Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) - patient leaflet, side effects, dosage

1. What Adjupanrix is and what it is used for

What Adjupanrix is and what it is used for

Adjupanrix is a vaccine for use in adults from 18 years old to prevent pandemic flu (influenza).

Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.

How Adjupanrix works

When a person is given the vaccine, the body’s natural defence system (immune system) produces its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.

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

2. What you need to know before you receive Adjupanrix

Adjupanrix should not be given

• If you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts, such as: 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.

• – However, in a pandemic situation, you may still be given the vaccine. This is as long as medical treatment is available straight away, in case you have an allergic reaction.

Do not have Adjupanrix if any of the above apply to you.

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

Warning and precautions:

Talk to your doctor or nurse before you are given Adjupanrix

• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient of Adjupanrix (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
• if you have a serious 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 will advise whether you could still be vaccinated with Adjupanrix.
• 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 Adjupanrix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently received Adjupanrix.
• you have a bleeding problem or you bruise easily.

Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having Adjupanrix. This is because the vaccination may not be recommended, or may need to be delayed.

Children

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.

Other medicines and Adjupanrix

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.

In particular, tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system. Adjupanrix can still be given but your response to the vaccine may be poor.

Adjupanrix is not intended to be given at the same time as some other vaccines. However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious.

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 taking this vaccine.

Driving and using machines

Some side effects listed in Section 4. “Possible side effects” may affect your ability to drive or use tools or machines. It is best to see how Adjupanrix affects you before you try these activities.

Adjupanrix contains thiomersal

Adjupanrix 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.

Adjupanrix contains sodium and potassium

Adjupanrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose. It is essentially sodium- and potassium-free.

• 3. How Adjupanrix is given

If you have not previously received doses of Prepandrix

• From 18 years onwards: you will receive two doses of Adjupanrix. The second dose should be given after an interval of at least three weeks and up to twelve months after the first dose.
• From 80 years onwards: you may receive two double injections of Adjupanrix. The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.

If you have previously received one or two doses of Prepandrix

• From 18 years onwards: you will receive one dose of Adjupanrix.

Use in children

In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses. Your doctor will decide the appropriate dose for your child.

Your doctor or nurse will give you Adjupanrix.

• They will give Adjupanrix as an injection into a muscle.
• This will usually be in the upper arm.
• The double injections will be given in opposite 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 happen with this medicine:

Allergic reactions

Allergic reactions which may cause you to have dangerously low blood pressure. If this is not treated it may lead to shock. Your doctors know that this might happen and will have emergency treatment ready to use.

Other side effects:

Very common: may affect more than 1 in 10 people

• Headache
• Feeling tired
• Pain, redness, swelling or a hard lump where the injection was given
• Fever
• Aching muscles, joint pain

Common: may affect less than 1 in 10 people

• Warmth, itching or bruising where the injection was given
• Increased sweating, shivering, flu-like symptoms
• Swollen glands in your neck, armpit or groin

Uncommon: may affect less than 1 in 100 people

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

Additional side effects in children

In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses. The frequency of side effects was lower in the group of children who received half of the adult dose. There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.

In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.

The side effects listed below have happened with H1N1 AS03-containing vaccines. They may also happen with Adjupanrix. If any of the side effects below occur, please tell your doctor or nurse immediately:

• Allergic reactions leading to a dangerously low blood pressure. If this is not treated, it may lead to shock. Your doctors will know that this might happen and will have emergency treatment ready to use
• Fits
• Generalised skin reactions including urticaria (hives)

The side effects listed below have happened in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. They may also happen with Adjupanrix. If any of the side effects below occur, please tell your doctor or nurse immediately:

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

• Problems with your brain and nerves such as inflammation of the central nervous system (encephalomye­litis), inflammation of nerves (neuritis) or a type of paralysis known as ‘GuillainBarre Syndrome’.
• Inflammation of your blood vessels (vasculitis). This can cause skin rashes, joint pain and

kidney problems

Rare: may affectless than 1 in 1,000 people

• Serious stabbing or throbbing pain along one or more nerves
• Low blood platelet count. This can cause bleeding or bruising

Reporting of side effects

If you get 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 via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Adjupanrix

Keep this vaccine out of the sight and reach 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Adjupanrix contains

• Active substance:

Split influenza virus, inactivated, containing antigen* equivalent to:

A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14) 3.75 micrograms** per 0.5 ml dose

*propagated in eggs

**expressed in microgram haemagglutinin

This vaccine complies with the WHO recommendation and EU decision for the pandemic.

• Adjuvant:

The vaccine contains an ‘adjuvant’ AS03. This adjuvant contains squalene (10.69 milligrams), DL-a-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, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections

What Adjupanrix looks like and contents of the pack

The suspension is a colourless light opalescent liquid.

The emulsion is a whitish to yellowish homogeneous milky liquid.

Before the vaccine is given, the two parts will be mixed together. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.

One pack of Adjupanrix 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 medicinal vaccine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/ Belgie/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00	Lietuva GlaxoSmithKline Lietuva UAB Tel: +370 5 264 90 00
Etnrapua r.iaKCoC’MHTK.iaHH EOOfl Ten. + 359 2 953 10 34	Luxembourg/Lu­xemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
Česká republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11	Magyarország GlaxoSmithKline Kft. Tel.: + 36–1–2255300
Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00	Malta GlaxoSmithKline (Malta) Ltd Tel: + 356 21 238131
Deutschland GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701	Nederland GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100
Eesti GlaxoSmithKline Eesti OÜ Tel: +372 667 6900	Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00
EMáSa GlaxoSmithKline A.E.B.E Tql: + 30 210 68 82 100	Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
España GlaxoSmithKline, S.A. Tel: + 34 902 202 700	Polska GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9000
France Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44	Portugal GlaxoSmithKline – Produtos Farmacéuticos, Lda. Tel: + 351 21 412 95 00
Hrvatska GlaxoSmithKline d.o.o. Tel.: + 385 (0)1 6051999	Romania GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208
Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5000	Slovenija GlaxoSmithKline d.o.o. Tel: + 386 (0) 1 280 25 00
Ísland	Slovenská republika

GlaxoSmithKline Slovakia s.r.o.

Tel.: + 421 (0)2 48 26 11 11

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

This medicine has been authorised under ‘exceptional circumstances’.

This means that for scientific reasons it has been impossible to get complete information on this medicine.

The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for healthcare professionals only:

Adjupanrix 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 (for a minimum of 15 minutes); 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 5 ml syringe and by adding it to the vial containing the antigen. It is recommended to equip the syringe with a 23-G needle. However, in the case this needle size would not be available, a 21-G needle might be used. The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.

• 3. After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion. In the event of other variation being observed, discard the vaccine.

• 4. The volume of the Adjupanrix vial after mixing is at least 5 ml. The vaccine should be administered in accordance with the recommended posology (see section 3 “How Adjupanrix 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 is withdrawn into a 1 ml syringe for injection and administered intramuscularly. It is recommended to equip the syringe with a needle gauge not larger than 23G.

• 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 (for a minimum of 15 minutes) before each withdrawal.