Fluad 2020/2021, suspension for Injection in Pre-filled Syringe

Influenza Vaccine Surface Antigen, Inactivated, Adjuvanted with MF59C.1

Fluad is a vaccine. This vaccine helps to protect you against influenza (flu). It is used as active immunisation in the elderly (of 65 years of age and over), particularly in people with an increased risk of associated complications.

Fluad should be used in accordance with the official recommendations.

Through vaccination with Fluad, the immune system (the body’s natural defence system) is stimulated to produce its own protection (antibodies) against the illness. None of the ingredients of this vaccine can by itself cause flu.

Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Therefore, this is why you might need to be vaccinated every year. The greatest risk of catching flu is during the cold months between October and March. If you were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you run the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.

Fluad will protect you against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection.

As the incubation period (the time between being infected with a disease pathogen and the occurrence of the first symptoms) for flu is several days, you could still develop the illness if you are exposed to flu immediately before or after your vaccination.

The vaccine will not protect you against the common cold, even though some of the symptoms are similar to flu.

To make sure that Fluad is suitable for you, it is important to tell your doctor or pharmacist if any of the points below apply to you. If there is anything you do not understand, ask your doctor or pharmacist to explain.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Fluad can cause side effects, although not everybody gets them.

More mild post-immunisation reactions were reported with Fluad compared to non-adjuvanted influenza vaccines.

During clinical trials, the following side effects have been observed:

Frequencies estimated as very common (affects 1 or more users in 10):

• headache
• muscular pain (myalgia)
• tenderness, pain at injection site, fatigue

Frequencies estimated as common (affects 1 to 10 users in 100):

• nausea, diarrhoea, vomiting
• sweating
• joint pain (arthralgia)
• fever, generally feeling unwell (malaise), shivering
• local reactions: redness, swelling, bruising (ecchymosis), hardness (induration) around the area where the vaccine is injected

Frequency estimated as uncommon (affects 1 to 100 users in 1000):

• rash

Most reactions are mild or moderate and resolve spontaneously within 1 to 2 days.

Next to the above common side effects, the following side effects occurred after the vaccine came on the market:

• reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (thrombocytopenia); swelling of the glands in the neck, armpit or groin (lymphadenopathy)
• asthenia, Influenza-like Illness (ILI)
• swelling, pain and redness at the injection site extending to more than 10 cm and lasting more than one week (Injection site cellulitis-like reaction)
• extensive swelling of injected limb lasting more than one week
• allergic reactions:
  • sudden fall in blood pressure (anaphylaxis) that in rare cases can lead to failure of the circulatory system to maintain adequate blood flow to the different organs shock
  • swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema)
• pain in the extremity, muscular weakness
• pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and cold (paraesthesia), fits (convulsions), fainting, feeling faint (syncope, presyncope), 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)
• skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash
• severe skin rash (erythema multiforme)
• blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases in temporary kidney problems

Keep out of the sight and reach of children.

Do not use Fluad after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in 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 your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom: Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Suspension for Injection in Pre-filled Syringe