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Fluvirin Suspension for injection in pre-filled syringe Influenza Vaccine

What Fluvirin is and what it is used for

Fluvirin is a vaccine. This vaccine helps to protect you or your child against influenza (flu), particularly in subjects who run a high risk of associated complications. The use of Fluvirin should be based on official recommendations.

When a person is given the vaccine Fluvirin, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can 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 or your child was not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you or your child runs the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.

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

The incubation period for flu is a few days, so if you are exposed to flu immediately before or after your vaccination, you could still develop the illness.

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

Before you or your child use Fluvirin

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

Do not use Fluvirin

If you or your child is allergic (hypersensitive) to the active substances, to any of the excipients of Fluvirin, to Fluvirin specific residues: e.g. eggs, chicken proteins, such as ovalbumin. (For other ingredients of Fluvirin, see section 6″Further information”).

If you oryour child has an illness with a high temperature or acute infection,the vaccination shall be postponed until afteryou oryour child has recovered.

Take special care with Fluvirin

You should tell your doctor before vaccination if you or your child has a poor immune response (immunodeficiency or taking medicines affecting the immune system).

Thiomersal is present (in trace amounts) in this product, and it is possible that you/your child may experience an allergic reaction. Tell your doctor if you/your child have/has experience any known allergies. Tell your doctor if you/your child have/has experience any health problems after previous administration of a vaccine.

Your doctor will decide if you or your child should receive the vaccine.

If, for any reason, you or your child has 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, Fluvirin may not fully protect all persons who are vaccinated.

Using other medicines

Please tell your doctor or pharmacist if you or your child is taking or has recently taken other vaccines or any other medicines, including medicines obtained without a prescription.

Fluvirin can be given at the same time as other vaccines by using separate limbs. It should be noted that the side effects may be stronger.

The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.

Pregnancy and breast-feeding

Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.

Limited data from flu vaccinations in pregnant women do not indicate that the vaccine would have harmful effects on the pregnancy or the baby. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from the flu, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

Fluvirin may be used during breast-feeding.

Your doctor/pharmacist will be able to decide if you should receive Fluvirin.

Askyour doctor or pharmacist for advice before taking any medicine.

Driving and using machines

The vaccine is unlikely to affect your ability to drive or use machines.

Important information about some of the ingredients of Fluvirin

One dose of Fluvirin (0.5 ml) contains less than 1 mmol (39 mg) potassium and less than Immol (23 mg) sodium.This means that Fluvirin is essentially free from potassium and sodium.

How to use Fluvirin dosage

Adults and children aged from 48 months receive one 0.5 ml dose. If your child has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.

Method and/or route(s) of administration

Your doctor will administer the recommended dose of the vaccine as an injection into the muscle or deep under the skin.

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

Possible side effects

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

During clinical trials,the following side effects have been observed. Their frequencies have been estimated as

Common: affects 1 to 10 users in 100:

  • headache
  • sweating
  • muscular pain (myalgia), joint pain (arthralgia)
  • fever, generally feeling unwell (malaise), shivering, fatigue
  • local reactions: redness, swelling, pain, bruising (ecchymosis), hardness (induration) around the area where the vaccine is injected.

These reactions usually disappear within 1-2 days without treatment.

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

  • allergic reactions:
    • leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock) in rare cases,
    • swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases
  • skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash
  • blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases in temporary kidney problems
  • pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and cold (paraesthesia), fits (convulsions) associated with fever, 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-Barre Syndrome)
  • temporary 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 (transient thrombocytopenia); temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy).

Thiomersal is present (in trace amounts) in this product and it is possible that you/your child may experience an allergic reaction.

Tell your doctor if you/your child have any known allergies.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Fluvirin

Keep out of the reach and sight of children.

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

Store at +2°C to +8°C (in a refrigerator). Do not freeze. Keep container in the original carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

Influenza virus surface antigens (haemagglutinin and neuraminidase), of the following strains:

A/California/7/2009 (HIN1)-derived strain used NYMCX-181 15 micrograms HA

A/Perth/16/2009 (H3N2) – like strain used

NYMCX-187 derived from A/Victoria/210/2009 15 micrograms HA

B/Brisbane/60/2008 15 micrograms HA

Per 0.5 ml dose

This vaccine complies with the WHO (World Health Organisation) recommendations (Northern hemisphere) and EL) decision forthe 2010/2011 season.

The other ingredients are: Potassium dihydrogen phosphate Disodium hydrogen phosphate Sodium chloride Waterfor injection

What Fluvirin looks like and contents of the pack

The vaccine is a suspension for injection presented in a pre-filled syringe of 0.5 ml in a box of 1 or 10.

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