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Incellipan
Eintrag öffnenIncellipan · 4.1 Therapeutic indications · 1
Eintrag öffnenIncellipan · 4.3 Contraindications · 1
Eintrag öffnenIncellipan · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to possible tra
Eintrag öffnenIncellipan · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenIncellipan · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenIncellipan · 4.5 · No interaction studies have been performed. If Incellipan is given at the same time as another injectable vacc
Eintrag öffnenIncellipan · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenIncellipan · 4.8 Undesirable effects · 1
Eintrag öffnenIncellipan · 4.8 · 5 Data on the safety of a heterologous booster dose with aH5N6c were evaluated in Study V89_18E1 in which 258
Eintrag öffnenIncellipan · 4.8 · 7 Table 3: Post-marketing experience reported after use of influenza vaccines in general MedDRA system organ c
Eintrag öffnenIncellipan · 4.8 · Adults 18 years of age and older The most common local and systemic reactions reported in adults within 7 days
Eintrag öffnenIncellipan · 4.8 · Clinical safety data for Incellipan in children 6 months to less than 18 years of age was collected in Study V
Eintrag öffnenIncellipan · 4.8 · Data on the safety of an aH5N8c vaccine were evaluated in Study V205_01 in which 479 subjects were randomised
Eintrag öffnenIncellipan · 4.8 · Description of selected adverse reactions There is no post-marketing experience following administration of In
Eintrag öffnenIncellipan · 4.8 · Elderly individuals 65 years and older generally reported fewer solicited local and systemic reactions compare
Eintrag öffnenIncellipan · 4.8 · In addition, the following adverse events were reported from post-marketing surveillance with aH1N1 (a monoval
Eintrag öffnenIncellipan · 4.8 · MedDRA system Very Common Uncommon organ class common (≥1/100 to <1/10) (≥1/1 000 to <1/100) (≥1/10) Blood and
Eintrag öffnenIncellipan · 4.8 · Paediatric population 6 months to less than 18 years of age
Eintrag öffnenIncellipan · 4.8 · Reporting of suspected adverse reactions
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