Prepandrix suspension and emulsion for emulsion for injection.Prepandemic influenza vaccine (H5N1) (split virion,inactivated, adjuvanted)

Prepandrix is a vaccine for use in adults from 18 years old. It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus. Pandemic flu is a type of influenza that occurs at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The symptoms of pandemic flu are similar to those of ordinary flu but are usually more severe.

When a person is given the vaccine, 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.

As with all vaccines, Prepandrix may not fully protect all persons who are vaccinated.

Prepandrix should not be given:

• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandrix (these are listed at the end of this leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• if you have a severe infection with a high temperature (over 38°C). If this applies to you then your vaccination will be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandrix.

Do not have Prepandrix if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having this vaccine.

Take special care with Prepandrix:

• if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate. (see section 6. Further information).
• if you have problems with your immune system, since your response to the vaccine may then be poor.
• if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with Prepandrix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently received Prepandrix.

Using other medicines or vaccines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.

There are no data on the use of Prepandrix given at the same time as other vaccines. Therefore, Prepandrix is not intended to be given at the same time as other vaccines. However, if this cannot be avoided, the other vaccine will be injected into the other arm. Any side effects that occur may be more severe.

If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandrix can still be given but your response to the vaccine may be poor.

Pregnancy and breast-feeding

There is no information on the use of Prepandrix in pregnant or breast-feeding women. Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breast-feeding. Please tell your doctor if you are/may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice.

Driving and using machines

Some effects mentioned under section 4. ?Possible side effects? may affect the ability to drive or use machines.

Important information about some of the ingredients of Prepandrix

Thiomersal (preservative) is present in this product, and it is possible that you may experience an allergic reaction.

This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.

You will receive two doses of Prepandrix. The second dose should be given after an interval of at least three weeks.

If you are older than 80 years of age, you may receive two double injections of Prepandrix. The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.

The doctor or nurse will give Prepandrix as an injection into your upper arm muscle. The vaccine should never be given into a vein or into the skin. The double injections will be given in opposite arms.

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

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

The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. These side effects may occur with Prepandrix.

Very rare (these may occur with up to 1 in 10,000 doses of the vaccine):

• Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may spread across the body.
• Narrowing or blockage of blood vessels with kidney problems

Rare (these may occur with up to 1 in 1,000 doses of the vaccine):

• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death
• Fits
• Severe stabbing or throbbing pain along one or more nerves
• Low blood platelet count which can result in bleeding or bruising

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

• Generalised skin reactions including urticaria (hives)

If any of these side effects occur, please tell your doctor or pharmacist immediately.

The side effects listed below have occurred with Prepandrix in clinical studies:

Very common (these may occur with more than 1 in 10 doses of the vaccine):

• Tiredness
• Headache
• Pain, redness, swelling or a hard lump at the injection site
• Fever
• Aching muscles, joint pain

Common (these may occur with up to 1 in 10 doses of the vaccine):

• Warmth, itching or bruising at the injection site
• Increased sweating, shivering, flu-like symptoms
• Swollen glands in the neck, armpit or groin

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

• Tingling or numbness of the hands or feet
• Dizziness
• Sleepiness
• Sleeplessness
• Diarrhoea, vomiting, stomach pain, feeling sick
• Itching, rash
• Generally feeling unwell

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

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.

Keep out of the reach and sight of children.

Before the vaccine is mixed:

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

Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect from light.
Do not freeze.

After the vaccine is mixed:

After mixing, use the vaccine within 24 hours and do not store above 25°C.

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.

What Prepandrix contains

• Active substance: After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

• Adjuvant: The emulsion vial contains an ?adjuvant? (AS03). This compound contains squalene (10.69 milligrams), DL-?-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). Adjuvants are used to improve the body?s response to the vaccine.
• Other ingredients: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na 2HPO 4), potassium dihydrogen phosphate(KH 2PO 4), potassium chloride (KCl), magnesium chloride (MgCl 2), water for injections

What Prepandrix looks like and contents of the pack

Suspension and emulsion for emulsion for injection.

One pack of Prepandrix consists of:

• one pack containing 50 vials of 2.5 ml suspension (active substance) for 10 doses
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant) for 10 doses

The suspension is a colourless light opalescent liquid.
The emulsion is a whitish homogeneous liquid.

Prior to administration, the two components should be mixed. The mixed vaccine is a whitish emulsion.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l?Institut 89
B-1330 Rixensart
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11

. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com

GlaxoSmithKline A.E.B.E T 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 22 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354-530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 02 48 26 11 11

recepcia.sk@gsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0808 100 9997 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel. +370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in {MM/YYYY}.

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

Prepandrix consists of two containers:
Vial A: multidose vial containing the antigen (suspension),
Vial B: multidose vial containing the adjuvant (emulsion).

Prior to administration, the two components should be mixed.

Instructions for mixing and administration of the vaccine:

1. Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.

2. The vaccine is mixed by withdrawing the contents of the vial containing the emulsion (Vial B) by means of a syringe and by adding it to the vial containing the suspension (Vial A).

3. After the addition of the emulsion to the suspension, the mixture should be well shaken. The mixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the vaccine.

4. The volume of Prepandrix (5 ml) after mixing corresponds to 10 doses of vaccine.

5. The vial should be shaken prior to each administration.

6. Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.

7. The needle used for withdrawal must be replaced by a needle suitable for intramuscular injection. Any unused product or waste material should be disposed of in accordance with local requirements.