Примери за използване на To nintedanib на Английски и техните преводи на Български
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Exposure to nintedanib increased linearly with age.
An inverse correlation between body weight and exposure to nintedanib was observed.
Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Potent P-gp inducers(e.g. rifampicin, carbamazepine, phenytoin, and St. John's Wort)may decrease exposure to nintedanib.
Do not take Ofev- if you are allergic to nintedanib, peanut or soya, or any of the other ingredients of this medicine.
If coadministered with Ofev, potent P-gp inhibitors(e.g. ketoconazole, erythromycin or cyclosporine)may increase exposure to nintedanib.
PopPK analyses indicated moderate effects on exposure to nintedanib depending on age, body weight, and race(see below).
If co-administered with nintedanib, potent P-gp inhibitors(e.g. ketoconazole or erythromycin)may increase exposure to nintedanib.
Vargatef must not be used in patients who are hypersensitive(allergic) to nintedanib, peanut or soya, or any of the other ingredients.
The geometric mean exposure to nintedanib was 33% higher in Chinese, Taiwanese, and Indian patients while it was 22% lower in Koreans compared to Caucasians(body weight corrected).
Ofev must not be used in patients who are hypersensitive(allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Clinical research results relating to nintedanib in SSc-ILD will be shared with the scientific community during the American Thoracic Society Congress(May 17-22).
Concomitant treatment with nintedanib and pirfenidone has been investigated in an exploratory openlabel, randomised trial of nintedanib 150 mg twice daily with add-on pirfenidone(titrated to 801 mg three times a day)compared to nintedanib 150 mg twice daily alone in 105 randomised patients for 12 weeks.
Do not take Vargatef- if you are allergic to nintedanib, to peanut or soya, or to any of the other ingredients of this medicine(listed in section 6).
Exposure to nintedanib was not influenced by gender(body weight corrected), mild and moderate renal impairment(estimated by creatinine clearance), liver metastases, ECOG performance score, alcohol consumption, and P-gp genotype.
Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.
The population mean exposure to nintedanib was 33- 50% higher in Chinese, Taiwanese, and Indian patients and 16% higher in Japanese patients while it was 16- 22% lower in Koreans compared to Caucasians(body weight corrected).
Based on results of a Population PK(PopPK) analysis in patients with IPF and non small cell lung cancer(NSCLC)(N=1,191) and descriptive investigations,exposure to nintedanib was not influenced by sex(body weight corrected), mild and moderate renal impairment(estimated by creatinine clearance), alcohol consumption, or P-gp genotype.
In a dedicated single dose phase I study and compared to healthy subjects,exposure to nintedanib based on Cmax and AUC was 2.2-fold higher in volunteers with mild hepatic impairment(Child Pugh A; 90% CI 1.3- 3.7 for Cmax and 1.2- 3.8 for AUC, respectively).
In a drug-drug interaction study with the potent P-gp inducer rifampicin,exposure to nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
Nausea led to discontinuation of nintedanib in 2.0% of patients.
In particular, treatment of tumour xenografts with nintedanib led to a rapid reduction in tumour micro vessel density, pericytes vessel coverage and tumour perfusion.
Nintedanib binds competitively to the adenosine triphosphate(ATP) binding pocket of these receptors and blocks the intracellular signalling.
Diarrhoea led to dose reduction in 10.7% of the patients and to discontinuation of nintedanib in 4.4% of the patients in clinical trials.
As shown in Table 4, the addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 23% for the adenocarcinoma population(HR 0.77; 95% CI: 0.62- 0.96).
The addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 21% for the overall population(hazard ratio(HR) 0.79; 95% confidence interval(CI): 0.68- 0.92; p= 0.0019) as determined by the Independent Review Committee.
Nintedanib binds competitively to the adenosine triphosphate(ATP) binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells(pericytes and vascular smooth muscle cells).
Additionally, the first Phase IV trial following the approval of Ofev for the treatment of IPF is completed andwill add evidence to the safety and tolerability of nintedanib in combination with pirfenidone.
Nintedanib This medicine is subject to additional monitoring.
The annual rate of decline of FVC(in mL)was significantly reduced in patients receiving nintedanib compared to patients receiving placebo.