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Adjupanrix (Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) (split influenza virus, inactivated,...) – Package leaflet - J07BB02

Updated on site: 05-Oct-2017

Medication nameAdjupanrix (Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
ATC CodeJ07BB02
Substancesplit influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
ManufacturerGlaxoSmithKline Biologicals S.A.

Package leaflet: Information for the user

Adjupanrix suspension and emulsion for emulsion for injection

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

This vaccine has been prescribed for you only. Do not pass it on to others.

If you get any side effects, talk to your doctor.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Adjupanrix is and what it is used for

2.What you need to know before you receive Adjupanrix

3.How Adjupanrix is given

4.Possible side effects

5.How to store Adjupanrix

6.Contents of the pack and otherinformation

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 or Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg

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 or Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg

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

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

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 ‘Guillain- Barré 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 Appendix V. 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-α-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 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:

België/Belgique/Belgien

Lietuva

GlaxoSmithKline Pharmaceuticals s.a./n.v.

GlaxoSmithKline Lietuva UAB

Tél/Tel: + 32 10 85 52 00

Tel: +370 5 264 90 00

 

info.lt@gsk.com

България

Luxembourg/Luxemburg

ГлаксоСмитКлайн ЕООД

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Тел. + 359 2 953 10 34

Tél/Tel: + 32 10 85 52 00

Česká republika

Magyarország

GlaxoSmithKline s.r.o.

GlaxoSmithKline Kft.

Tel: + 420 2 22 00 11 11

Tel.: + 36-1-2255300

cz.info@gsk.com

 

Danmark

Malta

GlaxoSmithKline Pharma A/S

GlaxoSmithKline (Malta) Ltd

Tlf: + 45 36 35 91 00

Tel: + 356 21 238131

dk-info@gsk.com

 

Deutschland

Nederland

GlaxoSmithKline GmbH & Co. KG

GlaxoSmithKline BV

Tel: + 49 (0)89 360448701

Tel: + 31 (0)30 69 38 100

produkt.info@gsk.com

nlinfo@gsk.com

Eesti

Norge

GlaxoSmithKline Eesti OÜ

GlaxoSmithKline AS

Tel: +372 667 6900

Tlf: + 47 22 70 20 00

estonia@gsk.com

firmapost@gsk.no

Ελλάδα

Österreich

GlaxoSmithKline A.E.B.E

GlaxoSmithKline Pharma GmbH.

Tηλ: + 30 210 68 82 100

 

at.info@gsk.com

España

Polska

GlaxoSmithKline, S.A.

GSK Services Sp. z o.o.

Tel: + 34 902 202 700

Tel.: + 48 (22) 576 9000

es-ci@gsk.com

 

France

Portugal

Laboratoire GlaxoSmithKline

GlaxoSmithKline - Produtos Farmacêuticos, Lda.

Tél: + 33 (0) 1 39 17 84 44

Tel: + 351 21 412 95 00

diam@gsk.com

FI.PT@gsk.com

Hrvatska

România

GlaxoSmithKline d.o.o.

GlaxoSmithKline (GSK) SRL

Tel.: + 385 (0)1 6051999

Tel: +40 (0)21 3028 208

Ireland

Slovenija

GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline d.o.o.

Tel: + 353 (0)1 495 5000

Tel: + 386 (0) 1 280 25 00

 

medical.x.si@gsk.com

Ísland

Slovenská republika

Vistor hf.

GlaxoSmithKline Slovakia s.r.o.

Sími: +354 535 7000

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

 

recepcia.sk@gsk.com

Italia

Suomi/Finland

GlaxoSmithKline S.p.A.

GlaxoSmithKline Oy

Tel:+ 39 04 59 21 81 11

Puh/Tel: + 358 10 30 30 30

 

Finland.tuoteinfo@gsk.com

Κύπρος

Sverige

GlaxoSmithKline (Cyprus) Ltd

GlaxoSmithKline AB

Τηλ: + 357 22 39 70 00

Tel: + 46 (0)8 638 93 00

gskcyprus@gsk.com

info.produkt@gsk.com

Latvija

United Kingdom

GlaxoSmithKline Latvia SIA

GlaxoSmithKline UK

Tel: + 371 67312687

Tel: +44 (0)800 221 441

lv-epasts@gsk.com

customercontactuk@gsk.com

This leaflet was last revised in .

 

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: http://www.ema.europa.eu/

---------------------------------------------------------------------------------------------------------------------

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 23- G.

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.

The vaccine should not be administered intravascularly.

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

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