Prevenar
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
24-11-2017
Svojstava lijeka
(SPC)
24-11-2017
Izvješće o ocjeni javnog
(PAR)
24-11-2017
Aktivni sastojci:
pneumococcal oligosaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14
Dostupno od:
Pfizer Limited
ATC koda:
J07AL02
INN (International ime):
pneumococcal saccharide conjugated vaccine, adsorbed
Terapijska grupa:
Vaccines
Područje terapije:
Pneumococcal Infections; Immunization
Terapijske indikacije:
Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas.
Proizvod sažetak:
Revision: 23
Status autorizacije:
Withdrawn
Datum autorizacije:
2001-02-02
Uputa o lijeku
47
B. PACKAGE LEAFLET
Medicinal product no longer authorised
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREVENAR SUSPENSION FOR INJECTION
PNEUMOCOCCAL SACCHARIDE CONJUGATED VACCINE, ADSORBED
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD RECEIVES THIS
VACCINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist 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 or pharmacist.
IN THIS LEAFLET:
1.
What Prevenar is and what it is used for
2.
Before your child receives Prevenar
3.
How Prevenar is given
4.
Possible side effects
5.
How to store Prevenar
6.
Further information
1.
WHAT PREVENAR IS AND WHAT IT IS USED FOR
Prevenar is a pneumococcal vaccine. Prevenar is given to children from
2 months to 5 years to help protect
against diseases such as: meningitis, sepsis or bacteraemia (bacteria
in blood stream), pneumonia and ear
infection caused by seven types of the bacteria _Streptococcus
pneumoniae._
The vaccine works by helping the body to make its own antibodies,
which protect your child against
these diseases.
2.
BEFORE YOUR CHILD RECEIVES PREVENAR
DO NOT USE PREVENAR:
-
if your child is allergic (hypersensitive) to the active substances,
to any other ingredients or to
diphtheria toxoid.
-
if your child has a severe infection with a high temperature (over
38°C). If this applies to your child,
then the vaccination will be postponed until your child is feeling
better. A minor infection, such as a
cold, should not be a problem. However, talk to your doctor,
pharmacist, or nurse first.
TAKE SPECIAL CARE WITH PREVENAR:
-
if your child has any present or past medical problems after any dose
of Prevenar.
-
if your child has any bleeding problems.
Prevenar will only protect against ear infections caused by the types
of _Streptococcus pneumoniae_ for
which the vaccine has been developed. It will not protect against
other infectious agents that can cause
ear infect
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Prevenar suspension for injection
Pneumococcal saccharide conjugated vaccine, adsorbed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml dose contains:
Pneumococcal polysaccharide serotype 4*
2 micrograms
Pneumococcal polysaccharide serotype 6B*
4 micrograms
Pneumococcal polysaccharide serotype 9V*
2 micrograms
Pneumococcal polysaccharide serotype 14*
2 micrograms
Pneumococcal polysaccharide serotype 18C*
2 micrograms
Pneumococcal polysaccharide serotype 19F*
2 micrograms
Pneumococcal polysaccharide serotype 23F*
2 micrograms
* Conjugated to the CRM
197
carrier protein and adsorbed on aluminium phosphate (0.5 mg)
For a 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 against disease caused by _Streptococcus
pneumoniae _serotypes 4, 6B, 9V, 14, 18C,
19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and
acute otitis media) in infants and
children from 2 months up to 5 years of age (see sections 4.2, 4.4 and
5.1).
For the number of doses to be administered in the different age
groups, see section 4.2.
The use of Prevenar should be determined on the basis of official
recommendations taking into
consideration the impact of invasive disease in different age groups
as well as variability of serotype
epidemiology in different geographical areas (see sections 4.4, 4.8
and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The immunisation schedules for Prevenar should be based on official
recommendations.
Infants aged 2 - 6 months:
The primary infant series consists of three doses, each of 0.5 ml, the
first dose usually given at 2 months of
age and with an interval of at least 1 month between doses. A fourth
dose is recommended in the second
year of life.
Medicinal product no longer authorised
3
Alternatively, when Pr
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