VAXIGRIP 0,5 ML Injectable suspension in pre-filled syringe

Зміст інструкції

1. Vaxigrip injectable suspension in pre-filled syringe
   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. Package contents and other information

Vaxigrip injectable suspension in pre-filled syringe

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

Read 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 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 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 given to you or your child starting from 6 months of age, helps
to protect you or your child from influenza.
When a vaccine Vaxigrip is administered to a subject, the immune system (the body's natural defense
system) will produce its own protection (antibodies) against the disease. When administered
during pregnancy, the vaccine helps protect pregnant women, but also helps protect your
child from birth 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 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 greatest
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 sensible to be vaccinated 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 is indicated to protect you or your child against the three strains of virus contained in the vaccine starting
from about 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 in
as much 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

To be sure that Vaxigrip is a suitable 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, ask your doctor or pharmacist for clarification.

Do not use Vaxigrip

• 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.

Warnings and precautions
Consult your doctor or pharmacist before you are given Vaxigrip.
Inform 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),
• Bleeding problems or conditions that easily cause bruising. If you, or your child have an acute illness with fever, vaccination should be postponed until the fever has resolved. The doctor will decide whether you or your child should receive the vaccine. Fainting (especially in adolescents) may occur following, or even before, any injection with a needle. Therefore, inform your doctor or nurse if you or your child have fainted on a previous injection. As with all vaccines, Vaxigrip 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.

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 vaccine or medicines.
Vaxigrip can be administered simultaneously with other vaccines using different sites.
The immunological 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, or suspect you are pregnant, or if you 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.
The doctor/pharmacist will decide whether you should be vaccinated with Vaxigrip.

Driving and using machines
Vaxigrip does not or negligibly alters 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,
meaning it is essentially "potassium-free" and "sodium-free".

3. How to use Vaxigrip

Dosage
Adults should receive a dose of 0.5 mL.

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

How Vaxigrip is administered
The 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 dose higher than the recommended one 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 (see section 4).
Contact your doctor or pharmacist for 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 professional immediately or go to the
nearest hospital emergency room.

Allergic reactions
These can occur immediately after the vaccine is given 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, fast heart rate 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, heat sensation, blood in the white of the eye (ocular hyperemia), redness and irritation of the eye (conjunctivitis), irritation of the throat, sore throat, irritation inside the nose, runny nose, sneezing, congestion of the nose, sinuses or throat, or a pins and needles sensation in the mouth (oral paresthesia), rash in the mouth (oral mucosal eruption), 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 the elderly
Very common (may affect more than 1 in 10 people):

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

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

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

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

• Swelling of the lymph nodes in the neck, armpits or groin (lymphadenopathy), unusual weakness, fatigue, drowsiness, dizziness, increased sweating (hyperhidrosis), joint pain, diarrhea, feeling sick (nausea), reactions at the injection site: bruising, hives, heat, discomfort.

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

• Numbness or pins and needles sensation (paresthesia), vomiting, loss of appetite, flu-like illness.
• Decreased sensitivity (hypoesthesia), abdominal pain, allergy at the injection site: only found in adults.
• Scaling skin (exfoliation) at the injection site: observed only in elderly subjects.

Other side effects reported in children from 3 to 17 years of age
Very common (may affect more than 1 in 10 people):

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

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

• Fever, bruising at the injection site.

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

• - Fatigue, dizziness, diarrhea, reactions at the injection site: itching, heat.
• - Swelling of the lymph nodes in the neck, armpits or groin, abdominal pain, vomiting, restlessness, crying, joint pains, crying: observed only in children between 3 and 8 years of age.
• - Reduction in the number of certain types of blood cells, called platelets; a reduced number of these can cause excessive bruising or bleeding (thrombocytopenia): observed only in a 3-year-old child.
• - Unusual weakness, discomfort at the injection site: observed only in children between 9 and 17 years of age. Other side effects reported in children from 6 to 35 months of ageVery common (may affect more than 1 in 10 people):
• Irritability, vomiting, muscle pain, general feeling of being unwell, fever, loss of appetite, reaction at the injection site: sensitivity, redness.
• Unusual crying, drowsiness: only found in children under 24 months of age.
• Headache: only found in children from 24 months of age.

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

• Diarrhea, reactions at the injection site: hardening, bruises, swelling.
• Chills: only found in children from 24 months of age.

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

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

In children from 6 months to 8 years of age who have received two doses, the side effects are similar after
the first and second dose. Few side effects may occur after the second dose in children from
6 to 35 months of age.
Most side effects generally occurred within the first 3 days after vaccination
and resolved spontaneously within 1-3 days after administration. The severity of the majority of
these side effects was from mild to moderate.
The frequency of the following side effects is not known (cannot be estimated from available data) in the entire
population, except for the population for which the side effect is listed above:

• Swelling of the lymph nodes in the neck, armpits or groin,
• Numbness or pins and needles sensation (paresthesia), pain located along the course of a nerve (neuralgia), seizures, neurological disorders that can cause stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, partial or total 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,
• Temporary reduction in the number of certain types of blood cells, called platelets; a reduced number of these can cause excessive bruising or bleeding (transient thrombocytopenia).

Reporting of side effects
If you or your child gets any side effect, talk to your doctor, pharmacist or nurse. 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

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 pack after SCAD.
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 in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vaxigrip contains
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**

Per a 0.5 mL dose
* cultivated in fertilised hen eggs from healthy chicken farms
** 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 paragraph 2).

Description of the appearance of Vaxigrip and contents of the pack
The vaccine, after being gently shaken, is a colourless opalescent liquid.
Vaxigrip is an injectable suspension presented in a pre-filled 0.5 mL syringe, with a pre-attached needle,
with a separate needle or without a 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
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. - Building Dc5 - Campona Utca 1 - Budapest XXII,1225 - Hungary

This medicinal product is authorised in the Member States of the European Community with the following
denominations:
Other sources of information
The latest information approved for this product is available by

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

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The following information is intended exclusively for doctors or healthcare professionals:
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. Visually inspect before administration.
The vaccine must not be used if the presence of foreign particles in the suspension is observed.
The vaccine must not be mixed in the same syringe with other medicines.
This vaccine must not be injected directly into a blood vessel.
See also paragraph 3. How to use Vaxigrip.