Vaxigrip solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Vaxigrip injectable suspension in pre-filled syringe
Trivalent influenza vaccine (split virion, inactivated)
Read the entire leaflet carefully before you or your child are vaccinated, as it contains important information for you or your child.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This vaccine has been prescribed for you or your child only, and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you or your child experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Vaxigrip is and what it is used for
- What you need to know before you or your child are given Vaxigrip
- How to use Vaxigrip
- Possible side effects
- How to store Vaxigrip
- Contents of the pack and other information
1. What Vaxigrip is and what it is used for
Vaxigrip is a vaccine.
This vaccine is administered to you or your child from the age of 6 months and is indicated to protect you or your child against influenza (flu).
When the Vaxigrip vaccine is injected into a person, the immune system (the body's natural defense system) will produce protection (antibodies) against infection. When administered during pregnancy, in addition to protecting the pregnant woman, it also protects her baby from birth up to 6 months of age through the transmission of protection from mother to baby during pregnancy (see also sections 2 and 3).
None of the components of 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 each year. Due to this potential annual change in circulating strains, as well as the duration of protection provided by the vaccine, vaccination is recommended every year. The risk of catching influenza is higher during the colder months, between October and March. If you or your child were not vaccinated in the autumn, vaccination is still possible up to the spring, as you or your child remain at risk of becoming infected with influenza during this period. Your doctor can advise you on the best time to get vaccinated.
The purpose of Vaxigrip is to protect you or your child against the three virus strains contained in the vaccine, starting about 2 to 3 weeks after injection.
Furthermore, the incubation period of influenza is several days, so if you or your child are exposed to influenza immediately before or after vaccination, you or your child may still develop the disease.
The vaccine will not protect you or your child against the common cold, even if some of the symptoms are similar to those of influenza.
2. What you need to know before using Vaxigrip
To ensure that Vaxigrip is suitable for you or your child, it is important that you consult your doctor or pharmacist if any of the points described below apply to you or your child. If there is anything you do not understand, please consult your doctor or pharmacist for clarification.
Do not use Vaxigrip
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If you or your child are allergic to:
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The active substances, or
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Any of the other components of this vaccine (listed in section 6), or
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Any of the components that may be present in trace amounts, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde, or octoxinol-9.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Vaxigrip.
Talk to your doctor before vaccination if you or your child have:
- A weakened immune response (immunodeficiency or treatment with medicines affecting the immune system),
- Bleeding disorders or bruise 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 (especially in adolescents) may occur before or after any injection. 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 infants under 6 months of age born to women who were vaccinated during pregnancy will be protected.
Children
Vaxigrip is not recommended for use in children under 6 months of age.
Use of Vaxigrip with other medicines
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines or vaccines.
- Vaxigrip can be administered at the same time as other vaccines, provided different injection sites are used.
- The immune response may be reduced in patients receiving immunosuppressive treatments, such as corticosteroids, cytotoxic drugs, or radiotherapy.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using 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 has no or negligible influence on the ability to drive and use machines.
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; essentially "potassium-free" and "sodium-free".
3. How to use Vaxigrip
Dosage
Adults: 1 dose of 0.5 ml.
Use in children and adolescents
Children from 6 months to 17 years of age receive a dose of 0.5 ml.
If your child is under 9 years of age and has not previously been vaccinated against influenza, a second dose of 0.5 ml should be administered after an interval of at least 4 weeks.
If you are pregnant, a single dose of 0.5 ml administered during pregnancy may protect your baby from birth up to 6 months of age. For further information, consult your doctor or pharmacist.
How Vaxigrip is administered
Your doctor or nurse will administer the recommended dose of the vaccine as an injection into the muscle or under the skin.
If you or your child receive more Vaxigrip than you should
In some cases, more than the recommended dose has been inadvertently administered.
In such cases, when adverse events were reported, they were consistent with those described after administration of the recommended dose (see section 4).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.
If you experience an allergic reaction, contact your doctor or healthcare professional immediately or go immediately to the nearest hospital emergency department.
Allergic reactions
These may occur immediately after administration of the vaccine and may 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 (atopic dermatitis), flushing, hot flush, blood in the white part of the eye (ocular hyperemia), redness and irritation of the eye (conjunctivitis), throat irritation, sore throat, irritation inside the nose, runny nose, sneezing, nasal, sinus, or throat congestion, numbness or tingling sensation in the mouth (oral paresthesia), mouth rash (oral mucosal rash), asthma.
These allergic reactions were reported as uncommon (may affect up to 1 in 100 people) to rare (may affect up to 1 in 1,000 people).
Additional adverse effects in adults and elderly people
Very common (may affect more than 1 in 10 people):
- Headache, muscle pain, general malaise (malaise) (1), pain at injection site.
(1) Common in elderly people
Common (may affect up to 1 in 10 people):
- Fever (2), chills, injection site reactions: redness (erythema), hardness (induration), swelling.
(2) Uncommon in elderly people
Uncommon (may affect up to 1 in 100 people):
- Swelling of lymph nodes in the neck, armpit, or groin (lymphadenopathy) (3), unusual weakness (3), fatigue, drowsiness (4), dizziness (4), increased sweating (hyperhidrosis) (3), joint pain (3), diarrhoea, feeling unwell (nausea), injection site reactions: bruising, itching, warmth, and discomfort.
(3) Rare in elderly people (4) Rare in adults
Rare (may affect up to 1 in 1,000 people):
- Numbness or tingling sensation (paresthesia), vomiting, decreased appetite, flu-like illness.
- Decreased sensitivity (hypoesthesia), abdominal pain, allergic reaction at injection site: observed only in adults.
- Skin peeling (exfoliation) at injection site: observed only in elderly people.
Additional adverse effects 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, hardness (5).
(5) Common in children aged 9 to 17 years
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 lymph nodes in the neck, armpits, or groin, abdominal pain, vomiting, restlessness, moaning, joint pain, crying: observed only in children aged 3 to 8 years.
- Decrease in the number of certain types of blood particles called platelets; a low number of these may cause excessive bruising or bleeding (thrombocytopenia): observed only in a 3-year-old child.
- Unusual weakness, injection site discomfort: observed only in children aged 9 to 17 years.
Additional adverse effects in children between 6 and 35 months of age
Very common (may affect more than 1 in 10 people):
- Irritability (6), vomiting (7), muscle pain (8), general malaise (8), fever, decreased appetite (6), injection site reactions: tenderness, redness.
- Abnormal crying, drowsiness: observed only in children under 24 months of age.
- Headache: observed only in children from 24 months of age.
(6) Rare in children aged 24 to 35 months
(7) Uncommon in children aged 24 to 35 months
(8) Rare in children aged 6 to 23 months
Common (may affect up to 1 in 10 people):
- Diarrhoea, injection site reactions: hardening, 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, rash.
In children aged 6 months to 8 years who receive 2 doses, adverse effects are similar after both the first and second dose. Some adverse effects may occur after administration of the second dose in children aged 6 months to 35 months.
Most adverse effects generally occurred within 3 days after vaccination and resolved within 1 to 3 days without treatment. The intensity of most of these adverse effects was mild to moderate.
The frequency of the following adverse effects is unknown (cannot be estimated from available data) in the overall population, except for the population in which the adverse effect is specified above:
- Swelling of glands in the neck, armpits, or groin.
- Numbness or tingling sensation (paresthesia), nerve pathway pain (neuralgia) (9), seizures, neurological disorders that may cause neck stiffness, confusion, numbness, pain and weakness in limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis (9), Guillain-Barré Syndrome (9)).
- Inflammation of blood vessels (vasculitis), which may lead to skin rashes and, in very rare cases, temporary kidney problems.
- Temporary reduction in the number of certain types of blood particles called platelets; a low number of these may cause bruising or excessive bleeding (transient thrombocytopenia).
(9) Not reported in children aged 6 to 35 months
Reporting of adverse effects
If you or your child experiences any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Vaxigrip
Keep this medicine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the syringe in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Vaxigrip
The active substances are: Influenza virus (split, inactivated) from the following strains*:
- Strain similar to A/Victoria/4897/2022 (H1N1)pdm09: (IVR-238)....... 15 micrograms HA**
- Strain similar to A/Croatia/10136RV/2023 (H3N2): (X-425A)............. 15 micrograms HA**
- Strain similar to B/Austria/1359417/2021: B/Michigan/01/2021 ..…... 15 micrograms HA**
Per 0.5 ml dose
- grown in embryonated hens' eggs from healthy chickens
** haemagglutinin
This vaccine complies with the recommendations of the World Health Organization (Northern Hemisphere) and the decision of the European Union for the 2025-2026 season.
The other components are: a buffer solution containing sodium chloride, sodium dihydrogen phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride, and water for injections.
Some components such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9 may be present in very small amounts (see section 2).
Appearance of the product and contents of the pack
After thorough shaking, the vaccine is a slightly colourless, opalescent liquid.
Vaxigrip is supplied in a pre-filled syringe containing 0.5 ml of injectable suspension, with fixed needle, separate needle, safety needle, or without needle, in packs of 1 or 10. Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France
Manufacturer:
The manufacturer responsible for batch release is:
Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
or
Sanofi Winthrop Industrie
Voie de l’Institut – Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
or
Sanofi-Aventis Zrt.
Building Dc5 - Campona Utca 1
Budapest XXII, 1225
Hungary
Local Representative
sanofi-aventis, S.A.
C/ Rosselló i Porcel, 21
08016 Barcelona
Spain
Tel: +34 93 485 94 00
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Member State | Name |
Austria, Belgium, Bulgaria, Croatia, Czech Republic, Germany, Denmark, Estonia, Finland, France, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Spain | Vaxigrip |
Cyprus, Greece | Vaxigrip TIV |
Date of the latest review of this leaflet: June 2025
Other sources of information
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://vaxigrip-nh.info.sanofi.
This information is intended for healthcare professionals only:
As with all injectable vaccines, appropriate medical treatment and supervision must be available in case an anaphylactic reaction occurs following administration of the vaccine.
The vaccine should reach room temperature before use.
Shake well before use. Visually inspect before administration.
The vaccine must not be used if foreign particles are present in the suspension.
It must not be mixed with other medicines in the same syringe.
This vaccine must not be injected directly into any blood vessel.
See also section 3. How to use Vaxigrip.
<Preparation for administration
Instructions for use of the safety needle with the pre-filled Luer Lock syringe:
Image A: Safety needle (within the carrier) | Image B: Components of the safety needle (ready for use) |
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Step 1: To attach the needle to the syringe, remove the center cap to expose the needle hub, and gently screw the needle into the syringe's Luer Lock adapter until you feel slight resistance. |
Step 2: Remove the safety needle shield. The needle is covered by the safety device and the shield. |
Step 3: A: Separate the safety device from the needle away from the syringe barrel at the angle shown. B: Remove the shield straight out. |
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Step 4: After completing the injection, lock (activate) the safety device using one of the three illustrated techniques (3) with one hand only: activation against a surface, with the thumb, or with the index finger. Note: Activation is confirmed by an audible and/or tactile "click." |
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Step 5: Visually inspect the activation of the safety device. The safety device must be fully locked (activated) as shown in Figure C. Figure D shows the safety device is NOT fully locked (not activated). |
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Caution: Do not attempt to unlock (deactivate) the safety device by forcing the needle out of the safety device. > |
Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.