Vaxigrip

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Vaxigrip, suspension for injection in a pre-filled syringe

Trivalent influenza vaccine (split virion), inactivated

Please read carefully the contents of this leaflet before using the vaccine, as it contains important information for the adult patient or child.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed specifically for you. Do not pass it on to others.
• If the adult patient or child experiences any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Vaxigrip and what is it used for
• 2. Important information before using Vaxigrip vaccine
• 3. How to use Vaxigrip vaccine
• 4. Possible side effects
• 5. How to store Vaxigrip vaccine
• 6. Contents of the pack and other information

1. What is Vaxigrip and what is it used for

Vaxigrip is a vaccine.
This vaccine given to adults and children from 6 months of age helps
protect against flu.
After receiving the Vaxigrip vaccine, the immune system (the body's natural defense system)
produces its own protection against the disease (antibodies). The vaccine given during pregnancy
helps protect pregnant women, as well as the child from birth to under 6 months of age,
passing protection from mother to child during pregnancy (see also sections 2 and 3).
None of the vaccine components can cause flu.
The use of Vaxigrip vaccine should be in accordance with official recommendations.
Flu is a disease that can spread quickly and is caused by many different
strains of the virus, which can change every year. Due to this possible annual change
in circulating strains, as well as the duration of protection provided by
the vaccine, it is recommended to get vaccinated every year. The greatest risk of getting
flu occurs during the cold months between October and March. In the case of adults and children who have not been vaccinated in the fall, it is still justified to get vaccinated
until spring, as there is still a risk of getting flu. The doctor will be able to recommend the best time to get vaccinated.
Vaxigrip vaccine is intended to protect adults and children against the three strains of
the virus contained in the vaccine, after about 2-3 weeks after vaccination.
Because the incubation period for flu is a few days, in the event of exposure of an adult or child
to the flu virus shortly before or after vaccination, it is still possible to get flu.
The vaccine does not protect against the common cold, although some of its symptoms are similar to flu.

2. Important information before using Vaxigrip vaccine

Please inform your doctor or pharmacist if any of the following statements apply to the adult or child who is to receive the Vaxigrip vaccine. If anything is unclear, please ask your doctor or pharmacist to explain.

When not to use Vaxigrip vaccine

• If the adult patient or child is allergic to:
• Active substances, or
• Any of the other ingredients of this vaccine (listed in section 6), or
• Any ingredient that may be present in very small amounts, such as egg residue (egg albumen, chicken protein), neomycin, formaldehyde, or octoxynol-9.

Warnings and precautions

Before using Vaxigrip vaccine, talk to your doctor, pharmacist, or nurse.
Before vaccination, please inform your doctor if the adult patient or child has:

• Impaired immune response (due to immunodeficiency or taking medications that affect the immune system),
• Bleeding or bruising easily. If the adult patient or child has an acute illness with a fever, vaccination should be postponed until the fever has resolved. The doctor will decide whether the adult patient or child should receive the vaccine. Fainting may occur (especially in adolescents) after, or even before, any needle injection. Therefore, please inform your doctor or nurse if the patient or their child has experienced fainting spells during previous injections.

As with any vaccine, Vaxigrip vaccine may not provide full protection to all vaccinated individuals.
Not all children under 6 months of age, born to women vaccinated during pregnancy, will be protected.

Children

Vaxigrip vaccine is not recommended for children under 6 months of age.

Vaxigrip vaccine and other medicines

Please tell your doctor or pharmacist about all medicines or vaccines that the adult patient or child is currently taking or has recently taken, as well as any medicines or vaccines that they plan to take.

• Vaxigrip vaccine can be given at the same time as other vaccines, but in different limbs.
• If immunosuppressive drugs or therapies, such as corticosteroids, cytotoxic drugs, or radiation therapy, are used, the immune response to vaccination may be weakened.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this vaccine.
Vaxigrip vaccine can be given at any stage of pregnancy.
Vaxigrip vaccine can be used during breastfeeding.
The doctor/pharmacist will decide whether Vaxigrip vaccine can be given.

Driving and using machines

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

Vaxigrip vaccine 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., the medicine is essentially "potassium-free" and "sodium-free".

3. How to use Vaxigrip vaccine

Dosage

Adults receive one dose of 0.5 ml.

Use in children and adolescents

Children from 6 months of age to 17 years of age receive one dose of 0.5 ml.
Children under 9 years of age who have not been previously vaccinated against flu should receive a second dose of 0.5 ml at least 4 weeks later.
In the case of pregnant women, one dose of 0.5 ml given during pregnancy may protect the child from birth to under 6 months of age. For further information, please consult your doctor or pharmacist.

How to take Vaxigrip vaccine

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

Overdose of Vaxigrip vaccine

In some cases, a higher dose than recommended was accidentally given.
In these cases, when side effects were reported, they were consistent with those described after the recommended dose (see section 4).
If you have any further questions about the use of this vaccine, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Please contact your doctor or healthcare professional immediately or go to the nearest emergency room if you experience an allergic reaction.

Allergic reactions

May occur immediately after vaccination and can be life-threatening.
Symptoms may include:

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

Other symptoms may include:

• areas of itchy, red, swollen (edematous), and cracked skin (atopic dermatitis), sudden redness of the skin, flushing, blood in the white of the eye (conjunctival hemorrhage), redness and irritation of the eye (conjunctivitis), throat irritation, sore throat, nasal irritation, runny nose, sneezing, stuffy nose, sinuses, or throat, numbness or tingling in the mouth (oral paresthesia), rash in the mouth (oral mucosal eruption), asthma.

These allergic reactions have been reported as occurring uncommonly (affecting up to 1 in 100 people) or rarely (affecting up to 1 in 1,000 people).

Additional side effects in adults and the elderly

Very common (affecting more than 1 in 10 people):

• headache, muscle pain, general feeling of being unwell, pain at the injection site.

Common (affecting up to 1 in 10 people):

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

Uncommon (affecting up to 1 in 100 people):

• enlarged lymph nodes in the neck, armpits, or groin (lymphadenopathy), unusual weakness, feeling tired, drowsiness, dizziness, excessive sweating, joint pain, diarrhea, feeling sick (nausea), reactions at the injection site: bruising (ecchymosis), itching, warmth, discomfort.

Rare (affecting up to 1 in 1,000 people):

• numbness or tingling (paresthesia), vomiting, decreased appetite, flu-like symptoms.
• decreased sensation (hypoesthesia), abdominal pain, allergy at the injection site: observed only in adults.
• skin peeling at the injection site: observed only in adults.

Additional side effects in children aged 3 to 17 years

Very common (affecting more than 1 in 10 people):

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

Common (affecting up to 1 in 10 people):

• fever, bruising (ecchymosis) at the injection site. Uncommon (affecting up to 1 in 100 people):
• feeling tired, dizziness, diarrhea, reactions at the injection site: itching, warmth.
• enlarged lymph nodes in the neck, armpits, or groin, abdominal pain, vomiting, irritability, fussiness, joint pain, crying: observed only in children aged 3 to 8 years.
• decreased number of certain types of blood cells called platelets; their low number may cause excessive bruising or bleeding (thrombocytopenia): observed only in one child aged 3 years.
• unusual weakness, discomfort at the injection site: observed only in children aged 9 to 17 years.

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

Very common (affecting more than 1 in 10 people):

• irritability, vomiting, muscle pain, general feeling of being unwell, fever, decreased appetite, reactions at the injection site: tenderness, redness.
• unusual crying, drowsiness: observed only in children under 24 months.
• headache: observed only in children over 24 months of age.

Common (affecting up to 1 in 10 people):

• diarrhea, reactions at the injection site: induration, bruising (ecchymosis), swelling.
• chills: observed only in children over 24 months of age. Rare (affecting up to 1 in 1,000 people):
• flu-like symptoms, reactions at the injection site: itching, rash.

In children aged 6 months to 8 years who receive 2 doses, the side effects after the first and second doses are similar. Fewer side effects may occur after the second dose in children aged 6 months to 35 months. Most side effects occurred usually within 3 days after vaccination and resolved without treatment within 1 to 3 days of onset. 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 the available data) in the overall population, except for the population for which the side effect is mentioned above:

• enlarged lymph nodes in the neck, armpits, or groin.
• numbness or tingling (paresthesia), nerve pain (neuralgia), seizures (convulsions), neurological disorders that can cause stiffness of the neck, disorientation, numbness, pain, and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalitis, neuritis, Guillain-Barré syndrome).
• inflammation of blood vessels, which can lead to skin rashes and, in very rare cases, to temporary kidney function disorders.
• temporary decrease in the number of certain types of blood cells called platelets; their low number may cause excessive bruising or bleeding (transient thrombocytopenia).

Reporting side effects

If the adult patient or child experiences any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vaxigrip vaccine

Store the vaccine out of sight and reach of children.
Do not use this vaccine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month.
Store in a refrigerator (2°C–8°C). Do not freeze. Store the pre-filled syringe in the outer carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Vaxigrip vaccine contains

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/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A)
............................................................................................................. 15 micrograms HA**
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type)
............................................................................................................. 15 micrograms HA**
in a dose of 0.5 ml
*grown in chicken embryos from healthy flocks
**hemagglutinin
The vaccine is in line with the recommendations of the World Health Organization (WHO) for the Northern Hemisphere and with the recommendations of the European Union for the 2025/2026 season.
Other ingredients are: buffer solution containing sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections.
Some ingredients such as eggs (egg albumen, chicken protein), neomycin, formaldehyde, or octoxynol-9 may be present in very small amounts (see section 2).

What Vaxigrip vaccine looks like and contents of the pack

After gentle agitation, the vaccine is a colorless, opalescent liquid.
Vaxigrip vaccine is a suspension for injection in a pre-filled syringe of 0.5 ml, with a attached needle, with a separate needle or without a needle or with a separate needle in a protective shield, in a pack of 1 or 10, all in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly, France
Manufacturer:
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., Budynek Dc5, Campona Utca 1, Budapest XXII,1225, Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:June 2025

Other sources of information

Currently approved information on this product is available at the following URL: https://vaxigrip-nh.info.sanofi
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Information intended for healthcare professionals only:

As with all injectable vaccines, it is necessary to ensure adequate treatment and medical supervision in case of anaphylactic reaction after vaccination.
Before administration, the vaccine should be at room temperature.
Shake before use. Check visually before administration.
The vaccine should not be used if particles are present in the suspension.
The vaccine should not be mixed with other medicinal products in the same syringe.
The vaccine should not be injected directly into blood vessels.
See also section 3. How to use Vaxigrip vaccine

Instructions for using the safety needle shield with the pre-filled syringe with Luer Lock tip
Lock:
Rycina A: Needle with safety shield (in housing)	Rycina B: Elements of the safety shield (prepared for use)

Step 1: To attach the needle to the syringe, remove the needle hub cap to expose the needle hub and gently screw the needle into the Luer Lock adapter of the syringe until a slight resistance is felt.
Step 2: Remove the needle shield. The needle is protected by a safety shield and a protective cap.
Step 3: A: Pull the safety shield away from the needle in the direction of the syringe body at the shown angle. B: Remove the protective cap.
Step 4: After injection, lock (activate) the safety shield, using one of the three (3) presented one-handed techniques: activation on a flat surface, with the thumb, or with the index finger. Note: Activation is confirmed by an audible and/or palpable “click”.
Step 5: Visually check the function of the safety shield. The safety shield should be fully locked (activated), as shown in Figure C. Figure D shows that the safety shield is NOT fully locked (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by pushing the needle back into the safety shield.>

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.