FrancophonIA/ELRC3.0 huggingface dataset:
English: • Medicines called monoamine-oxidase (MAO) inhibitors (used for severe depression) or have done so in the past 2 weeks.
Danish: • Lægemidler, der kaldes monoaminooxidasehæmmere (MAO-hæmmere) (anvendes mod svær depression), eller hvis De har taget disse inden for de sidste to uger.
English: In studies on pre and postnatal development in rats the survival rate of offspring was significantly reduced at doses causing severe maternal toxicity.
Danish: I studier af præ- og postnatal udvikling hos rotter var overlevelsesraten af afkommet signifikant reduceret ved doser, som forårsagede alvorlig maternel toksicitet.
English: Plasma Fentanyl Concentration (ng/mL)
Danish: Fentanyl plasmakoncentration (ng/ml)
English: Effentora should be individually titrated to an “effective” dose that provides adequate analgesia and minimises adverse reactions.
Danish: Effentora bør titreres individuelt for at finde frem til en “effektiv” dosis, der giver tilstrækkelig analgesi og minimerer bivirkningerne.
English: Sixty-seven percent of the patients were able to be titrated to an effective dose.
Danish: 67 % af patienterne kunne titreres til en effektiv dosis.
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 det administrerede fentanyl elimineres ved biotransformation til N-dealkylerede og hydroxylerede inaktive metabolitter.
English: Please tell your doctor about all sedative medicines you are taking (such as sleeping pills, medicines to treat anxiety, some medicines to treat allergic reactions (antihistamines), or tranquillisers) and follow your doctor's dose recommendation closely.
Danish: Fortæl lægen om alle sløvende lægemidler, De tager (såsom sovepiller, angstdæmpende medicin, nogle lægemidler til behandling af allergiske reaktioner (antihistaminer) eller beroligende medicin), og følg nøje lægens dosisanbefaling.
English: During an initial open-label phase, patients were titrated to an effective dose of Effentora.
Danish: Under den første åbne fase blev patienterne titreret til en effektiv dosis af Effentora.
English: You may drink some water before using Effentora to help moisten your mouth, but you should not drink or eat anything while taking the medicine.
Danish: Inden De tager Effentora, må De gerne drikke lidt vand som en hjælp til at gøre munden fugtig, men De må ikke drikke eller spise noget som helst, mens De tager medicinen.
English: In these cases, a second tablet of the same strength may be used.
Danish: I disse tilfælde kan yderligere én Effentora-tablet af samme styrke anvendes.
English: As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl.
Danish: Som med alle opioider er der en risiko for klinisk signifikant respirationsdepression i forbindelse med brugen af fentanyl.
English: If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly.
Danish: Hvis der skiftes fra et andet oralt produkt, der indeholder fentanylcitrat, kræves der uafhængig Effentora dosistitrering, da biotilgængeligheden produkterne imellem er signifikant forskellig.
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: However, in these patients, a starting dose higher than 100 micrograms may be considered.
Danish: Til disse patienter kan en startdosis højere end 100 mikrogram dog overvejes.
English: It is recommended that one tablet should be placed in each side of the mouth.
Danish: Det anbefales at placere én tablet i hver side af munden.
English: The metabolic pathways following buccal administration of Effentora have not been characterised in clinical studies.
Danish: De metaboliske veje efter bukkal administration af Effentora er ikke blevet karakteriseret i kliniske studier.
English: Using benzodiazepines can increase the chances of getting serious side effects including death
Danish: Brugen af benzodiazepiner kan øge risikoen for at få alvorlige bivirkninger, herunder død
English: About 30% of the amount swallowed (50% of the total dose) escapes hepatic and intestinal first-pass elimination and becomes systemically available.
Danish: Cirka 30 % af den slugte mængde (50 % af den totale dosis) undgår førstepassage-elimination i leveren og tarmene og bliver systemisk tilgængelig.
English: When you place a tablet in your mouth, it dissolves and the medicine is absorbed through the lining of your mouth, into the blood system.
Danish: Når De placerer en tablet i munden, bliver tabletten opløst, og lægemidlet absorberes gennemslimhinderne i munden ind i blodsystemet.
English: If you have not been using these medicines you must not use Effentora, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Danish: Hvis De ikke har brugt denne slags medicin, må De ikke anvende Effentora, fordi det kan øge risikoen for, at Deres åndedræt kunne blive faretruende langsomt og/eller overfladisk eller endda helt ophøre.
English: If you begin to feel very dizzy, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away.
Danish: Hvis De begynder at føle Dem meget svimmel eller meget søvnig, inden tabletten er helt opløst, skal De straks skylle munden med vand og spytte de resterende tabletstykker ud enten i vasken eller i toilettet.
English: Effentora must not be prescribed in patients below 18 years of age
Danish: Effentora må ikke ordineres til patienter under 18 år
English: • blisters in the mouth, dry lips, collection of pus under the skin in the mouth
Danish: • blærer i munden, tørre læber, ansamling af pus under huden i munden
English: A condition in which the adrenal glands do not produce enough hormones.
Danish: En tilstand, hvor binyrerne ikke danner nok hormoner.
English: • You have liver or kidney problems, as these organs have an effect on the way in which your system breaks down the medicine.
Danish: • De har lever- eller nyreproblemer, da disse organer har indvirkning på, hvordan medicinen bliver nedbrudt i kroppen.
English: • You have problems with your heart especially slow heart rate.
Danish: • De har problemer med Deres hjerte, især en meget langsom hjertefrekvens.
English: If you are not sure about the right dose, or if you have questions about taking this medicine, you should contact your doctor.
Danish: Hvis De ikke er sikker på, hvilken dosis der er den rigtige til Dem, eller hvis De har spørgsmål vedrørende brugen af dette lægemiddel, bør De kontakte Deres læge.
English: Following oromucosal administration of Effentora, fentanyl is readily absorbed with an absolute bioavailability of 65%.
Danish: Efter oromukosal administration af Effentora absorberes fentanyl hurtigt med en absolut biotilgængelighed på 65 %.
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Danish: Patienter, der modtager opioid-vedligeholdelsesbehandling, er patienter, der tager mindst 60 mg oral morfin daglig, mindst 25 mikrogram transdermal fentanyl pr. time, mindst 30 mg oxycodon daglig, mindst 8 mg oral hydromorfon daglig eller en tilsvarende analgetisk dosis af et andet opioid i en uge eller længere.
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Danish: Fentanyl er yderst lipofilt og fordeles godt uden for det vaskulære system med et stort tilsyneladende fordelingsvolumen.
English: Maintenance opioid treatment
Danish: Opioid-vedligeholdelsesbehandling
English: The risk of respiratory depression is less in patients receiving chronic opioid therapy as these patients will develop tolerance to respiratory depressant effects.
Danish: Risikoen for respirationsdepression er mindre hos patienter, der er i kronisk opioidbehandling, da disse patienter udvikler tolerance over for respirationsdepressive virkninger.
English: • If you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
Danish: • hvis De ikke regelmæssigt bruger ordineret medicin (opioider) (f.eks. codein, fentanyl, hydromorphon, morfin, oxycodon, pethidin), hver dag i henhold til et regelmæssigt skema, i mindst en uge, for at kontrollere Deres vedvarende smerte.
English: Once an effective dose has been established during titration, patients should continue to take this dose as a single tablet of that given strength.
Danish: Når der først er blevet fastsat en effektiv dosis under titreringen, bør patienten fortsætte med at tage denne dosis som en enkelt tablet af den givne styrke.
English: It is subject to first-pass hepatic and intestinal metabolism and the metabolites do not contribute to fentanyl's therapeutic effects.
Danish: Det undergår “førstepassage” hepatisk og intestinal metabolisme, og metabolitterne bidrager ikke til fentanyls terapeutiske virkninger.
English: For dose-readjustment the same principles apply as outlined for dose titration (see above).
Danish: For justering af dosis gælder samme principper, som beskrevet for dosistitrering (se ovenfor).
English: Effentora contains sodium
Danish: Effentora indeholder natrium
English: Patients receiving Effentora concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Danish: Patienter, der behandles med Effentora samtidig med moderate eller stærke CYP3A4-hæmmere bør monitoreres omhyggeligt i længere tid.
English: Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy in cancer patients.
Danish: Behandlingen bør påbegyndes og gennemføres under vejledning af en læge med erfaring i opioidbehandling af cancerpatienter.
English: In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p<0.0001).
Danish: I det andet pivotale studie (studie 2) var det primære endepunkt SPID30, som ligeledes var statistisk signifikant sammenlignet med placebo (p<0,0001).
English: Although muscle rigidity interfering with respiration has not been seen following the use of Effentora, this is possible with fentanyl and other opioids.
Danish: Selv om muskulær rigiditet med påvirkning af respirationen ikke er set efter anvendelse af Effentora, kan dette forekomme i forbindelse med fentanyl og andre opioider.
English: If you become very sleepy or have slow and/or shallow breathing, you or your carer should contact your doctor immediately and call for emergency help.
Danish: Hvis De bliver meget søvnig eller har langsomt og/eller overfladisk vejrtrækning, skal De eller Deres hjælper/plejer omgående kontakte Deres læge og ringe efter ambulancen.
English: Further findings at maternally toxic doses in F1 pups were delayed physical development, sensory functions, reflexes and behaviour.
Danish: Yderligere fund i F1 unger ved maternelt toksiske doser var forsinket fysisk udvikling samt forsinket udvikling af sensoriske funktioner, reflekser og adfærd.
English: Anaemia Neutropenia
Danish: Anæmi Neutropeni
English: • You have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use (see section 4 under “Serious side effects”).
Danish: • De nogensinde har udviklet binyreinsufficiens eller mangel på kønshormoner (androgenmangel) ved anvendelse af et opioid (se punkt 4 under ”Alvorlige bivirkninger”).
English: If you still have some of these fentanyl treatments at home, contact your pharmacist to check how to dispose of them.
Danish: Hvis De stadig har nogle af disse fentanylpræparater hjemme, skal De kontakte apoteket angående bortskaffelse.
English: You must let your doctor know immediately if you are using Effentora more than four times per day, as a change may be required to your treatment regimen.
Danish: De skal omgående fortælle det til Deres læge, hvis De tager Effentora mere end fire gange om dagen, da det kan være nødvendigt at ændre Deres behandlingsprogram.
English: Approximately 50% of the total dose administered is rapidly absorbed transmucosally and becomes systemically available.
Danish: Cirka 50 % af den totalt administrerede dosis absorberes hurtigt transmukosalt og bliver systemisk tilgængelig.
English: Two double-blind, randomized, placebo-controlled crossover studies have been conducted involving a total of 248 patients with BTP and cancer who experienced on average 1 to 4 episodes of BTP per day while taking maintenance opioid therapy.
Danish: Der er udført to dobbeltblinde, randomiserede, placebokontrollerede, crossover-studier med i alt 248 cancerpatienter med gennembrudssmerter, som oplevede i gennemsnit 1 til 4 anfald af gennembrudssmerter om dagen, mens de modtog opioid-vedligeholdelsesbehandling.
English: • prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2)
Danish: • langvarig behandling med fentanyl under graviditet kan forårsage abstinenssymptomer hos det nyfødte barn, som kan være livstruende (se punkt 2)
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.
English: The judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.
Danish: Velovervejet anvendelse af naloxon eller anden opioid-antagonist kan være berettiget i visse tilfælde, men er forbundet med risiko for akut abstinenssyndrom.
English: Cognitive disorder Motor dysfunction
Danish: Kognitiv forstyrrelse Motorisk dysfunktion
English: • unusually low heart rate, feeling very warm (hot flushes),
Danish: • usædvanlig langsom hjerterytme, følelse af, at have det meget varmt (hedeture)
English: • You have an exceptionally slow heart rate or other heart problems.
Danish: • De har usædvanlig langsom hjerterytme eller andre hjerteproblemer.
English: Respiratory arrest*
Danish: Respirationsstop*
English: Caution is advised when Effentora is co-administered with drugs that affect the serotoninergic neurotransmitter systems.
Danish: Der rådes til forsigtighed, når Effentora administreres sammen med lægemidler, der påvirker de serotonerge neurotransmittersystemer.
English: • The most serious side effects are shallow breathing, low blood pressure and shock.
Danish: • De alvorligste bivirkninger er overfladisk vejrtrækning, lavt blodtryk og shock.
English: Taking the medicine in this way allows it to be absorbed quickly to relieve your breakthrough pain.
Danish: Når medicinen tages på denne måde, bliver den absorberet hurtigt og kan dermed lindre Deres gennembrudssmerter.
English: Evaluation of brain slides from the carcinogenicity study in rats revealed brain lesions in animals administered high doses of fentanyl citrate.
Danish: Evaluering af hjernesnit fra karcinogenicitetsstudiet med rotter viste hjernelæsioner hos dyr, der fik administreret høje doser fentanylcitrat.
English: Carcinogenicity studies (26-week dermal alternative bioassay in Tg.AC transgenic mice; two-year subcutaneous carcinogenicity study in rats) with fentanyl did not reveal any findings indicative of oncogenic potential.
Danish: Karcinogenicitetsstudier (26-ugers dermal alternativ bioassay på Tg.AC-transgene mus; 2-års subkutant karcinogenicitetsstudie på rotter) med fentanyl viste ingen resultater, der indikerer onkogent potentiale.
English: All opioid µ-receptor agonists, including fentanyl, produce dose dependent respiratory depression.
Danish: Alle opioid-µ-receptor-agonister, inklusive fentanyl, medfører dosisafhængig respirationsdepression.
English: • Instructions for use of fentanyl buccal tablet and how to place the tablet
Danish: • Vejledning i brug af fentanylbukkaltablet, samt hvordan bukkaltabletten placeres
English: If serotonin syndrome is suspected, treatment with Effentora should be discontinued.
Danish: Hvis et serotonergt syndrom mistænkes, bør behandling med Effentora seponeres.
English: However if your doctor does prescribe Effentora together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Danish: Hvis din læge imidlertid ordinerer Effentora sammen med sløvende lægemidler, skal dosis og varighed af den samtidige behandling begrænses af lægen.
English: The tablet must be used immediately once removed from the blister.
Danish: Tabletten skal tages omgående, så snart den er taget ud af blisteren.
English: Mean Plasma Concentration Versus Time Profiles Following Singles Doses of EFFENTORA and OTFC in Healthy Subjects
Danish: Middel plasmakoncentration versus tid Profiler efter enkelte doser af EFFENTORA og OTFC hos raske forsøgspersoner
English: A comparison study between one 400 mcg Effentora tablet administered either buccally (i.e., between the cheek and the gum) or sublingually met the criteria of bioequivalence.
Danish: Et sammenlignende studie mellem én 400 mikrogram Effentora-tablet givet enten bukkalt (dvs. mellem kinden og gummen) eller sublingualt opfyldte kriterierne for bioækvivalens.
English: Titration in patients not switching from other fentanyl containing products The initial dose of Effentora should be 100 micrograms, titrating upwards as necessary through the range of available tablets strengths (100, 200, 400, 600, 800 micrograms).
Danish: Titrering hos patienter, der ikke skifter fra andre produkter, der indeholder fentanyl Startdosis af Effentora bør være 100 mikrogram, hvorefter der optitreres efter behov ved brug af de tilgængelige tabletstyrker (100, 200, 400, 600, 800 mikrogram).
English: Pharmacokinetic parameter (mean)
Danish: Farmakokinetisk parameter (middel)
English: For each BTP episode, pain intensity was assessed prior to and at several time points after treatment.
Danish: For hvert anfald af gennembrudssmerter blev smerteintensiteten vurderet inden behandlingen samt ved flere tidspunkter efter behandlingen.
English: The following adverse reactions have been reported with Effentora and/or other fentanyl-containing compounds during clinical studies and post marketing experience.
Danish: Følgende bivirkninger er blevet rapporteret med Effentora og/eller andre fentanyl-holdige stoffer i kliniske studier og efter markedsføring.
English: • feeling anxious or confused, depression, insomnia
Danish: • følelse af angst eller forvirring, depression, søvnløshed
English: Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
Danish: Der blev observeret en statistisk signifikant forbedring i forskellen i smerteintensitet med Effentora versus placebo så tidligt som ved 10 minutter i studie 1 og så tidligt som ved 15 minutter (det tidligst målte tidspunkt) i studie 2.
English: • You may feel a gentle bubbling sensation between your cheek and gum as the tablet dissolves.
Danish: • De vil muligvis mærke en svagt boblende fornemmelse mellem gummen og kinden, mens tabletten opløses.
English: Patients experiencing xerostomia are advised to drink water to moisten the buccal cavity prior to administration of Effentora.
Danish: Patienter, der oplever xerostomi, rådes til at drikke vand for at fugte mundhulen, inden de anvender Effentora.
English: As a result, the dose of Effentora should be individually titrated to achieve the desired effect (see section 4.2).
Danish: Derfor skal Effentora-doserne titreres individuelt for at opnå den ønskede virkning (se pkt.
English: Pharmacokinetic Parameters* in Adult Subjects Receiving Effentora
Danish: Farmakokinetiske parametre* hos voksne forsøgspersoner, der behandles med Effentora
English: • Instructions on how to open the child-resistant blister
Danish: • Vejledning i åbning af den børnesikrede blister
English: Norfentanyl is not pharmacologically active in animal studies.
Danish: I dyreforsøg er norfentanyl ikke farmakologisk aktiv.
English: It is recommended that increased caution should be exercised in titrating the dose of Effentora in elderly patients.
Danish: Det anbefales at udvise særlig forsigtighed i forbindelse med titrering af Effentora-doser til ældre patienter.
English: You should not use Effentora during childbirth because fentanyl may cause respiratory depression in the new-born child.
Danish: De bør ikke anvende Effentora under fødsel, da fentanyl kan forårsage respirationsdepression hos det nyfødte barn.
English: Patients and carers must be advised to dispose of any unopened tablets remaining from a prescription as soon as they are no longer needed.
Danish: Patienter og plejere/hjælpere skal informeres om at bortskaffe eventuelt resterende tabletter, så snart der ikke længere er behov for dem.
English: Do not drive or operate machinery if you: are feeling sleepy or dizzy; have blurred or double vision; or have difficulty in concentrating.
Danish: Kør ikke bil eller motorcykel og lad være med at cykle eller arbejde med maskiner, hvis De: føler Dem søvnig eller svimmel; har sløret syn eller dobbeltsyn; eller hvis De har vanskeligt ved at koncentrere Dem.
English: Pre-emptive use of Effentora for predictable pain episodes was not investigated in the clinical trials.
Danish: Forebyggende brug af Effentora mod forudsigelige smerteepisoder blev ikke undersøgt i de kliniske forsøg.
English: Chronic obstructive pulmonary disease
Danish: Kronisk obstruktiv lungesygdom
English: For the most effective relief, let your doctor know about your pain and how Effentora is working for you, so that the dose can be changed if needed.
Danish: For at opnå den mest effektive smertelindring skal De fortælle Deres læge om Deres smerter og om, hvordan Effentora virker for Dem, så lægen om nødvendigt kan ændre Deres dosis.
English: Alternatively, the tablet could be placed sublingually (see section 5.2).
Danish: Alternativt kan tabletten placeres sublingualt (se pkt.
English: Do not change doses of Effentora or your other pain medicines on your own.
Danish: De må ikke selv ændre Deres dosis af Effentora eller Deres andre smertestillende lægemidler.
English: What to do if someone accidentally takes Effentora
Danish: Hvad De skal gøre, hvis en anden person utilsigtet tager Effentora
English: In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 mcg/kg/day, s.c.) and is considered secondary to the sedative effects of fentanyl in animal studies.
Danish: I et fertilitets- og tidligt embryoudviklingsstudie på rotter blev en han-medieret effekt observeret ved høje doser (300 mikrogram/kg/døgn s.c.), hvilket anses for at være sekundært til fentanyls sedative virkning i dyrestudier.
English: • Your other opioid pain medicine taken for your persistent (around-the-clock) cancer pain is not stabilised yet.
Danish: • Deres anden smertestillende medicin (opioider), som De tager for Deres vedvarende (som er der hele døgnet) kræftsmerter, endnu ikke er stabiliseret.
English: Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Danish: De sekundære farmakologiske virkninger er respirationsdepression, bradykardi, hypotermi, forstoppelse, miosis, fysisk afhængighed og eufori.