VAXIGRIP 0.5 ml Injectable suspension

Зміст інструкції

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

Vaxigrip Tetra, injectable suspension in pre-filled syringe

Quadrivalent influenza vaccine (prepared with fragmented “split”, inactivated viruses)

Read this leaflet carefully before you or your child receive this vaccine because
it contains important information for you and your child.

• 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 side effects, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Vaxigrip Tetra is and what it is used for

Vaxigrip Tetra is a vaccine. This vaccine given to you or your child starting from 6 months of
age, helps to protect you or your child against influenza.
When administered to a subject, Vaxigrip Tetra helps the immune system (the body's natural defense
system) produce its own protection (antibodies) against the disease. When administered
during pregnancy, the vaccine helps protect pregnant women, but also helps protect their
child from birth and up to 6 months of age through the transmission of protection from mother to
child during pregnancy (see also sections 2 and 3).
None of the components contained in the vaccine can cause influenza.
The use of Vaxigrip Tetra should be based on official recommendations.
Influenza is a disease that can spread rapidly and is caused by different strains that
can change every year. Due to this potential change of circulating strains on an annual basis,
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 cold months between October and March. If you or your
child have not been vaccinated in autumn, it is still reasonable to proceed with vaccination until the
spring season, as you or your child are at risk of contracting influenza until this
time of year. Your doctor will be able to advise you on the best time for vaccination.
Vaxigrip Tetra is indicated to protect you or your child against the four strains of virus contained in the
vaccine from approximately 2-3 weeks after vaccination. Furthermore, if you or your child have been
exposed to influenza immediately before or after being vaccinated, you or your child may still
contract the disease as the incubation period of influenza is a few days.
The vaccine will not protect you or your child from the common cold, even if some of the symptoms are
similar to those of influenza.

2. What you need to know before you or your child receive Vaxigrip Tetra

To be sure that Vaxigrip Tetra is a suitable vaccine for you or your child, it is important to inform your doctor or pharmacist if you or your child have any of the conditions listed below. If any information is unclear, ask your doctor or pharmacist for clarification.

Do not use Vaxigrip Tetra
if you or your child are allergic:

• to the active ingredients, 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 quantities such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or 9-octoxinol, if you or your child have a disease with high or moderate fever or an acute illness, vaccination should be postponed until you or your child have recovered.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Vaxigrip Tetra.
Tell your doctor before vaccination if you or your child have:
A reduced immune response (immunodeficiency or taking medicines with an effect on the immune system),
A condition that easily causes bruising or bleeding problems.
The doctor will decide whether you or your child should receive the vaccine.
Fainting may occur (especially in adolescents) following, or even before, any injection with a needle. Therefore, inform your doctor or nurse if you or your child have fainted after a previous injection.
As with all vaccines, Vaxigrip Tetra may not fully protect all people who have been vaccinated.
Not all children under 6 months of age born to women who were vaccinated during pregnancy will be protected.
If, for any reason, you or your child have a blood test a few days after the flu vaccine, inform your doctor. This is important as false positive blood test results have been observed in some patients who had been recently vaccinated.

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

Other medicines and Vaxigrip Tetra
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other vaccine or medicines.
Vaxigrip Tetra can be given at the same time as other vaccines by injecting into different limbs.
The immune response may be reduced in case of treatment with immunosuppressant drugs, such as corticosteroids, cytotoxic drugs or radiotherapy.

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

Driving and using machines
Vaxigrip Tetra does not or negligibly alters the ability to drive vehicles or use machinery.

Vaxigrip Tetra 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, which means it is essentially "potassium-free" and "sodium-free".

3. How to use Vaxigrip Tetra

Dosage
Adults should receive a 0.5 mL dose.

Use in children
Children from 6 months to 17 years of age should receive a 0.5 mL dose.
If your child is less than 9 years of age and has not been previously vaccinated against influenza, a second
vaccine dose of 0.5 mL must be administered after a time interval of at least 4
weeks.
If you are pregnant, administering a 0.5 mL dose during pregnancy may protect your
baby from birth up to 6 months of age. Ask your doctor or pharmacist for further
information.

How Vaxigrip Tetra is administered
The doctor or nurse will administer the recommended vaccine dose by intramuscular or
subcutaneous injection.

If you or your child receive more Vaxigrip Tetra than you should
In some cases, more than the recommended dose has been inadvertently administered. In these cases, when
side effects have been reported, they were consistent with what is described after administration of the
recommended dose (section 4).
Contact your doctor or pharmacist for any further questions regarding the use of this
medicinal product.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
manifest them.

Allergic reactions
Seek immediate medical attention or contact healthcare professionals or go immediately to the emergency room
of the nearest hospital if you or your child experience
Allergic reactions (reported as rare: may affect up to 1 in 1,000 people) which can be
life-threatening.
Symptoms may include skin rash, itching, hives, redness, difficulty breathing, shortness of
breath, swelling of the face, lips, throat or tongue, cold and clammy skin, palpitations, dizziness,
weakness or fainting.

Other side effects reported in adults and the elderly
Very common (may affect more than 1 in 10 people):

• Headache, muscle pain (myalgia), general feeling of discomfort, pain at the injection site. Common in elderly subjects

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

• Fever, chills, reactions at the injection site: redness (erythema), swelling, hardness (induration). Uncommon in elderly subjects

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

• Dizziness, diarrhea, feeling unwell (nausea), fatigue, reactions at the injection site: bruising (ecchymosis), hives (itching) and warmth. Rare in adults Rare in elderly subjects
• Hot flushes: only observed in elderly subjects.
• Swelling of the lymph nodes in the neck, armpits or groin (lymphadenopathy): only observed in adults.

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

• Abnormalities in the perception of touch, pain, heat and cold (paresthesia), drowsiness, increased sweating (hyperhidrosis), unusual fatigue and weakness (asthenia), flu-like illness.
• Joint pain (arthralgia), discomfort at the injection site: only observed in adults. Other side effects reported in children aged 3 to 17 yearsVery common (may affect more than 1 in 10 people):
• Headache, muscle pain (myalgia), general feeling of discomfort, chills, reactions at the injection site: pain, swelling, redness (erythema), hardness (induration).

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 aged 3 to 8 years:

• Temporary reduction in the number of certain types of blood particles called platelets; a low number of these particles can cause bruising or excessive bleeding (transient thrombocytopenia): only observed in a 3-year-old child.
• Unusual crying, irritability.
• Dizziness, diarrhea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, warmth at the injection site. Uncommon (may affect up to 1 in 100 people) in children aged 9 to 17 years:
• Diarrhea, itching at the injection site. Other adverse reactions reported in children aged 6 to 35 monthsVery common (may affect more than 1 in 10 people):
• Vomiting, muscle pain (myalgia), irritability, loss of appetite, general feeling of discomfort (malaise), fever.
• Reaction at the injection site: pain/sensitivity, redness (erythema).
• Headache: only observed in children from 24 months of age.
• Drowsiness, unusual crying: only observed in children under 24 months of age.

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

• Chills: observed in children from 24 months of age.
• Reaction at the injection site: hardness (induration), swelling, hematomas (ecchymosis).

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

• Diarrhea, hypersensitivity.

Rare (may affect up to 1 in 1000 people):

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

In children from 6 months to 8 years of age who have received two doses, side effects are similar after
the first and second dose. Few side effects may occur after the second dose in children
aged 6 to 35 months.
When observed, side effects generally occurred within the first 3 days after
vaccination and resolve spontaneously within 1-3 days after administration. The intensity of the side effects
observed was mild.
Overall, side effects were generally less frequent in the elderly than in adults
and children.
The following side effects have been reported after the administration of Vaxigrip. These side effects
may occur with Vaxigrip Tetra:

• Pain located along the nerve path (neuralgia), convulsions, neurological disorders that can cause torticollis, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, total or partial paralysis of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
• Inflammation of blood vessels (vasculitis) which can cause skin rashes and, in very rare cases, temporary kidney problems.
• Transient thrombocytopenia, lymphadenopathy, paresthesia in age groups different from those described above for these side effects.

Reporting of side effects
If you or your child experience any side effects, including those not listed in this
leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through 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 Tetra

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 on the package after SCAD.
The expiry date refers to the last day of that month.
Store in a refrigerator (2  C - 8  C). Do not freeze. Store the syringe in the outer packaging to
protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
the medicine you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VaxigripTetracontains
The active substances are: Influenza virus (“split” inactivated) of 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**
B/Phuket/3073/2013-equivalent strain (B/Phuket/3073/2013, wild
type)………………………………………………………………………...15 micrograms HA**
Per 0.5 mL dose
* grown in fertilised hen eggs from healthy chicken flocks
** haemagglutinin
The composition of this vaccine is in accordance with the recommendations of the WHO (World Health
Organization) (Northern Hemisphere) and the decisions of the EU adopted for the 2025/2026 season.
The excipients are: a buffer solution containing sodium chloride, potassium chloride, disodium phosphate
dihydrate, dipotassium hydrogen phosphate and water for injections.
Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or 9-octoxinol
may be present in very small quantities (see section 2).

Description of VaxigripTetraand contents of the pack
The vaccine, after being gently shaken, appears as a colourless, opalescent liquid.
Vaxigrip Tetra is an injectable suspension presented in a pre-filled syringe of 0.5 mL, with a needle
pre-attached or without a needle (in packs of 1, 10 or 20 units) or with a 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
94250 Gentilly
France

Representative for Italy
Sanofi S.r.l.
Viale L. Bodio, 37/B
20158 Milan
The Manufacturer is:
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. - Campona utca 1. (Harbor Park) - 1225 Budapest - Hungary

This medicinal product is authorised in the Member States of the European Community with the following
denominations:

• Austria: VaxigripTetra Injektionssuspension in einer Fertigspritze.
• Lithuania: VaxigripTetra injekcinė suspensija užpildytame švirkšte.
• Bulgaria, Croatia, Cyprus, Estonia, Finland, France, Greece, Iceland, Latvia, Malta, Poland, Portugal, Romania, Slovenia, Sweden, Netherlands: VaxigripTetra.
• Denmark, Norway: Vaxigriptetra.
• Belgium, Luxembourg: Vaxigrip Tetra suspension injectable en seringue préremplie.
• Germany, Italy, Spain, Czech Republic, Slovakia, Hungary: Vaxigrip Tetra.
• Ireland, United Kingdom (Northern Ireland): Quadrivalent influenza vaccine (split virion, inactivated).

The most up-to-date information approved for this product is available on the
outer packaging with a smartphone or > by visiting the following URL: https://vaxigriptetra-nh.info.sanofi

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

Figure A: Safety needle (inside the casing)	n Figure B: Components of the safety needle (prepared for use)
i a I t a	l i a

Step 1:To connect the needle to the syringe, remove the cap of the connector to expose the needle connector
and gently rotate the needle into the Luer Lock adapter of the syringe until a slight resistance is felt.

Step 2:Remove the safety needle from the casing. The needle is covered by the safety guard and the needle
cap.

Step 3: A: Remove the safety guard from the needle and direct it towards the body of the syringe as shown. B: Remove the needle cap.	m a c o
Step 4: At the end of the injection, lock (activate) the safety guard using one of the three (3) illustrated one-handed activation techniques: surface, thumb or finger. Note: Activation is verified by an audible and/or tactile "click".	e l F a r
Step 5: Visually inspect the activation of the safety guard. The safety guard must be completely closed (activated) as shown in Image C. a i l a t I Image D indicates that the safety guard is NOT fully closed (not a activated). i z n	n a d
e Caution: Do not attempt to unlock (deactivate) the safety device by forcibly removing the needle from the safety guard.

Unused medicinal product and waste materials derived from such medicinal product should be disposed of in
accordance with local regulations.˃