Examples of using Rapinyl in English and their translations into Polish
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Computer
Before Rapinyl therapy is initiated,
Before taking Rapinyl for the first time your doctor will explain how Rapinyl should be taken to effectively treat your breakthrough pain.
However, although the interim data support the proposed dose range for Rapinyl, the CHMP requested additional clinical data clearly demonstrating the efficacy/ safety of Rapinyl.
From the efficacy and safety data provided, Rapinyl seems to be comparable to other fentanyl containing products(Actiq
Rapinyl is a different type of medicine from other medicines you may have used to treat your breakthrough pain.
Once you and your doctor have found a dose of Rapinyl tablets that controls your breakthrough pain you should take this dose no more than four times a day.
The Applicant referred to the provided analysis of Pain Intensity Difference(PID) for Rapinyl compared to placebo from the 10 minute time point in the EN3267-005 study.
no longer require treatment for breakthrough pain, Rapinyl therapy may usually be discontinued immediately.
Rapinyl will dissolve rapidly under the tongue
The pain-relieving medicine in Rapinyl is very strong
Do not use Rapinyl after the expiry date which is stated on the carton after EXP.
For patients no longer requiring any opioid therapy, the Rapinyl dose should be taken into consideration before a gradual downward titration of opioids to minimise possible withdrawal effects.
A statistically significant decrease in pain intensity was achieved and clinically important decreases in pain occurred more rapidly in patients treated with Rapinyl compared to placebo.
The Applicant also provided data demonstrating that Rapinyl met the primary efficacy endpoint(Sum of Pain Intensity Difference from baseline to 30 minutes(SPID30)) and that the results were highly statistically significant p=0.0004.
proposed dose range and also showing that Rapinyl achieves similar plasma concentrations
The use of Rapinyl in patients with hepatic or renal impairment may
In conclusion, the Applicant considered that the results from studies EN3267-005 and EN3267-007 confirm the conclusions based on the original bridging strategy and demonstrate that Rapinyl can be safely and effectively used to treat multiple episodes of cancer breakthrough pain in opioid-tolerant patients.
A marketing authorization application was submitted by the Applicant ProStrakan Ltd through the Decentralised Procedure for Rapinyl, a sublingual tablet containing 50,
After Rapinyl administration, the main elimination half-life of fentanyl is about 7 hours(range 3-12.5 hours) and the terminal half-life is about 20 hours range 11.5-25 hours.
requested further safety analyses to be provided: detailed exposition of patients to Rapinyl, full safety analysis, narratives of the deaths.