FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observed.
Croatian: Uočena je teška dehidracija zbog gastrointestinalne toksičnosti kod primjene pemetrekseda u kombinaciji s cisplatinom.
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.
Croatian: U multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (PARAMOUNT) uspoređivala se djelotvornost i sigurnost liječenja pemetreksedom kao terapije održavanja uz BSC (N = 359) s djelotvornošću i sigurnošću primjene placeba uz BSC (N = 180) u bolesnika s lokalno uznapredovalim (stadij IIIB) ili metastatskim (stadij IV) NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice u kojih nije došlo do progresije nakon 4 ciklusa prve linije dvojne terapije pemetreksedom u kombinaciji s cisplatinom.
English: Large cell (N = 153)
Croatian: Karcinom velikih stanica (N = 153)
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 doses should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Croatian: U bolesnika s blagim do umjerenim zatajenjem bubrega (klirens kreatinina od 45 do 79 ml/min) mora se izbjegavati istodobna primjena NSAIL-a (npr. ibuprofena) ili viših doza acetilsalicilatne kiseline dva dana prije, na sam dan i dva dana nakon primjene pemetrekseda (vidjeti dio 4.4).
English: Median overall survival (months) (95% CI)
Croatian: Medijan ukupnog preživljenja (mjeseci) (95% CI)
English: Erythematous oedema mainly of the lower limbs has been reported with an unknown frequency.
Croatian: Prijavljeni su slučajevi eritematoznog edema uglavnom donjih ekstremiteta s učestalosti nepoznato.
English: Oral folic acid and intramuscular vitamin B12 supplementation do not affect the pharmacokinetics of pemetrexed.
Croatian: Na farmakokinetiku pemetrekseda ne utječu ni peroralna primjena folatne kiseline ni intramuskularno primijenjen nadomjestak vitamina B12.
English: 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.
Croatian: U tablici koja slijedi navedena je učestalost i težina nuspojava koje su prijavljene u > 5% od 265 bolesnika randomiziranih u skupinu koja je primala samo pemetreksed te nadomjestak folatne kiseline i vitamina B12 i 276 bolesnika randomiziranih u skupinu koja je primala samo docetaksel.
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study medicinal product 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.
Croatian: Tablica koja slijedi prikazuje učestalost i težinu nuspojava za koje se smatra da bi mogle biti povezane s ispitivanim lijekom, a koje su prijavljene u > 5% od 839 bolesnika s rakom pluća nemalih stanica randomiziranih da primaju cisplatin i pemetreksed i 830 bolesnika s rakom pluća nemalih stanica randomiziranih da primaju cisplatin i gemcitabin.
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
Croatian: Prašak za koncentrat za otopinu za infuziju.
English: **In the pemetrexed /cisplatin arm, randomised and treated (N=225) and fully supplemented (N=167).
Croatian: *p-vrijednost se odnosi na usporedbu između dviju skupina bolesnika ** Skupina liječena kombinacijom pemetreksed /cisplatin, randomizirani i liječeni bolesnici (N = 225) i bolesnici s potpunim nadomjeskom (N = 167).
English: Non-small cell lung cancer
Croatian: Rak pluća nemalih stanica
English: Pemetrexed is primarily eliminated unchanged by renal excretion.
Croatian: Pemetreksed se prvenstveno eliminira putem bubrega u nepromijenjenom obliku.
English: What Pemetrexed Pfizer looks like and contents of the pack Pemetrexed Pfizer is a powder for concentrate for solution for infusion in a glass vial.
Croatian: Pemetreksed Pfizer je prašak za koncentrat za otopinu za infuziju u staklenoj bočici.
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95%CI=0.64-0.96, p=0.0195).
Croatian: Nakon uvodnog liječenja pemetreksedom i cisplatinom (4 ciklusa), liječenje pemetreksedom bilo je statistički značajno bolje od placeba s obzirom na ukupno preživljenje (medijan 13,9 mjeseci naspram 11,0 mjeseci, omjer hazarda = 0,78, 95% CI = 0,64 - 0,96, p = 0,0195).
English: There were no clinically relevant differences observed for the safety profile of pemetrexed plus cisplatin within the histology subgroups.
Croatian: Nisu uočene klinički značajne razlike u sigurnosnom profilu pemetrekseda u kombinaciji s cisplatinom unutar podskupina prema histološkom tipu.
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).
Croatian: U bolesnika s blagim do umjerenim zatajenjem bubrega koji mogu biti liječeni pemetreksedom, uzimanje nesteroidnih protuupalnih lijekova s dugim poluvremenom eliminacije mora se prekinuti najmanje 5 dana prije, na sam dan i najmanje 2 dana nakon primjene pemetrekseda (vidjeti dio 4.5).
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.
Croatian: U tablici koja slijedi navedene su učestalost i težina nuspojava koje su prijavljene u > 5% od 168 bolesnika s mezoteliomom randomiziranih u skupinu koja je primala cisplatin i pemetreksed i 163 bolesnika s mezoteliomom randomiziranih u skupinu koja je primala samo cisplatin.
English: Clinically relevant CTC toxicities that were reported in < 1% of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Croatian: Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u < 1% bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju supraventrikularne aritmije.
English: Clinically relevant CTC toxicity that was reported in <1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Croatian: Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u < 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijske reakcije/reakcije preosjetljivosti, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva često osip/ deskvamacija
English: If pemetrexed solutions contact the mucous membranes, flush thoroughly with water.
Croatian: Ako otopina pemetrekseda dođe u dodir sa sluznicom, treba je temeljito isprati vodom.
English: This suggests that pemetrexed may impair male fertility.
Croatian: Ovo ukazuje da pemetreksed može smanjiti plodnost mužjaka.
English: A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the pemetrexed /cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Croatian: Lung Cancer Symptom Scale) u skupini bolesnika liječenih kombinacijom pemetreksed/cisplatin (212 bolesnika) uočeno je statistički značajno poboljšanje klinički značajnih simptoma (bol i dispneja) povezanih s malignim pleuralnim mezoteliomom u odnosu na bolesnike liječene samo cisplatinom (218 bolesnika).
English: Dose modification table for pemetrexed (as a single agent or in combination) and cisplatin - neurotoxicity
Croatian: Tablica 3. Tablica za prilagodbu doze pemetrekseda (u monoterapiji ili u kombinaciji) i cisplatina - neurotoksičnost
English: Overall response rate** 41.3% (95% CI)
Croatian: Stopa ukupnog odgovora** (95% CI)
English: Read the package leaflet for the shelf life of the reconstituted product.
Croatian: Pročitajte uputu o lijeku za navode o roku valjanosti rekonstituiranog lijeka.
English: If you are breast-feeding, tell your doctor.
Croatian: Ako dojite, obavijestite o tome svog liječnika.
English: In clinical trials, cases of interstitial pneumonitis with respiratory insufficiency, sometimes fatal, have been reported uncommonly in patients treated with pemetrexed.
Croatian: Tijekom kliničkih ispitivanja u bolesnika liječenih pemetreksedom manje su često prijavljeni slučajevi intersticijskog pneumonitisa s respiratornom insuficijencijom, ponekad sa smrtnim ishodom.
English: Rarely, immune-mediated haemolytic anaemia has been reported in patients treated with pemetrexed.
Croatian: U bolesnika liječenih pemetreksedom rijetko je prijavljena imunološki posredovana hemolitička anemija.
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Croatian: *** Prema Nacionalnom Institutu za rak CTC (v2.0; NCI 1998), poremećaj osjeta okusa i alopecija prijavljuju se isključivo kao nuspojave stupnja 1 ili 2.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic
Croatian: DRUGO POSEBNO UPOZORENJE, AKO JE POTREBNO
English: The active substance is pemetrexed.
Croatian: Djelatna tvar je pemetreksed.
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.
Croatian: Tijekom kliničkih ispitivanja pemetrekseda manje su često prijavljeni ozbiljni kardiovaskularni događaji, uključujući infarkt miokarda te cerebrovaskularni događaji, obično onda kad se lijek davao u kombinaciji s drugim citotoksičnim lijekom.
English: EMPHACIS, a multi-centre, randomised, single-blind Phase 3 study of pemetrexed plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with pemetrexed and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone.
Croatian: EMPHACIS, multicentrično, randomizirano, jednostruko slijepo ispitivanje faze III pemetrekseda i cisplatina u odnosu na monoterapiju cisplatinom u bolesnika s malignim pleuralnim mezoteliomom koji nisu ranije primali kemoterapiju, pokazalo je da je u bolesnika liječenih pemetreksedom i cisplatinom medijan preživljenja bio 2,8 mjeseci dulji nego u bolesnika liječenih samo cisplatinom, što se smatra klinički značajnom razlikom.
English: Grade toxicity
Croatian: Toksičnost stupnja
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetreksed Pfizer 100 mg prašak za koncentrat za otopinu za infuziju Pemetreksed Pfizer 500 mg prašak za koncentrat za otopinu za infuziju Pemetreksed Pfizer 1000 mg prašak za koncentrat za otopinu za infuziju
English: The pharmacokinetic properties of pemetrexed are not influenced by concurrently administered cisplatin.
Croatian: Istodobna primjena cisplatina ne utječe na farmakokinetička svojstva pemetrekseda.
English: 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).
Croatian: Medijan ukupnog preživljenja za ukupnu populaciju (N = 663) iznosio je 13,4 mjeseci u skupini koja je primala pemetreksed i 10,6 mjeseci u skupini koja je primala placebo, omjer hazarda= 0,79 (95% CI = 0,65 - 0,95, p= 0,01192).
English: Hepatobiliary disorders
Croatian: Pemetreksed u monoterapiji
English: Nephrogenic diabetes insipidus and renal tubular necrosis have been reported in post marketing setting with an unknown frequency.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljeni su nefrogeni dijabetes insipidus i renalna tubularna nekroza, s nepoznatom učestalošću.
English: Pancytopenia- combined low counts of white cells, red cells and platelets Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their pemetrexed therapy.
Croatian: Neki su bolesnici doživjeli srčani udar, moždani udar ili „mali moždani udar“ pri primjeni pemetrekseda, obično u kombinaciji s nekim drugim protutumorskim lijekom pancitopenija - udruženi nizak broj bijelih krvnih stanica, crvenih krvnih stanica i krvnih pločica radijacijski pneumonitis (stvaranje ožiljaka na mjehurićima u plućima (alveolama) povezano s terapijom zračenjem) može se pojaviti u bolesnika koji su zračeni prije, tijekom ili nakon liječenja pemetreksedom prijavljeni su bol u udovima, snižena temperatura i promjene boje krvni ugrušci u krvnim žilama u plućima (plućna embolija)
English: The effect of third-space fluid, such as pleural effusion or ascites, on pemetrexed is not fully defined.
Croatian: Nije sasvim jasno kako na pemetreksed utječu tekućine u transcelularnom prostoru, primjerice pleuralni izljev ili ascites.
English: Pemetrexed Pfizer 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).
Croatian: Pemetreksed Pfizer je u kombinaciji s cisplatinom indiciran u prvoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice (vidjeti dio 5.1).
English: pemetrexed*** (N = 800)
Croatian: Učestalost* Događaj** pemetreksed*** (N = 800)
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomised and treated patients Fully supplemented patients
Croatian: Djelotvornost pemetrekseda + cisplatina u odnosu na monoterapiju cisplatinom u bolesnika s malignim pleuralnim mezoteliomom Randomizirani i liječeni bolesnici
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.
Croatian: uz najbolju potpornu njegu (engl. best supportive care, BSC) (N = 441) s djelotvornošću i sigurnošću primjene placeba uz BSC (N = 222) u bolesnika s lokalno uznapredovalim (stadij IIIB) ili metastatskim (stadij IV) rakom pluća nemalih stanica (NSCLC) u kojih nije došlo do progresije nakon 4 ciklusa prve linije dvojne terapije cisplatinom ili karboplatinom u kombinaciji s gemcitabinom, paklitakselom ili docetakselom.
English: Men are advised not to father a child during and up to 6 months following treatment with pemetrexed and should therefore use effective contraception during treatment with pemetrexed and for up to 6 months afterwards.
Croatian: Muškarcima se savjetuje da ne začinju djecu tijekom liječenja i do 6 mjeseci nakon završetka liječenja pemetreksedom.
English: Pemetrexed Pfizer 1,000mg vial:
Croatian: Pemetreksed Pfizer bočica od 1000 mg:
English: Further dilution by a healthcare provider is required prior to administration.
Croatian: Zdravstveni radnik mora dodatno razrijediti otopinu prije primjene.
English: • If you experience sudden breathlessness, intense chest pain or cough with bloody sputum
Croatian: • ako iskusite iznenadni nedostatak zraka, osjećate intenzivnu bol u prsnom košu ili iskašljavate krv (manje često) (može ukazivati na krvni ugrušak u krvnim žilama u plućima).
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion 18 months
Croatian: Pemetreksed Pfizer 100 mg prašak za koncentrat za otopinu za infuziju 18 mjeseci
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Store below 30°C.
Croatian: Pemetreksed Pfizer 100 mg prašak za koncentrat za otopinu za infuziju Čuvati na temperaturi ispod 30°C.
English: Clinically relevant CTC toxicities that were reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Croatian: Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u < 1% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed uključuju aritmiju i motoričku neuropatiju.
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).
Croatian: Ispitivanje je ispunilo primarni ishod i pokazalo statistički značajno poboljšanje PFS-a u skupini koja je primala pemetreksed u odnosu na skupinu koja je primala placebo (N=581, neovisno procijenjena populacija; medijan od 4 odnosno 2 mjeseca) (omjer hazarda= 0,60, 95% CI = 0,49 - 0,73, p < 0,00001).
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).
Croatian: Ispitivanje je ispunilo primarni ishod i pokazalo statistički značajno poboljšanje PFS-a u skupini koja je primala pemetreksed u odnosu na skupinu koja je primala placebo (N = 472, neovisno procijenjena populacija; medijan od 3,9 odnosno 2,6 mjeseci) (omjer hazarda = 0,64, 95% CI = 0,51 - 0,81, p = 0,0002).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
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).
Croatian: U bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (N=430, neovisno procijenjena populacija), medijan PFS-a bio je 4,4 mjeseci u skupini koja je primala pemetreksed te 1,8 mjeseci u skupini koja je primala placebo, omjer hazarda= 0,47 (95% CI = 0,37 - 0,60, p = 0,00001).
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.
Croatian: Klinički značajne toksičnosti prijavljene u < 1% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsištu, aritmiju i motoričku neuropatiju.
English: 50% of previous dose (both pemetrexed and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Croatian: Ovi kriteriji odgovaraju definiciji krvarenja stupnja ≥ 2 prema Zajedničkim kriterijima toksičnosti Nacionalnog instituta za rak (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998).
English: Pemetrexed Pfizer 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).
Croatian: Pemetreksed Pfizer je indiciran kao monoterapija u drugoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice (vidjeti dio 5.1).
English: Polyglutamated metabolites have an increased intracellular half-life resulting in prolonged drug action in malignant cells.
Croatian: Poluvrijeme poliglutamatnih metabolita u stanicama je produljeno, zbog čega se produljuje i djelovanje lijeka na tumorske stanice.
English: For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Croatian: U ovu su tablicu uključene sve nuspojave čija je učestalost bila najmanje 5% i za koje je prijavitelj procijenio da bi mogle biti povezane s primjenom pemetrekseda i cisplatina.
English: Mesothelioma
Croatian: Mezoteliom
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.
Croatian: Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala pemetreksed, ubrajaju se: infekcija bez neutropenije, neutropenijska vrućica, alergijska reakcija/preosjetljivost, povišene vrijednosti kreatinina, motorička neuropatija, senzorna neuropatija, multiformni eritem i bol u abdomenu.
English: Breast-feeding must be discontinued during pemetrexed treatment.
Croatian: Tijekom liječenja pemetreksedom dojenje se mora prekinuti.
English: Time to treatment failure (months) (95% CI)
Croatian: Vrijeme do prestanka odgovora na liječenje (mjeseci) (95% CI)
English: Pemetrexed Pfizer 100mg vial:
Croatian: Pemetreksed Pfizer bočica od 100 mg:
English: Neuropathy-sensory Common Taste disturbance
Croatian: Poremećaji živčanog sustava često senzorna neuropatija 8,5* poremećaj okusa
English: Further dilution is required, as below.
Croatian: Otopina se mora dodatno razrijediti kako je opisano u nastavku.
English: Conjunctivitis (inflamed eye) Upset stomach
Croatian: Poremećaji oka često konjunktivitis
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1,000 mg
Croatian: Prašak za koncentrat za otopinu za infuziju 1000 mg
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).
Croatian: Prema procjeni ispitivača medijan PFS-a randomiziranih bolesnika, mjeren od početka prve linije uvodnog liječenja pemetreksedom i cisplatinom, iznosio je 6,9 mjeseci za skupinu koja je primala pemetreksed i 5,6 mjeseci za skupinu s placebom (omjer hazarda = 0,59, 95% CI = 0,47 - 0,74).
English: Pemetrexed Pfizer 500mg vial:
Croatian: Pemetreksed Pfizer bočica od 500 mg:
English: Time to treatment failure (TTTF - months)
Croatian: Vrijeme do prestanka odgovora na liječenje (mjeseci)