Vaxigrip 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.
• 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.

1. What Vaxigrip is and what it is used for
2. What you need to know before you or your child use Vaxigrip
3. How to use Vaxigrip
4. Possible side effects
5. How to store Vaxigrip
6. Contents of the pack and other information

• 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 or chicken proteins), neomycin, formaldehyde or octoxinol-9.

Talk to your doctor or pharmacist before using Vaxigrip.

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.

If you or your child have an acute illness with fever, the vaccination should be postponed until the fever is resolved.

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, Vaxigrip 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.

Vaxigrip is not recommended for use in children below 6 months of age.

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.

• Vaxigrip can be given at the same time as other vaccines by using separate injection sites.
• The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.

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

Vaxigrip can be used in all stages of pregnancy.

Vaxigrip may be used during breast-feeding.

Your doctor/pharmacist will be able to decide if you should receive Vaxigrip.

Vaxigrip has no or negligible influence on the ability to drive or use machines.

This medicine contains less than 1 mmol potassium (39 mg) and sodium (23 mg) per dose, i.e. essentially 'potassium-free' and 'sodium-free'.

Adults receive one 0.5 mL dose.

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

If your child is less than 9 years of age 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.

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

In some cases, more than the recommended dose has been inadvertently 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).

They can occur immediately after vaccine administration and may be life-threatening.

Symptoms may include:

• Rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat or tongue, low blood pressure, rapid heart rate and weak pulse, cold, clammy skin, dizziness, weakness or fainting (anaphylactic reaction, angioedema, shock).

Other symptoms may include:

• areas of itchy, red, swollen, and cracked skin (dermatitis atopic), flushing, hot flush, blood in the white of the eye (ocular hyperaemia), redness and irritation of the eye (conjunctivitis), throat irritation, sore throat, irritation inside the nose, runny nose, sneezing, stuffy nose, sinus or throat, numbness or pins and needles sensation in the mouth (paraesthesia oral), rash in the mouth (oral mucosal eruption), asthma.

These allergic reactions were reported as uncommon (may affect up to 1 in 100 people) to rare (may affect up to 1 in 1 000 people).

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

• Headache, muscular pain, 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), hardness (induration), swelling

⁽²⁾ Uncommon in elderly

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

• Swelling of the glands in the neck, armpit or groin (lympha-denopathy)⁽³⁾, unusual weakness⁽³⁾, tiredness, sleepiness ⁽⁴⁾, dizziness ⁴⁾, increased sweating (hyperhidrosis)⁽³⁾, joint pain⁽³⁾, diarrhoea, feeling sick (nausea), reactions at the injection site: bruising, itching, warmth, discomfort

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

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

• Numbness or pins and needles sensation (paraesthesia), vomiting, decreased appetite, flu-like illness
• Decrease sensitivity (hypoesthesia), abdominal pain, allergy at the injection site: only seen in adults
• Peeled off skin (exfoliation) at the injection site: only seen in elderly

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

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

⁽⁵⁾ Common in children from 9 to 17 years old

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

• Fever, bruising at the injection site

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

• Tiredness, dizziness, diarrhoea, reactions at the injection site: itching, warmth.
• Swelling of the glands in the neck, armpit or groin, abdominal pain, vomiting, restlessness, moaning, joint pain, crying: only seen in children from 3 to 8 years of age.
• 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 (thrombocytopenia): only seen in one child of 3 years of age.
• Unusual weakness, discomfort at the injection site: only seen in children from 9 to 17 years of age.

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

• Irritability⁽⁶⁾, vomiting⁽⁷⁾, muscular pain⁽⁸⁾, generally feeling unwell⁽⁸⁾, fever, decrease of appetite⁽⁶⁾, reactions at the injection site: tenderness, redness
• Unusual crying, drowsiness: only seen in children less than 24 months of age
• Headache: only seen in children from 24 months of age

⁽⁶⁾ Rare in children from 24 to 35 months old

⁽⁷⁾ Uncommon in children from 24 to 35 months old

⁽⁸⁾ Rare in children from 6 to 23 months old

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

• Diarrhoea, reactions at the injection site: hardness, bruising, swelling
• Shivering: only seen in children from 24 months of age

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

• Flu-like illness, reactions at the injection site: itching, rash

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.

Most side effects usually occurred within the 3 days following vaccination and disappeared within 1 to 3 days without treatment. The intensity of most these side effects was mild to moderate.

The frequency of the following side effects is not known (cannot be estimated from the available data) in the whole population except in the population for which the side effect is listed above:

• Swelling of the glands in the neck, armpit or groin
• Numbness or pins and needles sensation (paraesthesia), pain situated on the nerve route (neuralgia)⁽⁹⁾, 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⁽⁹⁾, Guillain-Barré Syndrome⁽⁹⁾)
• Blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems
• 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 thrombocytopenia).

⁽⁹⁾ Not reported in children from 6 to 35 months old

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 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. By reporting side effects, you can help provide more information on the safety of this medicine.

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

• A/Victoria/4897/2022 (H1N1)pdm09-like strain
  (A/Victoria/4897/2022, IVR-238) ...... 15 micrograms HA**
• A/Darwin/9/2021 (H3N2)-like strain
  (A/Darwin/9/2021, IVR-228)...........15 micrograms HA**
• B/Austria/1359417/2021-like strain
  (B/Michigan/01/2021, 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 2023/2024 season.

The other ingredients are: a buffer solution containing sodium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride, 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).

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

Vaxigrip is a suspension for injection presented in a pre-filled syringe of 0.5 mL, with attached needle, with separate needle or without needle, in box of 1 or 10. Not all pack sizes may be marketed.

The Marketing Authorisation Holder is:

The Manufacturer is: