FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the randomised patients, 44.9% had a complete/partial response and 51.9% had a response of stable disease to pemetrexed plus cisplatin induction.
Croatian: Od svih randomiziranih bolesnika njih je 44,9% imalo kompletan/djelomičan odgovor na uvodno liječenje lijekom pemetreksed u kombinaciji s cisplatinom, a 51,9% njih odgovor u obliku stabilne bolesti.
English: Patients received a median of 4 cycles of maintenance treatment with pemetrexed and 4 cycles of placebo.
Croatian: Bolesnici su primili medijan od 4 ciklusa terapije održavanja lijekom pemetreksed i 4 ciklusa placeba.
English: How to store Armisarte
Croatian: Kako čuvati Armisarte
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.
Croatian: Odgovarajući volumen pemetreksed koncentrata mora se razrijediti 5%-tnom otopinom glukoze do ukupnog volumena od 100 ml i primijeniti kao intravenska infuzija tijekom 10 minuta.
English: 11 Ion Mihalache Blvd. 011171 Bucharest Romania
Croatian: S.C. Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd. 011171 Bucharest Rumunjska
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.
Croatian: Liječenje pemetreksedom se mora obustaviti ako se u bolesnika pojavi bilo kakva hematološka ili nehematološka toksičnost stupnja 3 ili 4 nakon dvaju sniženja doze, odnosno odmah kada se ustanovi neurotoksičnost stupnja 3 ili 4.
English: Armisarte is provided in a colourless glass vial with rubber stopper and an aluminium cap with polypropylene disk.
Croatian: Armisarte je dostupan u bočici od bezbojnog stakla s gumenim čepom i aluminijskim zatvaračem s polipropilenskim diskom.
English: Patients received a median of 5 cycles of maintenance treatment with pemetrexed and 3.5 cycles of placebo.
Croatian: Bolesnici su primili medijan od 5 ciklusa terapije održavanja lijekom pemetreksed i 3,5 ciklusa placeba.
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.
Croatian: Ako ste primali ili ćete primati terapiju zračenjem, obavijestite o tome svog liječnika jer se uz primjenu lijeka Armisarte mogu pojaviti rane ili kasne reakcije na zračenje.
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.
Croatian: Vitaminska nadoknada: liječnik će Vam propisati folatnu kiselinu (vitamin) koja se uzima kroz usta ili multivitaminski pripravak koji sadrži folatnu kiselinu (350 do 1000 mikrograma), koji morate uzimati jedanput na dan za vrijeme liječenja lijekom Armisarte.
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.
Croatian: Manja toksičnost i smanjenje hematološke i nehematološke toksičnosti stupnja 3/4, poput neutropenije, febrilne neutropenije i infekcija praćenih neutropenijom stupnja 3/4 prijavljene su kada je primijenjeno prethodno liječenje folatnom kiselinom i vitaminom B12.
English: The pemetrexed maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Croatian: Sigurnosni profili terapije održavanja lijekom pemetreksed bili su podjednaki u ispitivanjima JMEN i PARAMOUNT.
English: Response rate (%) (95 % CI) Stable disease (%)
Croatian: Odgovor (n: broj bolesnika u kojih se mogao ocijeniti odgovor) stopa odgovora (%) (95% CI) stabilna bolest (%)
English: Median HR (95 % CI)
Croatian: HR (95% CI)
English: Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza “Rok valjanosti“.
English: Armisarte is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Croatian: Armisarte se također primjenjuje u kombinaciji s cisplatinom za početno liječenje bolesnika s uznapredovalim stadijem raka pluća.
English: For instructions on dilution of Armisarte before administration, see section 6.6.
Croatian: Za upute o razrjeđivanju lijeka Armisarte prije primjene, vidjeti dio 6.6.
English: The percentage of patients that received post study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Croatian: Postotak bolesnika koji su liječeni nakon završetka ispitivanja iznosio je 64,3% u skupini koja je primala lijek pemetreksed te 71,7% u skupini koja je primala placebo.
English: The concentrate is clear, colourless to slightly yellowish or yellow-greenish solution.
Croatian: Koncentrat je bistra, bezbojna do blago žućkasta ili žuto-zelenkasta otopina.
English: For precautions to be taken before handling or administering pemetrexed, see section 6.6.
Croatian: Za mjere opreza koje treba poduzeti prije rukovanja lijekom ili primjene pemetrekseda, vidjeti dio 6.6.
English: Docetaxel N=276
Croatian: Docetaksel N = 276
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.
Croatian: Relativan učinak liječenja lijekom pemetreksed bio je konzistentan u svim podskupinama (uključujući podskupine prema stadiju bolesti, odgovoru na uvodno liječenje, ECOG izvedbeni status, pušački status, spol, histološki tip tumora i dob) te podjednak onome opaženom u nekorigiranim analizama OS-a i PFS-a.
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
Croatian: Kratice: CI = interval pouzdanosti; HR = omjer hazardahazarda; ITT = populacija svih uključenih bolesnika; n = ukupan broj bolesnika.
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).
Croatian: Ograničeni klinički podaci iz zasebnog randomiziranog kontroliranog ispitivanja faze III ukazuju na to da su podaci o djelotvornosti (ukupno preživljenje, preživljenje bez progresije bolesti) za pemetreksed podjednaki u bolesnika prethodno liječenih docetakselom (n = 41) i bolesnika koji prethodno nisu primali docetaksel (n = 540).
English: Pemetrexed belongs to a group of medicines known as folic acid analogues and disrupts processes that are essential for cells to divide.
Croatian: Pemetreksed pripada grupi lijekova pod imenom analozi folatne kiseline koji ometaju procese nužne za diobu stanice.
English: Dose adjustments at the start of a subsequent cycle should be based on nadir haematologic counts or maximum non-haematologic toxicity from the preceding cycle of therapy.
Croatian: Prilagođavanje doze na početku svakog ciklusa mora se temeljiti na najnižem broju krvnih stanica ili najvećoj nehematološkoj toksičnosti u prethodnom ciklusu kemoterapije.
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Armisarte.
Croatian: Vam se uzorak krvi kako bi se provjerilo jesu li Vam bubrežna ili jetrena funkcija dovoljno dobre i imate li dovoljno krvnih stanica da biste primili lijek Armisarte.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja lijeka nakon razrijeđenja, vidjeti dio 6.3.
English: - Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis - Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) - Hepatitis (inflammation of the liver) - Anaphylactic shock (severe allergic reaction)
Croatian: Johnsonov sindrom i toksičnu epidermalnu nekrolizu - imunološki posredovana hemolitička anemija (anemija koja nastaje kao posljedica razaranja crvenih krvnih stanica) - hepatitis (upala jetre) - anafilaktički šok (teška alergijska reakcija)
English: Gemcitabine/ cisplatin (N=830)
Croatian: Gemcitabin/ Cisplatin (N = 830)
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.
Croatian: Armisarte se primjenjuje u kombinaciji s cisplatinom, još jednim protutumorskim lijekom, za liječenje zloćudnog pleuralnog mezotelioma, oblika raka koji zahvaća plućne ovojnice, u bolesnika koji prethodno nisu primali kemoterapiju.
English: Efficacy of pemetrexed vs docetaxel in NSCLC - ITT population Pemetrexed
Croatian: Djelotvornost lijeka pemetreksed u odnosu na docetaksel kod NSCLC - ITT populacija Pemetreksed
English: The other ingredients are trometamol (for pH adjustment), anhydrous citric acid, methionine and water for injection.
Croatian: Drugi sastojci su trometamol (za podešavanje pH vrijednosti), bezvodna citratna kiselina, metionin i voda za injekcije
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).
Croatian: Klinički značajni oblici toksičnosti stupnja 3 i 4 utvrđeni laboratorijskim pretragama bili su podjednaki u objedinjenim rezultatima triju ispitivanja faze II pemetrekseda u monoterapiji (n = 164) i rezultatima gore opisanog kliničkog ispitivanja faze III pemetrekseda u monoterapiji, s iznimkom neutropenije (12,8% naspram 5,3%) i povišenih vrijednosti alanin aminotransferaze (15,2% naspram
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Croatian: Djelotvornost lijeka pemetreksed + cisplatin u odnosu na gemcitabin + cisplatin u prvoj liniji liječenja raka pluća nemalih stanica - ITT populacija i podskupine prema histološkom tipu
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzimali ili biste mogli uzeti bilo koji lijek, uključujući lijek protiv bolova ili upale (otekline), poput lijekova iz skupine takozvanih
English: Patients also required lower administration of erythropoietin/darbopoietin (10.4% versus 18.1%, p<0.001), G-CSF/GM-CSF (3.1% versus 6.1%, p=0.004), and iron preparations (4.3% versus 7.0%, p=0.021).
Croatian: U tih je bolesnika također rjeđe trebalo primijeniti eritropoetin/darbopoetin (10,4% naspram 18,1%, p<0,001), G-CSF/GM-CSF (3,1% naspram 6,1%, p = 0,004) i pripravke željeza (4,3% naspram 7,0%, p = 0,021).
English: Side effects with Armisarte may include:
Croatian: Moguće nuspojave lijeka Armisarte su:
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
Croatian: EU/1/15/1063/001 bočica od 4 ml EU/1/15/1063/002 bočica od 20 ml EU/1/15/1063/004 bočica od 34 ml EU/1/15/1063/003 bočica od 40 ml
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.
Croatian: Armisarte se također primjenjuje u bolesnika s uznapredovalim rakom pluća u kojih je bolest napredovala nakon primjene neke druge početne kemoterapije.
English: 4 ml vial 20 ml vial 34 ml vial 40 ml vial
Croatian: 4 ml bočica 20 ml bočica 34 ml bočica 40 ml bočica
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.
Croatian: Preživljenje bez progresije bolesti (PFS) i stopa ukupnog odgovora bili su podjednaki između terapijskih skupina: medijan PFS-a iznosio je 4,8 mjeseci za lijek pemetreksed i cisplatin u usporedbi s 5,1 mjeseci za gemcitabin i cisplatin (prilagođen omjer hazardahazarda 1,04; 95% CI = 0,94-1,15), a stopa ukupnog odgovora bila je 30,6% (95% CI = 27,3-33,9) za lijek pemetreksed i cisplatin u usporedbi s 28,2% (95% CI = 25,0-31,4) za gemcitabin i cisplatin.
English: One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid) One vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid) One vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid) One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid)
Croatian: Jedna bočica s 4 ml koncentrata sadrži 100 mg pemetrekseda (u obliku pemetrekseddikiseline) Jedna bočica s 20 ml koncentrata sadrži 500 mg pemetrekseda (u obliku pemetrekseddikiseline) Jedna bočica s 34 ml koncentrata sadrži 850 mg pemetrekseda (u obliku pemetrekseddikiseline) Jedna bočica s 40 ml koncentrata sadrži 1000 mg pemetrekseda (u obliku pemetrekseddikiseline)
English: Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer's injection and Ringer's injection.
Croatian: Pemetreksed je fizički inkompatibilan s otapalima koja sadrže kalcij, uključujući Ringerovu otopinu s laktatom i Ringerovu otopinu za injekcije.
English: The PFS and OS results in patients with squamous cell histology suggested no advantage for pemetrexed over placebo.
Croatian: Rezultati PFS-a i ukupnog preživljenja u bolesnika s rakom pluća skvamoznih stanica nisu pokazali prednost lijeka pemetreksed nad placebom.
English: Package leaflet: Information for the user Armisarte 25 mg/ml concentrate for solution for infusion pemetrexed
Croatian: Uputa o lijeku: Informacije za korisnika Armisarte 25 mg/ml koncentrat za otopinu za infuziju pemetreksed
English: Fully supplemented Patients
Croatian: Bolesnici s potpunim bolesnici nadomjeskom
English: It contains the active substance pemetrexed.
Croatian: Sadrži djelatnu tvar pemetreksed.
English: Use aseptic techniques during dilution of pemetrexed for intravenous infusion administration.
Croatian: Koristiti aseptičku tehniku kod razrjeđivanja pemetrekseda za primjenu u intravenskoj infuziji.
English: Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4% versus 28.9%, p<0.001), red blood cell transfusions (16.1% versus 27.3%, p<0.001) and platelet transfusions (1.8% versus 4.5%, p=0.002).
Croatian: Bolesnici liječeni lijekom pemetreksed i cisplatinom trebali su manje transfuzija (16,4% naspram 28,9%, p < 0,001), transfuzija eritrocita (16,1% naspram 27,3%, p < 0,001) i transfuzija trombocita (1,8% naspram 4,5%, p = 0,002).
English: National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Croatian: Nacionalnog instituta za rak (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998).
English: How to use Armisarte
Croatian: Kako se primjenjuje Armisarte
English: Nadir platelets <50,000/mm 3 with bleedinga, regardless of nadir ANC
Croatian: Najniži broj trombocita < 50 000/mm3 uz krvarenjea, bez obzira na najniži ABN
English: At the request of the European Medicines Agency;
Croatian: Nadopunjeni RMP treba dostaviti: • Na zahtjev Europske agencije za lijekove.
English: Patient with hepatic impairment
Croatian: Bolesnici s oštećenjem jetre
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.
Croatian: Muškarcima se savjetuje da ne začinju djecu tijekom liječenja i do 6 mjeseci nakon završetka liječenja lijekom Armisarte.
English: Upon recovery patients should be retreated using the guidelines in Tables 1, 2 and 3, which are applicable for pemetrexed used as a single agent or in combination with cisplatin.
Croatian: Nakon oporavka bolesnika treba ponovno liječiti prema smjernicama za primjenu pemetrekseda u monoterapiji ili u kombinaciji s cisplatinom, prikazanima u Tablicama 1, 2 i 3.
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).
Croatian: Pemetreksed je indiciran kao monoterapija u terapiji održavanja lokalno uznapredovalog ili metastatskog raka pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice u bolesnika u kojih bolest nije napredovala neposredno nakon kemoterapije na bazi platine (vidjeti dio 5.1).
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)
Croatian: PARAMOUNT: Kaplan Meierova krivulja preživljenja bez progresije bolesti (PFS) i ukupnog preživljenja (OS) za nastavak terapije održavanja lijekom pemetreksed u odnosu na placebo u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (mjereno od randomizacije)
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.
Croatian: Otopina za infuziju: Pokazalo se da je otopina za infuziju lijeka pemetreksed fizikalno i kemijski stabilna tijekom 3 dana na sobnoj temperaturi i 21 dana ako se čuva u hladnjaku.
English: Women must use effective contraception during treatment with Armisarte.
Croatian: Žene moraju primjenjivati djelotvornu kontracepciju tijekom liječenja lijekom Armisarte
English: Extravasation should be managed by local standard practice as with other non-vesicants.
Croatian: Ekstravazaciju treba zbrinuti sukladno standardnoj lokalnoj praksi za lijekove koji nisu vezikant.
English: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Croatian: JMEN: Kaplan Meierova krivulja preživljenja bez progresije bolesti (PFS) i ukupnog preživljenja uz primjenu lijeka pemetreksed u odnosu na placebo u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice:
English: There were no clinically relevant differences observed for the safety profile of pemetrexed within the histology subgroups.
Croatian: Nisu uočene klinički značajne razlike u sigurnosnom profilu lijeka pemetreksed unutar podskupina prema histološkom tipu.
English: In vitro studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Croatian: Ispitivanja in vitro pokazala su da pemetreksed djeluje antifolatno na više načina, inhibirajući timidilat sintetazu (TS), dihidrofolat reduktazu (DHFR) i glicinamid ribonukleotid formiltransferazu (GARFT),
English: The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of AC versus GC.
Croatian: Analize djelotvornosti na PQ populaciji konzistentne su s analizom ITT populacije i podupiru neinferiornost kombinacije pemetreksed /cisplatin naspram kombinacije gemcitabin/cisplatin.
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: Tablica koja slijedi prikazuje učestalost i težinu nuspojava za koje se smatra da bi mogle biti povezane 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 the pemetrexed/cisplatin arm, randomized and treated (N=225) and fully supplemented (N=167)
Croatian: ** Skupina liječena kombinacijom pemetreksed/cisplatin, randomizirani i liječeni bolesnici (N = 225) i bolesnici s potpunim nadomjeskom (N = 167) Primjenom ljestvice simptoma raka pluća (eng.
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with Armisarte.
Croatian: - ako dojite; tijekom liječenja lijekom Armisarte morate prestati dojiti.
English: Actavis Italy S.p.A. Viale Pasteur 10
Croatian: Viale Pasteur 10
English: Dose of pemetrexed (mg/m2)
Croatian: Doza pemetrekseda (mg/m2)
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.
Croatian: - radijacijski „recall“ dermatitis (kožni osip poput teške opekline od sunca) koji se može pojaviti na koži prethodno izloženoj zračenju, više dana ili više godina nakon zračenja.
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)
Croatian: Veličine pakiranja 1 x 4 ml bočica (100 mg/4 ml) 1 x 20 ml bočica (500 mg/20 ml) 1 x 34 ml bočica (850 mg/34 ml) 1 x 40 ml bočica (1000 mg/40 ml)
English: Excipients: trometamol, anhydrous citric acid, methionine and water for injections.
Croatian: Pomoćne tvari: trometamol, bezvodna citratna kiselina, bezvodna, metionin i voda za injekcije
English: 11 Ion Mihalache Blvd.
Croatian: S.C. SINDAN-PHARMA S.R.L. 11 Ion Mihalache Blvd.
English: Consistent with other pemetrexed studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Croatian: Kao i u drugim ispitivanjima lijeka pemetreksed, u ispitivanju JMEN opažena je razlika u djelotvornosti s obzirom na histološki tip NSCLC-a.
English: Table 3 - Dose modification table for pemetrexed (as 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: 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.
Croatian: Pokazalo se da je otopina za infuziju lijeka pemetreksed fizički i kemijski stabilna tijekom 3 dana na sobnoj temperaturi i 21 dana ako se čuva u hladnjaku.
English: ***Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
Croatian: Prikazane stope prijavljivanja u skladu su s CTCAE verzijom 3.0. *** Integrirana tablica nuspojava objedinjuje rezultate ispitivanja terapije održavanja pemetreksedom (JMEN) (N=663) i kontinuirane terapije održavanja pemetreksedom (PARAMOUNT) (N=539).