FrancophonIA/ELRC3.0 huggingface dataset:
English: Other undesirable effects include renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis and neuropathy.
Danish: Andre bivirkninger omfatter renal toksicitet, forhøjede aminotransferaser, alopeci, træthed, dehydrering, udslæt, infektion/sepsis og neuropati.
English: A total of 213 patients (48.3%) completed ≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with pemetrexed.
Danish: I alt gennemførte 213 (48,3 %) patienter ≥ 6 serier og i alt 103 (23,4 %) ≥10 serier med pemetrexed.
English: Consistent with other pemetrexed studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Danish: I lighed med andre studier med pemetrexed blev der i JMEN set en forskel i virkning i overensstemmelse med NSCLC´s histologi.
English: Concomitant administration of substances that are also tubularly secreted (e.g., probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Danish: Samtidig indgivelse af præparater, som også udskilles tubulært (f.eks. probenecid, penicillin), kan resultere i en forsinket clearance af pemetrexed.
English: Pemetrexed solutions are for single use only.
Danish: Pemetrexedopløsninger er kun til engangsbrug.
English: All patients were diagnosed with locally advanced or metastatic non-small cell lung cancer and received prior chemotherapy.
Danish: Alle patienterne var blevet diagnosticeret med lokalt fremskreden eller metastatisk ikke- småcellet lungecancer og havde tidligere modtaget kemoterapi.
English: Preparation and administration precautions: As with other potentially toxic anti-cancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Danish: Forsigtighedsregler i forbindelse med forberedelse og indgivelse: Som med et hvilket som helst andet potentielt toksisk lægemiddel til behandling af kræft skal der udvises forsigtighed ved håndtering og forberedelse af infusionsopløsninger af pemetrexed.
English: In vitro studies have shown that pemetrexed behaves as a multi-targeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Danish: In vitro-forsøg har vist, at pemetrexed fungerer som et bredspektret anti-folat ved at hæmme thymidylatsyntase (TS), dihydrofolatreduktase (DHFR) og glycinamidribonucleotidformyltransferase (GARFT), som er folatafhængige nøgleenzymer i forbindelse med de novo-biosyntesen af thymidin og purinnukleotider.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Contraceptive measures or abstinence are recommended.
Danish: Det anbefales at anvende prævention eller afholde sig fra seksuelt samkvem.
English: Contents of the pack and other information
Danish: PAKNINGSSTØRRELSER OG YDERLIGERE OPLYSNINGER
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), pemetrexed should be withheld until resolution to less than or equal to the patient's pre-therapy value.
Danish: Hvis patienter udvikler ikke-hæmatologisk toksicitet ≥ grad 3 (undtagen neurotoksicitet), skal behandlingen med pemetrexed seponeres, indtil patientens værdier er nået ned på eller under niveauet fra før behandlingen.
English: Infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue have been reported with an unknown frequency (e.g. acute bacterial dermo-hypodermitis, pseudocellulitis, dermatitis).
Danish: Infektiøse og ikke-infektiøse sygdomme i dermis, hypodermis og/eller det subkutane væv (f.eks. akut bakteriel dermo-hypodermitis, pseudocellulitis, dermatitis) er rapporteret med hyppigheden ikke kendt.
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Pfizer.
Danish: Informér Deres læge, hvis De for nylig er blevet vaccineret, da det muligvis kan forårsage dårlige virkninger med Pemetrexed Pfizer.
English: Dose of pemetrexed (mg/m2)
Danish: Dosis af pemetrexed (mg/m
English: If a pemetrexed solution contacts the skin, wash the skin immediately and thoroughly with soap and water.
Danish: Hvis pemetrexedopløsning kommer i kontakt med huden, skal det berørte område straks vaskes grundigt med vand og sæbe.
English: Further dilution by a healthcare provider is required prior to administration.
Danish: Opløsningen skal fortyndes yderligere af sundhedsfagligt personale inden indgivelse.
English: A Phase 2 study of pemetrexed in 31 solid tumour patients with stable third-space fluid demonstrated no difference in pemetrexed dose normalised plasma concentrations or clearance compared to patients without third-space fluid collections.
Danish: Et pemetrexed fase 2-studie med 31 patienter med solide tumorer og stabil ekstracellulærvæske viste ingen forskel i pemetrexeds dosis-normaliserede plasmakoncentrationer eller clearance sammenlignet med patienter uden ekstracellulære væskeansamlinger.
English: 75% of previous dose
Danish: 75 % af tidligere dosis
English: Treatment with pemetrexed should be discontinued if a patient experiences any haematologic or nonhaematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Danish: Behandlingen med pemetrexed skal afbrydes, hvis patienten efter to dosisreduktioner oplever hæmatologisk eller ikke-hæmatologisk toksicitet af grad 3 eller 4 eller omgående, hvis der observeres neurotoksicitet af grad 3 eller 4.
English: First-line doublet therapy containing pemetrexed was not included.
Danish: 1. linje-dubletbehandling inkluderende pemetrexed blev ikke inkluderet.
English: As with other potentially toxic anti-cancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Danish: Som med et hvilket som helst andet potentielt toksisk lægemiddel til behandling af kræft skal der udvises forsigtighed ved håndtering og forberedelse af infusionsopløsninger af pemetrexed.
English: Low white blood cells
Danish: Lavt antal blodplader
English: 100% of previous dose
Danish: 100 % af tidligere dosis
English: Pemetrexed Pfizer is for intravenous use.
Danish: Pemetrexed Pfizer er til intravenøs brug.
English: Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single-agent pemetrexed studies (N = 164) and the Phase 3 single-agent pemetrexed study described above, with the exception of neutropenia (12.8% versus 5.3%, respectively) and alanine aminotransferase elevation (15.2% versus 1.9%, respectively).
Danish: De klinisk relevante laboratorierelaterede toksiciteter af grad 3 og 4 var ensartede mellem de integrerede fase 2-resultater fra tre studier med pemetrexed som enkeltstofbehandling (N = 164) og det fase 3-enkeltstofstudie med pemetrexed, som er beskrevet ovenfor, med undtagelse af neutropeni (12,8 % versus 5,3 %) og forhøjet alaninaminotransferase (15,2 % versus 1,9 %).
English: A white to light yellow or green-yellow lyophilised powder.
Danish: Et hvidt til lysegult eller grøngult frysetørret pulver.
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: 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 Pfizer.
Danish: Hvis De har fået eller skal have strålebehandling, skal De fortælle det til Deres læge, idet Pemetrexed Pfizer kan medføre en tidlig eller sen strålingsreaktion.
English: Pemetrexed is transported into cells by both the reduced folate carrier and membrane folate binding protein transport systems.
Danish: Pemetrexed transporteres ind i cellerne både via to proteintransportsystemer: den reducerede folatbærer og membranens folatbindingsprotein.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Pfizer powder with water for injections and 5% glucose solution for injection before it is given to you.
Danish: Hospitalsapoteket, lægen eller sygeplejersken blander på forhånd Pemetrexed Pfizer-pulveret med vand til injektionsvæske og injektionsvæske, opløsning med 5 % glukose, før det indgives til Dem.
English: Driving and using machines Pemetrexed Pfizer may make you feel tired.
Danish: Pemetrexed Pfizer kan muligvis gøre Dem træt.
English: Dose for cisplatin (mg/m2)
Danish: Dosis af cisplatin (mg/m
English: Pemetrexed Pfizer must only be further diluted with 5% glucose solution, without preservative.
Danish: Pemetrexed Pfizer må kun fortyndes yderligere med en opløsning med 5 % glukose uden konserveringsmiddel.
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur;
English: Each pack contains one glass vial of 100 mg, 500 mg or 1,000 mg pemetrexed.
Danish: Hver pakke indeholder et hætteglas med 100 mg, 500 mg eller 1.000 mg pemetrexed
English: A subgroup analysis was performed on patients who received folic acid and vitamin B12 supplementation during the entire course of study therapy (fully supplemented).
Danish: Der blev udført en undergruppeanalyse af de patienter, som fik et folsyre- og B12-vitamintilskud under hele studieforløbet (fuldt tilskud).
English: Limited clinical data from a separate randomised, Phase-3, controlled trial, suggest that efficacy data (overall survival, progression-free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (N = 41) and patients who did not receive previous docetaxel treatment (N =
Danish: Begrænsede kliniske data fra et andet randomiseret, kontrolleret fase 3-studie tyder på, at effektdata (total overlevelse, progressionsfri overlevelse) for pemetrexed er sammenlignelig for patienter, som tidligere er behandlet med docetaxel (n=41), og patienter, som ikke tidligere har fået docetaxelbehandling (n=540).
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) Lavtantalhvideblodlegemer
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1,000 micrograms) that you must take once a day while you are taking Pemetrexed Pfizer.
Danish: Vitamintilskud: Deres læge vil udskrive folsyretabletter (vitamin) eller en multivitamin indeholdende folsyre (350 - 1000 mikrogram) som De skal tage 1 gang dagligt, mens De tager Pemetrexed Pfizer.
English: Efficacy of pemetrexed vs. docetaxel in NSCLC - ITT population pemetrexed docetaxel
Danish: Effekt af pemetrexed versus docetaxel i NSCLC - ITT-populationen Pemetrexed
English: 2D barcode carrying the unique identifier included
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: You may want to seek counselling on sperm storage before starting your therapy.
Danish: Det kan være en god idé at søge rådgivning om opbevaring af sæd, inden behandlingen påbegyndes.
English: • If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
Danish: Hvis De bløder fra gummer, næse eller mund eller anden blødning, som ikke vil stoppe, rødlig eller lyserødlig urin, uventede blå mærker (fordi De muligvis har færre blodplader end normalt, hvilket er meget almindeligt).
English: Pemetrexed is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Danish: Pemetrexed er et bredspektret anti-cancer-antifolat, som virker ved at forstyrre de centrale folatafhængige metaboliske processer, der er afgørende for celledannelsen.
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
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
English: Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Danish: Brug af anden medicin sammen med Pemetrexed Pfizer Hvis De tager medicin mod smerter eller inflammation (betændelse/hævelse), såsom de såkaldte nonsteroide anti-inflammatoriske lægemidler (NSAID-præparater), herunder ikke-receptpligtig medicin (som f.eks. ibuprofen), skal De fortælle det til lægen.
English: • If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
Danish: Hvis De føler træthed, svimmelhed, hurtigt mister vejret, eller hvis De er bleg (fordi De muligvis har mindre hæmoglobin end normalt, hvilket er meget almindeligt).
English: Concomitant use contraindicated Yellow fever vaccine: Risk of fatal generalised vaccinale disease (see section 4.3).
Danish: Følgende samtidig brug er kontraindiceret Gul feber vaccine: risiko for generel vaccinesygdom (se pkt.
English: Patients received a median of 4 cycles of maintenance treatment with pemetrexed and 4 cycles of placebo.
Danish: Patienterne fik mediant 4 serier vedligeholdelsesbehandling med pemetrexed og 4 serier med placebo.
English: ***Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
Danish: *** Den integrerede bivirkningstabel kombinerer resultaterne fra de to studier JMEN (pemetrexed vedligeholdelsesbehandling(n=663))ogPARAMOUNT(pemetrexedinduktionsbehandling efterfulgt af pemetrexed-vedligeholdesbehandling (n=539)).
English: Patients received a median of 5 cycles of maintenance treatment with pemetrexed and 3.5 cycles of placebo.
Danish: Patienterne fik i gennemsnit 5 serier vedligeholdelsesbehandling af pemetrexed og 3,5 serier af placebo.
English: UNIQUE IDENTIFIER- HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Rare cases of bullous conditions have been reported including Stevens-Johnson syndrome and Toxic epidermal necrolysis which in some cases were fatal.
Danish: Der er rapporteret sjældne tilfælde af bulløse tilstande omfattende Stevens-Johnsons syndrom og toksisk epidermal nekrolyse, som i nogle tilfælde var dødelige.
English: If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive Pemetrexed Pfizer.
Danish: Hvis De har eller tidligere har haft nyreproblemer, skal De tale med Deres læge eller hospitalsapoteket, da De muligvis ikke må få Pemetrexed Pfizer.
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 5% glucose solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Danish: Den passende mængde rekonstituerede pemetrexedopløsning skal fortyndes yderligere til 100 ml med en injektionsvæske, opløsning med 5 % glukose, uden konserveringsmiddel, og indgives som intravenøs infusion over 10 minutter.
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: It is a white to either light yellow or green-yellow lyophilised powder.
Danish: Det er et hvidt til lysegult eller grøngult frysetørret pulver.
English: The relative treatment effect of pemetrexed was internally consistent across subgroups (including disease stage, induction response, ECOG PS, smoking status, gender, histology and age) and similar to that observed in the unadjusted OS and PFS analyses.
Danish: Den relative behandlingseffekt af pemetrexed var internt konsistent imellem undergrupperne (inklusive sygdomsstadie, induktionsrespons, ECOG performancestatus, rygestatus, køn, histologi og alder) og svarende til det, som blev observeret i analyserne for den ikke-justerede totale overlevelse og progressionsfri overlevelse.
English: There is no relevant use of pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Danish: Det er ikke relevant at bruge pemetrexed til malignt pleuramesoteliom og ikke-småcellet lungecancer i den pædiatriske population.
English: The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality.
Danish: Opløsningen er klar og kan variere i farve fra farveløs til gul eller grøngul, uden at det har negativ indflydelse på produktets kvalitet.
English: An insufficient number of patients have been studied with creatinine clearance of below 45 ml/min.
Danish: Der er ikke foretaget studier med tilstrækkeligt mange patienter med en kreatininclearance på under 45 ml/min.
English: There are insufficient data on the use of pemetrexed in patients with creatinine clearance below 45 ml/min; therefore, the use of pemetrexed is not recommended (see section 4.4).
Danish: Der foreligger ikke tilstrækkelige data om anvendelse af pemetrexed til patienter med en kreatininclearance under 45 ml/min, og pemetrexed anbefales derfor ikke til disse patienter (se pkt.
English: Pemetrexed Pfizer can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
Danish: Pemetrexed Pfizer kan ordineres til Dem, hvis De har fremskreden lungekræft, og Deres sygdom har reageret på behandling, eller hvis den stort set er uforandret efter den indledende kemoterapibehandling.
English: Skin reactions have been reported in patients not pre-treated with a corticosteroid.
Danish: Der er rapporteret om hudreaktioner hos patienter, som ikke modtog forbehandling med et kortikosteroidpræparat.
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1,000 micrograms) on a daily basis.
Danish: Patienter skal dagligt tage et oralt folsyretilskud eller en multivitamin indeholdende folsyre (350-1.000 mikrogram).
English: Most of the patients in whom these events have been observed had preexisting cardiovascular risk factors (see section 4.8).
Danish: Størstedelen af de patienter, hvor disse hændelser er observeret, havde allerede kardiovaskulære risikofaktorer (se pkt.
English: Concomitant administration of nephrotoxic medicinal products (e.g., aminoglycoside, loop diuretics, platinum compounds, ciclosporin) could potentially result in delayed clearance of pemetrexed.
Danish: Samtidig behandling med nefrotoksiske lægemidler (f.eks. aminoglycosid, loop- diuretika, platinforbindelser, ciclosporin) kan resultere i forsinket clearance af pemetrexed.
English: Chemical and physical in-use stability of reconstituted and infusion solutions of Pemetrexed Pfizer were demonstrated for 24 hours at refrigerated temperature and 25°C.
Danish: Rekonstituerede opløsninger og infusionsopløsninger Rekonstituerede opløsninger og infusionsopløsninger af Pemetrexed Pfizer har vist sig at have en kemisk og fysisk holdbarhed på 24 timer ved køleskabstemperatur og ved 25 °C.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) Akut nyresvigt
English: However, patients with hepatic impairment, such as bilirubin > 1.5times the upper limit of normal and/or aminotransferase > 3.0-times the upper limit of normal (hepatic metastases absent) or > 5.0 times the upper limit of normal (hepatic metastases present), have not been specifically studied.
Danish: Der er dog ikke foretaget specifikke studier med patienter med nedsat leverfunktion såsom bilirubin > 1,5 gange den normale øvre grænseværdi og/eller aminotransferase > 3,0 gange den normale øvre grænseværdi (uden forekomst af levermetastaser) eller > 5,0 gange den normale øvre grænseværdi (med forekomst af levermetastaser).
English: Rare cases of radiation recall have been reported in patients who have received radiotherapy previously (see section 4.4).
Danish: Der er rapporteret sjældne tilfælde af radiation recall hos patienter, som tidligere har fået strålebehandling (se pkt.
English: Nephrogenic diabetes insipidus and renal tubular necrosis have been reported in post marketing setting with an unknown frequency.
Danish: Nefrogen diabetes insipidus og renal tubulær nekrose er indberettet efter markedsføring af lægemidlet med hyppigheden ”ikke kendt”.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C.
Danish: Anvendelse af andre opbevaringstider og -betingelser er på brugerens eget ansvar og må ikke overstige 24 timer ved 2 °C til 8 °C.
English: • Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
Danish: De skal omgående kontakte Deres læge, hvis De mærker nogen af følgende bivirkninger: Feber eller infektion (almindelig): Hvis Deres temperatur er 38 ºC eller højere, hvis De sveder eller viser andre tegn på infektion (fordi De muligvis har færre hvide blodlegemer end normalt, hvilket er meget almindeligt).
English: Rare cases of hepatitis, potentially serious, have been reported during clinical studies with pemetrexed.
Danish: Potentielt alvorlige tilfælde af hepatitis er sjældent rapporteret under kliniske studier med pemetrexed.
English: Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i overensstemmelse med lokale krav.
English: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased”.
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: Nadir platelets < 50,000/mm3 with bleedinga, regardless of nadir ANC
Danish: Nadir for trombocytter < 50.000/ mm 3 med blødning a uanset ANC-nadir
English: Dose modification table for pemetrexed (as a single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500/mm3 and nadir platelets ≥ 50,000/mm3
Danish: Tabel 1 - Dosisjustering for pemetrexed (som et enkeltstof eller i kombination) og cisplatinhæmatologiske toksiciteter ANC-nadir < 500 /mm 3 og nadir for trombocytter ≥ 50.000 /mm
English: Pemetrexed undergoes limited hepatic metabolism.
Danish: Pemetrexed gennemgår en begrænset metabolisering i leveren.
English: Dose reductions for subsequent cycles are based on nadir ANC, platelet count, and maximum non-haematologic toxicity seen from the previous cycle (see section 4.2).
Danish: Dosisreduktioner for efterfølgende serier baseres på ANC-nadir, trombocyttal og maksimal ikke-hæmatologisk toksicitet, som er observeret under den foregående serie (se pkt.
English: Fisher's exact p-value* <0.001
Danish: Fishers eksakte p-værdi*
English: NSCLC, second-line treatment
Danish: NSCLC, 2. linje-behandling