The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 46752/0001.
Fluad, Influenza vaccine surface antigen, inactivated, adjuvanted with MF59C.1
Fluad 2020/2021, suspension for Injection in Pre-filled Syringe
Influenza Vaccine Surface Antigen, Inactivated, Adjuvanted with MF59C.1
1. What Fluad is and what it is used for
2. What you need to know before you use Fluad
3. How to use Fluad
4. Possible side effects
5. How to store Fluad
6. Contents of the pack and other information
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.
You should tell your doctor before vaccination if you have a poor immune response (immunodeficiency or taking medicines affecting the immune system).
Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection. Tell your doctor or nurse if you have experienced this kind of reaction previously.
Your doctor will decide if you should receive the vaccine.
If, for any reason, you have a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.
As with all vaccines, Fluad may not fully protect all persons who are vaccinated.
It is possible that a protective immune response will not be triggered in all vaccinated persons.
Although no natural rubber latex is detected in the syringe tip cap, the safe use of Fluad in latex-sensitive individuals has not been established.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If Fluad needs to be used at the same time as other vaccines, immunisation should be carried out by injecting into separate limbs. It should be noted that the side effects may be more intense if given at the same time as other vaccines.
A higher frequency of some solicited systemic reactions has been reported in subjects vaccinated with trivalent inactivated influenza vaccine and pneumococcal vaccine compared with trivalent inactivated influenza vaccine alone.
The immunological response may decrease in patients also receiving immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.
Fluad has no or negligible influence on the ability to drive and use machines.
One dose of Fluad (0.5 ml) contains less than 1 mmol (39 mg) potassium and less than 1 mmol (23 mg) sodium. This means that Fluad is essentially free from potassium and sodium.
Fluad does not contain more than 0.2 micrograms of ovalbumin per 0.5 ml dose.
One 0.5 ml dose.
Your doctor will administer the recommended dose of the vaccine as an injection in the upper arm muscle (deltoid muscle).
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):
Frequencies estimated as common (affects 1 to 10 users in 100):
Frequency estimated as uncommon (affects 1 to 100 users in 1000):
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:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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 vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2020/2021 season.
The vaccine is a suspension for injection in a pre-filled syringe of 0.5 ml in box of 1 or 10, with or without needle.
Not all pack sizes may be marketed.
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
This leaflet was last revised in 29/06/2020.