Примери за използване на Evolocumab на Английски и техните преводи на Български
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The mutagenic potential of evolocumab has not been evaluated.
What Repatha contains- The active substance is evolocumab.
Evolocumab was estimated to have an effective half-life of 11 to 17 days.
No data on the effect of evolocumab on human fertility are available.
NAME OF THE MEDICINAL PRODUCT Repatha 420 mg solution for injection in cartridge evolocumab.
Evolocumab safely and effectively reduced the patients' levels of bad, or LDL, cholesterol.
The pharmacokinetic interaction between statins and evolocumab was evaluated in the Repatha clinical trials.
Evolocumab(trade name Repatha) is a monoclonal antibody designed for the treatment of hyperlipidemia.
An approximately 20% increase in the clearance of evolocumab was observed in patients co-administered statins.
Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9(PCSK9).
The review of all reported hypersensitivity reactions revealed a clear evidence of different clinical presentations of hypersensitivity associated with evolocumab.
The pharmacokinetics of evolocumab were influenced by body weight without having any notable effect on LDL-C lowering.
In hamsters andcynomolgus monkeys at exposures much higher than patients receiving 420 mg evolocumab once monthly, no effect on male or female fertility was observed.
Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface.
Body weight was a significant covariate in population PK analysis impacting evolocumab trough concentrations, however there was no impact on LDL-C reduction.
Evolocumab is designed to attach to a substance called PCSK9 that affects the liver's ability to take in cholesterol.
In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDL-C reduction.
Evolocumab was not carcinogenic in hamsters at exposures much higher than patients receiving evolocumab at 420 mg once monthly.
Reductions in serum LDL-C andtotal cholesterol were more pronounced than observed previously with evolocumab alone, and were reversible upon cessation of treatment.
Repatha contains the active substance evolocumab, a monoclonal antibody(a type of specialised protein designed to attach to a target substance in the body).
Following a single 420 mg Repatha intravenous dose, the mean(SD) steady-state volume of distribution was estimated to be 3.3(0.5)L, suggesting evolocumab has limited tissue distribution.
The active substance in Repatha, evolocumab, is a monoclonal antibody(a type of protein) that has been designed to recognise and attach to an enzyme called‘PCSK9'.
An approximately 20% increase in the clearance is in part mediated by statins increasing the concentration of PCSK9 which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
The FDA approved evolocumab injection on 27 August 2015, for some patients who are unable to get their LDL cholesterol under control with current treatment options.
In combination withrosuvastatin for 3 months, no adverse effects were observed in cynomolgus monkeys at exposures much higher than patients receiving 420 mg evolocumab once monthly.
Known hypersensitivity to evolocumab is contraindicatedin the EU SmPC, however clinicians and patients should be informed about the possible onset of hypersensitivity reactions during the evolocumab treatment.
This increased clearance is in part mediated by statins increasing the concentration of ProproteinConvertase Subtilisin/Kexin Type 9(PCSK9) which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
No increase in unbound PCSK9 or LDL-C above baseline was observed during the washout of evolocumab suggesting that compensatory mechanisms to increase production of PCSK9 and LDL-C do not occur during treatment.
Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor(LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation.
Population pharmacokinetic analysis indicated no appreciable differences in evolocumab serum concentrations in hypercholesterolaemic patients(nonfamilial hypercholesterolaemia or familial hypercholesterolaemia) taking concomitant statins.