Synflorix
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
24-05-2023
Valmisteyhteenveto
(SPC)
24-05-2023
Julkisesta arviointikertomuksesta
(PAR)
09-01-2018
Aktiivinen ainesosa:
Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F
Saatavilla:
GlaxoSmithKline Biologicals S.A.
ATC-koodi:
J07AL52
INN (Kansainvälinen yleisnimi):
pneumococcal polysaccharide conjugate vaccine (adsorbed)
Terapeuttinen ryhmä:
Vaccines
Terapeuttinen alue:
Pneumococcal Infections; Immunization
Käyttöaiheet:
Active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. See sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes.The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.
Tuoteyhteenveto:
Revision: 36
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2009-03-29
Pakkausseloste
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYNFLORIX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Pneumococcal polysaccharide
_ _
conjugate vaccine (adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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 or pharmacist.
•
This vaccine has been prescribed for your child only. Do not pass it
on to others.
•
If your child gets 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 Synflorix is and what it is used for
2.
What you need to know before your child receives Synflorix
3.
How Synflorix is given
4.
Possible side effects
5.
How to store Synflorix
6.
Contents of the pack and other information
1.
WHAT SYNFLORIX IS AND WHAT IT IS USED FOR
Synflorix is a pneumococcal conjugate vaccine. Your doctor or nurse
will inject your child with this
vaccine.
IT IS USED TO HELP PROTECT YOUR CHILD FROM 6 WEEKS UP TO 5 YEARS OF
AGE AGAINST:
a bacteria called ‘
_Streptococcus pneumoniae_
’. This bacteria can cause serious illnesses including
meningitis, sepsis and bacteraemia (bacteria in blood stream) as well
as ear infection or pneumonia.
HOW SYNFLORIX WORKS
Synflorix helps your body to make its own antibodies. The antibodies
form a part of the immune
system that will protect your child against these diseases.
2.
WHAT YOU NEED TO KNOW BEFORE YOUR CHILD RECEIVES SYNFLORIX
SYNFLORIX SHOULD NOT BE GIVEN IF:
•
your child is allergic to the active substance, or any of the other
ingredients of this vaccine
(listed in section 6).
Signs of an allergic reaction may include itchy skin rash, being short
of breath and swelling of
the face or tongue.
•
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 ch
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Synflorix suspension for injection in pre-filled syringe
Synflorix suspension for injection
Synflorix suspension for injection in multidose container (2 doses)
Synflorix suspension for injection in multidose container (4 doses)
Pneumococcal polysaccharide
_ _
conjugate vaccine (adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Pneumococcal polysaccharide serotype 1
1,2
1 microgram
Pneumococcal polysaccharide serotype 4
1,2
3 micrograms
Pneumococcal polysaccharide serotype 5
1,2
1 microgram
Pneumococcal polysaccharide serotype 6B
1,2
1 microgram
Pneumococcal polysaccharide serotype 7F
1,2
1 microgram
Pneumococcal polysaccharide serotype 9V
1,2
1 microgram
Pneumococcal polysaccharide serotype 14
1,2
1 microgram
Pneumococcal polysaccharide serotype 18C1,3
3 micrograms
Pneumococcal polysaccharide serotype 19F1,4
3 micrograms
Pneumococcal polysaccharide serotype 23F
1,2
1 microgram
1
adsorbed on aluminium phosphate
0.5 milligram Al
3+
in total
2
conjugated to protein D (derived from non-typeable
_Haemophilus influenzae_
) carrier protein
9–16 micrograms
3
conjugated to tetanus toxoid carrier protein
5–10 micrograms
4
conjugated to diphtheria toxoid carrier protein
3–6 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_ _
Suspension for injection (injection).
The vaccine is a turbid white suspension.
4.
CLINICAL PARTICULARS
_ _
4.1
THERAPEUTIC INDICATIONS
_ _
Active immunisation against invasive disease, pneumonia and acute
otitis media caused by
_Streptococcus pneumoniae_
in infants and children from 6 weeks up to 5 years of age. See
sections 4.4
and 5.1 for information on protection against specific pneumococcal
serotypes.
_ _
_ _
The use of Synflorix should be determined on the basis of official
recommendations taking into
consideration the impact on pneumococcal diseases in different age
groups as well as the variability of
the epidemiology in different geographic
Lue koko asiakirja
