An evaluation of the safety and tolerance of XXXX .

@entity1 @entity9102 @entity295 @entity798 @entity4967 @entity56 @entity158 @entity3527
The safety and tolerance of four intravenous formulations of @entity9102 ( @entity4967 + @entity798 ) have been evaluated in 1659 @entity1 (1512 adults and 147 paediatric) included in clinical trials conducted in Europe and U.S.A. @entity9102 3.2 and 5.2 g were administered respectively to 877 and 635 adults and @entity9102 1.6 and 2.6 g to 117 and 30 paediatric @entity1 three, four or six times daily for between 7.7 and 9.0 days in adults and 8.0 and 12.0 days in paediatric cases. @entity1 with @entity295 were 16%, 14% and 28% respectively of the @entity9102 3.2, 5.2 g and paediatric groups, which together with respiratory tract and other serious miscellaneous infections accounted for the majority of cases treated within these three groups. Of the 1659 @entity1 studied, 161 adverse reactions were reported from 151 @entity1 (9.1%), 36 of which (2.2%) resulted in discontinuation of treatment. The reactions were at the injection site in 86 cases (5.2%), @entity56 in 35 (2.1%) and miscellaneous systemic symptoms in 40 cases (2.4%). Local reactions, i.e. @entity3527 , @entity158 and erythema, were self-limiting and did not necessitate early cessation of treatment. @entity56 occurred equally in all groups and necessitated cessation of treatment in about half of the @entity1 . Gastro-intestinal disturbances were observed in eight, four and one @entity1 within the @entity9102 3.2, 5.2 g and paediatric groups. Changes in haemostatic status were reported in nine @entity1 treated with @entity9102 . In all cases they were associated with contributory pathology and/or concurrent use of anticoagulants. Laboratory monitoring revealed transient variations in haemoglobin, blood cellular or plasma composition and plasma enzymatic activity.(ABSTRACT TRUNCATED AT 250 WORDS)
