Prepandrix - patient leaflet, side effects, dosage

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

GlaxoSmithKline Biologicals

Branch of SmithKline Beecham Pharma GmbH & Co. KG

Zirkusstraße 40, D-01069 Dresden

Germany

Name and address of the manufacturer responsible for batch release

GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut

B-1330 Rixensart

Belgium

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

• Official batch release

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

• Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

D CONDITI R RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

• Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

• At the request of the European Medicines Agency
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS

OF EMULSION

• 1. NAME OF THE MEDICINAL PRODUCT

Prepandrix suspension and emulsion for emulsion for injection

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

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

After mixing, 1 dose (0.5 ml) contains:

Split influenza virus, inactivated, containing antigen equivalent to:

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

AS03 adjuvant composed of squalene, DL-a-tocopherol and polysorbate 80

haemagglutinin

• 3. LIST OF EXCIPIENTS

Polysorbate 80

Octoxynol 10

Thiomersal

Sodium chloride (NaCl)

Disodium hydrogen phosphate (Na2HPO4)

Potassium dihydrogen phosphate (KH2PO4)

Potassium chloride (KCl)

Magnesium chloride (MgCl2)

Water for injections

• 4. PHARMACEUTICAL FORM AND CONTENTS

Suspension and emulsion for emulsion for injection

50 vials: suspension (antigen)

50 vials: emulsion (adjuvant)

The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of 0.5 ml vaccine

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use

Shake before use

Read the package leaflet before use

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

Suspension and emulsion to be mixed before administration

• 8. EXPIRY DATE

EXP: MM/YYYY

EU/1/08/453/002

• 13. BATCH NUMBER

Lot:

• 14. GENERAL CLASSIFICATION FOR SUPPLY

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

• 17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included.

• 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

PACK OF 50 VIALS OF SUSPENSION

• 1. NAME OF THE MEDICINAL PRODUCT

Suspension for emulsion for injection for Prepandrix

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

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Split influenza virus, inactivated, containing antigen equivalent to

• 3. 75 micrograms haemagglutinin/dose

*Antigen: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) — 3. LIST OF EXCIPIENTS

Excipients:

Polysorbate 80

Octoxynol 10

Thiomersal

Sodium chloride

Disodium hydrogen phosphate

Potassium dihydrogen phosphate

Potassium chloride

Magnesium chloride

Water for injections

Antigen suspension for injection 50 vials: suspension 2.5 ml per vial

After mixing with adjuvant emulsion: 10 doses of 0.5 ml

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

Intramuscular use

Shake before use

Read the package leaflet before use

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

Suspension to be exclusively mixed with adjuvant emulsion before administration

• 8. EXPIRY DATE

EXP: MM/YYYY

• 9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

Store in the original package in order to protect from light

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

  
  

GSK Biologicals, Rixensart – Belgium

• 12. MARKETING AUTHORISATION

EU/1/08/453/002

• 13. BATCH NUMBER

Lot:

• 14. GENERAL CLASSIFICATION FOR SUPPLY

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

PACK OF 25 VIALS OF EMULSION

• 1. NAME OF THE MEDICINAL PRODUCT

Emulsion for emulsion for injection for Prepandrix

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-a-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

Emulsion to be exclusively mixed with antigen suspension before administration

• 8. EXPIRY DATE

EXP: MM/YYYY

• 9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

Store in the original package in order to protect from light

• 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Antigen suspension for Prepandrix

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) I.M.

• 2. METHOD OF ADMINISTRATION

Mix with adjuvant emulsion before use

• 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Adjuvant emulsion for Prepandrix I.M.

• 2. METHOD OF ADMINISTRATION

Mix into Antigen suspension before use

Package Leaflet: Information for the user

Prepandrix suspension and emulsion for emulsion for injection

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

Read all of this leaflet carefully before you receive 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

What Prepandrix is and what it is used for

What you need to know before you receive Prepandrix

How Prepandrix is given

Possible side effects

How to store Prepandrix

Contents of the pack and other information

What Prepandrix is and what it is used for

What Prepandrix is and what it is used for

Prepandrix is a vaccine for use in adults from 18 years the next influenza (flu) pandemic to prevent flu caused

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 Prepandrix 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, Prepandrix may not fully protect all persons who are vaccinated.

2. What you need to know before you receive Prepandrix

Prepandrix 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.

• if you have a serious infection with a high temperature (over 38°C). If this applies to you then your vaccination will 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 Prepandrix.

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

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

Warnings and precautions

Talk to your doctor or nurse before you are given Prepandrix:

if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.

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 Prepandrix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently received Prepandrix.

if 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 Prepandrix. 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 Prepandrix

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. Prepandrix can still be given but your response to the vaccine may be poor.

Prepandrix 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 you receive 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 Prepandrix affects you before you try these activities.

Prepandrix contains thiomersal

Prepandrix 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.

Prepandrix contains sodium and potassium

Prepandrix 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 Prepandrix is given

• From 18 years onwards: you will receive two doses of Prepandrix. 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 Prepandrix. The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.

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 of a similar vaccine containing A/Vietnam/1194/200­4. Your doctor will decide the appropriate dose for your child.

Your doctor or nurse will give you Prepandrix.

• They will give Prepandrix 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

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

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

ling or a hard lump where the injection was given

Aching muscles, joint pain

Common : may affect up to 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 upt o 1 in 100 people

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

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 of a similar vaccine containing A/Vietnam/1194/200­4. 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 Prepandrix, 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 Prepandrix. 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 other vaccines given routinely every year to prevent flu. These side effects may also happen with Prepandrix. If any of the side effects below occur, please tell your doctor or nurse immediately:

Very rare : may affect up to 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 affect up to 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. 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 Prepandrix

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 Prepandrix contains

Active substance:

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

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 3.75 micrograms** per 0.5 ml

*propagated in eggs

**expressed in microgram haemagglutinin

Adjuvant:

The vaccine contains an ‘adjuvant’ AS03. This adjuvant contains squalene (10.69 milligrams),

DL-a-tocopherol (11.86 milligrams) and polysorbate 80 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 Prepandrix 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

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 vaccine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Bel­gien

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 10 85 52 00

Etnrapua rnaKCoCMumKnaňH EOOfl Ten. + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 2 22 00 11 11

GlaxoSmithKline Lietuva UAB

Tel: +370 5 264 90 00

Luxembourg/Lu­xemburg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tel/Tel: + 32 10 85 52 00

Magyarorszag

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

España

GlaxoSmithKline, S.A.

Tel: + 34 902 202 700

Polska

GSK Services Sp. z o.o.

Tel.: + 48 (22) 576 9000

Portugal

GlaxoSmithKline – Produtos Farmacéuticos, Lda.

Tel: + 351 21 412 95 00

Romania

GlaxoSmithKline (GSK) SRL

Tel: +40 (0)21 3028 208

Ireland

GlaxoSmithKline (Ireland) Ltd

Tel: + 353 (0)1 495 5000

island

Vistor hf.

Simi: +354 535 7000

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0) 1 280 25 00

Slovenská republika

GlaxoSmithKline Slovakia s.r.o

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

Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 9218 111

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 10 30 30 30

Kûnpoç

GlaxoSmithKline (Cyprus) Ltd

Tql: + 357 22 39 70 00

Latvija

GlaxoSmithKline Latvia SIA Tel: + 371 67312687

United Kingdom

GlaxoSmithKline UK

Tel: +44 (0)800 221 441

This leaflet was last revised in

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:

Prepandrix 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 Prepandrix vial after mixing is at least 5 ml. The vaccine should be administered in accordance with the recommended posology (see section 3 “How Prepandrix 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.