Arexvy

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology

Saatavilla:

GlaxoSmithKline Biologicals S.A. 

ATC-koodi:

J07

INN (Kansainvälinen yleisnimi):

Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E

Terapeuttinen ryhmä:

Vaccines

Terapeuttinen alue:

Respiratory Syncytial Virus Infections

Käyttöaiheet:

Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older.The use of this vaccine should be in accordance with official recommendations. 

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2023-06-06

Pakkausseloste

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
AREXVY POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
Respiratory Syncytial Virus (RSV) vaccine (recombinant, 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 pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Arexvy is and what it is used for
2.
What you need to know before you receive Arexvy
3.
How Arexvy is given
4.
Possible side effects
5.
How to store Arexvy
6.
Contents of the pack and other information
1.
WHAT AREXVY IS AND WHAT IT IS USED FOR
Arexvy is a vaccine that helps to protect adults aged 60 years and
older against a virus called
‘respiratory syncytial virus’ (RSV).
RSV is a respiratory virus that spreads very easily.

RSV can cause lower respiratory tract disease - infections of the
lungs and other parts of the
body that help you breathe.
RSV infection can happen at any age, and usually causes mild,
cold-like signs in adults. But it can
also:

cause more serious respiratory illness in infants and older adults

make some illnesses worse, such as long-term respiratory or heart
diseases.
HOW AREXVY WORKS
Arexvy helps your body’s natural defences make antibodies and
special white blood cells. These
protect you against RSV.
Arexvy does not contain the virus. This means it cannot cause an
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE AREXVY
DO NOT USE AREXVY

if you are alle

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Arexvy powder and suspension for suspension for injection
Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
RSVPreF3
1
antigen
2,3
120 micrograms
1
Respiratory Syncytial Virus recombinant glycoprotein F stabilised in
the pre-fusion conformation =
RSVPreF3
2
RSVPreF3 produced in Chinese Hamster Ovary (CHO) cells by recombinant
DNA technology
3
adjuvanted with AS01
E
containing:
plant extract _Quillaja saponaria_ Molina, fraction 21 (QS-21)
25 micrograms
3-O-desacyl-4’-monophosphoryl lipid A (MPL) from _Salmonella
minnesota_
25 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
The powder is white.
The suspension is an opalescent, colourless to pale brownish liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arexvy is indicated for active immunisation for the prevention of
lower respiratory tract disease
(LRTD) caused by respiratory syncytial virus in adults 60 years of age
and older.
The use of this vaccine should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Arexvy is administered as a single dose of 0.5 mL.
The need for revaccination with a subsequent dose has not been
established.
_Paediatric population _
The safety and efficacy of Arexvy in children have not been
established.
No data are available.
3
Method of administration
For intramuscular injection only, preferably in the deltoid muscle.
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
4.3
CONTRAINDICATIONS
Hypersensitivi