Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe

Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you.

• 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 or your child only. Do not pass it on to others.
• If you or your child 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.

What is in this leaflet

1. What Quadrivalent Influenza Vaccine (split virion, inactivated) is and what it is used for
2. What you need to know before you or your child use Quadrivalent Influenza Vaccine (split virion, inactivated)
3. How to use Quadrivalent Influenza Vaccine (split virion, inactivated)
4. Possible side effects
5. How to store Quadrivalent Influenza Vaccine (split virion, inactivated)
6. Contents of the pack and other information

Do not use Quadrivalent Influenza Vaccine (split virion, inactivated)

• If you or your child 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), neomycin, formaldehyde or octoxinol-9,
• If you or your child have an illness with a high or moderate temperature or an acute illness, the vaccination should be postponed until after you or your child have recovered.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Quadrivalent Influenza Vaccine (split virion, inactivated).

You should tell your doctor before vaccination if you or your child have:

• A poor immune response (immunodeficiency or taking medicines affecting the immune system),
• Bleeding problem or bruising easily.

Your doctor will decide if you or your child should receive the vaccine.

Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell your doctor or nurse if you or your child fainted with a previous injection.

As with all vaccines, Quadrivalent Influenza Vaccine (split virion, inactivated) may not fully protect all persons who are vaccinated.

Not all babies less than 6 months of age born to pregnant women vaccinated during pregnancy will be protected.

If, for any reason, you or your child 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.

Children

Quadrivalent Influenza Vaccine (split virion, inactivated) is not recommended for use in children below 6 months of age.

Other medicines and Quadrivalent Influenza Vaccine (split virion, inactivated)

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

• Quadrivalent Influenza Vaccine (split virion, inactivated) can be given at the same time as other vaccines by using separate limbs.
• The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before using this vaccine.

Quadrivalent Influenza Vaccine (split virion, inactivated) can be used in all stages of pregnancy.

Quadrivalent Influenza Vaccine (split virion, inactivated) may be used during breast-feeding.

Your doctor/pharmacist will be able to decide if you should receive Quadrivalent Influenza Vaccine (split virion, inactivated).

Driving and using machines

Quadrivalent Influenza Vaccine (split virion, inactivated) has no or negligible influence on the ability to drive or use machines.

Quadrivalent Influenza Vaccine (split virion, inactivated) contains potassium and sodium

This medicine contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘potassium-free’ and ‘sodium-free’.

Dosage

Adults receive one 0.5 mL dose.

Use in children

Children from 6 months to 17 years of age receive one 0.5 mL dose.

If your child is less than 9 years old and has not been previously vaccinated against flu, a second dose of 0.5 mL should be given after at least 4 weeks.

If you are pregnant, one 0.5 mL dose given to you during pregnancy may protect your baby from birth to less than 6 months of age. Ask your doctor or pharmacist for more information.

How Quadrivalent Influenza Vaccine (split virion, inactivated) is given

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

If you or your child receive more Quadrivalent Influenza Vaccine (split virion, inactivated) than you should

In some cases, more than the recommended dose has been inadvertantly administered.

In these cases, when side effects were reported, they were in line with what is described following the administration of the recommended dose (see Section 4).

Allergic reactions

Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you or your child experience allergic reactions (reported as rare: may affect up to 1 in 1,000 people) that can be life threatening.

Symptoms may include rash, itching, hives, redness, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold, clammy skin, palpitations, dizziness, weakness or fainting.

Other side effects reported in adults and elderly

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

• Headache, muscular pain (myalgia), generally feeling unwell (malaise) ⁽¹⁾, pain at the injection site.

⁽¹⁾ Common in elderly

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

• Fever ⁽²⁾, shivering, reactions at the injection site: redness (erythema), swelling, hardness (induration).

⁽²⁾ Uncommon in elderly

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

• Dizziness ⁽³⁾, diarrhoea, feeling sick (nausea) ⁽⁴⁾, fatigue, reactions at the injection site: bruising (ecchymosis), itching (pruritus), and warmth.

⁽³⁾ Rare in adults ⁽⁴⁾ Rare in elderly

• Hot flush: only seen in the elderly.
• Swelling of the glands in the neck, armpit or groin (lymphadenopathy): only seen in adults.

Rare (may affect up to 1 in 1,000 people):

• Anomalies in the perception of touch, pain, heat and cold (paraesthesia), sleepiness, increased sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), flu-like illness.
• Joint pain (arthralgia), discomfort at the injection site: only seen in adults.

Other side effects reported in children from 3 to 17 years of age

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

• Headache, muscular pain (myalgia), generally feeling unwell (malaise), shivering ⁽⁵⁾, reactions at the injection site: pain, swelling, redness (erythema) ⁽⁵⁾, hardness (induration) ⁽⁵⁾.

⁽⁵⁾ Common in children from 9 to 17 years of age

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

• Fever, bruising (ecchymosis) at the injection site.

Uncommon (may affect up to 1 in 100 people) in children from 3 to 8 years of age:

• Temporary 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 (transient thrombocytopaenia): only seen in one child of 3 years of age.
• Moaning, restlessness.
• Dizziness, diarrhoea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, warmth at the injection site.

Uncommon (may affect up to 1 in 100 people) in children from 9 to 17 years of age:

• Diarrhoea, itching (pruritus) at the injection site.

Other side effects reported in children from 6 to 35 months of age

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

• Vomiting ⁽¹⁾, muscular pain (myalgia) ⁽²⁾, irritability ⁽³⁾, appetite lost ⁽³⁾, generally feeling unwell (malaise) ⁽²⁾, fever.

⁽¹⁾ Uncommon in children from 24 to 35 months of age ⁽²⁾ Rare in children less than 24 months of age

⁽³⁾ Rare in children from 24 to 35 months of age

• Reactions at the injection site: pain/tenderness, redness (erythema).
• Headache: only seen in children from 24 months of age.
• Drowsiness, unusual crying: only seen in children less than 24 months of age.

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

• Shivering: only seen in children 24 months and older.
• Reactions at the injection site: hardness (induration), swelling, bruising (ecchymosis).

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

• Diarrhoea, hypersensitivity.

Rare (may affect up to 1 in 1,000 people):

• Flu-like illness, reactions at the injection site: rash, pruritus (itching).

In children from 6 months to 8 years of age who receive 2 doses, side effects are similar after the first and after the second dose. Fewer side effects may happen after the second dose in children from 6 to 35 months of age.

When seen, side effects generally happen in the first 3 days after the vaccination and go away by themselves in 1 to 3 days after they start. The intensity of observed side effects was mild.

Overall, side effects were generally less frequent in elderly than in adults and children.

The following side effects have been reported after administration of Inactivated Influenza Vaccine (Split Virion) BP. These side effects may occur with Quadrivalent Influenza Vaccine (split virion, inactivated):

• Pain situated on the nerve route (neuralgia), fits (convulsions), 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, neuritis, Guillain-Barré syndrome).
• Blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems.
• Transient thrombocytopenia, lymphadenopathy, paraesthesia in other age groups than those described above for these side effects.

Reporting of side effects

If you or your child 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.

Ireland

Health Products Regulatory Authority (HPRA):

What Quadrivalent Influenza Vaccine (split virion, inactivated) contains

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

A/Victoria/2570/2019 (H1N1)pdm09 - like strain

(A/Victoria/2570/2019, IVR-215)…………..............…........................................15 micrograms HA**

A/Cambodia/e0826360/2020 (H3N2) - like strain

(A/Tasmania/503/2020, IVR-221)..........................................................................15 micrograms HA**

B/Washington/02/2019 - like strain

(B/Washington/02/2019, wild type)……………………………………………...15 micrograms HA**

B/Phuket/3073/2013 - like strain

(B/Phuket/3073/2013, wild type)…………………………………………………15 micrograms HA**

Per 0.5 mL dose

* propagated in fertilised hens’ eggs from healthy chicken flocks

** haemagglutinin

This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2021/2022 season.

• The other ingredients are: a buffer solution containing sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.

Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol- 9 may be present in very small amounts (see Section 2).

What Quadrivalent Influenza Vaccine (split virion, inactivated) looks like and contents of the pack

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

Quadrivalent Influenza Vaccine (split virion, inactivated) is a suspension for injection presented in a pre-filled syringe of 0.5 mL, with attached needle or without needle, in box of 1, 10 or 20. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

The distributor is:

United Kingdom:

Ireland:

The Manufacturer is: