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Enzira (Influenza vaccine split virion, inactivated)

What Enzira is and what it is used for

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

When a person is given the vaccine Enzira, 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 were not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you or your child run the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.

Enzira will protect you or your child against the three strains of virus contained in the vaccine from about 2-3 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 Enzira

To make sure that Enzira 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 or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain.

Do not use Enzira

  • If you or your child is allergic (hypersensitive) to the active substances, to any of the ingredients of Enzira, to eggs, ovalbumin, chicken proteins or the antibiotics neomycin or polymyxin. (For other ingredients of Enzira, 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 after you or your child has recovered.

Take special care with Enzira

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, Enzira 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.
  • Enzira 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.

Enzira may be used during breast-feeding.

Your doctor/pharmacist will be able to decide if you should receive Enzira. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Enzira is unlikely to affect your ability to drive or use machines.

Important information about some of the ingredients of Enzira

Enzira does not contain more than 1 ug ovalbumin per dose (0.5 ml).

This medicine contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially “potassium free”.

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium free”.

How to use Enzira

Dosage

Adults and children aged from 5 years receive one 0.5 ml dose.

If your child is younger than 9 years of age and has not previously been 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, Enzira 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 onto 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 Enzira

Keep out of the reach and sight of children.

Do not use Enzira 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 a refrigerator (2°C to 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.

This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2010/2011 season.

The other ingredients are:

Sodium chloride, anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate, potassium chloride, potassium dihydrogen phosphate, calcium chloride and water for injections.

What Enzira looks like and contents of the pack

Enzira is 0.5 ml suspension for injection presented in a pre-filled syringe with plunger stopper (chlorobutyl rubber) with or without attached needle in pack sizes of 1 or 10, respectively.

The suspension is a clear to slightly opaque liquid with some sediment that resuspends upon shaking.

For medical or healthcare professionals only

Enzira

Suspension for injection, pre-filled syringe

Influenza vaccine (split virion, inactivated)

For intramuscular or deep subcutaneous injection only. Enzira should NEVER be administered intravascularly.

Preparation and instructions

The vaccine should be allowed to reach room temperature before use. Shake before use. The vaccine should appear as a homogenous clear to slightly opaque liquid suspension with some sediment that re-suspends upon shaking. The vaccine must be inspected visually prior to administration and should not be used if there is any variation of physical appearance.

Enzira is presented as a single use syringe (with or without attached needle) and any remaining contents should be disposed of in accordance with local requirements.

Posology and administration

Adults and children aged from 5 years receive one 0.5 ml dose.

If a child is younger than 9 years of age and has not previously been vaccinated against flu, a second dose should be given after at least 4 weeks.

Warnings

During the 2010 Southern Hemisphere influenza season, there was an unexpected increase in reports of fever and febrile convulsions in children aged less than 5 years following seasonal influenza vaccination with the flu vaccine of the same strain composition as contained in this product. Febrile convulsions were reported uncommonly (i.e. reporting frequency estimated to be in the range >1/1000 to < 1/100). However, the vaccine is recommended for use only in children from 5 years of age. (estimated from epidemiological investigations)

Appropriate medical treatment and supervision should be readily available in case of a rare anaphylactic event following administration of the vaccine.

Incompatibilities

Enzira must not be mixed with other medicinal products.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze.

Keep the syringe in the outer carton in order to protect from light.

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