Примери за използване на Patients with severe sepsis на Английски и техните преводи на Български
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Xigris is used in adult patients with severe sepsis.
The company that makes Xigris will conduct an additional study looking at the safety andeffectiveness of Xigris in patients with severe sepsis.
Xigris is used in adult patients with severe sepsis, when bacteria get in the bloodstream and produce substances which are harmful(toxins).
Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis.
Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.
Xigris was studied in one Phase 3 international, multi-centre, randomised, double-blind,placebocontrolled trial(PROWESS) in 1690 patients with severe sepsis.
The pharmacokinetics of drotrecogin alfa(activated) have not been studied in patients with severe sepsis and pre-existing end stage renal disease and chronic hepatic disease.
Clinical Efficacy Xigris was studied in one Phase 3 international, multi-centre, randomised, double-blind,placebo- controlled trial(PROWESS) in 1690 patients with severe sepsis.
In placebo-controlled clinical trials in patients with severe sepsis, Xigris exerted an antithrombotic effect by limiting thrombin generation and improved sepsis-associated coagulopathy.
In a Phase 3b international, single-arm, open-label clinical trial(ENHANCE),2378 adult patients with severe sepsis received drotrecogin alfa(activated).
Patients with severe sepsis treated with Xigris had a more rapid decline in interleukin-6 levels, a global marker of inflammation, consistent with a reduction in the inflammatory response.
The Committee for Medicinal Products for Human Use(CHMP)decided that Xigris' s benefits are greater than its risks for patients with severe sepsis and multiple organ failure.
In patients with severe sepsis, infusion of drotrecogin alfa(activated) from 12 μg/kg/hr to 30 μg/kg/hr rapidly produced steady-state plasma concentrations that were proportional to infusion rates.
In the Phase 3 trial,the pharmacokinetics of drotrecogin alfa(activated) were evaluated in 342 patients with severe sepsis administered a 96-hour continuous infusion at 24 μg/kg/hr.
No dose adjustments are required in adult patients with severe sepsis with regard to age, gender, hepatic function(as measured by transaminase levels), renal function, obesity or co-administration of prophylactic heparin.
Further Clinical Experience In a Phase 3b international, single-arm, open-label clinical trial(ENHANCE),2378 adult patients with severe sepsis received drotrecogin alfa(activated).
In patients with severe sepsis, the plasma clearance of drotrecogin alfa(activated) was significantly decreased by renal impairment and hepatic dysfunction, but the magnitude of the differences in clearance(< 30%) does not warrant any dosage adjustment.
Plasma concentrations of endogenous Activated Protein C in healthy subjects and patients with severe sepsis are usually below detection limits(< 5 ng/ml) and do not significantly influence the pharmacokinetic properties of drotrecogin alfa(activated).
In the multiple organ dysfunction subgroup of ADDRESS the 28-day placebo mortality was 21.9%, similar to the single organ dysfunction subgroup of PROWESS(21.2%),confirming the lack of efficacy in patients with severe sepsis who are at low risk of death.
Prolongation of the APTT in patients with severe sepsis receiving Xigris may be due to the underlying coagulopathy, the pharmacodynamic effect of drotrecogin alfa(activated), and/ or the effect of other concurrent medicinal products.
There is no experience with ceftaroline in the treatment of cSSTI in the following patient groups:the immunocompromised, patients with severe sepsis/septic shock, necrotizing fasciitis, perirectal abscess and patients with third degree and extensive burns.
A total of 2640 adult patients with severe sepsis who were at low risk of death(e.g. patients with APACHE II< 25 or with only one sepsis-induced organ failure) were enrolled in a randomised, doubleblind, placebo-controlled trial(ADDRESS).
Drotrecogin alfa(activated) has minimal effect on the PT. Prolongation of the APTT in patients with severe sepsis receiving Xigris may be due to the underlying coagulopathy, the pharmacodynamic effect of drotrecogin alfa(activated), and/or the effect of other concurrent medicinal products.
There is no experience with ceftaroline in the treatment of CAP in the following patient groups:the immunocompromised, patients with severe sepsis/septic shock,severe underlying lung disease, those with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to methicillinresistant S. aureus or patients requiring intensive care.
To quote from[25],“Patients with severe infections as in sepsis have a high prevalence of vitamin D deficiency and high mortality rates.”.
Patients with severe blood infection(sepsis) are at increased risk for developing blood clots(thrombembolic phenomena) and may require medication to reduce the risk for thrombosis.
A direct quote from this article states,"Patients with severe infections as in sepsis have a high prevalence of vitamin D deficiency and high mortality rates.".
Cases of hepatic necrosis up to fatal hepatic failure have been reported with levofloxacin,primarily in patients with severe underlying diseases, e.g. sepsis(see section 4.8).
There is a risk of blood and fluid abnormality(high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, particularly in certain groups of patients at risk,e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used.
Serious bleeding during the infusion period occurred in 1%(1 in 100) of patient with severe sepsis and in 2.4%(roughly 1 in 40) of patients treated with Xigris, with most bleeding in both groups occurring in the stomach and bowel.