Apexxnar

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F

Saadav alates:

Pfizer Europe MA EEIG

ATC kood:

J07AL02

INN (Rahvusvaheline Nimetus):

pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)

Terapeutiline rühm:

Vaccines

Terapeutiline ala:

Pneumococcal Infections

Näidustused:

Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.Apexxnar should be used in accordance with official recommendations.  

Toote kokkuvõte:

Revision: 6

Volitamisolek:

Authorised

Loa andmise kuupäev:

2022-02-14

Infovoldik

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREVENAR 20 SUSPENSION FOR INJECTION
pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
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.

This vaccine has been prescribed for you or your child only. Do not
pass it on to others.

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 Prevenar 20 is and what it is used for
2.
What you need to know before you or your child receive Prevenar 20
3.
How Prevenar 20 is given
4.
Possible side effects
5.
How to store Prevenar 20
6.
Contents of the pack and other information
1.
WHAT PREVENAR 20 IS AND WHAT IT IS USED FOR
Prevenar 20 is a pneumococcal vaccine given to:

CHILDREN FROM 6 WEEKS TO LESS THAN 18 YEARS OF AGE to help prevent
diseases such as meningitis
(inflammation around the brain), sepsis or bacteraemia (bacteria in
the blood stream),
pneumonia (lung infection) and ear infections (acute otitis media)
caused by 20 types of the
bacteria _Streptococcus pneumoniae_.

INDIVIDUALS AGED 18 YEARS AND OLDER to help prevent disease such as:
pneumonia (lung
infection), sepsis or bacteraemia (bacteria in the blood stream) and
meningitis (inflammation
around the brain) caused by 20 types of the bacteria _Streptococcus
pneumoniae._
Prevenar 20 provides protection against 20 types of _Streptococcus
pneumoniae_ bacteria.
The vaccine works by helping the body to make its own antibodies,
which protect you or your child
against these dis

Toote omadused

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
Prevenar 20 suspension for injection in pre-filled syringe
Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Pneumococcal polysaccharide serotype 1
1,2
2.2 µg
Pneumococcal polysaccharide serotype 3
1,2
2.2 µg
Pneumococcal polysaccharide serotype 4
1,2
2.2 µg
Pneumococcal polysaccharide serotype 5
1,2
2.2 µg
Pneumococcal polysaccharide serotype 6A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 6B
1,2
4.4 µg
Pneumococcal polysaccharide serotype 7F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 8
1,2
2.2 µg
Pneumococcal polysaccharide serotype 9V
1,2
2.2 µg
Pneumococcal polysaccharide serotype 10A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 11A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 12F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 14
1,2
2.2 µg
Pneumococcal polysaccharide serotype 15B
1,2
2.2 µg
Pneumococcal polysaccharide serotype 18C
1,2
2.2 µg
Pneumococcal polysaccharide serotype 19A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 19F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 22F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 23F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 33F
1,2
2.2 µg
1
Conjugated to CRM
197
carrier protein (approximately 51 µg per dose)
2
Adsorbed on aluminium phosphate (0.125 mg aluminium per dose)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
The vaccine is a homogeneous white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation for the prevention of invasive disease, pneumonia,
and acute otitis media caused
by _Streptococcus pneumoniae_ in i