Vaxigrip Tetra Suspension

This vaccine complies with the WHO recommendations (Southern Hemisphere) for the 2024 season. VAXIGRIP TETRA may contain traces of eggs, such as ovalbumin and of neomycin, formaldehyde and octoxinol-9, which are used during the manufacturing process. VAXIGRIP TETRA is intended to protect you or your child from 6 months of age against influenza (flu). When you or your child is given VAXIGRIP TETRA, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. When given during pregnancy, VAXIGRIP TETRA helps to protect you, but also helps to protect your 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 ingredients in the vaccine can cause flu. VAXIGRIP TETRA is intended to protect you or your child against the four strains of virus contained in the vaccine about 2 to 3 weeks following the injection. The four strains of virus are made up of 2 influenza A subtypes and two influenza B types. However, if you or your child is exposed to flu immediately before or after your vaccination, you or your child could still develop the illness as the incubation period for flu is a few days.

VAXIGRIP TETRA should not be administered:

• If you or your child has a history of severe allergic reaction (which may have required medical attention) to:
  • the active substances, or
  • any of the other ingredients of this vaccine (listed in What VAXIGRIP TETRA contains ), or
  • any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9.
• If you or your child has a history of severe allergic reaction after a previous administration of VAXIGRIP TETRA or a vaccine containing the same ingredients (listed in What VAXIGRIP TETRA contains ).
• If you or your child has an illness with a high or moderate temperature or an acute illness, the vaccination should be postponed until after you or your child has recovered.

Warnings and precautions

Tell your doctor or health care provider before being vaccinated with VAXIGRIP TETRA:

• Vaccination with VAXIGRIP TETRA may not protect 100 % of susceptible individuals.
• VAXIGRIP TETRA should not be given by intravenous route.
• Influenza virus is remarkably unpredictable in that significant antigenic changes may occur from time to time. It is known that VAXIGRIP TETRA, as constituted per annual seasonal composition, is not effective against all possible strains of influenza virus.
• VAXIGRIP TETRA is intended to provide protection against those strains of virus from which the vaccine is prepared.
• If the vaccine is used in persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy, the expected immune response may not be obtained.
• Bleeding might occur following intramuscular injection; inform your health care provider if you have a bleeding disorder.
• Fainting can occur following, or even before any needle injection. Therefore, tell your health care provider if you or your child fainted with a previous injection.
• Not all babies less than 6 months of age, born to pregnant women who were vaccinated during pregnancy, will be protected.
• If, for any reason, you or your child has a blood test within a few days following a flu vaccination, please tell your doctor or health care provider. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.

You will not be expected to give yourself VAXIGRIP TETRA, it will be given to you by a person who is qualified to do so. Given the antigenic variation in circulating influenza viruses and the duration of immunity provided by the vaccine, it is recommended to perform vaccination against influenza every year at the beginning of the risk period.

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of VAXIGRIP TETRA. The vaccine should be allowed to reach room temperature before use. Parenteral medicines should be inspected visually for particulate matter and/or discolouration prior to administration whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered. Shake before use.

Adults: one dose of 0,5 mL. Paediatric population:

• Children from 6 months to 17 years of age: one dose of 0,5 mL. For children less than 9 years of age who have not previously been vaccinated, a second dose of 0,5 mL should be given after an interval of at least 4 weeks.
• Infants less than 6 months of age: the safety and efficacy of VAXIGRIP TETRA administration (active immunisation) have not been established. No data are available. If you are pregnant: one 0,5 mL dose given to you during pregnancy may protect your baby from birth up to 6 months of age. Ask your doctor or pharmacist for more information.

The vaccine should be given by intramuscular or deep subcutaneous injection.

If you take more VAXIGRIP TETRA than you should: Not documented. Since a health care provider will administer VAXIGRIP TETRA, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

VAXIGRIP TETRA can cause side effects, although not everybody gets them. Not all side effects reported for VAXIGRIP TETRA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving VAXIGRIP TETRA, please consult your doctor, pharmacist or other health care provider for advice. See a doctor immediately or go to the casualty department at your nearest hospital if you or your child experiences:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

Data from clinical studies Side effects reported within 7 days after vaccination during clinical trials with VAXIGRIP TETRA: Adults (18 to 60 years) Frequently occurring:

• headache, muscle pain (myalgia), discomfort or uneasiness (malaise), injection site pain, fever, shivering, injection site reactions: redness (erythema), swelling, hardening (induration).

• injection site bruising (ecchymosis).

• headache, muscle pain, injection site pain
• shivering, discomfort or uneasiness, injection site reactions: redness, swelling, hardening.

• fever, injection site bruising.

• headache, muscle pain, discomfort or uneasiness, injection site reactions: pain and swelling
• shivering, fever, injection site reactions: redness, hardening, bruising.

• headache, muscle pain, discomfort or uneasiness, shivering, injection site reactions: pain, swelling, redness, hardening
• fever, injection site bruising.

Adults (18 to 60 years) Less frequently occurring:

• injection site itching and warmth, fatigue, diarrhoea, nausea, swelling of the glands in the neck, armpit or groin (lymphadenopathy)
• injection site discomfort, influenza-like illness, unusual tiredness and weakness (asthenia), breathing difficulty (dyspnoea), dizziness, abnormal sensation of touch, pain, heat and cold (paraesthesia), drowsiness (somnolence), excessive sweating (hyperhidrosis), hives (urticaria), severe allergic reaction which causes swelling of the face or throat (angioedema), itching, generalised itching, red itchy rash (allergic dermatitis), redness, joint pain (arthralgia), allergy (hypersensitivity).

• injection site itching and warmth, fatigue, diarrhoea, dizziness, hot flushes, itching, unusual tiredness and weakness, influenza-like illness, nausea, abnormal sensation of touch, pain, heat and cold, drowsiness, redness, excessive sweating (hyperhidrosis).

• injection site itching, diarrhoea.

• vomiting (1) , muscular pain (myalgia) (2) , irritability (1) , appetite loss (1) , generally feeling unwell (malaise) (2) , fever (1)

• reactions at the injection site: pain/tenderness, redness (erythema)
• headache (only seen in children from 24 months of age)
• drowsiness, unusual crying (only seen in children less than 24 months of age)
• shivering (only seen in children 24 months and older)
• reactions at the injection site: hardness (induration), swelling, bruising (ecchymosis).

• Fatigue, injection site warmth, diarrhoea, vomiting, upper abdominal pain, restlessness, moaning, dizziness, joint pain, temporary reduction in the number of certain types of particles called platelets; a low number of these can result in excessive bruising or bleeding (thrombocytopenia).

• Severe allergic reactions that may lead to medical emergency with low blood pressure, rapid shallow breathing, rapid heart rate and weak pulse, cold, clammy skin, dizziness, that may lead to collapse (shock).
• Allergic reactions such as skin reactions that may spread throughout the body (rash, redness).
• Pain situated on the nerve route (neuralgia), fits (convulsions), neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all of the body (encephalomyelitis, neuritis, Guillain-Barré syndrome).
• Inflammation of the blood vessels (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems.

• Store in a refrigerator between 2 °C and 8 °C.
• Do not freeze.
• Shake before use.
• Keep the syringe in the outer carton in order to protect from light.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date indicated on the label or the package.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).