Consumer Medicine Information

FLUARIX™

Inactivated Split Influenza Vaccine

What is in this leaflet

This leaflet answers some of the common questions about FLUARIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you/your child having FLUARIX against the expected benefits.

Keep this leaflet. You may need to read it again.

What FLUARIX is used for

FLUARIX is used to prevent type A and B influenza. The vaccine works by causing the body to produce its own protection (antibodies) against three different strains of influenza virus. Each year new strains of influenza virus can appear, so every year FLUARIX is changed to contain fragments of the new strains of virus. Therefore, influenza vaccination is recommended every year.

FLUARIX will only protect you against the three types of influenza virus used to make the vaccine. It will not protect you from infections with other agents causing influenza-like symptoms (such as the common cold).

Influenza is an infectious illness. Influenza is spread by small droplets from the nose, throat or mouth of an infected person. Symptoms of influenza begin 48 hours after coming into contact with the virus. These consist of chills, fever, generalised aches and pains, headache and respiratory symptoms (sore throat, runny nose, cough). The severity and type of symptoms can vary. Most people recover completely within a week. The risk of serious complications (eg. pneumonia and death) is greater in very young, very old and chronically ill persons.

Who can have FLUARIX?

FLUARIX can be used in adults and children older than 6 months of age. Annual vaccination against influenza is especially recommended for the following groups:

• Persons over 60 years of age
• Persons who suffer from chronic diseases, especially those with diseases of the heart, lung, kidney or metabolic system (eg diabetics)
• Persons receiving medicines that lower natural immunity

Vaccination may also be given to medical and health services personnel caring for patients with lowered immunity. Staff of nursing homes and other chronic care facilities may also be vaccinated in an attempt to protect the patients.

FLUARIX may also be prescribed for certain other persons.

Before receiving FLUARIX

DO NOT HAVE FLUARIX IF:

• you/your child have had an allergic reaction to FLUARIX, or any ingredient contained in this vaccine. The ingredients are listed at the end of this leaflet. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

If you/your child have had FLUARIX before and became unwell, tell your doctor, nurse or pharmacist before you receive the vaccine again if

• you/your child have had an allergic reaction or became unwell after any other influenza vaccine (Fluvax® or Vaxigrip®).
• you/your child are allergic to egg proteins such as in eggs or feathers
• you/your child are allergic to gentamicin (an antibiotic).
• you/your child have a severe infection with a high temperature. A minor infection such as a cold should not be a problem, but talk to your doctor or nurse about this before being vaccinated.

If you are not sure whether you/your child should have FLUARIX, talk to your doctor or practice nurse.

TELL YOUR DOCTOR IF:

• you are or think you may be pregnant or if you intend to become pregnant.
  Your doctor will discuss with you the possible risks and benefits of receiving FLUARIX during pregnancy.
• you are breast feeding.
  Your doctor will discuss the risks and benefits of vaccination, however the vaccine is not expected to cause problems for breast-fed babies.
• you/your child have had or have Guillain-Barre Syndrome (an inflammatory illness affecting nerves resulting in weakness of muscles)
• you/your child have any medical conditions, such as an immune deficiency condition or a bleeding disorder
• you/your child have allergies to any medicines or substances, such as dyes, foods or preservatives.
• you/your child have received another vaccine, or are taking any prescription (eg theophylline or warfarin) or OTC (over-the-counter) medicines or any other medicine or herbal remedy you have bought from a supermarket, pharmacy or health food shop.

In particular mention if you/your child are taking medicines which suppress the immune system, such as steroids or cyclosporin.

Some vaccines may be affected by other vaccines or medicines. Your doctor or pharmacist will be able to tell you what to do if FLUARIX is to be given with another vaccine or medicine.

How FLUARIX is given

The doctor or nurse will give FLUARIX as an injection.

How much is given

For adults and children over 9 years of age: 0.5mL is given.

For children aged from 3 to 8 years: 0.5mL is given

For children aged from 6 to 35 months: 0.25mL is given

How it is given

FLUARIX is generally injected into the upper leg muscle in infants under 15 months of age. In children over 15 months of age and older children and adults the injection may be given in the upper arm muscle. For some people with bleeding problems, the dose may need to be given under the skin (subcutaneously).

FLUARIX should never be given intravenously.

When it is given

For adults and older children FLUARIX is generally given as a single dose each year during autumn.

For children aged from 6 months to 8 years, who are receiving influenza vaccination for the first time, a second dose should be given 4 weeks after the first dose. However, one dose is sufficient for such children who have been previously vaccinated against influenza.

If a dose is missed

If a scheduled dose is missed, talk to your doctor or nurse and arrange another visit as soon as possible.

After receiving FLUARIX

THINGS TO BE CAREFUL OF:

Be careful driving or operating machinery until you know how FLUARIX affects you. FLUARIX should not normally interfere with your ability to drive a car or operate machinery. But in some people vaccination can cause dizziness or light-headedness. Make sure you know how you react to FLUARIX before you drive a car or operate machinery, or do anything that could be dangerous if you are dizzy or light-headed.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you/your child does not feel well during or after having had a dose of FLUARIX.

All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment.

Most unwanted effects with FLUARIX are mild and usually clear up within a few days. These effects, as with other vaccines, generally occur around the injection site.

MILD EVENTS

Tell your doctor if you notice any of the following that are troublesome or ongoing:

• redness, swelling, a hard lump, soreness, bruising or itching around the injection site
• fever, chills, headache, malaise (generally unwell), muscle aches and pains.

MORE SERIOUS EFFECTS (RARE)

As with all vaccines given by injection there is a very small risk of serious allergic reaction. Contact your doctor immediately or go to the Accident and Emergency department of your nearest hospital if any of the following happens:

• swelling of limbs, face, eyes, inside of nose, mouth or throat
• shortness of breath, breathing or swallowing difficulties, hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions
• unusual tiredness or weakness that is sudden and severe.

Any such severe reactions will usually occur within the first few hours of vaccination.

Other events reported after influenza vaccination include:

• rare reports of serious neurological disorders.
• Guillain-Barre Syndrome (an inflammatory illness affecting nerves resulting in weakness of muscles).

However, these events have not been definitely linked to the use of influenza vaccines.

Other events not listed above, can also occur during or soon after a dose of vaccine. Check with your doctor if you notice any other effects.

Storage

FLUARIX is usually stored at the doctor's clinic or surgery, or at the pharmacy. But if you need to store FLUARIX always:

• Keep FLUARIX in the refrigerator stored between +2°C and +8°C. THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
• Keep the vaccine out of the reach of children.
• Keep FLUARIX in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over FLUARIX that has expired or has not been used.

Product description

WHAT IT LOOKS LIKE

FLUARIX comes in a prefilled syringe. It is a colourless, slightly opalescent liquid.

INGREDIENTS

Each 0.5mL dose of FLUARIX contains 15 micrograms of each of the three types of influenza virus fragments in a phosphate buffered salt solution.

The strains may change from year to year.

The vaccine also contains traces of egg protein, gentamicin, formaldehyde, polysorbate 80, octoxinal 9 and a trace amount of thiomersal.

FLUARIX is not made with any human blood or blood products, or any other substances of human origin.

Further information

FLUARIX is a Prescription Medicine.

DISTRIBUTOR

Distributed in New Zealand by:

GlaxoSmithKline NZ Ltd
Private bag 106600
Auckland

Telephone 09 367 2900
Fax: 09 367 2910

This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way.

Prepared April 2005.