FrancophonIA/ELRC3.0 huggingface dataset:
English: No statistically significant differences in any other individual Grade 3/4/5 adverse reactions were seen with longer exposure.
Danish: Der blev ikke set statistisk signifikant forskel for andre individuelle bivirkninger af grad 3/4/5 ved længere eksponering.
English: Based on the planned date of your infusion of Pemetrexed Fresenius Kabi and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Danish: Ud fra den planlagte dato for din infusion med Pemetrexed Fresenius Kabi og/eller status for din nyrefunktion, vil din læge fortælle dig, hvilke typer medicin du må tage og hvornår du må tage dem.
English: The 1 year and 2 year survival rates for patients on pemetrexed were 58% and 32% respectively, compared to 45% and 21% for patients on placebo.
Danish: Den 1-årige og 2-årige overlevelsesrate for patienterne i behandling med pemetrexed var hhv. 58 % og 32 % sammenlignet med 45 % og 21 % for patienterne i placebo-behandling.
English: Statistically significant differences in pulmonary function tests were also observed.
Danish: Der blev desuden observeret en statistisk signifikant forskel ved test af lungefunktionen.
English: Log rank p-value*
Danish: Log Rank p-værdi*
English: Fisher's exact p-value*
Danish: Fishers eksakte p-værdi*
English: In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Danish: Der er i kliniske studier ikke fundet tegn på, at patienter på 65 år eller ældre har øget risiko for bivirkninger sammenlignet med patienter under 65 år.
English: Each pack consists of one vial.
Danish: Hver pakning indeholder ét hætteglas.
English: The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of PC versus GC.
Danish: Effektanalyser med brug af PQ-populationen er konsistente med analyser for ITT-populationen og understøtter noninferioritet af PC mod GC.
English: This medicine is given to you to reduce the frequency and severity of skin reactions that you may experience during your anticancer treatment.
Danish: Du får denne medicin for at reducere hyppigheden og sværhedsgraden af eventuelle hudreaktioner, som du kan opleve under kræftbehandlingen.
English: Do not use Pemetrexed Fresenius Kabi if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Pemetrexed Fresenius Kabi: hvis du er allergisk over for pemetrexed eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Excluding neurotoxicity
Danish: Eksklusive neurotoksicitet
English: Grade 3 or 4 mucositis
Danish: Grad 3 eller 4 mucositis
English: Pemetrexed is primarily eliminated in the urine, with 70 % to 90 % of the administered dose being recovered unchanged in urine within the first 24 hours following administration.
Danish: Pemetrexed udskilles primært i urinen, og 70-90 % af den indgivne dosis kan genfindes uforandret i urinen indenfor de første 24 timer efter indgift.
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 ved 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: Your doctor will discuss with you the potential risk of taking Pemetrexed Fresenius Kabi during pregnancy.
Danish: Din læge vil drøfte med dig den potentielle risiko ved at tage Pemetrexed Fresenius Kabi under graviditet.
English: Immunodepressed status is common in cancer patients.
Danish: Svækkelse af immunsystemet er almindelig hos cancerpatienter.
English: If you would like to father a child during the treatment or in the 6 months following receipt of treatment, seek advice from your doctor or pharmacist.
Danish: Hvis du ønsker at gøre en kvinde gravid under behandlingsforløbet eller tidligere end 6 måneder efter afsluttet behandling, skal du søge vejledning hos din læge eller på apoteket.
English: There are many sorts of NSAIDs with different durations of activity.
Danish: Der findes mange slags NSAIDpræparater med forskellige virksningsvarigheder af det aktive stof.
English: Thus, drainage of third space fluid collection prior to pemetrexed treatment should be considered, but may not be necessary.
Danish: Derfor bør drænage af ekstracellulære væskeansamlinger inden behandling med pemetrexed overvejes, men kan være unødvendig.
English: ** Refer to NCI CTCAE Criteria (Version 3.0; NCI 2003) for each grade of toxicity.
Danish: ** Se NCI CTCAE Criteria (Version 3.0; NCI 2003) for hver toksicitetsgrad.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Fresenius Kabi has finished.
Danish: Cisplatin gives også ved infusion i en af dine blodårer og gives cirka 30 minutter efter, at infusionen med Pemetrexed Fresenius Kabi er afsluttet.
English: Live attenuated vaccines (except yellow fever, for which concomitant use is contraindicated): risk of systemic, possibly fatal, disease.
Danish: Levende svækkede vacciner (med undtagelse af gul feber, for hvilken samtidig brug er kontraindiceret): risiko for systemisk sygdom med mulig dødelig udgang.
English: Uncommon cases of peripheral ischaemia leading sometimes to extremity necrosis have been reported.
Danish: Ikke almindelige tilfælde af perifer iskæmi, som af og til fører til ekstremitetsnekrose, er blevet rapporteret.
English: The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is not fully defined.
Danish: Effekten af ekstracellulærvæske, såsom pleural effusion eller ascites, på pemetrexed er ikke fuldt defineret.
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 antiemetisk behandling og relevant hydrering inden og/eller efter behandlingen.
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of medicinal product metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Danish: Resultater fra in vitro-forsøg med humane levermikrosomer indikerer, at pemetrexed ikke burde forårsage en klinisk signifikant inhibition af den metaboliske clearance af lægemidler, der metaboliseres af CYP3A, CYP2D6, CYP2C9 og CYP1A2.
English: Abbreviation: CI = confidence interval * p-value refers to comparison between arms.
Danish: Forkortelse: CI = konfidensinterval p-værdi henviser til sammenligning mellem arme.
English: Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low.
Danish: Din læge kan beslutte at ændre dosis eller udskyde behandlingen, afhængigt af din generelle tilstand, og hvis dine blodtal er for lave.
English: There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy.
Danish: Der er ingen data for anvendelse af pemetrexed til gravide kvinder, men ligesom andre antimetabolitter formodes pemetrexed at kunne forårsage alvorlige misdannelser, hvis det indgives under graviditeten.
English: Most of the patients in whom these events have been observed had pre-existing cardiovascular risk factors.
Danish: Størstedelen af de patienter, hvor disse hændelser er blevet observeret, havde eksisterende kardiovaskulære risikofaktorer.
English: Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Danish: Mange af patienterne der oplevede disse bivirkninger, havde underliggende risikofaktorer for udvikling af nyrepåvirkninger inklusiv dehydrering, tidligere hypertension eller diabetes.
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 dit blodtal og din generelle tilstand.
English: Caution should be made when these medicinal product are combined with pemetrexed.
Danish: Der skal udvises forsigtighed, når disse stoffer bruges i kombination med pemetrexed.
English: To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration.
Danish: For at reducere incidensen og sværhedsgraden af hudreaktioner bør der indgives et kortikosteroidpræparat dagen før, på selve dagen og dagen efter indgift af pemetrexed.
English: OTHER SPECIAL WARNING IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Fresenius Kabi and cisplatin is documented in Table 3.
Danish: I tilfælde af neurotoksicitet er den anbefalede dosisjustering for Pemetrexed Fresenius Kabi og cisplatin angivet i tabel 3.
English: Package leaflet: Information for the user
Danish: Indlægsseddel: Information til patienten
English: Any Grade 3 or 4 toxicities except mucositis
Danish: Enhver toksicitet af grad 3 eller 4, med undtagelse af mucositis.
English: Polyglutamation is a time-and concentration-dependent process that occurs in tumour cells and, to a lesser extent, in normal tissues.
Danish: Polyglutamation er en tids- og koncentrationsafhængig proces, som primært finder sted i tumorceller og i mindre grad i normalt væv.
English: ** In the pemetrexed /cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Danish: ** I pemetrexed/cisplatin-armen, randomiseret og behandlet (n = 225) og fuldt tilskud (n = 167).
English: Kaplan Meier plots of overall survival by histology
Danish: Kaplan Meier plot over samlet overlevelse (overall survival) efter histologi
English: ▪ Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Danish: • Allergisk reaktion: Hvis du udvikler udslæt (meget almindeligt)/en brændende eller prikkende fornemmelse (almindeligt) eller feber (almindeligt).
English: It is not known whether pemetrexed is excreted in human milk and adverse reactions on the suckling child cannot be excluded.
Danish: Det er ukendt, om pemetrexed udskilles i human mælk, og påvirkning af ammede børn kan ikke udelukkes.
English: Large cell (N=153)
Danish: Store celler (n = 153)
English: Pemetrexed Fresenius Kabi may make you feel tired.
Danish: Pemetrexed Fresenius Kabi kan muligvis gøre dig træt.
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: 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 Fresenius Kabi.
Danish: Før hver indgivelse vil du få taget blodprøver til vurdering af, om din nyre- og leverfunktion er tilstrækkelig god, og for at kontrollere, om du har blodlegemer nok til at få Pemetrexed Fresenius Kabi.
English: Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section 4.2).
Danish: Forbehandling med dexamethason (eller tilsvarende) kan reducere forekomsten og sværhedsgraden af hudreaktioner (se pkt.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
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 og effektivt til polyglutamatformer via enzymfolylpolyglutamat syntetase.
English: Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for Pemetrexed Fresenius Kabi used as a single agent or in combination with cisplatin.
Danish: Efter rekonvalescens skal patienter efterbehandles ud fra retningslinjerne i tabel 1, 2 og 3, der gælder for brug af Pemetrexed Fresenius Kabi som monoterapi eller i kombination med cisplatin.
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 939 patienter, som blev behandlet med pemetrexed og cisplatin i induktionsfasen, blev 539 patienter randomiseret til vedligeholdelsesbehandling med pemetrexed eller placebo.
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 838 mg/m infused over a 10-minute period.
Danish: Pemetrexeds farmakokinetiske egenskaber efter enkeltstof-administration, er blevet vurderet hos 426 cancerpatienter med forskellige typer massive tumorer i doser på 0,2-838 mg/m infunderet over 10
English: ▪ If you have pain, redness, swelling or sores in your mouth (very common).
Danish: • Hvis du har smerter, rødmen, hævelse eller sår i munden (meget almindeligt).
English: If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Danish: Hvis du er usikker, skal du spørge lægen eller på apoteket, om noget af den medicin du tager, er et NSAID-prærarat.
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 nyre og leverfunktion.
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 understøttende behandling.
English: Fully supplemented patients
Danish: Fuldt tilskud patienter
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 af vedligeholdelsesbehandlingen med pemetrexed, hvilket svarer til mindst 10 komplette serier pemetrexed.
English: Rare cases of hepatitis, potentially serious, have been reported during clinical studies with pemetrexed.
Danish: Sjældne, potentielt alvorlige, tilfælde af hepatitis er blevet rapporteret under kliniske studier med pemetrexed.
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 Fresenius Kabi treatment.
Danish: Kortikosteroider: Din læge vil udskrive steroidtabletter til dig (svarende til 4 milligram dexamethason 2 gange dagligt), som du skal tage dagen før, på behandlingsdagen og dagen efter behandling med Pemetrexed Fresenius Kabi.
English: White to off-white lyophilised powder or solid.
Danish: Hvidt til off-white frysetørret pulver eller fast stof.
English: Detailed information on this product is available on the website of European Medicinal Agency http://www.ema/europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Dose of pemetrexed (mg/m
Danish: Dosis af pemetrexed (mg/m
English: Hydrochloric acid concentrated (E507) (pH adjustment) Trometamol (pH adjustment)
Danish: Saltsyre, koncentreret (E507) (til pH-justering) Trometamol (til pH-justering)
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 injektion hver tredje cyklus.
English: You will always receive Pemetrexed Fresenius Kabi by infusion into one of your veins.
Danish: Du vil altid få Pemetrexed Fresenius Kabi ved infusion i en af dine blodårer.
English: Treatment with Pemetrexed Fresenius Kabi 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 Pemetrexed Fresenius Kabi skal afbrydes, hvis patienten efter to dosisreduktioner oplever hæmatologisk eller non-hæmatologisk toksicitet af grad 3 eller 4 eller omgående, hvis der observeres neurotoksicitet af grad 3 eller 4.
English: Common Pain Edema 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 oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Danish: Almindelig Smerter Ødemer Nyrer og urinveje Almindelig Nyresygdomme**** Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute.
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 overlevelse, lavere føtal fødselsvægt, ufuldstændig knogledannelse af visse skeletstrukturer og ganespalte.
English: Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Danish: a Statistisk signifikans for non-inferioritet med hele konfidensintervallet for HR pænt under 1,17645 for noninferiøritet-margin (p <0,001).
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: Forekomsten af bivirkninger blev evalueret for de patienter, som fik ≤ 6 serier af pemetrexed vedligeholdelsesbehandling (N=519), og sammenlignet med de patienter, som fik > 6 serier pemetrexed (N=281).
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Fresenius Kabi and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Fresenius Kabi treatment).
Danish: Du vil også få en injektion med B12-vitamin (1.000 mikrogram) i løbet af ugen op til første dosis Pemetrexed Fresenius Kabi og derefter cirka hver 9. uge (svarende til tre behandlingsforløb med Pemetrexed Fresenius Kabi).
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 non-hæmatologiske toksicitet fra den foregående behandlingsserie.
English: Do not use this medicine after the expiry date which is stated on the label and carton.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på etiketten og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Danish: Effekt af pemetrexed versus docetaxel hos NSCLC - ITT population
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: 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: These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥CTC Grade 2 bleeding.
Danish: Disse kriterier opfylder National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition på ≥CTC grad 2 blødning.
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 og cisplatin.
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Fresenius Kabi.
Danish: Du skal tage mindst 5 doser i løbet af de 7 dage op til den første dosis Pemetrexed Fresenius Kabi.
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 forudgående 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: ▪ If you start feeling chest pain (common) or having a fast heart rate (uncommon).
Danish: • Hvis du begynder at føle brystsmerter (almindeligt) eller har hjertebanken (ikke almindeligt).
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: Efficacy and safety were measured from the time of randomisation after completion of first line (induction) therapy.
Danish: Virkning og sikkerhed blev målt fra tidspunktet for randomisering efter gennemført førstevalgs- (induktions) behandling.
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 potentielt resultere i en forsinket clearance af 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 behandlingsrelateret toksicitet (se pkt.
English: Dose for cisplatin (mg/m
Danish: Dosis af cisplatin (mg/m
English: First line doublet therapy containing pemetrexed was not included.
Danish: Førstevalg dubletbehandling inkluderende pemetrexed blev ikke inkluderet.
English: The use of Pemetrexed Fresenius Kabi should be avoided during pregnancy.
Danish: Pemetrexed Fresenius Kabi må ikke anvendes under graviditet.