FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are also receiving cisplatin, your doctor will make sure that you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.
Danish: Hvis De også får cisplatin, vil Deres læge kontrollere, at De får tilstrækkelig med væske og får den rette behandling før og efter indgivelse af cisplatin for at forebygge opkastning.
English: This dose may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
Danish: Denne dosis skal muligvis justeres, eller behandlingen skal udskydes, afhængigt af Deres blodtal og generelle tilstand.
English: Vitamin B12 and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
Danish: De får B12-vitamin og folsyre for at mindske risikoen for mulige toksiske virkninger af kræftbehandlingen.
English: Large cell (N = 153)
Danish: Store celler (N = 153)
English: Adjusted hazard ratio (HR) (95% CI)
Danish: Justeret Hazard ratio (HR) (95 % CI)
English: Of the 939 patients treated with pemetrexed plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Danish: Ud af de 939 patienter, som blev behandlet med pemetrexed og cisplatin i induktionfasen, blev 539 patienter randomiseret til vedligeholdelsesbehandling med pemetrexed eller placebo.
English: *p-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Danish: *P-værdier <0.05 sammenligning af pemetrexed/cisplatin med gemcitabin/cisplatin, ved brug af Fisher Exact test. ** Se National Cancer Institute CTC (v2.0; NCI 1998) for hver toksicitetsgrad.
English: During post-marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
Danish: I forbindelse med overvågning efter markedsføring er der rapporteret følgende bivirkninger hos patienter behandlet med pemetrexed:
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 brystcancer patienter med eksisterende levermetastaser og/eller unormale leverfunktionsanalyser ved baseline.
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Danish: Forkortelser: CI = konfidensinterval; ITT = intent-to-treat; N = samlet populationsstørrelse.
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed Pfizer.
Danish: Før hver indgivelse vil De få taget blodprøver til vurdering af, om Deres nyre- og leverfunktion er tilstrækkelig god, og for at kontrollere, om De har blodlegemer nok til at få Pemetrexed Pfizer.
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 apoteketspersonalet om noget af den medicin, De tager, er et NSAID-prærarat.
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 cisplatin induktionsbehandling.
English: The pemetrexed maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Danish: Sikkerhedsprofilerne for vedligeholdelsesbehandlingen med pemetrexed var sammenlignelig i de to studier JMEN og PARAMOUNT.
English: Additional medicines
Danish: Andre lægemidler
English: Polyglutamated metabolites have an increased intracellular half-life resulting in prolonged drug action in malignant cells.
Danish: Polyglutamerede metabolitter har en forøget intracellulær halveringstid, hvilket resulterer i en forlænget virkning af lægemidlet i maligne celler.
English: Common Fever
Danish: Almindelig Feber
English: Patients randomised to maintenance treatment were required to have an ECOG performance status 0 or 1.
Danish: De patienter, som blev randomiseret til vedligeholdelsesbehandling, skulle have en ECOG performancestatus på 0 eller 1.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing pemetrexed in all subsets of the paediatric population for the granted indications (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med pemetrexed i alle undergrupper af den pædiatriske population for de godkendte indikationer (se pkt.
English: Alkaline phosphatase (ALP), 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 eller SGOT) og alaninaminotransferase (ALAT eller SGPT) skal være ≤ 3 gange den normale øvre grænseværdi.
English: Rare cases of anaphylactic shock have been reported.
Danish: Der er rapporteret sjældne tilfælde af anafylaktisk shock.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
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 (kreatininclearance på 90 ml/min).
English: The PFS and OS results in patients with squamous cell histology suggested no advantage for pemetrexed over placebo.
Danish: PFS og OS resultaterne hos patienter med pladecellehistologi tydede ikke på nogen fordel for pemetrexed i forhold til placebo.
English: Kaplan-Meier plots of overall survival by histology
Danish: Kaplan-Meier-kurver over samlet overlevelse (OS) efter histologi
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 hyperrnatriæmi).
English: It must be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Det skal administreres som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren, der er ansvarlig for batchfrigivelse
English: Use in combination with cisplatin
Danish: Brug sammen med cisplatin
English: Do not use Pemetrexed Pfizer - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Pemetrexed Pfizer hvis De er allergisk over for pemetrexed eller et af de øvrige indholdsstoffer i Pemetrexed Pfizer (angivet i punkt 6).
English: A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed.
Danish: I alt fuldførte 169 patienter (47,1 %) ≥ 6 serier vedligeholdelsesbehandling med pemetrexed, hvilket svarer til mindst 10 komplette serier pemetrexed.
English: The use of pemetrexed should be avoided during pregnancy.
Danish: Pemetrexed må ikke anvendes under graviditet.
English: UNIQUE IDENTIFIER- 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Kidney: abnormal blood tests
Danish: Nyrer: abnorme blodprøveresultater
English: Studies to assess the carcinogenic potential of pemetrexed have not been conducted.
Danish: Der er ikke foretaget studier til klarlæggelse af pemetrexeds mulige karcinogene effekt.
English: You will always receive Pemetrexed Pfizer by infusion into one of your veins.
Danish: De vil altid få Pemetrexed Pfizer som infusion i en af Deres blodårer.
English: Patients should discontinue therapy if Grade 3 or 4 neurotoxicity is observed.
Danish: Patienten bør afbryde behandlingen, hvis der observeres neurotoksicitet af grad 3 eller 4.
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 kreatininclearance på ≥45 ml/min ingen særlige dosisjusteringer ud over de, der anbefales til alle patienter.
English: Pemetrexed is not a vesicant.
Danish: Pemetrexed er ikke blæretrækkende.
English: Creatinine elevation
Danish: Forhøjet kreatinin
English: Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observed.
Danish: Grundet den gastrointestinale toksicitet af pemetrexed i kombinationsbehandling med cisplatin forekommer der observationer på svær dehydrering.
English: Owing to the possibility of pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment.
Danish: På grund af risikoen for, at behandling med pemetrexed kan forårsage irreversibel infertilitet, rådes mandlige patienter til at søge rådgivning om opbevaring af sæd, inden behandlingen påbegyndes.
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 (kreatininclearance ≥ 80 ml/min).
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: Clinically relevant toxicities with respect to gender were similar to the overall population in patients receiving pemetrexed plus cisplatin.
Danish: Den klinisk relevante toksicitet med hensyn til køn var den samme for den totale population af de patienter, som fik pemetrexed plus cisplatin.
English: Due to the increased thrombotic risk in patients with cancer, the use of anticoagulation treatment is frequent.
Danish: På grund af den forøgede risiko for trombotiske komplikationer hos cancerpatienter anvendes antikoagulationsbehandling ofte til disse patienter.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: In the event of suspected overdose, patients should be monitored with blood counts and should receive supportive therapy as necessary.
Danish: Hvis der er mistanke om overdosering, skal patienten monitoreres med blodtællinger og eventuelt i understøttende behandling.
English: Honey Lane
Danish: Honey Lane Hurley
English: Pre-medication regimen
Danish: Præmedicineringsregime
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 (ikke almindelig).
English: Oral folic acid and intramuscular vitamin B12 supplementation do not affect the pharmacokinetics of pemetrexed.
Danish: Oral folsyre og intramuskulær tilskud af B12-vitamin påvirker ikke pemetrexeds farmakokinetik.
English: Most of these events resolved after pemetrexed withdrawal.
Danish: De fleste af disse bivirkninger forsvandt efter seponering af pemetrexed.
English: *p-value refers to comparison between arms.
Danish: Forkortelse: CI = konfidensinterval * p-værdi henviser til sammenligning mellem arme.
English: The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day (see section 4.4).
Danish: Dette kortikosteroidpræparat skal svare til 4 mg dexamethason indgivet oralt 2 gange dagligt (se pkt.
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Pfizer.
Danish: De skal tage mindst 5 doser i løbet af de 7 dage op til den første dosis Pemetrexed Pfizer.
English: Patients must also receive an intramuscular injection of vitamin B12 (1,000 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: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
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: Animal studies have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har vist reproduktionstoksicitet (se pkt.
English: Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/or after receiving cisplatin (see also cisplatin Summary of Product Characteristics for specific dosing advice).
Danish: Patienten skal have modtaget passende antiemetisk behandling og relevant hydrering inden og/eller efter indgift af cisplatin (se også produktresuméet for cisplatin for at få specifikke oplysninger om dosering).
English: Preparation and administration precautions
Danish: Forsigtighedsregler i forbindelse med forberedelse og administration
English: Dose adjustments at the start of a subsequent cycle should be based on nadir haematologic counts or maximum non-haematologic toxicity from the preceding cycle of therapy.
Danish: Dosisjusteringer i begyndelsen af en efterfølgende serie skal baseres på hæmatologisk nadir eller den maksimale ikke-hæmatologiske toksicitet fra den foregående behandlingsserie.
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 forsøgsmedicin som initial behandling for lokalt fremskreden eller metastatisk NSCLC, og patienterne i begge behandlingsgrupper fik fuldstændigt dækkende tilskud af folsyre og vitamin B12.
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, nyresvigtogandrerenale/genitourinalefaktorer.
English: The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
Danish: Pemetrexeds farmakokinetik er ensartet over flere behandlingscykler.
English: The separation between the treatment arms was achieved by improvement in lung function in the pemetrexed /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 pemetrexed/cisplatin-armen og en med tiden dårligere lungefunktion i kontrolarmen.
English: Pemetrexed Pfizer is a medicine used in the treatment of cancer.
Danish: Pemetrexed Pfizer er et lægemiddel, der anvendes til behandling af kræft.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Pfizer treatment.
Danish: Kortikosteroider: Deres læge vil udskrive steroidtabletter til Dem (svarende til 4 milligram dexamethason 2 gange dagligt), som De skal tage på dagen før, på behandlingsdagen og dagen efter behandling med Pemetrexed Pfizer.
English: Prior chemotherapy did not include pemetrexed.
Danish: Forudgående kemoterapi inkluderede ikke pemetrexed.
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: A significant increase in the incidence of possibly study-medicinal product-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤6 cycles: 3.3%, >6 cycles: 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 will also receive an injection of vitamin B12 (1,000 micrograms) in the week before administration of Pemetrexed Pfizer and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Pfizer treatment).
Danish: De vil også få en injektion med B12-vitamin (1.000 mikrogram) i løbet af ugen op til første dosis Pemetrexed Pfizer og derefter cirka hver 9. uge (svarende til 3 Pemetrexed Pfizer behandlingsforløb).
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: There are limited data in patients with malignant pleural mesothelioma treated with pemetrexed alone.
Danish: Der foreligger en begrænset mængde data for de patienter med malignt pleuramesoteliom, som blev behandlet med pemetrexed alene.
English: Reconstituted and infusion solutions: When prepared as directed, chemical and physical in-use stability has been demonstrated for 24 hours at refrigerated temperature (2°C to 8°C) and at 25°C.
Danish: Rekonstituerede opløsninger og infusionsopløsninger: Hvis produktet er forberedt som angivet, har det vist sig at have en kemisk og fysisk holdbarhed på 24 timer ved køleskabstemperatur (2°C til 8°C) og ved 25 °C.
English: Cases of radiation recall have been reported in patients who received radiotherapy weeks or years previously.
Danish: Der er rapporteret tilfælde af radiation recall hos patienter, som uger eller år forinden har modtaget strålebehandling.
English: All patients were diagnosed with Stage IIIB or IV NSCLC and had received prior platinum-based chemotherapy.
Danish: Alle patienter var diagnosticeret med NSCLC stadie IIIB eller IV og havde forud fået platinbaseret kemoterapi.
English: Common SGPT (ALT) elevation 7.9 SGOT (AST) elevation 6.8
Danish: Almindelig ALAT-øgning 7,9 ASAT-øgning 6,8
English: Pemetrexed is mainly eliminated unchanged renally by tubular secretion and to a lesser extent by glomerular filtration.
Danish: Pemetrexed udskilles primært uforandret gennem nyrerne ved tubulær sek retion og i mindre grad ved glomerulær filtration.
English: Calculate the dose and the number of Pemetrexed Pfizer vials needed.
Danish: Beregn den nødvendige dosis og det nødvendige antal hætteglas med Pemetrexed Pfizer.
English: Uncommon cases of peripheral ischaemia leading sometimes to extremity necrosis have been reported.
Danish: Der er rapporteret ikke almindelige tilfælde af perifer iskæmi, som af og til medfører ekstremitetsnekrose.
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Pfizer.
Danish: Hvis De har en væskeansamling omkring lungerne, vil lægen muligvis beslutte at fjerne denne væske, før De modtager behandling med Pemetrexed Pfizer.
English: Patients receiving pemetrexed should be monitored before each dose with a complete blood count, including a differential white cell count (WCC) and platelet count.
Danish: Patienter i behandling med pemetrexed, skal før hver dosis monitoreres med en komplet blodtælling, herunder differentialtælling af hvide blodlegemer (WCC) og bestemmelse trombocyttal.
English: To reduce toxicity, patients treated with pemetrexed must also receive vitamin supplementation (see section 4.4).
Danish: For at mindske risikoen for toksicitet skal patienter, der er i behandling med pemetrexed, også have vitamintilskud (se pkt.
English: For instructions on reconstitution and dilution of Pemetrexed Pfizer before administration, see section 6.6
Danish: For instruktioner vedrørende rekonstitution og fortynding af Pemetrexed Pfizer før administration, se pkt.
English: Administration of pemetrexed to male mice resulted in reproductive toxicity characterised by reduced fertility rates and testicular atrophy.
Danish: Indgift af pemetrexed til hanmus resulterede i reproduktionstoksicitet karakteriseret ved nedsatte fertilitetsrater og testikelatrofi.
English: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Danish: PFS data blevdelvistbekræftetaf en uafhængiggennemgang(400/1725 patienterblevrandomiseretogudvalgttilundersøgelsen).
English: Each vial contains an excess of pemetrexed to facilitate delivery of label amount.
Danish: Hvert hætteglas indeholder tilstrækkeligt pemetrexed til at levere den angivne mængde.
English: At least five doses of folic acid must be taken during the seven days preceding the first dose of pemetrexed, and dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
Danish: Patienter skal indtage mindst fem doser folsyre i løbet af de sidste syv dage inden indgift af den første dosis pemetrexed, og doseringen skal fortsætte under hele behandlingsforløbet og i 21 dage efter indgift af den sidste dosis pemetrexed.
English: Therefore, all patients treated with pemetrexed must be instructed to take folic acid and vitamin B12 as a prophylactic measure to reduce treatment-related toxicity (see section 4.2).
Danish: Alle patienter, der skal behandles med pemetrexed, skal derfor bedes om at tage et profylaktisk tilskud af folsyre og B12-vitamin for at reducere den behandlingsrelaterede toksicitet (se pkt.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Superio rity pvalue pemetrexed + cisplatin gemcitabine + cisplatin
Danish: Superioritet p-værdi pemetrexed + cisplatin gemcitabin + cisplatin
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Pfizer.
Danish: De skal fortsætte med at tage folsyre i 21 dage efter indgift af den sidste dosis Pemetrexed Pfizer.
English: Once in the cell, pemetrexed is rapidly and efficiently converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase.
Danish: Når pemetrexed er trængt ind i cellen, omdannes det hurtigt til polyglutamatformer via enzymfolylpolyglutamatsyntetase.