ADJUPANRIX 3.75 micrograms EMULSION AND SUSPENSION FOR INJECTABLE EMULSION

2. What you need to know before you are given Adjupanrix

You must not be given Adjupanrix

• If you have previously had a sudden and potentially life-threatening allergic reaction to any component of this vaccine (including those listed in section 6) or to any other substance that may be present in very small amounts, such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulfate (antibiotic) or sodium desoxycholate.

• The signs of an allergic reaction may include a skin rash with itching, shortness of breath, and swelling of the face or tongue.
• However, in a pandemic situation, it may be appropriate for you to be vaccinated, provided that medical treatment is available immediately in case of an allergic reaction.

Do not use Adjupanrix if you are in any of the above situations.

If you are not sure, consult your doctor or nurse before you are given the vaccine.

Warnings and precautions

Before you are given Adjupanrix, talk to your doctor or nurse:

• if you have had any allergic reaction other than a sudden and potentially life-threatening allergic reaction to any of the components contained in Adjupanrix (including those listed in section 6), to thiomersal, to egg and chicken protein, to ovalbumin, to formaldehyde, to gentamicin sulfate (antibiotic) or to sodium desoxycholate.
• if you have a severe infection with fever (over 38°C). If this is the case, you should postpone vaccination until you feel better. A minor infection, such as a cold, should not be a problem, but it will be up to your doctor to decide whether you should be given Adjupanrix.
• if you have problems with your immune system, as your response to the vaccine may be insufficient.
• if you are going to have a blood test to determine the presence of infection with certain viruses. In the first few weeks after vaccination with Adjupanrix, the results of these tests may not be correct. Inform the doctor who requested these tests that you have recently been given Adjupanrix.
• if you have bleeding problems or bruise easily.

Before or after any injection, fainting may occur, so you should inform your doctor or nurse if you have fainted after previous injections.

If any of the above circumstances apply to you (or you are not sure), talk to your doctor or nurse before you are given Adjupanrix. This is because you may not be recommended for vaccination or it may be necessary to delay it.

Children under 6 years of age

If your child is given the vaccine, you should know that side effects can be more intense after the second dose, especially a temperature over 38°C. Therefore, it is recommended to monitor the temperature as well as take measures to reduce it (such as administering paracetamol or other medications that reduce fever) after each dose.

Other medicines and Adjupanrix

Tell your doctor or nurse if you are using, have recently used, or might use any other medicine, or if you have been given any other vaccine recently.

In particular, tell your doctor or nurse if you are taking any treatment (such as corticosteroids or chemotherapy for cancer) that affects your immune system. You can be given Adjupanrix, although your response to the vaccine may be insufficient.

It is not recommended to administer Adjupanrix at the same time as other vaccines. However, if necessary, the other vaccine should be injected into the other arm. Any side effect that occurs may be more severe.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this vaccine.

Driving and using machines

Some of the side effects mentioned in Section 4 "Possible side effects" may affect your ability to drive or use tools or machines. It is preferable that you observe how Adjupanrix affects you before undertaking these activities.

Adjupanrix contains thiomersal

Adjupanrix contains thiomersal as a preservative and you may have an allergic reaction. Inform your doctor if you have any known allergy.

Adjupanrix contains sodium and potassium

Adjupanrix contains less than 1 mmol (23 mg) of sodium and less than 1 mmol (39 mg) of potassium per dose; i.e., it is "essentially sodium- and potassium-free".

3. How Adjupanrix is given

Adults from 18 years of age

• From 18 years of age: you will receive two doses of Adjupanrix (each of 0.5 ml). The second dose should be given at least three weeks and up to twelve months after the first dose.

• From 80 years of age: you may receive two double injections of Adjupanrix. The first two injections should be given on the chosen date and the other two injections should be given preferably three weeks later.

Children from 6 months to less than 36 months of age

Your child will receive two doses of Adjupanrix (each of 0.125 ml, equivalent to one-quarter of the adult dose per injection). Preferably, the second dose should be given at least three weeks after the first dose.

Children and adolescents from 36 months to less than 18 years of age

Your child will receive two doses of Adjupanrix (each of 0.25 ml, equivalent to half the adult dose per injection). Preferably, the second dose should be given at least three weeks after the first dose.

Your doctor or nurse will give you Adjupanrix.

• You will be given Adjupanrix by injection into a muscle.
• The injection will normally be given into the upper arm.
• Double injections will be given into different arms.

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

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Allergic reactions

Allergic reactions that can cause a dangerous drop in blood pressure. If not treated, it can lead to collapse. Doctors are aware of this and have emergency treatment available for use in these cases.

Other side effects:

Side effects that occurred in adults ≥18 years of age

Very common: may affect more than 1 in 10 people

• Headache.
• Feeling tired.
• Pain, redness, swelling, or induration at the injection site.
• Fever.
• Muscle and joint pain.

Common: may affect up to 1 in 10 people

• Heat, itching, or bruising at the injection site.
• Increased sweating, chills, flu-like symptoms.
• Swelling of the lymph nodes in the neck, armpits, or groin.

Uncommon: may affect up to 1 in 100 people

• Numbness or tingling of the hands or feet.
• Drowsiness.
• Dizziness.
• Diarrhea, vomiting, abdominal pain, nausea.
• Itching, rash.
• General malaise.
• Insomnia.

Side effects that occurred in children from 6 to less than 36 months of age

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

• Gastrointestinal symptoms (such as diarrhea and vomiting).
• Loss of appetite.
• Drowsiness.
• Pain at the injection site.
• Fever.
• Irritability/Agitation.

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

• Redness and swelling at the injection site.

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

• Lump (hard), crust, hematoma, and eczema at the injection site.
• Swelling of the face.
• Rash, including red spots.
• Hives.

Side effects that occurred in children from 3 to less than 6 years of age

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

• Loss of appetite.
• Drowsiness.
• Pain at the injection site.
• Irritability/Agitation.

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

• Gastrointestinal symptoms (such as nausea, diarrhea, vomiting, abdominal pain).
• Fever.
• Redness and swelling at the injection site.

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

• Headache.
• Rash.
• Muscle pain.
• Tiredness.
• Chills.
• Bruising and itching at the injection site.

Side effects that occurred in children from 6 to less than 18 years of age

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

• Headache.
• Muscle pain.
• Joint pain.
• Pain at the injection site.
• Tiredness.

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

• Gastrointestinal symptoms (such as nausea, diarrhea, vomiting, abdominal pain).
• Excessive sweating.
• Fever.
• Redness and swelling at the injection site.
• Chills.

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

• Loss of appetite.
• Irritability/Agitation.
• Drowsiness.
• Numbness.
• Dizziness.
• Fainting.
• Tremors.
• Rash.
• Skin ulcer.
• Musculoskeletal stiffness.
• Itching at the injection site.
• Pain in the armpit.

In children from 3 to 9 years of age, the following side effects were also observed: bruising, chills, and increased sweating.

The following side effects have occurred with H1N1 vaccines containing AS03. They may also occur with Adjupanrix. If you experience any of the following side effects, tell your doctor or nurse immediately:

• Allergic reactions that can cause a dangerous drop in blood pressure. If not treated, it can lead to collapse. Doctors are aware of this and have emergency treatment available for use in these cases.
• Seizures.
• Generalized skin reactions, including hives (urticaria).

The following side effects occurred during the days or weeks following vaccination with influenza vaccines that are given routinely each year. These side effects may also occur with Adjupanrix. If you experience any of these side effects, please inform your doctor or nurse immediately:

Very rare: may affect less than 1 in 10,000 people

• Brain and nerve problems, such as inflammation of the central nervous system (encephalomyelitis), inflammation of the nerves (neuritis), or a type of paralysis known as "Guillain-Barré syndrome".
• Inflammation of blood vessels (vasculitis), which can cause skin rashes, joint pain, and kidney problems.

Rare: may affect less than 1 in 1,000 people

• Severe stabbing pain in one or more nerves.
• Low blood platelet count, which can lead to bleeding or bruising.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adjupanrix

Keep this vaccine out of the sight and reach of children.

Before mixing the vaccine:

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

Store in a refrigerator (between 2°C and 8°C).

Store in the original packaging to protect from light.

Do not freeze.

After mixing the vaccine:

After mixing, the vaccine should be used within 24 hours and should not be stored at a temperature 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. This will help protect the environment.

6. Container contents and additional information

Composition of Adjupanrix

• Active principle:

Influenza virus fractions, inactivated, containing antigen* equivalent to:

Strain similar to A/Vietnam/1194/2004 (H5N1): (NIBRG-14) 3.75 micrograms** per 0.5 ml dose

• propagated in eggs

**expressed in micrograms of hemagglutinin

This vaccine complies with the WHO recommendation and the EU Decision on the pandemic.

• Adjuvant:

The vaccine contains an "adjuvant" AS03. This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams), and polysorbate 80 (4.86 milligrams). Adjuvants are used to enhance the body's response to the vaccine.

• Other components:

The other components are: polysorbate 80, octoxinol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injectable preparations.

Appearance of the product and container contents

The suspension is a colorless, slightly opalescent liquid.

The emulsion is a homogeneous, milky liquid with a white to yellowish color.

Before administration, the two parts must be mixed. The mixed vaccine is a homogeneous, milky liquid emulsion with a white to yellowish color.

An Adjupanrix container contains:

• a container with 50 vials of 2.5 ml of suspension (antigen)
• two containers with 25 vials of 2.5 ml of emulsion (adjuvant)

Marketing authorization holder and manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For further information on this vaccine, please contact the local representative of the marketing authorization holder:

Date of last revision of this prospectus:

This medicinal product has been authorized under "exceptional circumstances". This authorization mechanism means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.

The European Medicines Agency will review annually any new information on this medicinal product that may be available, and this prospectus will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals:

Adjupanrix consists of 2 containers:

Suspension: multidose vial containing the antigen.

Emulsion: multidose vial containing the adjuvant.

Before administration, the two components must be mixed.

Instructions for mixing and administering the vaccine:

1. Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature (for at least 15 minutes). Each vial should be shaken and visually inspected for the presence of any foreign particles and/or changes in physical appearance. If any of these circumstances are observed (including rubber stopper particles), the vaccine should not be mixed.
2. The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant with a 5 ml syringe and adding it to the vial containing the antigen. It is recommended to use a 23-G needle. However, if this needle size is not available, a 21-G needle may be used. The vial containing the adjuvant should be kept upside down to facilitate the emptying of its contents.
3. After adding the adjuvant to the antigen, the mixture should be shaken well. The mixed vaccine is a homogeneous, milky liquid emulsion with a white to yellowish color. If any variation is observed, the vaccine should not be administered.
4. The volume of the Adjupanrix vial after mixing is at least 5 ml. The vaccine should be administered according to the recommended dosage (see section 3 "How to administer Adjupanrix").
5. The vial should be shaken before each administration and visually inspected for the presence of any foreign particles and/or changes in physical appearance. If any of these circumstances are observed (including rubber stopper particles), the vaccine should not be administered.
6. Each 0.5 ml or 0.25 ml or 0.125 ml dose of the vaccine should be withdrawn with a syringe with an appropriate graduation for injection and administered intramuscularly. It is recommended to use a syringe with a narrow needle, not larger than 23-G.
7. After mixing, use within 24 hours. The mixed vaccine can be stored in the refrigerator (between 2 °C and 8 °C) or at room temperature not exceeding 25 °C. If the mixed vaccine is stored in the refrigerator, it should be allowed to reach room temperature (for at least 15 minutes) before withdrawing each dose.

The vaccine should not be administered intravascularly.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.