Abrysvo

Země: Evropská unie

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktivní složka:

Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein

Dostupné s:

Pfizer Europe MA EEIG

ATC kód:

J07BX05

INN (Mezinárodní Name):

Respiratory syncytial virus vaccine (bivalent, recombinant)

Terapeutické skupiny:

Vaccines

Terapeutické oblasti:

Respiratory Syncytial Virus Infections

Terapeutické indikace:

Abrysvo is indicated for:Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See sections 4.2 and 5.1.Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV.The use of this vaccine should be in accordance with official recommendations.

Stav Autorizace:

Authorised

Datum autorizace:

2023-08-23

Informace pro uživatele

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABRYSVO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Respiratory syncytial virus vaccine (bivalent, recombinant)
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Abrysvo is and what it is used for
2.
What you need to know before you receive Abrysvo
3.
How Abrysvo is given
4.
Possible side effects
5.
How to store Abrysvo
6.
Contents of the pack and other information
1.
WHAT ABRYSVO IS AND WHAT IT IS USED FOR
Abrysvo is a vaccine to prevent lung (respiratory tract) disease
caused by a virus called respiratory
syncytial virus (RSV). Abrysvo is given to:
•
pregnant individuals to protect their infants from birth through 6
months of age
or
•
individuals 60 years of age and older.
RSV is a common virus which, in most cases, causes mild, cold-like
symptoms such as a sore throat,
cough or a blocked nose. However, in young infants RSV can cause
serious lung problems. In older
adults and people with chronic medical conditions, RSV can worsen
illnesses such as chronic
obstructive pulmonary disease (COPD) and congestive heart failure
(CHF). RSV can lead to
hospitalisation in severe cases and in some cases it can be fatal.
HOW ABRYSVO WORKS
This vaccine helps the immune system (the body’s natural defences)
to make antibodies (substances in
the blood that help the body fight infections) which protect against
lung disease caused by RSV. In
pregnant indivi

Charakteristika produktu

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
Abrysvo powder and solvent for solution for injection
Respiratory syncytial virus vaccine (bivalent, recombinant)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
RSV subgroup A stabilised prefusion F antigen
1,2
60 micrograms
RSV subgroup B stabilised prefusion F antigen
1,2
60 micrograms
(RSV antigens)
1
glycoprotein F stabilised in the prefusion conformation
2
produced in Chinese Hamster Ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white.
The solvent is a clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abrysvo is indicated for:
•
Passive protection against lower respiratory tract disease caused by
respiratory syncytial virus
(RSV) in infants from birth through 6 months of age following maternal
immunisation during
pregnancy. See sections 4.2 and 5.1.
•
Active immunisation of individuals 60 years of age and older for the
prevention of lower
respiratory tract disease caused by RSV.
The use of this vaccine should be in accordance with official
recommendations.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Pregnant individuals _
A single dose of 0.5 mL should be administered between weeks 24 and 36
of gestation (see sections
4.4 and 5.1).
3
_Individuals 60 years of age and older _
A single dose of 0.5 mL should be administered.
_Paediatric population _
The safety and efficacy of Abrysvo in children (from birth to less
than 18 years of age) have not yet
been established. Limited data are available in pregnant adolescents
and their infants (see section 5.1).
Method o