FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
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: Neuropathy-sensory
Slovenian: Pogosto Nevropatija - senzorna
English: Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Neurotoxicity
Slovenian: Preglednica 3 - Preglednica za prilagajanje odmerkov zdravila Pemetreksed Sandoz (kot edine učinkovine ali v kombinaciji) in cisplatina - Nevrotoksičnost
English: What Pemetrexed Sandoz looks like and contents of the pack
Slovenian: Izgled zdravila Pemetreksed Sandoz in vsebina pakiranja
English: Mondseestrasse 11, Unterach 4866 Austria
Slovenian: Ebewe Pharma Ges.m.b.H Nfg.KG Mondseestrasse 11, Unterach 4866 Avstrija
English: Pemetrexed Sandoz 1000 mg contains 108 mg sodium per vial.
Slovenian: Pemetreksed Sandoz 1000 mg vsebuje 108 mg natrija v eni viali.
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree'.
Slovenian: Pemetreksed Sandoz 100 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v eni viali, kar v bistvu pomeni “brez natrija”.
English: 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).
Slovenian: Bolniki z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina od 45 do 79 ml/min) naj se izogibajo jemanju nesteroidnih protivnetnih zdravil (NSAID), denimo, ibuprofena in acetilsalicilne kisline (> 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
English: Pemetrexed Sandoz 500 mg contains 54 mg sodium per vial.
Slovenian: Pemetreksed Sandoz 500 mg vsebuje 54 mg natrija v eni viali.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 mg
English: Excipient with known effect Each vial contains approximately 108 mg sodium.
Slovenian: Pomožna snov z znanim učinkom Ena viala vsebuje približno 108 mg natrija.
English: In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Slovenian: Ker ni podatkov o možnem medsebojnem delovanju pemetrekseda in NSAID-ov z daljšimi razpolovnimi časi, denimo piroksikama ali rofekoksiba, moramo sočasno dajanje NSAID-ov s pemetreksedom pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic prekiniti vsaj za 5 dni pred dajanjem pemetrekseda, na dan dajanja in še vsaj za 2 dni po dajanju pemetrekseda (glejte poglavje 4.4).
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Sandoz.
Slovenian: Po zadnjem odmerku zdravila Pemetreksed Sandoz morate še 21 dni jemati folno kislino.
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.
Slovenian: Spodnja preglednica podaja pogostnost in izraženost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 800 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali pemetreksed kot edino zdravilo, in 402 bolnikov, ki so naključno prejemali placebo v študijah vzdrževalnega zdravljenja samo s pemetreksedom (JMEN: N=663) ter nadaljevalnega zdravljenja s pemetreksedom (PARAMOUNT: N=539).
English: Pemetrexed Sandoz contains sodium
Slovenian: Zdravilo Pemetreksed Sandoz vsebuje natrij
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 839 patients with NSCLC who were randomised to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomised to receive cisplatin and gemcitabine.
Slovenian: Spodnja preglednica podaja pogostnost in resnost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 839 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali cisplatin in pemetreksed in 830 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali cisplatin in gemcitabin.
English: 50% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: 100% predhodnega odmerka 50% predhodnega odmerka a Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998)
English: Taste disturbance Nausea
Slovenian: Pogosto Motnje okusa
English: Excipient with known effect Each vial contains approximately 54 mg sodium.
Slovenian: Pomožna snov z znanim učinkom Ena viala vsebuje približno 54 mg natrija.
English: Stomatitis ALT (SGPT) elevation
Slovenian: Povišanje SGPT (ALT)
English: Excipient with known effect Each vial contains approximately 11 mg sodium.
Slovenian: Pomožna snov z znanim učinkom Ena viala vsebuje približno 11 mg natrija.
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed, and 163 patients with mesothelioma randomised to receive single-agent cisplatin.
Slovenian: Spodnja preglednica navaja pogostnost in hudost neželenih učinkov, o katerih so poročali pri > 5 % 168 bolnikov z mezoteliomom, ki so jih naključno razporedili, da so prejemali cisplatin in pemetreksed, ter pri 163 bolnikov z mezoteliomom, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, cisplatin.
English: • Fever
Slovenian: • Vročina
English: Creatinine elevation 10.1* 0.8
Slovenian: Alopecija Povišan kreatinin 10,7
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).
Slovenian: Pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina 45 do 79 ml/min) se moramo izogibati sočasnemu dajanju pemetrekseda z NSAID-i (denimo ibuprofenom) ali acetilsalicilno kislino v visokih odmerkih 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.4).
English: Intravenous use after reconstitution and dilution
Slovenian: Za intravensko uporabo po rekonstituciji in redčenju.
English: 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).
Slovenian: Mediana skupnega preživetja za celotno populacijo (n = 663) je bila 13,4 mesece za skupino s pemetreksedom in 10,6 mesecev za skupino s placebom, razmerje tveganja = 0,79 (95 % CI: 0,65 do 0,95; p = 0,01192).
English: Domaniewska 50C 02-672 Warszawa
Slovenian: Domaniewska 50C
English: Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Haematologic toxicities
Slovenian: Preglednica 2 - Preglednica za prilagajanje odmerkov zdravila Pemetreksed Sandoz (kot edine učinkovine ali v kombinaciji) in cisplatina - Nehematološke toksičnostia, b
English: 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.
Slovenian: Ustrezno prostornino rekonstituirane raztopine pemetrekseda moramo še nadalje redčiti do 100 ml z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje (brez konzervansa) ali s 50 mg/ml (5%) raztopino glukoze za injiciranje (brez konzervansa), damo jo kot intravensko infuzijo, ki teče 10 minut.
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET
English: Rarely, immune-mediated haemolytic anaemia has been reported in patients treated with pemetrexed.
Slovenian: Pri bolnikih, ki so se zdravili s pemetreksedom, so redko poročali o imunsko pogojeni hemolitični anemiji.
English: • Interstitial pneumonitis (scarring of the air sacs of the lung)
Slovenian: • Intersticijska pljučnica (vnetje pljučnih mešičkov)
English: Blood and lymphatic system disorders Common
Slovenian: Bolezni krvi in limfatičneg a sistema Pogosto
English: 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).
Slovenian: Študija je dosegla svoj primarni ciljni učinek in dokazala statistično pomembno izboljšanje preživetja brez napredovanja bolezni v skupini, ki je prejemala pemetreksed, v primerjavi s skupino, ki je prejemala placebo (n = 472, neodvisno pregledana populacija; mediano 3,9 meseca in 2,6 meseca) (razmerje tveganja=0,64, 95 % CI = 0,51-0,81, p = 0,0002).
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).
Slovenian: Študija je dosegla svojo primarno končno točko in pokazala statistično značilno izboljšanje preživetja brez napredovanja v skupini s pemetreksedom glede na skupino s placebom (n = 581, neodvisno pregledana populacija; mediana 4,0 mesece in 2,0 meseca) (razmerje tveganja = 0,60, 95 % CI: 0,490,73, p < 0,00001).
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion This medicinal product contains 54 mg sodium per vial.
Slovenian: Pemetreksed Sandoz 500 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje 54 mg natrija v eni viali.
English: Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Slovenian: 02-672 Warszawa Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
English: Progression-free survival (months)
Slovenian: Čas preživetja brez napredovanja (meseci)
English: Pemetrexed Sandoz 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).
Slovenian: Pemetreksed Sandoz je v kombinaciji s cisplatinom indiciran kot zdravljenje prvega izbora za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
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.
Slovenian: *P-vrednosti < 0,05 v primerjavi pemetreksed/cisplatin proti gemcitabin/cisplatin, z uporabo Fisherjevega Exact testa.
English: Nephrogenic diabetes insipidus and renal tubular necrosis have been reported in post marketing setting with an unknown frequency.
Slovenian: V obdobju po prihodu zdravila na trg som poročali o nefrogenem diabetesu insipidus, z neznano pogostnostjo.
English: 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)
Slovenian: PARAMOUNT: Kaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion This medicinal product contains 108 mg sodium per vial.
Slovenian: Pemetreksed Sandoz 1000 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje 108 mg natrija v eni viali.
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.
Slovenian: V multicentrični, randomizirani, dvojno slepi in s placebom nadzorovani študiji v tretji fazi (PARAMOUNT) so primerjali učinkovitost in varnost nadaljevanja vzdrževalnega zdravljenja s pemetreksedom in najboljšo podporno oskrbo (n = 359) s placebom in najboljšo podporno oskrbo (n =1 80) pri bolnikih z lokalno napredovanim (faza IIIB) ali metastatskim (faza IV) nedrobnoceličnim karcinomom pljuč, ki nima prevladujoče ploščatocelične histologije, ter pri katerih ni bilo napredka po 4 ciklih zdravljenja prve izbire z dubletami pemetrekseda v kombinaciji s cisplatinom.
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).
Slovenian: Od začetka indukcijskega zdravljenja prve izbire s pemetreksedom skupaj s cisplatinom je bilo mediano skupno preživetje bolnikov 16,9 meseca v kraku pemetreksed in 14,0 mesecev v kraku s placebom (razmerje tveganja = 0,78, 95% % CI = 0,64-0,96).
English: The relative treatment effect of pemetrexed was internally consistent across subgroups (including disease stage, induction response, ECOG PS, smoking status, gender, histology and age) and similar to that observed in the unadjusted OS and PFS analyses.
Slovenian: zdravljenje, stanjem zmogljivosti po ECOG, kajenjem, spolom, histologijo in starostjo) in podoben tistemu, ki so ga opazili pri neprilagojenih analizah skupnega preživetja in preživetja brez napredovanja bolezni.
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek se posvetujte s svojim zdravnikom ali farmacevtom.
English: For precautions to be taken before handling or administering Pemetrexed Sandoz, see section 6.6.
Slovenian: Za previdnostne varnostne ukrepe pri pripravi in dajanju zdravila Pemetreksed Sandoz glejte poglavje
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu Randomizirani in zdravljeni
English: After reconstitution each vial contains 25 mg/ml of pemetrexed.
Slovenian: Po rekonstituciji ena viala vsebuje 25 mg/ml pemetrekseda.
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, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in  5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: febrilno nevtropenijo, infekcijo, znižane trombocite, diarejo, zaprtje, alopecijo, srbenje, vročino (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
English: 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
Slovenian: Pemetreksed Sandoz 100 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Sandoz 500 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Sandoz 1000 mg prašek za koncentrat za raztopino za infundiranje
English: Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Slovenian: Pemetreksed Sandoz je v kombinaciji s cisplatinom indiciran za zdravljenje bolnikov z neresektabilnim malignim plevralnim mezoteliomom, ki jih še nismo zdravili s kemoterapijo.
English: Pemetrexed Sandoz 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).
Slovenian: Pemetreksed Sandoz je indiciran kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: Haemoglobin decreased Leucocytes decreased
Slovenian: Zelo pogosto Znižan hemoglobin Znižani levkociti
English: How to use Pemetrexed Sandoz
Slovenian: Kako uporabljati zdravilo Pemetreksed Sandoz
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.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: okužbo brez nevtropenije, febrilno nevtropenijo, alergijsko reakcijo/preobčutljivost, povišan kreatinin, motorično nevropatijo, senzorično nevropatijo, multiformni eritem in bolečino v trebuhu.
English: • Nausea
Slovenian: • Bruhanje
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 =
Slovenian: Za bolnike z NSCLC , ki nima pretežno ploščatocelične histologije (n = 430, neodvisno pregledana populacija) je bila mediana preživetja brez napredovanja 4,4 mesece za skupino s pemetreksedom in 1,8 meseca za skupino s placebom, razmerje tveganja = 0,47, 95% CI: 0,37-0,60, p = 0,00001).
English: • Fatigue (tiredness)
Slovenian: • Utrujenost (izčrpanost)
English: • Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving
Slovenian: • Nekateri bolniki so med terapijo s pemetreksedom/obsevanjem doživeli vnetje sluznice požiralnika (grla).
English: Women must use effective contraception during treatment with Pemetrexed Sandoz.
Slovenian: Med zdravljenjem z zdravilom Pemetreksed Sandoz morajo ženske uporabljati učinkovito metodo kontracepcije.
English: Pemetrexed/ Cisplatin (N = 839)
Slovenian: Pemetreksed/cisplatin (N = 839)
English: Pemetrexed Sandoz 500 mg
Slovenian: Pemetreksed Sandoz 500 mg
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).
Slovenian: Vključno z indukcijsko fazo je bila mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije 18,6 mesecev za skupino s pemetreksedom in 13,6 mesecev za skupino s placebom (razmerje tveganja = 0,71, 95% CI: 0,56-0,88, p = 0,002).
English: Pemetrexed/ Cisplatin (N = 168)
Slovenian: Pemetreksed/cisplatin (N = 168)
English: Pemetrexed Sandoz 1000 mg
Slovenian: Pemetreksed Sandoz 1000 mg
English: Pemetrexed at a dose of 500 mg/m2 was studied as a single agent in 64 chemonaive patients with malignant pleural mesothelioma.
Slovenian: Pemetreksed kot edino učinkovino so preučevali v odmerku 500 mg/m2 pri 64
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1037/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/15/1037/001
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).
Slovenian: Mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije (n = 481) je bila 15,5 mesecev za skupino s pemetreksedom in 10,3 mesecev za skupino s placebom (razmerje tveganja = 0,70, 95% CI: 0,56-0,88, p = 0,002).
English: Pemetrexed (N = 265)
Slovenian: Pemetreksed (N = 265)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1037/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/15/1037/002
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 = 0.47-0.74).
Slovenian: Za naključno izbrane bolnike, merjeno od začetka zdravljenja s pemetreksedom in indukcijskim zdravljenjem prve izbire s cisplatinom, je bilo mediano preživetje brez napredovanja bolezni po oceni raziskovalca 6,9 meseca za skupino, ki je prejemala pemetreksed, in 5,6 meseca za skupino, ki je prejemala placebo (razmerje tveganja = 0,59 95 % CI = 0,47-0,74).
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Clear, colorless 50 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 500 mg of pemetrexed.
Slovenian: Pemetreksed Sandoz 500 mg prašek za koncentrat za raztopino za infundiranje Prozorna, brezbarvna 50 ml viala iz stekla tipa I z gumijasto zaporko iz klorobutila in aluminijasto zaporko, ki vsebuje 500 mg pemetrekseda.
English: Neutrophils/ Granulocytes decreased
Slovenian: Znižani nevtrofilci/ granulociti Znižani levkociti
English: Pemetrexed Sandoz 1000 mg:
Slovenian: Pemetreksed Sandoz 1000 mg:
English: Pemetrexed Sandoz 500 mg:
Slovenian: Pemetreksed Sandoz 500 mg: