Arepanrix

Основна информация

  • Търговско наименование:
  • Arepanrix
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Arepanrix
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Influenza vaccines
  • Терапевтична област:
  • Influenza, Human, Immunization, Disease Outbreaks
  • Терапевтични показания:
  • Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance
  • Каталог на резюме:
  • Revision: 1

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Withdrawn
  • Номер на разрешението:
  • EMEA/H/C/001201
  • Дата Оторизация:
  • 22-03-2010
  • EMEA код:
  • EMEA/H/C/001201
  • Последна актуализация:
  • 31-03-2019

Доклад обществена оценка

Medicinal product no longer authorised

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.

EMA/33181/2010

EMEA/H/C/1201

EPAR summary for the public

Arepanrix

Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

This document is a summary of the European Public Assessment Report (EPAR) for Arepanrix. It

explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to

reach its opinion in favour of granting a marketing authorisation and its recommendations on the

conditions of use for Arepanrix.

What is Arepanrix?

Arepanrix is a vaccine that is given by injection. It contains parts of influenza (flu) viruses that have

been inactivated (killed). Arepanrix contains a flu strain called A/California/7/2009 (H1N1) v-like strain

(X-179A).

What is Arepanrix used for?

Arepanrix is a vaccine to protect against ‘pandemic’ flu. It should only be used for the influenza A

(H1N1) flu pandemic that was officially declared by the World Health Organization on 11 June 2009. A

flu pandemic happens when a new strain of flu virus appears that can spread easily from person to

person because people have no immunity (protection) against it. A pandemic can affect most countries

and regions around the world. Arepanrix is given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is Arepanrix used?

Arepanrix is given as one dose, injected into the shoulder muscle. A second dose may be given after

an interval of at least three weeks, particularly in children from six months to nine years of age.

Medicinal product no longer authorised

How does Arepanrix work?

Arepanrix is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences)

how to defend itself against a disease. Arepanrix contains small amounts of haemagglutinins (proteins

from the surface) of a virus called A(H1N1)v that is causing the current pandemic. The virus has first

been inactivated so that it does not cause any disease.

When a person is given the vaccine, the immune system recognises the virus as ‘foreign’ and makes

antibodies against it. The immune system will then be able to produce antibodies more quickly when it

is exposed to the virus again. This will help to protect against the disease caused by the virus.

Before use, the vaccine is made up by mixing together a suspension that contains the virus particles

with a solvent. The resulting ‘emulsion’ is then injected. The solvent contains an ‘adjuvant’ (a

compound containing oil) to enhance the immune response.

Arepanrix is very similar to another pandemic vaccine called Pandemrix, which has been available in

the European Union (EU) since September 2009. Both contain the same adjuvant, In Arepanrix, a

different method is used to prepare the haemagglutinins used in the vaccine.

How has Arepanrix been studied?

The company presented information from studies carried out with an earlier version of Arepanrix,

containing the ‘bird flu’ strain H5N1. This included one study in 4,561 adults, which looked at the

ability of Arepanrix H5N1 to trigger the production of antibodies (‘immunogenicity’) against this H5N1

strain, and one study comparing it with Pandemrix H5N1. A further study compared Arepanrix

containing the pandemic flu strain H1N1 with Pandemrix H1N1 in 334 adults. This study looked at the

immunogenicity against influenza A(H1N1)v.

Because Arepanrix is similar to Pandemrix, the company used the data on the use of Pandemrix in

children to support the use of Arepanrix in children.

What benefit has Arepanrix shown during the studies?

The studies of Arepanrix H5N1 showed that the vaccine was able to bring about protective levels of

antibodies in at least 70% of people in which it was studied. In line with the criteria laid down by the

CHMP, this demonstrated that the vaccine brought about an appropriate level of protection. The same

level of protection was obtained with Arepanrix as with Pandemrix.

The study comparing Arepanrix H1N1 with Pandemrix H1N1 showed that one dose was able to trigger

immunity to a satisfactory level. The percentage of subjects who had a level of antibodies in their

blood that was high enough to neutralise the H1N1 virus (seroprotection rate) was 100%.

What is the risk associated with Arepanrix?

The most common side effects with Arepanrix (seen with more than 1 in 10 doses of the vaccine) are

headache, joint pain, muscle aches, pain at the site of the injection and fatigue (tiredness). For the full

list of all side effects reported with Arepanrix, see the Package Leaflet.

Arepanrix should not be given to people who have had an anaphylactic reaction (severe allergic

reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in

the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde and

sodium deoxycholate. However, it may be appropriate to give the vaccine to these patients during a

pandemic, as long as facilities for resuscitation are available.

Arepanrix

EMA/236107/2010

Page 2/3

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Arepanrix

EMA/236107/2010

Page 3/3

Why has Arepanrix been approved?

The CHMP noted that Arepanrix had already been marketed in Canada and used to vaccinate over 5

million people with no safety concerns. The Committee decided that Arepanrix’s benefits are greater

than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation and

recommended that it be given marketing authorisation.

Arepanrix has been given ‘Conditional Approval’. This means that there is more evidence to come

about the medicine, in particular the results of further clinical studies in children, adolescents and

adults. Every year, the European Medicines Agency will review any new information that may become

available and this summary will be updated as necessary.

What information is still awaited for Arepanrix?

The company that makes Arepanrix will provide data collected in clinical trials of Arepanrix in adults

and children, as well as information collected on the safety and effectiveness of the vaccine, to the

CHMP for evaluation.

Which measures are being taken to ensure the safe use of Arepanrix?

The company that makes Arepanrix will collect information on the safety of the vaccine while it is being

used. This will include information on its side effects and its safety in children, the elderly, pregnant

women, patients with severe conditions and people who have problems with their immune systems.

Other information about Arepanrix:

The European Commission granted a marketing authorisation valid throughout the European Union for

Arepanrix to GlaxoSmithKline Biologicals s.a. on on 23 March 2010.

The full EPAR for Arepanrix can be found here

. For more information about treatment with Arepanrix,

read the Package Leaflet (also part of the EPAR).

This summary was last updated in 02-2010.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

Medicinal product no longer authorised

B. PACKAGE LEAFLET

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

Arepanrix suspension and emulsion for emulsion for injection

Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)

For the most up-to-date information please consult the website of the European Medicines

Agency (EMEA): http://www.emea.europa.eu/.

Read all of this leaflet carefully before you receive this vaccine.

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

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor.

In this leaflet

What Arepanrix is and what it is used for

Before you receive Arepanrix

How Arepanrix is given

Possible side effects

How to store Arepanrix

Further information

1.

What Arepanrix is and what it is used for

Arepanrix is a vaccine against a pandemic influenza (flu).

Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around

the world. The symptoms of pandemic flu are similar to those of ordinary flu but may be more severe.

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.

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

2.

Before you are given Arepanrix

You should not receive Arepanrix:

if you have previously had a sudden life-threatening allergic reaction to any ingredient of

Arepanrix (these are listed at the end of the leaflet) or to any of the substances that may be

present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde 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, it may be

appropriate for you to have the vaccine provided that appropriate medical treatment is

immediately available in case of an allergic reaction.

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

Take special care with Arepanrix:

if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any

Medicinal product no longer authorised

ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin,

formaldehyde or to sodium deoxycholate. (see section 6. Further information).

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 will advise whether you could still be

vaccinated with Arepanrix.

if you have a poor immune response (as for example because of immunosuppressive therapy,

e.g. corticosteroid treatments or chemotherapy for cancer),

if you are having a blood test to look for evidence of infection with certain viruses. In the first

few weeks after vaccination with Arepanrix the results of these tests may not be correct. Tell the

doctor requesting these tests that you have recently been given Arepanrix.

In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended,

or may need to be delayed.

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.

Please inform your doctor or nurse if you have a bleeding problem or bruise easily.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription or have recently been given any other vaccine.

Areapanrix 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

Arepanrix after an interval of at least three weeks.

There is no information on administration of Arepanrix with other vaccines and no information on

administration of the AS03-containing vaccine containing HA from H1N1v manufactured using a

different process with any other vaccines than non-adjuvanted seasonal influenza vaccine. 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

Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant. You should

discuss with your doctor whether you should receive Arepanrix.

The vaccine may be used during breast-feeding.

Driving and using machines

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

machines.

Important information about some of the ingredients of Arepanrix

This vaccine 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.

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.

Medicinal product no longer authorised

3.

How Arepanrix is given

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

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

Adults including the elderly and children from the age of 10 years onwards:

A dose (0.5 ml) of the vaccine will be given

Clinical data with an AS03-containing vaccine containing HA from H1N1v manufactured using a

different process 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.

When Arepanrix is given for the first dose, it is recommended that Arepanrix (and not another vaccine

against H1N1) be given for the complete vaccination course.

4.

Possible side effects

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

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.

The frequency of possible side effects listed below is defined using the following convention:

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Very rare (affects less than 1 user in 10,000)

The side effects listed below have occurred with Arepanrix (H5N1) in clinical studies in adults,

including the elderly. In these clinical studies most side effects were mild in nature and short term.

The side-effects are generally similar to those related to seasonal flu vaccines.

These side effects have also been observed with similar frequencies in clinical studies in adults

including the elderly and in children aged 10 to 17 years with a similar vaccine (H1N1), except for

redness (uncommon in the adults and common in the elderly) and fever (uncommon in the adults and

elderly). Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of

age. In children aged 3-9 years who received a first half adult dose of a similar vaccine (H1N1), the

side effects were similar compared to the side effects reported in adults, with the exception of

shivering, sweating and gastro-intestinal symptoms which were reported at a higher rate in children

aged 3 to 9 years. Additionally, in children aged 3 to 5 years of age, drowsiness, irritability and loss of

appetite were reported very commonly.

Very common:

Pain at the injection site

Medicinal product no longer authorised

Headache

Tiredness

Aching muscles, joint pain

Common:

Redness and swelling at the injection site

Fever

Sweating

Shivering

Diarrhoea, feeling sick

Uncommon:

Reactions at the injection site such as bruising, hard lump, itching, warmth

Swollen glands in the axilla

Dizziness

Generally feeling unwell

Unusual weakness

Being sick, stomach pain, acid indigestion

Inability 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, stiffness in the muscles, muscle spasms, pain in extremity such as leg

or hand

In children aged 6-35 months who received a half of the adult dose (0.25 ml) of a similar vaccine

(H1N1), fever and irritability occurred more often compared to the children 3-9 years who received a

half of the adult dose (0.25 ml) of a similar vaccine (H5N1).

In children aged 6-35 months who received two doses of 0.25 ml (half of the adult dose) the side

effects after the second dose were more intense, especially fever (≥38°C), which occurred very

commonly.

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

YOUR DOCTOR.

The side effects listed below have occurred during post-marketing surveillance with a similar vaccine

(H1N1). These side effects may occur with Arepanrix.

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

The side effects listed below have occurred in the days or weeks after vaccination with vaccines given

routinely every year to prevent flu. These side effects may occur with Arepanrix.

Rare

Severe stabbing or t

hrobbing pain along one or more nerves

Low blood platelet count which can result in bleeding or bruising

Very rare

Medicinal product no longer authorised

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

If any of these side effects occur, please tell your doctor or nurse immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

tell your doctor.

5.

How to store Arepanrix

Keep out of the reach and sight 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 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

Further information

What Arepanrix

contains

Active substance:

Split influenza virus, inactivated, containing antigen

equivalent to:

A/California/7/2009 (H1N1)v-like strain (X-179A) 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 to stimulate a better response. This adjuvant contains

squalene (10.69 milligrams), DL-

-tocopherol (11.86 milligrams) and polysorbate 80 (4.86

milligrams)

Other ingredients:

The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate,

potassium dihydrogen phosphate, potassium chloride, water for injections

What Arepanrix

looks like and contents of the pack

Medicinal product no longer authorised

Suspension and emulsion for emulsion for injection.

The suspension is a translucent to off white opalescent suspension, which may sediment slightly.

The emulsion is a whitish homogeneous liquid.

Prior to administration, the two components should be mixed. The mixed vaccine is a whitish

emulsion.

One pack of Arepanrix 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 s.a./n.v.

Tél/Tel: + 32 2 656 21 11

Luxembourg/Luxemburg

GlaxoSmithKline s.a./n.v.

Tél/Tel: + 32 2 656 21 11

България

ГлаксоСмитКлайн ЕООД

ул. Димитър Манов бл.10

София 1408

Тел. + 359 2 953 10 34

Magyarország

GlaxoSmithKline Kft.

Tel.: + 36-1-2255300

Česká republika

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

gsk.czmail@gsk.com

Malta

GlaxoSmithKline Malta

Tel: + 356 21 238131

Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

dk-info@gsk.com

Nederland

GlaxoSmithKline BV

Tel: + 31 (0)30 69 38 100

nlinfo@gsk.com

Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel: + 49 (0)89 360448701

produkt.info@gsk.com

Norge

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

firmapost@gsk.no

Eesti

GlaxoSmithKline Eesti OÜ

Tel: +372 667 6900

estonia@gsk.com

Österreich

GlaxoSmithKline Pharma GmbH.

Tel: + 43 1 970 75-0

at.info@gsk.com

Ελλάδα

GlaxoSmithKline A.E.B.E

Tηλ: + 30 210 68 82 100

Polska

GSK Commercial Sp. z o.o.

Tel.: + 48 (22) 576 9000

Medicinal product no longer authorised

España

GlaxoSmithKline, S.A.

Tel: + 34 902 202 700

es-ci@gsk.com

Portugal

GlaxoSmithKline - Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com

France

Laboratoire GlaxoSmithKline

Tél: + 33 (0) 800 00 12 12

grippeA@gsk.com

România

GlaxoSmithKline (GSK) SRL

Tel: +40 (0)21 3028 208

Ireland

GlaxoSmithKline (Ireland) Ltd

Tel: + 353 (0)1 4955000

Slovenija

GlaxoSmithKline d.o.o.

Tel: + 386 (0) 1 280 25 00

medical.x.si@gsk.com

Ísland

GlaxoSmithKline ehf.

Sími: +354 530 3700

Slovenská republika

GlaxoSmithKline Slovakia s.r.o.

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

recepcia.sk@gsk.com

Italia

GlaxoSmithKline S.p.A.

Tel:+ 39 04 59 21 81 11

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 10 30 30 30

Finland.tuoteinfo@gsk.com

Κύπρος

GlaxoSmithKline (Cyprus) Ltd

Τηλ: + 357 22 39 70 00

Sverige

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

info.produkt@gsk.com

Latvija

GlaxoSmithKline Latvia SIA

Tel: + 371 67312687

lv-epasts@gsk.com

United Kingdom

GlaxoSmithKline UK

Tel: + 44 (0)808 100 9997

customercontactuk@gsk.com

Lietuva

GlaxoSmithKline Lietuva UAB

Tel: +370 5 264 90 00

info.lt@gsk.com

This leaflet was last approved in

{MM/YYYY}.

Arepanrix has been authorised under “Conditional Approval”.

This means that there is more evidence to come about this medicine.

The European Medicines Agency (EMEA) will regularly review any new information on the medicine

and this package leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web

site:

http://www.emea.europa.eu/

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

The following information is intended for medical or healthcare professionals only:

Arepanrix consists of two containers:

Medicinal product no longer authorised

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

Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be

allowed to reach room temperature. 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

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.

The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by

means of a syringe and by adding it to the vial containing the antigen.

After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed

vaccine is a whitish emulsion. In the event of other variation being observed, discard the

vaccine.

The volume of the Arepanrix vial after mixing is at least 5 ml. The vaccine should be

administered in accordance with the recommended posology (see section 3 “How Arepanrix is

given”).

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.

Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for

injection and administered intramuscularly.

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 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.