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Synflorix · 4.8 · Following catch-up vaccination in children 12 to 23 months of age, urticaria was reported more frequently (unc
Eintrag öffnenSynflorix · 4.8 · Frequencies are reported as: Very common: (≥ 1/10) Common: (≥ 1/100 to < 1/10) Uncommon: (≥ 1/1 000 to < 1/100
Eintrag öffnenSynflorix · 4.8 · In comparative clinical studies, the incidence of local and general adverse events reported within 4 days afte
Eintrag öffnenSynflorix · 4.8 · In infants, the most common adverse reactions observed after primary vaccination were redness at the injection
Eintrag öffnenSynflorix · 4.8 · Local reactogenicity of primary vaccination course was similar in infants < 12 months of age and in children >
Eintrag öffnenSynflorix · 4.8 · No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the primar
Eintrag öffnenSynflorix · 4.8 · Reactogenicity was higher in children receiving whole cell pertussis vaccines concomitantly. In a clinical stu
Eintrag öffnenSynflorix · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenSynflorix · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenSynflorix · 4.8 · Safety assessment of Synflorix was based on clinical trials involving the administration of 63 905 doses of Sy
Eintrag öffnenSynflorix · 4.8 · Safety of Synflorix was assessed in 83 HIV positive (HIV+/+) infants (asymptomatic or with mild symptoms accor
Eintrag öffnenSynflorix · 4.8 · Special populations
Eintrag öffnenSynflorix · 4.8 · Summary of the safety profile
Eintrag öffnenSynflorix · 4.8 · System Organ Class Frequency Adverse reactions Clinical trials Immune system disorders Rare Allergic reactions
Eintrag öffnenSynflorix · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenSynflorix · 4.8 · Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness.
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