Important potential risks Haptoglobulin and reticulocyte In development D3720C00001 tests. Haemolytic anaemia Important missing Evaluation of safety data. information Eligibility for enrolment includes Immunocompromised subjects with the following population conditions: Pre-existing seizure Immunocompromised unless disorder severely compromised Pre-existing severe Seizure disorders * renal impairment CrCl 15 mL/min** ≥ Pre-existing significant Hepatic impairment unless hepatic disease as Child Pugh Stage C Study Important potential risks Targeted follow-up Fourth quarter D3720C00002 questionnaires for adverse events 2012 Convulsions /Seizures of acute renal failure, convulsions Drug-induced / seizures, drug induced liver injury failure and haemolytic anaemia. impairment Haptoglobulin and reticulocyte (including potential (for Haemolytic anaemia). drug interactions with nephrotoxic agents) Haemolytic anaemia Important missing Evaluation of safety data information Asian population exposure Important missing Evaluation of pharmacokinetic First Quarter D3720C00005 information data 2012 Asian population exposure Bacterial Important potential risks Monitor changes in ceftaroline In development resistance minimum inhibitory Bacterial resistance surveillance concentrations distributions development programme among target pathogens (i.e. Important those pathogens identified in PI information with clinical efficacy). Potential for off-label Isolates will be collected from use hospitals and medical centres across Europe, Latin America, Middle East-Africa and the Pacific Region. May also include
D3720C00001 Important potential risks Haemolytic anaemia Haptoglobulin and reticulocyte tests. In development Important missing information Immunocompromised population Pre-existing seizure disorder Pre-existing severe renal impairment Pre-existing significant hepatic disease Evaluation of safety data. Eligibility for enrolment includes subjects with the following conditions: Immunocompromised unless severely compromised Seizure disorders * CrCl ≥ 15 mL/min** Hepatic impairment unless as Child Pugh Stage C Study D3720C00002 Important potential risks Convulsions /Seizures Drug-induced injury impairment (including potential drug interactions with nephrotoxic agents) Haemolytic anaemia Targeted follow-up questionnaires for adverse events of acute renal failure, convulsions / seizures, drug induced liver failure and haemolytic anaemia. Haptoglobulin and reticulocyte (for Haemolytic anaemia). Fourth quarter 2012 Important missing information Asian population exposure Evaluation of safety data D3720C00005 Important missing information Asian population exposure Evaluation of pharmacokinetic data First Quarter 2012 Bacterial resistance surveillance programme Important potential risks Bacterial resistance development Important information Potential for off-label use Monitor changes in ceftaroline minimum inhibitory concentrations distributions among target pathogens (i.e. those pathogens identified in PI with clinical efficacy). Isolates will be collected from hospitals and medical centres across Europe, Latin America, Middle East-Africa and the Region. May also include In development Pacific
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