Примери за използване на Impairment defined на Английски и техните преводи на Български
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Severe renal impairment defined by creatinine clearance< 20 ml/ min.
There is limited experience with Repatha in patients with severe renal impairment(defined as eGFR< 30 mL/min/1.73 m2)(see section 5.2).
In a study of patients with mild hepatic impairment(defined as having two abnormal hepatic function tests at enrolment), AUC and Cmax were not significantly different from the control group.
In clinical studies, there was limited representation of patients with severe renal impairment(defined as eGFR< 30 mL/min/1.73 m2)(see section 5.2).
Patients should be assessed for renal impairment defined as creatinine clearance≤70 mL/min/1.73 m2 to ensure HSC transplantation is appropriate.
A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected patients with varying degrees of hepatic impairment defined according to CPT classification.
No adjustment of the starting dose is required in patients with hepatic impairment defined by total bilirubin≤ 2× upper limit of normal(ULN) and aspartate aminotransferase(AST)/alanine aminotransferase(ALT).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1- active clinically significant bleeding- acute bacterial endocarditis- severe renal impairment defined by creatinine clearance< 20 ml/min.
Pazopanib is not recommended in patients with severe hepatic impairment(defined as total bilirubin> 3 x ULN regardless of the ALT value).
In 3 patients with hepatic impairment defined by NCI ODWG category C(total bilirubin> 1.5-3× ULN and AST any level) and 1 patient with hepatic impairment defined by NCI ODWG category D(total bilirubin> 3× ULN and AST any level), inotuzumab ozogamicin clearance did not appear to be reduced.
Approximately 14 million Americans aged 12 andolder have self-reported visual impairment defined as distance visual acuity of 20/50 or worse.
Administration in patients with hepatic impairment defined as total bilirubin> 1 to≤ 5× ULN and AST≤ 10× ULN(see section 4.2) should therefore be performed with caution and they should be closely monitored with regard to increased liver impairment and myelosuppression.
About 14 million Americans aged 12 years andolder report that they have a visual impairment defined as distance visual acuity of 20/50 or worse.
No adjustment to the starting dose is required in patients with hepatic impairment defined by total bilirubin≤ 1.5× upper limit of normal(ULN) and aspartate aminotransferase(AST)/alanine aminotransferase(ALT)≤ 2.5× ULN(see section 5.2).
Hypersensitivity to the active substance orto any of the excipients- active clinically significant bleeding- acute bacterial endocarditis- severe renal impairment defined by creatinine clearance< 20 ml/min.
The maximally tolerated pazopanib dose(MTD)in patients with moderate hepatic impairment(defined as an elevation of bilirubin> 1.5 x to 3 x ULN regardless of the ALT values) was 200 mg once daily.
About 14 million people in the United States aged 12 years andolder have self-reported visual impairment defined as distance visual acuity of 20/50 or worse.
Based on a population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with hepatic impairment defined by National Cancer Institute Organ Dysfunction Working Group(NCI ODWG) category B1(total bilirubin≤ ULN and AST> ULN; n=133) or B2(total bilirubin> 1.0-1.5× ULN and AST any level; n=17) was similar to patients with normal hepatic function(total bilirubin/AST≤ ULN; n=611)(see section 4.2).
Hepatic impairment A single 245 mg dose of tenofovir disoproxil was administered to non-HIV, non-HBV infected patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte(CPT) classification.
No dose adjustment is required in patients with mild, moderate orsevere hepatic impairment defined based on National Cancer Institute Organ Dysfunction Working Group(NCI-ODWG)- criteria for hepatic impairment: .
Additionally, dabigatran exposure(at trough and peak)was assessed in a prospective open label randomized pharmacokinetic study in NVAF patients with severe renal impairment(defined as creatinine clearance[CrCl] 15-30 mL/min) receiving dabigatran etexilate 75 mg twice daily.
Following administration of a single 200 mg IV dose of tedizolid phosphate to 8 subjects with severe renal impairment defined as eGFR< 30 mL/min, the Cmax was basically unchanged and AUC0-∞ was changed by less than 10% compared to 8 matched healthy subject controls.
Based on the diminished exposure and limited hepatic reserve pazopanib is not recommended in patients with severe hepatic impairment(defined as total bilirubin> 3 X ULN regardless of any level of ALT)(see section 4.2).
A multiple-dose, open-label trial was conducted to evaluate the pharmacokinetics of the lower therapeutic dose of vildagliptin(50 mg once daily)in patients with varying degrees of chronic renal impairment defined by creatinine clearance(mild: 50 to< 80 ml/min, moderate: 30 to< 50 ml/min and severe:< 30 ml/min) compared to normal healthy control subjects.
Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV infected adult subjects with varying degrees of renal impairment defined according to baseline CrCl(normal renal function when CrCl> 80 mL/min; mild with CrCl= 50-79 mL/min; moderate with CrCl= 30-49 mL/min and severe with CrCl= 10-29 mL/min).
Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV,non-HBV infected adult patients with varying degrees of renal impairment defined according to baseline creatinine clearance(CrCl)(normal renal function when CrCl> 80 ml/min; mild with CrCl= 50-79 ml/min; moderate with CrCl= 30- 49 ml/min and severe with CrCl= 10- 29 ml/min).
Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV,non-HBV infected adult patients with varying degrees of renal impairment defined according to baseline creatinine clearance(CrCl)(normal renal function when CrCl> 80 ml/min; mild with CrCl= 50-79 ml/min; moderate with CrCl= 30-49 ml/min and severe with CrCl= 10-29 ml/min).
Cardiac impairment was defined as patients with previous cardiovascular abnormality.
Hepatic impairment was defined by National Cancer Institute(NCI) criteria of hepatic dysfunction.
Hepatic impairment was defined by the National Cancer Institute(NCI) criteria of hepatic dysfunction(see section 4.2).