Voorbeelden van het gebruik van Nintedanib in het Engels en hun vertalingen in het Nederlands
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Dose proportionality was shown by increase of nintedanib exposure dose range 50- 450 mg once daily and 150- 300 mg twice daily.
Nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies.
In INPULSIS-2, patients receiving placebo had a larger increase from baseline SGRQ total score as compared to patients receiving nintedanib 150 mg twice daily.
In the INPULSIS trials no increased risk of venous thromboembolism was observed in nintedanib treated patients.
In the pooled analysis of the INPULSIS trials, a numerically lower risk of first acute exacerbation was observed in patients receiving nintedanib compared to placebo.
Diarrhoea led to dose reduction in 10.7% of the patients and to discontinuation of nintedanib in 4.4% of the patients.
was significantly reduced in patients receiving nintedanib compared to patients receiving placebo.
were reported in 13.6% of nintedanib treated patients.
The deterioration of HRQoL was smaller in the nintedanib group; the difference between the treatment groups was statistically significant -2.69; 95% CI: -4.95, -0.43; p=0.0197.
In preclinical disease models nintedanib, as single agent,
Although bleeding is an expected adverse reaction of nintedanib due to its mechanism of action, the bleeding incidence was comparable between the 2 treatment groups(placebo: 11.1%, nintedanib: 10.9%)
rate of decline in FVC over 52 weeks was lower in the nintedanib arm(-0.060 L/year,
Nintedanib and its metabolites, the free acid moiety BIBF 1202
For the interaction potential of nintedanib with this transporter, see section 4.5. Nintedanib was shown to be not a substrate
caution should be exercised when administering nintedanib in patients who may develop QTc prolongation.
After food intake, nintedanib exposure increased by approximately 20% compared to administration under fasted conditions(CI:
In the pooled analysis of the INPULSIS trials, the estimated mean change from baseline to week 52 in SGRQ total score was smaller in the nintedanib group(3.53) than in the placebo group(4.96),
The active substance of Vargatef is nintedanib.
Nintedanib may affect the way your wounds heal.
Nintedanib may affect the way your wounds heal.