FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, the CHMP requested additional data supporting the efficacy and safety of Rapinyl (independently of Actiq) in the treatment of BTP and adopted a List of Outstanding Issues.
Danish: Endelig anmodede CHMP om yderligere data til understøttelse af effekten af og sikkerheden ved Rapinyl (uafhængigt af Actiq) til behandlingen af BTP og udarbejdede en liste med uafklarede spørgsmål (LoOI).
English: Once absorbed, fentanyl starts to work to relieve pain.
Danish: Når den er optaget, begynder fentanyl at virke smertelindrende.
English: The Applicant discussed the previously provided SAE dataset up to the 18th January 2008 safety cut off and considered that the new safety data supplemented the bridging strategy and was in line with a further review of SAE data up to the 15th May-08.
Danish: Ansøgeren redegjorde for det tidligere fremlagte datasæt om alvorlige uønskede hændelser indtil skæringsdatoen for sikkerhed d. 18. januar 2008 og anså de nye sikkerhedsdata for at supplere strategien om at bygge bro og for at være i overensstemmelse med en yderligere gennemgang af data om alvorlige uønskede hændelser indtil d. 15. maj 2008.
English: Up to this date there were no reports of any SAEs assessed as being related to Rapinyl in either study.
Danish: Før dette tidspunkt var der ingen rapporter om alvorlige uønskede hændelser, der blev vurderet som værende relateret til Rapinyl i de to forsøg.
English: In patients with chronic cancer pain on stable maintenance doses of opioids, Rapinyl has been shown to induce significantly superior relief of breakthrough pain compared to placebo from 15 minutes after administration onwards, with a significantly lower need for rescue analgesic therapy.
Danish: Hos patienter med kroniske cancersmerter, og som behandles med stabile vedligeholdelsesdoser af opioider, har Rapinyl vist sig at inducere signifikant bedre lindring af gennembrudssmerter sammenlignet med placebo fra 15 minutter efter administration og herefter med signifikant nedsat behov for akut smertebehandling.
English: 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.
Danish: Men selv om interimdata understøtter det foreslåede dosisområde for Rapinyl, anmodede CHMP om yderligere kliniske data, der tydeligt påviser effekten af og sikkerheden ved Rapinyl.
English: The Applicant considered the rate and extent of absorption to be similar for Rapinyl and Actiq and that the similarity in the PK profiles during the first 30-minute rapid absorption phase is established.
Danish: Ansøgeren anså forekomsten og omfanget af absorption for at være omtrent den samme for Rapinyl og Actiq og anså ligheden i de farmakokinetiske profiler i løbet af de første 30 minutters hurtige absorptionsfase for at være underbygget.
English: The Applicant also discussed the difference between the volunteers (opioid-naïve) and the target patient population (chronic opioid users), noting that the pattern of related events was consistent with available literature on the safety profile of fentanyl products and the absence of dose-related trends in the incidence of adverse events.
Danish: Ansøgeren redegjorde også for forskellen mellem de frivillige (opioid-naive) og målpatientpopulationen (kroniske opioidbrugere) og bemærkede, at mønstret for relaterede hændelser stemte overens med den foreliggende litteratur om sikkerhedsprofilen for fentanyl-produkter og udeblivelsen af dosisrelaterede tendenser i forekomsten af uønskede hændelser.
English: The Applicant provided an overview of the current knowledge of cancer breakthrough pain (BTP), describing the currently available treatment, and the published data and available safety and efficacy data for other fentanyl products, concluding that fentanyl is an ideal analgesic for treatment of breakthrough pain.
Danish: Ansøgeren leverede en oversigt over den aktuelle viden om gennembrudssmerter (BTP) ved cancer, hvor den nuværende tilgængelige behandling samt offentliggjorte data og tilgængelige sikkerheds- og effektdata for andre fentanyl-produkter blev beskrevet, og det blev konkluderet, at fentanyl er et ideelt analgesikum til behandling af gennembrudssmerter.
English: The Applicant provided further reassurances on the use of Rapinyl in patiens with mucositis, based on publications and guidelines, concluding that patients with mild/moderate mucositis can use oral medication, while transmucosal forms of fentanyl are not suitable for use in patients with severe mucositis where other routes of analgesia administration are preferable.
Danish: Ansøgeren gav yderligere forsikringer med hensyn til brugen af Rapinyl til patienter med mucositis på baggrund af publikationer og retningslinjer og konkluderede, at patienter med mild/moderat mocositis kan bruge peroral medicin, mens transmucosale former for fentanyl ikke er egnet til brug til patienter med svær mucositis, hvor andre indgiftsveje for analgesi foretrækkes.
English: The Applicant believes that the original bridging strategy plus the significant body of confirmatory efficacy and safety data in cancer patients provided demonstrate that Rapinyl does indeed have a positive benefit-risk profile.
Danish: Ansøgeren mener, at den originale strategi om at bygge bro samt den signifikante mængde leverede bekræftende effekt- og sikkerhedsdata for cancerpatienter viser, at Rapinyl bestemt har en positiv risk/benefit-profil.
English: Rapinyl should be used with caution in patients with bradyarrhythmias.
Danish: Rapinyl skal anvendes med forsigtighed til patienter med bradyarytmier.
English: Rapinyl should be administered with caution to patients with liver or kidney dysfunction, especially during the titration phase.
Danish: Rapinyl skal administreres med forsigtighed til patienter med nedsat lever- eller nyrefunktion, især under titreringsfasen.
English: Rapinyl may impair your mental and/or physical ability to perform potentially hazardous tasks such as driving or operating machinery.
Danish: Rapinyl kan nedsætte Deres mentale og fysiske evne til at udføre potentielt farlige opgaver såsom at føre motorkøretøj eller betjene maskiner.
English: You must continue to take/use your regular opioid pain relieving medicine for persistent pain as advised by your doctor.
Danish: De skal fortsætte med at tage Deres sædvanlige opioide smertelindrende medicin mod vedvarende smerter som anvist af lægen.
English: Finally, the CHMP considered that the database on efficacy and safety of Rapinyl in the treatment of cancer patients with BTP is rather poor and requested further safety analyses to be provided: detailed exposition of patients to Rapinyl, full safety analysis, narratives of the deaths.
Danish: Endelig anså CHMP databasen med data om effekten af og sikkerheden ved Rapinyl til behandlingen af cancerpatienter med BTP som værende utilstrækkelig og anmodede om, at yderligere sikkerhedsanalyser blev fremsendt: detaljerede oplysninger om patienters eksponering for Rapinyl, komplet sikkerhedsanalyse, beretning om dødsfald.
English: Rapinyl should only be administered to patients who are considered tolerant to their opioid therapy for persistent cancer pain.
Danish: Rapinyl må kun administreres til patienter, som anses for at være tolerante over for deres opioidbehandling for persisterende cancersmerter.
English: The CHMP agreed that the pharmacodynamic properties and the effectiveness of fentanyl are well established and noted the pain model in BTP.
Danish: CHMP var enig i, at de farmakodynamiske egenskaber for og effektiviteten af fentanyl er godt underbyggede og registrerede smertemodellen for BTP.
English: In addition, because limited PK data are available in patients, these data cannot be compared to the ones obtained in healthy volunteers.
Danish: Derudover kan disse data på grund af de begrænsede tilgængelige farmakokinetiske data fra patienterne ikke sammenlignes med dataene fra de raske frivillige.
English: If the long acting opioid or dose of long acting opioid is changed the Rapinyl dose should be re-evaluated and re-titrated as necessary to ensure the patient is on an optimal dose.
Danish: Hvis det langtidsvirkende opioid eller dosis af det langtidsvirkende opioid ændres, skal Rapinyldosis revurderes og gentitreres efter behov for at sikre, at patienten får en optimal dosis.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkel frekvensgruppe er bivirkningerne opstillet efter hvor alvorlige de er.
English: The CHMP also agreed that the proposed dose range for Rapinyl is sufficiently documented and that further efficacy and safety data on dose titration is not necessary.
Danish: CHMP var også enig i, at det foreslåede dosisområde for Rapinyl er tilstrækkeligt dokumenteret, og at yderligere data om effekt og sikkerhed vedrørende dosistitrering ikke er nødvendige.
English: Therefore, although the CHMP considers that Rapinyl could be used for the treatment of breakthrough pain in cancer patients the combined available pharmacokinetic, pharmacological and clinical data were considered insufficient and the CHMP requested the Applicant to provide clinical demonstration of the efficacy and safety of Rapinyl at the proposed dosages, including the highest one.
Danish: Det vil sige, at selv om CHMP anser Rapinyl for at kunne bruges til behandlingen af gennembrudssmerter hos cancerpatienter, vurderes de kombinerede tilgængelige farmakokinetiske, farmakologiske og kliniske data som værende utilstrækkelige, og CHMP anmodede ansøgeren om at fremlægge en klinisk påvisning af effekten af og sikkerheden ved Rapinyl ved de foreslåede doser, herunder den højeste dosis.
English: • Very common side effects (affects more than 1 user in 10 people): excessive sweating
Danish: • Meget almindelige bivirkninger (påvirker mere end 1 ud af 10 brugere): overdreven svedafsondring
English: Strength (micrograms) of first sublingual tablet per episode of breakthrough pain
Danish: Styrke (mikrogram) af første sublinguale resoriblet pr. periode med gennembrudssmerter
English: For the treatment of accidental overdose in opioid-naïve individuals, naloxone or other opioid antagonists should be used as clinically indicated and in accordance with their Summary of Product Characteristics.
Danish: Til behandling af utilsigtet overdosering hos opioidnaive individer, skal der anvendes naloxon eller andre opioidantagonister som klinisk indiceret og i overensstemmelse med disses produktresumé.
English: Sublingual use
Danish: Sublingual anvendelse
English: Pharmacokinetic characterisation following treatment with Rapinyl and pharmacokinetic comparisons of Rapinyl versus Actiq have been used as a basis for bridging to the extensive published data regarding clinical efficacy and safety data for authorized fentanyl products.
Danish: Den farmakokinetiske karakteristik efter behandling med Rapinyl og farmakokinetiske sammenligninger af Rapinyl med Actiq er blevet brugt som baggrund for at bygge bro til de omfattende offentliggjorte data om klinisk effekt og sikkerhed for godkendte fentanylprodukter.
English: 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.
Danish: CHMP anså de indgivne oplysninger for at være tilstrækkelige til at konkludere, at data om gentagne doser i forbindelse med Actiq og Rapinyl er omtrent ens, og dosisproportionaliteten mellem Actiq og Rapinyl blev anset for at være underbygget via data om enkeltdosis, mens yderligere data om klinisk sikkerhed og effekt afventes.
English: • general anaesthetics (used to make you sleep during operations)
Danish: • bedøvelsesmidler til fuld narkose (bruges til at få Dem til at sove under operationer)
English: The Applicant concluded that Rapinyl is safe and well tolerated in patients, with an appropriate safety-profile of Rapinyl for this indication.
Danish: Ansøgeren konkluderede, at Rapinyl er sikkert og godt tolereret hos patienter, og at der er en passende sikkerhedsprofil for Rapinyl til denne indikation.
English: You must not change your dose of Rapinyl unless directed by your doctor.
Danish: De må ikke ændre Deres dosis Rapinyl, medmindre lægen giver Dem besked derom.
English: Intravenous fentanyl has been shown to cause bradycardia.
Danish: Det er blevet påvist, at intravenøst administreret fentanyl medfører bradykardi.
English: In conclusion, the CHMP considered that the Applicant provided limited information on the patient treatment (titration towards an efficient dose, multiple administrations, administration up to the highest dosage) which prevented an evaluation of efficacy and safety of Rapinyl in the clinical setting and characterisation of the full clinically relevant time effect profile of the drug.
Danish: Afslutningsvis fandt CHMP, at ansøgeren gav begrænsede oplysninger om patientbehandlingen (titrering imod en effektiv dosis, flere indgivelser, indgift op til højeste dosis), hvilket forhindrede en vurdering af effekten af og sikkerheden ved Rapinyl inden for de kliniske rammer og en karakteristik af den fulde klinisk relevante profil for tid-effekt for lægemidlet.
English: Furthermore, the CHMP considered that the provided clinical data on the efficacy and safety of Rapinyl in the treatment of BTP under normal conditions are scarce and that no conclusion could be drawn from the clinical study provided.
Danish: Desuden anså CHMP de fremlagte kliniske data om effekten af og sikkerheden ved Rapinyl til behandling af BTP under normale omstændigheder som værende utilstrækkelige, og der kunne ikke udledes en konklusion fra det omtalte kliniske forsøg.
English: Respiratory, thoracic and mediastinal disorders Common: Respiratory depression, rhinitis, pharyngitis
Danish: Luftveje, thorax og mediastinum Almindelig: Respirationsdepression, rhinitis, pharyngitis
English: Uncommon: Bradycardia, tachycardia, hypertension Very rare: Arrhythmias
Danish: Ikke almindelig: Bradykardi, takykardi, hypertension Meget sjælden: Arytmier
English: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: [Se bilag I - udfyldes nationalt] (Navn og adresse) <{tlf}> <{fax}> <{e-mail}>
English: The CHMP not endorse the Applicant claims of dose-relationship between Rapinyl and Actiq and therefore could not conclude on the comparability of systemic exposure obtained with Rapinyl and
Danish: CHMP kunne ikke godkende ansøgerens påstande om et dosisforhold mellem Rapinyl og Actiq og kunne derfor heller ikke foretage en konklusion vedrørende sammenligneligheden af den systemiske eksponering opnået med Rapinyl og Actiq.
English: Slovak Republic
Danish: Slovakiske Republik
English: Unused product should be taken, if possible, to your pharmacist.
Danish: Ubrugte lægemidler skal returneres til apoteket, hvis det er muligt.
English: Similarly, the Applicant considered the clinical safety of fentanyl products to be well established and well tolerated in both volunteers and the target population and that the pattern of side effects was consistent with other fentanyl products, including those used for treating BTP.
Danish: Ligeledes anså ansøgeren den kliniske sikkerhed af fentanyl-produkter for at være godt underbygget og godt tolereret af både frivillige og målpopulationen og fandt, at bivirkningsmønstret stemte overens med andre fentanyl-produkter, herunder de produkter der bruges til behandling af BTP.
English: As a consequence, additional efficacy and safety data were required for the approval of Rapinyl for the management of breakthrough pain in the target population and the procedure was referred to the CHMP.
Danish: Som følge heraf var yderligere effekt- og sikkerhedsdata nødvendige med henblik på godkendelse af Rapinyl til behandling af gennembrudssmerter hos målpopulationen, og proceduren blev indbragt for Udvalget for Humanmedicinske Lægemidler (CHMP).
English: Rapinyl sublingual tablets should be administered directly under the tongue at the deepest part. Rapinyl sublingual tablets should not be swallowed, but allowed to completely dissolve in the sublingual cavity without chewing or sucking.
Danish: Rapinyl sublinguale resoribletter må ikke synkes, men skal have lov til at blive helt opløst i det sublinguale hulrum uden at tygges eller suges.
English: Store in the original blister package in order to protect from moisture.
Danish: Opbevares i den originale blisterpakning for at beskytte mod fugt.
English: The Applicant provided data supporting the pharmacokinetic bridging strategy and demonstrating that fentanyl delivery from Rapinyl provides effective pain relief in the target population.
Danish: Ansøgeren leverede data, der understøttede den farmakokinetiske strategi om at bygge bro og viste, at fentanyl frigivet fra Rapinyl giver effektiv smertelindring hos målpopulationen.
English: Rapinyl is a quick dissolving sublingual tablet formulation.
Danish: Rapinyl er en hurtigt opløsende sublingual tabletformulering.
English: The analgesic effects of fentanyl are related to the blood level of the active substance; in opioid-naïve patients, minimum effective analgesic serum concentrations of fentanyl range from 0.3-1.2 ng/ml, while blood levels of 10-20 ng/ml produce surgical anaesthesia and profound respiratory depression.
Danish: Hos opioidnaive patienter ligger den lavest effektive serumkoncentration af fentanyl til opnåelse af smertelindring i området 0,3 til 1,2 ng/ml, mens blodkoncentrationer på 10-20 ng/ml fremkalder kirurgisk anæstesi og udtalt respirationsdepression.
English: Care should be taken when using naloxone or other opioid antagonists to treat overdose in opioidmaintained patients, due to the risk of precipitating an acute withdrawal syndrome.
Danish: Der skal udvises forsigtighed ved anvendelese af naloxon eller andre opioidantagonister til behandling af overdosering hos patienter, der får vedligeholdelsesdoser af opioid, på grund af risikoen for at fremkalde et akut abstinenssyndrom.
English: Very common side effects (affects more than 1 user in 10) include: • nausea, headache, sleepiness/tiredness, dizziness.
Danish: Meget almindelige bivirkninger (påvirker mere end 1 ud af 10 brugere) omfatter: • kvalme, hovedpine, søvnighed/træthed, svimmelhed
English: In patients who have a dry mouth water may be used to moisten the buccal mucosa before taking Rapinyl.
Danish: Patienter, der er tørre i munden, er måske vant til at væde mundslimhinden, inden de tager Rapinyl.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines (other than your regular opioid pain-relieving medicine), including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig (undtagen Deres sædvanlige opioide smertestillende medicin).
English: The application was based on literature data on fentanyl, supplemented with pharmacokinetic data for Rapinyl and a comparison of Rapinyl bioavailability with Actiq lozenge, an authorised transmucosally administered fentanyl on demand.
Danish: Ansøgningen var baseret på litteratur om fentanyl sammen med farmakokinetiske data for Rapinyl og en sammenligning af biotilgængeligheden af Rapinyl med sugetabletten Actiq, en fentanyl godkendt til transmucosal indgift efter behov.
English: The Applicant was able to provide in the response to the LoOI the interim analyses from 2 ongoing Phase III safety and efficacy clinical studies (EN3267-005 and EN3267-007), performed in the US by Endo.
Danish: Ansøgeren var i stand til som svar på spørgsmålene på listen med uafklarede spørgsmål at fremskaffe interimanalyser fra to igangværende kliniske fase III-sikkerheds- og effektforsøg (EN3267-005 og EN3267-007) udført i USA af Endo.
English: • Rare side effects (affects 1 to 10 users in 10,000): hiccups
Danish: • Sjældne bivirkninger (påvirker mellem 1 og 10 ud af 10.000 brugere): Hikke
English: The safety and efficacy of Rapinyl have been evaluated in patients taking the drug at the onset of the breakthrough pain episode.
Danish: Sikkerheden og virkningen af Rapinyl er undersøgt hos patienter, der tager lægemidlet ved starten af en periode med gennembrudssmerter.
English: Fentanyl is passed on into breast milk and may cause extreme drowsiness and shallow breathing in the breastfed child.
Danish: Fentanyl passerer over i modermælken og kan forårsage ekstrem døsighed og overfladisk vejrtrækning hos det diende barn.
English: Rapinyl tablets are contained in blisters, available in cartons of 10 or 30 tablets.
Danish: Rapinyl sublinguale resoribletter fås i æsker med 10 eller 30 tabletter.
English: [See Annex I - To be completed nationally]
Danish: [Se bilag I - udfyldes nationalt]
English: • Certain types of antibiotic medicines used to treat infections (called macrolides, containing e.g. erythromycin ).
Danish: • Visse typer antibiotika, der bruges til at behandle betændelser (såkaldte makrolidantibiotika f.eks. erythromycin).
English: Patients and their carers must be instructed that Rapinyl contains an active substance in an amount that can be fatal to a child, and therefore to keep all tablets out of the reach and sight of children.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Patienter og deres plejere skal instrueres i, at Rapinyl indeholder et aktivt stof i en mænge, der kan være fatalt for et barn, og at alle tabletter derfor skal opbevares utilgængeligt for børn.
English: Dose titration needs to be approached with particular care and patients observed carefully for signs of fentanyl toxicity (see section 4.4).
Danish: Dosistitrering skal foregå med særlig forsigtighed, og patienterne skal observeres omhyggeligt for tegn på fentanyltoksicitet (se pkt.
English: The pain-relieving medicine in Rapinyl is very strong and could be life-threatening if taken accidentally by a child. Rapinyl must be kept out of the reach and sight of children.
Danish: Den smertelindrende medicin i Rapinyl er meget stærk og kan være livstruende, hvis den ved et uheld tages af et barn.
English: Use in patients with renal and hepatic impairment Patients with kidney or liver dysfunction should be carefully observed for signs of fentanyl toxicity during the Rapinyl titration phase (see section 4.4).
Danish: Anvendelse til patienter med nedsat nyre- og leverfunktion Patienter med nedsat nyre- eller leverfunktion skal observeres omhyggeligt for tegn på fentanyltoksicitet under titreringsfasen med Rapinyl (se pkt.
English: Other very commonly reported adverse reactions include: nausea, vomiting, constipation, headache, somnolence/fatigue and dizziness.
Danish: Andre meget almindeligt rapporterede bivirkninger omfatter: Kvalme, opkastning, obstipation, hovedpine, somnolens/træthed og svimmelhed.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - udfyldes nationalt]
English: The Applicant also defended the 800ug dose and discussed the safety of Rapinyl when superimposed on a continuous fentanyl or non-fentanyl opioid pain therapy and considered that the transmucosal delivery of fentanyl produces consistent results, independent of the type of baseline therapy.
Danish: Ansøgeren forsvarede dosis på 800 µg og redegjorde for sikkerheden ved Rapinyl, når det blev tilføjet i en kontinuerlig fentanyl- eller ikke-fentanyl opioidsmertebehandling og anså den transmucosale frigivelse af fentanyl for at frembringe ensartede resultater uafhængig af typen af baselinebehandling.
English: The active substance in Rapinyl sublingual tablets is fentanyl.
Danish: Det aktive stof i Rapinyl sublinguale resoribletter er fentanyl.
English: Rapinyl sublingual tablets are available in a range of strengths.
Danish: Rapinyl sublinguale resoribletter fås i et udvalg af styrker.