FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the randomised patients, 44.9 % had a complete/partial response and 51.9 % had a response of stable disease to pemetrexed plus cisplatin induction.
Danish: 44,9 % af de randomiserede patienter havde komplet/partielt respons, og 51,9 % af de randomiserede patienter havde respons i form af stabil sygdom på pemetrexed og cislatin induktionsbehandling.
English: For instructions on reconstitution and dilution of Pemetrexed Accord before administration, see section 6.6.
Danish: For instruktioner vedrørende rekonstitution og fortynding af Pemetrexed Accord før administration, se pkt.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER CYTOTOKSISK.
English: The use of Pemetrexed Accord should be avoided during pregnancy.
Danish: Pemetrexed Accord må ikke anvendes under graviditet.
English: Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Danish: Radiation recall (et hududslæt, der ligner en alvorlig solskoldning), som kan opstå på hud, der tidligere har været udsat for strålebehandling, dage eller op til år efter strålebehandlingen.
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Accord.
Danish: De skal fortsætte med at tage folsyre i 21 dage efter indgift af den sidste dosis Pemetrexed Accord.
English: Stomatitis/ Pharyngitis Nausea
Danish: Stomatitis/ pharyngitis
English: The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N=519), and compared to patients who received > 6 cycles of pemetrexed (N=281).
Danish: Incidensen af bivirkninger blev evalueret for de patienter, som fik ≤6 serier af pemetrexedvedligeholdelsesbehandling (N = 519), og sammenlignet med de patienter, som fik > 6 serier pemetrexed (N = 281).
English: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3%, > 6cycles: 6.4 %: p=0.046).
Danish: Der blev observeret en signifikant øget forekomst af grad 3/4 neutropeni, som muligvis var relateret til studiemedicinen, ved længere eksponering for pemetrexed (≤ 6 serier: 3,3%; > 6 serier: 6,4 %; p = 0,046).
English: Dose of Pemetrexed Accord (mg/m2)
Danish: Dosis af Pemetrexed Accord (mg/m2)
English: 5.2 Preclinical safety data
Danish: 5.3 Prækliniske sikkerhedsdata
English: If patients develop non-haematologic toxicities  Grade 3 (excluding neurotoxicity), Pemetrexed Accord 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 Accord seponeres, indtil patientens værdier er nået ned på eller under niveauet fra før behandlingen.
English: Pemetrexed Accord 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 Accord 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: 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 Accord.
Danish: Hvis De har eller tidligere har haft nyreproblemer, skal De tale med Deres læge eller hospitalsapoteket, da De muligvis ikke må få Pemetrexed Accord.
English: The median time from the start of pemetrexed plus cisplatin induction therapy to the start of maintenance treatment was 2.96 months on both the pemetrexed arm and the placebo arm.
Danish: Median-tiden fra start af pemetrexed og cisplatin-induktionsbehandling til start af vedligeholdelsesbehandling var 2,96 måneder i både pemetrexed- og placeboarmen.
English: Pemetrexed Accord should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Pemetrexed Accord skal administreres som intravenøs infusion over 10 minutter på den første dag i hver 21-dages serie.
English: Table 1 - Dose modification table for Pemetrexed Accord (as 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 Accord (som enkeltstof eller i kombination) og cisplatin - hæmatologisk toksicitet ANC-nadir < 500 /mm3 og nadir for trombocytter  50.000 /mm3
English: Log Rank p-value* Overall response rate**
Danish: Log-rank-p-værdi* Samlet responsrate**
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: 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: Each pack of Pemetrexed Accord consists of one vial.
Danish: Hver pakke Pemetrexed Accord indeholder ét Pemetrexed Accord hætteglas.
English: Talk to your doctor or hospital pharmacist or nurse before using Pemetrexed Accord.
Danish: Kontakt lægen eller sundhedspersonalet, før De får Pemetrexed Accord.
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)) og PARAMOUNT (pemetrexed-induktionsbehandling efterfulgt af pemetrexed-vedligeholdelsesbehandling (N = 539)).
English: Neuropathy-Sensory
Danish: Sensorisk neuropati
English: Premedication regimen
Danish: Præmedicineringsregime
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be  1500 cells/mm3 and platelets should be  100,000 cells/mm3.
Danish: Før påbegyndelse af en kemoterapiserie skal patienter opfylde følgende parametre: Det absolutte neutrofiltal (ANC) skal være  1.500 celler/mm3, og trombocyttallet skal være  100.000 celler/mm3.
English: Please tell your doctor if you are taking any medicines 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 Accord 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: Gemcitabine/ cisplatin (N= 830)
Danish: Gemcitabin/ cisplatin (N = 830)
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, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes med det samme, er det brugerens ansvar at vurdere holdbarheden og opbevaringsforholdene, inden produktet anvendes, og holdbarheden vil normalt ikke være længere end 24 timer ved 2 C-8 C, medmindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Limited clinical data from a separate randomized, 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 = 540).
Danish: Begrænsede kliniske data fra et andet randomiseret fase 3 kontrolleret 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: Lower limb swelling with pain and redness Increased urine output
Danish: Hævelse i de nedre lemmer med smerte og rødme Øget urinproduktion
English: Renal disorders Common Renal disorders**** Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Danish: Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute.
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (excess fluid in body tissue, causing swelling)Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving Pemetrexed Accord usually in combination with another anticancer therapy.
Danish: Ødemer (væskeophobning i væv, som medfører hævelse) Nogle patienter har oplevet et hjertetilfælde, et slagtilfælde eller et ”mini-slagtilfælde”, mens de har fået Pemetrexed Accord, sædvanligvis i kombination med anden kræftbehandling.
English: There is no relevant use of Pemetrexed Accord in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Danish: Det er ikke relevant at bruge Pemetrexed Accord til malignt pleuramesoteliom og ikke-småcellet lungecancer i den pædiatriske population.
English: Driving and using machines Pemetrexed Accord may make you feel tired.
Danish: Pemetrexed Accord kan muligvis gøre Dem træt.
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Danish: 100 % af tidligere dosis a National Cancer Institute Common Toxicity Criteria (CTC v 2.0; NCI 1998) b Undtagen neurotoksicitet
English: How to use Pemetrexed Accord
Danish: Sådan skal De bruge Pemetrexed Accord
English: Table 2 - Dose modification table for Pemetrexed Accord (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b
Danish: Tabel 2 - Dosisjustering for Pemetrexed Accord (som enkeltstof eller i kombination) og cisplatin - ikke-hæmatologisk toksicitet a, b
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Danish: Effekt af pemetrexed versus docetaxel mod NSCLC - ITT-population Pemetrexed Accord
English: Children and adolescents There is no relevant use of Pemetrexed Accord in the paediatric population
Danish: Børn og teenagere Det er ikke relevant at bruge Pemetrexed Accord til børn og teenagere.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet Accord efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
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: Table 3 - Dose modification table for Pemetrexed Accord (as single agent or in combination) and cisplatin - Neurotoxicity
Danish: Tabel 3 - Dosisjustering for Pemetrexed Accord (som enkeltstof eller i kombination) og cisplatin - neurotoksicitet
English: Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Danish: Anvend aseptisk teknik ved rekonstituering og yderligere fortynding af pemetrexed til administration ved intravenøs infusion.
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to  1500 cells/mm3 and platelet count returns to  100,000 cells/mm3.
Danish: Under behandlingen skal patienten monitoreres for myelosuppression, og pemetrexed må ikke gives til patienter, før det absolutte neutrofiltal (ANC) igen er  1.500 celler/mm3, og trombocyttallet igen er  100.000 celler/mm3.
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Danish: Effekt af pemetrexed + cisplatin mod gemcitabin + cisplatin ved 1. linje-behandling af ikkesmåcellet lungecancer - ITTpopulation og histologiske undergrupper.
English: Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Danish: Allergisk reaktion: udslæt/en brændende eller prikkende fornemmelse Infektion, inklusive sepsis (blodforgiftning) Feber
English: It is a white to either light yellow or greenish-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 progressionsfrie overlevelse.
English: Mannitol, hydrochloric acid, sodium hydroxide (see package leaflet for further information).
Danish: Mannitol, saltsyre, natriumhydroxid (se indlægssedlen for yderligere information).
English: Superiorityp-value
Danish: Superioritetp-værdi
English: Pemetrexed Accord is a powder for concentrate for solution for infusion in a glass vial.
Danish: Pemetrexed Accord er et pulver til koncentrat til infusionsvæskeopløsning i hætteglas af glas.
English: You must contact your doctor immediately if you notice any of the following: 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: 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: You must tell your doctor as soon as possible when you start experiencing any of these side effects.
Danish: De skal omgående kontakte Deres læge, hvis De mærker nogen af følgende bivirkninger:
English: Pemetrexed at a dose of 500 mg/m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Danish: Pemetrexed i en dosis på 500 mg/m2 blev undersøgt som enkeltstof behandling til 64 patienter med malignt pleuramesoteliom, som ikke tidligere havde modtaget kemoterapi.
English: Most of the patients in whom these events have been observed had pre-existing cardiovascular risk factors (see section 4.8).
Danish: Størstedelen af de patienter, hvor disse hændelser er observeret, havde allerede kardiovaskulære risikofaktorer (se pkt.
English: Patients received a median of4 cycles of maintenance treatment with pemetrexed and 4 cycles of placebo.
Danish: Median var 4 serier af vedligeholdelsesbehandling med pemetrexed og 4 serier med placebo.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the pemetrexed/cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Danish: Ved hjælp af lungecancersymptomskalaen blev der påvist en statistisk signifikant bedring af de klinisk relevante symptomer (smerte og dyspnø) i forbindelse med malignt pleuramesoteliom i pemetrexed/cisplatin-armen (212 patienter) versus armen med cisplatin alene (218 patienter).
English: Pemetrexed Accord is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Danish: Pemetrexed Accord anvendes sammen med cisplatin, en anden medicin mod kræft, til behandling af malignt pleuramesoteliom, en kræftform som påvirker lungehinderne, til patienter, som ikke tidligere har fået kemoterapi.
English: In patients with normal renal function (creatinine clearance > 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acidat higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Danish: Hos patienter med en normal nyrefunktion (kreatinin-clearance  80 ml/min) kan høje doser af nonsteroide anti-inflammatoriske lægemidler (NSAID-præparater såsom ibuprofen > 1600 mg/dag) og acetylsalicylsyre i høje doser ( 1,3 g daglig) nedsætte udskillelsen af pemetrexed, og dermed øge forekomsten af bivirkninger relateret til pemetrexed.
English: Nadir platelets < 50,000 /mm3 with bleedinga, regardless of nadir ANC
Danish: Nadir for trombocytter < 50.000/ mm3 med blødninga uanset ANC-nadir
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Accord powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Danish: Hospitalsapoteket, lægen eller sygeplejersken blander på forhånd Pemetrexed Accord-pulveret med natriumchloridinjektionsvæske 9 mg/ml (0,9%), før det indgives til Dem.
English: A white to either light yellow or greenish-yellow lyophilised powder.
Danish: Et hvidt til lysegult eller grøngult frysetørret pulver.
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Accord is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Til patienter, der behandles for ikke-småcellet lungecancer efter tidligere behandling med kemoterapi, er den anbefalede dosis af Pemetrexed Accord 500 mg/m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
English: Pemetrexed Accord in combination with cisplatin
Danish: Pemetrexed Accord i kombination med cisplatin
English: The other ingredients are mannitol, hydrochloric acid and sodium hydroxide (see section 2).
Danish: - Øvrige indholdsstoffer: Mannitol, saltsyre og natriumhydroxid (se pkt.
English: Pemetrexed Accord 100 mg contains less than 1 mmol sodium (23 mg) sodium per vial, i.e. essentially ‘sodium-free'.
Danish: Pemetrexed Accord 100 mg indeholder mindre end 1mmol natrium (23 mg) per hætteglas, hvilket vil sige, at det praktisk talt er ”natrium-frit”.
English: Median overall survival in months (95 % CI)
Danish: Middel overlevelse i måneder (95% CI)
English: Women must use effective contraception during treatment with Pemetrexed Accord.
Danish: Kvinder skal anvende effektive svangerskabsforebyggende midler under behandlingen med Pemetrexed Accord.
English: The percentage of patients that received post study treatment was 64.3 % for pemetrexed and 71.7 % for placebo.
Danish: 64,3 % af pemetrexed-patienterne og 71,7 % af placebo-patienterne fik behandling efter studiet.
English: Patients also required lower administration of erythropoietin/darbopoietin (10.4 % versus 18.1 %, p< 0.001), G-CSF/GM-CSF (3.1 % versus 6.1 %, p=0.004), and iron preparations (4.3 % versus 7.0 %, p=0.021).
Danish: Patienterne behøvede ligeledes mindre erythropoietin/darbopoietin (10,4 % mod 18,1 %, p < 0,001), G-CSF/GM-CSF (3,1 % mod 6,1 %; p = 0,004) og midler med jern (4,3 5 mod 7,0 %; p = 0,021).
English: NSCLC, second-line treatment
Danish: NSCLC, 2. linje-behandling:
English: Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4 % versus 28.9 %, p<0.001), red blood cell transfusions (16.1 % versus 27.3 %, p< 0.001) and platelet transfusions (1.8 % versus 4.5 %, p=0.002).
Danish: Patienter, der blev behandlet med pemetrexed og cisplatin, havde brug for færre transfusioner (16,4 % mod 28,9 %; p<0,001), transfusioner af røde blodlegemer (16,1 % mod 27,3 %; p<0,001) og blodpladetransfusioner (1,8 % mod 4,2 %; p = 0,002).
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95% CI= 0.94-1.15), and overall response rate was 30.6% (95% CI= 27.3-33.9) for pemetrexed plus cisplatin versus 28.2 % (95% CI= 25.0-31.4) for gemcitabine plus cisplatin.
Danish: Progressionsfri overlevelse (PFS) og størrelsen af det totale respons var ens mellem de to behandlingsarme: Middel PFS var 4,8 måneder for pemetrexed plus cisplatin mod 5,1 måneder for gemcitabin plus cisplatin (justeret hazard ratio 1.04; 95 % CI = 0,94-1,15) og det totale respons var 30,6 % (95 % CI = 27,3- 33,9) for pemetrexed plus cisplatin mod 28,2 % (95 % CI = 25,0-31,4) for gemcitabin plus cisplatin.
English: If you are pregnant, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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: Pemetrexed Accord is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Danish: Pemetrexed Accord er også en behandling til patienter med fremskreden lungekræft, hvor sygdommen har udviklet sig, efter anden indledende behandling med kemoterapi har været forsøgt.
English: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n= 283) and 7.9 months for patients treated with docetaxel (ITT n= 288).
Danish: Et åbent, randomiseret fase 3-multicenterstudie med pemetrexed versus docetaxel til patienter med lokalt fremskreden eller metastatisk NSCLC (ikke-småcellet lungekræft), der tidligere var behandlet med kemoterapi, har vist en median-overlevelsestid på 8,3 måneder for patienter, som blev behandlet med pemetrexed (intent-to-treat-population n = 283), og 7,9 måneder for patienter, som blev behandlet med docetaxel (ITT n = 288).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1071/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/15/1071/002
English: Patients with renal impairment: (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method)
Danish: Patienter med nedsat nyrefunktion (standardformel, der er udviklet af Cockcroft og Gault, eller glomerulær filtrationshastighed baseret på Tc99m-DPTA-serum-clearancemetoden) Pemetrexed udskilles primært uforandret via nyrerne.