natgillin/translations-raw huggingface dataset:
Pemetrexed Sandoz er et pulver til koncentrat til infusionsvæskeopløsning i hætteglas.
Pemetrexed Sandoz is a powder for concentrate for solution for infusion in a glass vial.
Vitamintilskud: Du skal tage en folsyretablet eller en multivitamin indeholdende folsyre (3501000 mikrogram) 1 gang dagligt, mens du tager Pemetrexed Sandoz.
Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking Pemetrexed Sandoz.
Bulløse tilstande (hudsygdomme med blæredannelser), inklusive Stevens-Johnson syndrom og toksisk epidermal nekrolyse.
• Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis
Kemisk og fysisk stabilitet af Pemetrexed Sandoz rekonstitueret opløsning er påvist i 4 dage ved 2-8 °C og i 4 dage under 25° C.
Chemical and physical in-use stability of reconstituted solutions of Pemetrexed Sandoz has been demonstrated for 4 days at 2°C to 8°C and for 4 days below 25°C.
Almindelig Dehydrering Meget almindelig
Common Dehydration
De forventede komplikationer ved overdosering omfattede knoglemarvshæmning, som ytrede sig ved neutropeni, trombocytopeni og anæmi.
Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia, and anaemia.
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev rapporteret hos >5 % af 265 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed og tilskud af folsyre og B12-vitamin, og 276 patienter, som var randomiseret til enkeltstofbehandling med docetaxel.
The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single-agent pemetrexed with folic acid and vitamin B12 supplementation, and 276 patients randomly assigned to receive single-agent docetaxel.
Nedsat neutrofiler/ granulocyter
Neutrophils/Granulocyte s decreased
Det er ikke relevant at bruge pemetrexed til malignt pleuramesoteliom og ikke-småcellet lungecancer i den pædiatriske population.
Paediatric population: There is no relevant use of pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Til patienter, der behandles for ikke-småcellet lungecancer efter tidligere behandling med kemoterapi, er den anbefalede dosis af Pemetrexed Sandoz 500 mg/m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
Pemetrexed Sandoz as single agent In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
AC: Pemetrexed + Cisplatin GC: Gemcitabin + Cisplatin
Pemetrexed + Cisplatin Gemcitabine + Cisplatin
PARAMOUNT: Kaplan Meier-kurver for progressionsfri overlevelse (PFS) og total overlevelse (OS, overall survival) for pemetrexed-induktionsbehandling efterfulgt af pemetrexed- vedligeholdelsesbehandling vs. placebo hos patienter med NSCLC bortset fra cancer hovedsagelig bestående af pladeepitelceller (målt fra randomiseringen)
PARAMOUNT: Kaplan-Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
En analyse af virkningen på NSCLCs histologi for behandlingens virkning på overlevelse var til fordel for Pemetrexed versus docetaxel bortset fra cancerformer hovedsageligt bestående af pladeepitelceller (n=399; 9,3 versus 8,0 måneder, justeret HR= 0,78; 95 % CI= 0,61-1,00; p= 0,047) og til fordel for docetaxel for carcinom af pladeepitelceller (n= 172; 6,2 versus 7,4 måneder, justeret HR = 1,56; 95 % CI= 1,08- 2,26; p= 0,0018).
An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (N = 399, 9.3 versus 8.0 months, adjusted hazard ratio (HR) = 0.78; 95% CI = 0.61-1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (N =172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95% CI = 1.08-2.26, p = 0.018).
Pemetrexed er inkompatibelt med fortyndinger indeholdende calcium, herunder Ringers-laktat-injektion og
Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection.
Når Pemetrexed Sandoz tages sammen med cisplatin:
When using Pemetrexed Sandoz in combination with cisplatin:
Nadir for trombocytter < 50.000/ mm3 med blødninga uanset ANC-nadir
Nadir platelets < 50,000/mm3 with bleedinga, regardless of nadir ANC
Lever: abnorme blodprøveresultater Rindende øjne
• Liver: abnormal blood tests
EU/1/15/1037/002
EU/1/15/1037/001 EU/1/15/1037/002 EU/1/15/1037/003
Den anbefalede dosis af pemetrexed er 500 mg/m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
The recommended dose of pemetrexed is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Almindelig Nedsat trombocytter Diarré
Common Platelets decreased Diarrhoea
Intravenøs brug efter rekonstitution og fortynding
Intravenous use after reconstitution and dilution
Amningen skal afbrydes under behandling med Pemetrexed Sandoz.
Breast-feeding must be discontinued during Pemetrexed Sandoz treatment.
Pemetrexed Sandoz er også en behandling, som gives i kombination med cisplatin, som indledende behandling af patienter med fremskreden lungecancer.
Pemetrexed Sandoz is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Pemetrexed Sandoz er også en behandling til patienter med fremskreden lungekræft, hvor sygdommen har udviklet sig, efter anden indledende behandling med kemoterapi har været forsøgt.
Pemetrexed Sandoz is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1000 mg
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 mg
NSCLC, 1. linje-behandling Et randomiseret, åbent, fase3-multicenterstudie afpemetrexedpluscisplatin mod gemcitabin plus cisplatin med patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (fase IIIb eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n=865) mødte dets primære endepunkt og viste lignende klinisk virkning som gemcitabin plus cisplatin (ITT n=863) på total overlevelse (justeret hazard ratio 0,94; 95 % CI = 0,84-1,05).
A multi-centre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population N = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT N = 863) in overall survival (adjusted hazard ratio (HR) 0.94; 95% CI= 0.84-1.05).
Median-tiden fra start af pemetrexed og cisplatininduktionsbehandling til start af vedligeholdelsesbehandling var 2,96 måneder i både pemetrexed- og placeboarmen.
The median time from the start of pemetrexed plus cisplatin induction therapy to the start of maintenance treatment was 2.96 months on both the pemetrexed arm and the placebo arm. Randomised patients received maintenance treatment until disease progression.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 500 mg
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
Pemetrexed Sandoz 1000 mg indeholder 108 mg natrium pr. hætteglas.
Pemetrexed Sandoz 1000 mg contains 108 mg sodium per vial.
Patienter med let til moderat nyreinsufficiens (kreatinin-clearance på 45-79 ml/min) 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 dagen for og i mindst 2 dage efter indgift af pemetrexed (se pkt.
Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (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).
Nedsat leukocytter
Leucocytes decreased
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 (trin IIIB) eller metastatisk (trin IV) ikke-småcellet lungecancer (NSCLC), som ikke fik bedring efter 4 serier med 1. linje-dubletbehandling bestående af cisplatin eller carboplatin sammen med gemcitabin, paclitaxel eller docetaxel.
A multi-centre, 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.
Nedsat neutrofiler
Neutrophils decreased
Pemetrexed Sandoz 500 mg indeholder 54 mg natrium pr. hætteglas.
Pemetrexed Sandoz 500 mg contains 54 mg sodium per vial.
Diarré
• Diarrhoea
Pemetrexed Sandoz 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.
Pemetrexed Sandoz 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).
Målt fra starttidspunktet for pemetrexed plus cisplatin førstelinje-induktionsbehandling var den mediane overlevelse 16,9 måneder for pemetrexedarmen og 14,0 måneder for placebo-armen (hazard ratio= 0,78, 95 % CI= 0,64-0,96).
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).
Den passende mængde rekonstitueret pemetrexedopløsning skal fortyndes yderligere til 100 ml med 0,9% natriumchlorid-injektionsvæske (uden konserveringsmiddel) eller med glucose-injektionsvæske 50 mg/ml (5%) (uden konserveringsmiddel), og indgives som langsom intravenøs infusion over 10 minutter.
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative) or with glucose 50 mg/ml (5%) solution for injection (without preservative) and administered as an intravenous infusion over 10 minutes.
Studiets primære endepunkt blev mødt og viste en statistisk signifikant forbedring i PFS i pemetrexed - armen over for placebo-armen (n = 472, uafhængigt evalueret population; median på henholdsvis 3,9 måneder og 2,6 måneder) (hazard ratio = 0,64; 95% CI = 0,51-0,81; p = 0,0002).
The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
Hurtig puls
• Fast heart rate
Tabel 3 - Dosisjustering for Pemetrexed Sandoz (som enkeltstof eller i kombination) og cisplatin - neurotoksicitet
Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Neurotoxicity
Den gennemsnitlige overlevelse (OS, overall survival) for den totale population (n = 663) var 13,4 måneder for pemetrexed-delen og 10,6 måneder for placebodelen, hazard ratio = 0,79 (95% CI = 0,65- 0,95; p = 0,01192).
The median OS for the overall population (N = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI= 0.65-0.95, p = 0.01192).
Median-tid til tumorprogression (måneder) (95 %-CI)
Median time to tumour progression (months)
Mænd rådes til ikke at gøre en kvinde gravid hverken under eller i op til 6 måneder efter behandlingen med Pemetrexed Sandoz.
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Sandoz and should therefore use effective contraception during treatment with Pemetrexed Sandoz and for up to 6 months afterwards.
Hos patienter med let til moderat nyreinsufficiens (kreatinin-clearance 45-79 ml/min) bør samtidig administration af pemetrexed og NSAID-præparater (for eksempel ibuprofen) eller acetylsalicylsyre i højere doser undgås 2 dage inden, på behandlingsdagen og i mindst 2 dage efter indgift af pemetrexed (se pkt.
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).
Se indlægssedlen for yderligerer information.
See package leaflet for further information.
Efter rekonstitution indeholder hvert hætteglas 25 mg/ml pemetrexed.
After reconstitution each vial contains 25 mg/ml of pemetrexed.
Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase;
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.
Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring i PFS i pemetrexed- delen i forhold til placebodelen (n = 581, en uafhængig overvåget population, gennemsnit på henholdsvis 4 måneder og 2 måneder) (hazard ratio = 0,60, 95% CI = 0,49-0,73; p < 0,00001).
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).
Et multi-center, randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie (PARAMOUNT) sammenlignede virkningen og sikkerheden af fortsat vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC, Best Supportive Care) (Nn=359) med placebo plus BSC (n=180) hos patienter med lokalt fremskreden (stadium IIIB) eller metastaserende (stadium IV) ikke-småcellet lungecancer (NSCLC) bortset fra cancer hovedsageligt bestående af pladeepitelceller, som ikke progredierede efter 4 serier med 1. linjedubletbehandling bestående af pemetrexed i kombination med cisplatin.
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.
Domaniewska 50C
Domaniewska 50C 02-672 Warszawa
Den uafhængige evaluering af patienternes skanninger bekræftede investigatorernes vurdering af PFS. Investigatorernes mediane 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%
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 = 0.47-0.74).
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.
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.
Under kliniske studier med pemetrexed er der ikke almindeligt rapporteret om svære kardiovaskulære hændelser herunder myokardieinfarkt og cerebrovaskulære hændelser sædvanligvis når pemetrexed gives i kombination med et andet cytotoksisk lægemiddelstof.
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.
Tabel 1 - Dosisjustering for Pemetrexed Sandoz (som enkeltstof eller i kombination) og cisplatin - hæmatologisk toksicitet
Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Haematologic toxicities
Nedsat hæmoglobin Nedsat leukocytter
Haemoglobin decreased Leucocytes decreased
Meget almindelige (kan forekomme hos flere end l ud af 10 behandlede) Lavt antal hvide blodlegemer
Very common (may affect more than 1 in 10 people)
02-672 Warszawa Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Træthed Smerte
Fatigue Pain
Respons (n: kvalificeret til respons) Responsrate (%) (95 %-CI) Stabilsygdom(%)
• Response rate (%) (95% CI)
Progressionsfri overlevelse (PFS) og størrelsen af det totale respons var ens mellem de to behandlingsarme: Middel PFS var 4,8 måneder for pemetrexed plus cisplatin mod 5,1 måneder for gemcitabin plus cisplatin (justeret hazard ratio 1.04; 95 % CI = 0,94-1,15) og det totale respons var
Progression-free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio (HR) 1.04; 95% CI= 0.94-1.15), and overall response rate was 30.6% (95% CI= 27.3- 33.9) for pemetrexed plus cisplatin versus 28.2% (95% CI= 25.0-31.4) for gemcitabine plus cisplatin.
Sådan skal du bruge Pemetrexed Sandoz
How to use Pemetrexed Sandoz
Pemetrexed Sandoz er indiceret til behandling af kemoterapinaive patienter med inoperabelt malignt pleuramesoteliom i kombination med cisplatin.
Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
For patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 430), uafhængig overvåget population) var middel PFS 4,4 måneder for pemetrexed-delen og 1,8 måneder for placebodelen, hazard ratio = 0,47, 95% CI = 0,37-0,60; p=0,00001.
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 =
Meget almindelig Alopeci Forhøjet kreatininniveau
Very common Alopecia
De klinisk relevante CTC-toksiciteter 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 konjunktivitis), øget tåreflåd, svimmelhed og motorisk neuropati.
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, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Pemetrexed Sandoz 500 mg pulver til koncentrat til infusionsvæske, opløsning Lægemiddelet indeholder 54 mg natirum pr. hætteglas.
Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion This medicinal product contains 54 mg sodium per vial.
Øget koncentration af natrium i blodet (hypernatriæmi)
• Hypernatraemia - increased sodium in blood
Patienten skal have modtaget passende antiemetisk behandling og relevant hydrering inden og/eller efter indgift af cisplatin.
Patients must receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving cisplatin (see also cisplatin Summary of Product Characteristics for specific dosing advice).
● Hvis du har smerter, rødmen, hævelse eller sår i munden (meget almindelig).
• If you have pain, redness, swelling or sores in your mouth (very common).
Nedsat hæmoglobin
Granulocytes decreased
Tid til behandlingssvigt (måneder) (95 %-CI)
Time to treatment failure (months)
Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder ca. 108 mg natrium.
Excipient with known effect Each vial contains approximately 108 mg sodium.
Almindelig Nyresygdomme****
Renal Disorders Common Renal disorders****
Pemetrexed Sandoz 100 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Sandoz 500 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Sandoz 1000 mg pulver til koncentrat til infusionsvæske, opløsning
Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder ca. 11 mg natrium.
Excipient with known effect Each vial contains approximately 11 mg sodium.
Pemetrexed Sandoz 1000 mg pulver til koncentrat til infusionsvæske, opløsning Lægemiddelet indeholder 108 mg natirum pr. hætteglas.
Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion This medicinal product contains 108 mg sodium per vial.
Pemetrexed anbefales derfor ikke til patienter med en kreatinin-clearance på < 45 ml/min
Therefore, the use of pemetrexed in patients with creatinine clearance of < 45ml/min is not recommended (see section 4.2).
Overlevelsestid (måneder) Median (m)
Survival time (months)
Effekt af pemetrexed sammen med cisplatin versus cisplatin alene til patienter med malignt pleuramesoteliom
Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma
Ved at inkludere induktionsfasen blev middel OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller 18,6 måneder for Pemetrexed Sandozdelen og 13,6 måneder for placebodelen (hazard ratio=0,71, 95% CI = 0,56 - 0,88, p=0,002).
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).