Vaxigrip Tetra

Quadrivalent seasonal influenza vaccine (split virion, inactivated) 2023 Southern Hemisphere Strain.

The active substances are: Influenza virus (inactivated, split) of the following strains*: A/Victoria/2570/2019 (H1N1)pdm09-like strain (A/Victoria/2570/2019, IVR-215) 15 micrograms HA**, A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/9/2021, IVR-228) 15 micrograms HA**, B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type) 15 micrograms HA**, B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) 15 micrograms HA** Per 0.5 mL dose.
*propagated in fertilised hens' eggs from healthy chicken flocks.
** haemagglutinin.
This vaccine complies with the WHO (World Health Organisation) recommendations (Southern Hemisphere) for the 2023 season.
Excipients/Inactive Ingredients: The other ingredients are: a buffer solution containing sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.
Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9 may be present in very small amounts (see Precautions).

Vaxigrip Tetra is a vaccine. This vaccine, administered to adult or child from 6 months of age, helps to protect the adult or child against influenza (flu).
When a person is given Vaxigrip Tetra, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. When administered during pregnancy, the vaccine helps to protect the pregnant woman but also helps to protect her baby(ies) from birth to almost 6 months of age through the transmission of protection from mother to baby during pregnancy (see also Precautions and Dosage & Administration).
None of the ingredients in the vaccine can cause flu.
The use of Vaxigrip Tetra should be based on official recommendations.
Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Due to this potential change in circulating strains on a yearly basis, as well as the duration of protection intended by the vaccine, vaccination is recommended every year. The greatest risk of catching flu is during the cold months. If the adult or child were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since the patient runs the risk of catching flu until then. The doctor will be able to recommend the best time to be vaccinated.
Vaxigrip Tetra is intended to protect the adult or child against the four strains of virus contained in the vaccine about 2 to 3 weeks after the injection. In addition, if the adult or child is exposed to flu immediately before or after the vaccination, the adult or child could still develop the illness as the incubation period for flu is a few days.
The vaccine will not protect the adult or child against the common cold, even though some of the symptoms are similar to flu.

Dosage: Adults receive one 0.5 mL dose.
Use in children: Children from 6 months to 17 years of age receive one 0.5 mL dose.
If the child is less than 9 years old and has not been previously vaccinated against flu, a second dose of 0.5 mL should be given after an interval of at least 4 weeks.
If the patient is pregnant, the 0.5 mL dose administered during pregnancy may protect the baby from birth to almost 6 months of age. Ask the doctor or pharmacist for more information.
How Vaxigrip Tetra is given: The doctor or nurse will administer the recommended dose of the vaccine as an injection into the muscle or under the skin.
If the adult or child receives more Vaxigrip Tetra than they should: In some cases, more than the recommended dose has been inadvertently administered. In these cases, when side effects were reported, they were in line with what is described following the administration of the recommended dose (see Side Effects).
If the patient has any further questions on the use of this product, ask the doctor or pharmacist.

To make sure that Vaxigrip Tetra is suitable for the adult or child, it is important to tell the doctor or pharmacist if any of the following points apply to the adult or child. If there is anything the patient did not understand, ask the doctor or pharmacist to explain.
Do not use Vaxigrip Tetra: If the adult or child is allergic to: The active substances, or any of the other ingredients of this vaccine (listed in Description), or any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9.
If the adult or child has an illness with a high or moderate temperature or an acute illness, the vaccination should be postponed until after the adult or child has recovered.

Talk to the doctor, pharmacist or nurse before using Vaxigrip Tetra.
Should tell the doctor before vaccination if the adult or child has: A poor immune response (immunodeficiency or taking medicines affecting the immune system); Bleeding problem or bruising easily.
The doctor will decide if the adult or child should receive the vaccine.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore, tell the doctor or nurse if the adult or child fainted with a previous injection.
As with all vaccines, Vaxigrip Tetra may not fully protect all persons who are vaccinated.
Not all babies less than 6 months of age born to pregnant women vaccinated during pregnancy may be protected.
If, for any reason, the adult or child have a blood test within a few days following a flu vaccination, please tell the doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.
Vaxigrip Tetra contains potassium and sodium: This medicine contains less than 1 mmol potassium (39 mg) and less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially "potassium-free" and "sodium-free".
Driving and using machines: Vaxigrip Tetra has no or negligible influence on the ability to drive and use machines.
Use in Children: Vaxigrip Tetra is not recommended for use in children below 6 months of age.

If the patient is pregnant or breast-feeding, think may be pregnant, ask the doctor or pharmacist for advice before using this vaccine.
Vaxigrip Tetra can be used in all stages of pregnancy.
Vaxigrip Tetra may be used during breast-feeding.
The doctor/pharmacist will be able to decide if the patient should receive Vaxigrip Tetra.

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions: Contact the doctor or a healthcare professional immediately or go to the nearest hospital emergency room immediately if the adult or child experience allergic reactions (reported as rare: may affect up to 1 in 1,000 people) that can be life threatening.
Symptoms may include 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 side effects reported in adults and elderly: Very common (may affect more than 1 in 10 people): Headache, muscular pain (myalgia), malaise ⁽¹⁾, pain at the injection site.
⁽¹⁾ Common in elderly.
Common (may affect up to 1 in 10 people): Fever ⁽²⁾, shivering, reactions at the injection site: redness (erythema), swelling, hardness (induration).
⁽²⁾ Uncommon in elderly.
Uncommon (may affect up to 1 in 100 people): Dizziness ⁽³⁾, diarrhoea, nausea ⁽⁴⁾, fatigue, reactions at the injection site: bruising (ecchymosis), itching (pruritus), and warmth.
⁽³⁾ Rare in adults.
⁽⁴⁾ Rare in elderly.
Hot flush: only seen in the elderly.
Swelling of the glands in the neck, armpit or groin (lymphadenopathy): only seen in adults.
Rare (may affect up to 1 in 1,000 people): Anomalies in the perception of touch, pain, heat and cold (paraesthesia), sleepiness, increased sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), flu-like illness.
Joint pain (arthralgia), discomfort at the injection site: only seen in adults.
Other side effects reported in children from 3 to 17 years of age: Very common (may affect more than 1 in 10 people): Headache, muscular pain (myalgia), malaise, shivering ⁽⁵⁾, reactions at the injection site: pain, swelling, redness (erythema) ⁽⁵⁾, hardness (induration) ⁽⁵⁾.
⁽⁵⁾ Common in children from 9 to 17 years of age.
Common (may affect up to 1 in 10 people): Fever, bruising (ecchymosis) at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 3 to 8 years of age: Temporary reduction in the number of certain blood elements called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia): only seen in one child of 3 years of age.
Moaning, restlessness.
Dizziness, diarrhoea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, warmth at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 9 to 17 years of age: Diarrhoea, itching (pruritus) at the injection site.
Other side effects reported in children from 6 to 35 months of age: Very common (may affect more than 1 in 10 people): Vomiting ⁽¹⁾, muscular pain (myalgia) ⁽²⁾, irritability ⁽³⁾, appetite lost ⁽³⁾, generally feeling unwell (malaise) ⁽²⁾, fever.
⁽¹⁾ Uncommon in children from 24 to 35 months of age.
⁽²⁾ Rare in children less than 24 months of age.
⁽³⁾ Rare in children from 24 to 35 months of age.
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.
Common (may affect up to 1 in 10 people): Shivering: only seen in children 24 months and older.
Reactions at the injection site: hardness (induration), swelling, bruising (ecchymosis).
Uncommon (may affect up to 1 in 100 people): Diarrhoea, hypersensitivity.
Rare (may affect up to 1 in 1,000 people): Flu-like illness, reactions at the injection site: rash, pruritus (itching).
In children from 6 months to 8 years of age who received 2 doses, side effects were similar after the first and after the second dose. Fewer side effects may happen after the second dose in children from 6 to 35 months of age.
When seen, side effects generally happen in the first 3 days after the vaccination and go away by themselves in 1 to 3 days after they start. The intensity of observed side effects was mild.
Side effects were generally less frequent in elderly than in adults and children.
The following side effects have been reported after administration of Vaxigrip. These side effects may occur with Vaxigrip Tetra: pain situated on the nerve route (neuralgia), 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 the body (encephalomyelitis, neuritis, Guillain-Barré syndrome); blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems; transient thrombocytopenia, lymphadenopathy, paraesthesia in other age groups than those described previously for these side effects.
Reporting of side effects: If the adult or child gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph. By reporting side effects the patient can help provide more information on the safety of this medicine.

Tell the doctor or pharmacist if the adult or child is receiving, has recently received or might receive any other vaccines or any other medicines.
Vaxigrip Tetra can be given at the same time as other vaccines by using separate limbs.
The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
The vaccine should be allowed to reach room temperature before use.
Shake before use. Inspect visually prior to administration.
The vaccine should not be used if foreign particles are present in the suspension.
It should not be mixed with other medicinal products in the same syringe.
This vaccine is not to be injected directly into a blood vessel.
See also Dosage & Administration.

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste.
Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Vaccines, Antisera & Immunologicals

J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.

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