Solution for injection, suspension in pre-filled syringe
Quadrivalent influenza vaccine (cleaved virus, inactivated)
What VaxigripTetra is and what it is used for
VaxigripTetra is a vaccine. This vaccine given to you or your child from the age of 6 months helps to protect you or your child against influenza.
When a person is given the VaxigripTetra vaccine, the immune system (the body’s natural defense system) begins to produce its protection ( antibodies ) against the disease. When the vaccine is given during pregnancy, it helps protect the pregnant woman and the baby from birth to 6 months of age by transferring protection from the mother to the baby during pregnancy (see also sections 2 and 3). No components of the vaccine can cause influenza.
The use of VaxigripTetra should be based on official recommendations.
Influenza is a disease that can spread quickly and is caused by different strains of viruses that can change every year. Based on the duration of protection you get from the vaccine, as well as the fact that the circulating strains can change from year to year, annual vaccination is recommended. The greatest risk of contracting the flu is during the cold months between October and March. If you or your child were not vaccinated in the autumn, it is still wise to be vaccinated right up to the spring because you or your child are then still at risk of being infected with influenza. Your doctor can recommend the most suitable time for you to be vaccinated.
VaxigripTetra is intended to protect you or your child from the four virus strains included in the vaccine from approximately 2 to 3 weeks after injection one. However, if you or your child is exposed to the flu virus immediately before or after vaccination, you may still develop the disease, as the incubation period for flu is a few days.
The vaccine does not protect you or your child against the common cold, even though some symptoms resemble the flu.
What you need to know before you or your child use VaxigripTetra
To ensure that VaxigripTetra is suitable for you or your child, it is important to inform the doctor or pharmacist if any of the points below apply to you or your child. If there is something you do not understand, ask your doctor or pharmacist to explain.
Do not use VaxigripTetra
- if you or your child is allergic to:
- the active substances, or
- any other ingredient in this vaccine, (listed in section 6), or
- any ingredients that may be present in very small amounts, such as egg (ovalbumin, chicken protein) neomycin, formaldehyde, or octoxinol‑9.
- if you or your child has an illness with a high or moderate fever or an acute illness, vaccination should be postponed until after recovery.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using VaxigripTetra.
Tell the doctor before the vaccination if you or your child have:
- impaired immune system (have an immune deficiency or take drugs that affect the immune system)
- problems with bleeding or easy bruising.
Your doctor will decide if you or your child should receive the vaccine.
Fainting may occur (mostly in young people) after, or even before, the needle stick. Therefore, tell the doctor or nurse if you or your child have previously fainted in connection with a needle stick.
As with all vaccines, there is a risk that VaxigripTetra may not provide full protection in all patients. The vaccine does not protect all children under 6 months whose mothers received the vaccine during pregnancy.
Tell your or your child’s doctor that you have been vaccinated against the flu if for any reason you or your child submits a blood test within a few days of flu vaccination. This should be done because false-positive blood tests have been observed in a few patients who have recently been vaccinated.
Children
Use of VaxigripTetra is not recommended for children under 6 months of age.
Other medicines and VaxigripTetra
Tell the doctor or pharmacist if you or your child are taking, have recently taken, or might take other vaccines or other medicines.
- VaxigripTetra can be given at the same time as other vaccines if they are given in different arms or legs.
- The immune response can become worse during treatment with drugs that inhibit the immune system, for example, corticosteroids, chemotherapy, or radiation therapy.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding or think you may be pregnant, ask your doctor or pharmacist for advice before using this vaccine.
VaxigripTetra can be used in all stages of pregnancy.
VaxigripTetra can be used during breastfeeding.
Your doctor or pharmacist can decide if you should receive VaxigripTetra.
Driving ability and use of machinery
VaxigripTetra has no or negligible effect on the ability to drive or use machines.
VaxigripTetra contains potassium and sodium
This medicine contains less than 1 mmol potassium (39 mg) and less is 1 mmol sodium (23 mg) per dose, i.e. is next to “potassium-free” and “sodium-free”.
How to use VaxigripTetra
Dosage
Adults receive a dose of 0.5 ml.
Use for children
Children aged between 6 months and 17 years 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 given after at least 4 weeks.
If you are pregnant, a dose of 0.5 ml that you received during pregnancy can protect your baby from birth up to 6 months of age. Ask your doctor or pharmacist for more information.
How VaxigripTetra is given
The doctor or nurse gives the recommended dose of the vaccine as an injection into a muscle or under the skin.
If you or your child has received too much VaxigripTetra
In some cases, more than the recommended dose has been accidentally injected.
When side effects in these cases were reported, they were consistent with the side effects described after injection of the recommended dose (see section 4).
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions
Contact a doctor or healthcare professional immediately or go to the nearest emergency department if you or your child experience allergic reactions that may be life-threatening (reported as rare side effects: in up to 1 in 1,000 users).
Symptoms may include skin rash, itching, hives, redness, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold, clammy skin, palpitations, dizziness, weakness, or fainting.
Other reported side effects are in adults and the elderly
Very common (may affect more than 1 in 10 users)
- Headache, muscle pain ( myalgia ), general malaise (1), and pain at the injection site.(1) Common in the elderly
Common (may affect up to 1 in 10 users)
- Fever (2), chills, reactions at the injection site: redness ( erythema ), swelling, induration. (2) Less common in the elderly
Uncommon (may affect up to 1 in 100 users)
- Dizziness (3), diarrhea, nausea (4), fatigue, reactions at the injection site: bruising, itching, and feeling of warmth.(3) Rare in adults (4) Rare in the elderly
- Hot flashes: only observed in the elderly.
- Swollen glands in the neck, armpit, or groin ( lymphadenopathy ): observed only in adults
Rare (may affect up to 1 in 1,000 users)
- Abnormalities in the sensation of touch, pain, heat and cold ( paresthesias ), sleepiness, increased sweating ( hyperhidrosis ), unusual tiredness or weakness, flu-like illness
- Joint pain, injection site discomfort: only observed in adults
Other reported side effects are in children between 3 and 17 years of age
Very common (may affect more than 1 in 10 users)
- Headache, muscle pain ( myalgia ), general malaise, chills (5), reactions at the injection site: pain, swelling, redness ( erythema ) (5), induration (5) . (5) Common between 9 and 17 years of age
Common (may affect up to 1 in 10 users)
- Fever, and bruising at the injection site.
Uncommon (may affect up to 1 in 100 users) in children aged 3 to 8 years:
- Temporarily reduced number of a certain type of blood cells called platelets; a low number of these may cause an increased tendency to bruise or bleed (transient thrombocytopenia ): only observed in a 3-year-old child.
- Wailing, restlessness
- Dizziness, diarrhea, vomiting, upper abdominal pain, joint pain, fatigue, and feeling of warmth at the injection site.
Uncommon (may affect up to 1 in 100 users) in children aged 9 to 17 years:
- Diarrhea, itching at the injection site.
Other reported side effects are in children between 6 and 35 months
Very common (may affect more than 1 in 10 users):
- Vomiting (1), muscle pain ( myalgia ) (2), irritability (3), loss of appetite (3), general malaise (2), fever.
(1) Uncommon in children between 24 and 35 months of age, (2) Rare in children younger than 24 months of age, (3) Rare in children between 24 and 35 months of age
- Reactions at the injection site: pain/tenderness, redness ( erythema ).
- Headache: only observed in children 24 months and older.
- Drowsiness, and unusual crying: only observed in children younger than 24 months.
Common (may affect up to 1 in 10 users):
- Chills: only observed in children 24 months and older.
- Injection site reactions: induration, swelling, bruising ( ecchymosis ).
Uncommon (may affect up to 1 in 100 users):
- Diarrhea, hypersensitivity.
Rare (may affect up to 1 in 1,000 users):
- Influenza-like illness, reactions at the injection site: eczema, itching.
In children between 6 months and 8 years who received two doses, side effects were similar after the first and the second dose. Fewer side effects may occur after the second dose in children between 6 and 35 months of age.
Most side effects were seen usually occurred within 3 days of vaccination and resolved on their own within 1 to 3 days of onset. The side effects observed were mild.
Side effects were overall less common in the elderly than in adults and children.
The following side effects have been reported after the administration of Vaxigrip. These side effects can occur with VaxigripTetra:
- Pain along the distribution of a nerve ( neuralgia ), seizures (convulsions), neurological disorders (affecting nerves) which can cause neck stiffness, confusion, numbness, pain and weakness in arms and legs, impaired balance, impaired reflexes, paralysis in parts of or whole body ( encephalomyelitis, neuritis, Guillain-Barré syndrome )
- Inflammation of blood vessels ( vasculitis ), which can lead to skin rashes and, in very rare cases, temporary kidney problems
- transient thrombocytopenia, lymphadenopathy, and paresthesias in other age groups than those listed above for these side effects.
How VaxigripTetra should be stored
Keep this vaccine out of the sight and reach of children.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2°C‑8°C). Do not freeze. Store the syringe in the outer carton. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are Influenza virus (inactivated, split) of the following strains*:
| A/Victoria/2570/2019 (H1N1)pdm09 – similar strain (A/Victoria/2570/2019, IVR-215) | 15 micrograms HA** |
| A/Darwin/9/2021 (H3N2) – similar strain (A/Darwin/9/2021, IVR-228) | 15 micrograms HA** |
| B/Austria/1359417/2021 – similar strain (B/Michigan/01/2021, wild type) | 15 micrograms HA** |
| B/Phuket/3073/2013 – similar strain (B/Phuket/3073/2013, wild type) | 15 micrograms HA** |
| Per 0.5 ml dose | |
| *produced from fertilized chicken eggs from healthy flocks**hemagglutinin |
This vaccine complies with WHO (World Health Organization, Northern Hemisphere) recommendations and EU decisions for the 2022/2023 season.
- Other ingredients: a buffer solution containing sodium chloride, and potassium chloride. disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.
Some ingredients such as egg (ovalbumin, chicken protein) neomycin, formaldehyde, or octoxinol‑9 may be present in very small amounts (see section 2).
Appearance and package sizes of VaxigripTetra
After gentle shaking, the vaccine is a colorless, opalescent suspension.
VaxigripTetra is an injection liquid in the form of a suspension in a pre-filled syringe with 0.5 ml, with or without an attached needle, in cartons of 1, 10, or 20 pcs. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
France
Manufacturer:
Sanofi Pasteur – 1541 avenue Marcel Mérieux – 69280 Marcy l’Etoile – France
Sanofi Pasteur – Parc Industriel d’Incarville – 27100 Val de Reuil – France
Sanofi Aventis Zrt. – Campona utca 1. (Harbor Park) – 1225 Budapest – Hungary
Local Representative:
Sanofi AB
Box 30052
104 25 Stockholm
Phone: +46 8-634 50 00