FrancophonIA/ELRC3.0 huggingface dataset:
English: 50μg 100μg 200μg 300μg 400μg 600μg 800μg
Danish: 50µg 100µg 200µg 300µg 400µg 600µg 800µg
English: Adequate body temperature and parenteral fluid intake should be maintained.
Danish: Der skal sørges for opretholdelse af passende legemstemperatur og parenteral væskeindtagelse.
English: The efficacy data show that Rapinyl is statistically different from placebo in the treatment of BTP and these results seem clinically relevant.
Danish: Effektdataene viste, at Rapinyl er statistisk anderledes end placebo til behandlingen af BTP, og disse resultater ser ud til at være klinisk relevante.
English: Thus, only limited clinical data have been generated for the use of Rapinyl.
Danish: Der findes således kun en begrænset mængde kliniske data om brugen af Rapinyl.
English: Strength (micrograms) of supplemental (second) sublingual tablet to be taken 15-30 minutes after first tablet, if required
Danish: Styrke (mikrogram) af supplerende (anden) sublinguale resoriblet, der om nødvendigt skal tages 15-30 minutter efter første resoriblet
English: Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain.
Danish: Gennembrudssmerter er en forbigående forværring af en ellers kontrolleret kronisk baggrundssmerte.
English: The packaging is colour-coded for each Rapinyl sublingual tablet strength.
Danish: Pakningen er farvekodet for hver styrke Rapinyl sublinguale resoribletter.
English: 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).
Danish: Efter administration af Rapinyl er fentanyls hovedeliminationshalveringstid ca. 7 timer (interval 312,5 timer) og den terminale halveringstid er ca. 20 timer (interval 11,5-25 timer).
English: Very common: Nausea
Danish: Meget almindelig: Kvalme
English: The CHMP agreed and considered the issue to be resolved.
Danish: CHMP var enig og anså spørgsmålet for at være besvaret.
English: In addition, the oral cavity was inspected by the clinician or nurse 15-20 minutes after treatment to check for local irritation, no abnormal results were identified and the tablets were well tolerated after both single and repeat doses.
Danish: Derudover blev mundhulen undersøgt af klinikeren eller sygeplejersken 15-20 minutter efter behandlingen for at kontrollere, om der var lokal irritation, og ingen unormale resultater blev registreret, og tabletterne blev tolereret godt efter både enkeltdoser og gentagne doser.
English: Common side effects (affects 1 to 10 users in 100) include:
Danish: Almindelige bivirkninger (påvirker mellem 1 og 10 ud af 100 brugere) omfatter:
English: Secondary effects of fentanyl on central nervous system (CNS), respiratory and gastro-intestinal function are typical of opioid analgesics and are considered to be class effects.
Danish: Sekundære virkninger af fentanyl på centralnervesystemet (CNS), respiratorisk og gastrointestinal funktion er typiske for opioidanalgetika og anses for at være klassevirkninger.
English: This allows the extrapolation of the conclusions from these studies to Rapinyl.
Danish: Dette giver mulighed for ekstrapolation af konklusionerne fra disse forsøg til Rapinyl.
English: This titration should follow the course of administering a single sublingual tablet, with administration of a supplemental second sublingual tablet after 15-30 minutes, if inadequate pain relief is obtained.
Danish: Denne titrering skal foregå ved at administrere en enkelt sublingual resoriblet efterfulgt af administration af en supplerende sublingual resoriblet efter 15-30 minutter, hvis der ikke er opnået tilstrækkelig smertelindring.
English: Severe respiratory depression or severe obstructive lung conditions.
Danish: Alvorlig respirationsdepression eller obstruktiv lungesygdom.
English: • Medicines called monoamine-oxidase (MAO) inhibitors, which are used for severe depression and Parkinson's disease.
Danish: • Medicin, der kaldes monoaminooxidase (MAO)-hæmmere, som bruges mod svær depression og Parkinsons sygdom.
English: Dose escalation should continue in a stepwise manner until adequate analgesia is achieved.
Danish: Dosisoptrapning skal fortsætte trinvist, indtil der er opnået tilstrækkelig analgesi.
English: Rapinyl should be used sublingually.
Danish: Rapinyl skal anvendes sublingualt.
English: The available data on exposition was provided as requested and even if the data are not the definitive ones, the CHMP considered that exposure to Rapinyl is sufficient at this point in time.
Danish: Der blev efter anmodning fremsendt tilgængelige data om eksponering, og selv om dataene ikke er definitive, fandt CHMP, at eksponeringen for Rapinyl er tilstrækkelig på dette tidspunkt.
English: The pharmacokinetics of Rapinyl have been shown to be dose proportional over the dose range of 100 to 800 µg.
Danish: Rapinyls farmakokinetik har vist sig at være dosisproportional i dosisområdet 100-800 µg.
English: In the absence of the data, the Applicant provided data demonstrating a direct correlation between 33% responder analysis and PID, and used the current available pain data and the PID values to estimate the responder rates between active and placebo treatment at earlier time points.
Danish: Da disse data ikke forelå, fremlagde ansøgeren data, der viste en direkte sammenhæng mellem en 33%responsanalyse og PID og brugte de aktuelle tilgængelige data om smerter og PID-værdier til at estimere responsraterne mellem aktiv behandling og placebobehandling på tidligere tidspunkter.
English: Pre-emptive use of Rapinyl for predictable pain episodes was not investigated in the clinical trials.
Danish: Forebyggende anvendelse af Rapinyl mod forudsigelige smerteperioder blev ikke undersøgt i de kliniske undersøgelser.
English: 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.
Danish: Når De og lægen har fundet en dosis af Rapinyl resoribletter, der kontrollerer Deres gennembrudssmerter, må De tage denne dosis højst fire gange om dagen.
English: • If your mouth is dry, take a sip of water to moisten it.
Danish: • Hvis De er tør i munden, så tag en slurk vand for at væde den. Spyt vandet ud eller synk det.
English: • sleeping tablets
Danish: • sovetabletter
English: The CHMP considered that this was not demonstrated by the data provided due to the questionability of the reliability of study EN3267-001, because the data does not allow the evaluation of the bioavailability of the two formulations, and because the pooled analysis cannot be endorsed.
Danish: CHMP anså ikke dette for at være påvist i de fremlagte data på grund af usikkerheden vedrørende pålideligheden af forsøg EN3267-001, da dataene ikke giver mulighed for en vurdering af biotilgængeligheden af de to formuleringer, og da den puljede analyse ikke kan godkendes.
English: Like other opioids fentanyl showed mutagenic effects in vitro in mammalian cells.
Danish: Ligesom andre opioider viste fentanyl mutagene virkninger in vitro i pattedyrsceller.
English: The most serious potential adverse reactions associated with opioid use are respiratory depression (which could lead to respiratory arrest), hypotension and shock.
Danish: De mest alvorlige bivirkninger forbundet med anvendelse af opioider er respirationsdepression (som kan føre til respirationsstop), hypotension og shock.
English: Based on the review of the data and on the Applicant responses to list of outstanding issues and to the remaining issues, the CHMP considered the benefit/risk ratio of Rapinyl to be positive and the application for Rapinyl sublingual tablet 50, 100, 200, 300, 400, 600 and 800 μg to be approvable, provided that the Applicant implements the amendments made to the text of the Product Information and fulfills the conditions to the Marketing Authorisation as described in Annex IV.
Danish: På baggrund af gennemgangen af dataene og ansøgerens svar på spørgsmålene på listen med uafklarede spørgsmål og på de resterende spørgsmål anså CHMP risk/benefit-forholdet for Rapinyl for at være positivt, og anvendelsen af Rapinyl sublingual tablet 50, 100, 200, 300, 400, 600 og 800 µg kan godkendes, forudsat at ansøgeren indarbejder ændringerne til teksten i produktinformationen og opfylder betingelserne for markedsføringstilladelsen som beskrevet i bilag IV.
English: It is recommended to keep Rapinyl in a locked storage space.
Danish: Det anbefales at opbevare Rapinyl på et aflåst sted.
English: The CHMP welcomed the new interim analyses of efficacy and safety data for Rapinyl, but considered that the new data must be regarded as preliminary data, as the complete trial results are not yet available for assessment.
Danish: CHMP hilste de nye interimanalyser af data om effekt og sikkerhed for Rapinyl velkommen, men fandt, at de nye data skal anses for at være foreløbige data, da de samlede forsøgsresultater endnu ikke er tilgængelige for en vurdering.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: However, the CHMP still considers that the safety of Rapinyl needs further clarification, in particular with regards to repeated administration, the 800 µg dose and the dose titration.
Danish: CHMP mener dog stadig, at sikkerheden ved Rapinyl kræver yderligere præcisering, i særlig grad med hensyn til gentagen indgift, dosis på 800 µg og dosistitreringen.
English: The CHMP considered that while there are no reasons to suspect that individualised dose titration would not work for the majority of the patients, the CHMP noted that the highest dose was not studied and considered the study size (n=8) to be too small to draw any reliable conclusions due to the limited number of observations and the absence of statistical analysis of the available data.
Danish: CHMP fandt, at selv om der ikke er grund til at formode, at individualiseret dosistitrering ikke vil virke for flertallet af patienter, er højeste dosis ikke undersøgt, og CHMP anså patientantallet (n=8) for at være for lille til at drage troværdige konklusioner på grund af det begrænsede antal observationer og den manglende statistiske analyse af de tilgængelige data.
English: Pack size: Packs of 10 or 30 sublingual tablets.
Danish: Pakningsstørrelse: Pakninger med 10 eller 30 sublinguale resoribletter.
English: No more than two (2) sublingual tablets should be administered for a single episode of breakthrough pain during this titration phase.
Danish: Der bør ikke indgives mere end to (2) sublinguale resoribletter i en enkelt periode med gennembrudssmerter under denne titreringsfase.
English: Always take Rapinyl exactly as your doctor has told you.
Danish: Tag altid Rapinyl nøjagtigt efter lægens anvisning.
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Danish: Samtidig anvendelse af partielle opioidagonister/-antagonister (f.eks. buprenorphin, nalbuphin, pentazocin) frarådes.
English: In patients with head injuries, the clinical course may be masked by the use of opioids.
Danish: Hos patienter med kranietraumer kan det kliniske forløb maskeres ved anvendelse af opioider.
English: Management of opioid overdose in the immediate term includes removal of any remaining Rapinyl sublingual tablets from the mouth, physical and verbal stimulation of the patient and an assessment of the level of consciousness.
Danish: Behandling af opioidoverdosering omfatter i første omgang fjernelse af eventuelle rester af Rapinyl sublinguale resoribletter fra munden, fysisk og verbal stimulation af patienten og en vurdering af bevidsthedsniveauet.
English: If you do not get adequate pain relief from one tablet your doctor may ask you to take two tablets to treat an episode of breakthrough pain.
Danish: Hvis ikke De får tilstrækkelig smertelindring med én resoriblet, kan lægen bede Dem tage to resoribletter til at behandle en episode af gennembrudssmerter.
English: • depression, difficulty in concentrating, excessive feeling of well being
Danish: • depression, koncentrationsvanskeligheder, ekstrem høj fornemmelse af velvære
English: Due to the potentially serious undesirable effects that can occur when taking an opioid 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.
Danish: På grund af de potentielle alvorlige bivirkninger, der kan opstå under opioidbehandling med f.eks. Rapinyl, skal patienter og deres plejere gøres fuldt opmærksomme på betydningen af at tage Rapinyl korrekt, og hvad de skal gøre, hvis der opstår symptomer på overdosis.
English: If patients are switched from another fentanyl containing product, a new dose titration with Rapinyl is required.
Danish: Hvis patienter skifter fra et andet fentanylholdigt produkt, kræves en ny dosistitrering med Rapinyl.
English: Fentanyl belongs to a group of strong pain-relieving medicines called opioids.
Danish: Fentanyl tilhører en gruppe af stærke smertestillende lægemidler, der kaldes opioider.
English: Rapinyl has not been studied in patients with mouth wounds or mucositis.
Danish: Rapinyl er ikke undersøgt hos patienter med mundsår eller mucositis.
English: The CHMP considered that the number of patients successfully titrating to an effective dose is close to the one observed for both Actiq and Effentora and observed that as 97% of the patients successfully titrating to an effective dose were able to complete the randomisation phase of the study, no particular safety issues were identified.
Danish: CHMP anså antallet af patienter med vellykket titrering til en effektiv dosis som værende tæt på antallet for både Actiq og Effentora og observerede, at eftersom 97% af de patienter, der havde en vellykket titrering til en effektiv dosis, var i stand til at gennemføre randomiseringsfasen i forsøget, blev der ikke registreret nogen særlige sikkerhedsmæssige problemer.
English: The Applicant concluded that an optimal dose of Rapinyl provides a rapid onset of analgesia which mirrors the profile of cancer breakthrough pain.
Danish: Ansøgeren konkluderede, at en optimal dosis Rapinyl giver en hurtig virkning af analgesi, som afspejler profilen for gennembrudssmerter ved cancer.
English: Do not take a second tablet unless your doctor tells you to as this may result in overdose.
Danish: Tag ikke en resoriblet mere, medmindre lægen siger det, da det kunne resultere i en overdosis.
English: Therefore the efficacy/safety profile of Rapinyl could be established.
Danish: Derfor kunne effekt/sikkerhedsprofilen for Rapinyl ikke fastsættes.
English: Particular caution should be exercised during dose titration with Rapinyl in patients with chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression (e.g. myasthenia gravis) because of the risk of further respiratory depression, which could lead to respiratory failure.
Danish: Der skal udvises særlig forsigtighed under dosistitrering med Rapinyl hos patienter med kronisk obstruktiv lungesygdom eller andre medicinske tilstande, der prædisponerer dem for respirationsdepression (f.eks. myasthenia gravis), på grund af risikoen for yderligere respirationsdepression, der ville kunne medføre respirationssvigt.
English: • other strong pain-relieving medicines (opioid-type medicines e.g. for pain and cough)
Danish: • andre stærkt smertestillende lægemidler (medicin af opioidtypen f.eks. mod smerter og hoste)
English: A large number of Rapinyl doses have been administered during these Phase III studies and high doses of Rapinyl have been used for long periods of administration without any cause for concern over the nature and frequency of reported SAEs.
Danish: Et stort antal Rapinyl-doser er blevet indgivet i disse fase III-forsøg, og høje doser af Rapinyl er anvendt under lange indgiftsperioder uden grund til bekymring over arten og hyppigheden af rapporterede alvorlige uønskede hændelser.
English: • mouth wounds or mucositis (swelling and redness of the inside of the mouth)
Danish: • sår i munden eller mucositis (hævelse og rødme inde i munden)
English: In addition, there is solid experience in treating BTP in patients with chronic cancer already receiving a stable dose of background analgesia with strong opioids.
Danish: Desuden er der stor erfaring med at behandle BTP hos patienter med kronisk cancer, som allerede får en stabil dosis baggrundsanalgesi med stærke opioider.
English: You may need to try different strengths of Rapinyl sublingual tablets over a number of episodes of breakthrough pain to find the most appropriate dose.
Danish: Det kan være, at De er nødt til at prøve forskellige styrker af Rapinyl sublinguale resoribletter over flere episoder af gennembrudssmerter for at finde den mest passende dosis.
English: Orally administered fentanyl undergoes pronounced hepatic and intestinal first pass effects.
Danish: Peroralt administreret fentanyl undergår udtalte hepatiske og intestinale førstepassage-virkninger.
English: WHAT RAPINYL IS AND WHAT IT IS USED FOR
Danish: RAPINYLS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
English: If inadequate pain relief is obtained with 2 x 100 microgram sublingual tablets, an increase in dose to the next higher available strength for the next episode of breakthrough pain should be considered.
Danish: Hvis smertelindring med 2 x 100 mikrogram sublinguale resoribletter er utilstrækkelig, bør en dosisøgning til den næste højere styrke til den næste episode af gennembrudssmerter overvejes.
English: This was supported by the known properties of fentanyl, the submitted clinical data, the revised SPC version recommending strict individual dose titration, and the proposed Risk Management Plan.
Danish: Dette blev understøttet af de kendte egenskaber ved fentanyl, de fremsendte kliniske data, det reviderede produktresumé, der anbefaler en streng individuel dosistitrering, og den foreslåede risikohåndteringsplan.
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.
Danish: De har høj affinitet til opioidreceptorer med relativ lav intrinsisk aktivitet og antagoniserer derfor delvist fentanyls analgetiske virkning og kan inducere abstinenssymptomer hos opioidafhængige patienter.
English: If you think that the dose of Rapinyl that you are using is not controlling your breakthrough pain satisfactorily tell your doctor, as he may need to adjust your dose.
Danish: Hvis De mener, at den dosis Rapinyl, De tager, ikke kontrollerer Deres gennembrudssmerter tilfredsstillende, så fortæl det til lægen, da det kan være nødvendigt at han/hun justerer dosis.
English: The CHMP considered the pharmacokinetic data in healthy volunteers vs. patients to be limited; however it agreed that the available data do not indicate alarming differences.
Danish: CHMP anså de farmakokinetiske data for raske frivillige i forhold til patienter for at være begrænsede, men var enig i, at de tilgængelige data ikke viste alarmerende forskelle.
English: Mean maximal plasma concentrations of fentanyl range from 0.2 to 1.3 ng/ml (after administration of 100 to 800 µg Rapinyl) and are reached within 22.5 to 240 minutes.
Danish: Gennemsnitlige, maksimale plasmakoncentrationer af fentanyl spænder fra 0,2 til 1,3 ng/ml (efter administration af 100 til 800 µg Rapinyl) og nås inden for 22,5 til 240 minutter.
English: Silicified microcrystalline cellulose Croscarmellose sodium
Danish: Silificeret mikrokrystallinsk cellulose Croscarmellosenatrium
English: However, the successful suicidal attempt requires attention, and because depression and mood liability are adverse events listed in the SPC of Actiq, the CHMP considered that these kinds of events should be closely monitored and requested the issue to be followed up in post-marketing Pharmacovigilance.
Danish: Det vellykkede selvmordsforsøg kræver imidlertid opmærksomhed, og da depression og humørsvingninger er uønskede hændelser, der er angivet i produktresuméet for Actiq, vurderede CHMP, at den type hændelser skulle monitoreres tæt, og anmodede om, at der bliver fulgt op på problemet i bivirkningsobservationerne post-marketing.
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Danish: Mutagenicitetstest med bakterier og gnavere gav negative resultater.
English: In patients who continue to take their chronic opioid therapy for persistent pain but no longer require treatment for breakthrough pain, Rapinyl therapy may usually be discontinued immediately.
Danish: Hos patienter, der fortsætter med kronisk opioidbehandling for persisterende smerter, men ikke længere har brug for behandling mod gennembrudssmerter, kan behandling med Rapinyl som regel seponeres med det samme.
English: This means that the tablet should be placed under the tongue where it dissolves rapidly in order to allow fentanyl to be absorbed across the lining of the mouth.
Danish: Det betyder, at tabletten skal anbringes under tungen, hvor den hurtigt opløses hvorved fentanyl kan optages gennem mundens slimhinde.
English: Alcohol potentiates the sedative effects of morphine-based analgesics, therefore concomitant administration of alcoholic beverages or medicinal products containing alcohol with Rapinyl is not recommended.
Danish: Alkohol potenserer de sedative virkninger af morfinbaserede analgetika, og derfor frarådes samtidig indtagelse af alkoholiske drikkevarer og lægemidler, der indeholder alkohol, og Rapinyl.
English: Rapinyl should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of hyperkapnia, such as those showing evidence of raised intracranial pressure, reduced consciousness, coma or brain tumours.
Danish: Rapinyl må kun administreres med yderste forsigtighed til patienter, der kan være særligt følsomme over for de intrakranielle virkninger af hyperkapni som f.eks. de patienter, der viser tegn på forhøjet intrakranielt tryk, nedsat bevidsthedsniveau, coma eller hjernetumorer.
English: Fentanyl should not be used during labour and delivery (including caesarean section) since fentanyl crosses the placenta and may cause respiratory depression in the foetus or in the new-born infant.
Danish: Fentanyl bør ikke anvendes under fødsel og forløsning (herunder kejsersnit), da fentanyl krydser placenta og kan medføre respirationsdepression hos fostret eller hos den nyfødte.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: If you start to feel unusually or extremely sleepy or your breathing becomes slow or shallow, you or your carer should immediately contact your doctor or local hospital for emergency help (see also section 3 “If you take more Rapinyl than you should”).
Danish: Hvis De begynder at føle Dem usædvanligt eller ekstremt søvnig, eller Deres vejrtrækning bliver langsom eller overfladisk, skal Deres plejer straks kontakte lægen eller akut lægehjælp (se også pkt.
English: 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.
Danish: Ansøgeren henviste til den fremsendte analyse af forskellen i smerteintensitet (PID) for Rapinyl sammenlignet med placebo fra 10-minutters-tidspunktet i EN3267-005-forsøget.
English: The Applicant also presented and extensively discussed exposure data for the 131 patients that successfully titrated in studies EN3267-005 and 007 and for the patients completing the 3 and 12-month follow-up periods.
Danish: Ansøgeren forelagde også og foretog en omfattende redegørelse af eksponeringsdata for de 131 patienter med vellykket titrering i forsøg EN3267-005 og 007 og for de patienter, der har gennemført opfølgningsperioderne på 3 og 12 måneder.