Prevenar 13

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

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 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F

Available from:

Pfizer Europe MA EEIG

ATC code:

J07AL02

INN (International Name):

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Therapeutic group:

Vaccines

Therapeutic area:

Pneumococcal Infections; Immunization

Therapeutic indications:

Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

Product summary:

Revision: 45

Authorization status:

Authorised

Authorization date:

2009-12-09

Patient Information leaflet

93
B. PACKAGE LEAFLET
94
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREVENAR 13 SUSPENSION FOR INJECTION
pneumococcal polysaccharide conjugate vaccine (13 valent, adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVES
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 or your child 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 13 is and what it is used for
2.
What you need to know before you or your child receives Prevenar 13
3.
How Prevenar 13 is given
4.
Possible side effects
5.
How to store Prevenar 13
6.
Contents of the pack and other information
1.
WHAT PREVENAR 13 IS AND WHAT IT IS USED FOR
Prevenar 13 is a pneumococcal vaccine given to:

CHILDREN FROM 6 WEEKS TO 17 YEARS
to help protect against diseases such as: meningitis
(inflammation around the brain), sepsis or bacteraemia (bacteria in
the blood stream), pneumonia
(lung infection) and ear infections

ADULTS 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 13 types of the bacteria
_Streptococcus pneumoniae._
Prevenar 13, provides protection against 13 types of
_Streptococcus pneumoniae_
bacteria, and replaces
Prevenar, which provided protection against 7 types.
The vaccine works by helping the body to make its own antibodies,
which protect you or your child
against these diseases.
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVES PREVENAR 13
PREVENAR 13 SHOULD NOT BE GIVEN
•
if you or your child is allergic (hypersensitive) to the active
substances or to any of the other
ingredients in this

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Prevenar 13 suspension for injection
pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Pneumococcal polysaccharide serotype 1
1
2.2 µg
Pneumococcal polysaccharide serotype 3
1
2.2 µg
Pneumococcal polysaccharide serotype 4
1
2.2 µg
Pneumococcal polysaccharide serotype 5
1
2.2 µg
Pneumococcal polysaccharide serotype 6A
1
2.2 µg
Pneumococcal polysaccharide serotype 6B
1
4.4 µg
Pneumococcal polysaccharide serotype 7F
1
2.2 µg
Pneumococcal polysaccharide serotype 9V
1
2.2 µg
Pneumococcal polysaccharide serotype 14
1
2.2 µg
Pneumococcal polysaccharide serotype 18C
1
2.2 µg
Pneumococcal polysaccharide serotype 19A
1
2.2 µg
Pneumococcal polysaccharide serotype 19F
1
2.2 µg
Pneumococcal polysaccharide serotype 23F
1
2.2 µg
1
Conjugated to CRM
197
carrier protein, adsorbed on aluminium phosphate.
1 dose (0.5 ml) contains approximately 32 µg CRM
197
carrier protein and 0.125 mg aluminium.
Excipients with known effect
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 infants, children and adolescents from 6 weeks to 17 years of age.
Active immunisation for the prevention of invasive disease and
pneumonia caused by
_ Streptococcus _
_pneumoniae _
in adults ≥18 years of age and the elderly.
See sections 4.4 and 5.1 for information on protection against
specific pneumococcal serotypes.
The use of Prevenar 13 should be determined on the basis of official
recommendations taking into
consideration the risk of invasive disease and pneumonia in different
age groups, underlying
comorbidities as well as the variability of serotype epidemiology in
different geographical areas.
3