Examples of using Clinically significant changes in English and their translations into Norwegian
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No clinically significant changes in renal function were observed.
In case of Konegra's single reception inside in a dose to 100 mg the preparation has no clinically significant changes of an electrocardiogram.
No clinically significant changes have been seen in clearance for doses ranging from 5 to 60 mg.
In case of single intake in doses to 100 mg the preparation didn't cause clinically significant changes of an electrocardiogram in healthy volunteers.
No clinically significant changes were observed in hepatic or renal assessments in clinical studies.
Co-administration of amprenavir with grapefruit juice was not associated with clinically significant changes in plasma amprenavir pharmacokinetics.
No clinically significant changes were shown on heart rate, atrioventricular(AV) conduction and cardiac repolarisation.
Hepatic impairment: In subjects with mild, moderate or severe hepatic impairment(Child-Pugh A-C) there were no clinically significant changes(maximum~30%) in exposure to vildagliptin.
No clinically significant changes in the mean QTc interval(i.e.,> 20 ms) from baseline were detected in the study.
The renal excretion of verteporfin and its metabolite is minimal(< 1% of the verteporfin dose)and thus, clinically significant changes in verteporfin exposure in patients with renal impairment are unlikely.
The observation of clinically significant changes from baseline in serum creatinine, unexplained haematuria, and/or proteinuria, should prompt further evaluation for nephropathies including immediate referral to a specialist.
Clinical interaction studies with nelfinavir, a moderately potent OATP inhibitor, and pravastatin, a low affinity OATP inhibitor,did not result in clinically significant changes in sitaxentan plasma levels.
The proportion of patients who had adverse, clinically significant changes in weight gain, glucose, total/LDL/HDL cholesterol or triglycerides increased over time.
Influence of concomitant medicinal products on enfuvirtide metabolism: In separate pharmacokinetic interaction studies, co-administration of ritonavir(potent CYP3A4 inhibitor) or saquinavir in combination with a booster dose of ritonavir or rifampicin(potent CYP34A inducer)did not result in clinically significant changes of the pharmacokinetics of enfuvirtide.
Comparisons between aripiprazole andplacebo in the proportions of patients experiencing potentially clinically significant changes in routine laboratory and lipid parameters(see section 5.1) revealed no medically important differences.
A population pharmacokinetic analysis did not indicate clinically significant changes in the systemic exposure of denosumab at steady state with respect to age(18 to 87 years), race/ethnicity(Blacks, Hispanics, Asians and Caucasians explored), gender or solid tumour types.
No clinically significant change is.
It does not produce a clinically significant change in pupil diameter.
No clinically significant change is observed in tipranavir PK parameters.
However, no clinically significant change in the percent decrease in serum uric acid concentration was observed where tested 80 mg multiple dose.
When either valproate or lithium were administered concomitantly with aripiprazole,there was no clinically significant change in aripiprazole concentrations.
Ketoconazole(substrate and inhibitor of CYP3A4/5):Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or ketoconazole.
Nelfinavir(substrate of CYP3A4/5, CYP2C19):Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or nelfinavir.
When either valproate or lithium was administered concomitantly with aripiprazole,there was no clinically significant change in aripiprazole concentrations, and, therefore, no dose adjustment is necessary when either valproate or lithium is administered with Abilify Maintena.
However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study,did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S-warfarin.
The CYP2C19 inhibitor omeprazole(40 mg q.d.) did not give rise to a clinically significant change in lacosamide exposure.
Neither of these clinical pathology changes appeared clinically significant.
The increases of plasma levels of buprenorphine andits active metabolite did not lead to clinically significant pharmacodynamic changes in a population of opioid tolerant patients.
No clinically significant pharmacokinetic change.