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Pumarix (pandemic influenza vaccine (H5N1) (split...) – Package leaflet - J07BB02

Updated on site: 09-Oct-2017

Medication namePumarix
ATC CodeJ07BB02
Substancepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
ManufacturerGlaxoSmithKline Biologicals S.A.  

Package Leaflet: Information for the user

Pumarix suspension and emulsion for emulsion for injection

Pandemic 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.

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

 

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

 

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

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If you get any side effects, talk to your doctor. This includes any possible side effects not l ted

 

in this leaflet.

 

What is in this leaflet:

 

1.

What Pumarix is and what it is used for

 

2.

What you need to know before you are given Pumarix

 

3.

How Pumarix is given

 

4.

Possible side effects

 

Pumarix is a vaccine for use in adults from 18 years ld longerto prevent pandemic flu (influenza).

5.

How to store Pumarix

 

6.

Contents of the pack and other information

 

1.

What Pumarix is and what it is used for

 

What Pumarix is and what it is used for

 

Pandemic flu is a type of influenza that happe s at i tervals that vary from less than 10 years to many

 

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decades. It spreads rapidly around the world. Thenosigns of pandemic flu are similar to those of

ordinary flu but may be more serious.

 

How Pumarix 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, Pumarix may not fully protect all persons who are vaccinated.

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2.

What you eed to know before you are given Pumarix

Pumar x 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 or sodium deoxycholate.

 

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Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling

 

 

of the face or tongue.

 

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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 Pumarix 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 Pumarix:

• 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 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 Pumarix.

• if you have problems with your immune system, since your response to the vaccine may th n 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 Pumarix the results of these tests may not be co ect. Tell the doctor requesting these tests that you have recently been given Pumarix.

• if you have a bleeding problem or you bruise easily.

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

Fainting can occur following, or even before, any needle injection. Th fo authorisede tell the doctor or nurse if

you fainted with a previous injection.

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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. Theref re monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.no

Other medicines and Pumarix

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

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

Pumarix is not intended to be given at the same time as some other vaccines. However, if this needs to Medicinalhappen, the other v ccine will be injected into the other arm. Any side effects that happen may be

more serious.

Pregnan y and breast-feeding

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

Driving and using machines

Some 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 Pumarix affects you before you try these activities.

Pumarix contains thiomersal

Pumarix 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.

Pumarix contains sodium and potassium

Pumarix 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 Pumarix is given

Adults from 18 years onwards: you will receive two doses of Pumarix. The second dose should be given after an interval of at least three weeks after the first dose.

If you have previously received one or two doses of a similar H5N1 AS03-containing vaccine

This will usually be in the upper arm.

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Adults from 18 years onwards: you will receive one dose of Pumarix.

Use in children

There is limited information available on the use of vaccine very similar to Pumarix (but manufactured in a different facility) to children aged from 3-9 years who received either two adult d ses r two half adult doses given three weeks apart. There is no information available on use in c ildren aged less than 3 years or aged from 10-17 years.

Your doctor or nurse will give you Pumarix.

• They will give Pumarix as an injection into a muscle

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

4.Possible side effects

Allergic reactions which may cause you o havenodangerously 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.

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

Allergic reactions

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Other side effects:

Very common: may affect mo e than 1 in 10 people

Pain where the injection was given

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Headache

Feeli

g tired

Ach

g muscles, joint pain

Common: may affect up to 1 in 10 people

Re ness and swelling where the injection was given

Fever

 

Sweating

Shivering

Diarrhoea, feeling sick

Uncommon: may affect up to 1 in 100 people

Reactions where the injection was given such as bruising, a hard lump, itching, warmth

Swollen glands in your neck

Feeling dizzy

Generally feeling unwell

Unusual weakness

Being sick, stomach pain, acid indigestion

Not being able to sleep

Tingling or numbness of the hands or feet

Shortness of breath

Pain in the chest

Itching, rash

Pain in the back or neck, stiff muscles, muscle spasms, pain in your leg or hand

Additional side effects in children

When a dose of 0.5 ml of a similar vaccine was given to children aged 3-9 years, fever occurred more often than when half of this dose (0.25 ml of vaccine) was given. Also fever occurred mo e often n children aged 6-9 years compared to the children aged 3-5 years. There was no increase after the second dose whether the children received half of the adult or the adult dose, except f r s me 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 simil r v ccine containing

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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 ag d l ss than 6 years.

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

 

 

 

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Allergic reactions leading to a dangerously l w bl od 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

 

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Fits

 

 

 

 

 

Generalised skin reactions incl ding urticaria (hives)

 

 

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

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

• Serious st bbing or throbbing pain along one or more of your nerves

Low blood pl telet count. This can cause bleeding or bruising.

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

Inflammation of your blood vessels (vasculitis). This can cause skin rashes, joint pain and ki ney problems

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’.Medicinal

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

5.How to store Pumarix

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 to 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 30°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 envir nment.

6.

Contents of the pack and other information

 

 

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What Pumarix contains

 

 

 

Active substance:

 

 

 

 

Split influenza virus, inactivated, containing antigen* equival nt to:

 

 

A/H5N1/Indonesia/5/2005 like strain used (PR8-IBCDC-RG2)3.75 micrograms** per 0.5 ml

 

dose

 

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*propagated in eggs

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**expressed in microgram haemaggluti

 

 

 

 

This vaccine complies with the WHO recommendationno

and EU decision for the pandemic.

Adjuvant:

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

DL-α-tocopherol product(11.86 milligrams) and polysorbate 80 (4.86 milligrams). Adjuvants are used to improve the body’s esp nse to the vaccine.

Other ingredients:

The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections

MedicinalWhat Pumar x looks like and contents of the pack

The suspension is a translucent to off white opalescent suspension, which may sediment slightly. The mulsion is a whitish homogeneous liquid.

Before the vaccine is given, the two parts will be mixed together. The mixed vaccine is a whitish emulsion.

One pack of Pumarix 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

GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00

България

ГлаксоСмитКлайн ЕООД Тел. + 359 2 953 10 34

Česká republika

GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11 czmail@gsk.com

Danmark

GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com

Deutschland

 

GlaxoSmithKline GmbH & Co. KG

Tel: + 49 (0)89 360448701

produkt.info@gsk.com

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Eesti

GlaxoSmithKline Eesti OÜ Tel: +372 667 6900 estonia@gsk.com

Ελλάδα

MedicinalGlaxoSmithKline A.E.B.E

Tηλ: + 30 210 68 82 100

España

GlaxoSm thKline, S.A. Tel: + 34 902 202 700 s-ci@gsk.com

France

Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com

Ireland

GlaxoSmithKline (Ireland) Ltd

Tel: + 353 (0)1 4955000

Luxembourg/Luxemburg

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GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tél/Tel: + 32 10 85 52 00

Magyarország

GlaxoSmithKline Kft.

Tel.: + 36-1-2255300

Malta

GlaxoSmithKline (M lta) Ltd

Tel: + 356 21 238131

Nederlandlonger

GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100 n inf @gsk.com

noN rge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00 firmapost@gsk.no

Österreich

GlaxoSmithKline Pharma GmbH. Tel: + 43 1 970 75-0 at.info@gsk.com

Polska

GSK Commercial Sp. z o.o.

Tel.: + 48 (22) 576 9000

Portugal

GlaxoSmithKline - Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com

România

GlaxoSmithKline (GSK) SRL

Tel: +40 (0)21 3028 208

Slovenija

GlaxoSmithKline d.o.o. 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

 

 

 

 

 

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Finland.tuoteinfo@gsk.com

Κύπρος

 

 

Sverige

 

GlaxoSmithKline (Cyprus) Ltd

 

GlaxoSmithKline AB

 

Τηλ: + 357 22 39 70 00

 

 

Tel: + 46 (0)8 638 93 00

 

 

 

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

Lietuva

 

 

 

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GlaxoSmithKline Lietuva UAB

 

 

 

 

Tel: +370 5 264 90 00

 

 

 

 

 

info.lt@gsk.com

 

 

 

 

 

 

 

 

 

 

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This medicine has been authorised under ’excepti

al circumstances’.

 

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

medicine.

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The European Medicines Agency will review any new information on this medicine every year and

this leaflet will be updated as necessary.

 

 

 

 

Other sources of informati n

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.euro a.eu/

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The follow g formation is intended for healthcare professionals only:

Pumar x consists of two containers:

Susp nsion: 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). Whitish sediments may be observed in the suspension vial; these sediments are part of the normal physical appearance of the suspension. The emulsion presents as a whitish appearance.

2.Each vial should be shaken and inspected visually for any foreign particulate matter (other than the white sediments described above) and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.

3.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.

4.After the addition of the adjuvant to the antigen, the mixture should beauthorisedwell shaken. The mixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the vaccine.

5.The volume of the Pumarix vial after mixing is at least 5 ml. The vaccine should be administered in accordance with the recommended posology (see section 3. “How Puma x s given”).

6.The vial should be shaken prior to each administration and inspected visually f r any f reign particulate matter and/or abnormal physical appearance. In the event of ei er being observed (including rubber particles from the stopper), discard the vaccine.

Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection nd administered

intramuscularly. It is recommended to equip the syringe with a needle not l rger than 23-G.7.

8.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 (25°C – 30°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 intravascular y.

Any unused medicinal product or waste material sh uld longerbe disposed of in accordance with local

requirements.

 

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THE TERMS OF THE MARKETINGlongerAUTHORISATION

 

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO

 

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Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR for Pumarix, the scientific conclusions of the PRAC are as follows:

In relation to the identified risk of fever in children (<6 years), the PRAC does not agree with the MAH that the EU SmPC contains appropriate information on this safety concern. As an identified

risk, an appropriate warning should be included in section 4.4. Moreover section 4.8 should be authorised

revised to reflect reactogenicity data from the three paediatric studies D-Pan H5N1-009, -013 and 032.

Therefore, in view of the available data regarding fever in children, the PRAC considered that changes to the product information were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds recommending the variation to the terms of the Marketing Authorisa ion

On the basis of the scientific conclusions for Pumarix, the CHMP is of the opinion that the benefit-

risk balance of the medicinal product containing the active substance purified ntigen fractions of

 

 

 

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inactivated split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 is favourable subject to the

proposed changes to the product information.

 

 

The CHMP recommends that the terms of the Marketing Authorisation should be varied.

 

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