Examples of using Esbriet in English and their translations into Polish
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Colloquial
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Official
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Medicine
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Ecclesiastic
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Ecclesiastic
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Financial
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Official/political
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Programming
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Computer
Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 13(p<
you need to take Esbriet, your doctor will discuss the risks
Therefore, it is recommended that Esbriet be administered with food to reduce the incidence of nausea and dizziness.
Concomitant use of strong inducers of CYP1A2 including smoking should be avoided during Esbriet therapy based on the observed relationship between cigarette smoking and its potential to induce CYP1A2.
The ruling by the ECJ on access to the documentation for Esbriet shows how in practice the interests of the owners of the documentation are weighed against the interests of their competitors.
5 x ULN, Esbriet should be discontinued and the patient should not be rechallenged.
an effect which has not been observed in patients receiving Esbriet.
Esbriet hard capsules(capsules) have a white to off-white opaque body
Esbriet is contraindicated in severe hepatic impairment and end stage liver disease see sections 4.2 and 4.3.
There is no relevant use of Esbriet in the paediatric population for the indication of IPF.
A dispute over the documentation to the medicine Esbriet shows how much controversy is stirred up by the disclosure of registration documents for medicines to third parties.
The MAH must ensure that at launch all physicians who are expected to prescribe Esbriet are provided with a physician information pack containing the following.
Additionally, in an ad hoc analysis, 33% of patients receiving Esbriet showed a decline of≥50 m in 6MWT distance, compared to 47% of patients receiving placebo in PIPF-006.
of mortality in IPF) was seen in 20% of patients receiving Esbriet compared to 35% receiving placebo Table 2.
In a Phase 1 study, the co-administration of Esbriet and fluvoxamine(a strong inhibitor of CYP1A2 with inhibitory effects on other CYP isoenzymes[CYP2C9,
Table 1 shows the adverse reactions reported at a frequency of≥2% in 623 patients receiving Esbriet at the recommended dose of 2,403 mg/day in three pivotal Phase 3 studies.
wheezing have been received in association with use of Esbriet in the post-marketing setting.
If the rash persists after 7 days, Esbriet should be discontinued for 15 days, with re-escalation to the recommended daily dose
The most commonly reported side effects during clinical study experience with Esbriet were nausea(feeling sick),
death was seen in 17% of patients receiving Esbriet compared to 32% receiving placebo Table 4.