FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Danish: Hvis De er usikker, skal De spørge lægen eller på apoteket, om noget af den medicin, De tager, er et NSAID-prærarat.
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: These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.
Danish: Disse forskelle skyldtes sandsynligvis forskelle i patientpopulationen, eftersom fase 2-studierne både omfattede patienter, som ikke tidligere havde modtaget kemoterapi, og intensivt forbehandlede brystcancerpatienter med eksisterende levermetastaser og/eller unormale leverfunktionsanalyser ved baseline.
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 ALIMTA.
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 ALIMTA.
English: Pemetrexed total systemic clearance is 91.8 ml/min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 ml/min).
Danish: Pemetrexeds samlede systemiske clearance er 91,8 ml/min, og halveringstiden i plasma er 3,5 timer hos patienter med normal nyrefunktion (kreatinin-clearance på 90 ml/min).
English: Survival Time (months) Median (m)
Danish: Overlevelsestid (måneder) Median (m)
English: Section 4.8 of the SmPC is being updated accordingly together with consequential changes in the Package leaflet.
Danish: Produktresumeets punkt 4.8 opdateres i overensstemmelse hermed og indlægssedlen ændres ligeledes.
English: Concomitant use not recommended: Live attenuated vaccines (except yellow fever, for which concomitant use is contraindicated): risk of systemic, possibly fatal, disease.
Danish: Følgende samtidig brug frarådes: Levende svækkede vacciner (med undtagelse af gul feber, for hvilken samtidig brug er kontraindiceret): risiko for systemisk sygdom med mulig dødelig udgang.
English: Dose of ALIMTA (mg/m2)
Danish: Dosis af ALIMTA (mg/m2)
English: The analysis of the impact of NSCLC histology on overall survival demonstrated clinically relevant differences in survival according to histology, see table below.
Danish: Analysen af indvirkningen på NSCLC-histologien for total overlevelse viste klinisk relevante forskelle i overlevelse baseret på histologi, se nedenstående tabel.
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 ALIMTA.
Danish: Hvis De har fået eller skal have strålebehandling, skal De fortælle det til Deres læge, idet ALIMTA kan medføre en tidlig eller sen strålingsreaktion.
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 ALIMTA 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 ALIMTA.
English: Overall Survival
Danish: Total overlevelse
English: A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with ALIMTA, representing at least 10 total cycles of ALIMTA.
Danish: I alt fuldførte 169 patienter (47,1 %) ≥ 6 serier af vedligeholdelsesbehandlingen med ALIMTA, hvilket svarer til mindst 10 komplette serier ALIMTA.
English: What you need to know before you use ALIMTA
Danish: Det skal De vide, før De begynder at bruge ALIMTA
English: The use of ALIMTA should be avoided during pregnancy.
Danish: ALIMTA må ikke anvendes under graviditet.
English: A number of cases describing cellulitis, pseudocellulitis, dermatitis and dermo-hypodermitis have been reported with an unknown frequency.
Danish: En række tilfælde, der beskriver cellulitis, pseudocellulitis, dermatitis og dermo-hypodermitis er blevet rapporteret med hyppigheden ikke kendt.
English: Therefore patients should be cautioned against driving or operating machines if this event occurs.
Danish: Patienten skal derfor advares mod at køre bil eller betjene maskiner, hvis han/hun oplever træthed.
English: Patients should be regularly monitored for acute tubular necrosis, decreased renal function and signs and symptoms of nephrogenic diabetes insipidus (e.g. hypernatraemia).
Danish: Patienterne bør overvåges regelmæssigt for akut tubulær nekrose, nedsat nyrefunktion og tegn og symptomer på nefrogen diabetes insipidus (f.eks. hypernatriæmi).
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with ALIMTA.
Danish: Informér Deres læge, hvis De for nylig er blevet vaccineret, da det muligvis kan forårsage dårlige virkninger med ALIMTA.
English: Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving treatment.
Danish: Patienter skal derfor have modtaget passende anti-emetisk behandling og relevant hydrering inden og/eller efter behandlingen.
English: **** Combined term includes increased serum/blood creatinine, decreased glomerular filtration rate, renal failure and renal/genitourinary- other.
Danish: **** Den kombinerede term omfatter forøget serum/blod-kreatinin, nedsat glomerulær filtrationshastighed, nyresvigt og andre renale/genitourinale faktorer.
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
Danish: Forkortelser: CI = konfidensinterval; HR = hazard-ratio; ITT = intent to treat; n = samlet populationsstørrelse.
English: 100 % of previous dose
Danish: 100 % af tidligere dosis
English: rue du Colonel Lilly F-67640 Fegersheim France
Danish: rue du Colonel Lilly F-67640, Fegersheim Frankrig
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: 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: 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: NSCLC, maintenance treatment
Danish: NSCLC, vedligeholdelsesbehandling
English: LIST OF EXCIPIENTS Mannitol, hydrochloric acid, sodium hydroxide (see package leaflet for further information).
Danish: LISTE OVER HJÆLPESTOFFER Mannitol, saltsyre, natriumhydroxid (se indlægssedlen for yderligere information).
English: The ALIMTA maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Danish: Sikkerhedsprofilerne for vedligeholdelsesbehandlingen med ALIMTA var sammenlignelig i de to studier JMEN og PARAMOUNT.
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you ALIMTA.
Danish: Hvis De har en væskeansamling omkring lungerne, vil lægen muligvis beslutte at fjerne denne væske, før De modtager behandling med ALIMTA.
English: INFORMATION ON BRAILLE
Danish: INFORMATION I BRAILLESKRIFT
English: All patients received study therapy as initial treatment for locally advanced or metastatic NSCLC and patients in both treatment groups were fully supplemented with folic acid and vitamin B12.
Danish: Alle patienter fik studiebehandling som initial behandling for lokalt fremskreden eller metastatisk NSCLC, og patienterne i begge behandlingsgrupper fik fuldstændigt dækkende tilskud af folsyre og vitamin B12.
English: Administration of pemetrexed to pregnant mice resulted in decreased foetal viability, decreased foetal weight, incomplete ossification of some skeletal structures and cleft palate.
Danish: Indgift af pemetrexed til gravide mus resulterede i lavere føtal levedygtighed, lavere føtal fødselsvægt, ufuldstændig forbening af visse skeletstrukturer og ganespalte.
English: In the data from the originator product, 91 cases of cellulitis, 42 of dermatitis, 13 cases of dermo-hypodermitis, and 3 cases of pseudocellulitis were identified.
Danish: Der blev identificeret 91 tilfælde af cellulitis, 42 tilfælde af dermatitis, 13 tilfælde af dermo-hypodermitis og 3 tilfælde af pseudocellulitis i data fra originalpræparatet.
English: There are limited data in patients with malignant pleural mesothelioma treated with ALIMTA alone.
Danish: Der foreligger en begrænset mængde data for de patienter med malignt pleuramesoteliom, som blev behandlet med ALIMTA alene.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal overvejes af patienter på saltfattig diæt.
English: Oral folic acid and intramuscular vitamin B12 supplementation do not affect the pharmacokinetics of pemetrexed.
Danish: Oral folsyre og intramuskulært tilskud af B12-vitamin påvirker ikke pemetrexeds farmakokinetik.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of ALIMTA and then approximately every 9 weeks (corresponding to 3 courses of ALIMTA treatment).
Danish: De vil også få en injektion med B12-vitamin (1.000 mikrogram) i løbet af ugen op til første dosis ALIMTA og derefter cirka hver 9. uge (svarende til 3 ALIMTA-behandlingsforløb).
English: Oedema (excess fluid in body tissue, causing swelling)Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving ALIMTA 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 ALIMTA, sædvanligvis i kombination med anden kræftbehandling.
English: ALIMTA should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: ALIMTA skal administreres som intravenøs infusion over 10 minutter på den første dag i hver 21dages serie.
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 pemetrexed vedligeholdelsesbehandling (N=519), og sammenlignet med de patienter, som fik >6 serierpemetrexed (N=281).
English: The separation between the treatment arms was achieved by improvement in lung function in the ALIMTA/cisplatin arm and deterioration of lung function over time in the control arm.
Danish: Spredningen mellem behandlingsarmene viste sig ved en forbedring af lungefunktionen i ALIMTA/cisplatin-armen og en med tiden dårligere lungefunktion i kontrolarmen.
English: Patients must also receive an intramuscular injection of vitamin B12 (1000 micrograms) in the week preceding the first dose of pemetrexed and once every three cycles thereafter.
Danish: Patienter skal også have en intramuskulær injektion af B12-vitamin (1.000 mikrogram) i ugen op til indgift af den første dosis pemetrexed og herefter én gang hver tredje cyklus.
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: You must continue taking the folic acid for 21 days after the last dose of ALIMTA.
Danish: De skal fortsætte med at tage folsyre i 21 dage efter indgift af den sidste dosis ALIMTA.
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 nyreog leverfunktion.
English: If you start feeling chest pain (common) or having a fast heart rate (uncommon).
Danish: Hvis De begynder at føle brystsmerter (almindelig) eller har hjertebanken (ualmindelig).
English: The PFS and OS results in patients with squamous cell histology suggested no advantage for ALIMTA over placebo.
Danish: PFS og OS resultaterne hos patienter med pladecellehistologi tydede ikke på nogen fordel for ALIMTA i forhold til placebo.
English: For instructions on reconstitution and dilution of ALIMTA before administration, see section 6.6.
Danish: For instruktioner vedrørende rekonstitution og fortynding af ALIMTA før administration, se pkt.
English: Efficacy parameter
Danish: Effektparameter
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: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
Danish: Fortæl det til Deres læge, hvis De får alvorligt udslæt, kløe eller blæredannelse (Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse).
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 vaccine sygdom med dødelig udgang (se pkt.
English: Common Vomiting Mucositis/ stomatitis
Danish: Almindelig Opkastning Mucositis/stomatitis
English: Dose for cisplatin (mg/m2)
Danish: Dosis af cisplatin (mg/m2)
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 ALIMTA.
Danish: Hvis De har eller tidligere har haft nyreproblemer, skal De tale med Deres læge eller hospitalsapoteket, da De muligvis ikke må få ALIMTA.
English: Of the randomised patients, 44.9% had a complete/partial response and 51.9% had a response of stable disease to ALIMTA 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 ALIMTA og cislatin induktionsbehandling.
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 intravenøs infusion.
English: Driving and using machines ALIMTA may make you feel tired.
Danish: Trafik- og arbejdssikkerhed ALIMTA kan muligvis gøre Dem træt.
English: For intravenous use after reconstitution and dilution.
Danish: Til intravenøs brug efter rekonstitution og fortynding.
English: Alimta 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: ALIMTA 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: 75 % of previous dose
Danish: 75 % af tidligere dosis
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: ALIMTA (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: ALIMTA (pemetrexed) er et bredspektret anti-cancer-antifolat, som virker ved at forstyrre de centrale folatafhængige metaboliske processer, der er afgørende for celledannelsen.
English: In vitro studies have shown that pemetrexed behaves as a multitargeted 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: As a result there is sufficient evidence suggesting a causal relationship between the use of pemetrexed and infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue including acute bacterial dermo-hypodermitis, cellulitis, pseudocellulitis and dermatitis.
Danish: Som resultat heraf er der tilstrækkelig evidens, som antyder et årsagsforhold mellem anvendelsen af pemetrexed og infektiøse og ikke-infektiøse sygdomme i dermis, hypodermis og/eller det subkutane væv, herunder akut bakteriel dermo-hypodermitis, cellulitis, pseudocellulitis og dermatitis.
English: Log Rank p-value*
Danish: Log-rank-p-værdi*
English: Adenocarcinoma (N=847)
Danish: Adenocarcinom (N=847)
English: How to use ALIMTA
Danish: Sådan skal de bruge ALIMTA
English: Kaplan Meier plots of overall survival by histology
Danish: Kaplan Meier-kurver over overlevelse (OS, overall survival) efter histologi
English: There have been a 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: *** 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: Treatment with ALIMTA should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Danish: Behandlingen med ALIMTA 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: Consistent with other ALIMTA studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Danish: I lighed med andre studier med ALIMTA blev der i JMEN set en forskel i virkning i overensstemmelse med NSCLC´s histologi.
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: Pemetrexed solutions are for single use only.
Danish: Pemetrexedopløsninger er kun beregnet til engangsbrug.
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, ALAT eller total-bilirubin og pemetrexeds farmakokinetik.
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), ALIMTA 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 ALIMTA seponeres, indtil patientens værdier er nået ned på eller under niveauet fra før behandlingen.
English: 50 % of previous dose
Danish: 50 % af tidligere dosis
English: ALIMTA in combination with cisplatin
Danish: ALIMTA i kombination med cisplatin
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: 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: DATE OF REVISION OF THE TEXT Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om ALIMTA findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Manufacturer Lilly France S.A.S.
Danish: Fremstiller Lilly France S.A.S.
English: A phase 2 study of pemetrexed in 31 solid tumour patients with stable third space fluid demonstrated no difference in pemetrexed dose normalized 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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2004
Danish: Dato for første markedsføringstilladelse: 20. september 2004
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: Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
Danish: Pemetrexedinfusionsopløsninger, der er forberedt som angivet ovenfor, er kompatible med indgivelsessæt og dropposer belagt med polyvinylchlorid og polyolefin.
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 ikkesmåcellet lungecancer og havde tidligere modtaget kemoterapi.