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Review Sempera Safety Reports submitted to FDA

Total Sempera reports: 2.
Sempera FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 2.
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FDA Reported Sempera Side Effects: haemorrhage, haematoma, sepsis, blood bilirubin increased.
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Sempera Side Effects Report #5449059-3
Physician from GERMANY reported SEMPERA problem on Sept 10, 2007. Male patient, weighting 183.0 lb, was treated with SEMPERA. After drug was administered, patient experienced the following problems/side effects: haematoma, haemorrhage. SEMPERA dosage: unknown. Patient recovered.

Sempera Side Effects Report #5402411-4
SEMPERA problem was reported by a Physician from GERMANY on July 30, 2007. Male patient, weighting 179.2 lb, was diagnosed with fungal infection, pneumonia primary atypical and was treated with SEMPERA. After drug was administered, patient experienced the following problems/side effects: blood bilirubin increased, sepsis. SEMPERA dosage: unknown. During the same period patient was treated with KLACID, CANCIDAS. Patient died on 07/22/2005.


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haematoma, haemorrhage, blood bilirubin increased, sepsis, , %drugN% %drugN% was diagnosed with fungal infection, pneumonia primary atypical and