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The eMC  

Last Updated 21 Aug 2013

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Pandemrix vaccine emulsion and suspension for emulsion for injection

Pandemrix (pan-dem-rix) is a medicine which is used in immunisation against influenza H1N1 (swine flu). Pandemrix contains influenza H1N1 vaccine. It is supplied by GlaxoSmithKline UK.

The information in this Medicine Guide for Pandemrix varies according to the condition being treated and the particular preparation used.

Pandemrix vaccine emulsion and suspension for emulsion for injection

Information specific to Pandemrix vaccine emulsion and suspension for emulsion for injection when used in immunisation against influenza H1N1 (swine flu)

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Your medicine

Pandemrix is used to give people immunity to the virus that causes swine flu. It only offers protection against certain strains of the virus.

Pandemrix is given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel unwell after having the medicine then talk to your prescriber or someone involved in your medical care.

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When to take your medicine

The person with responsibility for giving you your medicine will make sure that you have your medicine at the correct time.

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How to take your medicine

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

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Taking too much of your medicine

In the case of Pandemrix, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

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Stopping your medicine

As Pandemrix is a vaccination which is given as one or two doses, considerations to stopping this medicine are not relevant.

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Looking after your medicine

As Pandemrix will be given to you as an injection, it will usually be stored by the medical team.

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Whether this medicine is suitable for you

Pandemrix is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

  • are allergic or sensitive to or have had a bad reaction to any of the following substances in the past: egg or chicken products; formaldehyde; gentamicin; or sodium deoxycholate
  • are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
  • have a high temperature
  • have an infection
  • have bleeding problems
  • have problems with your immune system

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child under the age of six months.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects

Over time it is possible that Pandemrix can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Pandemrix has become unsuitable, it is important that the prescriber is contacted immediately.

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Side-effects

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 adults who have Pandemrix :

Very common: More than 1 in 10 children between 10 years and 17 years of age who have Pandemrix :

Very common: More than 1 in 10 children between six years and nine years of age who have Pandemrix :

Very common: More than 1 in 10 children between three years and five years of age who have Pandemrix :

  • feeling drowsy
  • feeling irritable
  • fever
  • loss of appetite
  • pain
  • redness of the skin
  • shivering
  • sweating
  • swelling

Very common: More than 1 in 10 children between 6 months and 35 months of age who have Pandemrix :

  • feeling drowsy
  • feeling irritable
  • loss of appetite
  • pain
  • redness of the skin
  • swelling

Common: More than 1 in 100 adults who have Pandemrix :

  • fever
  • gastrointestinal problems such as diarrhoea, vomiting, stomach pain or nausea

Common: More than 1 in 100 children between 10 years and 17 years of age who have Pandemrix :

Common: More than 1 in 100 children between six years and nine years of age who have Pandemrix :

Common: More than 1 in 100 children between three years and five years of age who have Pandemrix :

Common: More than 1 in 100 children between 6 months and 35 months of age who have Pandemrix :

Uncommon: More than 1 in 1000 adults who have Pandemrix :

Very rare: Fewer than 1 in 10,000 people under 20 years of age who have Pandemrix :

The frequency of these side-effects is unknown:

The following side effects have been reported in people who have had medicines similar to Pandemrix. The frequency of these side-effects in people who have Pandemrix is not known:

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following types of medicine may interact with Pandemrix:

If you are taking Pandemrix and one of the above types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Pandemrix.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

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Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Pandemrix can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

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Diet

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Pandemrix:

  • there are no specific foods that you must exclude from your diet when having Pandemrix
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Alcohol

Alcohol can interact with certain medicines.

In the case of Pandemrix:

  • there are no known interactions between alcohol and Pandemrix
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Family planning and pregnancy

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of having this medicine. You and your doctor can make a decision about whether you are going to have this medicine while you are pregnant.

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Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Pandemrix:

  • this medicine may be used by women who are breast-feeding

Women who are planning to breast-feed while having Pandemrix must inform their doctor or midwife.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Pandemrix contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Pandemrix before, do not have Pandemrix. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Pandemrix, Version 11, last updated 21 Aug 2013