limbs. In such cases, you should know that side effects may be more pronounced.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or nurse before receiving this vaccine. Your doctor must evaluate the benefits and potential risks of administering the vaccine.

Driving and using machines
Some of the side effects listed in section 4, "Possible side effects", may affect your ability to drive or operate machinery.

Zoonotic Influenza Vaccine Seqirus contains sodium and potassium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially 'potassium-free'.

3. How Zoonotic Influenza Vaccine Seqirus is administered

Your doctor or nurse will administer the vaccine according to official recommendations.
One dose (0.5 mL) of the vaccine will be injected into the upper arm (deltoid muscle) or
into the upper thigh, depending on muscle mass. The vaccine must never be administered intravenously.
Subjects aged 6 months and older:
A dose of 0.5 mL will be administered. A second dose of 0.5 mL should be given after an interval of at least 3 weeks.
Experience in elderly individuals over 70 years of age is limited.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, Zoonotic Influenza Vaccine Seqirus can cause side effects, although
not everyone experiences them.
Contact your doctor immediately or go to the nearest hospital emergency department if
you experience the following side effect; urgent medical treatment or hospitalisation
may be required:

• difficulty breathing, dizziness, weak and rapid pulse, and skin rash, which are symptoms of anaphylactic reaction (a very severe allergic reaction)

Allergic reactions may occur after vaccination, which can be serious. Your doctor is
aware of this possibility and has the necessary emergency treatment available for such
cases. Contact your doctor immediately if you experience any of the following signs or symptoms of a severe allergic reaction: difficulty breathing, swelling, mental confusion, rapid heartbeat, sweating, and loss of consciousness.
The side effects listed below have been observed with the use of a vaccine similar to Zoonotic
Influenza Vaccine Seqirus, based on a similar virus (H5N1), in clinical studies conducted in adults,
including the elderly, and children. These side effects may occur with Zoonotic Influenza
Vaccine Seqirus.
Side effects observed in clinical studies:
Very common (may affect more than 1 in 10 people):

• Pain/tenderness at the injection site
• Hardening of the skin at the injection site
• Redness at the injection site
• Swelling at the injection site
• Bruising at the injection site*
• Muscle pain
• Headache
• Fatigue
• General feeling of discomfort
• Chills
• Sweating*
• Nausea*
• Change in eating habits**
• Diarrhoea
• Vomiting
• Sweating and unusual sweating**
• Drowsiness**
• Irritability**
• Unusual crying**
• Fever*** * Reported with common frequency in adults and elderly ** Reported only in infants and young children aged 6 to 35 months *** Reported with very common frequency only in children aged 6 months to 8 years. Reported with common frequency in adolescents and adults aged 9 to 60 years, and with uncommon frequency in the elderly (over 61 years) Common (may affect up to 1 in 10 people):
• Joint pain
• Bleeding at the injection site
• Loss of appetite

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

• Hives

These side effects usually resolve within 1–2 days without treatment. If they persist, CONSULT YOUR DOCTOR.
Side effects in people with pre-existing chronic conditions such as diabetes, lung disease, heart problems, or weakened immune system (immunocompromised), including HIV patients
Nausea, joint pain, diarrhoea, and loss of appetite have been reported very
commonly. In addition, vomiting has been reported commonly.
Additional side effects observed after routine administration
The additional side effects listed below have occurred in the days or weeks
following vaccination with another vaccine based on a similar virus (H1N1) and containing the same adjuvant. These side effects may occur with Zoonotic Influenza Vaccine Seqirus.

• Generalised skin reactions including
• Itching sensation
• Skin rashes or swelling of the skin and mucous membranes
• Angioedema (abnormal swelling of the skin, typically around the eyes, lips, tongue, hands or feet, due to an allergic reaction)
• Gastrointestinal disorders such as:
• Abdominal pain
• Dizziness, drowsiness
• Neurological disorders such as
• Severe stabbing or pulsating pain in one or more nerves
• Tingling
• Seizures
• Neuritis (inflammation of nerves)
• Syncope or presyncope (fainting or feeling faint)
• Swollen lymph nodes, palpitations (irregular or forceful heartbeat), tachycardia (faster than normal heartbeat), weakness, limb pain, cough, and asthenia (unusual weakness)
• Allergic reactions possibly causing shortness of breath, wheezing, throat swelling, or a dangerous rise in blood pressure that, if untreated, may lead to shock.

Furthermore, the following side effects have occurred in the days or weeks
following vaccination with adjuvanted and non-adjuvanted vaccines routinely administered annually to prevent seasonal influenza. These side effects could occur with Zoonotic
Influenza Vaccine Seqirus.

• Low platelet count, which may lead to bleeding or bruising.
• Vasculitis (inflammation of blood vessels which may cause skin rashes, joint pain, and kidney problems).
• Erythema multiforme (a type of allergic skin reaction occurring in response to medicines, infections, or illness)
• Neurological disorders, such as encephalomyelitis (inflammation of the central nervous system) and a form of paralysis known as Guillain-Barré syndrome
• Swelling, pain, and redness at the injection site larger than 10 cm and lasting more than one week (injection-site reaction similar to cellulitis)
• Extensive swelling of the limb where the injection was given, lasting more than one week

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, speak to
your doctor or nurse. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Zoonotic Influenza Vaccine Seqirus

Keep this vaccine out of the sight and reach of children.
Do not use Zoonotic Influenza Vaccine Seqirus after the expiry date stated on the packaging
and label. The expiry date refers to the last day of that month.
Store in the refrigerator (2°C - 8°C).
Do not freeze.
Keep the pre-filled syringe in the original outer packaging to protect the medicine from
light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zoonotic Influenza Vaccine Seqirus contains

• Active substance: Surface antigens of the influenza virus (haemagglutinin and neuraminidase)* from the strain:

A/Astrakhan/3212/2020 (H5N8) equivalent strain (CBER-RG8A) (clade 2.3.4.4b)
7.5 micrograms** per 0.5 mL dose
* propagated in fertilized chicken eggs from healthy flocks
** expressed as micrograms of haemagglutinin.

• Adjuvant MF59C.1 The vaccine contains 9.75 mg of squalene, 1.175 mg of polysorbate 80, 1.175 mg of sorbitan trioleate, 0.66 mg of sodium citrate and 0.04 mg of citric acid per 0.5 mL.
• Other components: The other components are sodium chloride, potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate and water for injections. See section 2. Zoonotic Influenza Vaccine Seqirus contains sodium and potassium.

Description of the appearance of Zoonotic Influenza Vaccine Seqirus and contents of the pack
Zoonotic Influenza Vaccine Seqirus is an injectable suspension in a pre-filled syringe.
The suspension is a white, milky liquid.
It is supplied in a ready-to-use pre-filled syringe containing a single 0.5 mL injectable dose.
Packs containing 1 or 10 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Seqirus S.r.l.
Via del Pozzo 3/A, S. Martino
53035 Monteriggioni (SI)
Italy.

Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105 BJ Amsterdam
The Netherlands

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.