FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy results at the end of 24 hours, are presented in Table 2 below for the evaluable patient population.
Danish: Effektresultaterne efter 24 timer vises i Tabel 2 for den evaluerbare patientpopulation.
English: They will check that IONSYS is working properly.
Danish: De vil kontrollere, at IONSYS virker korrekt.
English: None of the four demographic factors studied [weight (lean/obese), age, race, or gender] had a significant effect on active substance exposure (AUC) following use of IONSYS.
Danish: Ingen af de fire demografiske faktorer, der er undersøgt (vægt [slank/overvægtig], alder, race eller køn), havde nogen signifikant virkning på eksponeringen for det aktive stof (AUC) efter anvendelse af IONSYS.
English: Swallowing or touching these gels may cause life-threatening breathing difficulties or death, even after you have stopped using the system and it has been removed.
Danish: Hvis man sluger eller berører denne gel, kan det forårsage livstruende vejrtrækningsbesvær eller dødsfald, selv efter at man er holdt op med at bruge systemet, og det er fjernet.
English: • Do not touch the sticky side of IONSYS.
Danish: • Rør ikke ved den klæbende side af IONSYS.
English: Patients were instructed to use the system for pain relief.
Danish: Patienterne blev anmodet om at bruge systemet til smertelindring.
English: With intravenous administration, the initial distribution half-life is approximately 6 minutes; the second distribution half-life is 1 hour, and the terminal half-life is 13 hours.
Danish: Efter intravenøs administration er den indledende distributionshalveringstid cirka 6 minutter; den næste distributionshalveringstid er 1 time, og den terminale halveringstid er 13 timer.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with IONSYS in one or more subsets of the paediatric population for the treatment of acute pain.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med IONSYS i en eller flere undergrupper af den pædiatriske population ved behandling af akutte smerter.
English: If you are an older patient your doctor will monitor you more carefully as IONSYS may affect you more than a younger patient.
Danish: Hvis du er en ældre patient, vil lægen overvåge dig særligt nøje, da IONSYS kan have kraftigere virkning hos dig end hos yngre patienter.
English: Its primary therapeutic actions are analgesia and sedation.
Danish: De primære terapeutiske virkninger er analgesi og sedering.
English: Patients could remain in their respective study up to 72 hours if they required parenteral opioid analgesia for this duration.
Danish: Patienterne kunne blive i deres respektive studier i op til 72 timer, hvis de i dette tidsrum havde behov for parenteral analgesi med opioider.
English: There are 6 systems per carton.
Danish: Der er 6 systemer i hver karton.
English: For management of respiratory depression, immediate countermeasures include removing the IONSYS system and physically or verbally stimulating the patient.
Danish: Ved behandling af respirationsdepression omfatter de umiddelbare modforanstaltninger fjernelse af IONSYS-systemet og fysisk eller verbal stimulering af patienten.
English: Hepatic disease may delay elimination.
Danish: Leversygdom kan forsinke elimineringen.
English: • IONSYS is ready to be used again and you may start another dose at any time you need it.
Danish: • IONSYS er klar til brug igen, og du kan starte en ny dosis, når du har behov for det.
English: Action required
Danish: Nødvendig foranstaltning
English: • System is not securely adhered
Danish: • Systemet sidder ikke godt nok fast
English: It works by delivering fentanyl through your skin to relieve your pain.
Danish: Den fungerer ved at tilføre fentanyl gennem huden for at lindre smerter.
English: Oxygen should be administered and respiration assisted or controlled, as appropriate.
Danish: Der skal gives ilt, og vejrtrækningen skal understøttes eller kontrolleres efter behov.
English: In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
Danish: I et forsøg med undersøgelse af den præ- og postnatale udvikling var afkommets overlevelsesrate markant nedsat ved doser, der reducerede den maternelle vægt en anelse.
English: IONSYS should be applied to intact, non-irritated and non-irradiated skin.
Danish: IONSYS skal sættes på intakt, ikke-irriteret og ikke-bestrålet hud.
English: Thus, the adverse reaction profile does not suggest a meaningful difference in safety compared to patients younger than 65 years of age.
Danish: Bivirkningsprofilen tyder således ikke på nogen relevant forskel i sikkerheden sammenlignet med patienter under 65 år.
English: Consequently, the patient may activate IONSYS more frequently to maintain fentanyl blood levels.
Danish: Patienten kan derfor aktivere IONSYS hyppigere for at opretholde niveauerne af fentanyl i blodet.
English: Each IONSYS carton contains 6 systems.
Danish: Hver karton med IONSYS indeholder 6 systemer.
English: These were mostly of mild to moderate severity.
Danish: Disse bivirkninger var hovedsagelig milde til moderate i sværhedsgrad.
English: Iatrogenic addiction following opioid administration is rare.
Danish: Iatrogen afhængighed efter administration af opioider er sjælden.
English: Your doctor will discuss the possible risks and potential benefits of using IONSYS while you are pregnant.
Danish: Lægen vil gennemgå mulige risici og fordele ved, at du bruger IONSYS, mens du er gravid.
English: Fentanyl is excreted into human milk.
Danish: Fentanyl udskilles i human mælk.
English: Administration during childbirth is not recommended because fentanyl crosses the placenta and the fetal respiratory centre is sensitive to opiates.
Danish: Administration under fødslen anbefales ikke, da fentanyl krydser placenta, og fosterets åndedrætscenter er følsomt over for opiater.
English: After this point 727 patients remained in the studies using only the IONSYS or control system, and were evaluated for efficacy.
Danish: Herefter fortsatte 727 patienter i studierne, hvor kun IONSYS eller kontrolsystemet blev anvendt, og blev undersøgt med hensyn til effekten.
English: Tolerance, physical dependence, and psychological dependence may develop upon repeated administration of opioids.
Danish: Der kan opstå tolerance, fysisk afhængighed og psykisk afhængighed efter gentagen administration af opioider.
English: Paralytic ileus
Danish: Paralytisk ileus
English: Fentanyl can be abused in a manner similar to other opioid agonists.
Danish: Fentanyl kan misbruges på samme måde som andre opioid-agonister.
English: Standard reproductive and developmental toxicity studies have been carried out using parenteral administration of fentanyl.
Danish: Der er udført standardundersøgelser af reproduktions- og udviklingstoksiciteten med anvendelse af parenteral administration af fentanyl.
English: The digital display will show the number of doses that have been
Danish: Det digitale display viser det antal doser, der er tilført.
English: In such patients, opioids may decrease respiratory drive and increase airway resistance.
Danish: Hos sådanne patienter kan opioider nedsætte det respiratoriske drive og øge luftvejsmodstanden.
English: Pharmacotherapeutic group: Analgesics; phenylpiperidine derivatives; ATC code: N02AB03.
Danish: Farmakoterapeutisk klassifikation: Analgetika; phenylpiperidinderivater, ATC-kode: N02AB03.
English: Effects on somatic development and behaviour of the offspring were not observed.
Danish: Der blev ikke observeret nogen virkninger på somatisk udvikling og afkommets adfærd.
English: To avoid oral ingestion of the fentanylcontaining hydrogel, which may cause life-threatening hypoventilation or death, the hydrogel must not touch the mouth or other mucosal areas.
Danish: For at undgå oral indtagelse af den fentanylholdige hydrogel, som kan forårsage livstruende hypoventilation eller dødsfald, må hydrogelen ikke berøre munden eller andre slimhindeområder.
English: absorption will be lower initially.
Danish: Absorptionen vil derfor være lavere i starten af hver ny påsætning.
English: Reversal of the narcotic effect may also result in acute onset of pain and release of catecholamines.
Danish: Reversering af den narkotiske effekt kan også medføre akut indtræden af smerter og frigivelse af katekolaminer.
English: • Information on the adequate use of the product with regards to medication errors (including accidental exposure), Device malfunction/failure, Product Disposal and Misuse/abuse/diversion/addiction and dependence.
Danish: • En beskrivelse af den korrekte brug af produktet, oplysninger om medicineringsfejl (herunder utilsigtet eksponering), funktionssvigt/fejl ved apparatet, bortskaffelse og misbrug/videresalg og afhængighed.
English: To make sure you get the correct amount of medicine, press IONSYS as soon as you start to feel pain.
Danish: For at sikre, at du får den rigtige mængde medicin, skal du trykke på IONSYS, så snart du begynder at mærke smerterne.
English: These actions can be followed by administration of a specific opioid antagonist such as naloxone, based on the clinical judgment of the treating health care professional.
Danish: Disse foranstaltninger kan efterfølges af administration af en specifik opioidantagonist, for eksempel naloxon, baseret på den behandlende læges kliniske vurdering.
English: Poor skin contact
Danish: Dårlig hudkontakt
English: Used systems should not be reapplied to a patient.
Danish: Brugte systemer må ikke bruges igen på en patient.
English: The safety of IONSYS has not been established in patients with American Society of Anesthesiologists (ASA) physical status classification IV (i.e. patients with a severe systemic disease that is a constant threat to life).
Danish: IONSYS' sikkerhed er ikke fastlagt hos patienter med ASA-klassifikation IV (ASA: American Society of Anesthesiologists) (dvs. patienter med alvorlig systemisk sygdom, som er konstant livstruende).
English: IONSYS is designed so that you can't use too much, provided that only you operate it, and that only you use it when you need pain relief.
Danish: IONSYS er konstrueret, så du ikke kan bruge for meget, forudsat at du kun selv betjener det, og du kun bruger det, når du har behov for smertelindring.
English: This tray contains: 1 Drug Unit, 1 Controller.
Danish: Denne bakke indeholder: 1 lægemiddelenhed 1 controller
English: Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment.
Danish: Patienter med tidligere stofafhængighed/alkoholmisbrug har større risiko for at udvikle afhængighed og misbrug i forbindelse med behandling med opioider.
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Danish: Fentanyl er stærkt lipofil og fordeles godt ud over det vaskulære system med et stort tilsyneladende fordelingsvolumen.
English: As with all fentanyl products, the clearance of fentanyl may be reduced in elderly patients, with a consequent increase in half life.
Danish: Som med alle andre fentanyl-produkter kan clearance af fentanyl være reduceret hos ældre patienter, hvorved halveringstiden øges.
English: IONSYS is not recommended for children and adolescents under 18 years of age due to the lack of data in these patients.
Danish: IONSYS anbefales ikke til børn og unge under 18 år, da der mangler data vedrørende anvendelse til disse patienter.
English: (86/1436 or 6%) showed no meaningful difference relative to patients with BMI ≤ 40.
Danish: 40 (86/1.436 eller 6%) ingen relevant forskel i forhold til patienter med et BMI på ≤ 40.
English: Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
Danish: Opioide analgetika kan svække de mentale og/eller fysiske evner, der er nødvendige for at udføre potentielt farlige funktioner (fx føre motorkøretøj eller betjene maskiner).
English: IONSYS may make you feel sleepy, dizzy or cause blurred vision.
Danish: IONSYS kan gøre dig søvnig eller svimmel eller forårsage sløret syn.
English: There are no clinical data on the effects of fentanyl on fertility.
Danish: Der er ingen kliniske data vedrørende fentanyls virkninger på fertiliteten.
English: Patients were enrolled shortly after major surgery if they were not opioid tolerant, were expected to have an uncomplicated recovery, and required at least 24 hours of parenteral opioid treatment.
Danish: Patienterne blev inkluderet hurtigt efter et større indgreb, hvis de ikke var opioid-tolerante, forventedes at restituere uden komplikationer og havde behov for mindst 24 timers parenteral behandling med opioider.
English: The following side effects may occur whilst using IONSYS:
Danish: Følgende bivirkninger kan opstå, mens du bruger IONSYS:
English: Steady state absorption of the nominal 40 microgram dose is achieved about 12 hours after application, indicating that the skin becomes more permeable to fentanyl during the first 12 hours.
Danish: Steady state-absorptionen af den nominelle dosis på 40 mikrogram opnås cirka 12 timer efter påsætning, hvilket tyder på, at huden bliver mere gennemtrængelig for fentanyl i løbet af de første 12 timer.
English: • you have a very slow heart rate, low blood pressure, or other serious heart problem
Danish: • du har en meget langsom hjerterytme, lavt blodtryk eller andre alvorlige hjerteproblemer
English: As illustrated in Table 1 below, IONSYS (fentanyl hydrochloride) was superior to placebo in all studies.
Danish: Som vist i Tabel 1 var IONSYS (fentanylhydrochlorid) bedre end placebo i alle studier.
English: Among these patients, the incidence of nausea was similar to adult patients; however, vomiting (32.1%) and fever (60.7%) were each reported at a higher incidence in paediatric patients relative to adults.
Danish: Blandt disse patienter var forekomsten af nausea den samme som hos voksne patienter; opkastning (32,1%) og feber (60,7%) blev dog hver især indberettet med en højere forekomst hos pædiatriske patienter end voksne patienter.
English: This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Danish: Denne virkning kunne enten skyldes ændret maternel omsorg eller fentanyls direkte virkning på afkommet.
English: The safety and efficacy of IONSYS in children and adolescents younger than 18 years of age has not been established.
Danish: IONSYS' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: If IONSYS is administered to the mother during this time, an antidote for the child should be readily available.
Danish: Hvis IONSYS på dette tidspunkt administreres til moderen, skal et antidot til barnet være umiddelbart tilgængeligt.
English: You control your own treatment under the guidance of your doctor or nurse in hospital.
Danish: Du skal selv kontrollere din behandling under vejledning af lægen eller sundhedspersonalet på hospitalet.
English: • Beeping for 15 seconds
Danish: • Bippelyd i 15 sekunder
English: You will hear IONSYS beep once each time you start a dose.
Danish: Du kan høre, at IONSYS bipper én gang, hver gang du starter en dosis.
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Danish: Mutagenicitetstest i bakterier og gnavere gav negative resultater.
English: The flashing digital display may be turned off by pressing the dose button for six seconds.
Danish: Det blinkende digitale display kan slukkes ved at trykke på doseringsknappen i 6 sekunder.
English: IONSYS only delivers the medicine when you activate it, so you control how much medicine you receive.
Danish: IONSYS tilfører kun medicin, når du aktiverer systemet, så du styrer selv den mængde medicin, du får.
English: Table 1: Placebo-controlled Trials (N=727) Patients Percent (n) of patients who withdrew due to inadequate analgesia Hours 3-24
Danish: Tabel 1: Placebokontrollerede studier (N=727) Patienter Procentdel (n) af patienter, der frafaldt på grund af utilstrækkelig analgesi Timer 3-24
English: Adequate body temperature and fluid intake should also be maintained.
Danish: Passende legemstemperatur og væskeindtagelse skal opretholdes.
English: Remove system from patient 2.
Danish: Tag systemet af patienten 2.
English: All adverse reactions are listed by System Organ Class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); and rare (≥1/10,000
Danish: (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) og sjælden (≥
English: When the system is applied on the lower inner arm, the amount of fentanyl absorbed is approximately 20% lower than at the upper outer arm or chest.
Danish: Når systemet sættes på indvendigt på underarmen, er den absorberede mængde fentanyl cirka 20% lavere end ved påsætning udvendigt på overarmen eller på brystet.
English: Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy.
Danish: Behandlingen bør initieres og forblive under tilsyn af en læge med erfaring inden for håndtering af behandlinger med opioider.
English: The concomitant use of ritonavir or other potent or moderate CYP3A4 inhibitors and IONSYS is not recommended unless the patient is closely monitored.
Danish: Samtidig anvendelse af ritonavir eller andre potente eller moderate CYP3A4-hæmmere og IONSYS anbefales ikke, medmindre patienten monitoreres nøje.
English: • low calcium/glucose/potassium in blood serum
Danish: • lavt niveau af calcium/glukose/kalium i blodet
English: Tell your doctor or nurse if you have taken them within the last 14 days before using IONSYS;
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du har taget dem inden for de seneste 14 dage inden anvendelse af IONSYS
English: • Remove and discard the clear plastic liner covering the adhesive.
Danish: • Fjern og kassér den gennemsigtige plastfilm, der dækker klæbestoffet.
English: In general, the maximum serum fentanyl concentration occurs approximately 15 minutes after the initiation of a dose.
Danish: Generelt forekommer de maksimale serumkoncentrationer af fentanyl cirka 15 minutter efter aktivering af en dosis.
English: Tell your doctor or nurse if:
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis:
English: However, once a system has been removed, the same system should not be reapplied.
Danish: Dog må det samme system ikke sættes på igen, når først det er fjernet.
English: Severe respiratory depression or cystic fibrosis.
Danish: Svær respirationsdepression eller cystisk fibrose.
English: Another published article of 52 elderly Japanese post-operative patients receiving continuous intravenous (IV) fentanyl infusion (0.5-1.5 µg/kg/h) showed increased fentanyl exposure in the CYP3A5*3 group (3*/3*) than in the 1* carrier group.
Danish: En anden publiceret artikel om 52 ældre japanske post-operative patienter, der fik kontinuerlig intravenøs fentanyl-infusion (0,5-1,5 µg/kg/t), viste større fentanyl-eksponering hos CYP3A5*3-gruppen (3*/3*) end hos 1*-gruppen.
English: A carcinogenicity study (daily subcutaneous injections of fentanyl hydrochloride for two years in Sprague Dawley rats) did not induce any findings indicative of oncogenic potential.
Danish: Et karcinogenicitetsstudie (daglige subkutane injektioner af fentanylhydrochlorid i to år til Sprague Dawley-rotter) forårsagede ingen fund, der kunne tyde på onkogent potentiale.
English: IONSYS is composed of an electronic controller and a drug unit with two hydrogels.
Danish: IONSYS består af en elektronisk controller og en lægemiddelenhed med to hydrogeler.
English: Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
Danish: Cirka 75% af fentanyl udskilles i urinen, fortrinsvis som metabolitter, og mindre end 10% som uændret aktivt stof.
English: Serotoninergic medicinal products
Danish: Serotonerge lægemidler
English: No overall differences were observed in the safety of IONSYS fentanyl 40 micrograms in elderly patients (≥ 65 years including a subpopulation ≥ 75 years) and adult patients for all controlled studies.
Danish: Der blev ikke observeret nogen overordnede forskelle i sikkerheden af IONSYS fentanyl 40 mikrogram til ældre patienter (≥ 65 år inklusive en delpopulation på ≥ 75 år) og voksne patienter for alle kontrollerede studier.
English: Refer to the Summary of Product of Characteristics (SmPC) for more information about IONSYS.
Danish: Se produktresuméet (SmPC) for mere information om IONSYS.
English: • No display
Danish: • Intet display
English: • if you are allergic (hypersensitive) to fentanyl, or any of the other ingredients of IONSYS (listed in section 6).
Danish: • hvis du er allergisk over for fentanyl eller et af de øvrige indholdsstoffer i IONSYS (angivet i afsnit 6).
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 dependant patients.
Danish: De har høj affinitet over for opioidreceptorer med relativt lav reel aktivitet og antagoniserer derfor delvist den analgetiske virkning af fentanyl og kan inducere seponeringssymptomer hos opioidafhængige patienter.
English: If severe or persistent hypotension occurs, hypovolaemia should be considered and the condition should be managed with appropriate parenteral fluid therapy or other interventions as needed, based upon the clinical judgment of the treating health care professional.
Danish: Hvis der forekommer alvorlig eller vedvarende hypotension, bør hypovolæmi overvejes, og tilstanden bør behandles med relevant parenteral væskebehandling eller andre tiltag efter behov, baseret på den behandlende læges kliniske vurdering.
English: The used IONSYS system contains a dangerous amount of fentanyl within the red hydrogel housing.
Danish: Det brugte IONSYS-system indeholder en farlig mængde fentanyl inde i det røde hydrogelhylster.
English: When IONSYS is applied without activating the electrical current, the average absorption rate of fentanyl over 24 hours was 2.3 micrograms fentanyl/hour, indicating minimal passive delivery.
Danish: Da IONSYS blev påsat uden aktivering af elektricitet, var fentanyls gennemsnitlige absorptionsrate i 24 timer 2,3 mikrogram fentanyl/time, hvilket tyder på en minimal passiv tilførsel.
English: See package leaflet for disposal information.
Danish: Se indlægssedlen for information om bortskaffelse.
English: • Information highlighting that IONSYS is a patient-controlled device to be used in a hospital setting only and that standard practices for monitoring patients using such devices should be followed by healthcare professionals.
Danish: • Tydelige anvisninger af, at IONSYS er et patient-kontrolleret apparat, der kun må anvendes på et hospital, og at standardprocedurerne for overvågning af patienter, der bruger denne type apparater, skal overholdes af sundhedspersonalet.
English: Fentanyl may produce bradycardia or hypotension and should, therefore, be administered with caution to patients with bradyarrhythmias or any significant cardiovascular disease.
Danish: Fentanyl kan fremkalde bradykardi eller hypotension og skal derfor administreres med forsigtighed til patienter med bradyarytmier eller signifikant kardiovaskulær sygdom.
English: - Do not let the IONSYS system get wet because it could stop working or fall off.
Danish: - IONSYS må ikke blive vådt, da det kan holde op med at virke eller falde af.
English: IV-PCA (morphine) n=1298
Danish: PCA (morfin) n=1298
English: The assembled IONSYS product measures 47 mm x 75 mm.
Danish: Det samlede IONSYS-produkt måler 47 mm x 75 mm.
English: The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h
Danish: Fentanyls totale plasmaclearance efter intravenøs administration er cirka 42 l/t.
English: Tel: +44 (0)800 587 4149 or +44 (0)203 684 6344 Email: medical.information@themedco.com
Danish: Tlf.: +44 (0)800 587 4149 eller +44 (0)203 684 6344