FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: U multicentričnom, randomiziranom, otvorenom ispitivanju faze III pemetrekseda u odnosu na docetaksel u bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om nakon prethodne kemoterapije medijan preživljenja bolesnika liječenih pemetreksedom iznosio je 8,3 mjeseca (populacija svih uključenih bolesnika, engl Intent to Treat [ITT], N = 283), a u bolesnika liječenih docetakselom 7,9 mjeseci (ITT, N = 288).
English: Efficacy of pemetrexed plus cisplatin vs.cisplatin in malignant pleural mesothelioma Randomized and treated patients
Croatian: Djelotvornost pemetrekseda + cisplatina u odnosu na cisplatin kod malignog pleuralnog mezotelioma Randomizirani i liječeni bolesnici
English: National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Croatian: 100% prethodne doze aZajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998)
English: Time to treatment failure (TTTF - months) Median
Croatian: Vrijeme do prestanka odgovora na liječenje (TTTF - mjeseci) Medijan HR (95% CI)
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Croatian: Kratice: CI = interval pouzdanosti; ITT = populacija uključenih bolesnika; N = ukupan broj bolesnika.
English: Common side effects (may affect up to 1 in 10 people) Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Croatian: Alergijska reakcija: kožni osip /osjećaj pečenja ili bockanja Infekcija, uključujući sepsu
English: Intravenous use after reconstitution and dilution
Croatian: Za primjenu u venu nakon rekonstitucije i razrjeđivanja
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 prikazane su učestalosti i težina nuspojava prijavljenih u > 5% od 265 bolesnika randomiziranih u skupinu koja je primala samo pemetreksed te nadomjestak folatne kiseline i vitamina B12, te u 276 bolesnika randomiziranih u skupinu koja je primala samo docetaksel.
English: IT A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Croatian: Menarini Farmaceutica Internazionale S.R.L.
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Croatian: Klinički značajne toksičnosti prema CTC kriterijima prijavljene u < 1 % bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju supraventrikularne aritmije.
English: A multicentre, 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 0.94; 95% CI = 0.84-1.05).
Croatian: NSCLC, prva linija liječenja Multicentrično, randomizirano, otvoreno ispitivanje faze III pemetrekseda i cisplatina u odnosu na gemcitabin i cisplatin u bolesnika s lokalno uznapredovalim ili metastatskim (stadij IIIb ili IV) rakom pluća nemalih stanica (NSCLC) koji prethodno nisu primali kemoterapiju, pokazalo je da su pemetreksed i cisplatin (ITT populacija, N = 862) ostvarili primarni ishod ispitivanja i pokazali sličnu kliničku djelotvornost kao gemcitabin i cisplatin (ITT N = 863) s obzirom na ukupno preživljenje (prilagođeni omjer rizika 0,94; 95% CI = 0,84-1,05).
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 randomized to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomized to receive cisplatin and gemcitabine.
Croatian: U tablici koja slijedi navedene su učestalosti i težina nuspojava za koje se smatra da je moguća povezanost 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: BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Croatian: mg/m2 tjelesne površine, primijenjene u infuziji tijekom dva sata, približno 30 minuta nakon završetka infuzije pemetrekseda, prvog dana svakog 21-dnevnog ciklusa.
English: Gemcitabine + cisplatin
Croatian: p-vrijednost za superiornost pemetreksed + cisplatin gemcitabin + cisplatin
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Croatian: - ako dojite; morate prestati dojiti za vrijeme liječenja lijekom CIAMBRA.
English: Therefore, caution should be made when administering higher doses of NSAIDs or aspirin, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/min).
Croatian: Stoga je nužan oprez kada se bolesnicima s normalnom bubrežnom funkcijom (klirens kreatinina > 80 ml/min) daju više doze NSAIL-a ili acetilsalicilatne kiseline istodobno s pemetreksedom.
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).
Croatian: Medijan ukupnog preživljenja za ukupnu populaciju (N = 663) iznosio je 13,4 mjeseca 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: CIAMBRA 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: CIAMBRA je u kombinaciji s cisplatinom indicirana 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: 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.
Croatian: U tablici koja slijedi prikazane su učestalost i težina nuspojava za koje je se smatra da je moguća povezanost s ispitivanim lijekom, a koje su zabilježene u > 5% od 800 bolesnika randomiziranih da primaju samo pemetreksed i 402 bolesnika randomizirana da primaju placebo u ispitivanju monoterapije pemetreksedom kao terapije održavanja (JMEN: N= 663) i ispitivanja kontinuirane terapije održavanja pemetreksedom (PARAMOUNT: N=539).
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, katkada sa smrtnim ishodom.
English: CIAMBRA must only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy.
Croatian: 4.2 Doziranje i način primjene CIAMBRA se smije primjenjivati samo pod nadzorom liječnika kvalificiranog za primjenu antitumorske kemoterapije.
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 značajne toksičnosti prema CTC kriterijima prijavljene u < 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijsku reakciju/preosjetljivost, multiformni eritem, supraventrikularnu aritmiju i plućnu emboliju.
English: The pharmacokinetic properties of pemetrexed are not influenced by concurrently administered cisplatin.
Croatian: Istodobna primjena cisplatin ne utječe na farmakokinetička svojstva pemetrekseda.
English: The vial contains 100 mg or 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Bočica sadrži 100 mg ili 500 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: If you have pain, redness, swelling or sores in your mouth.
Croatian: ako počnete osjećati bol u prsištu ili ubrzani broj otkucaja srca. ako imate bolove, crvenilo, oteklinu ili ranice u ustima.
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 značajne toksičnosti prema CTC kriterijima prijavljene u < 1% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju aritmiju i motornu neuropatiju.
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 blagom do umjerenom bubrežnom insuficijencijom koji mogu biti liječeni pemetreksedom, uzimanje NSAIL-a 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: Eye disorders Common Conjunctivitis
Croatian: Poremećaji oka često konjunktivitis
English: If pemetrexed solutions contact the mucous membranes, flush thoroughly with water.
Croatian: Ako otopina pemetrekseda dođe u dodir sa sluznicom, operite je temeljito vodom.
English: CIAMBRA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Croatian: CIAMBRA je u kombinaciji s cisplatinom indicirana za liječenje bolesnika s neoperabilnim malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju.
English: Polyglutamated metabolites have an increased intracellular half-life resulting in prolonged drug action in malignant cells.
Croatian: Poluvrijeme poliglutamatnih metabolita u stanici je produljeno, zbog čega se produljuje i djelovanje lijeka na maligne stanice.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava često neuropatijasenzorna
English: Log Rank p-value* Time to treatment failure (months) (95 % CI)
Croatian: Log-rang p-vrijednost* Medijan vremena do progresije tumora (mjeseci) (95 % CI)
English: **According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
Croatian: ** Prema CTC Nacionalnog Instituta za rak (v2.0; NCI 1998), alopecija se treba prijavljivati samo kao stupanj 1 ili 2.
English: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
Croatian: *Za sve stupnjeve toksičnosti vidjeti CTC Nacionalnog instituta za rak, verzija 2.
English: SGOT (AST) elevation
Croatian: SGOT-a (AST-a)
English: Loss of sensation
Croatian: Gubitak osjeta
English: CIAMBRA 100 mg powder for concentrate for solution for infusion CIAMBRA 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: CIAMBRA 100 mg prašak za koncentrat za otopinu za infuziju CIAMBRA 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Unopened vial 2 years
Croatian: 2 godine
English: If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (may indicate a blood clot in the blood vessels of the lungs)
Croatian: ako iznenada osjetite nedostatak zraka, osjećate intenzivnu bol u prsima ili iskašljavate krv
English: If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal).
Croatian: crvenkastu ili blago ružičastu boju mokraće, neočekivane modrice (budući da možete imati manje krvnih pločica nego što je normalno).
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: Klinički značajne toksičnosti prema CTC kriterijima, prijavljene u ≥ 1 % i < 5 % bolesnika randomiziranih u skupinu koja je primala pemetreksed uključuju: infekciju bez neutropenije, febrilnu neutropeniju, alergijsku reakciju/preosjetljivost, povišene vrijednosti kreatinina, motornu neuropatiju, senzornu neuropatiju, multiformni eritem i bol u abdomenu.
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: Hydrochloric acid (pH adjustment) Sodium hydroxide (pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari manitol (E421) kloridna kiselina (za prilagodbu pH) natrijev hidroksid (za prilagodbu pH)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Tel: +421 2 544 30 730 SI Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o.
Croatian: SK Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730 SI Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160 UK A.
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: CIAMBRA 100 mg contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Croatian: CIAMBRA 100 mg sadržimanje od 1mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija..
English: Breast-feeding must be discontinued during pemetrexed therapy (see section
Croatian: Dojenje se tijekom liječenja pemetreksedom mora prekinuti (vidjeti dio 4.3).
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.
Croatian: * P-vrijednosti <0,05 za usporedbu pemetreksed/cisplatin u odnosu na gemcitabin/cisplatin uz primjenu Fisherova egzaktnog testa.
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Croatian: Klinički značajne toksičnosti prema CTC kriterijima bilo kojeg stupnja, prijavljene u ≥ 1% i < 5 % bolesnika randomiziranih da primaju pemetreksed uključuju: febrilnu neutropeniju, infekciju, snižen broj trombocita, proljev, konstipaciju, alopeciju, pruritus/svrbež, vrućicu (bez neutropenije), bolest površine oka (uključujući konjunktivitis), pojačano suzenje, omaglicu i motornu neuropatiju.
English: EMPHACIS, a multicentre, 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 prethodno nisu 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: The vial is covered with a shrink-wrapped plastic sleeve.
Croatian: Bočica je prekrivena plastičnom navlakom („shrink-wrapped“).
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: 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,
Croatian: U multicentričnom, randomiziranom, dvostrukoslijepom, placebom kontroliranom ispitivanju faze III uspoređivala se djelotvornost i sigurnost liječenja pemetreksedom kao terapijom održavanja 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,
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, and administered as an intravenous infusion over 10 minutes.
Croatian: Odgovarajući volumen rekonstituirane otopine pemetrekseda mora se dodatno razrijediti otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa, do ukupnog volumena od 100 ml i dati u intravenskoj infuziji tijekom 10 minuta.
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 CTC Nacionalnog Instituta za rak (v2.0; NCI 1998), poremećaj osjeta okusa i alopecija trebaju se prijavljivati samo kao stupanj 1 ili 2.
English: Method of administration For precautions to be taken before handling or administering CIAMBRA, see section 6.6.
Croatian: Za mjere opreza koje treba poduzeti prije rukovanja lijekom ili primjene lijeka CIAMBRA, vidjeti dio
English: Nadir platelets <50,000/mm with bleeding a,
Croatian: Najniži broj trombocita <50 000/mm3 uz krvarenjea, bez obzira na najniži ABN
English: CIAMBRA in combination with cisplatin The recommended dose of CIAMBRA is 500 mg/m of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Croatian: U bolesnika koji se liječe zbog raka pluća nemalih stanica nakon prethodne kemoterapije, preporučena doza lijeka CIAMBRA iznosi 500 mg/m2 tjelesne površine, primijenjene intravenskom infuzijom tijekom 10 minuta, prvog dana svakog 21-dnevnog ciklusa.
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 postiglo 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 4,0 odnosno 2,0 mjeseca) (omjer hazarda = 0,60 (95% CI = 0,49 -0,73, p < 0,00001).
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 koja je primala placebo (omjer hazarda = 0,59; 95% CI = 0,47
English: Concomitant yellow fever vaccine (see section 4.5).
Croatian: Istodobno cijepljenje cjepivom protiv žute groznice (vidjeti dio 4.5) 4.4 Posebna upozorenja i mjere opreza pri uporabi
English: Taste disturbance 8.1
Croatian: Sukladno tome ažurira se dio 4.8
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).
Croatian: Ako se uključi i faza uvodnog liječenja, medijan ukupnog preživljenja bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice bio je 18,6 mjeseci u skupini koja je primala pemetreksed te 13,6 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,71 (95% CI = 0,56-0,88, p = 0,002).
English: CIAMBRA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: CIAMBRA 500 mg: jedna bočica sadrži 500 miligrama pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
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 CIAMBRA therapy.
Croatian: Radijacijski pneumonitis (oštećenje plućnih alveola povezano sa zračenjem) može se pojaviti u bolesnika koji su liječeni zračenjem prije, tijekom ili nakon liječenja lijekom CIAMBRA