Pandemrix suspension and emulsion for emulsion for injection.Influenza vaccine (H1N1)v (split virion, inactivated,adjuvanted)

Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus.

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.

You should not receive Pandemrix:

• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Pandemrix (these are listed at the end of the 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 usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor or nurse will advise whether you could still be vaccinated with Pandemrix.

If you are not sure, talk to your doctor or nurse before having this vaccine.

Take special care with Pandemrix:

• 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 are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with Pandemrix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently been given Pandemrix.

In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.

If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C. Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.

Please inform your doctor or nurse if you have a bleeding problem or bruise easily.

Taking other medicines

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

Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.

Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive Pandemrix after an interval of at least three weeks.

There is no information on administration of Pandemrix with other vaccines. However, if this cannot be avoided, the vaccines should be injected into separate limbs. In such cases, you should be aware that the side effects may be more intense.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant. You should discuss with your doctor whether you should receive Pandemrix.
The vaccine may be used during breast-feeding.

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 Pandemrix

This vaccine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction. Tell your doctor if you have any known allergies.

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.

Your doctor or nurse will administer the vaccine in accordance with official recommendations.

The vaccine will be injected into a muscle (usually in the upper arm).

Adults, including the elderly and children from the age of 10 years onwards
A dose (0.5 ml) of the vaccine will be given.
Clinical data suggest that a single dose may be sufficient.
If a second dose is administered there should be an interval of at least three weeks between the first and second dose.

Children from 6 months to 9 years of age
A dose (0.25 ml) of the vaccine will be given.
If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.

Children aged less than 6 months of age
Vaccination is currently not recommended in this age group.

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

Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.

The frequency of possible side effects listed below is defined using the following convention:

Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)

The side effects listed below have occurred with Pandemrix (H5N1) in clinical studies in adults, including the elderly. In these clinical studies most side effects were mild in nature and short term. The side-effects are generally similar to those related to seasonal flu vaccines.

These side effects have also been observed with similar frequencies in clinical studies in adults including the elderly and in children aged 10 to 17 years with Pandemrix (H1N1)v, except for redness (uncommon in the adults and common in the elderly) and fever (uncommon in the adults and elderly). Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age. In children aged 3-9 years who received a first half adult dose of Pandemrix (H1N1)v, the side effects were similar compared to the side effects reported in adults, with the exception of shivering, sweating and gastro-intestinal symptoms which were reported at a higher rate in children aged 3 to 9 years. Additionally, in children aged 3 to 5 years of age, drowsiness, irritability and loss of appetite were reported very commonly.

Very common:

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

Common:

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

Uncommon:

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

In children aged 6-35 months who received a half of the adult dose (0.25 ml) of Pandemrix (H1N1)v, fever and irritability occurred more often compared to the children 3-9 years who received a half of the adult dose (0.25 ml) of Pandemrix (H5N1).

In children aged 6-35 months who received two doses of 0.25 ml (half of the adult dose) the side effects after the second dose were more intense, especially fever (?38°C), which occurred very commonly.

These side effects usually disappear within 1-2 days without treatment. If they persist, CONSULT YOUR DOCTOR.

The side effects listed below have occurred during post-marketing experience with Pandemrix (H1N1)v vaccine:

• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
• Generalised skin reactions including facial swelling and urticaria (hives)
• Fits due to fever

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 Pandemrix.

Rare

• Severe stabbing or throbbing pain along one or more nerves
• Low blood platelet count which can result in bleeding or bruising

Very rare

• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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 Pandemrix contains

• Active substance: Split influenza virus, inactivated, containing antigen * equivalent to:

per 0.5 ml ACalifornia072009 H1N1 derived strain used NYMC X-179A 3.75 microgramsdose

*propagated in eggs
** expressed in microgram haemagglutinin

• Adjuvant: The vaccine contains an ?adjuvant? AS03 to stimulate a better response. This adjuvant contains squalene (10.69 milligrams), DL-?-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
• Other ingredients: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections

What Pandemrix looks like and contents of the pack

Suspension and emulsion for emulsion for injection.
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.

One pack of Pandemrix consists of:

• one pack containing 50 vials of 2.5 ml suspension (antigen)
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant)

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.co

România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 800 00 12 12 grippeAgsk.co

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.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 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.co

Latvija GlaxoSmithKline Latvia SIA United Kingdom GlaxoSmithKline UK

Tel 371 67312687 lv-epastsgsk.com 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}.

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

Pandemrix consists of two containers:
Suspension: multidose vial containing the antigen,
Emulsion: multidose vial containing the adjuvant.

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 (adjuvant) and suspension (antigen) should be allowed to reach room temperature; each vial should be shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.

2. The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a syringe and by adding it to the vial containing the antigen.

3. After the addition of the adjuvant to the antigen, 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 the Pandemrix vial after mixing is at least 5 ml. The vaccine should be administered in accordance with the recommended posology (see section 3 ?How Pandemrix is given?).

5. The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.

6. Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for injection and administered intramuscularly.

7. After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C. If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature before each withdrawal.

The vaccine should not be administered intravascularly.

Any unused product or waste material should be disposed of in accordance with local requirements.