Following new sentence added:
Meronem may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients.
Text is now in-line with MedDRA frequency descriptor table, aligning frequency with system order class and MedDRA terminology.
New text added to table under common frequency Abdominal Pain
New text also added under not known frequency Haemolytic anaemia
Following new sentence added to end of table:
2 For convulsions, the incidence is calculated on exposures in patients with infections other than meningitis.
Following first sentence deleted: Intentional overdosing with Meronem is unlikely.
Following sentence deleted: Limited post-marketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction.
And replaced with following new text: Limited post-marketing experience indicates that adverse events following overdosage are consistent with the adverse event profile described in section 4.8.
Date changed to 30th January 2008