FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviation: CI = confidence interval.
Danish: Forkortelse: CI = konfidensinterval.
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Krka during pregnancy.
Danish: Din læge vil sammen med dig drøfte den potentielle risiko ved at tage Pemetrexed Krka under graviditet.
English: Based on the planned date of your infusion of Pemetrexed Krka 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 af Pemetrexed Krka og/eller status for din nyrefunktion skal 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 2årige overlevelsesrate for patienterne i behandling med pemetrexed var henholdsvis 58 % og 32 % sammenlignet med 45 % og 21 % for patienterne i placebo-behandling.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du fortælle det til din læge.
English: The total bilirubin should be ≤ 1.5-times upper limit of normal.
Danish: Total-bilirubin skal være 1,5 gange den normale øvre grænseværdi.
English: Safety was assessed for patients who were randomised to receive pemetrexed (N=800).
Danish: Sikkerheden blev vurderet for de patienter, som blev randomiseret til pemetrexed (n = 800).
English: Common Renal disorders**** 7.6
Danish: Almindelig Nyresygdomme**** 7,6
English: There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other antimetabolites, is suspected to cause serious birth defects when administered during pregnancy.
Danish: Der er ingen data fra anvendelse af pemetrexed til gravide kvinder, men ligesom andre antimetabolitter formodes pemetrexed at kunne forårsage alvorlige misdannelser, hvis det indgives under graviditeten.
English: a Statistically significant for non-inferiority, with the entire confidence interval for HR well below the 1.17645 non-inferiority margin (p < 0.001).
Danish: Statistisk signifikans for non-inferioritet med hele konfidensintervallet for HR pænt under 1,17645 for non-inferioritet-margin (p < 0,001).
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af påvirkningen af evnen til at køre bil og betjene maskiner.
English: You will always receive Pemetrexed Krka by infusion into one of your veins.
Danish: Du vil altid få Pemetrexed Krka ved infusion i en af dine blodårer.
English: Use an inactivated vaccine where it exists (poliomyelitis) (see section
Danish: Brug en inaktiveret vaccine, hvis muligt (poliomyelitis) (se pkt.
English: 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: Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamin-oksalsyre-aminotransaminase; SGPT = serum glutamate-pyruvat-aminotransaminase.
English: Pack of 1 vial is available in a box.
Danish: Pakning med 1 hætteglas i en æske.
English: Excluding neurotoxicity
Danish: Undtagen neurotoksicitet
English: Randomised and treated patients
Danish: Randomiseret og behandlet
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Krka has finished.
Danish: Cisplatin indgives også ved infusion i en af dine blodårer, cirka 30 minutter efter at infusionen med Pemetrexed Krka er afsluttet.
English: Upon recovery, patients should be re-treated using the guidelines in Tables 1, 2, and 3, which are applicable for Pemetrexed Krka 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 Krka som enkeltstof eller i kombination med cisplatin.
English: Therefore, patients should receive adequate anti-emetic 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: - Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) - Hepatitis (inflammation of the liver) - Anaphylactic shock (severe allergic reaction)
Danish: - Immun-medieret hæmolytisk anæmi (antistof-medieret ødelæggelse af de røde blodlegemer) - Leverbetændelse (hepatitis) - Anafylaktisk shock (alvorlig allergisk reaktion)
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 almindelig)/en brændende eller prikkende fornemmelse (almindelig) eller feber (almindelig).
English: The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day (see section 4.4).
Danish: Dette kortikosteroid-præparat skal svare til 4 mg dexamethason indgivet oralt 2 gange dagligt (se pkt 4.4).
English: The European Medicines Agency has waived the obligation to submit the results of studies with pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
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 4.2 for oplysninger om pædiatrisk anvendelse).
English: You must contact your doctor immediately if you notice any of the following: - Fever or infection (common): if you have a temperature of 38°C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
Danish: Du skal omgående kontakte din læge, hvis du mærker nogen af følgende bivirkninger: - Feber eller infektion (almindelig): 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: 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 dine blodtal og generelle tilstand.
English: Chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at 2°C to 8°C (and 25°C).
Danish: Rekonstituerede opløsninger og infusionsopløsninger af pemetrexed har vist sig at have en kemisk og fysisk holdbarhed på 24 timer ved temperaturer på 2 °C-8 °C (og 25 °C).
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: Date of first authorisation: 22.
Danish: Dato for første markedsføringstilladelse: 22. maj 2018
English: Warnings and precautions Talk to your doctor or hospital pharmacist before using Pemetrexed Krka.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller hospitalsapoteket, før du bruger Pemetrexed Krka.
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: There have been a few reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator.
Danish: Der er kun rapporteret enkelte tilfælde af ekstravasation af pemetrexed, som investigatoren ikke betragtede som alvorlige.
English: In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Krka and cisplatin is documented in Table 3.
Danish: I tilfælde af neurotoksicitet er den anbefalede dosisjustering for Pemetrexed Krka og cisplatin angivet i tabel 3.
English: See section 2 "Pemetrexed Krka contains sodium".
Danish: Se punkt 2 ”Pemetrexed Krka indeholder natrium”.
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 Krka.
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 Krka.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemidde findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
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 Krka 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 Krka.
English: Common Pruritus Alopecia
Danish: Almindelig Pruritus Alopeci
English: The use of Pemetrexed Krka should be avoided during pregnancy.
Danish: Pemetrexed Krka må ikke anvendes under graviditet.
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: 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.
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.
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, folsyreanaloger, ATC-kode L01BA04.
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: 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: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased”
Danish: * Se National Cancer Institute CTC-version 2 for hver grad af toksicitet, undtagen udtrykket ”nedsat kreatinin-clearance”.
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/m2 infused over a 10-minute period.
Danish: Pemetrexeds farmakokinetiske egenskaber efter enkeltstofadministration er blevet vurderet hos 426 cancerpatienter med forskellige typer massive tumorer i doser på 0,2-838 mg/m2 infunderet over
English: Do not use Pemetrexed Krka - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Pemetrexed Krka - hvis du er allergisk over for pemetrexed eller et af de øvrige indholdsstoffer dette lægemiddel
English: Frequency estimate: - Very common (1/10) - Common (1/100 to <1/10) - Uncommon (1/1,000 to <1/100) - Rare (1/10,000 to <1/1,000) - Very rare (<1/10,000) - Not known (cannot be estimated from the available data)
Danish: Ikke almindelig (≥1/1.000 til <1/100) Sjælden (≥1/10.000 til <1/1.000) Meget sjælden (<1/10.000)
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
Danish: * Se National Cancer Institute CTC-version 2 for hver grad af toksicitet.
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: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Krka.
Danish: Hvis du har en væskeansamling omkring lungerne, vil lægen muligvis beslutte at fjerne denne væske, før du modtager behandling med Pemetrexed Krka.
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: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Krka.
Danish: Du skal tage mindst 5 doser i løbet af de 7 dage op til den første dosis Pemetrexed Krka.
English: Common Vomiting Mucositis/Stomatitis
Danish: Almindelig Opkastning Mucositis/stomatitis
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: Pemetrexed Krka is a medicine used in the treatment of cancer.
Danish: Pemetrexed Krka er et lægemiddel, der anvendes til behandling af kræft.
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%, >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: Side effects with Pemetrexed Krka may include:
Danish: Bivirkninger med Pemetrexed Krka kan være:
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 almindelig).
English: It is a white to either light yellow or green yellow lyophilized cake or powder.
Danish: Det er et hvidt til lysegult eller grøngult frysetørret kage eller pulver.
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1,500 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: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Krka.
Danish: Du skal fortsætte med at tage folsyre i 21 dage efter indgift af den sidste dosis Pemetrexed Krka.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Krka and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Krka treatment).
Danish: Du vil også få en injektion med B12-vitamin (1.000 mikrogram) i løbet af ugen op til første dosis Pemetrexed Krka og derefter cirka hver 9. uge (svarende til 3 Pemetrexed Krka-behandlingsforløb).
English: Calculate the dose and the number of Pemetrexed Krka vials needed.
Danish: Beregn den nødvendige dosis og det nødvendige antal hætteglas med Pemetrexed Krka.
English: Driving and using machines Pemetrexed Krka may make you feel tired.
Danish: Pemetrexed Krka kan muligvis gøre dig træt.
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
Danish: Før påbegyndelse af en kemoterapiserie skal patienter opfylde følgende parametre: Det absolutte neutrofiltal (ANC) skal være 1.500 celler/mm
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: AST (SGOT) elevation
Danish: ASAT (SGOT)forhøjelse
English: Pemetrexed Krka should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Pemetrexed Krka skal administreres som intravenøs infusion over 10 minutter på den første dag i hver 21-dages serie.
English: Dose of Pemetrexed Krka (mg/m
Danish: Dosis af Pemetrexed Krka (mg/m
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 Krka.
Danish: Hvis du har fået eller skal have strålebehandling, skal du fortælle det til din læge, idet Pemetrexed Krka kan medføre en tidlig eller sen strålingsreaktion.
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 Krka.
Danish: Hvis du har eller tidligere har haft nyreproblemer, skal du tale med din læge eller hospitalsapoteket, da du muligvis ikke må få Pemetrexed Krka.
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: 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: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Krka.
Danish: Informér din læge, hvis du for nylig er blevet vaccineret, da det muligvis kan forårsage dårlige virkninger med Pemetrexed Krka.
English: Posology Pemetrexed Krka must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Danish: Dosering Pemetrexed Krka må kun administreres under tilsyn af en læge, som er kvalificeret i brugen af kemoterapi mod cancer.
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 pemetrexedvedligeholdelsesbehandling (n = 539)).
English: Common ALT (SGPT) elevation
Danish: Almindelig ALAT (SGPT)forhøjelse
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: Brug af anden medicin sammen med Pemetrexed Krka 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: White to either light yellow or green yellow lyophilized cake or powder.
Danish: Hvidt til lysegult eller grøngult frysetørret kage eller pulver.
English: - If you start feeling chest pain (common) or having a fast heart rate (uncommon).
Danish: - Hvis du begynder at føle brystsmerter (almindelig) eller har hjertebanken (ualmindelig).
English: may occur in patients who are also treated with radiation either before, during or after their pemetrexed therapy - Extremity pain, low temperature and discolouration have been reported - Blood clots in the lung blood vessels (pulmonary embolism)
Danish: kan opstå hos patienter, som også behandles med stråling enten før, under eller efter deres behandling med pemetrexed - Smerter i arme og ben, lav temperatur og misfarvning er indberettet - Blodpropper i lungernes blodårer (lungeemboli)
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: When using Pemetrexed Krka in combination with cisplatin:
Danish: Når Pemetrexed Krka tages sammen med cisplatin:
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: Pemetrexed Krka 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 Krka kan ordineres 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: 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: For instructions on reconstitution and dilution of Pemetrexed Krka before administration, see section 6.6.
Danish: For instruktioner vedrørende rekonstitution og fortynding af Pemetrexed Krka før administration, se pkt.
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups
Danish: Effekt af pemetrexed + cisplatin mod gemcitabin + cisplatin ved 1. linje-behandling af ikke-småcellet lungecancer - ITTpopulation og histologiske undergrupper