FrancophonIA/ELRC3.0 huggingface dataset:
English: Ensure there is a seal between your lips and the mouthpiece.
Danish: Sørg for, at dine læber slutter tæt om mundstykket.
English: • Cough, throat irritation
Danish: • Hoste, halsirritation
English: Renal impairment
Danish: Klemme Hætte
English: Inhalation use
Danish: Kun til inhalation
English: • Difficulty in breathing
Danish: • Vejrtrækningsbesvær
English: • The Patient Information Leaflet
Danish: • Indlægssedlen
English: One capsule to be inhaled twice daily.
Danish: Voksne og børn i alderen 6 år og derover En kapsel til inhalation to gange dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vpriv on 26 August 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vpriv den 26. august 2010.
English: This document is a summary of the European public assessment report (EPAR) for Vpriv.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vpriv.
English: The dose can be adjusted according to each patient's symptoms and response to treatment.
Danish: Dosis kan tilpasses den enkelte patients symptomer og reaktion på behandlingen.
English: The most serious side effects are hypersensitivity (allergic) reactions.
Danish: De mest alvorlige bivirkninger er overfølsomhed (allergiske reaktioner).
English: Other information about Vpriv
Danish: Andre oplysninger om Vpriv
English: The main measure of effectiveness was the improvement in anaemia, one of the symptoms of the disease, after 41 weeks.
Danish: Virkningen blev hovedsagelig bedømt på forbedringen med hensyn til anæmi, som er en af sygdomssymptomerne, efter 41 uger.
English: What measures are being taken to ensure the safe and effective use of Vpriv?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vpriv?
English: The recommended dose of Vpriv is 60 units/kg bodyweight, which is given as a one-hour infusion once every two weeks.
Danish: Den anbefalede dosis af Vpriv er 60 enheder pr. kg legemsvægt, som gives hver anden uge ved en infusion, der varer en time.
English: Vpriv increased the amount of haemoglobin (the protein in red blood cells that carries oxygen) by an average of 1.6 grams per decilitre (from 11.4 g/dl) while imiglucerase increased the amount of haemoglobin by an average of 1.5 g/dl (from 10.6 g/dl).
Danish: Vpriv øgede gennemsnitligt mængden af hæmoglobin (det protein i de røde blodlegemer, som transporterer ilt) med 1,6 gram pr. deciliter (fra 11,4 g/dl), mens imiglucerase gennemsnitligt øgede mængden af hæmoglobin med 1.5 g/dl (fra 10,6 g/dl).
English: Because the number of patients with Gaucher disease is low, the disease is considered ‘rare', and Vpriv was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 June 2010.
Danish: Da antallet af patienter med Gauchers sygdom er lavt, anses sygdommen for at være "sjælden", og Vpriv blev udpeget som "lægemiddel til sjældne sygdomme" den 9. juni 2010.
English: For more information about treatment with Vpriv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vpriv, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company that markets Vpriv will provide educational material to all doctors and patients expected to use Vpriv, informing them of how to manage the risk of infusion-related reactions when the medicine is given at home.
Danish: Virksomheden, der markedsfører Vpriv, vil udlevere oplysningsmateriale til alle læger og patienter, der forventes at bruge Vpriv, med information om, hvordan risikoen for infusionsrelaterede reaktioner håndteres, når lægemidlet gives hjemme.
English: Vpriv is a medicine that contains the active substance velaglucerase alfa.
Danish: Vpriv er et lægemiddel, der indeholder det aktive stof velaglucerase alfa.
English: The first three infusions are given in hospital, but subsequent infusions may be given at home in patients who tolerate the medicine well.
Danish: De første tre infusioner gives på hospitalet, men for patienter, der tolererer infusionerne godt, kan det overvejes at foretage de efterfølgende infusioner i hjemmet.
English: The study also looked at control of other signs of the disease such as the increase in the number of platelets in the blood, and the reduction of the size of the liver and spleen.
Danish: Undersøgelsen så desuden nærmere på kontrollen med andre sygdomstegn som f.eks. stigning i blodets indhold af blodplader og reduktion af leverens og miltens størrelse.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vpriv.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Vpriv skal anvendes.
English: The full EPAR for Vpriv can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Vpriv findes på agenturets websted under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: The study also showed that Vpriv is as effective as imiglucerase in controlling other signs of Gaucher disease.
Danish: Undersøgelsen viste endvidere, at Vpriv er lige så effektivt som imiglucerase til at kontrollere andre af symptomerne på Gauchers sygdom.
English: Velaglucerase alfa replaces the missing enzyme in Gaucher disease, helping to break down glucocerebroside and stopping it building up in the body.
Danish: Velaglucerase alfa erstatter det manglende enzym ved Gauchers sygdom, som hjælper med at nedbryde glucocerebrosid og forhindrer det i at ophobe sig i kroppen.
English: What is the risk associated with Vpriv?
Danish: Hvilken risiko er der forbundet med Vpriv?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Vpriv is available on the Agency's website under EMA website/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme for Vpriv findes på agenturets websted under EMA website/Find medicine/Human medicines/Rare disease designations.
English: The CHMP decided that Vpriv's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Vpriv opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Vpriv.
English: Vpriv is used in patients who have type 1 Gaucher disease, the type that usually affects the liver, spleen and bones.
Danish: Vpriv anvendes til patienter med Gauchers sygdom, type 1, som normalt er den type, der påvirker lever, milt og knogler.
English: Gaucher disease occurs because of the lack of an enzyme called glucocerebrosidase.
Danish: Gauchers sygdom opstår som følge af mangel på et enzym kaldet glucocerebrosidase.
English: Home infusions should be supervised by a healthcare professional trained in emergency measures.
Danish: Infusioner i hjemmet skal indgives under overvågning af sundhedspersonale, der er udlært i akutpleje.
English: In one main study involving 35 patients (including 9 children) with type 1 Gaucher disease, Vpriv was compared with imiglucerase (another medicine for Gaucher disease).
Danish: Vpriv blev i en undersøgelse med 35 patienter (heriblandt 9 børn) med Gauchers sygdom, type 1, sammenlignet med imiglucerase (et andet lægemiddel mod Gauchers sygdom).
English: Vpriv is used for the long-term treatment of patients with Gaucher disease.
Danish: Vpriv anvendes til langtidsbehandling af patienter med Gauchers sygdom.
English: Vpriv must not be used in people who have a severe allergic reaction to velaglucerase alfa or any of the other ingredients.
Danish: Vpriv må ikke anvendes til patienter med svære allergiske reaktioner over for velaglucerase alfa eller andre af indholdsstofferne.
English: The most common side effects with Vpriv (seen in more than 1 patient in 10) are infusion-related reactions, which include headache, dizziness, hypotension (low blood pressure), hypertension (high blood pressure), nausea (feeling sick), asthenia (weakness) or fatigue (tiredness), and pyrexia (fever) or increased body temperature.
Danish: De hyppigste bivirkninger ved Vpriv (som optræder hos flere end 1 ud af 10 patienter) er infusionsrelaterede reaktioner, bl.a. hovedpine, svimmelhed, hypotension (lavt blodtryk), hypertension (højt blodtryk), kvalme, kraftesløshed eller træthed samt feber eller forhøjet kropstemperatur.
English: Vpriv was as effective as imiglucerase at reducing anaemia.
Danish: Vpriv var mere effektivt end imiglucerase til at mindske anæmi.
English: What is Vpriv?
Danish: Hvad er Vpriv?
English: Without the enzyme, glucocerebroside builds up in the body, typically in the liver, spleen and bone, which produces the symptoms of the disease: anaemia (low red blood cell counts), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and breaks.
Danish: Uden enzymet ophobes glucocerebrosid i kroppen, typisk i lever, milt og knogler, hvilket fremkalder sygdomssymptomer som anæmi (for lavt antal røde blodlegemer), træthed, tendens til at få blå mærker, blødningstendens, forstørret milt og lever samt knoglesmerter og knoglebrud.
English: Why has Vpriv been approved?
Danish: Hvorfor blev Vpriv godkendt?
English: It is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Det leveres som et pulver, der efter opløsning indgives ved infusion (drop) i en vene.
English: For the full list of all side effects and restrictions with Vpriv, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Vpriv fremgår af indlægssedlen.
English: Vpriv treatment should be supervised by a doctor experienced in managing patients with Gaucher disease.
Danish: Behandlingen med Vpriv bør overvåges af en læge med erfaring i behandling af patienter med Gauchers sygdom.
English: What is Vpriv used for?
Danish: Hvad anvendes Vpriv til?
English: How has Vpriv been studied?
Danish: Hvordan blev Vpriv undersøgt?
English: Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called glucocerebrosidase, which normally breaks down a fat called glucocerebroside.
Danish: Patienter med sygdommen producerer ikke tilstrækkeligt af enzymet glucocerebrosidase, som normalt nedbryder et fedtstof kaldet glucocerebrosid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vpriv have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Vpriv.
English: How is Vpriv used?
Danish: Hvordan anvendes Vpriv?
English: What benefit has Vpriv shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Vpriv?
English: How does Vpriv work?
Danish: Hvordan virker Vpriv?
English: Do not wait until the next planned cycle.
Danish: Vent ikke til den næste planlagte cyklus.
English: These events have occasionally been fatal.
Danish: Disse hændelser har lejlighedsvis være dødelige.
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Danish: TTP = tid til progression, "ne" angiver, at den ikke kunne estimeres, eller at den endnu ikke var nået.
English: Do not stop using this medicine without talking to your doctor first.
Danish: Du må ikke holde op med at bruge dette lægemiddel uden at tale med din læge først.
English: During pregnancy:
Danish: Under graviditet:
English: If this happens to you, contact your doctor immediately.
Danish: Hvis det sker for dig, skal du øjeblikkeligt kontakte lægen.
English: Regardless of the regimen used, most symptomatic cardiac events occurred within the first 18 months.
Danish: Uanset det anvendte regime forekom de fleste symptomatiske kardielle hændelser inden for de første 18 måneder.
English: Clinical experience is limited in patients above 65 years of age.
Danish: Klinisk erfaring er begrænset hos patienter over 65 år.
English: If you stop using Ontruzant
Danish: Hvis du holder op med at bruge Ontruzant
English: • Your doctor will advise you of the risks and benefits of taking Ontruzant during pregnancy.
Danish: • Lægen vil rådgive dig om risici og fordele ved at tage Ontruzant under graviditet.
English: For time to response and duration of response no difference could be recorded between the arms.
Danish: For tid til respons og responsvarighed kunne der ikke registreres nogen forskel mellem armene.
English: Time to steady-state
Danish: Tid til steady-state*
English: Overall response rate,%
Danish: Samlet responsrate, %
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstider og opbevaringsbetingelser under anvendelse brugerens ansvar.
English: Pre-medication may be used to reduce risk of occurrence of these events.
Danish: Præmedicinering kan anvendes til at reducere risikoen for forekomst af disse hændelser.
English: Study M77001: Full analysis set (intent-to-treat), 24 months results
Danish: Studie M77001: Fuldt analysesæt (intent-to-treat), 24 måneders-resultater
English: The majority of the deaths were due to events related to the underlying cancer.
Danish: Størstedelen af dødsfaldene skyldtes hændelser relateret til den underliggende cancer.
English: The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Danish: Det primære endepunkt var samlet overlevelse, der blev defineret som tiden fra randomiseringsdatoen til datoen for dødsfald af en hvilken som helst årsag.
English: Allow the vial to stand undisturbed for approximately 5 minutes.
Danish: Lad hætteglasset henstå i ca. 5 minutter.
English: AUCss, 0-21 days
Danish: AUCss, 0-21 dage
English: Ontruzant can cause breathing difficulties, especially when it is first given.
Danish: Ontruzant kan forårsage vejrtrækningsproblemer, specielt når det gives første gang.
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Danish: Produktet er ikke beregnet til at blive opbevaret efter rekonstitution og fortynding, medmindre dette har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.
Danish: Patienterne skal advares om muligheden for en sådan sen fremkomst og skal instrueres i at kontakte deres læge, hvis disse symptomer forekommer.
English: Unopened vials: 4 years.
Danish: Uåbnede hætteglas: 4 år.
English: Fertility There is no fertility data available.
Danish: Fertilitet Der foreligger ingen fertilitetsdata.
English: • you have ever had any other treatment for cancer.
Danish: • hvis du nogensinde har fået andre kræftbehandlinger.
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Danish: Den biologiske aktivitet af D7D og den kliniske betydning af den øgede eksponering af denne metabolit var uklar.
English: Only patients with a large amount of HER2 will be treated with Ontruzant.
Danish: Kun patienter med en stor mængde HER2 vil blive behandlet med Ontruzant.
English: All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule).
Danish: Du skal tage alle doser på det rigtige tidspunkt hver uge eller hver tredje uge (afhængigt af din doseringsplan).
English: Initial improvement followed by clinical deterioration and delayed reactions with rapid clinical deterioration have also been reported.
Danish: En initiel forbedring efterfulgt af klinisk forværring og forsinkede reaktioner med hurtig klinisk forværring er også rapporteret.
English: Fatalities have occurred within hours and up to one week following infusion.
Danish: Der er forekommet dødsfald inden for timer og op til én uge efter infusion.
English: The frequency of occurrence of hypoprothrombinaemia is not known.
Danish: Hyppigheden af forekomsten af hypoprotrombinæmi er ikke kendt.
English: Children and adolescents Ontruzant is not recommended for anyone under the age of 18 years.
Danish: Børn og unge Ontruzant bør ikke anvendes til børn og unge under 18 år.
English: Ontruzant should only be given by a doctor or nurse.
Danish: Ontruzant må kun gives af en læge eller sygeplejerske.
English: The majority of these events occur during or within 2.5 hours of the start of the first infusion.
Danish: Størstedelen af disse hændelser forekommer under eller inden for 2,5 timer efter start på den første infusion.
English: It is not known whether trastuzumab can affect reproductive capacity.
Danish: Det er uvist, om trastuzumab kan påvirke reproduktionskapaciteten.
English: A careful risk-benefit assessment should be made before deciding to treat with trastuzumab.
Danish: Der skal foretages en nøje vurdering af risk/benefit-forholdet, før det besluttes, om der skal behandles med trastuzumab.
English: All the terms included are based on the highest percentage seen in pivotal clinical trials.
Danish: Alle de omfattede termer er baseret på den højeste procent, der er observeret i kliniske pivotale studier.
English: The dose of Ontruzant depends on your body weight.
Danish: Dosen af Ontruzant afhænger af din legemsvægt.
English: Therefore your doctor may decide to continue to check your heart functions, even after you finish treatment.
Danish: Derfor kan din læge beslutte at fortsætte med at kontrollere din hjertefunktion, efter din behandling er stoppet.
English: Overexpression of HER2 is observed in 20%-30% of primary breast cancers.
Danish: Der er observeret overekspression af HER2 i 20 %-30 % af primære brystkræfttilfælde.
English: Anaphylactoid reactions have been observed in isolated cases.
Danish: Anafylaktoide reaktioner er observeret i isolerede tilfælde.
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Danish: Nogle af disse sympomer kan være alvorlige, og nogle patienter er døde (se punkt 2 under ”Advarsler og forsigtighedsregler”).
English: Do not dilute with glucose solutions since these cause aggregation of the protein.
Danish: Må ikke fortyndes med glucoseopløsninger, da disse kan forårsage aggregation af proteinet.
English: If anthracyclines are used, the patient's cardiac function should be monitored carefully.
Danish: Hvis der anvendes antracykliner, skal patientens kardielle funktion overvåges nøje.
English: Some of the side effects you experience may be due to your underlying cancer.
Danish: Nogle af de bivirkninger, du oplever, kan skyldes din underliggende kræft.
English: *Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
Danish: * Cmin,ss - Cmin ved steady-state ** Cmax,ss = Cmax ved steady-state *** tid til 90 % af steady-state
English: In other situations, the decision on the need for additional cytotoxic chemotherapy is determined based on individual factors.
Danish: I andre tilfælde baseres afgørelsen om et behov for yderligere cytotoksisk kemoterapi på individuelle faktorer.
English: These events may occur as part of an infusion-related reaction or with a delayed onset.
Danish: Disse hændelser kan forekomme som en del af en infusionsrelateret reaktion eller med en forsinket fremkomst.
English: Chemotherapy was administered as follows:
Danish: Kemoterapi blev administreret som følger:
English: However, capecitabine itself showed higher concentrations and a longer half-life when combined with trastuzumab.
Danish: Capecitabin viste dog selv højere koncentrationer og en længere halveringstid, når det blev kombineret med trastuzumab.
English: In this section, the following categories of frequency have been used: 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: er anvendt følgende hyppighedskategorier: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of trastuzumab versus observation.
Danish: Virkningsresultaterne fra interimanalysen af virkning krydsede den i protokollen præspecificerede statistiske grænse for sammenligningen af 1 års trastuzumab versus observation.
English: Overall survival, median months Progression-free survival, median months
Danish: Samlet overlevelse, median måneder Progressionfri overlevelse, median måneder
English: SISH technology is however, recommended to allow for the parallel evaluation of tumor histology and morphology.
Danish: SISH-teknologi anbefales dog til muliggørelse af parallel evaluering af tumorhistologi og morfologi.
English: Greater than 70% of patients enrolled exhibited 3+ overexpression.
Danish: Mere end 70 % af de inkluderede patienter fremviste 3+ overekspression.
English: In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Danish: Endvidere blev der udført en sammenligning af 2 års trastuzumab-behandling versus 1 års trastuzumab-behandling.
English: As animal reproduction studies are not always predictive of human response, trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus.
Danish: Da reproduktionsstudier med dyr ikke altid er prædiktive for et humant respons, skal trastuzumab undgås under graviditet, medmindre den potentielle fordel for moderen opvejer den potentielle risiko for fosteret.
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6-8 weeks).
Danish: Patienter, der udvikler asymptomatisk kardiel dysfunktion, kan have fordel af en hyppigere overvågning (f.eks. hver 6.-8. uge).
English: • you suffer from breathlessness., especially if you are currently using a taxane.
Danish: • hvis du lider af åndenød, særligt hvis du aktuelt får et taxan.
English: Such methods must clearly be precise and accurate enough to demonstrate overexpression of HER2 and must be able to distinguish between moderate (congruent with 2+) and strong (congruent with 3+) overexpression of HER2.
Danish: Sådanne metoder skal være præcise og nøjagtige nok til at påvise overekspression af HER2 og skal være i stand til at skelne mellem moderat (kongruent med 2+) og potent (kongruent med 3+) overekspression af HER2.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Danish: Din læge vil ordinere en dosis og en behandlingsplan, som passer til dig.
English: • anaphylactic reactions (serious allergic reaction)
Danish: • anafylaktiske reaktioner (alvorlig allergisk reaktion)
English: The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10.
Danish: Virkningsresultaterne fra BCIRG 006 er sammenfattet i tabel 9 og 10.
English: From a microbiological point of view, the reconstituted solution and Ontruzant infusion solution should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning og Ontruzantinfusionsopløsningen anvendes med det samme.