FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that Incruse Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Incruse Ellipta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Incruse Ellipta and why it is authorised in the EU
Danish: En oversigt over Incruse Ellipta, og hvorfor det er godkendt i EU
English: The active substance in Incruse Ellipta, umeclidinium bromide, is a muscarinic receptor antagonist.
Danish: Det aktive stof i Incruse Ellipta, umeclidiniumbromid, er en muskarin receptorantagonist.
English: Incruse Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Incruse Ellipta er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: What is Incruse Ellipta and what is it used for?
Danish: Hvad er Incruse Ellipta, og hvad anvendes det til?
English: Incruse Ellipta can only be obtained with a prescription.
Danish: Incruse Ellipta udleveres kun efter recept.
English: Incruse Ellipta contains the active substance umeclidinium bromide.
Danish: Incruse Ellipta indeholder det aktive stof umeclidiniumbromid.
English: The Agency concluded that Incruse Ellipta was shown to be effective at improving lung function and symptoms of COPD.
Danish: Agenturet fandt, at det er påvist, at Incruse Ellipta er effektivt til at forbedre lungefunktionen og lindre symptomerne på KOL.
English: Why is Incruse Ellipta authorised in the EU?
Danish: Hvorfor blev Incruse Ellipta godkendt i EU?
English: For the full list of side effects and restrictions with Incruse Ellipta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Incruse Ellipta fremgår af indlægssedlen.
English: What are the risks associated with Incruse Ellipta?
Danish: Hvilke risici er der forbundet med Incruse Ellipta?
English: It is available as an inhalation powder in a portable inhaler device.
Danish: Incruse Ellipta fås som et inhalationspulver i en bærbar inhalator.
English: Three studies compared Incruse Ellipta with placebo (a dummy treatment), while one study compared Incruse Ellipta with tiotropium (another medicine for COPD).
Danish: Incruse Ellipta blev i tre studier sammenlignet med placebo (ikke-aktivt stof) og i ét studie med tiotropium (et andet lægemiddel mod KOL).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Incruse Ellipta have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Incruse Ellipta.
English: How is Incruse Ellipta used?
Danish: Hvordan anvendes Incruse Ellipta?
English: What benefits of Incruse Ellipta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Incruse Ellipta?
English: How does Incruse Ellipta work?
Danish: Hvordan virker Incruse Ellipta?
English: Potential for Off-label Use
Danish: Potentiale for off-label-brug
English: Key elements to be included in the educational material
Danish: Centrale punkter, der skal være omfattet af informationsmaterialet
English: Food Interactions
Danish: Interaktioner med fødevarer
English: The Member States must ensure that all conditions with regard to the safe and effective use of the medicinal products described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser med hensyn til en sikker og effektiv anvendelse af de nedenfor beskrevne lægemidler bliver implementeret:
English: If use of eltrombopag is deemed necessary, the starting dose must be 25mg once daily.
Danish: Hvis behandlingen med eltrombopag vurderes at være nødvendig, skal startdosis være 25 mg én gang daglig.
English: Antacids, dairy products and other products containing polyvalent cations, such as mineral supplements, must be administered at least four hours apart from Revolade dosing to avoid significant reduction in Revolade absorption due to chelation.
Danish: Antacida, mejeriprodukter og andre produkter med polyvalente kationer, f.eks. mineraltilskud, skal gives mindst fire timer forskudt fra Revolade for at undgå en signifikant reducering af absorptionen af Revolade pga. chelering.
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal aftale indholdet i et undervisningsprogram med de relevante nationale myndigheder og skal derefter implementere programmet nationalt for at sikre, at læger, før de ordinerer lægemidlet, modtager en informationspakke, der er målrettet mod sundhedspersonale, og som har følgende indhold:
English: • Assist patient in developing a plan to administer Revolade at a time each day that fits into the patient's own daily schedule.
Danish: • Hjælp patienten med at lave en plan for, på hvilket tidspunkt på dagen de skal tage Revolade, så det passer ind i patientens egen daglige tidsplan.
English: • A dose reduction is recommended for ITP patients with platelet counts between 150,000250,000/μl.
Danish: • En dosisreduktion anbefales hos patienter med trombocyttal mellem 150.000-250.000 pr. µl.
English: • Following discontinuation of Revolade, platelet counts return to baseline levels within 2 weeks in the majority of patients, which increase the bleeding risk and in some cases may lead to bleeding.
Danish: • Efter behandlingen med Revolade er stoppet, vil trombocyttallet vende tilbage til udgangsniveauet inden for 2 uger hos de fleste patienter, hvilket øger risikoen for blødning og i nogle tilfælde kan føre til blødning.
English: Consideration should be given to performing a bone marrow aspirate and biopsy over the course of the disease and treatment, particularly in patients over 60 years of age, those with systemic symptoms or abnormal signs.
Danish: Det bør overvejes at udføre en knoglemarvsaspiration og -biopsi i løbet af sygdommen og behandlingen - især hos patienter over 60 år samt hos patienter med systemiske symptomer og unormale tegn.
English: • Importance of not using Revolade outside the context of its license unless in a clinical trial setting.
Danish: • Det er vigtigt, at Revolade ikke anvendes udenfor den godkendte indikation, medmindre det er i forbindelse med et klinisk forsøg.
English: • Following identification of a stable dose of Revolade, perform complete blood count (CBC) with white blood cell count (WBC) differential monthly.
Danish: • Efter fastlæggelse af en stabil dosis Revolade, skal det fuldstændige blodbillede (complete blood count (CBC)), med differentialtal for hvide blodlegemer, foretages hver måned.
English: • Awareness to prescribers of the labelled indication and warnings associated with non-indicated populations (e.g. not recommended for use in children, pregnant or lactating females, other off label uses).
Danish: • Gør lægerne opmærksom på den angivne indikationen og advarsler forbundet med populationer udenfor indikationen (f.eks. ikke anbefalet til behandling af børn, gravide eller ammende kvinder og andet off-label-brug)
English: • Revolade should be interrupted if platelet counts increase to > 250,000/μl.
Danish: • Behandlingen med Revolade bør stoppes, hvis trombocyttallet stiger til > 250.000 pr. µl.
English: • Measure serum ALT, AST and bilirubin prior to initiation of Revolade, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose.
Danish: • Måling af ALAT, ASAT og bilirubin før behandling med Revolade påbegyndes samt hver 2. uge i dosisjusteringsfasen og månedligt efter at en stabil dosis er fundet.
English: Once the platelet count is < 100,000/μl, reinitiate therapy at a reduced daily dose.
Danish: Når trombocyttallet er < 100.000 pr. µl genoptages behandlingen med en reduceret daglig dosis.
English: • The diagnosis of ITP in adults and elderly patients should have been confirmed by excluding other clinical entities with thrombocytopenia.
Danish: • ITP-diagnosen hos voksne og ældre patienter bør bekræftes ved at udelukke andre kliniske tegn forbundet med trombocytopeni.
English: • Monitor platelet count weekly for 4 weeks following discontinuation of Revolade.
Danish: • Monitorering af trombocyttallet ugentligt i 4 uger efter behandlingen med Revolade stoppes.
English: • Discontinue Revolade if ALT levels increase (≥ 3X the upper limit of normal [ULN]) and are: - progressive, or - persistent for > 4 weeks, or - accompanied by increased direct bilirubin, or - accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
Danish: • Afbrydelse af behandlingen med Revolade, hvis ALAT-niveauet stiger (≥ 3 gange den øvre normalgrænse) og er: - progressiv, eller - varer ved i > 4 uger, eller - ledsages af øget direkte bilirubin, eller - ledsages af kliniske symptomer på leverskader eller tegn på hepatisk dekompensation.
English: • The risk-benefit of Revolade in paediatric ITP has not been established.
Danish: • Forholdet mellem risikoen og fordelene ved Revolade til pædiatrisk ITP ikke er afklaret.
English: • Eltrombopag should not be used in patients with hepatic impairment (Child Pugh score ≥ 5) unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Danish: • Eltrombopag bør ikke gives til patienter med moderat til svært nedsat leverfunktion, medmindre den forventede fordel ved behandlingen er større end den identificerede risiko for portal venetromboser.
English: • Prior to initiation of Revolade, examine the peripheral blood smear closely to establish a baseline level of cellular morphologic abnormalities.
Danish: • Før behandlingen med Revolade påbegyndes, skal den perifere blodudstrygning undersøges nøje med henblik på at fastlægge et udgangsniveau for cellemorfologiske abnormiteter.
English: • If immature or dysplastic cells are observed, examine peripheral blood smears for new or worsening morphological abnormalities (e.g., teardrop and nucleated red blood cells, immature white blood cells) or cytopenia(s).
Danish: • Hvis der ses umodne eller dysplastiske celler, skal den perifere blodudstrygning undersøges for nye eller forværrede morfologiske abnormiteter (f.eks. dråbeformede, røde blodlegemer med kerne eller umodne hvide blodlegemer) eller cytopeni(er).
English: • Background information on reticulin in the bone marrow (i.e. background rates of reticulin in bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to Revolade).
Danish: • Baggrundsinformation om retikulin i knoglemarven (dvs. baggrundsmængde af retikulin i knoglemarven hos ITP-patienter og den observerede forekomst og potentielle virkningsmekanisme for retikulinaflejring ved behandling med Revolade).
English: • Educate patients about the potential food-drug interaction (i.e. chelation with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc).
Danish: • Information til patienterne om riskoen for interaktioner mellem fødevarer og lægemidlet (f.eks. chelering med polyvalente kationer som jern, calcium, magnesium, aluminium, selen og zink).
English: • Educate patients on the appropriate administration of Revolade (e.g. titration of Revolade, fooddrug interaction, dose recommendations for special populations [e.g. east Asians]).
Danish: • Information til patienterne om hensigtmæssig administration af Revolade (f.eks. titrering af Revolade, interaktion med fødevarer, dosisanbefalinger for specialle popupalationer [f.eks. østasiatere]).
English: • If the patient develops new or worsening morphological abnormalities or cytopenia(s), discontinue treatment with Revolade and consider a bone marrow biopsy, including staining for fibrosis.
Danish: • Hvis patienten udvikler nye eller forværrede morfologiske abnormiteter eller cytopeni(er), skal behandlingen med Revolade stoppes, og en knoglemarvsbiopsi inklusive farvning for fibrose skal overvejes.
English: • Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling
Danish: • Informationsmateriale • Produktresumé (SPC) samt indlægsseddel og etikettering.
English: Haematological malignancies
Danish: Hæmatologisk malignitet
English: Increased Bone Marrow Reticulin Fibres
Danish: Forøget retikulinfibre i knoglemarven
English: • Educate patients about the potential risk of bleeding after treatment has stopped (include incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment).
Danish: • Information til patienterne om risikoen for blødning efter behandlingen er stoppet (inkluder forekomsten i kliniske forsøg og sandsynligheden for trombocytopeni efter behandlingsophør).
English: • Educate patients about the theoretical risk of haematological malignancies with thrombopoietin receptor agonists.
Danish: • Information til patienterne om den teoretiske risiko for hæmatologisk malignitet forbundet med trombopoietin receptor-agonister.
English: • Educate patients about the potential for hepatic enzyme elevations, importance of monthly laboratory monitoring of ALT and AST, as well as the signs and symptoms associated with liver injury (e.g. jaundice).
Danish: • Information til patienterne om risikoen for stigninger i niveauer af leverenzymer og vigtigheden af en månedlig monitorering af ALAT og ASAT samt tegn og symptomer på leverskade (f.eks.
English: • Educate patients about the potential for bone marrow reticulin fibre formation.
Danish: • Information til patienterne om risikoen for dannelse af retikulinfibre i knoglemarven.
English: • Educate patients about chronic liver disease and the risk of thromboembolic events.
Danish: • Information til patienterne om patienter med kronisk leversygdom og risiko for tromboemboliske hændelser.
English: • The risk-benefit for the treatment of thrombocytopenia in non ITP patient populations has not been established.
Danish: • Forholdet mellem risikoen og fordelene ved behandling af trombocytopeni hos ikke-ITP
English: • Educate patients about the potential for thromboembolic events (TEE) in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome).
Danish: • Information til patienterne om risikoen for tromboemboliske hændelser hos patienter med kronisk ITP og de kendte risikofaktorer forbundet med tromboemboliske hændelser (f.eks.
English: Reoccurrence of Thrombocytopenia
Danish: Tilbagevendende trombocytopeni
English: Use a lower starting dose of eltrombopag and monitor closely when administering eltrombopag to patients with hepatic impairment..
Danish: • Administration til patienter med moderat til svært nedsat leverfunktion bør ske med forsigtighed og skal følges nøje pga. en øget eksponering af lægemidlet.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får ivirkninger.
English: Instructions for use, handling and disposal
Danish: Instruktioner vedrørende anvendelse, håndtering samt bortskaffelse
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Det skal der tages hensyn til hos patienter på en kontrolleret natriumdiæt.
English: Gently swirl each vial until the powder is completely dissolved.
Danish: Sving forsigtigt hvert hætteglas, indtil pulveret er helt opløst.
English: Pemetrexed Hospira can have a minor or moderate influence on ability to drive and use machines.
Danish: Pemetrexed Hospira kan i mindre eller moderat grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: It is not known whether pemetrexed is excreted in human milk, and adverse reactions on the suckling child cannot be excluded.
Danish: Det er ukendt, om pemetrexed udskilles i human mælk, og en påvirkning af ammede børn kan ikke udelukkes.
English: In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Hospira and cisplatin is documented in Table 3.
Danish: I tilfælde af neurotoksicitet er den anbefalede dosisjustering for Pemetrexed Hospira og cisplatin angivet i tabel 3.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C.
Danish: Hvis produktet ikke anvendes med det samme, er det brugerens ansvar at vurdere holdbarheden og opbevaringsforholdene, inden produktet anvendes, og holdbarheden vil normalt højst være 24 timer ved 2 °C-8 til 8 °C.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Hospira has finished.
Danish: Cisplatin indgives også som infusion i en af Deres blodårer, cirka 30 minutter efter at infusionen med Pemetrexed Hospira er afsluttet.
English: Upon recovery, patients should be re-treated using the guidelines in Tables 1, 2, and 3, which are applicable for Pemetrexed Hospira used as a single agent or in combination with cisplatin.
Danish: Efter rekonvalescens skal patienter efterbehandles ud fra retningslinjerne i tabel 1, 2 og 3, der gælder for brug af Pemetrexed Hospira som enkeltstof eller i kombination med cisplatin.
English: It has been reported that pemetrexed may cause fatigue.
Danish: Det er blevet rapporteret, at pemetrexed kan forårsage træthed.
English: You will always receive Pemetrexed Hospira by infusion into one of your veins.
Danish: De vil altid få Pemetrexed Hospira som infusion i en af Deres blodårer.
English: Calculate the dose and the number of Pemetrexed Hospira vials needed.
Danish: Beregn den nødvendige dosis og det nødvendige antal hætteglas med Pemetrexed Hospira.
English: 20 November 2015
Danish: Dato for første markedsføringstilladelse: 20. november 2015
English: Randomised and treated patients Fully supplemented patients
Danish: Randomiserede og behandlede patienter
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGS¬TILLADELSEN
English: Do not use Pemetrexed Hospira - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Pemetrexed Hospira hvis De er allergisk over for pemetrexed eller et af de øvrige indholdsstoffer i Pemetrexed Hospira (angivet i punkt 6).
English: Unopened vial 3 years
Danish: Ubrudt hætteglas 3 år.
English: • Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Danish: Allergisk reaktion: Hvis De udvikler udslæt (meget almindelig)/en brændende eller prikkende fornemmelse (almindelig) eller feber (almindelig).
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed Hospira.
Danish: Før hver indgivelse vil De få taget blodprøver til vurdering af, om Deres nyre- og leverfunktion er tilstrækkelig god, og for at kontrollere, om De har blodlegemer nok til at få Pemetrexed Hospira.
English: Pemetrexed Hospira is a medicine used in the treatment of cancer.
Danish: Pemetrexed Hospira er et lægemiddel, der anvendes til behandling af kræft.
English: CZ Pfizer, spol.
Danish: Pfizer, spol.
English: - If you get any side effects, talk to your doctor or pharmacist or nurse.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: Corticosteroids: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Hospira treatment.
Danish: Kortikosteroider: Deres læge vil udskrive steroidtabletter til Dem (svarende til 4 milligram dexamethason 2 gange dagligt), som De skal tage på dagen før, på behandlingsdagen og dagen efter behandling med Pemetrexed Hospira.
English: Pemetrexed Hospira must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Danish: Pemetrexed Hospira må kun administreres under tilsyn af en læge, som er kvalificeret i brugen af kemoterapi mod cancer.
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Hospira.
Danish: Hvis De har en væskeansamling omkring lungerne, vil lægen muligvis beslutte at fjerne denne væske, før De modtager behandling med Pemetrexed Hospira.
English: Hospira UK Limited
Danish: Fremstiller Hospira UK Limited Horizon
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Hospira.
Danish: De skal tage mindst 5 doser i løbet af de 7 dage op til den første dosis Pemetrexed Hospira.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs (EMA) hjemmeside http://www.ema.europa.eu.
English: You will also receive an injection of vitamin B12 (1,000 micrograms) in the week before administration of Pemetrexed Hospira and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Hospira treatment).
Danish: De vil også få en injektion med B12-vitamin (1.000 mikrogram) i løbet af ugen op til første dosis Pemetrexed Hospira og derefter cirka hver 9. uge (svarende til 3 Pemetrexed Hospira behandlingsforløb).
English: The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Danish: De øvrige indholdsstoffer er mannitol (E421), saltsyre (til pH justering) og natriumhydroxid (til pH justering).
English: For instructions on reconstitution and dilution of Pemetrexed Hospira before administration, see section 6.6
Danish: For instruktioner vedrørende rekonstitution og fortynding af Pemetrexed Hospira før administration, se pkt.
English: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤6 cycles: 3.3%, >6 cycles: 6.4%: p=0.046).
Danish: Der blev observeret en signifikant øget forekomst af grad 3/4 neutropeni, som muligvis var relateret til studiemedicinen, ved længere eksponering for pemetrexed (≤6 serier: 3,3 %; > 6 serier: 6,4 %; p=0,046).
English: If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with Pemetrexed Hospira.
Danish: Hvis De har fået eller skal have strålebehandling, skal De fortælle det til Deres læge, idet Pemetrexed Hospira kan medføre en tidlig eller sen strålingsreaktion.
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Hospira.
Danish: Informér Deres læge, hvis De for nylig er blevet vaccineret, da det muligvis kan forårsage dårlige virkninger med Pemetrexed Hospira.
English: Pancytopenia- combined low counts of white cells, red cells and platelets
Danish: Pancytopeni - en kombination af lavt antal hvide blodlegemer, røde blodlegemer og blodplader.
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Danish: Fortæl det til Deres læge, hvis De får alvorligt udslæt, kløen eller blæredannelse (Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse).
English: For intravenous use
Danish: Til intravenøs anvendelse.
English: Dose of Pemetrexed Hospira (mg/m2)
Danish: Dosis af Pemetrexed Hospira (mg/m
English: treatment until disease progression.
Danish: Patienterne fik vedligeholdelsesbehandling indtil sygdomsprogression.