FrancophonIA/ELRC3.0 huggingface dataset:
English: The 1 year and 2 year survival rates for patients on ALIMTA were 58% and 32% respectively, compared to 45% and 21% for patients on placebo.
Croatian: Za bolesnike liječene lijekom ALIMTA stopa jednogodišnjeg preživljenja iznosila je 58%, a stopa dvogodišnjeg preživljenja 32%, u usporedbi s 45% odnosno 21% za bolesnike koji su primali placebo.
English: The dose of ALIMTA is 500 milligrams for every square metre of your body's surface area.
Croatian: Kako se primjenjuje ALIMTA Doza lijeka ALIMTA je 500 miligrama po svakom kvadratnom metru Vaše površine tijela.
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), enzima ovisnih o folatima i ključnih za de novo biosintezu timidinskih i purinskih nukleotida.
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Croatian: Rezultati in vitro ispitivanja na ljudskim jetrenim mikrosomima pokazali su da pemetreksed vjerojatno neće izazivati klinički značajnu inhibiciju metaboličkog klirensa lijekova koji se metaboliziraju posredstvom CYP3A, CYP2D6,
English: Non-inferiority p-value (HR) Progression free survival (months) Median
Croatian: 95% CI za HR p-vrijednost za neinferiornost (HR) Preživljenje bez progresije bolesti (mjeseci) medijan
English: DATE OF REVISION OF THE TEXT Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: Patients received a median of 5 cycles of maintenance treatment with ALIMTA and 3.5 cycles of placebo.
Croatian: Bolesnici su primili medijan od 5 ciklusa terapije održavanja lijekom ALIMTA i 3,5 ciklusa placeba.
English: Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Croatian: Mnogi bolesnici u kojih se to dogodilo imali su podležeće čimbenike rizika za razvoj bubrežnih događaja, uključujući dehidraciju,
English: ALIMTA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Croatian: ALIMTA se također primjenjuje u kombinaciji s cisplatinom za početno liječenje bolesnika s uznapredovalim stadijem raka pluća.
English: Docetaxel N = 276
Croatian: Docetaksel N = 276
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: 50 % of previous dose
Croatian: 50% prethodne doze
English: Patients should discontinue therapy if Grade 3 or 4 neurotoxicity is observed.
Croatian: Tablici 3. Liječenje se mora prekinuti ako se ustanovi neurotoksičnost stupnja 3 ili 4.
English: LIST OF EXCIPIENTS Mannitol, hydrochloric acid, sodium hydroxide (see package leaflet for further information).
Croatian: Manitol, kloridna kiselina, natrijev hidroksid (za dodatne informacije vidjeti uputu o lijeku).
English: Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Croatian: Među rijetko zabilježene događaje ubrajaju se Stevens-Johnsonov sindrom i toksična epidermalna nekroliza.
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** which is derived from the term “renal/genitourinary other”.
Croatian: * Za sve stupnjeve toksičnosti vidjeti CTC NCI verziju 2, osim za izraz „smanjen klirens kreatinina“ ** Izveden iz izraza „ostali bubrežni/genitourinarni poremećaji“.
English: Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis
Croatian: Bulozna stanja (bolesti kože kod kojih se stvaraju mjehurići na koži) - uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu
English: Adenocarcinoma (N=847)
Croatian: Adenokarcinom (N=847)
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm3 and platelets should be ≥ 100,000 cells/mm3.
Croatian: Prije početka svakog ciklusa kemoterapije bolesnici moraju imate sljedeće vrijednosti laboratorijskih parametara: apsolutni broj neutrofila (ABN) mora biti ≥ 1500 stanica/mm3, a broj trombocita mora biti ≥ 100 000 stanica/mm3.
English: **** Combined term includes increased serum/blood creatinine, decreased glomerular filtration rate, renal failure and renal/genitourinary- other.
Croatian: **** Združeni termin obuhvaća povišene vrijednosti kreatinina u serumu/krvi, smanjenu brzinu glomerularne filtracije, zatajenje bubrega i ostale poremećaje bubrega/genitourinarnog sustava.
English: Unopened vial This medicinal product does not require any special storage conditions.
Croatian: Lijek ne zahtijeva posebne uvjete čuvanja.
English: The relative treatment effect of ALIMTA 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: 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: - If you have further questions, please ask your doctor or pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Administration of pemetrexed to pregnant mice resulted in decreased foetal viability, decreased foetal weight, incomplete ossification of some skeletal structures and cleft palate.
Croatian: Primjena pemetrekseda u gravidnih ženki miševa rezultirala je smanjenjem preživljenja i tjelesne težine ploda, nepotpunim okoštavanjem nekih koštanih struktura i pojavom rascjepa nepca.
English: In patients with normal renal function (creatinine clearance > 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acid at higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Croatian: U bolesnika s normalnom funkcijom bubrega (klirens kreatinina ≥ 80 ml/min) visoke doze nesteroidnih protuupalnih lijekova (NSAIL, npr. ibuprofen > 1600 mg na dan) i više doze acetilsalicilatne kiseline (≥ 1,3 g na dan) mogu smanjiti eliminaciju pemetrekseda i, posljedično povećati pojavu nuspojava izazvanih pemetreksedom.
English: All patients received study therapy as initial treatment for locally advanced or metastatic NSCLC and patients in both treatment groups were fully supplemented with folic acid and vitamin B12.
Croatian: Svi su bolesnici primali ispitivanu terapiju kao početnu terapiju za lokalno uznapredovali ili metastatski rak pluća nemalih stanica, a uz to su bolesnici u obje ispitne skupine primali i potpun nadomjestak folatne kiseline i vitamina B12.
English: Pemetrexed*** (N =800)
Croatian: Pemetreksed*** (N=800)
English: Efficacy of ALIMTA + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Croatian: Djelotvornost lijeka ALIMTA + cisplatina u odnosu na gemcitabin + cisplatin u prvoj liniji liječenja raka pluća nemalih stanica - ITT populacija i podskupine prema histološkom tipu
English: The ALIMTA maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Croatian: Sigurnosni profili terapije održavanja lijekom ALIMTA bili su podjednaki u ispitivanjima JMEN i PARAMOUNT.
English: OTHER SPECIAL WARNING(S), IF NECESSARY cytotoxic
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: Abbreviation: CI = confidence interval * p-value refers to comparison between arms.
Croatian: Kratice: CI = interval pouzdanosti * p-vrijednost se odnosi na usporedbu između dviju skupina bolesnika
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: Prilagodbe doze Prilagođavanje doze na početku svakog sljedećeg ciklusa mora se temeljiti na najnižem broju krvnih stanica ili najvećoj nehematološkoj toksičnosti u prethodnom ciklusu kemoterapije.
English: During a periodic regulatory review of the use of pemetrexed a number of cases describing pigmentation disorders has been described with a common frequency.
Croatian: Tijekom periodične regulatorne ocjene primjene pemetrekseda opisan je veći broj slučajeva poremećaja pigmentacije, čija je učestalost bila česta.
English: As a result there is sufficient evidence suggesting a causal relationship between the use of pemetrexed and infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue including acute bacterial dermo-hypodermitis, cellulitis, pseudocellulitis and dermatitis.
Croatian: Stoga postoji dovoljno dokaza koji ukazuju na uzročnu povezanost primjene pemetrekseda i infektivnih te neinfektivnih poremećaja dermisa, hipodermisa i/ili supkutanog tkiva, uključujući akutnu bakterijsku upalu dermisa i hipodermisa, celulitis, pseuodcelulitis i dermatitis.
English: Not known: frequency cannot be estimated from the available data Lower limb swelling with pain and redness Increased urine output
Croatian: Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) Oticanje donjih udova praćeno boli i crvenilom Povećano stvaranje mokraće
English: Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Croatian: Imunološki posredovana hemolitička anemija (razaranje crvenih krvnih stanica posredstvom protutijela)
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 which is very common).
Croatian: ako imate krvarenje iz desni, nosa ili usta ili bilo kakvo krvarenje koje ne prestaje, crvenkastu ili ružičastu boju mokraće, neočekivane modrice (jer broj krvnih pločica može biti niži od normalnog, što je vrlo česta pojava).
English: Discard unused contents appropriately.
Croatian: Neiskorišteni sadržaj propisno zbrinite.
English: Other (N=252)
Croatian: Drugi oblici (N=252)
English: For intravenous use after reconstitution and dilution.
Croatian: Za primjenu u venu nakon pripreme otopine i razrjeđivanja.
English: ALIMTA must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Croatian: ALIMTA se smije primjenjivati samo pod nadzorom liječnika koji je obučen za primjenu antitumorske kemoterapije.
English: When prepared as directed, reconstituted and infusion solutions of ALIMTA contain no antimicrobial preservatives.
Croatian: Kada se pripremaju prema uputama, rekonstituirana otopina i otopina za infuziju lijeka ALIMTA ne sadrže antimikrobne konzervanse.
English: Data from the originator medicinal product identified 141 cases of pigmentation disorders such as hyperpigmentation (n=48) and pigmentation disorders NEC (n=80) corresponding mostly to blackish or increased pigmentation, positive de-challenge and positive re-challenge in a number of cases was also described.
Croatian: Na temelju podataka za izvorni lijek utvrđen je 141 slučaj poremećaja pigmentacije, kao što su hiperpigmentacija (n=48) i poremećaji pigmentacije koji nisu drugdje svrstani (n=80), a koji su se prvenstveno očitovali kao crnkasta ili pojačana pigmentacija.
English: Uncommon cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Croatian: Slučajevi akutnog zatajenja bubrega prijavljeni su manje često kod primjene pemetrekseda samog ili u kombinaciji s drugim kemoterapeuticima (vidjeti dio 4.4).
English: During post marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
Croatian: Tijekom praćenja nakon stavljanja lijeka u promet u bolesnika liječenih pemetreksedom prijavljene su sljedeće nuspojave:
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
Croatian: Kratice: CI = interval pouzdanosti; HR = omjer hazarda; ITT = populacija svih uključenih bolesnika; N = ukupan broj bolesnika.
English: ≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with ALIMTA.
Croatian: Ukupno je 213 bolesnika (48,3%) završilo ≥ 6 ciklusa, dok su 103 bolesnika (23,4%) završila ≥ 10 ciklusa liječenja lijekom ALIMTA.
English: The percentage of patients that received post study treatment was 64.3% for ALIMTA and 71.7% for placebo.
Croatian: Postotak bolesnika koji su liječeni nakon završetka ispitivanja iznosio je 64,3% u skupini koja je primala lijek ALIMTA te 71,7% u skupini koja je primala placebo.
English: If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common).
Croatian: ako osjetite umor, nesvjesticu, nedostatak zraka ili ste blijedi (jer razina hemoglobina može biti niža od normalne, što je vrlo česta pojava).
English: Tel: +371 6 7364000
Croatian: Tel: +371 6 7364000 Lietuva
English: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Croatian: Kao i kod svih potencijalno toksičnih protutumorskih lijekova, treba biti oprezan pri rukovanju i pripremi otopine pemetrekseda za infuziju.
English: In the data from the originator product, 91 cases of cellulitis, 42 of dermatitis, 13 cases of dermo-hypodermitis, and 3 cases of pseudocellulitis were identified.
Croatian: 42 slučaja dermatitisa, 13 slučajeva upale dermisa i hipodermisa te 3 slučaja pseudocelulitisa.
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), ALIMTA should be withheld until resolution to less than or equal to the patient's pre-therapy value.
Croatian: Razvije li se u bolesnika nehematološka toksičnost stupnja ≥ 3 (osim neurotoksičnosti), primjena lijeka ALIMTA mora se prekinuti dok se vrijednosti ne vrate na razinu prije liječenja ili nižu.
English: However patients with hepatic impairment such as bilirubin > 1.5 times the upper limit of normal and/or aminotransferase > 3.0 times the upper limit of normal (hepatic metastases absent) or > 5.0 times the upper limit of normal (hepatic metastases present) have not been specifically studied.
Croatian: Međutim, nisu posebno ispitivani bolesnici s oštećenjem jetre u kojih je vrijednost bilirubina bila > 1,5 puta iznad gornje granice normale i/ili vrijednost aminotransferaza > 3,0 puta iznad gornje granice normale (bez metastaza u jetri) odnosno > 5,0 puta iznad gornje granice normale (uz metastaze u jetri).
English: Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
Croatian: Otopina pemetrekseda za infuziju pripremljena na opisani način kompatibilna je s infuzijskim priborom i infuzijskim vrećicama od polivinilklorida i poliolefina.
English: It is not known whether pemetrexed is excreted in human milk and adverse reactions on the suckling child cannot be excluded.
Croatian: Nije poznato izlučuje li se pemetreksed u majčino mlijeko pa se mogu isključiti nuspojave na dojenče.
English: 50 % of previous dose a 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: ALIMTA 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: ALIMTA 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: The separation between the treatment arms was achieved by improvement in lung function in the ALIMTA/cisplatin arm and deterioration of lung function over time in the control arm.
Croatian: Skupine su se razlikovale i po tome što se u bolesnika liječenih kombinacijom ALIMTA/cisplatin funkcija pluća poboljšala, dok se u kontrolnoj skupini s vremenom pogoršavala.
English: Table 3 - Dose modification table for ALIMTA (as single agent or in combination) and cisplatin - Neurotoxicity
Croatian: Tablica 3 - Tablica za prilagodbu doze lijeka ALIMTA (u monoterapiji ili u kombinaciji) i cisplatina - neurotoksičnost
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: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Croatian: Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: All Grades toxicity
Croatian: Svi stupnjevi toksičnosti
English: ALIMTA is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Croatian: ALIMTA se također primjenjuje u bolesnika s uznapredovalim rakom pluća u kojih je bolest napredovala nakon primjene neke druge početne kemoterapije.
English: Side effects with ALIMTA may include:
Croatian: Moguće nuspojave lijeka ALIMTA su:
English: Each pack of ALIMTA consists of one ALIMTA vial.
Croatian: Svako pakiranje lijeka ALIMTA sadrži jednu bočicu lijeka ALIMTA.
English: Pemetrexed has a steady-state volume of distribution of 9 l/m2.
Croatian: Volumen distribucije pemetrekseda u stanju dinamičke ravnoteže iznosi 9 l/m2.
English: Women must use effective contraception during treatment with ALIMTA.
Croatian: Žene moraju primjenjivati djelotvornu kontracepciju tijekom liječenja lijekom ALIMTA.
English: Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer's injection and Ringer's injection.
Croatian: Pemetreksed je fizikalno inkompatibilan s otapalima koja sadrže kalcij, uključujući Ringerovu otopinu s laktatom i Ringerovu otopinu za injekcije.
English: A phase 2 study of pemetrexed in 31 solid tumour patients with stable third space fluid demonstrated no difference in pemetrexed dose normalized plasma concentrations or clearance compared to patients without third space fluid collections.
Croatian: U ispitivanju pemetrekseda faze II u 31 bolesnika sa solidnim tumorom i stabilnom tekućinom u transcelularnom prostoru nije uočena razlika u koncentracijama pemetrekseda u plazmi normaliziranima za dozu, kao ni u klirensu pemetrekseda, u usporedbi s bolesnicima koji nisu imali nakupljanje tekućine u transcelularnom prostoru.
English: Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Croatian: Za vrijeme liječenja pemetreksedom dojenje se mora prekinuti (vidjeti dio 4.3).
English: For Precautions to be taken before handling or administering ALIMTA, see section 6.6.
Croatian: Za mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka ALIMTA vidjeti dio 6.6.
English: After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Croatian: Nakon pripreme, otopina sadrži 25 mg/ml pemetrekseda.
English: 8.3 months for patients treated with ALIMTA (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Croatian: Intent-To-Treat [ITT], N=283), a u bolesnika liječenih docetakselom 7,9 mjeseci (ITT populacija, N = 288).
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1500 cells/mm3 and platelet count returns to ≥ 100,000 cells/mm3.
Croatian: U bolesnika se tijekom liječenja moraju pratiti pokazatelji mijelosupresije i pemetreksed se ne smije davati sve dok apsolutni broj neutrofila (ABN) ne bude ≥ 1500 stanica/mm3, a broj trombocita ≥ 100 000 stanica/mm3.
English: Large cell (N=153)
Croatian: Karcinom velikih stanica (N=153)
English: Children and adolescents There is no relevant use of ALIMTA in the paediatric population
Croatian: ALIMTA nema relevantne primjene u pedijatrijskoj populaciji.
English: Cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to their pemetrexed therapy.
Croatian: Prijavljeni su slučajevi radijacijskog pneumonitisa u bolesnika koji su prije, tijekom ili poslije terapije pemetreksedom liječeni zračenjem.
English: Cases of radiation recall have been reported in patients who received radiotherapy weeks or years previously.
Croatian: Prijavljeni su slučajevi radijacijskog „recall“ dermatitisa u bolesnika koji su primali radioterapiju prije više tjedana ili godina.
English: There is no relevant use of ALIMTA in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Croatian: Pedijatrijska populacija Nema relevantne primjene lijeka ALIMTA u pedijatrijskoj populaciji za indikaciju malignog pleuralnog mezotelioma i raka pluća nemalih stanica.
English: Rare cases of radiation recall have been reported in patients who have received radiotherapy previously (see section 4.4).
Croatian: Slučajevi „recall“ radijacijskog dermatitisa prijavljeni su rijetko u bolesnika koji su prethodno liječeni radioterapijom (vidjeti dio 4.4).
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the ALIMTA arm versus 21.7% on the placebo arm.
Croatian: 28,7% bolesnika u skupini liječenoj lijekom ALIMTA bilo je živo ili izgubljeno iz praćenja, u odnosu na 21,7% bolesnika u skupini koja je primala placebo.
English: A hospital pharmacist, nurse or doctor will have mixed the ALIMTA powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Croatian: Prije primjene lijeka ALIMTA bolnički ljekarnik, medicinska sestra ili liječnik će pomiješati ALIMTA prašak s otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%).