Примери за използване на Flutiform на Английски и техните преводи на Български
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all provided rigorous statistical evidence that the inhaled corticosteroid effects of Flutiform were not less than those of fluticasone propionate+ formoterol fumarate.
The pre-dose FEV1 data in this study which were again a demonstrably inhaled corticosteroid-mediated effect provided no evidence of a lesser inhaled corticosteroid effect with Flutiform than seen with fluticasone propionate+ formoterol fumarate.
i.e. very close to unity for the comparison of Flutiform 500µg/20µg versus fluticasone propionate 500µg+ formoterol fumarate 24µg was therefore suggestive of non-inferiority
of the European Union(EU) regarding the authorisation of the medicines Flutiform and Iffeza and associated names.
therefore in this study are not a valid surrogate for clinical efficacy of Flutiform.
they facilitate a rigorous, internally validated examination as to whether the long-acting β2 agonist formoterol fumarate“masks” deficient corticosteroid effects of Flutiform upon pre-dose FEV1.
was of the view that the clinical effects of Flutiform in respect of asthma control are superior to the clinical effects of GSK fluticasone propionate administered alone.
PD studies both included the same strengths/doses of Flutiform, GSK fluticasone propionate pMDI
labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Flutiform and associated names(see Annex I).
to further assess exacerbation rates seen with Flutiform compared with fluticasone propionate administered concomitantly with formoterol fumarate or administered alone, are not required.
The question posed by CHMP implied that the 67% relative bioavailability of the fluticasone propionate component of Flutiform compared with GSK fluticasone propionate pMDI may translate to a lesser inhaled corticosteroid effect
However, an analysis of annualised exacerbation rates in this study was able to differentiate the effects of high dose ICS-LABA(inhaled corticosteroid- long-acting β2 agonist) treatments(Flutiform 500µg/20µg and fluticasone propionate 500µg+ formoterol fumarate 24µg)
was numerically greater with Flutiform 500µg/20µg than with GSK fluticasone propionate 500µg(either alone
The grounds for the referral were concerns raised by The Netherlands over data showing that the levels of fluticasone propionate in the blood following dosing with Flutiform and Iffeza are lower than when fluticasone propionate is given alone, which may indicate
experiencing exacerbations in the pivotal“Switch” study(Study FLT3503) was similar in Flutiform and fluticasone propionate+ formoterol fumarate treated patients(36.4%
it was insufficient to explain the magnitude of the predose FEV1 treatment effect difference between Flutiform and fluticasone propionate pMDI.
was numerically greater with Flutiform 500µg/20µg than with GSK fluticasone propionate 500µg(either administered alone
Study FLT 3503 also included a comparison with a lower dose of Flutiform and effects seen with this lower dose of Flutiform(100µg/10µg) upon pre-dose FEV1
The CHMP noted that the differences of the magnitude observed between Flutiform and GSK fluticasone propionate in Study FLT1501(67% relative bioavailability)
the CHMP considers there to be no reason to anticipate that the long-term exacerbation risk with Flutiform may exceed that with fluticasone propionate alone(the“Step-up” indication)