FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Če opazite katerega od spodaj naštetih učinkov, morate nemudoma poklicati zdravnika: - Povišana telesna temperatura ali okužba (pogosto): če se pojavi temperatura 38 ºC ali višja, znojenje ali drugi znaki okužbe (ker imate lahko manj belih krvničk kot normalno, kar je zelo pogosto).
English: Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Slovenian: aStatistično pomembna za prednost, s celotnim intervalom zaupanja za RT znatno pod 1,17645 mejo prednosti (p
English: Treatment with pemetrexed 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.
Slovenian: Zdravljenje s pemetreksedom moramo prekiniti, če bolnik izkusi kakršnokoli hematološko ali nehematološko toksičnost stopnje 3 ali 4 po 2 znižanjih odmerka ali nemudoma, če opazimo nevrološko toksičnost stopnje 3 ali 4.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo mora biti naveden izdelovalec odgovoren za sproščanje zadevne serije.
English: What you need to know before you use Armisarte Do not use Armisarte
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Armisarte Ne uporabljajte zdravila Armisarte:
English: 4 ml vial 20 ml vial 34 ml vial 40 ml vial
Slovenian: 4 ml viala 20 ml viala 34 ml viala 40 ml viala
English: Men are advised not to father a child during and up to 6 months following treatment with Armisarte and should therefore use effective contraception during treatment with Armisarte and for up to 6 months afterwards.
Slovenian: Moškim odsvetujemo, da bi v času zdravljenja z zdravilom Armisarte ter do 6 mesecev po zdravljenju s tem zdravilom spočeli otroka, zato naj v času zdravljenja z zdravilom Armisarte ter do 6 mesecev po zdravljenju s tem zdravilom uporabljajo učinkovito kontracepcijo.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, je za čase shranjevanja in pogoje pred uporabo odgovoren uporabnik, in naj bi ne presegali 24 ur pri 2 do 8°C, razen če je priprava potekala v kontroliranih in validiranih aseptičnih pogojih.
English: What Armisarte is and what it is used for What you need to know before you use Armisarte How to use Armisarte
Slovenian: Kaj je zdravilo Armisarte in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Armisarte Kako uporabljati zdravilo Armisarte Možni neželeni učinki
English: Median overall survival (months) (95% CI) Log Rank p-value* Median time to tumour progression (months) (95% CI) Log Rank p-value* Time to treatment failure (months) (95% CI) Log Rank p-value* Overall response rate** (95% CI) Fisher's exact p-value* Abbreviation: CI = confidence interval *p-value refers to comparison between arms.
Slovenian: Mediana skupnega preživetja (meseci) (95 % IZ) Log Rank p-vrednost* Mediana časa do napredovanja tumorja (meseci) (95 % IZ) Log Rank p-vrednost* Čas do neuspeha zdravljenja (meseci) (95 % IZ) Log Rank p-vrednost* Skupna stopnja odziva** (95 % IZ) Fisherjeva točna p-vrednost* Okrajšava: IZ = interval zaupanja *p-vrednost se nanaša na primerjavo med vejama zdravljenja.
English: A hospital pharmacist, nurse or doctor will have mixed the Armisarte concentrate with 5% glucose solution for injection before it is given to you.
Slovenian: Bolnišnični farmacevt, medicinska sestra ali zdravnik bo koncetrat zdravila Armisarte, preden ga boste prejeli, zmešal z 5 % raztopino glukoze za injiciranje.
English: EU/1/15/1063/001 4 ml vial EU/1/15/1063/002 20 ml vial EU/1/15/1063/004 34 ml vial EU/1/15/1063/003 40 ml vial
Slovenian: EU/1/15/1063/001 4 ml viala EU/1/15/1063/002 20 ml viala EU/1/15/1063/004 34 ml viala EU/1/15/1063/003 40 ml viala
English: Intravenous lines should be flushed after administration of Armisarte.
Slovenian: Intravenske linije je potrebno po uporabi zdravila Armisarte sprati.
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 Armisarte treatment.
Slovenian: Kortikosteroidi: zdravnik vam bo predpisal tablete steroidov (ustrezno 4 miligramom deksametazona dvakrat dnevno), ki jih boste morali jemati dan pred zdravljenjem z zdravilom Armisarte, na dan zdravljenja in na dan po zdravljenju z zdravilom Armisarte.
English: Armisarte 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.
Slovenian: Zdravnik vam lahko predpiše zdravilo Armisarte, če imate pljučni rak v napredovalem stadiju in če se vaša bolezen odziva na zdravljenje oz. če po začetni kemoterapiji ostaja večinoma nespremenjena.
English: Each pack of Armisarte contains one vial.
Slovenian: Eno pakiranje zdravila Armisarte vsebuje eno vialo.
English: ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJ(A)
English: Armisarte is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Slovenian: Zdravilo Armisarte se daje tudi v kombinaciji s cisplatinom, za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega raka.
English: Keep the vial in the outer carton to protect from light.
Slovenian: Vialo shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
English: 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 receiving Armisarte.
Slovenian: Dopolnjevanje vitaminov: zdravnik vam bo predpisal peroralno folno kislino (vitamin) ali multivitaminski pripravek, ki vsebuje folno kislino (350 do 1000 mikrogramov), ki ga boste morali med prejemanjem zdravila Armisarte jemati enkrat dnevno.
English: The appropriate volume of pemetrexed concentrate must be diluted to 100 ml with 5% glucose solution and administered as an intravenous infusion over 10 minutes.
Slovenian: Ustrezen volumen koncentrata pemetrekseda je potrebno razredčiti do 100 ml s 5 % raztopino glukoze in uporabiti kot intravensko infuzijo, ki traja 10 minut.
English: Armisarte must only be diluted with 5% glucose solution, without preservative.
Slovenian: Zdravilo Armisarte je potrebno razredčiti s 5 % raztopino glukoze brez konzervansa.
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).
Slovenian: Omejeni klinični podatki iz ločeno randomiziranih, kontroliranih preskušanj faze 3, nakazujejo, da so podatki o učinkovitosti (skupno preživetje, preživetje brez napredovanja) za pemetreksed podobni med bolniki, ki so bili predhodno zdravljeni z doksatakselom (n = 41) in bolniki, ki niso prejeli predhodnega zdravljenja z doksatakselom (n = 540).
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 Armisarte.
Slovenian: Če ste imeli ali če boste imeli zdravljenje z obsevanjem, prosimo, povejte to zdravniku, saj ob jemanju zdravila Armisarte lahko pride do zgodnje ali pozne reakcije na obsevanje.
English: Armisarte is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Slovenian: Zdravilo Armisarte je namenjeno tudi zdravljenju bolnikov z napredovalim stadijem pljučnega raka, katerih bolezen se širi po tem, ko je bila že uporabljena druga začetna kemoterapija.
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).
Slovenian: Klinično pomembne laboratorijske toksičnosti stopenj 3 in 4 so bile podobne pri integriranih rezultatih faze 2 treh študij pemetrekseda kot edine učinkovine (n = 164) in faze 3 študije pemetrekseda kot edine učinkovine, opisane zgoraj, z izjemo nevtropenije (12,8 % oziroma 5,3 %) in povišanja alaninske aminotransferaze (15,2 % oziroma 1,9 %).
English: During the study, low-dose folic acid and vitamin B12 supplementation was introduced to patients therapy to reduce toxicity.
Slovenian: V trajanju študije so bolnikom uvedli v terapijo nizke odmerke dopolnilne folne kisline in vitamina B12, za zmanjšanje toksičnosti.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po razredčitvi zdravila glejte poglavje 6.3.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Armisarte and then approximately every 9 weeks (corresponding to 3 courses of Armisarte treatment).
Slovenian: V tednu pred dajanjem zdravila Armisarte boste prejeli tudi injekcijo vitamina B12 (1000 mikrogramov), nato pa še približno na vsakih 9 tednov (ustrezno 3 ciklusom zdravljenja z zdravilom Armisarte).
English: Pemetrexed belongs to a group of medicines known as folic acid analogues and disrupts processes that are essential for cells to divide.
Slovenian: Pemetreksed sodi v skupino zdravil, znanih kot analogi folne kisline, in ruši procese, ki so ključni za podvajanje celic.
English: Armisarte contains trometamol as an excipient.
Slovenian: Armisarte kot pomožno snov vsebuje trometamol.
English: What Armisarte looks like and contents of the pack
Slovenian: Izgled zdravila Armisarte in vsebina pakiranja
English: Colourless glass vial (type I) with type I rubber (bromobutyl) serum stopper and an aluminium cap with polypropylene disk.
Slovenian: Brezbarvna steklena viala (tip I) z gumijastim (bromobutil) serumskim zamaškom tipa I in aluminijasto zaporko s polipropilensko ploščico.
English: Armisarte 25 mg/ml concentrate for solution for infusion will always be given to you by a healthcare professional.
Slovenian: Zdravilo Armisarte 25 mg/ml koncentrat za raztopino za infundiranje vam bo vedno dal zdravstveni delavec.
English: Armisarte is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Slovenian: Zdravilo Armisarte dajemo v kombinaciji s cisplatinom, drugim zdravilom proti raku, za zdravljenje malignega plevralnega mezotelioma, vrste raka, ki prizadene vrhnjo plast pljuč, bolnikom, ki pred tem še niso prejemali kemoterapije.
English: 100% of previous dose
Slovenian: 100 % predhodnega odmerka 100 % predhodnega odmerka
English: You will always receive Armisarte by infusion into one of your veins.
Slovenian: Zdravilo Armisarte boste vedno prejeli v obliki infuzije v veno.
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.
Slovenian: Poročali so o povprečno manjši toksičnosti ter znižanju hematoloških in nehematoloških toksičnosti stopnje 3/4, denimo nevtropeniji, febrilni nevtropeniji ter okužbi z nevtropenijo stopnje 3/4, kadar so pred zdravljenjem dajali folno kislino in vitamin B12.
English: For instructions on dilution of Armisarte before administration, see section 6.6.
Slovenian: Za informacije o redčenju zdravila Armisarte pred uporabo glejte poglavje 6.6.
English: Docetaxel N=276
Slovenian: Docetaksel N = 276
English: Armisarte should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Zdravilo Armisarte se daje kot 10-minutna intravenska infuzija prvi dan vsakega 21-dnevnega ciklusa.
English: Armisarte concentrate for solution for infusion (sterile concentrate) is a clear, colourless to slightly yellowish or yellow-greenish solution.
Slovenian: Zdravilo Armisarte koncentrat za raztopino za infundiranje (sterilni koncentrat) je bistra, brezbarvna do rahlo rumenkasta ali rumeno-zelenkasta raztopina.
English: 1 x 4 ml vial (100 mg/4 ml) 1 x 20 ml vial (500 mg/20 ml) 1 x 34 ml vial (850 mg/34 ml) 1 x 40 ml vial (1000 mg/40 ml)
Slovenian: Velikost pakiranj 1 x 4 ml viala (100 mg/4 ml) 1 x 20 ml viala (500 mg/20 ml) 1 x 34 ml viala (850 mg/34 ml) 1 x 40 ml viala (1000 mg/40 ml)
English: Not known (frequency cannot be estimated from the available data) - Lower limb swelling with pain and redness - Inflammation of the skin, mainly of the lower limb with swelling, pain and redness - Increased urine output - Thirst and increased water consumption - Hypernatraemia - increased sodium in blood
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) - otekanje spodnjih okončin z bolečino in pordelostjo - vnetje kože, večinoma spodnjih okončin, z otekanjem, bolečino in pordelostjo - povečano izločanje urina - zeja in povečano pitje vode
English: Like other chemotherapy medicines Armisarte is not recommended with live attenuated vaccines.
Slovenian: Tako kot pri ostalih kemoterapevtikih je odsvetovana sočasna uporaba zdravila Armisarte in živih oslabljenih cepiv.
English: Gemcitabine/ cisplatin (N=830)
Slovenian: Gemcitabin/cisplatin N = 830
English: Excipients: trometamol, anhydrous citric acid, methionine and water for injections.
Slovenian: Pomožne snovi: trometamol, brezvodna citronska kislina, metionin in voda za injekcije.
English: Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 3 days at room temperature and 21 days at refrigerated temperature.
Slovenian: Kemijsko in fizikalno obstojnost raztopine pemetrekseda za infundiranje so pokazali za 3 dni na sobni temperaturi in 21 dni pri temperaturah v hladilniku.
English: How to store Armisarte
Slovenian: Kako jemati zdravilo Armisarte
English: Infusion Solution: Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 3 days at room temperature and 21 days at refrigerated temperature.
Slovenian: Raztopina za infundiranje: Kemijsko in fizikalno obstojnost raztopin pemetrekseda za infundiranje so pokazali za 3 dni na sobni temperaturi in 21 dni pri temperaturah v hladilniku.
English: There is no relevant use of Armisarte in the paediatric population
Slovenian: Zdravilo Armisarte ni namenjeno za uporabo pri pediatrični populaciji.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pemetrexed, the scientific conclusions of CHMP are as follows:
Slovenian: Znanstveni zaključki Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za pemetreksed je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Armisarte should not been used if there are any signs of particles.
Slovenian: Zdravila Armisarte ne uporabljajte, če v njem opazite delce.
English: Nadir platelets <50,000/mm 3 with bleedinga, regardless of nadir ANC
Slovenian: Najnižje število trombocitov < 50.000 /mm3 s krvavitvijoa, ne glede na najnižji ANC
English: Vials may or may not be sheathed in a protective sleeve.
Slovenian: Viala je lahko shranjena v zaščitni ovojnici.
English: - If you get any side effects, talk to your doctor or nurse or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: You must take at least 5 doses during the seven days before the first dose of Armisarte.
Slovenian: V sedmih dneh pred prvim odmerkom zdravilom Armisarte morate vzeti vsaj 5 odmerkov.
English: Armisarte is provided in a colourless glass vial with rubber stopper and an aluminium cap with polypropylene disk.
Slovenian: Zdravilo Armisarte je na voljo v brezbarvni stekleni viali z gumijastim zamaškom in aluminijasto zaporko s polipropilensko ploščico.
English: The other ingredients are trometamol (for pH adjustment), anhydrous citric acid, methionine and water for injection.
Slovenian: Druge pomožne snovi so trometamol (za uravnavanje pH), brezvodna citronska kislina, metionin in voda za injekcije
English: Non-small cell lung cancer
Slovenian: Large Cell Carcinoma
English: There is no relevant use of pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Slovenian: Pri pediatrični populaciji se pemetreksed ne uporablja za zdravljenje malignega plevralnega mezotelioma in nedrobnoceličnega karcinoma pljuč.
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.
Slovenian: Multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija faze 3 (JMEN) je primerjala učinkovitost in varnost vzdrževalnega zdravljenja s pemetreksedom skupaj z najboljšo suportivno oskrbo (BSC) (n = 441) s placebom skupaj z BSC (n = 222) pri bolnikih z lokalno napredovalim (stopnja IIIB) ali metastatskim (stopnja IV) nedrobnoceličnim pljučnim karcinomom (NSCLC), ki po 4 ciklih dvojne terapije prvega izbora s cisplatinom ali karboplatinom v kombinaciji z gemcitabinom, paklitakselom ali docetakselom, ni napredoval.
English: Rare (may affect up to 1 in 1,000 people) - Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Slovenian: - radiacijski izpuščaj (kožni izpuščaj kot pri hudi sončni opeklini), ki se lahko pojavi na koži, ki je bila v preteklosti izpostavljena obsevanju, in sicer od nekaj dni do več let po obsevanju.
English: Actavis Italy S.p.A. Viale Pasteur 10
Slovenian: Viale Pasteur 10
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated patients
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu Randomizirani in zdravljeni
English: Unopened vial 18 months.
Slovenian: 18 mesecev
English: 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 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.
Slovenian: Preživetje brez napredovanja (PBN) in celokupno razmerje odziva sta bila podobna med vejama zdravljenja: mediana PBN je bila 4,8 mesecev za pemetreksed skupaj s cisplatinom proti 5,1 mesecev za gemcitabin skupaj s cisplatinom (prilagojeno razmerje tveganja 1,04; 95 % IZ 0,94-1,15) in celokupno razmerje odziva je bilo 30,6 % (95 % IZ 27,3-33,9) za pemetreksed skupaj s cisplatinom proti 28,2 % (95 % IZ 25,0-31,4) za gemcitabin skupaj s cisplatinom.
English: For precautions to be taken before handling or administering pemetrexed, see section 6.6.
Slovenian: Za previdnostne varnostne ukrepe pri pripravi in dajanju pemetrekseda glejte poglavje 6.6.
English: Nadir platelets <50,000 /mm 3 regardless of nadir ANC
Slovenian: Najnižje število trombocitov < 50.000 /mm3 ne glede na najnižji ANC
English: 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 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).
Slovenian: Analiza vpliva histologije NSCLC glede učinka zdravljenja na skupno preživetje je bila prednostna za pemetreksed proti docetakselu pri tistih, ki nimajo pretežno luskaste histologije (n = 399, 9,3 proti 8,0 mesecev, prilagojen RT = 0,78; 95 % IZ = 0,61-1,00, p = 0,047) in je bila prednostna za docetaksel za luskasto celično histologijo karcinoma (n = 172, 6,2 proti 7,4 mesecev, prilagojen RT = 1,56; 95 % IZ = 1,082,26, p = 0,018).
English: Hemoglobin decreased Neutrophils/ Granulocytes decreased Leukocytes Decreased Platelets Decreased
Slovenian: Znižan hemoglobin Znižani nevtrofilci/ granulociti Znižani
English: Dose of pemetrexed (mg/m2)
Slovenian: Odmerek pemetrekseda (mg/m2)
English: Breast-feeding must be discontinued during Armisarte treatment.
Slovenian: Dojenje morate med zdravljenjem z zdravilom Armisarte prekiniti.
English: Pemetrexed 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).
Slovenian: Pemetreksed je indiciran kot monoterapija za zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega karcinoma, ki nima pretežno ploščatocelične histologije pri bolnikih, pri katerih bolezen ni napredovala neposredno po kemoterapiji na osnovi platine (glejte poglavje 5.1).
English: Excluding neurotoxicity
Slovenian: Brez nevrološke toksičnosti
English: You must continue taking the folic acid for 21 days after the last dose of Armisarte.
Slovenian: Po zadnjem odmerku zdravila Armisarte morate še 21 dni jemati folno kislino.
English: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n=283) and 7.9 months for patients treated with docetaxel (ITT n=288).
Slovenian: Multicentrična, randomizirana študija faze 3 z znanim zdravilom, kjer so preskušali pemetreksed v primerjavi z docetakselom pri bolnikih z lokalno napredovalim ali metastatskim NSCLC po predhodni kemoterapiji, je pokazala mediano časa preživetja 8,3 mesece pri bolnikih, zdravljenih s pemetreksedom (Populacija z namenom zdraviti n = 283), in 7,9 mesecev pri bolnikih, zdravljenih z docetakselom (NZ n = 288).
English: Patient with hepatic impairment
Slovenian: Bolniki z okvarjenim delovanjem jeter