Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
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
GLAXO WELLCOME INDONESIA - Indonesia
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
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
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0,5 ML (1 DOSIS) + 1 JARUM SUNTIK
GlaxoSmithKline Biologicals SA - Belgium
2022-01-28
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 Lue koko asiakirja