Synflorix vaccine suspension for injection 0.5ml pre-filled syringes

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Streptococcus pneumoniae capsular polysaccharide protein conjugate

Disponibil de la:

GlaxoSmithKline UK Ltd

Codul ATC:

J07AL52

INN (nume internaţional):

Streptococcus pneumoniae capsular polysaccharide protein conjugate

Forma farmaceutică:

Suspension for injection

Calea de administrare:

Intramuscular

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 14040000; GTIN: 5000123112616

Prospect

1
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 has ever had an allergic reaction (is hypersensitive) to
the active substance, or any of
the other ingredients in 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 postp

Caracteristicilor produsului

OBJECT 1
SYNFLORIX SUSPENSION FOR INJECTION IN PRE-FILLED
SYRINGE
Summary of Product Characteristics Updated 20-Oct-2017 |
GlaxoSmithKline UK
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 18C
1,3
3 micrograms
Pneumococcal polysaccharide serotype 19F
1,4
3 micrograms
Pneumococcal polysaccharide serotype 23F
1,2
1 microgram
1
adsorbed on aluminium phosphate
0.5 milligram Al
3+
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