Vaxigrip

Patient Information Leaflet: Information for the User

Vaxigrip Injectable Suspension in Prefilled Syringe

Trivalent inactivated influenza vaccine (split virion)
Please read all of this leaflet carefully before you or your child are vaccinated, 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, pharmacist, or nurse.
• This vaccine has been prescribed only for you or your child. Do not give it to others.
• If you or your child experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Vaxigrip is and what it is used for

Vaxigrip is a vaccine. This vaccine, administered to you or your child from the age of 6 months, helps
protect you or your child against influenza.
When Vaxigrip vaccine is administered to an individual, the immune system (the body's natural defence system)
will produce its own protection (antibodies) against the disease. When administered during pregnancy, the
vaccine helps protect pregnant women, but also helps protect the baby from birth up to 6 months of age through
the transfer of protection from mother to baby during pregnancy (see also sections 2 and 3).
None of the components contained in the vaccine can cause influenza.
The use of Vaxigrip should be based on official recommendations.
Influenza is a disease that can spread rapidly and is caused by different strains which may change every year.
Because of this potential annual change in circulating strains, as well as the duration of protection induced by
the vaccine, vaccination is recommended every year. The highest risk of contracting influenza occurs during the
colder months between October and March. If you or your child have not been vaccinated in the autumn, it is still
advisable to get vaccinated up to the spring season, as you or your child remain at risk of contracting influenza
until that time of year. Your doctor will be able to advise you on the best time for vaccination.
Vaxigrip is indicated to protect you or your child against the three virus strains contained in the vaccine, starting
approximately 2-3 weeks after vaccination. Furthermore, if you or your child have been exposed to influenza
immediately before or after vaccination, you or your child may still contract the disease, as the incubation period
of influenza is several days.
The vaccine will not protect you or your child from the common cold, even though some of the symptoms may be
similar to those of influenza.

2. What you should know before you or your child receive Vaxigrip

To ensure that Vaxigrip is an appropriate vaccine for you or your child, it is important to inform your doctor or pharmacist if you or your child are in any of the conditions listed below. If any information is unclear, please ask your doctor or pharmacist for clarification.

Do not use Vaxigrip

• If you or your child are allergic to: the active substances, or to any of the other ingredients of this vaccine (listed in section 6), or to any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde, or octoxinol.

Warnings and precautions
Talk to your doctor or pharmacist before you are given Vaxigrip.
Inform your doctor before vaccination if you or your child have:

• A weakened immune response (immunodeficiency or taking medicines that affect the immune system),
• Bleeding problems or conditions where bruising occurs easily. If you or your child have an acute illness with fever, vaccination should be postponed until the fever has resolved. Your doctor will decide whether you or your child should receive the vaccine. Fainting (particularly in adolescents) may occur during or even before any injection with a needle. Therefore, inform your doctor or nurse if you or your child have previously fainted after an injection. As with all vaccines, Vaxigrip may not fully protect all individuals who are vaccinated. Not all children under 6 months of age born to women who were vaccinated during pregnancy will be protected.

Children
The use of Vaxigrip is not recommended in children under 6 months of age.

Other medicines and Vaxigrip
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other vaccines or other medicines.
Vaxigrip can be administered simultaneously with other vaccines using different injection sites.
The immune response may be reduced during treatment with immunosuppressive medicines, such as corticosteroids, cytotoxic drugs, or radiotherapy.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before receiving this vaccine.
Vaxigrip can be used during all stages of pregnancy.
Vaxigrip can be used during breastfeeding.
Your doctor/pharmacist will decide whether you should be vaccinated with Vaxigrip.

Driving and using machines
Vaxigrip does not affect, or has negligible effect on, the ability to drive vehicles or operate machinery.

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

3. How to use Vaxigrip

Dosage
Adults should receive a single dose of 0.5 mL.
Use in children and adolescents
Children from 6 months up to 17 years of age should receive a single dose of 0.5 mL.
If your child is under 9 years of age and has not been previously vaccinated against influenza, a second dose of 0.5 mL of vaccine should be administered after an interval of at least 4 weeks.
If you are pregnant, receiving a single dose of 0.5 mL during pregnancy may protect your baby from birth up to 6 months of age. Please consult your doctor or pharmacist for further information.
How Vaxigrip is administered
Your doctor or nurse will administer the recommended dose of vaccine by intramuscular or subcutaneous injection.
If you or your child receive more Vaxigrip than you should
In some cases, a higher than recommended dose has been inadvertently administered. In such cases, any reported side effects were consistent with those described after administration of the recommended dose (see section 4).
Please consult your doctor or pharmacist if you have any further questions regarding the use of this medicine.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
If you experience an allergic reaction, contact your doctor or healthcare provider immediately or go straight to the nearest hospital emergency department.

Allergic reactions
These may occur immediately after vaccination and can be life-threatening.
Symptoms may include:

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

Other symptoms may include:

• Itchy, red, swollen and cracked skin areas (atopic dermatitis), flushing, hot flushes, 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, nasal, paranasal sinus or throat congestion, or pins and needles sensation in the mouth (oral paresthesia), mouth rash (oral mucosal rash), asthma. These allergic reactions have been reported as uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).

Other side effects in adults and elderly

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

• Headache, muscle pain, general feeling of being unwell (malaise), pain at injection site.

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

• Fever, chills, injection site reactions: redness (erythema), hardness (induration), swelling.

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

• Swelling of glands in the neck, armpits or groin (lymphadenopathy), unusual weakness, fatigue, drowsiness, dizziness, increased sweating (hyperhidrosis), joint pain, diarrhoea, feeling unwell (nausea), injection site reactions: bruising, hives, warmth, discomfort.

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

• Numbness or pins and needles sensation (paresthesia), vomiting, decreased appetite, flu-like illness.
• Decreased sensation (hypoesthesia), abdominal pain, allergy at injection site: reported only in adults.
• Peeling skin (desquamation) at injection site: observed only in elderly subjects.

Other side effects reported in children aged 3 to 17 years

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

• Headache, muscle pain, general feeling of being unwell, chills, injection site reactions: pain, redness, swelling, induration.

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

• Fever, bruising at injection site.

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

• Fatigue, dizziness, diarrhoea, injection site reactions: itching, warmth.
• Swelling of glands in the neck, armpits or groin, abdominal pain, vomiting, restlessness, irritability, joint pain, crying: observed only in children aged 3 to 8 years.
• Decrease in the number of certain blood components called platelets; a reduced number of these may cause excessive bruising or bleeding (thrombocytopenia): observed in only one 3-year-old child.
• Unusual weakness, discomfort at injection site: observed only in children aged 9 to 17 years.

Other side effects reported in children aged 6 to 35 months

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

• Irritability, vomiting, muscle pain, general feeling of being unwell, fever, decreased appetite, injection site reactions: tenderness, redness.
• Unusual crying, drowsiness: observed only in children under 24 months of age.
• Headache: observed only in children from 24 months of age.

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

• Diarrhoea, injection site reactions: induration, bruising, swelling.
• Chills: observed only in children from 24 months of age.

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

• Flu-like illness, injection site reactions: itching, skin rash.

In children aged 6 months to 8 years who received two doses, side effects were similar after the first and second dose. Fewer side effects may occur after the second dose in children aged 6 to 35 months.
Most side effects generally occurred within the first 3 days after vaccination and resolved spontaneously within 1–3 days after administration. The intensity of most of these side effects was mild to moderate.

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

• Swelling of glands in the neck, armpits or groin,
• Numbness or pins and needles sensation (paresthesia), nerve pain (neuralgia), seizures, neurological disorders which may cause neck stiffness, confusion, numbness, pain and weakness in limbs, loss of balance, loss of reflexes, partial or complete paralysis of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome),
• Inflammation of blood vessels (vasculitis) which may cause skin rashes and, in very rare cases, temporary kidney problems,
• Temporary reduction in the number of certain blood components called platelets; a reduced number of these may cause excessive bruising or bleeding (transient thrombocytopenia).

Reporting of side effects
If you or your child experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vaxigrip

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the label and the carton after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C). Do not freeze. Keep the syringe in the 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 you no longer require. This will help protect the environment.

6. Package contents and other information

What Vaxigrip contains
The active substances are: Influenza virus (“split”, inactivated) from the following strains*:

• A/Victoria/4897/2022 (H1N1)pdm09-equivalent strain (A/Victoria/4897/2022, IVR-238) ……......……………………………………………………………………… ….15 micrograms HA**
• A/Croatia/10136RV/2023 (H3N2)-equivalent strain (A/Croatia/10136RV/2023, X-425A) ……………………………………………………………............................15 micrograms HA**
• B/Austria/1359417/2021-equivalent strain (B/Michigan/01/2021, wild type).......................................................................................................................15 micrograms HA**

Per 0.5 mL dose
* grown in fertilized hen's eggs from poultry flocks of healthy chickens
** haemagglutinin
The composition of this vaccine complies with WHO (World Health Organization) recommendations (Northern Hemisphere) and with EU decisions adopted for the 2025/2026 season.
The excipients are: a buffer solution containing sodium chloride, potassium chloride, disodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.
Some components such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or 9-octoxinol may be present in very small quantities (see section 2).

Description of the appearance of Vaxigrip and contents of the pack
After gentle shaking, the vaccine is an opalescent, colourless liquid.
Vaxigrip is an injectable suspension supplied in 0.5 mL pre-filled syringes, with or without a pre-attached needle, separate needle, or safety needle, in packs of 1 or 10 units. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder in Italy is:
Sanofi Winthrop Industrie
82 avenue Raspail
Bp 35
94250 Gentilly
France
Representative for Italy
Sanofi S.r.l.
Viale L. Bodio, 37/B
20158 Milano
Italy

The Manufacturers are:
Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
Sanofi-Aventis Zrt. - Building Dc5 - Campona Utca 1 - Budapest XXII,1225 - Hungary

This medicinal product is authorised in the Member States of the European Community under the following names:

Other sources of information
The latest approved information on this product is available

on the outer packaging, using a smartphone or > by visiting the following URL: https://vaxigrip-nh.info.sanofi .

The following information is intended exclusively for physicians or healthcare professionals:
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of an anaphylactic reaction following administration of the vaccine.
The vaccine should be brought to room temperature before use.
Shake well before use. Visually inspect before administration.
The vaccine must not be used if foreign particles are observed in the suspension.
The vaccine must not be mixed in the same syringe with other medicinal products.
This vaccine must not be injected directly into a blood vessel.
See also section 3. How to use Vaxigrip.
< Preparation for administration
Instructions for use of the safety needle for the pre-filled syringe with Luer Lock:

Figure A: Safety needle (inside the protective housing)	Figure B: Components of the safety needle (ready for use)
Step 1: To attach the needle to the syringe, remove the connector cap to expose the needle hub and gently rotate the needle into the syringe's Luer Lock adapter until slight resistance is felt.
Step 2: Remove the safety needle from its housing. The needle is covered by the safety shield and the needle cap.
Step 3: A: Pull the safety shield away from the needle and angle it toward the syringe body as shown. B: Remove the needle cap.
Step 4: After completing the injection, lock (activate) the safety shield using one of the three (3) illustrated single-handed activation techniques: surface, thumb, or finger method. Note: Activation is confirmed by an audible and/or tactile "click".
Step 5: Visually inspect the activation of the safety shield. The safety shield must be fully closed (activated), as shown in Image C. Image D indicates that the safety shield is NOT fully closed (not activated).

Warning: Do not attempt to unlock (deactivate) the safety device by forcing the needle out
of the safety shield.
Unused medicine and waste material from this medicine must be disposed of in accordance with
applicable local regulations.˃