Vaxigrip

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vaxigrip, suspension for injection in prefilled syringe
Trivalent inactivated influenza vaccine (split virion)
Please read all of this leaflet carefully before this vaccine is administered, because it contains
important information for the adult or child.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If any adverse reactions occur in the adult or child, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Vaxigrip is and what it is used for
2. Important information before vaccination with Vaxigrip
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 Vaxigrip is and what it is used for

Vaxigrip is a vaccine.
This vaccine is given to adults and children from 6 months of age to help protect against influenza (flu).
After administration of Vaxigrip vaccine, the immune system (the body's natural defence system) produces its own protection against the disease (antibodies). Vaccination during pregnancy helps protect pregnant women as well as their infants from birth up to less than 6 months of age by transferring protection from mother to child during pregnancy (see also sections 2 and 3).
None of the components of the vaccine can cause influenza.
Use of Vaxigrip vaccine should follow official recommendations.
Influenza is an illness that can spread quickly and is caused by many different strains of virus, which may change each year. Because of these possible annual changes in circulating strains, as well as the limited duration of protection provided by the vaccine, annual vaccination is recommended. The highest risk of contracting influenza occurs during the colder months, between October and March. For adults and children who have not been vaccinated in the autumn, vaccination is still justified during the period up to spring, since the risk of contracting influenza remains until that time. Your doctor can advise on the best time to be vaccinated.
The Vaxigrip vaccine is intended to protect adults and children against the three virus strains contained in the vaccine, approximately 2 to 3 weeks after vaccination.
Since the incubation period for influenza is several days, it is still possible for an adult or child to develop influenza if exposed to the influenza virus shortly before or after vaccination.
The vaccine does not protect against the common cold, although some of its symptoms may resemble those of influenza.

2. Important information before administering Vaxigrip vaccine

Inform your doctor or pharmacist if any of the following apply to the adult or child who is to receive the Vaxigrip vaccine. If anything is unclear, please ask your doctor or pharmacist for clarification.

When not to use Vaxigrip vaccine

• If the adult or child has a known allergy to:
• The active substances, or
• Any of the other ingredients of this vaccine (listed in section 6), or
• Any component which may be present in trace amounts, such as egg residue (ovalbumin, chicken proteins), neomycin, formaldehyde, or octoxynol-9.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before administration of the Vaxigrip vaccine.
Inform your doctor if the adult or child has:

• A weakened immune response (due to immunodeficiency or treatment with medicines affecting the immune system),
• Bleeding disorders or a tendency to bruise easily.

If the adult or child has an acute illness with fever, vaccination should be postponed until the fever has resolved. Your doctor will decide whether the adult or child should receive the vaccine.

Fainting may occur (particularly in adolescents) during or even before any injection. Therefore, inform your doctor or nurse if you or your child has previously fainted following an injection.

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

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

Vaxigrip vaccine and other medicines
Tell your doctor or pharmacist about any other medicines or vaccines the adult or child is currently taking, has recently taken, or plans to take.

• Vaxigrip vaccine may be administered simultaneously with other vaccines, but in separate limbs.
• If the patient is receiving treatments that suppress the immune system, such as corticosteroids, cytotoxic drugs, or radiotherapy, the immune response to vaccination may be reduced.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this vaccine.
Vaxigrip vaccine may be given at any stage of pregnancy.
Vaxigrip vaccine may be used during breastfeeding.
Your doctor/pharmacist will decide whether Vaxigrip vaccine can be administered.

Driving and using machines
Vaxigrip vaccine has no effect or negligible effect on the ability to drive and operate machinery.

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, meaning the medicine is considered "potassium-free" and "sodium-free".

3. How to use Vaxigrip vaccine

Dosage
Adults should receive a single dose of 0.5 ml.
Use in children and adolescents
Children from the completed 6th month of life up to the end of the 17th year of life should receive a single dose of 0.5 ml.
Children below the age of 9 years who have not previously been vaccinated against influenza should be given a second dose of 0.5 ml at least 4 weeks after the first dose.
In pregnant women, a single dose of 0.5 ml administered during pregnancy may protect the infant from birth up to less than 6 months of age. For further information, consult your doctor or pharmacist.
How to administer Vaxigrip vaccine
Your doctor or nurse will administer the recommended dose of the vaccine as an intramuscular or subcutaneous injection.
Administration of a higher than recommended dose of Vaxigrip vaccine
In some cases, a dose higher than recommended has been accidentally administered.
In such cases, reported adverse reactions were consistent with those described after administration of the recommended dose (see section 4).
If you have any further doubts regarding the use of this vaccine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this vaccine can cause adverse reactions, although not everyone experiences them.
You should contact a doctor or healthcare professional immediately, or go to the nearest emergency room, if an allergic reaction occurs.
Allergic reactions
These may occur immediately after vaccination and may 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, cold and clammy 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 skin redness, hot flushes, blood in the white of the eye (subconjunctival hemorrhage), redness and irritation of the eye (conjunctivitis), throat irritation, sore throat, nasal irritation, runny nose, sneezing, nasal congestion, sinus or throat congestion, numbness or tingling sensation in the mouth (oral paresthesia), mouth rash (lesions on the oral mucosa), asthma.

These allergic reactions have been reported as occurring uncommonly (may affect up to 1 in 100 people) or rarely (may affect up to 1 in 1000 people).
Additional adverse reactions in adults and elderly people
Very common (may affect more than 1 in 10 people):

• Headache, muscle pain, general malaise, injection site pain.

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

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

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

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

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

• Tingling or numbness sensation (paresthesia), vomiting, decreased appetite, influenza-like symptoms.
• Reduced sensation (hypoesthesia), abdominal pain, allergic reaction at injection site: observed only in adults.
• Skin peeling at injection site: observed only in adults.

Additional adverse reactions reported in children aged 3 to 17 years
Very common (may affect more than 1 in 10 people):

• Headache, muscle pain, general malaise, chills, injection site reactions: pain, redness, swelling, induration.

Common (may affect fewer than 1 in 10 people):

• Fever, bruising (bruising) at injection site.
  Uncommon (may affect up to 1 in 100 people):
• Feeling of tiredness, dizziness, diarrhea, injection site reactions: itching, warmth.
• Enlarged lymph nodes in the neck, armpit or groin, abdominal pain, vomiting, restlessness, irritability, joint pain, crying: observed only in children aged 3 to 8 years.
• Decreased number of certain types of blood cells called platelets; low platelet count 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.

Additional adverse reactions reported in children from completion of 6th month of life to completion of 35th month of life
Very common (may affect more than 1 in 10 people):

• Irritability, vomiting, muscle pain, general malaise, fever, decreased appetite, injection site reactions: tenderness, redness.
• Unusual crying, drowsiness: observed only in children below 24 months of age.
• Headache: observed only in children after completion of 24th month of life.

Common (may affect fewer than 1 in 10 people):

• Diarrhea, injection site reactions: induration, bruising, swelling.
• Chills: observed only in children after completion of 24th month of life.
  Rare (may affect up to 1 in 1000 people):
• Influenza-like symptoms, injection site reactions: itching, rash.

In children aged from completion of 6th month of life to 8 years receiving two doses, adverse reactions after the first and second dose are similar. Fewer adverse reactions may occur after administration of the second dose in children aged from completion of 6th month to completion of 35th month of life. Most adverse reactions usually occurred within 3 days after vaccination and resolved without treatment within 1 to 3 days. The intensity of most of these adverse reactions was mild to moderate.

The frequency of the following adverse reactions is unknown (cannot be estimated from available data) in the overall population, except for populations in which the adverse reaction was listed above:

• Enlarged lymph nodes in the neck, armpit or groin.
• Tingling or numbness sensation (paresthesia), nerve pain (neuralgia), seizures, neurological disorders which may cause neck stiffness, disorientation, numbness, pain and weakness of limbs, loss of balance, loss of reflexes, paralysis of part or whole body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
• Inflammation of blood vessels (vasculitis), which may lead to skin rashes and, in very rare cases, to transient kidney function disorders.
• Temporary decrease in the number of certain types of blood cells called platelets; low platelet count may cause excessive bruising or bleeding (transient thrombocytopenia).

Reporting of adverse reactions
If any adverse reactions occur in adult patients or children, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the Vaxigrip vaccine

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

6. Contents of the pack and other information

What Vaxigrip vaccine contains
The active substances are: Influenza virus (inactivated, split) from 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**
per 0.5 ml dose
*propagated in embryonated chicken eggs from healthy flocks
**haemagglutinin

The vaccine complies 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.
The other ingredients are: buffer solution containing sodium chloride, potassium chloride, disodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate, water for injections.
Some components such as eggs (chicken egg albumin, chicken proteins), 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 shaking, the vaccine is a colourless, opalescent liquid.
Vaxigrip vaccine is a 0.5 ml suspension for injection in a pre-filled syringe with attached needle, with separate needle or without needle, or with a separate needle in a protective shield, packed in cartons of 1 or 10. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly, France

Manufacturers:
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 Economic Area under the following names:

Other sources of information
Currently approved information about this product is available under the QR code provided on the outer carton or at the following URL: https://vaxigrip-nh.info.sanofi

Information intended exclusively for healthcare professionals:

As with all injectable vaccines, appropriate medical treatment and supervision must be available in case of an anaphylactic reaction following vaccination.
The vaccine should reach room temperature before administration.
Shake well before use. Visually inspect the vaccine before administration.
The vaccine must not be used if particulate matter is present in the suspension.
The vaccine must not be mixed with other medicinal products in the same syringe.
The vaccine must not be injected directly into blood vessels.
See also section 3. How to use Vaxigrip vaccine.

Instructions for use of safety needle shield with cartridge-syringe with Luer tip
Lock:
Figure A: Needle with safety shield (in housing)	Figure B: Components of the needle safety shield (ready 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 syringe's Luer Lock adapter until slight resistance is felt.
Step 2: Remove the needle housing. The needle is protected by a safety shield and a protective cap.
Step 3: A: Slide the safety shield away from the needle towards the syringe barrel at the angle shown. B: Remove the protective cap.
Step 4: After injection, lock (activate) the safety shield using one of the three (3) illustrated one-handed techniques: activation on a flat surface, with the thumb, or with the index finger. Warning: Activation is confirmed by an audible and/or palpable "click".
Step 5: Visually inspect the function of the safety shield. The safety shield should be fully locked (activated), as shown in Figure C. Figure D shows the safety shield is NOT fully locked (not activated).
Warning: Do not attempt to unlock (deactivate) the safety device by pushing the needle out of the safety shield.

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