FrancophonIA/ELRC3.0 huggingface dataset:
English: However, fentanyl may impair the mental or physical ability to perform potentially hazardous tasks such as driving or operating machinery.
Danish: Fentanyl kan imidlertid nedsætte den mentale og fysiske evne til at udføre potentielt farlige opgaver såsom at føre motorkøretøj eller betjene maskiner.
English: If the response (analgesia or adverse reactions) to the titrated Rapinyl dose markedly changes, an adjustment of dose may be necessary to ensure that an optimal dose is maintained.
Danish: Hvis responset (analgesi eller bivirkninger) på den titrerede Rapinyldosis ændrer sig markant, kan en dosisjustering være nødvendig for at sikre at en optimal dosis bibeholdes.
English: The optimal dose of Rapinyl will be determined by upward titration, on an individual patient basis.
Danish: Den optimale dosis Rapinyl vil blive fastlagt ved optitrering baseret på den enkelte patient.
English: Fentanyl should only be used during pregnancy when clearly necessary.
Danish: Fentanyl må kun anvendes under graviditet på tvingende indikation.
English: Your doctor will advise you which strength of tablet to use.
Danish: Lægen vil vejlede Dem om, hvilken styrke resoriblet De skal tage.
English: One patient had a successful suicide attempt but while suicidal ideation is known to be more common in patients with cancer than in the general population, neither suicide nor suicidal ideation has been reported as an adverse event associated with Actiq nor with Fentora/Effentora and based on the similar pharmacokinetic profile of Rapinyl and Actiq, the Applicant believes that this was a sporadic case, consistent with the investigator's assessment as being unrelated.
Danish: Én patient havde et vellykket selvmordsforsøg, men selv om selvmordstanker er kendt for at være mere almindelige hos patienter med cancer end i befolkningen som helhed, har hverken selvmord eller selvmordstanker været rapporteret som en uønsket hændelse forbundet med Actiq eller Fentora/Effentora, og på baggrund af at den farmakokinetiske profil for Rapinyl ligner profilen for Actiq, mener ansøgeren, at dette var et sporadisk tilfælde, hvilket stemmer overens med investigators vurdering af, at hændelsen ikke er relateret.
English: Rapinyl is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
Danish: Anvendelse af Rapinyl frarådes til patienter, der har fået monoaminooxidase (MAO)-hæmmere inden for 14 dage, fordi alvorlig og uforudsigelig potensering af MAO-hæmmere er rapporteret i forbindelse med opioide analgetika.
English: Thus the Applicant considered the safety-profile of Rapinyl to be appropriate for this indication.
Danish: Således anså ansøgeren sikkerhedsprofilen for Rapinyl som værende passende til denne indikation.
English: From the efficacy and safety data provided, Rapinyl seems to be comparable to other fentanyl containing products (Actiq and Effentora) for the treatment of BTP in cancer patients.
Danish: Ud fra de leverede data om effekt og sikkerhed ser det ud til, at Rapinyl er sammenlignelig med andre produkter, der indeholder fentanyl (Actiq og Effentora) til behandlingen af BTP hos cancerpatienter.
English: Rapinyl is a different type of medicine from other medicines you may have used to treat your breakthrough pain.
Danish: Rapinyl er en anderledes type medicin, end den medicin De måske har taget tidligere til behandling af Deres gennembrudssmerter.
English: A range of dose strengths allow individualised upward titration from the recommended starting dose to a dose that provides analgesia with acceptable side-effects.
Danish: Forskellige dosisstyrker muliggør individuel optitrering fra den anbefalede startdosis til en dosis, der giver analgesi med acceptable bivirkninger.
English: The conditions to the Marketing Authorisation as listed in Annex IV.
Danish: Betingelserne for markedsføringstilladelsen er angivet i bilag IV.
English: Patients should be carefully monitored until an appropriate dose is reached, i.e. that provides adequate analgesia with acceptable adverse reactions for each episode of breakthrough pain.
Danish: Patienterne skal kontrolleres omhyggeligt, indtil en passende dosis er opnået, dvs. en dosis som giver tilstrækkelig analgesi med acceptable bivirkninger for hver periode med gennembrudssmerter.
English: The CHMP considered that while the efficacy data showed statistically significant difference in favour of Rapinyl versus placebo on SPID 30, the CHMP considered that the primary endpoints should include the assessment of pain intensity difference by simple scale and to define responder.
Danish: CHMP mente, at selv om effektdataene viste en statistisk signifikant forskel til fordel for Rapinyl versus placebo med hensyn til SPID 30, skulle de primære endepunkter omfatte vurderingen af forskel i smerteintensitet ved hjælp af en simpel skala og en definition af de responderende.
English: 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.
Danish: Der blev opnået en statistisk signifikant reduktion i smerteintensiteten, og klinisk vigtige smertereduktioner forekom hurtigere hos patienter behandlet med Rapinyl end hos patienter behandlet med placebo.
English: Elderly, cachectic, or debilitated patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Danish: Ældre, kakektiske eller debile patienter skal observeres nøje for tegn på fentanyltoksicitet, og dosis skal om nødvendigt reduceres.
English: Total plasma clearance of fentanyl is about 0.5 l/h/kg.
Danish: Fentanyls totale plasmaclearance er ca. 0,5 l/t/kg.
English: Therefore, the CHMP was unable to agree that the safety and efficacy profile of Rapinyl could be anticipated from the provided documentation.
Danish: Derfor var CHMP ikke enig i, at sikkerheds- og effektprofilen for Rapinyl kunne forudses ud fra den leverede dokumentation.
English: • Certain types of antifungal medicines containing e.g. ketoconazole or itraconazole (used to treat fungal infections).
Danish: • Visse typer svampedræbende medicin, der indeholder ketoconazol eller itraconazol (bruges til at behandle svampeinfektioner).
English: Furthermore, the data generated for Rapinyl and the substantial additional cancer patient exposure data demonstrate that volunteers and patients have similar pharmacokinetics, negating the need for additional studies in healthy volunteers.
Danish: Desuden viser de genererede data for Rapinyl og de betydelige yderligere data om eksponering med hensyn til cancerpatienter, at frivillige og patienter har omtrent samme farmakokinetik, hvilket ophæver behovet for yderligere forsøg med raske frivillige.
English: While opioids generally increase the tone of urinary tract smooth muscle, the net effect tends to be variable, in some cases producing urinary urgency, in others, difficulty in urination.
Danish: Mens opioider generelt øger muskeltonus i urinrørets glatte muskulatur, har nettovirkningen tendens til at være variabel og fremkalder i visse tilfælde imperiøs vandladningstrang og hos andre vandladningsbesvær.
English: The pharmacokinetics of Rapinyl are dose proportional and predictable with single and multiple dosing and this simple and quick to administer formulation therefore fulfils an unmet need for a product indicated for the treatment of breakthrough pain in cancer patients.
Danish: Farmakokinetikken af Rapinyl er dosisproportional og forudsigelig ved enkeltdoser og flere doser, og denne enkle og hurtigt indgivne formulering opfylder derfor et uopfyldt behov for et produkt indiceret til behandling af gennembrudssmerter hos cancerpatienter.
English: While not validated, the results obtained from the extrapolations compared favourably to Effentora and Actiq.
Danish: På trods af manglende validering blev der foretaget en vellykket sammenligning af resultaterne fra ekstrapolationerne med Effentora og Actiq.
English: POSSIBLE SIDE EFFECTS Like all medicines, Rapinyl can cause side-effects, although not everybody gets them.
Danish: Rapinyl kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If necessary an oropharyngeal airway or endotracheal tube should be inserted, oxygen administered and mechanical ventilation initiated, as appropriate.
Danish: Om nødvendigt anlægges en tungeholder eller endotrakealt rør, gives ilt og mekanisk ventilation initieres efter behov.
English: The Applicant confirmed that the tablets used in the Endo Phase III studies, EN3267-005 and EN3267-007, are qualitatively and quantitatively identical to the tablets currently under review in Europe and that the manufacturing process is the same using fentanyl citrate from the same supplier, with identical specifications.
Danish: Ansøgeren bekræftede, at de tabletter, der blev brugt i Endos fase III-forsøg EN3267-005 og EN3267007 , er kvalitativt og kvantitativt identiske med de tabletter, der i øjeblikket undersøges i Europa, og at fremstillingsprocessen er den samme, idet der bruges fentanylcitrat fra samme leverandør og med identiske specifikationer.
English: You must always use the dose of Rapinyl as prescribed by your doctor - this may be a different dose from that which you have used with other medicines for breakthrough pain.
Danish: De skal altid bruge den dosis Rapinyl, som lægen har ordineretdette kan være en anderledes dosis, end den De har taget med anden medicin mod gennembrudssmerter.
English: If adequate analgesia is not obtained within 15-30 minutes of administration of a single sublingual tablet, a second 100 microgram sublingual tablet may be administered.
Danish: Hvis der ikke opnås tilstrækkelig analgesi inden for 15-30 minutter efter indtagelse af en enkelt sublingualresoriblet, kan der gives en 100 mikrogram sublingual resoriblet mere.
English: In addition, the suicidality should be monitored, as depression and mood liability are part of the reported AEs for Actiq.
Danish: Desuden skal selvmordstrangen monitoreres, idet depression og humørsvingninger udgør nogle af de rapporterede uønskede hændelser for Actiq.
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed overfor det aktive stof eller over for et eller flere af hjælpestofferne.
English: This risk is higher in opioid-naïve subjects than in patients experiencing severe pain or receiving chronic opioid therapy.
Danish: Risikoen er højere for opioidnaive personer end hos patienter, der oplever svære smerter eller som er i kronisk opioidbehandling.
English: 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.
Danish: Ansøgeren betragtede yderligere den aktuelle strategi om at bygge bro som værende passende til godkendelse af Rapinyl i dosisområdet 100-800 µg til behandling af BTP hos patienter, da Rapinyl frigiver fentanyl inden for et plasmakoncentrationsområde, der allerede er fastsat som sikkert og effektivt.
English: The symptoms of fentanyl overdose are an extension of its pharmacological actions, the most serious effect being respiratory depression, which may lead to respiratory arrest.
Danish: Symptomerne på fentanyl overdosering er en udvidelse af stoffets farmakologiske virkninger hvoraf den alvorligste er respirationsdepression, som kan føre til respirationsstop.
English: In this situation, endotracheal intubation, assisted ventilation and administration of opioid antagonists as well as muscle relaxants may be requested.
Danish: I denne situation kan det være nødvendigt med endotracheal intubation, kunstig ventilation og administration af opioidantagonister samt muskelrelaksantia.
English: Safety data from EN3267-005 and EN3267-007 have also been provided based on an interim cut of the safety database in January 2008, comprising only serious adverse events (SAEs).
Danish: Sikkerhedsdata fra EN3267-005 og EN3267-007 er også fremlagt på baggrund af et foreløbigt skæringstidspunkt for sikkerhedsdatabasen i januar 2008, der udelukkende omfatter alvorlige uønskede hændelser.
English: Concomitant use of other CNS depressants, such as other morphine derivatives (analgesics and antitussives), general anaesthetics, skeletal muscle relaxants, sedative antidepressants, sedative H1 antihistamines, barbiturates, anxiolytics (ie benzodiazepines), hypnotics, antipsychotics, clonidine and related substances may produce increased CNS depressant effects.
Danish: Samtidig anvendelse af andre CNS-depressiva såsom andre morfinderivater (analgetika og antitussiva), universel anæstesi, skeletmuskelrelaksantia, sedative antidepressiva, sedative H1antihistaminer, barbiturater, anxiolytika (dvs. benzodiazepiner), hypnotika, antipsykotika, clonidin og beslægtede stoffer kan fremkalde øgede CNS dæmpende virkninger.
English: The use of Rapinyl in patients with hepatic or renal impairment may increase the bioavailability of fentanyl and decrease its systemic clearance, which could lead to accumulation and increased and prolonged opioid effects.
Danish: Anvendelsen af Rapinyl til patienter med nedsat lever- eller nyrefunktion kan øge biotilgængeligheden af fentanyl og nedsætte dets systemiske clearance, hvilket kunne føre til akkumulation og øgede og forlængede opioidvirkninger.
English: Fentanyl is a well-known and widely used synthetic short acting strong opioid analgesic, used in the treatment of patients with severe pain.
Danish: Fentanyl er et kendt og almindeligt anvendt syntetisk korttidsvirkende stærkt opioidanalgetikum, der bliver anvendt til behandlingen af patienter med svære smerter.
English: Before taking Rapinyl for the first time your doctor will explain how Rapinyl should be taken to effectively treat your breakthrough pain.
Danish: Inden De tager Rapinyl første gang, vil lægen forklare, hvordan Rapinyl skal tages for at behandle Deres gennembrudssmerter effektivt.
English: 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.
Danish: Afslutningsvis fandt ansøgeren, at resultaterne fra forsøg EN3267-005 og EN3267-007 bekræfter konklusionerne baseret på den originale strategi om at bygge bro og påviser, at Rapinyl sikkert og effektivt kan bruges til at behandle flere episoder af gennembrudssmerter ved cancer hos opioidtolerante patienter.
English: Fentanyl should therefore be given to patients with caution if administered concomitantly with CYP3A4 inhibitors.
Danish: Fentanyl skal derfor administreres med forsigtighed til patienter, hvis det indtages samtidigt med CYP3A4-hæmmere.
English: For Rapinyl to work successfully, your doctor will need to identify the most appropriate dose for treating a single episode of breakthrough pain.
Danish: For at Rapinyl skal virke succesfuldt, er lægen nødt til at bestemme den mest passende dosis til behandling af en enkelt episode med gennembrudssmerter.
English: The CHMP also considered it necessary to assess the full report of the analysis on the comparability of Rapinyl and Actiq, as the available PK data could not support the similarity of both products.
Danish: CHMP anså det også for nødvendigt at vurdere hele rapporten om analysen af sammenligneligheden mellem Rapinyl og Actiq, eftersom de tilgængelige PK-data ikke kunne understøtte ligheden mellem de to produkter.
English: Before Rapinyl therapy is initiated, it is important that the patient's long-acting opioid treatment used to control their persistent pain has been stabilised.
Danish: Før behandlingen med Rapinyl initieres, er det vigtigt, at patientens langtidsvirkende opioidbehandling, der anvendes til at kontrollere deres persisterende smerter, er blevet stabiliseret.
English: Muscle rigidity interfering with respiration has been reported with fentanyl and other opioids.
Danish: Muskelstivhed, der påvirker respirationen, er rapporteret i forbindelse med fentanyl og andre opioider.
English: The initial dose of Rapinyl used should be 100 micrograms, titrating upwards as necessary through the range of available dosage strengths.
Danish: Den initiale dosis Rapinyl, der anvendes, bør være 100 mikrogram, idet der optitreres efter behov under anvendelse af tilgængelige dosisstyrker.
English: Active substances that inhibit CYP3A4 activity such as macrolide antibiotics (e.g. erythromycin), azole antifungal agents (e.g. ketoconazole, itraconazole) or certain protease inhibitors (e.g. ritonavir) may increase the bioavailability of fentanyl by decreasing its systemic clearance, potentially enhancing or prolonging opioid effects.
Danish: Lægemidler, der hæmmer CYP3A4-aktivitet såsom makrolidantibiotika (f.eks. erythromycin), azolsvampemidler (f.eks. ketoconazol, itraconazol) eller visse proteasehæmmere (f.eks. ritonavir), kan øge fenatyls biotilgængelighed ved at nedsætte dets systemiske clearance og potentielt forstærke eller forlænge opioidvirkningerne.
English: In conclusion, the Applicant believes that the demonstration of a statistically significant improvement in PID at 10 and 15 minutes in EN3267005 is the appropriate, clinically relevant measure of the early effectiveness of Rapinyl, and that an improvement in PID is directly reflected in an increase in responder rate.
Danish: Afslutningsvis mener ansøgeren, at påvisningen af en statistisk signifikant forbedring i PID efter 10 og 15 minutter i EN3267-005 er den passende, klinisk relevante måling af den hurtige effekt af Rapinyl, og at en forbedring i PID afspejles direkte som en stigning i responsraten.
English: Grapefruit juice is also known to inhibit CYP3A4.
Danish: Det er kendt at grapefrugtjuice også hæmmer CYP3A4.
English: Rapinyl is a small white sublingual tablet to be inserted under the tongue.
Danish: Rapinyl er en lille hvid sublingual resoriblet, der skal placeres under tungen.
English: If you have not, this medicine could cause severe breathing difficulties (see section 4 - Possible side effects).
Danish: Hvis dette ikke er tilfældet, kan denne medicin forårsage alvorligt vejrtrækningsbesvær (se pkt.
English: 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 and pharmacokinetic profiles as Actiq at both low and high doses.
Danish: Ansøgeren har karakteriseret den farmakokinetiske profil for Rapinyl ved at påvise hurtig frigivelse, forudsigelig PK i det foreslåede dosisområde og har også vist, at Rapinyl opnår omtrent samme plasmakoncentrationer og farmakokinetiske profiler som Actiq ved både lave og høje doser.
English: The CHMP acknowledged the data submitted, noting and assessing the data from the clinical studies EN3267-005 and EN3267-007.
Danish: CHMP anerkendte de fremsendte data og registrerede og vurderede dataene fra de kliniske forsøg EN3267-005 og EN3267-007.
English: The 50 microgram strength sublingual tablet may be used for an intermediate dose-titration step.
Danish: Den sublinguale resoriblet à 50 microgram kan anvendes som et intermediært dosistitreringstrin.
English: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract leading to a prolongation in gastrointestinal transit time, which may be responsible for the constipating effect of fentanyl.
Danish: Opioider øger tonus og nedsætter de propulsive kontraktioner i den glatte muskulatur i mavetarmkanalen, der medfører en forlængelse i gastrointestinal gennemløbstid, hvilket kan være ansvarlig for fentanyls obstiperende virkning.
English: The Applicant also discussed xerostomia and mucositis and was of the opinion that neither was expected to significantly affect the dissolution or absorption of sublingual Rapinyl, although noting that Rapinyl was not expected to be used in patients with severe mucositis.
Danish: Ansøgeren omtalte også xerostomi og mucositis og mente, at ingen af dem forventedes at have en signifikant indvirkning på opløsningen eller absorptionen af sublingual Rapinyl, selv om det blev bemærket, at Rapinyl ikke forventedes at blive brugt til patienter med svær mucositis.
English: 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.
Danish: Hos patienter, der ikke længere har brug for opioidbehandling, skal Rapinyl dosis tages i betragtning, før en gennemførelse af en gradvis nedtitrering af opioider for at minimere mulige abstinenssymptomer.
English: Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action.
Danish: Fentanyl er et potent µ-opioid analgetikum med hurtig analgetisk virkning og kort virkningsvarighed.
English: - the dose range of Rapinyl and the dose proportionalilty between Actiq and Rapinyl was considered as established
Danish: - Dosisområdet for Rapinyl og dosisproportionaliteten mellem Actiq og Rapinyl blev anset som værende underbygget,
English: Fentanyl is metabolised by CYP3A4.
Danish: Fentatyl metaboliseres af CYP3A4.
English: The Applicant further described data from the time of the safety cut-off (Jan-08) and considered that the derived information compared favourably to values quoted for Effentora and Actiq, although the reason for patient drop-out was not provided by the sponsor.
Danish: Ansøgeren beskrev yderligere data fra skæringstidspunktet for sikkerhed (jan. 08) og vurderede, at de udledte oplysninger kunne sammenlignes med de angivne værdier for Effentora og Actiq, selv om grunden til patientfrafaldet ikke blev angivet af sponsor.
English: What Rapinyl contains
Danish: Rapinyl indeholder
English: Common: Asthenia, application site irritation
Danish: Almindelig: Asteni, irritation på applikationsstedet
English: The Applicant considered that Rapinyl can be successfully titrated and repeatedly administered effectively and safely to treat patients with multiple episodes of breakthrough pain.
Danish: Ansøgeren anså Rapinyl for med held at kunne titreres og gentagne gange indgives effektivt og sikkert til behandling af patienter med flere episoder af gennembrudssmerter.
English: The Applicant provided the case narratives for all the deaths notified to the Applicant and reviewed the adverse events with an outcome of death, and concluded that these deaths not considered as related to the study drug by the study investigators.
Danish: Ansøgeren leverede case-beretninger for alle de dødsfald, der var meddelt til ansøgeren, og gennemgik de uønskede hændelser, der var resulteret i dødsfald, og konkluderede, at investigatorerne ikke anså disse dødsfald for at være relateret til forsøgslægemidlet.
English: The CHMP was reassured by the absence of safety signals related to SAEs were reported but requested the Applicant to submit a full safety analysis as conditions to the Marketing Authorisations.
Danish: CHMP blev forsikret i kraft af rapporteringen af de udeblevne sikkerhedssignaler med relation til alvorlige uønskede hændelser, men anmodede ansøgeren om at fremsende en komplet sikkerhedsanalyse som en betingelse for markedsføringstilladelserne.
English: Ask your doctor or pharmacist for advice before taking any medicine when pregnant or breast-feeding.
Danish: Spørg lægen eller apoteket til råds inden De tager nogen form for medicin.
English: You must not use Rapinyl during pregnancy unless you have been specifically told to by your doctor.
Danish: De må ikke tage Rapinyl, mens De er gravid, medmindre lægen udtrykkeligt har sagt, at De skal.