Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F
GlaxoSmithKline Biologicals s.a.
J07AL52
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F
1mcg/dose+ 3mcg/dose+ 1mcg/dose+ 1mcg/dose+ 1mcg/dose+ 1mcg/dose+ 1mcg/dose+ 3mcg/dose+ 3mcg/dose+ 1mcg/dose
suspension for injection
(100) glass vials 1ml (2 dose)
Prescription
Registered
2016-07-20
" . SUMMARY OF PRODUCT CHARACTERISTICS I , I I. NAME OFTHE MEDICINAL PRODUCT Syntlorix suspension for injection in multidose container Pneumococca I polysaccharide conjugate vaccine (adsorbed) 2. QUALITATIVE ANO QUANTITATIVE COMPOSITION I dose (0.5 ml) contains: , Pneumococcal polysaccharide serotype 11.1 Pneumococcal polysaccharide serotype 4'·2 Pneumococcal polysaccharide serotype 5'·2 Pneumococcal polysaccharide serotype 613,·2 Pneumococcal polysaccharide serotype 7P1.2 Pneumococcal polysaccharide serotype 9V u Pneumococcal polysaccharide serotype 14 '.' Pneumococcal polysaccharide serotype 18C"] Pneumococcal polysaccharide serotype 19FI.·· Pneumococcal polysaccharide serotype 23F u microgram 3 micrograms I microgram I microgram I microgram I III icrograrn I microgram 3 micrograms 3 micrograms I microgram •adsorbed on aluminium phosphate 0.5 milligram All' ~conjugated to protein [) (derived Irom non-typeable _l loetnophilus_ _il!/lllr.!lI:::ae)_ carrier protein 9- 16 III icrogra rns 5-10 micrograms 3-6 micrograms > conj ugated to tetanus toxoid carrier protein "conjugated to diphtheria toxoid carrier protein This is a III lilt idose container. See section 6.5 tor the number of doses per vial. For the full list of excipients. see section 6.1. 3. PHARMACEUTICAL FORM Suspension tor injection (injection). The vaccine is a turbid white suspension. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Active inununisation ugains: invasive disease. pneumonia and acute otitis media caused by _Streptococcus_ _P'H'II/1wl1i(le_ ill infants and children from 6 weeks up to S years or age. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes, The LiseofSynflorix should be determined on the basi, of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas. 4.2 Posology and method of administration I'osolog,y The immunisation schedules 1'01' Synllor Baca dokumen lengkap