SYNFLORIX

البلد: أندونيسيا

اللغة: الإندونيسية

المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

العنصر النشط:

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D

متاح من:

GLAXO WELLCOME INDONESIA - Indonesia

INN (الاسم الدولي):

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO PROTEIN D, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO PROTEIN D

جرعة:

1 µG PS1 - 1.6 µG PD MCG /3 µG PS4 - 5.1 µG PD MCG /1 µG PS5 - 1.0 µG PD MCG /1 µG PS6B ~ 0.8 µG P

الشكل الصيدلاني:

SUSPENSI INJEKSI

الوحدات في الحزمة:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML (1 DOSIS) + 1 JARUM SUNTIK

المصنعة من قبل:

GlaxoSmithKline Biologicals SA - Belgium

تاريخ الترخيص:

2022-01-28

خصائص المنتج

FAW_leaSYNinj_Update PI GDS18 IPI18 (onePFS)_circ1_22Nov22 - for
submission
Page 1 of 9
SYNFLORIX
PNEUMOCOCCAL POLYSACCHARIDE AND NON-TYPEABLE _HAEMOPHILUS_
_INFLUENZAE_ (NTHI) PROTEIN D
CONJUGATE VACCINE, ADSORBED
SUSPENSION FOR INJECTION
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.
CLINICAL INFORMATION
INDICATIONS
Active immunization against invasive disease (including sepsis,
meningitis, bacteraemic pneumonia
and bacteremia) and acute otitis media caused by _Streptococcus
pneumonia_ serotype 1, 4, 5, 6B, 7F,
9V, 14, 18C, 19F and 23F in infants and children from 2 months up to 5
years of age. See section
_Warnings and Precautions _ and _ Pharmacodynamics _ 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.
DOSAGE AND ADMINISTRATION
Official recommendations should be taken into account when immunising
with _SYNFLORIX_
.
INFANTS FROM 2 MONTHS TO 6 MONTHS OF AGE:
_3-dose primary series _
The recommended immunization series to ensure optimal protection
consists of four doses, each of
0.5 mL. The primary infant series consists of three doses with the
first dose usually given at 2 months
of age and with an interval of at least 1 month between doses. A
booster dose is recommended at
l