Примери за използване на Alirocumab на Английски и техните преводи на Български
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Alirocumab binds to PCSK9.
The active substance is alirocumab.
Effects of alirocumab on other medicinal products.
Praluent 75 mg injection alirocumab.
Efficacy of Alirocumab in ODYSSEY OUTCOMES(Overall Population).
Praluent contains the active substance alirocumab.
The active substance in Praluent, alirocumab, is a monoclonal antibody.
Two elimination phases were observed for alirocumab.
Each pre-filled pen contains 150 mg alirocumab in 1 ml solution(150 mg/ml).
Praluent 150 mg solution for injection in a pre-filled pen alirocumab.
The long-term consequences of continuing alirocumab treatment in the presence of ADA are unknown.
(75 milligrams per ml) or150 milligrams(150 milligrams per ml) of alirocumab.
The pharmacodynamic effect of alirocumab in lowering LDL-C is indirect, and mediated through the binding to PCSK9.
This leads to the increased target-mediated clearance andreduced systemic exposure of alirocumab.
Alirocumab is a human IgG1 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Based on a population pharmacokinetic analysis,race had no impact on alirocumab pharmacokinetics.
The absolute bioavailability of alirocumab after subcutaneous administration was about 85% as determined by population pharmacokinetic analysis.
At week 8,the mean reduction in LDL-C from baseline with all patients treated with alirocumab was 72.4%.
After subcutaneous administration of 50 mg to 300 mg alirocumab, median times to maximum serum concentration(tmax) were 3-7 days.
Statins and other lipid-modifying therapy are known to increase production of PCSK9,the protein targeted by alirocumab.
All-cause mortality in phase 3 studies was 0.6%(20 of 3182 patients) in the alirocumab group and 0.9%(17 of 1792 patients) in the control group.
The use of Praluent is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
At week 12,82.1% of patients in the alirocumab group reached an LDL-C˂70 mg/dL(˂1.81 mmol/L) compared to 7.2% of patients in the placebo group.
Body weight was identified as one significant covariate in the final population PK model impacting alirocumab pharmacokinetics.
Although adverse consequences of very low LDL-C were not identified in alirocumab trials, the long-term effects of very low levels of LDL-C are unknown.
Dose up-titration of alirocumab to 150 mg Q2W occurred at week 12 in patients with LDL-C≥70 mg/dL(≥1.81 mmol/L) or≥100 mg/dL(≥2.59 mmol/L), depending on their level of CV risk.
The discontinuation rate due to local injection site reactions was comparable between the two groups(0.2% in the alirocumab group versus 0.3% in the control group).
At week 12(before up-titration), 76.0% of patients in the alirocumab group reached an LDL-C of˂70 mg/dL(˂ 1.81 mmol/L) as compared to 11.3% in the placebo group.
Alirocumab exposure(AUC0-14d) at steady state at both the 75 and 150 mg Q2W dosing regimen was decreased by 29% and 36% in patients weighing more than 100 kg as compared to patients weighing between 50 kg and 100 kg.
Based on a population pharmacokinetic analysis,age was associated with a small difference in alirocumab exposure at steady state, with no impact on efficacy or safety.