SUMMARY TABULATION OF INFANRIX™ HEXA ADVERSE EVENTS - 23 OCTOBER 2009 TO 22 OCTOBER 2011
OVERALL SAFETY EVALUATION AND CONCLUSION
From the review of data received during the reporting period and presented in this report, it has been concluded that the safety profile of Infanrix hexa is adequately reflected in the RSI. No further amendments to the RSI are considered
necessary at this time.
The benefit/risk profile of Infanrix hexa continues to be favourable.
The Company will continue to monitor cases of
anaemia haemolytic autoimmune,
thrombocy topenia,
thrombocy topenic purpura,
autoimmune thrombocy topenia,
idiopathic thrombocy topenic purpura,
haemolytic anemia,
cyanosis,
injection site nodule,
abcess and injection site abscess,
Kawasaki’s disease,
important neurological events (including encephalitis and encephalopathy),
Henoch -Schonlein purpura,
petechiae,
purpura,
haematochezia,
allergic reactions (including anaphy lactic and anaphy lactoid reactions),
cases of lack of effectiveness as well as fatal cases
