FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Krystexxa
Danish: Andre oplysninger om Krystexxa
English: Uricase breaks down uric acid into another substance, allantoin, which can be passed out of the body in the urine.
Danish: Uricase nedbryder urinsyre til et andet stof, allantoin, som kan udskilles af kroppen i urinen.
English: Overall, 42% of patients (36 out of 85) given the medicine every two weeks showed a persistent response; the figure for those given Krystexxa every four weeks was 35% (29 out of 84).
Danish: I alt var der vedvarende respons hos 42 % af de patienter (36 ud af 85), der fik Krystexxa hver anden uge, og hos 35 % (29 ud af 84) af dem, der fik Krystexxa hver fjerde uge.
English: Krystexxa is a medicine containing the active substance pegloticase.
Danish: Krystexxa er et lægemiddel, der indeholder det aktive stof pegloticase.
English: The most common serious side effects with Krystexxa are anaphylaxis (a severe allergic reaction), seen in about 7 patients in 100, infusion reactions (including flushing, skin rashes, itching, sweating, chest pain, difficulty in breathing, chills, and raised blood pressure), seen in about 26 patients in 100, and gout flares (worsening of gout symptoms) which were more common in the first 3 months of treatment.
Danish: De hyppigste alvorlige bivirkninger med Krystexxa er anafylaksi (en svær allergisk reaktion), der optrådte hos 7 ud af hver 100 patienter, infusionsreaktioner (herunder rødme, udslæt, kløe, svedtendens, brystsmerter, vejrtrækningsbesvær, kulderystelser og blodtryksstigning), der optrådte hos ca. 26 ud af hver 100 patienter, samt opblussen af urinsyregigt, der hovedsagelig forekom de første tre måneder af behandlingstiden.
English: The uricase in Krystexxa is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce uricase.
Danish: Uricase i Krystexxa fremstilles ved "rekombinant dna-teknologi": Det produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere uricase.
English: What measures are being taken to ensure the safe use of Krystexxa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Krystexxa?
English: The CHMP therefore decided that Krystexxa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Krystexxa opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Krystexxa.
English: The active substance in Krystexxa, pegloticase, contains an enzyme called uricase.
Danish: Det aktive stof i Krystexxa, pegloticase, indeholder enzymet uricase.
English: Krystexxa is used to treat adult patients with severe chronic (long-term) tophaceous gout.
Danish: Krystexxa anvendes til behandling af voksne patienter med svær, kronisk (langvarig) toføs urinsyregigt.
English: Krystexxa must not be used in people who are hypersensitive (allergic) to pegloticase or any of the other ingredients, and in people with a rare blood disorder called glucose 6-phosphate dehydrogenase (G6PD) deficiency (favism) or similar disorders.
Danish: Krystexxa må ikke anvendes hos personer, der er overfølsomme (allergiske) over for pegloticase eller andre af indholdsstofferne, eller hos personer med den sjældne blodsygdom favisme (glukose-6-fosfat dehydrogenase-mangel) eller lignende sygdomme.
English: In Krystexxa, uricase has been attached to a chemical, polyethylene glycol (PEG), which decreases the rate at which uricase is removed from the body, allowing its action to last longer.
Danish: I Krystexxa er uricase bundet til det kemiske stof polyethylenglycol (PEG), der nedsætter den hastighed, hvormed uricase udskilles fra kroppen, så det virker i længere tid.
English: The CHMP concluded that Krystexxa was highly effective in reducing uric acid levels.
Danish: CHMP konkluderede, at Krystexxa var meget effektivt til at nedsætte indholdet af urinsyre.
English: Krystexxa was studied in two main studies involving 225 patients with severe tophaceous gout in whom allopurinol, a xanthine oxidase inhibitor, had previously failed to control their uric acid levels or could not be used due to side effects.
Danish: Krystexxa blev undersøgt i to hovedundersøgelser med 225 patienter med svær toføs urinsyregigt, hos hvem allopurinol, der er en xanthinoxidasehæmmer, ikke havde været i stand til at kontrollere urinsyreindholdet eller ikke kunne anvendes på grund af bivirkninger.
English: It is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Danish: Det leveres som et koncentrat, der efter opløsning indgives ved infusion (drop i en vene).
English: Krystexxa was shown to be more effective than placebo in reducing uric acid levels.
Danish: Det blev påvist, at Krystexxa var mere effektivt end placebo til at nedsætte urinsyreindholdet.
English: Although uric acid levels were quickly lowered by Krystexxa, its effect was reduced within a few weeks in more than half the patients.
Danish: Krystexxa sænkede hurtigt urinsyreindholdet, men hos over halvdelen af patienterne aftog virkningen efter få uger.
English: What is the risk associated with Krystexxa?
Danish: Hvilken risiko er der forbundet med Krystexxa?
English: Once levels of uric acid are below 6 mg/dl, this allows crystals in the joints to dissolve, slowly shrinking the tophi.
Danish: Når urinsyreindholdet kommer under 6 mg/dl, kan krystallerne i leddene opløses, så gigtknuderne langsomt bliver mindre.
English: This lowers the levels of uric acid in the blood.
Danish: Derved mindskes blodets indhold af urinsyre.
English: Krystexxa, given at a dose of 8 mg every two or four weeks, was compared with placebo (a dummy treatment), over a period of six months.
Danish: I en seks måneders periode blev Krystexxa givet i en dosis af 8 mg hver anden eller hver fjerde uge og sammenlignet med placebo (virkningsløs behandling).
English: Why has Krystexxa been approved?
Danish: Hvorfor blev Krystexxa godkendt?
English: Levels of uric acid are therefore measured before each infusion and the doctor should only continue Krystexxa treatment as long as the patient continues to benefit with uric acid levels in the blood lowered below a threshold of 6 mg/dl.
Danish: Indholdet af urinsyre måles derfor før hver infusion, og lægen bør kun fortsætte behandlingen med Krystexxa, så længe patienterne har fordel af behandlingen og har et urinsyreindhold i blodet under tærskelværdien på 6 mg/dl. Mens patienterne er i behandling med Krystexxa, bør de undgå at bruge anden medicin, der sænker urinsyreindholdet.
English: For the full list of side effects reported with Krystexxa, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Krystexxa fremgår af indlægssedlen.
English: For further information on the use of Krystexxa see the package leaflet.
Danish: Yderligere oplysninger om brugen af Krystexxa fremgår af indlægssedlen.
English: Krystexxa is only used in patients who cannot control their uric acid levels even at maximum doses of conventional medicines called xanthine oxidase inhibitors, or who are unable to use such medicines.
Danish: Krystexxa anvendes kun til patienter, hos hvem urinsyreindholdet ikke kan kontrolleres med selv maksimale doser af de sædvanlige lægemidler mod sygdommen (xanthinoxidasehæmmere), eller som ikke må få sådanne lægemidler.
English: What is Krystexxa?
Danish: Hvad er Krystexxa?
English: Krystexxa is given as an infusion into a vein every two weeks, at a recommended dose of 8 mg.
Danish: Krystexxa gives som en infusion i en vene hver anden uge, sædvanligvis i en dosis på 8 mg. Infusionen gives langsomt i løbet af mindst to timer.
English: Treatment with Krystexxa should be given under the supervision of a doctor who has experience in the treatment of severe chronic gout, in a setting where facilities for resuscitation are available.
Danish: Behandling med Krystexxa bør gives under opsyn af en læge med erfaring i behandling af svær kronisk urinsyregigt.
English: The main measure of effectiveness was the number of patients who showed a persistent response to the treatment, defined as uric acid level in the blood below 6 mg/dl for at least 80% of the time during both the third and sixth months of the study.
Danish: Herved forstås, at urinsyreindholdet i blodet var under 6 mg/dl mindst 80 % af tiden både i undersøgelsens tredje og sjette måned.
English: This is where high levels of the substance uric acid develop in the blood and then crystallise in joints and tissues, forming tophi (stones) that cause pain and joint damage.
Danish: Urinsyren udkrystalliserer sig derfor i leddene og danner tophi (gigtknuder), som medfører smerter og beskadigelse af leddene.
English: For severely affected patients who cannot be treated effectively with conventional methods, the Committee considered that Krystexxa addressed an unmet need, since no alternative treatments are available.
Danish: Udvalget fandt, at Krystexxa imødekom et uopfyldt behov hos svært angrebne patienter, der ikke kan behandles effektivt med konventionelle metoder, da der ikke foreligger andre behandlingsmuligheder.
English: What is Krystexxa used for?
Danish: Hvad anvendes Krystexxa til?
English: How has Krystexxa been studied?
Danish: Hvordan blev Krystexxa undersøgt?
English: How is Krystexxa used?
Danish: Hvordan anvendes Krystexxa?
English: What benefit has Krystexxa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Krystexxa?
English: How does Krystexxa work?
Danish: Hvordan virker Krystexxa?
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppigheden kan ikke vurderes udfra forhåndenværende data
English: * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10%.
Danish: * Definition af hyppighed: Meget almindelig - ≥ 10%; Almindelig - > 5% og < 10%.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 January 2016
Danish: Dato for første markedsføringstilladelse: 18 januar 2016
English: Interactions common to all cytotoxics:
Danish: Interaktioner, der er fælles for alle cytotoksiske stoffer:
English: Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, Hungary
Danish: Wessling Hungary Kft. Fòti ùt 56., Budapest, 1047, Ungarn
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning ved patienter, der er på en natriumkontrolleret diæt.
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Accord during pregnancy.
Danish: Deres læge vil sammen med Dem drøfte den potentielle risiko ved at tage Pemetrexed Accord under graviditet.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, indenfør De begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: The total bilirubin should be  1.5 times upper limit of normal.
Danish: Total-bilirubin skal være  1,5 gange den normale øvre grænseværdi.
English: Based on the planned date of your infusion of Pemetrexed Accord and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Danish: Ud fra den planlagte dato for Deres infusion af Pemetrexed Accord og/eller status for Deres nyrefunktion skal Deres læge fortælle Dem, hvilke typer medicin De må tage, og hvornår De må tage dem.
English: Do not use this medicine if you notice any visible signs of deterioration.
Danish: Brug ikke lægemidlet, hvis der er synlige tegn på nedbrydning.
English: Do not use Pemetrexed Accord - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Pemetrexed Accord: hvis De er allergisk over for pemetrexed eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Frequency estimate: 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) and not known (cannot be estimated from available data).
Danish: Hyppighed: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: 319, Pinner Road North Harrow Middlesex HA1 4HF United Kingdom
Danish: 319, Pinner Road North Harrow Middlesex HA1 4HF Storbritannien
English: Other sources of information
Danish: Andre informationskilder:
English: The 1 year and 2 year survival rates for patients on pemetrexed were 58 % and 32 % respectively, compared to 45 % and 21 % for patients on placebo.
Danish: Den 1-årige og 2årige overlevelsesrate for patienterne i behandling med pemetrexed var henholdsvis 58 % og 32 % sammenlignet med 45 % og 21 % for patienterne i placebo-behandling.
English: Side effects with Pemetrexed Accord may include:
Danish: Bivirkninger med Pemetrexed Accord kan være:
English: Abbreviation: CI = confidence interval * p-value refers to comparison between arms.
Danish: Forkortelse: CI = konfidensinterval * p-værdi henviser til sammenligning mellem arme.
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
Danish: * Se National Cancer Institute CTC version 2 for hver grad af toksicitet.
English: Safety was assessed for patients who were randomised to receive pemetrexed (N=800).
Danish: Sikkerheden blev vurderet for de patienter, som blev randomiseret til pemetrexed (N = 800).
English: Pemetrexed Accord is a medicine used in the treatment of cancer.
Danish: Pemetrexed Accord er et lægemiddel, der anvendes til behandling af kræft.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Accord has finished.
Danish: Cisplatin indgives også ved infusion i en af Deres blodårer, cirka 30 minutter efter at infusionen med Pemetrexed Accord er afsluttet.
English: In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Accord and cisplatin is documented in Table 3.
Danish: I tilfælde af neurotoksicitet er den anbefalede dosisjustering for Pemetrexed Accord og cisplatin angivet i tabel 3.
English: Creatinine clearance should be  45 ml/min.
Danish: Kreatinin-clearance skal være  45 ml/min.
English: ** In the pemetrexed/cisplatin arm, randomized and treated (N= 225) and fully supplemented (N = 167)
Danish: ** I Pemetrexed/cisplatin-armen, randomiseret og behandlet (n = 225) og fuldt tilskud (n = 167)
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** which is derived from the term “renal/genitourinary other”.
Danish: * Se National Cancer Institute CTC version 2 for hver grad af toksicitet, undtagen udtrykket "nedsat kreatininclearance", ** som stammer fra udtrykket "andre renale/genitourinære faktorer".
English: Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for Pemetrexed Accord 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 Accord som enkeltstof eller i kombination med cisplatin.
English: You will always receive Pemetrexed Accord by infusion into one of your veins.
Danish: De vil altid få Pemetrexed Accord ved infusion i en af Deres blodårer.
English: This medicine is for single use only.
Danish: Dette lægemiddel er kun beregnet til engangsbrug.
English: Adjusted Hazard ratio (HR) (95 %CI)
Danish: Justeret Hazard ratio (HR) (95 % CI)
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af påvirkningen af evnen til at køre bil eller betjene maskiner.
English: Infection (sepsis) may be severe and could lead to death.
Danish: En infektion (sepsis blodforgiftning) kan være alvorlig og kan medføre døden.
English: a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001).
Danish: a Statistisk signifikans for non-inferiøritet med hele konfidensintervallet for HR pænt under 1,17645 for noninferiøritet-margin (p <0,001).
English: Pemetrexed Accord must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Danish: Pemetrexed Accord må kun administreres under tilsyn af en læge, som er kvalificeret i brugen af kemoterapi mod cancer.
English: *P-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Danish: * P-værdier < 0.05 sammenligning af pemetrexed/cisplatin med gemcitabin/cisplatin, ved brug af Fisher Exact test. ** Se National Cancer Institute CTC (v2.0; NCI 1998) for hver toksicitetsgrad.
English: The European Medicines Agency has waived the obligation to submit the results of studies with pemetrexed in all subsets of the paediatric population in the granted indications (see Section 4.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med pemetrexed i alle undergrupper af den pædiatriske population for de godkendte indikationer (se pkt 4.2 for oplysninger om pædiatrisk anvendelse).
English: At the time of this final survival analysis, 28.7 % of patients were alive or lost to follow up on the pemetrexed arm versus 21.7 % on the placebo arm.
Danish: På tidspunktet for den endelige analyse af den totale overlevelse var 28,7 % af patienterne i pemetrexed-armen i live eller kunne ikke følges op versus 21,7 % i placebo-armen.
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 Accord.
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 Accord.
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, folsyreanaloger, ATC-kode L01BA04
English: Randomised patients received maintenance treatment until disease progression.
Danish: De randomiserede patienter fik vedligeholdelsesbehandling indtil sygdomsprogression.
English: Alkaline phosphatase, AST and ALT  5 times upper limit of normal is acceptable if liver has tumour involvement.
Danish: Alkalisk fosfatase, ASAT og ALAT  5 gange den normale øvre grænseværdi er acceptabelt, hvis patientens lever er beskadiget af tumor.
English: Calculate the dose and the number of Pemetrexed Accord vials needed.
Danish: Beregn den nødvendige dosis og det nødvendige antal hætteglas med Pemetrexed Accord.
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Accord.
Danish: De skal tage mindst 5 doser i løbet af de 7 dage op til den første dosis Pemetrexed Accord.
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Accord.
Danish: Hvis De har en væskeansamling omkring lungerne, vil lægen muligvis beslutte at fjerne denne væske, før De modtager behandling med Pemetrexed Accord.
English: What you need to know before you use Pemetrexed Accord
Danish: Det skal De vide, før De begynder at bruge Pemetrexed Accord
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a 10-minute period.
Danish: Pemetrexeds farmakokinetiske egenskaber efter enkeltstofadministration er blevet vurderet hos 426 cancerpatienter med forskellige typer massive tumorer i doser på 0,2-838 mg/m2 infunderet over 10
English: Corticosteriods: 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 Accord 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 Accord.
English: Prior to each chemotherapy administration blood chemistry tests should be collected to evaluate renal and hepatic function.
Danish: Inden hver administration af kemoterapi skal der indsamles laboratorieanalyser af blodet til evaluering af nyre- og leverfunktion.
English: 75 % of previous dose (both Pemetrexed Accord and cisplatin)
Danish: 75 % af tidligere dosis (både Pemetrexed Accord og cisplatin)
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Accord and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Accord treatment).
Danish: De vil også få en injektion med B12-vitamin (1.000 mikrogram) i løbet af ugen op til første dosis Pemetrexed Accord og derefter cirka hver 9. uge (svarende til 3 Pemetrexed Accord-behandlingsforløb).
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment)
Danish: Saltsyre (E507) (til pH-justering) Natriumhydroxid (E524) (til pH-justering)
English: First line doublet therapy containing pemetrexed was not included.
Danish: 1. linje-dubletbehandling inkluderende pemetrexed blev ikke inkluderet.
English: In clinical studies, patients with creatinine clearance of  45 ml/min required no dose adjustments other than those recommended for all patients.
Danish: I kliniske studier krævede patienter med en kreatinin-clearance på  45 ml/min ingen særlige dosisjusteringer ud over de, der anbefales til alle patienter.
English: A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed.
Danish: I alt fuldførte 169 patienter (47,1 %) ≥ 6 serier af vedligeholdelsesbehandlingen med pemetrexed, hvilket svarer til mindst 10 komplette serier pemetrexed.
English: • Additional risk minimisation measures
Danish: • Yderligere risikominimeringsforanstaltninger Ikke relevant.
English: Therefore, caution should be made when administering higher doses of NSAIDs or acetylsalicylic acid, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/min).
Danish: Der skal derfor udvises forsigtighed ved indgift af højere doser af NSAID-præparater eller acetylsalicylsyre samtidig med pemetrexed hos patienter med normal nyrefunktion (kreatinin-clearance  80 ml/min).
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Accord.
Danish: Informér Deres læge, hvis De for nylig er blevet vaccineret, da det muligvis kan forårsage dårlige virkninger med Pemetrexed Accord.
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 Accord.
Danish: Hvis De har fået eller skal have strålebehandling, skal De fortælle det til Deres læge, idet Pemetrexed Accord kan medføre en tidlig eller sen strålingsreaktion.
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be  3 times upper limit of normal.
Danish: Alkalisk fosfatase (AP), aspartataminotransferase (ASAT) og alaninaminotransferase (ALAT) skal være  3 gange den normale øvre grænseværdi.
English: • Obligation to conduct post-authorisation measures Not applicable
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Ikke relevant.