FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with mild to moderate renal insufficiency eligible for pemetrexed therapy NSAIDs with long elimination half-lives should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).
Danish: Hos patienter med let til moderat nyreinsufficiens, som er egnet til behandling med pemetrexed, skal behandling med NSAID-præparater med en lang halveringstid afbrydes mindst 5 dage før, på selve dagen og i mindst 2 dage efter indgift af pemetrexed (se pkt.
English: **According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
Danish: ** I henhold til National Cancer Institute CTC (v2.0; NCI 1998), bør alopeci kun rapporteres som grad 1eller 2.
English: What Pemetrexed Fresenius Kabi is and what it is used for What you need to know before you use Pemetrexed Fresenius Kabi How to use Pemetrexed Fresenius Kabi Possible side effects
Danish: Det skal du vide, før du begynder at bruge Permetrexed Fresenius Kabi Sådan skal du bruge Permetrexed Fresenius Kabi Bivirkninger
English: Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Fresenius Kabi and should therefore use effective contraception during treatment with Pemetrexed Fresenius Kabi and for up to 6 months afterwards.
Danish: Mænd rådes til ikke at gøre en kvinde gravid hverken under eller i op til 6 måneder efter behandlingen med Pemetrexed Fresenius Kabi.
English: Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1).
Danish: Pemetrexed Fresenius Kabi er indiceret som monoterapi til vedligeholdelsesbehandling af lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller, hos patienter, hvis sygdom ikke har vist progression umiddelbart efter platinbaseret kemoterapi (se pkt.
English: Extravasation should be managed by local standard practice as with other nonvesicants.
Danish: Som med andre ikke-blæretrækkende stoffer skal eventuel ekstravasation håndteres i henhold til lokal standardpraksis.
English: Side effects with Pemetrexed Fresenius Kabi may include:
Danish: Pemetrexed Fresenius Kabi indeholder:
English: Patients in both study arms were fully supplemented with folic acid and vitamin B12.
Danish: Patienterne i begge behandlingsgrupper fik fuldstændigt dækkende tilskud af folsyre og B12-vitamin.
English: Table 1 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin- Haematologic toxicities
Danish: Tabel 1 - Dosisjustering for pemetrexed (som monoterapi eller i kombination) og cisplatinHæmatologisk toksicitet
English: How to use Pemetrexed Fresenius Kabi
Danish: Sådan skal du bruge Pemetrexed Fresenius Kabi
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (n = 441) with that of placebo plus BSC (n = 222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first line doublet therapy containing cisplatin or carboplatin in combination with gemcitabine, paclitaxel, or docetaxel.
Danish: Et randomiseret, dobbeltblindt, placebokontrolleret fase 3-multicenterstudie (JMEN) sammenlignede virkning og sikkerhed af vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC) (n = 441) med placebo plus BSC (n = 222) hos patienter med lokalt fremskreden (stadie IIIB) eller metastatisk (stadie IV) ikke-småcellet lungecancer (NSCLC), som ikke var i bedring efter 4 serier med førstevalg dubletbehandling bestående af cisplatin eller carboplatin plus gemcitabin, paclitaxel eller docetaxel.
English: Low haemoglobin level (anaemia) Low platelet count
Danish: Lavt hæmoglobin niveau (blodmangel) Lavt antal blodplader
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60, 95% CI = 0.49-0.73, p < 0.00001).
Danish: Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring i PFS i pemetrexedarmen i forhold til placebo-armen (n = 581, en uafhængig overvåget population; gennemsnit på hhv. 4 måneder og 2 måneder) (hazard ratio = 0,60, 95 % CI = 0,49-0,73; p < 0,00001).
English: Table 3 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin-Neurotoxicity
Danish: Tabel 3 - Dosisjustering for pemetrexed (som monoterapi eller i kombination) og cisplatinNeurotoksicitet
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Danish: *** I henhold til National Cancer Institute CTC (v2.0; NCI 1998), smagsforstyrrelser og alopeci bør kun rapporteres som grad 1 eller 2.
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Danish: Målt fra starttidspunktet for pemetrexed plus cisplatin førstevalgs-induktionsbehandling var median overlevelsen 16,9 måneder for pemetrexed-armen og 14,0 måneder for placebo-armen (hazard ratio= 0,78, 95 % CI= 0,64-0,96).
English: For patients with NSCLC other than predominantly squamous cell histology (n = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p = 0.00001).
Danish: For patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 430), uafhængig overvåget population) var middel PFS 4,4 måneder for pemetrexed-armen og 1,8 måneder for placebo-armen, hazard ratio = 0,47, 95 % CI =0,37-0,60; p=0,00001.
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Danish: De klinisk relevante CTC-toksiciteter, som blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, der var randomiseret til pemetrexed, omfattede: infektion uden neutropeni, febril neutropeni, allergisk reaktion/overfølsomhed, forhøjet kreatinin, motorisk neuropati, sensorisk neuropati, erythema multiforme og mavesmerter.
English: For precautions to be taken before handling or administering Pemetrexed Fresenius Kabi, see section 6.6.
Danish: For information om sikkerhedsforanstaltninger, der skal tages før håndtering og administration af Pemetrexed Fresenius Kabi, se pkt.
English: Clinically relevant toxicity that was reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Danish: Klinisk relevant toksicitet, som blev rapporteret hos < 1% af de patienter, som blev randomiseret til at få cisplatin og pemetrexed, omfattede: forhøjet GGT, brystsmerter, arytmier og motorisk neuropati.
English: Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion Pemetrexed Fresenius Kabi 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Fresenius Kabi 100 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Fresenius Kabi 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomised and treated patients
Danish: Effekt af pemetrexed plus cisplatin versus cisplatin alene Til patienter med malignt pleuramesoteliom
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Fresenius Kabi is 500 mg/m
Danish: Til patienter, der behandles for ikke-småcellet lungecancer efter tidligere behandling med kemoterapi, er den anbefalede dosis af Pemetrexed Fresenius Kabi 500 mg/m legemsoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
English: After reconstitution, each vial contains 25 mg/ml of pemetrexed.
Danish: Efter rekonstitution indeholder hvert hætteglas 25 mg/ml pemetrexed.
English: 50 % of previous dose 100 % of previous dose a
Danish: 100 % af tidligere dosis a
English: When prepared as directed, chemical and physical in-use stability of reconstituted solution of pemetrexed was demonstrated for 24 hours at refrigerated temperature.
Danish: Hvis produktet er forberedt som angivet, har rekonstiturerede opløsninger af pemetrexed vist sig at have en kemisk og fysisk i-brug stabilitet på 24 timer ved køleskabstemperatur.
English: Pemetrexed Fresenius Kabi 100 mg:
Danish: Permetrexed Fresenius Kabi 100 mg:
English: Nadir platelets < 50,000 /mm regardless of nadir ANC
Danish: Nadir for trombocytter < 50.000 /mm uanset
English: Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Danish: Pemetrexed Fresenius Kabi er indiceret til behandling af kemoterapinaive patienter med inoperabelt malignt pleuramesoteliom i kombination med cisplatin.
English: Each vial contains 100 mg of pemetrexed (as pemetrexed diacid).
Danish: Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddiacid).
English: regardless of nadir ANC
Danish: ANC-nadir
English: Serious cardiovascular events, including myocardial infarction and cerebrovascular events have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Danish: Under kliniske studier med pemetrexed, er der, ikke almindeligt, rapporteret om alvorlige kardiovaskulære hændelser, herunder myokardieinfarkt og cerebrovaskulære hændelser, sædvanligvis når pemetrexed gives i kombinationsbehandling med andre cytostatika.
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Danish: Klinisk relevant CTC-toksicitet af enhver grad, der blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, som var randomiseret til pemetrexed, omfatter: febril neutropeni, infektion, nedsat antal blodplader, diarré, forstoppelse, alopeci, kløe, feber (uden neutropeni), sygdom i øjets overflade (inklusive konjunctivitis), øget tåreflåd, svimmelhed og motorisk neuropati.
English: Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving Pemetrexed Fresenius Kabi usually in combination with another anticancer therapy.
Danish: Interstitiel lungebetændelse (tør hoste uden slim pga. betændelse i lungernes bindevæv) Ødemer (væskeophobning i væv, som medfører hævelse) Nogle patienter har oplevet et hjertetilfælde, et slagtilfælde eller et ”mini-slagtilfælde”, mens de har fået Permetrexed Fresenius Kabi, sædvanligvis i kombination med anden kræftbehandling.
English: Each vial contains 500 mg of pemetrexed (as pemetrexed diacid).
Danish: Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddiacid).
English: Pemetrexed Fresenius Kabi as single agent
Danish: Pemetrexed Fresenius Kabi givet alene
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, folsyreanalog.
English: Constipation Common Dyspepsia
Danish: Almindelig Dyspepsi
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Danish: Klinisk relevant toksicitet, som blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: forhøjet ASAT, forhøjet ALAT, infektion, febril neutropeni, nyresvigt, pyreksi, dehydrering, konjunktivitis og nedsat kreatinin-clearance.
English: Common Dyspepsia/ Heartburn
Danish: Almindelig Dyspepsi/halsbrand
English: NeuropathySensory
Danish: Sensorisk neuropati
English: Chemical and physical in-use stability of reconstituted solutions of pemetrexed was demonstrated for 24 hours at refrigerated temperature.
Danish: Rekonstituerede opløsninger af pemetrexed har vist sig at have en kemisk og fysisk holdbarhed på 24 timer ved køleskabstemperatur.
English: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Danish: Forsigtighedsregler i forbindelse med forberedelse og administration Som med et hvilket som helst andet potentielt toksisk lægemiddel til behandling af cancer, skal der udvises forsigtighed ved håndtering og forberedelse af infusionsopløsninger af pemetrexed.
English: A multi-centre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (N = 359) with that of placebo plus BSC (N = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first-line doublet therapy of pemetrexed in combination with cisplatin.
Danish: Et multi-center, randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie (PARAMOUNT) sammenlignede virkningen og sikkerheden af fortsat vedligeholdelsesbehandling med pemetrexed plus BSC (n=359) med placebo plus BSC (n=180) hos patienter med lokalt fremskreden (stadie IIIB) eller metastaserende (stadie IV) ikke-småcellet lungecancer (NSCLC), bortset fra cancer hovedsageligt bestående af pladeepitelceller, som ikke var i bedring efter 4 serier med førstevalgs-dubletbehandling, bestående af pemetrexed i kombination med cisplatin.
English: Common Leukocytes decreased
Danish: Fald i hæmoglobin Almindelig Fald i leukocytter
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Danish: De klinisk relevante CTC-toksiciteter, som blev rapporteret hos ≥ 1 % og ≤ 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: nyresvigt, infektion, pyreksi, febril neutropeni, forhøjet ASAT, ALAT og GGT, nældefeber og brystsmerter.
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N= 539) studies.
Danish: Bivirkningerne blev rapporteret hos > 5 % af de 800 patienter, som var randomiseret til monoterapi med pemetrexed og 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN: N=663) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: N=539).
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Danish: Ved at inkludere induktionsfasen blev middel OS for patienter med NSCLC, bortset fra cancer hovedsageligt bestående af pladeepitelceller, 18,6 måneder for pemetrexed-armen og 13,6 måneder for placeboarmen (hazard ratio=0,71, 95 % CI = 0,56 - 0,88, p=0,002).
English: Squamous cell (N=473)
Danish: Pladeepitelceller (n = 473)
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Danish: Den gennemsnitlige OS for patienter med NSCLC, bortset fra cancer hovedsageligt bestående af pladeepitelceller, (n = 481) var 15,5 måneder for pemetrexed-armen og 10,3 måneder for placeboarmen (hazard ratio = 0,70, 95 % CI = 0,56 - 0,88, p = 0,002).
English: Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: Pemetrexed Fresenius Kabi er indiceret til behandling sammen med cisplatin, som 1. linje-behandling til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory medicinal product (NSAIDs) such as ibuprofen, and acetylsalicylic acid (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Danish: skal undgå at tage non-steroide anti-inflammatoriske lægemidler (NSAID-præparater) såsom ibuprofen og acetylsalicylsyre (>1,3 g daglig) i mindst 2 dage før, på selve dagen og i mindst 2 dage efter indgift af pemetrexed (se pkt.
English: Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: Pemetrexed Fresenius Kabi er indiceret som 2. linjes monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Children and adolescents There is no relevant use of Pemetrexed Fresenius Kabi in the paediatric population
Danish: Børn og unge Det er ikke relevant at bruge Pemetrexed til børn og unge.
English: In patients with normal renal function (creatinine clearance > 80 ml/min), high doses of non-steroidal anti-inflammatory medicinal product (NSAIDs, such as ibuprofen > 1600 mg/day)
Danish: Hos patienter med normal nyrefunktion (kreatinin-clearance ≥ 80 ml/min.)
English: What Pemetrexed Fresenius Kabi looks like and contents of the pack Pemetrexed Fresenius Kabi is a powder for concentrate for solution for infusion in a glass vial.
Danish: Pemetrexed Fresenius Kabi er et pulver til koncentrat til infusionsvæske, opløsning i hætteglas.
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with Pemetrexed Fresenius Kabi / radiation therapy.
Danish: Betændelse i spiserørets overflade er forekommet med Pemetrexed Fresenius Kabi i kombination med strålebehandling.
English: Talk to your doctor or hospital pharmacist before receiving Pemetrexed Fresenius Kabi.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Pemetrexed Fresenius Kabi.
English: Pharyngitis
Danish: Mavegener
English: Reconstitute 500-mg vials with 20 ml of 5% glucose intravenous infusion resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Rekonstituér 500 mg hætteglas med 20 ml 5% glucose infusionsvæske, som vil resultere i en opløsning indeholdende 25 mg/ml pemetrexed.
English: Leukocytes decreased
Danish: Nedsat føleevne
English: Taste disturbance 8.1 0.0*** 8.9 0.0***
Danish: ATC-kode: L 01 BA 04.
English: Reconstitute 100-mg vials with 4.2 ml of 5% glucose intravenous infusion resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Rekonstituér 100 mg hætteglas med 4,2 ml 5% glucose infusionsvæske, som vil resultere i en opløsning indeholdende 25 mg/ml pemetrexed.
English: Stomatitis/
Danish: Udslæt
English: Time to treatment failure (TTTF - months) ▪ Median ▪ HR (95% CI)
Danish: Tid til behandlingssvigt (TTTF - måneder)
English: Median time to tumour progression (months) (95% CI)
Danish: Log Rank p-værdi* Median tid til tumorprogression (måneder) (95 % CI)
English: If you have heart disease or a history of heart disease, please tell your doctor.
Danish: Fortæl din læge, hvis du har en hjertesygdom eller tidligere har haft en hjertesygdom.
English: Leukocytes decreased Haemoglobin decreased Platelets decreased
Danish: Fald i neutrophiler/ granulocytter Fald i leukocytter Fald i hæmoglobin Fald i trombocytter
English: Event**
Danish: <{MM/ÅÅÅÅ}>
English: Common SGPT (ALT) elevation
Danish: Almindelig Forstoppelse Lever og galdeveje Almindelig ALAT-øgning ASAT-øgning
English: Constipation Stomatitis/
Danish: Udslæt/hudafskalning
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: FREMSTILLERENS BATCHNUMMER<, DONATIONS- OG PRODUKTKODER>
English: Upset stomach
Danish: Øjenbetændelse
English: Pemetrexed Fresenius Kabi 500 mg powder for concentrate for solution for infusion
Danish: Pemetrexed Fresenius Kabi 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min), the concomitant administration of pemetrexed with NSAIDs (e.g. ibuprofen) or acetylsalicylic acid at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Danish: bør samtidig administration af pemetrexed og NSAID-præparater (f.eks. ibuprofen) eller acetylsalicylsyre i højere doser undgås 2 dage inden, på behandlingsdagen og i mindst 2 dage efter indgift af pemetrexed (se pkt.
English: Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
Danish: Pemetrexed Fresenius Kabi 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Kidney failure
Danish: Hudirritation og-kløe
English: Reconstitute each 100 mg vial with 4.2 ml of 5% glucose intravenous infusion resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 100 mg rekonstitueres med 4,2 ml 5% glucose infusionsvæske til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Reconstitute each 500 mg vial with 20 ml of 5% glucose intravenous infusion resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 500 mg rekonstitueres med 20 ml 5% glucose infusionsvæske til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in association with other chemotherapeutic agents.
Danish: Der er rapporteret om alvorlige nyrepåvirkninger, inklusiv akut nyresvigt, for pemetrexed både som monoterapi, og når det blev brugt i kombinationsbehandling med andre cytostatika.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95% CI =
Danish: Investigatorens median PFS-vurdering for de randomiserede patienter var 6,9 måneder for pemetrexed-armen og 5,6 måneder for placebo-armen (hazard ratio = 0,59; 95 % CI = 0,47-0,74) målt fra start af pemetrexed og cisplatin førstevalg-induktionsbehandling.