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Agrippal Suspension for injection in pre-filled syringe

Influenza vaccine (surface antigen, inactivated). This medicinal product is authorised in the Member States of the EEAunderthe following names:

  • Agrippal
  • Agrippal SI (Italy)
  • Chiroflu (Portugal and Spain)
  • Begripal (Germany)
  • Sandovac (Austria)

What Agrippal is and what it is used for

Agrippal 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 Agrippal should be based on official recommendations.

Agrippal

When a person is given the vaccine Agrippal, 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.

Agrippal 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 Agrippal

To make sure that Agrippal 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 Agrippal

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

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).

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, Agrippal 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.
  • Agrippal 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.

Agrippal may be used during breast-feeding.

Begripal

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

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 Agrippal

Agrippal does not contain more than 0.2 ug of ovalbumin per 0.5 ml dose and 0.1 ug of ovalbumin per 0.25 ml dose.

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

How to use Agrippal

Dosage

Adults and children aged from 36 months receive one 0.5 ml dose. Children from 6 months to 35 months may receive one 0.25 ml dose or 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, Agrippal 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)

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 Agrippal

Keep out of the reach and sight of children.

Do not use Agrippal 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.

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:

Per 0.5 ml dose

propagated in fertilized hens’eggs from healthy chicken flocks  haemagglutinin

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

The other ingredients are:

Sodium chloride; potassium chloride; potassium dihydrogen phosphate; disodium phosphate dihydrate; magnesium chloride hexahydrate; calcium chloride dihydrate and waterfor injections.

What Agrippal looks like and contents of the pack

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

Not all the pack sizes may be marketed.

The following information is intended for medical or healthcare professional only:

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

The vaccine should be allowed to reach room temperature before use.

Shake before use.

The vaccine appears as a clear liquid.

It must not be mixed with other medicinal products.

The vaccine should under no circumstances be administered intravascularly.

If half a dose (0.25 ml) is to be administered, discard half the contained volume (up to the mark indicated on the syringe barrel), before injection.

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