FrancophonIA/ELRC3.0 huggingface dataset:
English: If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube.
Danish: Hvis den kliniske situation berettiger det, bør en åben luftvej etableres og opretholdes, eventuelt med en orofaryngeal luftvej eller endotrakeal slange.
English: The efficacy and safety of IONSYS for treatment of acute, moderate to severe postoperative pain was evaluated in seven controlled studies in 1763 IONSYS patients: three placebo-controlled studies and four active-controlled studies.
Danish: IONSYS' sikkerhed og virkning i behandlingen af akutte moderate til kraftige postoperative smerter blev evalueret i syv kontrollerede studier med 1.763 IONSYS-patienter: tre placebokontrollerede studier og fire aktivkontrollerede studier.
English: Excessive sweating may reduce delivery of fentanyl.
Danish: Kraftig sved kan nedsætte tilførslen af fentanyl.
English: The most commonly reported adverse reactions were nausea, vomiting, and application site reactions such as erythema and pruritus.
Danish: De hyppigst indberettede bivirkninger var nausea, opkastning og reaktioner på påsætningsstedet såsom erythem og pruritus.
English: The primary endpoint in each placebo-controlled study was the proportion of withdrawals due to inadequate analgesia during the period from 3 to 24-hours after IONSYS application.
Danish: Det primære endemål i hvert placebokontrolleret studie var andelen af frafald på grund af utilstrækkelig analgesi i et tidsrum fra 3-24 timer efter påsætning af IONSYS.
English: Less than 10% of administered fentanyl is excreted unchanged by the kidney.
Danish: Mindre end 10% af den administrerede fentanyl udskilles uændret af nyrerne.
English: • Choose healthy, unbroken skin (non-irritated and nonirradiated skin) site on the chest or upper outer arm ONLY.
Danish: • Vælg KUN et sted med sund, intakt hud (ikke-irriteret og ikkebestrålet) på bryst eller udvendigt på overarmen.
English: IONSYS should be used with caution in patients with hearing impairment who might not be able to hear the audible signals from the system.
Danish: IONSYS skal anvendes med forsigtighed til patienter med nedsat hørelse, som muligvis ikke vil kunne høre systemets lydsignaler.
English: Fentanyl should not be used in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.
Danish: Fentanyl bør ikke anvendes til patienter, som kan være særligt modtagelige over for de intrakranielle virkninger af CO2-retention, for eksempel patienter med tegn på forhøjet intrakranielt tryk, nedsat bevidsthedsniveau eller coma.
English: IONSYS is removed from the patient by lifting the system at the red tab and peeling it away from the skin site.
Danish: IONSYS fjernes fra patienten ved at løfte systemet ved den røde flig og trække det væk fra huden.
English: In Study CAPSS-319, half the patients in each group received rofecoxib perioperatively and in Study FEN-PPA-401 patients were allowed non-opioid analgesics throughout the study period.
Danish: I studie CAPSS-319 fik halvdelen af patienterne i hver gruppe rofecoxib perioperativt, og i studie FEN-PPA-401 måtte patienterne få non-opioide analgetika i hele studieperioden.
English: Fentanyl is an opioid analgesic, interacting predominantly with the opioid μ-receptor.
Danish: Fentanyl er et opioidt analgetikum, der fortrinsvis interagerer med den opioide μ-receptor.
English: • tightness/tension in muscles, muscle pain
Danish: • trykken/spændinger i musklerne, muskelsmerter
English: • The slow blinking green light means IONSYS is ready to dose.
Danish: • Det langsomt blinkende grønne lys betyder, at IONSYS er klar til at dosere.
English: Its secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria (see section 5.2).
Danish: De sekundære farmakologiske virkninger er respirationsdepression, bradykardi, hypothermi, obstipation, miosis, fysisk afhængighed og eufori (se pkt.
English: In this study 28 paediatric patients, 6 to 16 years old, were treated with IONSYS fentanyl 40 micrograms after experiencing inadequate analgesia with IONSYS fentanyl 25 micrograms.
Danish: I dette studie blev 28 pædiatriske patienter i alderen 6 til 16 år behandlet med IONSYS fentanyl 40 mikrogram efter utilstrækkelig analgesi med IONSYS fentanyl 25 mikrogram.
English: Itraconazole, a potent CYP3A4 inhibitor, at 200 mg/day orally for 4 days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Danish: Itraconazol, en potent CYP3A4-hæmmer, havde ved 200 mg/dag oralt i 4 dage ingen signifikant virkning på farmakokinetikken for intravenøs fentanyl.
English: • severe headache (migraine)
Danish: • kraftig hovedpine (migræne)
English: Supplemental intravenous opioid medication (fentanyl or morphine) was only allowed during the first 3 hours of IONSYS or PCA morphine treatment.
Danish: Supplerende medicinering med intravenøse opioider (fentanyl eller morfin) var kun tilladt i de første 3 timer med behandling med IONSYS eller PCA med morfin.
English: • Patients should not wear more than one IONSYS at the same time.
Danish: • Patienten bør ikke bære mere end ét IONSYS-system ad gangen.
English: The overall adverse reaction profile for morbidly obese patients (BMI > 40) does not suggest a meaningful difference in safety compared to patients with BMI ≤ 40.
Danish: Overvægtige patienter Den samlede bivirkningsprofil for sygeligt overvægtige patienter (BMI > 40) tyder ikke på nogen relevant forskel i sikkerheden sammenlignet med patienter med et BMI på ≤ 40.
English: The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression (see section 5.2).
Danish: Manifestationerne af en overdosis af fentanyl er en udvidelse af dets farmakologiske virkemåde, hvor den mest alvorlige virkning er respirationsdepression (se pkt.
English: Only you know how much pain you are having, and only you should operate IONSYS to start a dose of medicine.
Danish: Kun du selv ved, hvor mange smerter du har, og du må kun betjene IONSYS, når du skal have en dosis medicin.
English: IONSYS is a transdermal system (to be applied on intact skin) that contains a strong analgesic (pain reliever) medicine called fentanyl.
Danish: IONSYS er et transdermalt system (skal sættes på intakt hud), der indeholder et kraftigt smertestillende middel (et analgetikum), som kaldes for fentanyl.
English: Breast-feeding is not recommended for 24 hours following removal of IONSYS.
Danish: Amning anbefales ikke i 24 timer, efter at IONSYS er taget af.
English: • Continuous blinking red light
Danish: • Kontinuerligt blinkende rødt lys
English: The use of concomitant CNS-active medicinal products may increase the risk of respiratory depression (see section 4.5).
Danish: Samtidig anvendelse af CNS-aktive lægemidler kan forhøje risikoen for respirationsdepression (se pkt.
English: The design of the system allows separate disposal of the hydrogel housing and the Controller.
Danish: Systemets design giver mulighed for at kassere hydrogelhylsteret og controlleren separat.
English: Head injuries and increased intracranial pressure
Danish: Kranietraumer og forhøjet intrakranielt tryk
English: • Only 1 IONSYS system should be applied at any given time.
Danish: • Der må kun påsættes 1 IONSYS-system ad gangen.
English: Do not use IONSYS:
Danish: Brug ikke IONSYS:
English: Data on IONSYS in paediatrics is limited to information from a single clinical trial.
Danish: Data vedrørende anvendelse af IONSYS i den pædiatriske population er begrænsede til informationer fra et enkelt klinisk studie.
English: • chest pain, feeling of general discomfort or uneasiness
Danish: • brystsmerter, en generel følelse af ubehag eller utilpashed
English: Transdermal system
Danish: Transdermalt system
English: • you are severely obese or have a condition called sleep apnoea that causes interrupted breathing during sleep and which can occur in severely obese individuals.
Danish: • du er svært overvægtig eller har en tilstand, der kaldes for søvnapnø, som medfører afbrydelse af vejrtrækningen under søvn, og som kan forekomme hos svært overvægtige personer.
English: • if you suffer from severe breathing problems or cystic fibrosis.
Danish: • hvis du lider af alvorlige vejrtrækningsproblemer eller cystisk fibrose.
English: The pharmacokinetic absorption profile will repeat with each application to a new skin site, therefore with each new application,
Danish: Den farmakokinetiske absorptionsprofil gentages med hver ny påsætning et nyt sted på huden.
English: Fentanyl induced mutagenic effects in mammalian cells in vitro, comparable to other opioid analgesics.
Danish: Fentanyl inducerede mutagene effekter i pattedyrsceller in vitro, der var sammenlignelige med andre opioid-analgetika.
English: Systemic absorption of fentanyl increases as a function of time independent of the frequency of dosing, with the initial dose being approximately 16 micrograms.
Danish: Den systemiske absorption af fentanyl stiger som en funktion af tid, uafhængigt af doseringshyppighed, med en initialdosis på cirka 16 mikrogram.
English: Therefore, the use of any of these medicinal products concomitantly with IONSYS requires special patient care and observation.
Danish: Anvendelse af disse lægemidler sammen med IONSYS kræver derfor særlig forsigtighed og observation af patienten.
English: IONSYS may be removed at any time.
Danish: IONSYS kan fjernes når som helst.
English: As shown below, the primary endpoint, proportion of patients reporting “Good or Excellent” ratings for the two methods of pain relief in all four studies demonstrated equivalence, with each 95% confidence interval contained within the prespecified ± 10% equivalence boundaries.
Danish: Som vist nedenfor udviste det primære endemål (andelen af patienter, der gav vurderingen “god eller meget god” af de to smertelindringsmetoder i alle fire studier) ækvivalens med hvert 95% konfidensinterval indeholdt inden for de forud fastlagte ækvivalensgrænser på ± 10%.
English: More than 90% of the administered dose of fentanyl is eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Danish: Mere end 90% af den administrerede dosis fentanyl elimineres ved biotransformation til N-dealkylerede og hydroxylerede inaktive metabolitter.
English: At the initiation of each dose, an electrical current moves a pre-determined amount of fentanyl from the active substance-containing reservoir through the skin and into systemic circulation.
Danish: Efter aktivering af hver dosis flyttes ved hjælp af elektricitet en forud fastlagt mængde fentanyl fra hylsteret med det aktive stof ind gennem huden og ind i det systemiske kredsløb.
English: Special precautions for disposal should be followed (see section 6.6).
Danish: Særlige forsigtighedsregler vedrørende bortskaffelse skal følges (se pkt.
English: Fentanyl pharmacokinetics are similar with both single and multiple 24 hour applications.
Danish: Fentanyls farmakokinetik er den samme efter både enkelte og flere 24-timers påsætninger.
English: The green light will change from a slow flash rate to a rapid flash rate and the digital display will alternate between a rotating circle and the number of completed doses during the entire 10-minute dose delivery period.
Danish: Det grønne lys vil skifte fra at blinke langsomt til hurtigt, og det digitale display vil skifte mellem at vise en roterende cirkel og antal fuldførte doser i hele doseringsperioden på 10 minutter.
English: • No light
Danish: • Intet lys
English: Local arrangements should be in place to ensure that used systems are returned appropriately (e.g., to hospital pharmacies) for disposal of the residual fentanyl in the hydrogel.
Danish: Der bør forefindes lokale foranstaltninger, som sikrer, at brugte systemer returneres på passende vis (fx på sygehusapoteket), når resterende fentanyl i hydrogelen skal kasseres.
English: A new IONSYS system was applied every 24 hours to different skin sites, or earlier if all doses were used.
Danish: Der blev påsat et nyt IONSYS-system forskellige steder på huden for hver 24 timer eller tidligere, hvis alle doser var opbrugt.
English: Due to the well-known potential of abuse of fentanyl, physicians should evaluate patients for a history of drug abuse (see section 4.4).
Danish: På grund af den velkendte risiko for misbrug af fentanyl bør lægen evaluere patienten med hensyn til tidligere medicinmisbrug (se pkt.
English: The following adverse reactions have been reported with IONSYS during clinical studies and post marketing experience.
Danish: Nedenstående bivirkninger er blevet indberettet for IONSYS under kliniske studier og efter markedsføring.
English: You will know you have started a dose when you hear a beep.
Danish: Du ved, at en dosis er startet, når der lyder et bip.
English: About 9% of the dose is recovered in the faeces, primarily as metabolites.
Danish: Cirka 9% af dosis findes i fæces, primært som metabolitter.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where IONSYS is launched all healthcare professionals who are expected to prescribe, dispense or administer IONSYS are informed through an information letter on having access to / are provided with the following items:
Danish: Efter drøftelse og indgåelse af aftale med den nationale kompetente myndighed i de enkelte medlemsstater, hvor IONSYS lanceres, skal indehaveren af markedsføringstilladelsen sørge for, at alle sundhedspersoner, der forventes at ordinere, udlevere eller administrere IONSYS, får tilsendt et informationsbrev med besked om, hvordan de får adgang til eller får udleveret følgende materiale:
English: Additional analyses suggest that the surgical procedure type did not influence the trends in efficacy endpoints and the efficacy of IONSYS was similar across the range of body mass indices studied (< 25 to > 40 kg/m2
Danish: Yderligere analyser tyder på, at det kirurgiske indgreb ikke påvirkede tendenserne i effektendemålene, og at effekten af IONSYS var ensartet på tværs af de undersøgt BMI'er (< 25 til > 40 kg/m2 body mass index)
English: Currently available data are described in section 4.8, but no recommendation on posology can be made.
Danish: 4.8, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Only limited data are available in patients with thoracic/chest and upper abdominal surgeries.
Danish: Der findes kun begrænsede data vedrørende patienter, der har gennemgået thorax-/brystkirurgi og øvre abdominalkirurgi.
English: IONSYS is used to treat short-term moderate to severe pain in adults after an operation.
Danish: IONSYS bruges til behandling af kortvarige moderate til kraftige smerter hos voksne efter en operation.
English: The hospital staff will store IONSYS.
Danish: Hospitalspersonalet vil opbevare IONSYS.
English: Each IONSYS system is packaged in a sealed thermoform tray.
Danish: Hvert IONSYS-system er pakket i en forseglet termoformet bakke.
English: Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance.
Danish: Patienterne skal frarådes at føre motorkøretøj og betjene maskiner, hvis de oplever somnolens, svimmelhed eller synsforstyrrelser.
English: Do not press the dosing button.
Danish: Tryk ikke på doseringsknappen.
English: - You will know the dose is being delivered when the green light blinks faster.
Danish: - Du ved, at dosen tilføres, når det grønne lys blinker hurtigere.
English: Hypoventilation, hypotension, and profound sedation or coma may occur.
Danish: Der kan opstå hypoventilation, hypotension og dyb sedering.
English: Oral ritonavir, one of the most potent CYP3A4 inhibitors, reduced the clearance of intravenous fentanyl by two thirds.
Danish: Oral ritonavir, en af de mest potente CYP3A4-hæmmere, reducerede clearancen af intravenøs fentanyl med to tredjedele.
English: IONSYS should be removed prior to certain procedures such as cardioversion (electrical current used to restore normal heart rhythm), defibrillation (electric shock given to the heart) or diathermy (electrical current used in physical therapy or surgery).
Danish: IONSYS skal fjernes inden visse procedurer, for eksempel kardioversion (elektricitet, der bruges til at genoprette en normal hjerterytme), defibrillering (elektrisk stød, der gives til hjertet) eller diatermi (elektricitet, der bruges i forbindelse med fysioterapi eller operationer).
English: If you are given IONSYS during childbirth your baby may need to be given an antidote when it is born.
Danish: Hvis du får IONSYS under fødslen, vil barnet muligvis skulle have en modgift, når det er født.
English: • Information to aid healthcare professionals in selecting patients appropriate for treatment with IONSYS.
Danish: • Anvisninger, der hjælper relevante sundhedspersoner med at udvælge patienter, som egner sig til at blive behandlet med IONSYS.
English: IONSYS should only be activated by the patient.
Danish: IONSYS bør kun aktiveres af patienten.
English: Dry mouth Dyspepsia Flatulence Ileus
Danish: Mundtørhed Dyspepsi Flatulens Ileus
English: If you have a genetic condition (polymorphism) which affects certain enzymes in your body (CYP3A4 and CYP3A5), inform your doctor.
Danish: Hvis du har en genetisk forstyrrelse (polymorfi), der berører bestemte enzymer i kroppen, (CYP3A4 og CYP3A5), skal du sige det til lægen.
English: IONSYS should not be administered during childbirth.
Danish: IONSYS må ikke gives under fødsel.
English: Soap, alcohol, or other solvents should not be used to remove the hydrogel because they may enhance the active substances' ability to penetrate the skin.
Danish: Sæbe, alkohol eller andre opløsningsmidler må ikke anvendes til at fjerne hydrogelen, da de kan forstærke det aktive stofs evne til at gennemtrænge huden.
English: Opioids may obscure the clinical course of patients with head injury.
Danish: Opioider kan sløre det kliniske forløb hos patienter med kranietraume.
English: Prior to launch of IONSYS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden IONSYS lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen indgå en aftale med den nationale kompetente myndighed om indholdet og formatet af oplæringsprogrammet, herunder kommunikationsmedier, distributionsmåder og lignende.
English: In these studies, 1313 patients undergoing major surgery were randomized to PCA with intravenous morphine (1 mg morphine bolus, 5 minute lock-out, total of 10 mg/h) delivered by a pump, and 1288 patients were randomized to IONSYS.
Danish: I disse studier blev 1.313 patienter, der havde gennemgået større indgreb, randomiseret til PCA med intravenøs morfin (1 mg morfinbolus, 5 minutters lukning, i alt 10 mg/t) tilført med pumpe, og 1.288 patienter blev randomiseret til IONSYS.
English: Data obtained with intravenous fentanyl in patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis.
Danish: Data, der er indsamlet efter anvendelse af intravenøs fentanyl til patienter med nyreinsufficiens, tyder på, at fentanyls distributionsvolumen kan ændres ved dialyse.
English: IONSYS should, therefore, be used with caution in these patients.
Danish: IONSYS skal derfor anvendes med forsigtighed til disse patienter.
English: Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Danish: Fentanyl, et aktivt stof med høj clearance, metaboliseres hurtigt og omfattende, fortrinsvis af CYP3A4.
English: IONSYS should be removed before the patient is discharged.
Danish: IONSYS skal fjernes, inden patienten udskrives.
English: • you have severe headaches, have had a significant head injury, or have a brain tumour
Danish: • du lider af kraftig hovedpine, har haft en betydelig skade i hovedet eller har en kræftknude i hjernen
English: During the first 3 hours post-enrollment, patients could supplement with bolus intravenous fentanyl given, as needed, to achieve comfort.
Danish: I de første 3 timer efter inklusion kunne patienterne supplere efter behov med intravenøs fentanyl givet som bolus til et acceptabelt niveau.
English: If system beeps again, then remove and dispose of system, and place a new system on a different skin site.
Danish: Hvis systemet bipper igen, så fjern og kassér systemet, og sæt et nyt system på huden et andet sted.
English: Before any surgery, the healthcare professional should ensure that the patient has been properly informed on how to use IONSYS post-operatively.
Danish: Sundhedspersonalet skal før ethvert kirurgisk indgreb sikre, at patienten er korrekt informeret om anvendelsen af IONSYS postoperativt.
English: • you are taking medicines that might make you sleepy such as sleeping tablets, tranquilisers, medicines for anxiety or medicines for allergies (anti-histamines);
Danish: • du tager lægemidler, der kan gøre dig søvnig - for eksempel sovepiller, beroligende midler, midler mod angst eller midler mod allergi (antihistaminer)
English: If device failure or malfunction is suspected by a healthcare professional, IONSYS should be immediately removed from the patient and The Medicines Company contacted straightaway.
Danish: Hvis sundhedspersonalet har mistanke om funktionssvigt eller fejl ved systemet, skal IONSYS straks tages af patienten, og The Medicines Company skal kontaktes med det samme.
English: • IONSYS may be removed at any time.
Danish: • IONSYS kan fjernes når som helst.
English: The mean amount of supplemental opioid used during this time was also similar among patients treated with IONSYS or PCA morphine i.e. a range across the 4 studies of a mean dose of 5.0 - 7.5 mg morphine in patients treated with IONSYS compared to a mean dose of 5.4 - 7.7mg morphine in patients receiving PCA morphine.
Danish: Den gennemsnitlige mængde ekstra opioider, der blev brugt i dette tidsrum, var også ens hos patienter, der blev behandlet med IONSYS eller PCA med morfin, dvs. inden for et interval på tværs af de fire studier med en gennemsnitsdosis på 5,0 - 7,5 mg morfin hos patienter, der blev behandlet med IONSYS, sammenlignet med en gennemsnitsdosis på 5,4 - 7,7 mg morfin hos patienter, der fik PCA med morfin.
English: • you are using medicines for topical use (i.e. medicines that are applied on the skin).
Danish: • du tager lægemidler til topisk anvendelse (for eksempel lægemidler, der smøres på huden).
English: Each tray is packaged in a folding cardboard carton.
Danish: Hver bakke er pakket i en foldet papkarton.
English: • you have problems with your liver or kidneys
Danish: • du har problemer med lever eller nyrer
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 doses
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 80 doser
English: When applying tape, care should be taken not to tape over the light window, the digital display, or the dosing button.
Danish: Ved påsætning af tape må tapen ikke sættes hen over lysruden, det digitale display eller doseringsknappen.
English: Literature has shown that the genetic polymorphisms only account for a small amount of variability in concentrations of fentanyl with transdermal administration.
Danish: Det er påvist i litteraturen, at de genetiske polymorfier kun kan tilskrives en lille del af variationen i fentanyl-koncentrationen ved transdermal administration.
English: Prolonged treatment with fentanyl, the active substance in IONSYS, may cause withdrawal symptoms in the newborn baby.
Danish: Længerevarende behandling med fentanyl, der er det aktive stof i IONSYS, kan give det nyfødte barn abstinenssymptomer.
English: IONSYS should be used with caution in patients with paralytic ileus.
Danish: IONSYS skal anvendes med forsigtighed til patienter med paralytisk ileus.
English: Pharmacokinetic /pharmacodynamic relationship
Danish: Farmakokinetiske/farmakodynamiske forhold