Examples of using Rapinyl in English and their translations into Hungarian
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Rapinyl and associated names,
The Applicant has characterised the pharmacokinetic profile of Rapinyl by demonstrating rapid delivery, predictable PK over the proposed dose range and also showing that Rapinyl achieves similar plasma concentrations
The Applicant further considered the current bridging strategy to be appropriate for the approval of Rapinyl over the 100-800µg dose range for the treatment of BTP in patients as Rapinyl delivers fentanyl within a plasma concentration range already established as safe and effective.
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.
significant body of confirmatory efficacy and safety data in cancer patients provided demonstrate that Rapinyl does indeed have a positive benefit-risk profile.
therapy such as Rapinyl, patients and their carers should be made fully aware of the importance of taking Rapinyl correctly and what action to take should symptoms of overdose occur.
that the fast dissolution of the Rapinyl tablet might be indicative of a higher Cmax
A large number of Rapinyl doses have been administered during these Phase III studies and high doses of Rapinyl have been
should limit consumption to a maximum of four Rapinyl doses per day.
Rapinyl and associated names(see Annex I) 50 µg sublingual tablets[See Annex I- To be completed nationally] Rapinyl 100 µg sublingual tablets Rapinyl 200 µg sublingual tablets Rapinyl 300 µg sublingual tablets Rapinyl 400 µg sublingual tablets Rapinyl 600 µg sublingual tablets Rapinyl 800 µg sublingual tablets.
Rapinyl and associated names(see Annex I) 50 microgram sublingual tablets[See Annex I- To be completed nationally] Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets.
The CHMP considered that the information provided was sufficient for concluding that repeat dose data following Actiq and Rapinyl are similar, and the dose proportionalilty between Actiq and Rapinyl was considered as established through the single dose data, pending further clinical safety and efficacy data.
Therefore, although the CHMP considers that Rapinyl could be used for the treatment of breakthrough pain in cancer patients the combined available pharmacokinetic,
the CHMP considered the benefit/ risk ratio of Rapinyl to be positive and the application for Rapinyl sublingual tablet 50, 100, 200, 300,
What Rapinyl contains.
Rapinyl can make some people feel drowsy.
The active substance in Rapinyl sublingual tablets is fentanyl.
What rapinyl is and what it is used for?
What Rapinyl looks like and contents of the pack.