FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of gloves is recommended.
Danish: Det anbefales at bruge handsker.
English: Response (n: qualified for response)
Danish: Respons (n: kvalificeret til respons)
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal produktet anvendes med det samme.
English: You should usually receive your infusion once every 3 weeks.
Danish: De vil normalt få infusionen én gang hver tredje uge.
English: This combination should be used with caution.
Danish: Denne kombination skal anvendes med forsigtighed.
English: Treatment should be resumed according to the guidelines in Table 2.
Danish: Behandlingen bør genoptages i henhold til retningslinjerne i tabel 2.
English: The active substance is pemetrexed.
Danish: Det aktive stof er pemetrexed.
English: Further dilution is required, as below.
Danish: Yderligere fortynding er nødvendig, som nedenfor.
English: *Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Danish: * Definition af hyppighed: Meget almindelig - ≥ 10%; Almindelig - > 5% og < 10%.
English: Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Myelosuppression is usually the dose-limiting toxicity.
Danish: Myelosuppression er normalt den dosisbegrænsende toksicitet.
English: - if you have recently received or are about to receive a vaccine against yellow fever.
Danish: hvis De for nylig er blevet eller snart skal vaccineres mod gul feber.
English: Further dilution is required.
Danish: Yderligere fortynding er nødvendig.
English: The infusion will last approximately 10 minutes.
Danish: Infusionen tager omkring 10 minutter.
English: Store below 30°C
Danish: Opbevares ved temperaturer under 30 °C
English: Your doctor will discuss with you the potential risk of taking pemetrexed during pregnancy.
Danish: Deres læge vil sammen med Dem drøfte den potentielle risiko ved at tage pemetrexed under graviditet.
English: Non-small cell lung cancer
Danish: Ikke-småcellet lungecancer
English: In vitro studies indicate that pemetrexed is approximately 81% bound to plasma proteins.
Danish: In vitro-forsøg tyder på, at omtrent 81 % bindes til plasmaproteiner.
English: Be careful when driving a car or using machines.
Danish: Vær derfor forsigtig, hvis De kører bil eller betjener maskiner.
English: The infusion of cisplatin will last approximately 2 hours.
Danish: Infusionen af cisplatin tager omkring 2 timer.
English: Survival time (months)
Danish: Overlevelsestid (måneder)
English: The other ingredient is mannitol.
Danish: Det andet indholdsstof er mannitol.
English: There are many sorts of NSAIDs with different durations of activity.
Danish: Der findes mange slags NSAID-præparater med forskellig varighed af det aktive stof.
English: Patients received maintenance treatment until disease progression.
Danish: Patienterne fik vedligeholdelsesbehandling indtil sygdomsprogression.
English: Your doctor will use this body surface area to work out the right dose for you.
Danish: Deres læge vil bruge dette mål på overfladeareal til at bestemme den rette dosis til Dem.
English: Anaphylactic shock (severe allergic reaction)
Danish: Anafylaktisk shock (alvorlig allergisk reaktion)
English: Particular attention should be paid to these patients, and caution exercised with use of other radiosensitising agents.
Danish: Man skal være særlig opmærksom ved disse patienter, og der bør udvises forsigtighed ved brug af andre radiosensibiliserende stoffer.
English: However, it has been reported that pemetrexed may cause fatigue.
Danish: Det er dog blevet rapporteret, at pemetrexed kan forårsage træthed.
English: Based on the planned date of your infusion of pemetrexed 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 og/eller status for Deres nyrefunktion skal Deres læge fortælle Dem, hvilke typer medicin De må tage, og hvornår De må tage dem.
English: The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
Danish: Lægen eller hospitalsfarmaceuten beregner den nødvendige dosis ud fra Deres højde og vægt.
English: Treatment may be delayed to allow sufficient time for recovery.
Danish: Behandlingen kan eventuelt udsættes, så der er tilstrækkelig tid til rekonvalescens.
English: Log rank p-value*
Danish: Log rank p-værdi*
English: Pemetrexed total systemic exposure (AUC) and maximum plasma concentration increase proportionally with dose.
Danish: Pemetrexeds samlede systemiske eksponering (AUC) og maksimale plasmakoncentration stiger proportionalt med dosis.
English: No dose reductions other than those recommended for all patients are necessary.
Danish: Der kræves ingen særlige dosisreduktioner ud over de, der anbefales til alle patienter.
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: There is not a specific antidote for extravasation of pemetrexed.
Danish: Der findes ikke en specifik modgift mod ekstravasation af pemetrexed.
English: Contains mannitol
Danish: Indeholder mannitol
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS.
Danish: Den uafhængige undersøgelse af patientscanninger bekræftede PFS fundene som fastslået af investigator.
English: In addition, infection with or without fever, diarrhoea, and/or mucositis may be seen.
Danish: Derudover kan der optræde infektion med eller uden feber, diarré og/eller mucositis.
English: No statistically significant differences in any other individual Grade 3/4/5 adverse reactions were seen with longer exposure.
Danish: Der blev ikke set statistisk signifikante forskelle i andre individuelle grad 3/4/5 bivirkninger ved længere eksponering.
English: Between-patient variability in clearance is moderate at 19.3%.
Danish: Der er en moderat variation i clearance blandt patienterne på 19,3 %.
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 placebobehandling.
English: If concomitant administration of NSAIDs is necessary, patients should be monitored closely for toxicity, especially myelosuppression and gastrointestinal toxicity.
Danish: Hvis samtidig administration af NSAID-præparater er nødvendig, skal patienterne følges nøje for toksicitet, især myelosuppression og gastrointestinal toksicitet.
English: Side effects with pemetrexed may include:
Danish: Bivirkninger med pemetrexed kan være:
English: Pemetrexed can have genetically damaging effects.
Danish: Pemetrexed kan have genetisk skadelige virkninger.
English: Pack of 1 vial.
Danish: Pakning med 1 hætteglas.
English: Increases in adverse reactions (all grades) were observed with longer exposure.
Danish: Der blev observeret en øget frekvens af bivirkninger (alle grader) ved længere eksponering.
English: Infection (sepsis) may be severe and could lead to death.
Danish: En infektion (sepsis - blodforgiftning) kan være alvorlig og kan medføre døden.
English: Interactions common to all cytotoxics
Danish: Interaktioner, der er fælles for alle cytotoksiske stoffer:
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: 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: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
Danish: Hvis De er gravid, har mistanke om, at De er gravid eller planlægger at blive gravid, skal De fortælle det til Deres læge.
English: Statistically significant differences in pulmonary function tests were also observed.
Danish: Der blev også observeret en signifikant forskel ved test af lungefunktionen.
English: Subsequent vitamin B12 injections may be given on the same day as pemetrexed.
Danish: De efterfølgende injektioner af B12-vitamin kan indgives samme dag som pemetrexed.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The primary efficacy analysis was based on the ITT population.
Danish: De primære effektanalyser var baseret på ITT-populationen.
English: In vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter).
Danish: In vitro-forsøg indikerer, at pemetrexed udskilles ved aktiv sekretion via OAT3 (organisk anion-transportør).
English: The pH of the reconstituted solution is between 5.7 and 7.7.
Danish: Den rekonstituerede opløsning har en pH-værdi på 5,7-7,7.
English: Increased skin pigmentation
Danish: Øget hudpigmentering
English: In the event of neurotoxicity, the recommended dose adjustment for pemetrexed and cisplatin is documented in Table 3.
Danish: I tilfælde af neurotoksicitet er den anbefalede dosisjustering for pemetrexed og cisplatin angivet i tabel 3.
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: Any diarrhoea requiring hospitalisation (irrespective of grade) or Grade 3 or 4 diarrhoea
Danish: Alle tilfælde af diarré, der kræver indlæggelse (uanset grad) eller diarré af grad 3 eller 4.
English: Female fertility was not investigated.
Danish: Fertiliteten hos hunner blev ikke undersøgt.
English: Hospira UK Limited
Danish: Hospira UK Limited Horizon
English: Immunodepressed status is common in cancer patients.
Danish: Svækkelse af immunsystemet er almindelig hos kræftpatienter.
English: Upon recovery, patients should be re-treated using the guidelines in Tables 1, 2, and 3, which are applicable for pemetrexed 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 som enkeltstof eller i kombination med cisplatin.
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Danish: Følsomhedsanalyser af hovedvirkningensendepunkterblevogsåbedømtud fra den protokolkvalificerede(PQ)population.
English: The risk is increased in subjects who are already immunosuppressed by their underlying disease.
Danish: Risikoen øges hos patienter, som i forvejen har et svækket immunforsvar på grund af deres tilgrundliggende sygdom.
English: Thus, drainage of third-space fluid collection prior to pemetrexed treatment should be considered, but may not be necessary.
Danish: Derfor bør drænage af ekstracellulære væskeansamlinger inden behandling med pemetrexed overvejes, men er muligvis ikke nødvendig.
English: This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
Danish: De får denne medicin for at reducere hyppigheden og sværhedsgraden af eventuelle hudreaktioner, som De kan opleve under kræftbehandlingen.
English: There are no data from the use of pemetrexed in pregnant women; but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy.
Danish: Der er ingen data fra anvendelse af pemetrexed til gravide kvinder, men ligesom andre anti-metabolitter formodes pemetrexed at kunne forårsage alvorlige misdannelser, hvis det indgives under graviditeten.
English: Any Grade 3 or 4 toxicities except mucositis
Danish: Al toksicitet af grad 3 eller 4 undtagen mucositis
English: The effect of third-space fluid, such as pleural effusion or ascites, on pemetrexed is not fully defined.
Danish: Effekten af ekstracellulærvæske, såsom pleuraeffusion eller ascites, på pemetrexed er ikke fuldt defineret.
English: It is not known whether pemetrexed is excreted in human milk, and adverse reactions on the breast-feeding 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 clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Danish: Der er i kliniske studier ikke fundet tegn på, at patienter på 65 år eller ældre har forøget risiko for bivirkninger sammenlignet med patienter under 65 år.
English: Binding was not notably affected by varying degrees of renal impairment.
Danish: Bindingen blev ikke bemærkelsesværdigt påvirket af varierende grader af nedsat nyrefunktion.
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 føre motorkøretøj eller betjene maskiner.
English: The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anti-cancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Danish: Den høje intra-individuelle variation i koagulationsstatus under sygdomsforløb og risikoen for interaktion mellem orale antikoagulantia og kemoterapi mod cancer kræver hyppigere monitorering af INR (International Normalised Ratio), hvis der træffes beslutning om at behandle patienten med orale antikoagulantia.
English: Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
Danish: Pemetrexed må ikke anvendes under graviditet, medmindre det er strengt nødvendigt og kun efter nøje vurdering af moderens behov og risikoen for fostret (se pkt.
English: a Statistically significant for non-inferiority, with the entire confidence interval for HR well below the 1.17645 non-inferiority margin (p < 0.001).
Danish: Statistisk signifikans for non-inferiøritet med hele konfidensintervallet for HR pænt under 1,17645 for non- inferiøritet-margin(p<0,001).
English: Live attenuated vaccines (except yellow fever, for which concomitant use is contraindicated): Risk of systemic, possibly fatal, disease.
Danish: Levende svækkede vacciner (med undtagelse af gul feber, for hvilken samtidig brug er kontraindiceret): risiko for systemisk sygdom med mulig dødelig udgang.
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 pemetrexedarmen i live eller kunne ikke følges op versus 21,7 % i placebo-armen.
English: If necessary, creatinine clearance should be closely monitored.
Danish: Patientens kreatinin-clearance skal om nødvendigt monitoreres nøje.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Pfizer has finished.
Danish: Cisplatin indgives også som infusion i en af Deres blodårer, cirka 30 minutter efter at infusionen med Pemetrexed Pfizer er afsluttet.
English: ITT population and histology subgroups
Danish: ITT-population og histologiske undergrupper
English: Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low.
Danish: Deres læge kan beslutte at ændre dosen eller udskyde behandlingen, afhængigt af Deres generelle tilstand, og hvis Deres blodtal er for lave.
English: The results of these analyses of efficacy are summarised in the table below.
Danish: Resultaterne af disse effektanalyser er vist i nedenstående tabel:
English: Therefore, patients should be cautioned against driving or operating machines if this event occurs.
Danish: Patienterne skal derfor advares mod at køre bil eller betjene maskiner, hvis de oplever træthed.
English: Many of the patients in whom these occurred had underlying risk factors for the development of renal events, including dehydration or pre-existing hypertension or diabetes.
Danish: Mange af de patienter, der oplevede disse bivirkninger, havde underliggende risikofaktorer for udvikling af nyrepåvirkninger inklusive dehydrering, tidligere hypertension eller diabetes.
English: Use an inactivated vaccine where it exists (poliomyelitis) (see section 4.4).
Danish: Brug en inaktiveret vaccine, hvis muligt (poliomyelitis) (se pkt.
English: Creatinine clearance should be ≥ 45 ml/min.
Danish: Kreatininclearance skal være ≥ 45 ml/min.
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of medicinal products metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Danish: Resultaterne af in vitro-forsøg med humane levermikrosomer tyder på, at pemetrexed ikke burde forårsage en klinisk signifikant inhibition af den metaboliske clearance af lægemidler, der metaboliseres af CYP3A, CYP2D6, CYP2C9 og CYP1A2.
English: Caution should be made when these medicinal products are combined with pemetrexed.
Danish: Der skal udvises forsigtighed, når disse stoffer bruges i kombination med pemetrexed.
English: Pemetrexed is primarily eliminated in the urine, with 70% to 90% of the administered dose being recovered unchanged in urine within the first 24 hours following administration.
Danish: Pemetrexed udskilles primært med urinen, og 70-90 % af den indgivne dosis kan genfindes uforandret i urinen inden for de første 24 timer efter indgift.
English: Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer therapy.
Danish: Nogle patienter har oplevet et hjertetilfælde, et slagtilfælde eller et ”mini-slagtilfælde”, mens de har fået pemetrexed, sædvanligvis i kombination med anden kræftbehandling.
English: Therefore, patients should receive adequate anti-emetic treatment and appropriate hydration prior to and/or after receiving treatment.
Danish: Patienter skal derfor have modtaget passende antiemetisk behandling og relevant hydrering inden og/eller efter behandlingen.
English: Hyperpigmentation has been commonly reported.
Danish: Hyperpigmentering er rapporteret med hyppigheden almindelig.
English: Concomitant use not recommended
Danish: Følgende samtidig brug frarådes
English: No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified.
Danish: Der er ikke fundet nogen sammenhæng mellem ASAT (SGOT), ALAT (SGPT) eller total-bilirubin og pemetrexeds farmakokinetik.
English: Common Dehydration
Danish: Almindelig Dehydrering
English: The polyglutamate forms are retained in cells and are even more potent inhibitors of TS and GARFT.
Danish: Polyglutamatformerne forbliver i cellerne og fungerer som endnu mere potente hæmmere af TS og GARFT.
English: To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration.
Danish: For at reducere incidensen og sværhedsgraden af hudreaktioner bør der indgives et kortikosteroidpræparat dagen før, på dagen for og dagen efter indgift af pemetrexed.
English: The primary analysis of this study was performed on the population of all patients randomly assigned to a treatment arm who received study drug (randomised and treated).
Danish: Den primære analyse af dette studie blev udført på en population bestående af alle de patienter, som var randomiseret til en behandlingsarm, og som modtog forsøgsmedicinen (randomiseret og behandlet).
English: Pemetrexed must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Danish: Pemetrexed må kun administreres under tilsyn af en læge, som er kvalificeret i brugen af kemoterapi mod cancer.
English: All patients included in this study had an ECOG performance status 0 or 1.
Danish: Alle patienter, som var inkluderet i dette studie, havde en ECOG performancestatus på 0 eller 1.
English: Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section
Danish: Forbehandling med dexamethason (eller tilsvarende) kan reducere incidensen og sværhedsgraden af hudreaktioner (se pkt.
English: 75% of previous dose (both pemetrexed and cisplatin)
Danish: 75 % af tidligere dosis (både pemetrexed og cisplatin)
English: Gently swirl each vial until the powder is completely dissolved.
Danish: Rotér forsigtigt hvert hætteglas, indtil pulveret er helt opløst.
English: Efficacy and safety were measured from the time of randomisation after completion of first-line (induction) therapy.
Danish: Virkning og sikkerhed blev målt fra randomiseringstidspunktet efter fuldførelse af 1. linje-behandlingen (induktion).
English: There have been few reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator.
Danish: Der er rapporteret enkelte tilfælde af ekstravasation af pemetrexed, som investigatoren ikke betragtede som alvorlige.
English: Haemolytic anaemia (anaemia due to destruction of red blood cells) Hepatitis (inflammation of the liver)
Danish: Hæmolytisk anæmi (anæmi på grund af ødelæggelse af de røde blodlegemer) Leverbetændelse (hepatitis)
English: Pain, redness, swelling or sores in your mouth Nausea
Danish: Smerter, rødmen, hævelse eller sår i munden Kvalme
English: If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist.
Danish: Hvis De ønsker at gøre en kvinde gravid under behandlingsforløbet eller tidligere end 6 måneder efter, behandlingen er stoppet, skal De søge vejledning hos Deres læge eller på apoteket.
English: Polyglutamation is a time- and concentration-dependent process that occurs in tumour cells and, to a lesser extent, in normal tissues.
Danish: Polyglutamation er en tids- og koncentrationsafhængig proces, som primært finder sted i tumorceller og i mindre grad i normalt væv.
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: Most of the patients in whom these events have been observed had pre-existing cardiovascular risk factors.
Danish: Størstedelen af de patienter, hvor disse hændelser er observeret, havde allerede kardiovaskulære risikofaktorer.
English: Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Danish: Anvend aseptisk teknik ved rekonstitution og yderligere fortynding af pemetrexed til intravenøs infusion.
English: **In the pemetrexed /cisplatin arm, randomised and treated (N=225) and fully supplemented (N=167).
Danish: ** I pemetrexed/cisplatin-armen, randomiseret og behandlet (N = 225) og fuldt tilskud (N = 167)