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Pandemrix (split influenza virus inactivated, containing...) – Package leaflet - J07BB02

Updated on site: 09-Oct-2017

Medication namePandemrix
ATC CodeJ07BB02
Substancesplit influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A
ManufacturerGlaxoSmithKline Biologicals S.A.

Package leaflet: Information for the user

Pandemrix suspension and emulsion for emulsion for injection

Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 of 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 Pandemrix is and what it is used for

2.What you need to know before you receive Pandemrix

3.How Pandemrix is given

4.Possible side effects

5.How to store Pandemrix

6. Contents of the pack and other information

1. What Pandemrix is and what it is used for

What Pandemrix is and what it is used for

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

Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix).

How Pandemrix works

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.

2. What you need to know before you receive Pandemrix

Pandemrix 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 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.

Warnings and precautions

Talk to your doctor or nurse before you receive Pandemrix:

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), to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate. .

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.

• if you have a bleeding problem or bruise easily.

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

Excessive sleepiness during the day, often at the wrong times (a long-term condition called narcolepsy), has been reported very rarely after vaccination with Pandemrix in several European countries. Narcolepsy can occur with or without sudden muscle weakness that can cause falls (a condition called cataplexy).

Children and adolescents

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.

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

Other medicines and Pandemrix

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.

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

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 effects mentioned under section 4. “Possible side effects” may affect the ability to drive or use machines.

Pandemrix contains thiomersal

Pandemrix 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.

Pandemrix contains sodium and potassium

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.

3.How Pandemrix is given

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

Adults, including the elderly

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.

Use in children and adolescents

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.

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

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.

Allergic reactions:

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.

Other side effects:

The side effects listed below have occurred with Pandemrix in clinical studies in adults, including the elderly.

Very common: may affect more than 1 in 10 people

Headache

Tiredness

Pain and swelling at the injection site

Shivering

Increased sweating

Aching muscles, joint pain

Common: may affect up to 1 in 10 people

Redness and itching at the injection site

Fever

Feeling sick, diarrhoea, vomiting, stomach pain

Uncommon: may affect up to 1 in 100 people

A hard lump and warmth at the injection site

Swollen glands in the neck, armpit or groin

Tingling or numbness of the hands or feet

Sleeplessness

Dizziness

Itching, rash

Generally feeling unwell

Flu-like symptoms

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

Additional side effects in children and adolescents

Children aged 10-17 years

The side effects listed above have also been observed with similar frequencies in clinical studies in children 10 to 17 years of age, except for redness at the injection site which was very common and sweating which was common.

Children aged 3-9 years

In children 3 to 9 years of age who received two 0.25 ml doses of Pandemrix (H1N1) the side effects reported were similar to those reported in adults, except for redness at the injection site and gastrointestinal symptoms which were very common and shivering and sweating which were common. In addition, fever was very common in children aged 3-5 years. Some side effects (including local redness and fever) occurred more frequently after the second dose compared to the first dose.

Children aged 6-35 months

In children aged 6-35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an increase in reports of pain, redness and swelling at the injection site as well as fever (>38°C), drowsiness, irritability and loss of appetite after the second dose compared to the first dose. All these side effects were reported very commonly after each dose.

The side effects listed below have happened after Pandemrix (H1N1)v came on the market:

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

A long-term condition with excessive daytime sleepiness (narcolepsy), with or without sudden weakness (cataplexy), which may lead to falls without loss of consciousness

Short-term sleepiness following vaccination

Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation), hard lump (mass)

The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. They may also happen with Pandemrix.

Rare: may affect up to 1 in 1,000 people

Severe stabbing or throbbing pain along one or more nerves

Low blood platelet count which can result in bleeding or bruising

Very rare: may affect up to 1 in 10,000 people

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist 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 Pandemrix

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 Pandemrix contains

Active substance:

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

A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** per 0.5 ml dose

*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-α-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 to yellowish homogeneous milky liquid.

Prior to administration, the two components should be mixed. The mixed vaccine is a whitish to yellowish homogeneous milky liquid 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:

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

GlaxoSmithKline ehf.

GlaxoSmithKline Slovakia s.r.o.

Sími: +354 530 3700

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)808 100 9997

lv-epasts@gsk.com

customercontactuk@gsk.com

 

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:

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 brought to room temperature (allow 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 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 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 brought to room temperature (allow a minimum of 15 minutes) before each withdrawal.

The vaccine should not be administered intravascularly.

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

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