FrancophonIA/ELRC3.0 huggingface dataset:
English: The fourth study compared IONSYS to morphine given by injection into a vein, and looked at the number of patients who judged their pain relief as ‘good' or ‘excellent'.
Danish: Den fjerde undersøgelse sammenlignede IONSYS med morfin, som blev injiceret i en vene, og så på antallet af patienter, der bedømte deres smertelindring som ”god” eller ”særdeles god”.
English: In the studies where IONSYS was compared to placebo, the proportion of patients who stopped treatment because their pain was not controlled was lower in patients treated with IONSYS than those treated with placebo.
Danish: I de undersøgelser, hvor IONSYS blev sammenlignet med placebo, var antallet af patienter, der stoppede behandlingen, fordi deres smerter ikke blev lindret, lavere hos dem, der blev behandlet med IONSYS, end hos dem, der blev behandlet med placebo.
English: When in pain, the patient uses a button on the IONSYS system to start the delivery of a dose of fentanyl (40 micrograms).
Danish: Når patienten har smerter, trykker denne på en knap på IONSYS-systemet, som starter indgivelsen af en dosis fentanyl (40 mikrogram).
English: IONSYS is an iontophoretic transdermal system (ITS), which delivers the active substance, fentanyl hydrochloride, into the body through the skin.
Danish: IONSYS er et iontoforetisk transdermalt system (ITS), der indgiver det aktive stof, fentanylhydrochlorid, i kroppen gennem huden.
English: Which measures are being taken to ensure the safe use of IONSYS?
Danish: Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af IONSYS?
English: When the patient activates IONSYS, a small electrical current moves a dose of fentanyl from the reservoir through the skin and into the bloodstream.
Danish: Når patienten aktiverer IONSYS, flytter en lille mængde elektrisk strøm en dosis fentanyl fra beholderen gennem huden og ind i blodbanen.
English: The full EPAR for IONSYS can be found here.
Danish: Den fuldstændige EPAR om IONSYS findes her.
English: In three of them, IONSYS was compared with placebo (a transdermal system identical to IONSYS, but from which the medicine could not be released).
Danish: I tre af disse blev IONSYS sammenlignet med placebo (et transdermalt system magen til IONSYS, som ikke kunne frigive lægemidlet).
English: The results of the study comparing IONSYS with morphine were insufficient to determine whether the two medicines were of similar effectiveness in relieving pain or not.
Danish: Resultaterne af undersøgelsen, hvor IONSYS blev sammenlignet med morfin, var utilstrækkelige til at afgøre, om de to lægemidler var lige effektive til at lindre smerte.
English: The fentanyl is contained inside a reservoir.
Danish: Fentanyl befinder sig inden i en beholder.
English: Fentanyl is derived from opium.
Danish: Fentanyl er et afledet produkt af opium.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to prevent pain.
Danish: Når først fentanyl er nået ind i blodbanen, påvirker det receptorerne i hjernen og rygmarven og forebygger derved smerte.
English: These results show that IONSYS has a benefit in controlling pain after an operation.
Danish: Disse resultater viser, at IONSYS har smertekontrollerende virkning efter en operation.
English: IONSYS is used to control pain after an operation, in patients who are in hospital.
Danish: IONSYS anvendes til smertekontrol efter en operation hos patienter, som er indlagt på hospitalet.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that IONSYS offers potential benefits compared to systems where the pain relief is given via a vein: it is non-invasive, needle-free and pre-programmed, and it can be activated by the patient.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at IONSYS udviser potentielle fordele i forhold til systemer, hvor det smertelindrende stof indgives gennem en vene: det er ikkeinvasivt, kræver ikke brug af kanyle, det er forprogrammeret og kan aktiveres af patienten.
English: IONSYS contain the active ingredient fentanyl, which is a strong painkiller.
Danish: IONSYS indeholder det aktive indholdsstof fentanyl, som er et stærkt smertestillende middel.
English: Therefore, the Committee decided that IONSYS's benefits are greater than its risks for the management of acute moderate to severe post-operative pain for use in a hospital setting only.
Danish: CHMP besluttede derfor, at fordelene ved IONSYS er større end risiciene til behandling af akut, moderat til svær smerte efter operation udelukkende i hospitalsomgivelser.
English: What is the risk associated with IONSYS?
Danish: Hvilken risiko er der forbundet med IONSYS?
English: For the full list of all side effects reported with IONSYS, see the Package Leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved IONSYS fremgår af indlægssedlen.
English: Why has IONSYS been approved?
Danish: Hvorfor blev IONSYS godkendt?
English: What is IONSYS?
Danish: Hvad er IONSYS?
English: What benefit has IONSYS shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved IONSYS?
English: How has IONSYS been studied?
Danish: Hvordan blev IONSYS undersøgt?
English: What is IONSYS used for?
Danish: Hvad anvendes IONSYS til?
English: How is IONSYS used?
Danish: Hvordan anvendes IONSYS?
English: How does IONSYS work?
Danish: Hvordan virker IONSYS?
English: 1 bottle + 1 syringe + 1 bottle adapter
Danish: 1 flaske + 1 sprøjte + 1 flaskeadapter
English: Oral solution Oral use
Danish: Oral opløsning Oral anvendelse Flaske (HDPE)
English: 20 mg/ml
Danish: EU/1/04/279/044 Lyrica 20 mg/ml
English: • Tablets must only be given if the child is able to swallow tablets.
Danish: • Tabletterne må kun gives, hvis barnet er i stand til at sluge tabletterne.
English: Problems with balance or coordination
Danish: • Balance- eller koordinationsproblemer
English: • Existing symptomatic arrhythmias.
Danish: • Eksisterende symptomatiske arytmier.
English: Keep it in a clean safe place with the medicine.
Danish: Opbevar den på et rent og sikkert sted sammen med medicinen.
English: • you have had an allergic reaction to other azoles.
Danish: • De har haft en allergisk reaktion over for andre azoler.
English: If a dose of VFEND has been forgotten
Danish: Hvis en dosis af VFEND er blevet glemt
English: Plasma protein binding is estimated to be 58%.
Danish: Plasmaproteinbindingen anslås til 58%.
English: The syringe should be washed after each dose.
Danish: Sprøjten skal vaskes efter hver dosis.
English: Medicinal product [Mechanism of interaction]
Danish: Lægemiddel [Interaktionsmekanisme]
English: In this analysis a successful response was seen in 41% of patients in both treatment arms.
Danish: I denne analyse var der succesfuld respons hos 41 % af patienterne i begge behandlingsarme.
English: Dry the two parts.
Danish: Tør begge dele.
English: Date of first authorisation: 19 March 2002 Date of latest renewal: 21 February 2012
Danish: Dato for første markedsføringstilladelse: 19. marts 2002 Dato for seneste fornyelse: 21. februar 2012
English: Do not squirt the medicine out quickly.
Danish: Sprøjt ikke medicinen for hurtigt ud.
English: Continue taking VFEND until your doctor tells you to stop.
Danish: Fortsæt med at tage VFEND indtil Deres læge siger, De skal stoppe.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Danish: Da De vil få denne medicin under tæt medicinsk overvågning, er det mindre sandsynligt, at en dosis vil blive glemt.
English: The asterisk (*) indicates a twoway interaction.
Danish: En asterix (*) indikerer en to-vejs interaktion.
English: For example, 15-20% of Asian populations may be expected to be poor metabolisers.
Danish: For eksempel forventes det, at det hos 15-20% af de asiatiske populationer metaboliseres dårligt.
English: This will force the medicine back into the bottle.
Danish: Derved vil medicinen komme tilbage i flasken.
English: Repeat step 3 again.
Danish: Gentag trin 3.
English: Any unused suspension should be discarded after this date.
Danish: Ubrugt suspension skal kasseres efter denne dato.
English: Package Leaflet: Information for the user
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
English: The majority (>94%) of the total radioactivity is excreted in the first 96 hours after both oral and intravenous dosing.
Danish: Størstedelen (>94%) af den totale radioaktivitet bliver udskilt i de første 96 timer efter både oral og intravenøs dosering.
English: Località Marino del Tronto 63100 Ascoli Piceno (AP) Italy
Danish: Località Marino del Tronto 63100 Ascoli Piceno (AP) Italien
English: It is important to take your VFEND suspension regularly at the same time each day.
Danish: Det er vigtigt, at De tager VFEND suspension regelmæssigt på samme tidspunkt hver dag.
English: It is important to take your VFEND tablets regularly at the same time each day.
Danish: Det er vigtigt, at De tager VFEND tabletter regelmæssigt på samme tidspunkt hver dag.
English: Four additional patients with fusariosis had an infection caused by several organisms; 2 of them had a successful outcome.
Danish: Yderligere 4 patienter havde en fusarium-infektion forårsaget af adskillige organismer; 2 af dem havde et succesrigt resultat.
English: • you are suffering from, or have ever suffered from liver disease.
Danish: • De lider af eller har lidt af en leversygdom.
English: Interaction Geometric mean changes (%)
Danish: Interaktion Geometrisk gennemsnitlig ændring (%)
English: Do not stop treatment early because your infection may not be cured.
Danish: Stop ikke behandlingen i utide, da Deres infektion muligvis ikke er kureret.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk.7 i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: This product should only be used under the supervision of a doctor.
Danish: Denne medicin bør kun bruges under tilsyn af en læge.
English: Please see instructions below before using VFEND suspension.
Danish: Se venligst brugsanvisningen nedenfor, før De bruger VFEND suspension.
English: Contact your doctor immediately if you become pregnant while taking VFEND.
Danish: Kontakt straks Deres læge, hvis De bliver gravid, mens De tager VFEND.
English: including T. beigelii infections.
Danish: herunder T. beigelii infektioner.
English: If you forget to take one dose, take your next dose when it is due.
Danish: Hvis De glemmer at tage en dosis, så tag næste dosis, når det er tid.
English: Your doctor may change your dose depending on your condition.
Danish: Deres læge kan ændre Deres dosis afhængig af Deres tilstand.
English: The absolute bioavailability of voriconazole after oral administration is estimated to be 96%.
Danish: Den absolutte biotilgængelighed af voriconazol efter oral administration er anslået til 96%.
English: The contents of the infusion bag are now ready for infusion to the patient.
Danish: Indholdet i infusionsposen er nu klar til infusion hos patienten.
English: Patients with a weakened immune system or those with difficult infections may require long-term treatment to prevent the infection from returning.
Danish: Patienter med et nedsat immunsystem eller med svære infektioner kan have behov for langvarig behandling for at undgå, at infektionen kommer igen.
English: Includes febrile neutropenia and neutropenia.
Danish: Inkluderer febril neutropeni og neutropeni.
English: Prolonged optic neuritis has been reported post-marketing.
Danish: Længerevarende optisk neuritis er rapporteret efter markedsføringen.
English: Frequency categories are expressed as: Very common (1/10); Common (1/100 to 1/10); Uncommon (1/1,000 to 1/100); Rare (1/10,000 to 1/1,000); Very rare (1/10,000); Not known (cannot be estimated from the available data).
Danish: Bivirkningsfrekvenser er angivet som: meget almindelig >1/10, almindelig >1/100 og <1/10, ikke almindelig >1/1000 og <1/100, sjælden <1/1000, meget sjælden <1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Cardiomyopathy, in particular when heart failure is present.
Danish: • Kardiomyopati, især hvis hjerteinsufficiens er tilstede.
English: • For storage information, please refer to Section 5 ‘How to store VFEND'.
Danish: • For opbevaring se afsnit 5 ”Sådan opbevarer De VFEND”.
English: In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp.
Danish: In vitro aktivitet over for følgende patogener er vist, men den kliniske betydning er ukendt: Curvularia spp.
English: Slowly draw off the required volume of the solution.
Danish: Udtag langsomt det fornødne volumen opløsning.
English: Your treatment will be started as an infusion
Danish: Behandlingen af barnet vil blive startet som en indsprøjtning
English: Take your box of VFEND tablets with you.
Danish: Tag æsken med VFEND tabletter med.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Pull the plunger out of the syringe and wash both parts in warm soapy water.
Danish: Træk stemplet ud af sprøjten, og vask delene i varmt sæbevand.
English: The suspension should not be further diluted with water or any other liquids.
Danish: Suspensionen må ikke yderligere fortyndes med vand eller andre væsker.
English: While being treated with VFEND:
Danish: Mens De er i behandling med VFEND:
English: If the medicine is to be given to a child, make sure the child is sitting, or is held, upright before giving the medicine.
Danish: Hvis medicinen gives til et barn, så vær sikker på at barnet sidder eller holdes, før medicinen gives.
English: You should always add a total of 46 ml of water irrespective of the dose you are taking.
Danish: Der skal altid tilsættes 46 ml vand, uanset hvilken dosis De skal have.
English: Infusion of total parenteral nutrition can occur simultaneously with VFEND but not in the same line or cannula.
Danish: Infusion med total parenteral ernæring kan ske samtidig medVFEND, men ikke i samme dropslange eller kanyle.
English: Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Danish: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Frankrig.
English: Bioequivalence between the powder for oral suspension and tablets has not been investigated in a paediatric population.
Danish: Bioækvivalens mellem pulver til oral suspension og tabletter er ikke undersøgt i en børnepopulation.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Danish: Der er vist kemisk og fysisk stabilitet i 24 timer ved 2°C-8°C.
English: Pregnancy There are no adequate data on the use of VFEND in pregnant women available.
Danish: Graviditet Der foreligger ikke tilstrækkelig data fra anvendelse af VFEND til gravide kvinder.
English: VFEND suspension should not be mixed with any other medicine.
Danish: VFEND suspension må ikke blandes med anden medicin.
English: Clinical experience Successful outcome in this section is defined as complete or partial response.
Danish: Positivt resultat defineres i dette afsnit som fuldstændigt eller delvis respons.
English: The bag should be checked to ensure that the infusion is complete.
Danish: Posen skal kontrolleres for at sikre, at infusionen er tilendebragt.
English: For Caucasians and Blacks the prevalence of poor metabolisers is 3-5%.
Danish: Blandt kaukasiere og personer af negroid afstamning er prævalensen af personer med dårlig metaboliseringsevne 3-5%.
English: 3c Swirl the vial gently until all the powder is dissolved.
Danish: 3c Rotér forsigtigt, indtil al pulveret er opløst.
English: Treatment of serious fungal infections caused by Scedosporium spp.
Danish: Behandling af alvorlige svampeinfektioner forårsaget af Scedosporium spp.
English: The following instructions apply to both Treatment and Prophylaxis
Danish: Følgende instruktioner angår både behandling og profylakse
English: VFEND may cause blurring of vision or uncomfortable sensitivity to light.
Danish: VFEND kan forårsage sløring af synet eller ubehagelig lysfølsomhed.
English: • Sinus bradycardia.
Danish: • Sinusbradykardi.
English: Contact your doctor if you experience this.
Danish: Kontakt Deres læge, hvis De oplever dette.
English: Powder for oral suspension 45 g
Danish: Pulver til oral suspension 45 g
English: Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended, and the dose of anticoagulants should be adjusted accordingly.
Danish: Tæt monitorering af protrombintid eller andre passende antikoagulations-test anbefales og dosis af antikoagulantia bør tilsvarende justeres.
English: It is therefore recommended to use the oral suspension formulation in children aged 2 to <12.
Danish: Derfor anbefales det at bruge den orale suspension til børn i alderen 2 til <12 år.
English: These visual impairments were transient and fully reversible, with the majority spontaneously resolving within 60 minutes and no clinically significant long-term visual effects were observed.
Danish: Disse former for synsnedsættelse er forbigående og fuldt reversible og er for størstedelen spontant gået over inden for 60 minutter, og der ses ingen klinisk betydende visuelle langtidsvirkninger.
English: Tap the bottle to release the powder.
Danish: Bank på flasken for at frigøre pulveret.
English: Clinical efficacy defined as partial or complete response, has been demonstrated for Aspergillus spp.
Danish: Klinisk virkning, defineret som delvist eller fuldstændigt respons, er vist over for Aspergillus spp.
English: Not for use with other products
Danish: Må ikke anvendes sammen med andre produkter.
English: The modified intent-to-treat (MITT) group included 465 allogeneic HSCT recipients with 45% of patients having AML.
Danish: Den modificerede intentto-treat-gruppe (MITT-gruppe) omfattede 465 patienter, der havde fået allogen HSCT, hvoraf 45% havde AML.
English: Infusions of blood products must not occur simultaneously with VFEND.
Danish: Infusioner med blodprodukter må ikke indgives samtidigt med VFEND.
English: Skin cancer
Danish: • Hudkræft
English: including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp.
Danish: herunder P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis og Trichosporon spp.
English: This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100% mortality).
Danish: Dette studie bekræftede fund fra et tidligere prospektivt studie, hvor der sås positivt resultat hos patienter med risikofaktorer for dårlig prognose, herunder graft-versus-host sygdom og i særdeleshed cerebrale infektioner (normalt forbundet med næsten 100% mortalitet).
English: Further information is provided for medical or healthcare professionals at the end of the Package Leaflet.
Danish: Yderligere oplysninger til læger og sundhedspersonale er angivet sidst i indlægssedlen.
English: If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for VFEND.
Danish: Hvis det infunderes gennem et multi-lumen kateter, skal TPN administreres i en anden port end den, der benyttes til VFEND.
English: Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Danish: Forbigående hepatiske reaktioner, herunder hepatitis og gulsot, er set blandt patienter uden andre erkendte risikofaktorer.
English: Standard genotoxicity and reproduction studies with the excipient SBECD reveal no special hazard for humans.
Danish: Standard genotoksicitet og reproduktionsstudier med hjælpestoffet SBECD tyder ikke på speciel risiko for mennesker.
English: VFEND must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Danish: VFEND må ikke anvendes under graviditet, medmindre den forventede fordel for moderen klart opvejer den potentielle risiko for fostret.
English: Includes immune thrombocytopenic purpura.
Danish: Inkluderer immun trombocytopenisk purpura.
English: Take your bottle of VFEND suspension with you.
Danish: Tag flasken med VFEND suspension med.
English: VFEND must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10% Plus).
Danish: VFEND må ikke infunderes i samme dropslange eller kanyle samtidig med andre lægemiddelinfusioner, herunder parenteral ernæring (f.eks. Aminofusin 10% Plus).
English: The infusion bag should be checked to ensure that the entire contents of the bag have been infused, especially if the same intravenous line is to be used for sequential infusion of other drugs.
Danish: Infusionsposen skal efterses for at sikre, at hele indholdet er infunderet, særligt hvis den samme slange anvendes til sekventiel infusion af andre lægemidler.
English: If you have liver disease, your doctor may prescribe a lower dose of VFEND.
Danish: Hvis De har en leversygdom, kan Deres læge ordinere en lavere dosis af VFEND.
English: In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medicinal product was defined as resolution/improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites 12 weeks after the end of therapy (EOT).
Danish: I den primære analyse var succesfuld respons, i følge en ”Data Review Committee” (DRC), der var blindet over for studiemedicinen, defineret som resolution/forbedring i alle kliniske tegn og symptomer på infektion med eradikation af Candida fra blodet og infektion i dybtliggende vævssteder 12 uger efter endt behandling (EOT).
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende oplysninger er kun til læger og sundhedspersonale:
English: • Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Danish: • Oral svangerskabsforebyggende medicin (hvis De tager VFEND sammen med oral svangerskabsforebyggende medicin, kan De få bivirkninger, såsom kvalme og menstruationsforstyrrelser)
English: Includes akathisia and parkinsonism.
Danish: Inkluderer akatisi og parkinsonisme.
English: Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Danish: Behandling af fluconazol-resistente alvorlige invasive Candida-infektioner (herunder C. krusei).
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Danish: Pilens retning for hver farmakokinetisk parameter er baseret på 90% konfidensinterval af det geometriske gennemsnitlige ratio, indenfor (↔), under (↓) eller over (↑) grænserne 80-125%.
English: The effect of voriconazole on either erythromycin or azithromycin is unknown.
Danish: Voriconazols virkning på både erythromycin og azithromycin er ukendt.