FrancophonIA/ELRC3.0 huggingface dataset:
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Fresenius Kabi.
Danish: Du skal fortsætte med at tage folsyre i 21 dage efter den sidste dosis af Pemetrexed Fresenius Kabi.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Fresenius Kabi powder with 5% glucose intravenous infusion before it is given to you.
Danish: Hospitalsapoteket, lægen eller sygeplejersken blander på forhånd Pemetrexed Fresenius Kabi pulveret med 5% glucose infusionsvæske, før det gives til dig.
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: 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 antifolat ved at hæmme thymidylat syntase (TS), dihydrofolat reduktase (DHFR) og glycinamidribonucleotidformyl transferase (GARFT), som er folatafhængige nøgleenzymer, i forbindelse med de novo-biosyntesen af thymidin og purinnukleotider.
English: For instructions on reconstitution and dilution of Pemetrexed Fresenius Kabi before administration, see section 6.6.
Danish: For instruktioner vedrørende rekonstitution og fortynding af Pemetrexed Fresenius Kabi før administration, se pkt.
English: Germany
Danish: Tyskland eller
English: It is a white to off-white lyophilised powder or solid.
Danish: Det er et hvidt til off-white frysetørret pulver eller fast stof.
English: Overall response rate** (95% CI)
Danish: Samlet respons rate** (95 % CI)
English: Consistent with other pemetrexed studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Danish: I lighed med andre studier med pemetrexed, blev der i JMEN set en forskel i effekt i overensstemmelse med NSCLC´s histologi.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige (kan påvirke op til 1 ud af 100 patienter) Akut nyresvigt
English: Concomitant use contraindicated Yellow fever vaccine: risk of fatal generalised vaccinale disease (see section 4.3).
Danish: Samtidig brug er kontraindiceret for følgende: Gul feber vaccine: risiko for generel vaccine sygdom med dødelig udgang (se pkt.
English: Creatinine clearance decreased**
Danish: Forhøjet kreatinin Nedsat kreatininclearance**
English: Pemetrexed Fresenius Kabi is a medicine used in the treatment of cancer.
Danish: Pemetrexed Fresenius Kabi er et lægemiddel, der anvendes til behandling af kræft.
English: If a pemetrexed solution contacts the skin, wash the skin immediately and thoroughly with soap and water.
Danish: Hvis pemetrexedopløsningen kommer i kontakt med huden, skal det berørte område straks vaskes grundigt med vand og sæbe.
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Danish: Patienter skal dagligt tage et oralt folsyretilskud eller et multivitamin indeholdende folsyre (350 til 1.000 mikrogram).
English: Adenocarcinoma (N=847)
Danish: Adenocarcinom (n = 847)
English: Other medicines and Pemetrexed Fresenius Kabi Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Danish: Brug af anden medicin sammen med Pemetrexed Fresenius Kabi Hvis du 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 du fortælle det til lægen.
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 nedsat fertilitet og testikelatrofi.
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Danish: Effekten af pemetrexed + cisplatin versus gemcitabin + cisplatin som førstevalg til ikke-småcellet lungecancer - ITT population og histologiske undergrupper
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Fresenius Kabi.
Danish: Fortæl din læge, hvis du for nylig er blevet vaccineret, da det muligvis kan forårsage dårlige virkninger med Pemetrexed Fresenius Kabi.
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), Pemetrexed Fresenius Kabi should be withheld until resolution to less than or equal to the patient's pre-therapy value.
Danish: Hvis patienter udvikler non-hæmatologisk toksicitet ≥ grad 3 (undtagen neurotoksicitet), skal behandlingen med Pemetrexed Fresenius Kabi seponeres, indtil patientens værdier er på niveau eller under niveauet fra før behandlingen.
English: Rare cases of bullous conditions have been reported including Stevens-Johnson syndrome and Toxic epidermal necrolysis which in some cases were fatal.
Danish: Der er rapporteret sjældne tilfælde af bulløse tilstande, inklusiv Stevens-Johnson's syndrom og toksisk epidermal nekrolyse, som i nogle tilfælde var dødelige.
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Fresenius Kabi.
Danish: Hvis du har en væskeansamling omkring lungerne, vil lægen muligvis beslutte at fjerne denne væske, før du modtager behandling med Pemetrexed Fresenius Kabi.
English: Common(may affect up to 1 in 10 people) Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Danish: Almindelige (kan påvirke op til 1 ud af 10 patienter) Allergisk reaktion: udslæt/en brændende eller prikkende fornemmelse Infektion, herunder blodforgiftning Feber
English: 75 % of previous dose (both pemetrexed and cisplatin)
Danish: 75 % af tidligere dosis (både pemetrexed og cisplatin)
English: There were no clinically relevant differences observed for the safety profile of pemetrexed plus cisplatin within the histology subgroups.
Danish: Der blev ikke observeret klinisk relevante forskelle i sikkerhedsprofilen for pemetrexed plus cisplatin inden for de histologiske undergrupper.
English: Pemetrexed Fresenius Kabi must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Danish: Pemetrexed Fresenius Kabi må kun administreres under tilsyn af en læge, som er kvalificeret i brugen af kemoterapi mod cancer.
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, kontrolleret fase 3-studie tyder på, at effektdata (total overlevelse, progressionsfri overlevelse) for pemetrexed er sammenlignelig for patienter, som tidligere er behandlet med docetaxel (n=41), og patienter, som ikke tidligere er blevet behandlet med docetaxel (n=540).
English: 50 % of previous dose (both pemetrexed and cisplatin)
Danish: 50 % af tidligere dosis (både pemetrexed og cisplatin)
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 forligelige med indgivelsessæt og dropposer, som er belagt med polyvinylchlorid og polyolefin.
English: Rare cases of radiation recall have been reported in patients who have received radiotherapy previously (see section 4.4).
Danish: Sjældne tilfælde af radiation recall er blevet rapporteret hos patienter, som tidligere har modtaget strålebehandling (se pkt.
English: Pancytopenia-combined low counts of white cells, red cells and platelets
Danish: Pancytopeni - en kombination af lavt antal hvide blodlegemer, røde blodlegemer og blodplader.
English: Pancytopenia has been uncommonly reported during clinical trials with pemetrexed.
Danish: Pancytopeni er blevet rapporteret i ikke almindelig grad under kliniske studier med pemetrexed.
English: You must tell your doctor as soon as possible when you start experiencing any of these side effects.
Danish: Du skal omgående kontakte din læge, hvis du mærker nogen af følgende bivirkninger:
English: Pemetrexed is transported into cells by both the reduced folate carrier and membrane folate binding protein transport systems.
Danish: Pemetrexed transporteres ind i cellerne via to transportsystemer: den reducerede folatbærer og via membranens folatbindingsprotein.
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 fase 2-studie af pemetrexed 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: Pemetrexed Fresenius Kabi should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Pemetrexed Fresenius Kabi skal administreres som intravenøs infusion over 10 minutter på den første dag i hver 21-dages serie.
English: Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
Danish: Hvert hætteglas indeholder et overskud af pemetrexed, så den angivne mængde kan indgives.
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
English: ▪ If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon) (may indicate a blood clot in the blood vessels of the lungs)
Danish: • Hvis du pludselig får åndenød, stærke smerter i brystet eller hoste med blodigt spyt (ikke almindeligt) (dette kan betyde, at der er en blodprop i en af dine lungers blodårer).
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm and platelets should be
Danish: Før påbegyndelse af en kemoterapiserie skal patienter opfylde følgende parametre: Det absolutte neutrofiltal (ANC) skal være ≥ 1.500 celler/mm
English: ▪ If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
Danish: • Hvis du føler træthed, svimmelhed, hurtigt mister vejret, eller hvis du er bleg (fordi du muligvis har mindre hæmoglobin end normalt, hvilket er meget almindeligt).
English: When using Pemetrexed Fresenius Kabi in combination with cisplatin:
Danish: Når Pemetrexed Fresenius Kabi bruges sammen med cisplatin:
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 filtrations-hastighed baseret på Tc99m-DPTA-serum-clearancemetoden):
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 farmakokinetikken for pemetrexed.
English: The other ingredients are mannitol, hydrochloric acid concentrated and trometamol.
Danish: - Øvrige indholdsstoffer: mannitol, saltsyre koncentreret og trometamol.
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 (inklusiv sygdomsstadie, induktionsrespons, ECOG performancestatus, rygestatus, køn, histologi og alder) og svarende til det, som blev observeret i analyserne for den ikkejusterede totale overlevelse og progressionsfrie overlevelse.
English: Concomitant use not recommended
Danish: Samtidig brug anbefales ikke for følgende:
English: Pemetrexed Fresenius Kabi 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 Fresenius Kabi kan blive ordineret til dig, hvis du har fremskreden lungekræft, og din sygdom har reageret på behandling, eller hvis den stort set er uforandret efter den indledende kemoterapibehandling.
English: Pack of 1 vial.
Danish: Pakningsstørrelse: 1 hætteglas.
English: An insufficient number of patients has been studied with creatinine clearance of below 45 ml/min.
Danish: Der er ikke foretaget studier med tilstrækkeligt mange patienter med en kreatinin-clearance under 45 ml/min.
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** which is derived from the term “renal/genitourinary other”.
Danish: * Se National Cancer Institute CTC version 2 for hver grad af toksicitet, undtagen udtrykket "nedsat kreatininclearance".
English: Less toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was administered.
Danish: Der blev observeret en mindre toksicitet og en reduktion i antallet af hæmatologisk og nonhæmatologisk toksicitet af grad 3/4 såsom neutropeni, febril neutropeni og infektion med neutropeni af grad 3/4, når patienterne var i forbehandling med folsyre og B12-vitamin.
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 Fresenius Kabi.
Danish: Hvis du har eller tidligere har haft nyreproblemer, skal du tale med din læge eller hospitalsapoteket, da du muligvis ikke må få Pemetrexed Fresenius Kabi
English: Dose reductions for subsequent cycles are based on nadir ANC, platelet count and maximum non-haematologic toxicity seen from the previous cycle (see section 4.2).
Danish: Dosisreduktioner for efterfølgende serier baseres på ANC-nadir, trombocyttal og maksimal non-hæmatologisk toksicitet, som er observeret under den foregående serie (se pkt.
English: Common Vomiting Mucositis/ stomatitis
Danish: Mucositis/ stomatitis
English: 50 % of previous dose a
Danish: 50 % af tidligere dosis a
English: Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia and anaemia.
Danish: De forventede komplikationer ved overdosering omfatter knoglemarvssuppression, manifesteret ved neutropeni, trombocytopeni og anæmi.
English: If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with Pemetrexed Fresenius Kabi.
Danish: Hvis du har fået eller skal have strålebehandling, skal du fortælle det til din læge, idet Pemetrexed Fresenius Kabi kan medføre en tidlig eller sen strålingsreaktion.
English: Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their Pemetrexed Fresenius Kabi therapy.
Danish: Strålingspneumonitis (arvæv i de fineste bronkier samt alveolerne på grund af strålebehandling) kan opstå hos patienter, som også behandles med stråling enten før, under eller efter deres behandling med Permetrexed Fresenius Kabi.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C, unless 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 højst være 24 timer ved 2°C-8°C, medmindre fortyndingen er udført under kontrollerede og validerede aseptiske betingelser.
English: ▪ If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common).
Danish: • Hvis du bløder fra gummer, næse eller mund eller har en anden blødning, som ikke vil stoppe, rødlig eller lyserød urin, uventede blå mærker (fordi du muligvis har færre blodplader end normalt, hvilket er meget almindeligt).
English: If you are breastfeeding, tell your doctor.
Danish: Hvis du ammer, skal du fortælle din læge dette.
English: 75 % of previous dose 75 % of previous dose
Danish: 75 % af tidligere dosis
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 blevet observeret, havde i forvejen kardiovaskulære risikofaktorer (se pkt.
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 monoterapi (n = 164) og det fase 3enkeltstofstudie med pemetrexed, som er beskrevet ovenfor, med undtagelse af neutropeni (12,8 % versus 5,3 %) og forhøjet ALAT (15,2 % versus 1,9 %).
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/mm and platelet count returns to ≥ 100,000 cells/mm
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/mm
English: Nadir ANC < 500 /mm and nadir platelets
Danish: ANC-nadir < 500 /mm og nadir for trombocytter ≥ 50.000 /mm
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 (almindeligt): Hvis din temperatur er 38 ºC eller højere, hvis du sveder eller viser andre tegn på infektion (fordi du muligvis har færre hvide blodlegemer end normalt, hvilket er meget almindeligt).
English: Oesophagitis/ radiation oesophagitis has been uncommonly reported during clinical trials with pemetrexed.
Danish: Øsophagitis/strålings-øsophagitis er blevet rapporteret i ikke almindelig grad under kliniske studier med pemetrexed.
English: Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia, mucositis, sensory polyneuropathy and rash.
Danish: De rapporterede symptomer ved overdosering inkluderer neutropeni, anæmi, trombocytopeni, mucositis, sensorisk polyneuropati og udslæt.
English: Women must use effective contraception during treatment with Pemetrexed Fresenius Kabi.
Danish: Kvinder skal anvende effektive svangerskabsforebyggende midler under behandlingen med Pemetrexed Fresenius Kabi.
English: Concomitant administration of nephrotoxic medicinal product (e.g. aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed.
Danish: Samtidig behandling med nefrotoksiske lægemidler (f.eks. aminoglycosid, loopdiuretika, platinforbindelser, ciclosporin) kan resultere i forsinket clearance af pemetrexed.
English: Patients received a median of 4 cycles of maintenance treatment with pemetrexed and 4 cycles of placebo.
Danish: Medianen var 4 serier af vedligeholdelsesbehandling med pemetrexed og 4 serier med placebo.
English: Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischaemic attack have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Danish: Alvorlige kardiovaskulære og cerebrovaskulære bivirkninger, herunder myokardieinfarkt, angina pectoris, cerebrovaskulære hændelser og forbigående iskæmisk anfald, er i ikke almindelig grad blevet rapporteret under kliniske studier med pemetrexed, sædvanligvis når pemetrexed gives i kombination med et andet cytotoksisk lægemiddelstof.
English: Calculate the dose and the number of Pemetrexed Fresenius Kabi vials needed.
Danish: Beregn den nødvendige dosis og det nødvendige antal hætteglas med Pemetrexed Fresenius Kabi.
English: Women of childbearing potential must use effective contraception during treatment with pemetrexed.
Danish: Kvinder i den fertile alder skal anvende effektiv prævention under behandling med pemetrexed.
English: In clinical trials, cases of colitis (including intestinal and rectal bleeding, sometimes fatal, intestinal perforation, intestinal necrosis and typhlitis) have been reported uncommonly in patients treated with pemetrexed.
Danish: Tilfælde af colitis (inklusiv intestinal og rektal blødning, til tider dødelig, intestinal perforation, intestinal nekrose og typhlitis) er blevet rapporteret i ikke almindelig grad hos patienter behandlet med pemetrexed i kliniske studier.
English: What you need to know before you use Pemetrexed Fresenius Kabi
Danish: Det skal du vide, før du begynder at bruge Pemetrexed Fresenius Kabi
English: Type I, clear, colourless glass vial, with 20 mm chlorobutyl rubber stopper and sealed with blue flip-off aluminium seal.
Danish: Type 1, klart farveløst hætteglas med 20 mm chlorbutyl gummiprop og forseglet med blå flipp-off aluminiumskapsel.
English: Sepsis, sometimes fatal, has been commonly reported during clinical trials with pemetrexed.
Danish: Sepsis, til tider dødelig, blev rapporteret med frekvensen almindelig under kliniske studier med pemetrexed.
English: ≥ 100,000 cells/mm
Danish: celler/mm
English: Other (N=252)
Danish: Andre (n = 252)
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 % mod 7,0 %; p=0,021).