FrancophonIA/ELRC3.0 huggingface dataset:
English: EU Number Invented name Strength
Danish: EU nummer Særnavn Styrke
English: 2 to 4 GBq per vial at calibration date
Danish: 1,3 GBq/ml på den referencedato
English: Package size
Danish: Indhold (koncentration) Pakningsstørrelse
English: Intravenous use
Danish: Emballage
English: 1.5 - 3.1 ml 1 vial
Danish: Intravenøs anvendelse Pulver: hætteglas 1.5 - 1.3 ml
English: Pharmaceutical form Route of administration Packaging Content
Danish: Lægemiddelform Indgivelsesvej
English: ... and for 2 hours after
Danish: ... og i 2 timer efter
English: But there will still be some left in the bottle, even though you may not be able to see it.
Danish: Men der vil stadig være noget tilbage i flasken, selvom du ikke nødvendigvis kan se det.
English: Date of first authorisation: 11 March 2010 Date of latest renewal: 15 January 2015
Danish: Dato for første markedsføringstilladelse: 11. marts 2010 Dato for seneste fornyelse: 15. januar 2015
English: • progressive, or
Danish: • progressive, eller
English: Your doctor will discuss this with you.
Danish: Lægen vil diskutere dette med dig.
English: This is normal.)
Danish: Det er normalt).
English: Avoid direct contact with the medicine.
Danish: Undgå direkte kontakt med lægemidlet.
English: • persistent for ≥4 weeks, or
Danish: • varer ved i ≥ 4 uger, eller
English: You have now given the child nearly all of their dose of medicine.
Danish: Du har nu givet barnet næsten hele dets dosis medicin.
English: Before you start Read these messages first
Danish: Før du begynder Læs denne information først
English: It is important to tell a doctor if you develop these symptoms.
Danish: Det er vigtigt, at du fortæller lægen, hvis du udvikler disse symptomer.
English: Multilineage responses were reported by 45% of patients.
Danish: Multilineært respons var rapporteret af 45 % af patienterne.
English: • accompanied by increased direct bilirubin, or
Danish: • ledsages af øget direkte bilirubin, eller
English: % patients achieving virologic response
Danish: % patienter, der opnåede virologisk respons
English: • Try not to let the medicine touch your skin.
Danish: • Prøv at undgå, at medicinen berører din hud.
English: This was measured by delayed phototoxic index.
Danish: Dette blev målt ved forsinket fototoksisk indeks.
English: Now you need to complete steps 11 to 13 to make sure the child receives all of the medicine.
Danish: Du skal nu gennemføre trin 11 til 13 for at sikre, at barnet får al medicinen.
English: Patients received study medication for up to 8 years (in EXTEND).
Danish: Patienterne fik forsøgsmedicinen i op til 8 år (i EXTEND).
English: • Wash your hands with soap and water.
Danish: • Vask dine hænder med sæbe og vand.
English: Don't drive or use machines unless you are sure you're not affected.
Danish: Kør ikke bil og betjen ikke maskiner, medmindre du er sikker på, at du ikke er påvirket.
English: Make sure the child has time to swallow.
Danish: Sørg for at give barnet tid til at synke.
English: Effects were less severe at lower doses and were characterised by a spectrum of regenerative changes.
Danish: Virkningen var mindre alvorlig ved lavere doser og var kendetegnet ved en række regenerative ændringer.
English: Table 4 Secondary efficacy results from RAISE
Danish: Tabel 4 Sekundære effektresultater fra RAISE
English: Always start with a complete new kit for each 30 sachets.
Danish: Begynd altid med et helt nyt sæt for hver 30 breve.
English: If you have MDS and take Revolade, your MDS may get worse.
Danish: Hvis du har MDS og tager Revolade, kan din MDS blive værre.
English: Absorption and bioavailability
Danish: Absorption og biotilgængelighed
English: Read and follow these instructions to prepare a dose of Revolade and give it to the child.
Danish: Læs og følg disse anvisninger for at fremstille en dosis Revolade, og for at give den til barnet.
English: Juvenile animal studies
Danish: Juvenile dyrestudier
English: • lack of energy
Danish: • mangel på energi
English: Older people (65 years and above)
Danish: Ældre personer (65 år og derover)
English: Double-blind placebo-controlled studies
Danish: Dobbeltblindede, placebokontrollerede studier
English: The majority of TEEs were non-serious and resolved by the end of the study.
Danish: Størstedelen af TEEs var ikke alvorlige og var ikke længere til stede ved studiets afslutning.
English: • and the 2 hours after you take Revolade you don't consume any of the following:
Danish: • og i 2 timer, efter at du har taget Revolade ikke indtager et eller flere af følgende produkter:
English: If treatment is considered clinically indicated, close monitoring of these patients is required.
Danish: Hvis behandling er klinisk indiceret, kræves tæt monitorering af disse patienter.
English: Contact a doctor or pharmacist immediately.
Danish: Kontakt lægen eller apotekspersonalet med det samme.
English: Side effects with frequency not known Frequency cannot be estimated from the available data
Danish: Bivirkninger, hvor frekvensen ikke er kendt Frekvensen kan ikke estimeres ud fra forhåndenværende data
English: Revolade may take 1 to 2 weeks to work.
Danish: Det kan tage 1-2 uger, før Revolade virker.
English: Don't stop taking Revolade without talking to your doctor.
Danish: Stop ikke med at tage Revolade uden at have talt med lægen.
English: Table 5 Efficacy results from TRA100773B
Danish: Tabel 5 Effektresultater fra TRA100773B
English: Make sure that
Danish: Sørg for, at du
English: Make sure that the bottle, cap and lid are dry before you use them.
Danish: Sørg for, at flasken, hætten og låget er tørre, før du bruger dem.
English: QT/QTc prolongation
Danish: QT/QTc-forlængelse
English: Package Leaflet: Information for the patient
Danish: Indlægsseddel: Information til patienten
English: The clinical significance of these QTc prolongation events is unknown.
Danish: Den kliniske betydning af disse QTc-forlængelser er ukendt.
English: In non-splenectomised patients this should include evaluation relative to splenectomy.
Danish: Hos ikke-splenektomerede patienter bør dette inkludere evaluering i forhold til splenektomi.
English: Do not take more than one dose of Revolade in one day.
Danish: Tag ikke mere end 1 dosis Revolade om dagen.
English: If you do, the medicine will not be properly absorbed into your body.
Danish: Hvis du ikke overholder ovenstående, vil medicinen ikke blive ordentligt optaget i din krop.
English: • Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Danish: • Fortæl det til lægen, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: If the laboratory results and clinical observations are inconsistent, re-testing using another method may help in determining the validity of the result.
Danish: Hvis laboratorieresultater og kliniske observationer er modstridende, kan gentagen undersøgelse ved hjælp af en anden metode muligvis hjælpe med at bestemme resultaternes validitet.
English: Again fill the syringe, this time with 10 ml of drinking water.
Danish: Fyld sprøjten igen, denne gang med 10 ml drikkevand.
English: The above warnings and precautions for ITP also apply to the paediatric population.
Danish: De ovenstående advarsler og forsigtighedsregler for ITP, gælder også for den pædiatriske population.
English: • IMPORTANT: Because some medicine will remain in the mixing bottle, complete the following steps.
Danish: • VIGTIGT: Da nogle rester af medicinen vil blive tilbage i flasken, skal følgende trin udføres:
English: Warnings and precautions Talk to your doctor before taking Revolade:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Revolade:
English: To prepare and give a dose of Revolade, you need:
Danish: Til at fremstille og give en dosis Revolade skal du bruge:
English: Albumin levels f
Danish: Albuminniveauer f
English: IMPORTANT:
Danish: VIGTIGT:
English: • if you have liver problems.
Danish: • hvis du har leverproblemer.
English: • Prepare the suspension with water only.
Danish: • Klargør suspensionen udelukkende med vand.
English: Eltrombopag is highly bound to human plasma proteins (>99.9%), predominantly to albumin.
Danish: Eltrombopag er i høj grad bundet til humane plasmaproteiner (> 99,9 %), hovedsagelig albumin.
English: (The mixing bottle may become stained from the medicine.
Danish: (Blandeflasken kan blive misfarvet af medicinen.
English: Routine ophthalmologic monitoring of patients is recommended.
Danish: Rutinemæssig oftalmologisk monitorering af patienterne anbefales.
English: The studies consisted of two phases - a pre-antiviral treatment phase and an antiviral treatment phase.
Danish: Studierne bestod af to faser - en fase før antiviral behandling og en fase med antiviral behandling.
English: Your doctor will review the medicines you are taking, and suggest suitable replacements if necessary.
Danish: Lægen vil gennemgå den medicin, du tager, og vil foreslå alternativer, hvis det er nødvendigt.
English: Asian patients
Danish: Asiatiske patienter
English: Nevertheless, a potential risk of photoallergy cannot be ruled out since no specific preclinical study could be performed.
Danish: Ikke desto mindre kan en potentiel risiko for fotoallergi ikke udelukkes, idet intet specifikt præklinisk studie kunne udføres.
English: • if you have another blood condition, such as myelodysplastic syndrome (MDS).
Danish: • hvis du har andre blodsygdomme såsom myelodysplastisk syndrom (MDS).
English: The powder for oral suspension is in sachets, the contents of which will need to mixed before you can take the medicine.
Danish: Pulveret til oral suspension er i breve, hvis indhold skal blandes, før du kan tage medicinen.
English: Repeat steps 7 to 10 - gently shake the bottle to mix the rest of the medicine, then give all the rest of the liquid to the child.
Danish: Gentag trin 7 til 10 - ryst flasken forsigtigt for at blande resten af medicinen, og giv derefter hele resten af væsken til barnet.
English: ITP study population
Danish: ITP-studie population
English: Reddish-brown to yellow powder.
Danish: Rødlig-brunt til gult pulver.
English: If this happens, wash the area immediately with soap and water.
Danish: Hvis det sker, skal du straks vaske området med sæbe og vand.
English: • The medicine is a dark brown liquid.
Danish: • Medicinen er en mørkebrun væske.
English: Stop eltrombopag; for at least one week.
Danish: Seponer eltrombopag i mindst én uge.
English: Data are limited to 21 out of the planned 60 patients with haematological responses reported by 52% of patients at 6 months.
Danish: Data er begrænset til 21 ud af de planlagte 60 patienter med hæmatologisk respons rapporteret af 52 % af patienterne ved 6 måneder.
English: No case of TEE was identified from a clinical study in refractory SAA, however the risk of these events cannot be excluded in this patient population due to the limited number of exposed patients.
Danish: Der er ikke identificeret nogen tilfælde af TEE fra et klinisk studie med refraktær SAA, men risikoen for disse hændelser kan ikke udelukkes i denne patientpopulation pga. begrænset antal eksponerede patienter.
English: The absolute oral bioavailability of eltrombopag after administration to humans has not been established.
Danish: Den absolutte, orale biotilgængelighed af eltrombopag efter administration til mennesker er ikke fastlagt.
English: • Administer the oral suspension immediately after preparation.
Danish: • Den orale suspension administreres straks efter klargøring.
English: Read the information ‘Liver problems' in section 4 of this leaflet.
Danish: Læs informationen under 'Leverproblemer' i punkt 4 i denne indlægsseddel.
English: • Take care that the child does not play with the bottle, cap, lid or syringes - there is a risk of choking if the child puts them in their mouth.
Danish: • Sørg omhyggeligt for, at barnet ikke leger med flasken, hætten, låget eller sprøjterne - der er risiko for kvælning, hvis barnet putter dem i munden.
English: Revolade can make you dizzy and have other side effects that make you less alert.
Danish: Revolade kan gøre dig svimmel og du kan få bivirkninger, som gør dig mindre agtpågivende.
English: Gently and slowly shake the mixing bottle backwards and forwards for at least 20 seconds to mix the water with the powder.
Danish: Ryst forsigtigt og langsomt blandeflasken frem og tilbage i mindst 20 sekunder, så vandet blandes med pulveret.
English: • ciclosporin used in the context of transplantations or immune diseases
Danish: • ciclosporin anvendt i forbindelse med transplantationer eller sygdomme i immunsystemet
English: It is not known whether eltrombopag/metabolites are excreted in human milk.
Danish: Det er ukendt, om eltrombopag/metabolitter udskilles i human mælk.
English: You should not take Revolade unless your doctor considers that the expected benefits outweigh the risk of blood clots.
Danish: Du bør ikke tage Revolade, medmindre lægen mener, at de forventede fordele opvejer risikoen for at få blodpropper.
English: • pain in extremities (arms, legs, hands and feet)
Danish: • smerter i ekstremiteterne (arme, ben, hænder og fødder)
English: Fill the syringe with 20 ml drinking water from the glass or cup.
Danish: Fyld sprøjten med 20 ml drikkevand fra glasset eller koppen.
English: Revolade is not recommended for use in children under the age of one year with ITP due to insufficient data on safety and efficacy.
Danish: Revolade bør ikke anvendes til børn under et år med ITP på grund af utilstrækkelige data om sikkerhed og virkning.
English: Polyvalent cations (chelation)
Danish: Polyvalente kationer (chelering)
English: This includes medicines obtained without prescription and vitamins.
Danish: Dette gælder også medicin, som ikke er købt på recept og vitaminer.
English: Table 7 Virologic response in HCV patients in ENABLE 1 and ENABLE 2
Danish: Tabel 7 Virologisk respons hos patienter med HCV i ENABLE 1 og ENABLE 2
English: The majority of patients (84%) had received at least 2 prior immunosuppressive therapies.
Danish: Hovedparten af patienterne (84 %) havde tidligere fået mindst to immunsuppressive behandlinger.
English: Increase of alanine aminotransferase and aspartate aminotransferase may occur simultaneously, although at a lower frequency.
Danish: Forhøjet alaninaminotransferase og aspartataminotransferase kan forekomme samtidig, men med en lavere frekvens
English: All events were resolved without sequelae following treatment.
Danish: Alle hændelser forsvandt uden komplikationer efter behandlingen.
English: Following reconstitution, the medicinal product should be administered immediately but may be stored for a maximum period of 30 minutes.
Danish: Efter rekonsitution af lægemidlet bør det anvendes straks, men kan opbevares i en periode på maksimalt 30 minutter.
English: • If you do become pregnant during treatment with Revolade, tell your doctor.
Danish: • Hvis du bliver gravid, mens du er i behandling med Revolade, skal du fortælle det til lægen.
English: Fill the syringe with the medicine.
Danish: Fyld sprøjten med medicin.
English: The relevance of this finding, as with other thrombopoietin receptor (TPO-R) agonists, has not been established yet.
Danish: Relevansen af dette fund er - som for andre trombopoietin-receptor(TPO-R)-agonister - endnu ikke fastslået.
English: • in the 4 hours before you take Revolade
Danish: • i 4 timer, før du tager Revolade
English: If you have either of these signs of liver problems:
Danish: Hvis du oplever nogle af disse tegn på leverproblemer:
English: People with ITP have an increased risk of bleeding.
Danish: Personer med ITP har en øget risiko for blødninger.
English: Many people with hepatitis C have low platelet counts, not only as a result of the disease, but also due to some of the antiviral medicines that are used to treat it.
Danish: Mange personer med hepatitis C har lave trombocyttal, ikke kun på grund af sygdommen, men også på grund af de antivirale lægemidler, de får som behandling.
English: OATP1B1 and BCRP substrates
Danish: OATP1B1- og BCRP-substrater
English: However a risk for humans cannot be ruled out (see section 5.3).
Danish: En risiko for mennesker kan imidlertid ikke udelukkes (se pkt.
English: Overall, eltrombopag was administered to 277 ITP patients for at least 6 months and 202 patients for at least 1 year.
Danish: Samlet set blev eltrombopag givet til 277 ITP-patienter i mindst 6 måneder og 202 patienter i mindst 1 år.
English: • The correct number of sachets your doctor has prescribed (supplied in the kit)
Danish: • Det korrekte antal breve, som din læge har ordineret (findes i sættet)
English: You may also be checked for the occurrence of any bleeding in or around your retina (the light-sensitive layer of cells at the back of the eye).
Danish: Du kan også få undersøgt om der er opstået blødning i eller rundt om retina (det lysfølsomme lag af celler bagerst i øjet).
English: • lack of interest, mood changes
Danish: • mangel på interesse, humørændringer
English: Progression of existing myelodysplastic syndrome (MDS)
Danish: Forværring af eksisterende myelodysplastisk syndrom (MDS)
English: Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration.
Danish: Eltrombopag absorberes med en maksimal koncentration 2-6 timer efter oral administration.
English: • Revolade powder must be mixed only with water at room temperature.
Danish: • Revolade pulver må kun blandes med vand, der har stuetemperatur.
English: Requiring rescue therapy, n (%) p-value a
Danish: Behov for ”rescue”-behandling, n (%) p-værdi a
English: If you forget to take Revolade Take the next dose at the usual time.
Danish: Hvis du har glemt at tage Revolade Tag den næste dosis på det sædvanlige tidspunkt.
English: • medicines called statins, to lower cholesterol
Danish: • medicin, som kaldes statiner, til at sænke kolesteroltallet
English: These findings were mostly mild (Grade 1-2), reversible and not accompanied by clinically significant symptoms that would indicate an impaired liver function.
Danish: Disse fund var oftest lette (grad 1-2), reversible og ikke fulgt af klinisk signifikante symptomer, der tyder på nedsat leverfunktion.
English: These in vitro and in vivo findings suggest that eltrombopag does not pose a genotoxic risk to humans.
Danish: Disse in vitro- og in vivofund tyder på, at eltrombopag ikke udgør nogen genotoksisk risiko for mennesker.
English: If you stop taking Revolade, your blood platelet count is likely to become low again within several days.
Danish: Hvis du stopper med at tage Revolade, er der sandsynlighed for, at dit blodpladetal vil falde igen inden for nogle dage.
English: The TPO-R is predominantly expressed on the surface of cells of the myeloid lineage.
Danish: TPO-R udtrykkes overvejende på overfladen af celler af myeloid herkomst.
English: Therefore, data from these animals do not fully model potential adverse effects related to the pharmacology of eltrombopag in humans, including the reproduction and carcinogenicity studies.
Danish: Derfor udgør data fra disse dyr ikke en reel model for bivirkninger relateret til eltrombopags farmakologi hos mennesker inklusive reproduktions- og karcinogenicitetsstudier.
English: • 1 clean glass or cup filled with drinking water (not supplied)
Danish: • 1 rent glas eller en ren kop med drikkevand (medfølger ikke)
English: The plasma elimination half-life of eltrombopag is approximately 21-32 hours.
Danish: Halveringstiden for eltrombopag er ca. 21-32 timer.
English: Eltrombopag is highly coloured and so has the potential to interfere with some laboratory tests.
Danish: Eltrombopag er stærkt farvet og kan derfor potentielt påvirke visse laboratorieundersøgelser.
English: Patients did not receive direct acting antiviral agents.
Danish: Patienterne fik ikke direkte virkende antivirale midler.
English: Platelets are blood cells that help to reduce or prevent bleeding.
Danish: Blodplader er blodceller, som hjælper til med at mindske eller helt undgå blødninger.
English: Abnormal serum liver tests should be evaluated with repeat testing within 3 to 5 days.
Danish: Ved unormale serum-levertal skal analysen gentages i løbet af 3-5 dage.
English: Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see section 5.2).
Danish: Anden rapporteret, klinisk erfaring har ikke identificeret forskelle i respons mellem ældre og yngre patienter, men større følsomhed hos nogle ældre patienter kan ikke udelukkes (se pkt.
English: After you have used all 30 sachets in the kit, dispose of the bottle.
Danish: Når du har brugt alle 30 breve i sættet, skal flasken smides ud.
English: Monitoring and dose adjustment
Danish: Monitorering og dosisjustering
English: Eltrombopag was discontinued after 16 weeks if no haematological response or transfusion independence was observed.
Danish: Eltrombopag blev seponeret efter 16 uger, hvis der ikke blev observeret noget hæmatologisk respons eller transfusionsuafhængighed.
English: Medicinal products for treatment of ITP
Danish: Lægemidler til behandling af ITP
English: <50,000/µl following at least 2 weeks of therapy
Danish: < 50.000 pr. µl efter mindst 2 ugers behandling
English: Take only the prescribed number of sachets for one dose out of the kit.
Danish: Tag kun det ordinerede antal breve til én dosis ud af sættet.
English: • Let all the equipment dry in the air.
Danish: • Lad alt udstyret lufttørre.
English: The remaining 10 patients had insufficient platelet response to prior therapies.
Danish: De resterende 10 patienter havde ikke tilstrækkeligt trombocytrespons på tidligere behandlinger.
English: The long-term safety of eltrombopag should be considered prior to starting therapy.
Danish: Den langsigtede sikkerhed af eltrombopag bør overvejes, før behandlingen påbegyndes.
English: ENABLE 1 utilised peginterferon alfa-2a plus ribavirin for antiviral treatment and ENABLE 2 utilised peginterferon alfa-2b plus ribavirin.
Danish: I ENABLE 1 blev der benyttet peginterferon alfa-2a plus ribavirin som antiviral behandling, og i ENABLE 2 blev der benyttet peginterferon alfa-2b plus ribavirin.
English: Haemorrhages occurred on the surface of the retina (preretinal), under the retina (subretinal), or within the retinal tissue.
Danish: Blødning forekom på overfladen af retina (præretinal), under retina (subretinal) eller i det retinale væv.
English: • some medicines to treat HIV infection, such as lopinavir and/or ritonavir
Danish: • nogle lægemidler til behandling af hiv-infektion, f.eks. lopinavir eller ritonavir
English: Nine of these patients achieved a multi-lineage response, 4 of the 9 remain on treatment and 5 tapered off treatment with eltrombopag and maintained the response (median follow up: 20.6 months, range: 5.7 to 22.5 months).
Danish: Ni af disse patienter opnåede et multilineært respons, 4 af de 9 forblev i behandling, og 5 trappede ud af behandling med eltrombopag og fastholdt responset (median opfølgning: 20,6 måneder, interval: 5,7 til 22,5 måneder).
English: It is not known whether Revolade passes into breast-milk.
Danish: Det vides ikke, om Revolade går over i modermælken.
English: • Add 20 ml of water and the contents of the prescribed number of sachets (depending on the recommended dose) to the provided mixing bottle and mix gently.
Danish: • Tilsæt 20 ml vand samt indholdet af det ordinerede antal breve (afhængigt af den anbefalede dosis) til den medfølgende blandeflaske og bland forsigtigt.
English: Eltrombopag was an inhibitor of a number of UGT enzymes in vitro.
Danish: Eltrombopag var en hæmmer af et antal UGT-enzymer in vitro.
English: • interruption of blood supply to part of the heart
Danish: • afbrydelse af blodforsyningen til dele af hjertet
English: • if you are allergic to eltrombopag or any of the other ingredients of this medicine (listed in section 6 under ‘What Revolade contains').
Danish: • hvis du er allergisk over for eltrombopag eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6 under ‘Revolade indeholder').
English: • Don't shake the bottle hard - that could make the medicine foam.
Danish: • Flasken må ikke rystes kraftigt - det kan få medicinen til at skumme.
English: • difficulty in sleeping (insomnia)
Danish: • besvær med at sove (søvnløshed)