Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS PNEUMONIAE
100 Vials
GLAXOSMITHKLINE BIOLOGICALS S.A
Not Applicable Les hele dokumentet
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 Les hele dokumentet