FrancophonIA/ELRC3.0 huggingface dataset:
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 CIAMBRA.
Danish: Hvis De har fået eller skal have strålebehandling, skal De fortælle det til Deres læge, idet CIAMBRA kan medføre en tidlig eller sen strålingsreaktion.
English: Unopened vial 2 years
Danish: Ubrudt hætteglas 2 år
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: Uncommon side effects (may affect up to 1 in 100 people) Acute renal failure
Danish: Ualmindelige bivirkninger (som kan berøre op til 1 ud af 100) Akut nyresvigt
English: Common Vomiting Mucositis/ stomatitis
Danish: Almindelig Opkastning Mucositis/ stomatitis
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with CIAMBRA.
Danish: Informér Deres læge, hvis De for nylig er blevet vaccineret, da det muligvis kan forårsage dårlige virkninger med CIAMBRA.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of CIAMBRA and then approximately every 9 weeks (corresponding to 3 courses of CIAMBRA treatment).
Danish: De vil også få en injektion med B12-vitamin (1.000 mikrogram) i løbet af ugen op til første dosis CIAMBRA og derefter cirka hver 9. uge (svarende til 3 behandlingsforløb med CIAMBRA).
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
Danish: Fortæl det til Deres læge, hvis De får alvorligt udslæt, kløe eller blæredannelse (StevensJohnsons syndrom eller toksisk epidermal nekrolyse).
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 administreret oralt 2 gange dagligt (se pkt.
English: Rare cases of anaphylactic shock have been reported.
Danish: Der er rapporteret sjældne tilfælde af anafylaktisk chok.
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 toksiske virkninger af kræftbehandlingen.
English: The use of CIAMBRA should be avoided during pregnancy.
Danish: CIAMBRA må ikke anvendes under graviditet.
English: Rash/ desquamation Common Pruritus Alopecia
Danish: Udslæt/ hudafskalning Almindelig Pruritus Alopeci
English: Immune-mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Danish: Immunmedieret, hæmolytisk anæmi (antistofmedieret ødelæggelse af de røde blodlegemer) Leverbetændelse (hepatitis).
English: The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of AC versus GC.
Danish: Effektanalyser med brug af PQ-populationen er konsistente med analyser for ITT-populationen og understøtter noninferioriteten af AC mod GC.
English: CIAMBRA contains sodium
Danish: CIAMBRA indeholder natrium
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 induktionsbehandling med pemetrexed og cisplatin.
English: First line doublet therapy containing pemetrexed was not included.
Danish: 1. linje-dubletbehandling omfattende pemetrexed blev ikke medtaget.
English: What CIAMBRA contains
Danish: CIAMBRA indeholder
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: All patients received study therapy as initial treatment for locally advanced or metastatic NSCLC and patients in both treatment groups were fully supplemented with folic acid and vitamin B12.
Danish: Alle patienter fik studiebehandling som initial behandling for lokalt fremskreden eller metastatisk NSCLC, og patienterne i begge behandlingsgrupper fik fuldstændigt dækkende tilskud af folsyre og B12-vitamin.
English: All patients included in this study had an ECOG performance status 0 or 1.
Danish: Alle patienter, der var inkluderet i dette studie havde, en ECOG (Eastern Cooperative Oncology Group) performancestatus på 0 eller 1.
English: Further dilution by a healthcare provider is required prior to administration.
Danish: Opløsningen skal fortyndes yderligere af sundhedsfagligt personale inden administration.
English: Therefore, caution should be made when administering higher doses of NSAIDs or aspirin, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/min).
Danish: Der skal derfor udvises forsigtighed ved administration af højere doser af NSAID-præparater eller acetylsalicylsyre samtidig med pemetrexed hos patienter med normal nyrefunktion (kreatininclearance ≥ 80 ml/min.
English: For storage conditions after reconstitution/dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution/fortynding af lægemidlet, se pkt.
English: What you need to know before you use CIAMBRA
Danish: Det skal De vide, før De begynder at bruge CIAMBRA
English: You must continue taking the folic acid for 21 days after the last dose of CIAMBRA.
Danish: De skal fortsætte med at tage folsyre i 21 dage efter administration af den sidste dosis CIAMBRA.
English: Prior to each chemotherapy administration blood chemistry tests should be collected to evaluate renal and hepatic function.
Danish: Hver gang inden administration af kemoterapi skal der indsamles laboratorieanalyser af blodet til evaluering af nyre- og leverfunktion.
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 vedligeholdelsesbehandling med pemetrexed (n=519), og sammenlignet med de patienter, som fik > 6 serier pemetrexed (n=281).
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 5 doser folsyre i løbet af de sidste 7 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: Blood clots in the lung blood vessels (pulmonary embolism)
Danish: Blodpropper i lungernes blodårer (lungeemboli)
English: Fatigue Common Fever
Danish: Træthed Almindelig Feber
English: Unopened vial 3 years
Danish: Ubrudt hætteglas 3 år
English: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤6 cycles: 3.3%, > 6cycles: 6.4%: p=0.046).
Danish: Der blev observeret en signifikant øget forekomst af grad 3/4 neutropeni, som muligvis var relateret til studiemedicinen, ved længere eksponering for pemetrexed (≤ 6 serier: 3,3 %, > 6 serier: 6,4 %; p=0,046).
English: The reconstituted solution should be used immediately to prepare the infusion solution.
Danish: Den rekonstituerede opløsning skal straks anvendes til infusionsopløsningen.
English: Administration of pemetrexed to male mice resulted in reproductive toxicity characterised by reduced fertility rates and testicular atrophy.
Danish: Administration af pemetrexed til hanmus resulterede i reproduktionstoksicitet karakteriseret ved nedsatte fertilitetsrater og testikelatrofi.
English: If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (may indicate a blood clot in the blood vessels of the lungs)
Danish: Hvis De pludselig får åndenød, stærke smerter i brystet eller hoste med blodigt spyt(dette kan betyde, at der er en blodprop i en af lungernes blodårer).
English: For instructions on reconstitution and dilution of CIAMBRA before administration, see section 6.6.
Danish: For instruktioner vedrørende rekonstitution og fortynding af CIAMBRA før administration, se pkt.
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Danish: Farmakoterapeutisk gruppe: antineoplastiske stoffer, folsyreanaloger, ATC-kode L01BA04
English: Concomitant administration of substances that are also tubularly secreted (e.g. probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Danish: Samtidig administration af præparater, som også udskilles tubulært (f.eks. probenecid, penicillin), kan resultere i en forsinket clearance af pemetrexed.
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: 95 % CI for HR Non-inferiority p-value (HR)
Danish: P-værdi for non-inferioritet (HR)
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 10 minutter.
English: All patients were diagnosed with Stage IIIB or IV NSCLC and had received prior platinumbased chemotherapy.
Danish: Alle patienter var diagnosticeret med NSCLC stadie IIIB eller IV og havde forud fået platinbaseret kemoterapi.
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 CIAMBRA.
Danish: Hvis De har eller tidligere har haft nyreproblemer, skal De tale med Deres læge eller hospitalsapoteket, da De muligvis ikke må få CIAMBRA.
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 vaccinesygdom med dødelig udgang (se pkt.
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 mg) i ugen op til indgift af den første dosis pemetrexed og herefter én gang hver tredje cyklus.
English: CIAMBRA 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: De kan blive ordineret CIAMBRA, hvis De har fremskreden lungekræft, og Deres sygdom har reageret på behandling, eller hvis den stort set er uforandret efter den indledende kemoterapibehandling.
English: Treatment with CIAMBRA should be discontinued if a patient experiences any haematologic or nonhaematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Danish: Behandlingen med CIAMBRA skal afbrydes, hvis patienten efter 2 dosisreduktioner oplever hæmatologisk eller ikke-hæmatologisk toksicitet af grad 3 eller 4 eller omgående, hvis der observeres neurotoksicitet af grad 3 eller 4.
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 af trombocyttal.
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).
Danish: Hvis De bløder fra gummer, næse eller mund eller anden blødning, som ikke vil stoppe, rødlig eller lyserødlig urin, uventede blå mærker (fordi De muligvis har færre blodplader end normalt).
English: Frequency estimate: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to<1/100), Rare (≥1/10,000 to<1/1000), Very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: Hyppighed: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til <1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Frequency estimate: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: Hyppighed: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Kaplan Meier plots of overall survival by histology
Danish: Kaplan Meier-kurver for overlevelse (overall survival - OS) efter histologi
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 experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal).
Danish: Hvis De føler træthed, svimmelhed, hurtigt mister vejret, eller hvis De er bleg (fordi De muligvis har mindre hæmoglobin end normalt).
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), CIAMBRA should be withheld until resolution to less than or equal to the patient's pre-therapy value.
Danish: Hvis patienter udvikler ikke-hæmatologisk toksicitet ≥ grad 3 (undtagen neurotoksicitet), skal behandlingen med CIAMBRA seponeres, indtil patientens værdier er nået ned på eller under niveauet fra før behandlingen.
English: CIAMBRA in combination with cisplatin
Danish: CIAMBRA i kombination med cisplatin
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 ekstremitetsnekroser.
English: Common side effects (may affect up to 1 in 10 people) Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Danish: Almindelige bivirkninger (som kan berøre op til 1 ud af 10) Allergisk reaktion: udslæt/en brændende eller prikkende fornemmelse Infektion, inklusive sepsis (blodforgiftning) Feber
English: CIAMBRA (pemetrexed) is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Danish: CIAMBRA (pemetrexed) er et bredspektret anti-cancer-anti-folat, som virker ved at forstyrre de centrale folatafhængige metaboliske processer, der er afgørende for celledannelsen.
English: If particulate matter is observed, do not administer.
Danish: Hvis der observeres partikler, må opløsningen ikke administreres.
English: Sepsis, sometimes fatal, has been commonly reported during clinical trials with pemetrexed.
Danish: Sepsis, sommetider dødelig, blev almindeligt rapporteret i kliniske studier med pemetrexed.
English: Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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 virkning i overensstemmelse med NSCLC's histologi.
English: - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of CIAMBRA
Danish: hvis De er overfølsom (allergisk) over for pemetrexed eller et af de øvrige indholdsstoffer i CIAMBRA (angivet i punkt 6).
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,der er behandlet med pemetrexed:
English: Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Danish: Hvis De tager medicin mod smerter eller inflammation (betændelse/hævelse), såsom såkaldte nonsteroide anti-inflammatoriske lægemidler (NSAID-præparater), herunder ikke-receptpligtig medicin (som f.eks. ibuprofen), skal De fortælle det til lægen.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. det er praktisk taget fri for natrium.
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Parenterale lægemidler bør kontrolleres visuelt for partikler og misfarvning før administration.
English: Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration.
Danish: Parenterale lægemidler skal kontrolleres visuelt for partikler og misfarvning før administration.
English: There are insufficient data on the use of pemetrexed in patients with creatinine clearance below 45 ml/min; therefore the use of pemetrexed is not recommended (see section 4.4).
Danish: Der foreligger ikke tilstrækkelige data om anvendelse af pemetrexed til patienter med en kreatininclearance under 45 ml/min., og pemetrexed anbefales derfor ikke til disse patienter (se pkt.
English: You must contact your doctor immediately if you notice any of the following: Fever or infection: 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).
Danish: Feber eller infektion: Hvis Deres temperatur er 38 °C eller højere, hvis De sveder eller viser andre tegn på infektion (fordi De muligvis har færre hvide blodlegemer end normalt).
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 2 studier JMEN (vedligeholdelsesbehandling med pemetrexed (n=663)) og PARAMOUNT (induktionsbehandling med pemetrexed efterfulgt af vedligeholdelsesbehandling med pemetrexed (n=539)).
English: Women must use effective contraception during treatment with CIAMBRA.
Danish: Kvinder skal anvende effektive svangerskabsforebyggende midler under behandlingen med CIAMBRA.
English: The pharmacokinetic properties of pemetrexed are not influenced by concurrently administered cisplatin.
Danish: De farmakokinetiske egenskaber for pemetrexed påvirkes ikke af samtidig administration af cisplatin.
English: Very common
Danish: Meget Almindelig
English: Pemetrexed has a steady-state volume of distribution of9 l/m2.
Danish: Pemetrexed har et steady state-fordelingsvolumen på 9 l/m².
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 =
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 har fået docetaxelbehandling (n=540).
English: NSCLC, maintenance treatment:
Danish: NSCLC, vedligeholdelsesbehandling
English: Instructions for use, handling and disposal.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale Instruktioner vedrørende anvendelse, håndtering samt bortskaffelse.
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: Dose of CIAMBRA (mg/m
Danish: Dosis CIAMBRA (mg/m²)
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 2 proteintransportsystemer: den reducerede folatbærer og membranens folatbindingsprotein.
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 enkeltstofbehandling (n=164) og det fase 3-enkeltstofstudie med pemetrexed, som er beskrevet ovenfor, med undtagelse af neutropeni (12,8 % versus 5,3 %) og forhøjet alaninaminotransferase (15,2 % versus 1,9 %).
English: Nadir platelets <50,000 /mm regardless of nadir ANC
Danish: Nadir for trombocytter < 50.000 /mm uanset ANC-nadir
English: Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection.
Danish: Pemetrexed er inkompatibel med opløsningsvæsker, der indeholder calcium, herunder lakteret Ringer's opløsning og Ringer's opløsning.
English: When using CIAMBRA in combination with cisplatin:
Danish: Når CIAMBRA tages sammen med cisplatin:
English: A hospital pharmacist, nurse or doctor will have mixed the CIAMBRA powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Danish: Hospitalsapoteket, lægen eller sygeplejersken blander på forhånd CIAMBRA-pulveret med natriumchloridinjektionsvæske 9 mg/ml (0,9 %), før det indgives til Dem.
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 pretreatment with folic acid and vitamin B12 was administered.
Danish: Der blev observeret en mindre toksicitet og en reduktion i antallet af hæmatologiske og ikkehæmatologiske toksiciteter 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: Extremity pain, low temperature and discolouration have been reported.
Danish: Smerter i arme og ben, lav temperatur og misfarvning er indberettet.