Daronrix, suspension for injection in pre-filled syringePandemic influenza vaccine (whole virion, inactivated,adjuvanted)

Daronrix is a vaccine used in adults aged 18 to 60 years to prevent influenza (flu) in an officially declared pandemic. The vaccine works by causing the body to produce its own protection (antibodies) against the disease.

Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world. The symptoms of pandemic flu are similar to those of ?ordinary? flu but are usually more severe.

Daronrix should not be given:

• if you have previously had any allergic reaction to Daronrix, or any ingredient (including eggs, chicken protein, gentamicin sulphate (antibiotic)) contained in this vaccine. The active substances and other ingredients in Daronrix are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.

Take special care with Daronrix:

• if you have a severe infection with a high temperature (over 38°C). A minor infection such as a cold should not be a problem, but talk to your doctor first.

Using other medicines

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. 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, Daronrix 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 Daronrix in pregnant women. Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant. Please tell your doctor if you are pregnant.

Daronrix may be used during lactation.

Driving and using machines
After administration of Daronrix, it is unlikely that side effects would unable you to drive or use machines.

Important information about some of the ingredients of Daronrix

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

Adults from the age of 18 to 60 years will receive two injections of Daronrix, the first injection will be administered at an elected date, the second at least three weeks after the first injection.

There is no information on the use of Daronrix below 18 years of age. Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are below the age of 18 years.

The doctor will give Daronrix as an injection into your upper arm muscle.

The vaccine should never be given into a vein.

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

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

Very common more than 1 per 10 doses of vaccine Headache Fatigue Pain and redness at the injection site

Common less than 1 per 10 but more than 1 per 100 doses of vaccine Increased sweating, bruising Aching muscles, joint pain Swelling at the injection site, hard lump Shivering, fever

Uncommon less than 1 per 100 but more than 1 per 1000 doses of vaccine Sore nose and throat and discomfort when swallowing, runny nose Itching at the injection site

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

Other side effects which have occurred in the days or weeks after vaccination with ordinary flu vaccines include:

Uncommon less than 1 per 100 but more than 1 per 1000 doses of vaccine Generalised skin reactions such as itching, hives or rash

Rare less than 1 per 1000 but more than 1 per 10,000 doses of vaccine Severe stabbing or throbbing pain along one or more nerves Pins and needles Fits Low blood platelet count Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death

Very rare less than 1 per 10,000 doses of vaccine Narrowing or blockage of blood vessels with kidney problems Inflammation of the brain and spinal column Painful swelling in the arms or legs Temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face.

Do not be alarmed by this list of possible side effects. It is possible that you have no side effects from vaccination.

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.

Do not use Daronrix 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.

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 Daronrix contains

• The active substances are:Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen * equivalent to:

AVietnam11942004 H5N115 micrograms

per 0.5 ml dose

propagated in eggs haemagglutinin adjuvanted by aluminium phosphate and aluminium hydroxide, hydrated 0.45 milligrams Al30.05 milligrams Al3

• The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, thiomersal, water for injections

What Daronrix looks like and contents of the pack

Daronrix is a white, slightly milky liquid and is presented in a pre-filled syringe (0.5 ml) for 1 dose in pack sizes of 1 and 10 with or without needles

Not all pack sizes may be marketed.

Marketing Authorisation Holder

GlaxoSmithKline Biologicals s.a.Rue de l?Institut 89
B-1330 Rixensart
Belgium

Manufacturer

Sächsisches Serumwerk Dresden (SSW)
Zirkusstraße 40
D-01069 Dresden
Germany

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 infoglaxosmithkline.dk 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 Smith Kline French Portuguesa, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.co

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

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 49 10 33 11 recepcia.skgsk.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 89 95 01 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.co

Latvija GlaxoSmithKline Latvia SIA Tel 371 7312687 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}.

Daronrix has been authorised under ?Exceptional Circumstances?.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.