Synflorix 4-Dose Vaccine Suspension for Injection

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE

Units in package:

100 Vials

Manufactured by:

GLAXOSMITHKLINE BIOLOGICALS S.A

Patient Information leaflet

Not Applicable

Summary of Product characteristics

CONFIDENTIAL
_________________________________________________________________________________
SYNFLORIX
PNEUMOCOCCAL POLYSACCHARIDE AND NON-TYPEABLE _HAEMOPHILUS_
_INFLUENZAE_ (NTHI) PROTEIN D CONJUGATE VACCINE, ADSORBED
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml) contains 1 microgram of polysaccharide for serotypes
1
1,2
, 5
1,2
, 6B
1,2
, 7F
1,2
,
9V
1,2
, 14
1,2
and 23F
1,2
, and 3 micrograms for serotypes 4
1,2
, 18C
1,3
and 19F
1,4
.
1
adsorbed on aluminium phosphate
0.5 milligram Al
3+
2
conjugated to protein D (derived from NTHi) carrier protein
~13 micrograms
3
conjugated to tetanus toxoid carrier protein
~8 micrograms
4
conjugated to diphtheria toxoid carrier protein
~5 micrograms
_SYNFLORIX_
is a turbid white suspension. Upon storage, a fine white deposit with
a clear
colourless supernatant can be observed.
PHARMACEUTICAL FORM
Suspension for injection.
CLINICAL PARTICULARS
INDICATIONS
Active immunization of infants and children from 6 weeks up to 5 years
of age against disease
caused by
_Streptococcus pneumoniae_
vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F
and cross-reactive serotype 19A (including sepsis, meningitis,
pneumonia, bacteraemia and
acute otitis media) and against acute otitis media caused by
Non-Typeable
_Haemophilus _
_influenzae_
.
DOSAGE AND ADMINISTRATION
Official recommendations should be taken into account when immunising
with
_SYNFLORIX_
.
INFANTS FROM 6 WEEKS TO 6 MONTHS OF AGE:
_3-dose primary series _
An immunization series of 4 doses, each of 0.5 ml, is recommended to
ensure optimal
protection: 3 primary doses with an interval of at least 1 month
between doses and a booster
dose at least 6 months after the last primary dose. The first dose may
be given as early as 6
weeks of age and the booster dose from the age of 9 months onwards
(see
Pharmacodynamics).
_2-dose primary series _
Alternatively, when
_SYNFLORIX_
is given as part of a routine infant immunization programme, a
series of 3 doses, each of 0.5 ml, may be given: 2 primary doses given
2 months