FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of pemetrexed to male mice resulted in reproductive toxicity characterised by reduced fertility rates and testicular atrophy.
Croatian: U mužjaka miševa primjena pemetrekseda je uzrokovala reproduktivnu toksičnost, čija su obilježja bila smanjena stopa plodnosti i atrofija testisa.
English: For instructions on reconstitution and dilution of Pemetrexed Pfizer before administration, see section 6.6
Croatian: Za uputu o rekonstituciji i razrjeđivanju lijeka Pemetreksed Pfizer prije primjene vidjeti dio 6.6.
English: An insufficient number of patients have been studied with creatinine clearance of below 45 ml/min.
Croatian: Nije ispitan dovoljan broj bolesnika s klirensom kreatinina manjim od 45 ml/min.
English: What Pemetrexed Pfizer contains
Croatian: Što Pemetreksed Pfizer sadrži
English: Infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue have been reported with an unknown frequency (e.g. acute bacterial dermo-hypodermitis, pseudocellulitis, dermatitis).
Croatian: Prijavljeni su infektivni i neinfektivni poremećaji dermisa, hipodermisa i/ili supkutanog tkiva, čija je učestalost nepoznata (npr. akutna bakterijska upala dermisa i hipodermisa, pseudocelulitis i dermatitis).
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Croatian: Analiza osjetljivosti glavnih ishoda djelotvornosti obuhvaćala je i populaciju koja je ispunila kriterije protokola za uključenje u ispitivanje (PQ = protocol qualified).
English: Patients randomised to maintenance treatment were required to have an ECOG performance status 0 or 1.
Croatian: Bolesnici randomizirani u skupinu koja je primala terapiju održavanja morali su imati ECOG izvedbeni status 0 ili 1.
English: Preparation and administration precautions: As with other potentially toxic anti-cancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Croatian: Mjere opreza pri pripremanju i primjeni: Kao i kod svih potencijalno toksičnih protutumorskih lijekova, potreban je oprez pri rukovanju i pripremi otopine pemetrekseda za infuziju.
English: At least five doses of folic acid must be taken during the seven days preceding the first dose of pemetrexed, and dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
Croatian: Bolesnici moraju uzeti najmanje pet doza folatne kiseline tijekom sedam dana koji prethode prvoj dozi pemetrekseda te je moraju nastaviti uzimati za cijelog trajanja liječenja i još 21 dan nakon posljednje doze pemetrekseda.
English: Frequency Event**
Croatian: Događaj**
English: Owing to the possibility of pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment.
Croatian: Budući da liječenje pemetreksedom može izazvati trajnu neplodnost, muškarcima se preporučuje da prije početka liječenja potraže savjet o pohrani sperme.
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 te 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: Rare cases of bullous conditions have been reported including Stevens-Johnson syndrome and Toxic epidermal necrolysis which in some cases were fatal.
Croatian: Prijavljeni su rijetki slučajevi buloznih stanja, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, koji su u nekim slučajevima završili smrću.
English: Extravasation should be managed by local standard practice as with other non-vesicants.
Croatian: Ekstravazaciju treba zbrinuti sukladno standardnoj lokalnoj praksi kao za lijekove koji nisu vezikanti.
English: In vitro studies have shown that pemetrexed behaves as a multi-targeted 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: Progression-free survival (months)
Croatian: Preživljenje bez progresije bolesti (mjeseci)
English: Method of administration For Precautions to be taken before handling or administering Pemetrexed Pfizer, see section 6.6.
Croatian: Za mjere opreza koje treba poduzeti prije rukovanja lijekom ili primjene lijeka Pemetreksed Pfizer, vidjeti dio 6.6.
English: The incidence of adverse reactions was evaluated for patients who received ≤6 cycles of pemetrexed maintenance (N=519), and compared to patients who received >6 cycles of pemetrexed (N=281).
Croatian: Incidencija nuspojava ocijenjena je u bolesnika koji su primili ≤ 6 ciklusa pemetrekseda kao terapije održavanja (N=519) te je uspoređena s bolesnicima koji su primili > 6 ciklusa pemetrekseda (N=281).
English: Pemetrexed solutions are for single use only.
Croatian: Otopine pemetrekseda namijenjene su isključivo za jednokratnu primjenu.
English: Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Croatian: Dojenje se mora prekinuti za vrijeme liječenja pemetreksedom (vidjeti dio 4.3).
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 pemetreksed te 71,7% u skupini koja je primala placebo.
English: Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter.
Croatian: Spolno zrelim muškarcima preporučuje se da ne začinju dijete tijekom liječenja i do šest mjeseci po njegovu završetku.
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 sljedećeg ciklusa mora se temeljiti na najnižem broju krvnih stanica ili najvećoj nehematološkoj toksičnosti u prethodnom ciklusu kemoterapije.
English: Skin reactions have been reported in patients not pre-treated with a corticosteroid.
Croatian: Prijavljene su kožne reakcije u bolesnika koji prije početka liječenja nisu uzimali kortikosteroid.
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Croatian: Nakon rekonstitucije (vidjeti dio 6.6), jedna bočica sadrži 25 mg/ml pemetrekseda.
English: Your height and weight are measured to work out the surface area of your body.
Croatian: Površina tijela izračunava se prema Vašoj izmjerenoj visini i težini.
English: Pemetrexed Pfizer must only be further diluted with 5% glucose solution, without preservative.
Croatian: Pemetreksed Pfizer dodatno se smije razrjeđivati isključivo s 5%-tnom otopinom glukoze, bez konzervansa.
English: All grades toxicity
Croatian: Svi stupnjevi toksičnosti
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 s namjerom liječenja; N = ukupan broj bolesnika.
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: The primary analysis of this study was performed on the population of all patients randomly assigned to a treatment arm who received study drug (randomised and treated).
Croatian: Primarnom analizom rezultata ispitivanja obuhvaćeni su svi bolesnici koji su bili randomizirani u skupinu koja je primala ispitivani lijek (randomizirani i liječeni bolesnici).
English: Increases in adverse reactions (all grades) were observed with longer exposure.
Croatian: Zabilježeno je povećanje broja nuspojava (svih stupnjeva) pri duljoj izloženosti lijeku.
English: There is no relevant use of pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Croatian: Nema relevantne primjene pemetrekseda u pedijatrijskoj populaciji za indikaciju malignog pleuralnog mezotelioma i raka pluća nemalih stanica.
English: Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja pemetreksedom (vidjeti dio 4.6).
English: Cases of radiation recall have been reported in patients who received radiotherapy weeks or years previously.
Croatian: Prijavljeni su slučajevi odzivne radijacijske upalne reakcije (engl. radiation recall) u bolesnika koji su primali radioterapiju prije više tjedana ili godina.
English: Do not use Pemetrexed Pfizer - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primati lijek Pemetreksed Pfizer - ako ste alergični na pemetreksed ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako dojite; tijekom liječenja lijekom Pemetreksed Pfizer morate prestati dojiti.
English: Therefore, patients should be cautioned against driving or operating machines if this event occurs.
Croatian: Stoga se bolesnike mora upozoriti da u tom slučaju ne upravljaju vozilima niti rukuju strojevima.
English: Concomitant administration of substances that are also tubularly secreted (e.g., probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Croatian: Istodobna primjena lijekova koji se također uklanjaju tubularnom sekrecijom (npr. probenecid, penicilin) može rezultirati odgođenim klirensom pemetrekseda.
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 pemetreksedom 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 ukupnog preživljenja i PFSa.
English: Other (N = 252)
Croatian: Drugi oblici (N = 252)
English: Patients should be regularly monitored for acute tubular necrosis, decreased renal function and signs and symptoms of nephrogenic diabetes insipidus (e.g. hypernatraemia).
Croatian: Potrebno je redovito praćenje bolesnika zbog moguće pojave akutne tubularne nekroze, smanjenja funkcije bubrega te znakova i simptoma nefrogenog dijabetesa insipidusa (npr. hipernatremija).
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 ispitivane skupine primali i potpuni nadomjestak folatne kiseline i vitamina B12.
English: 50% of previous dose
Croatian: 50% prethodne doze
English: Other undesirable effects include renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis and neuropathy.
Croatian: Ostale nuspojave uključuju bubrežnu toksičnost, povišene vrijednosti aminotransferaza, alopeciju, umor, dehidraciju, osip, infekciju/sepsu i neuropatiju.
English: Once in the cell, pemetrexed is rapidly and efficiently converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase.
Croatian: Kad uđe u stanicu, pemetreksed se pod utjecajem enzima folilpoliglutamat sintetaze brzo i učinkovito pretvara u poliglutamatne oblike.
English: Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia, and anaemia (or pancytopenia) (see section 4.8).
Croatian: Pemetreksed može suprimirati funkciju koštane srži, što se očituje neutropenijom, trombocitopenijom i anemijom (ili pancitopenijom) (vidjeti dio 4.8).
English: Women must use effective contraception during treatment with pemetrexed.
Croatian: Žene moraju primjenjivati djelotvornu kontracepciju tijekom liječenja pemetreksedom.
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 doses (≥ 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: Each vial contains an excess of pemetrexed to facilitate delivery of label amount.
Croatian: Jedna bočica sadrži pemetreksed u suvišku kako bi se olakšala primjena deklarirane količine lijeka.
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: Concomitant administration of nephrotoxic medicinal products (e.g., aminoglycoside, loop diuretics, platinum compounds, ciclosporin) could potentially result in delayed clearance of pemetrexed.
Croatian: Istodobna primjena s nefrotoksičnim lijekovima (npr. aminoglikozidom, diureticima Henleove petlje, spojevima platine, ciklosporinom) može rezultirati odgođenim klirensom pemetrekseda.
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 manji od normalnog, što je vrlo česta pojava)
English: Adenocarcinom a (N = 847)
Croatian: Adenokarcinom (N = 847)
English: Children and adolescents There is no relevant use of pemetrexed in the paediatric population.
Croatian: Nema relevantne primjene pemetrekseda u pedijatrijskoj populaciji.
English: Pemetrexed must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Croatian: Pemetreksed se smije primjenjivati samo pod nadzorom liječnika koji je obučen za primjenu antitumorske kemoterapije.
English: Limited clinical data from a separate randomised, 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 =
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: The separation between the treatment arms was achieved by improvement in lung function in the pemetrexed /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 pemetreksed/cisplatin funkcija pluća poboljšala, dok se u kontrolnoj skupini s vremenom pogoršavala.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Pfizer powder with water for injections and 5% glucose solution for injection before it is given to you.
Croatian: Prije primjene lijeka Pemetreksed Pfizer bolnički ljekarnik, medicinska sestra ili liječnik će pomiješati Pemetreksed Pfizer prašak s vodom za injekcije i 5%-tnom otopinom glukoze za injekciju.
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups
Croatian: Djelotvornost pemetrekseda + cisplatina u odnosu na gemcitabin + cisplatin u prvoj liniji liječenja raka pluća nemalih stanica - ITT populacija i podskupine prema histološkom tipu
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: Pemetrexed undergoes limited hepatic metabolism.
Croatian: Pemetreksed podliježe ograničenom jetrenom metabolizmu.
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Croatian: Kratice: CI = interval pouzdanosti; ITT = populacija s namjerom liječenja; N = ukupan broj bolesnika.
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 1,9%).
English: Patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/or after receiving cisplatin (see also cisplatin Summary of Product Characteristics for specific dosing advice).
Croatian: Prije i/ili nakon primjene cisplatina bolesnici moraju primiti odgovarajući antiemetik i primjerenu hidrataciju (vidjeti i posebne preporuke za doziranje u sažetku opisa svojstava lijeka za cisplatin).
English: These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.
Croatian: Te su razlike vjerojatno posljedica razlika između populacija bolesnika, s obzirom da su u ispitivanja faze II bile uključene i bolesnice s rakom dojke koje prethodno nisu primale kemoterapiju i one koje su prethodno primale više linija terapije i imale metastaze u jetri i/ili abnormalne vrijednosti jetrenih enzima na početku ispitivanja.
English: Women of childbearing potential must use effective contraception during treatment with pemetrexed.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja pemetreksedom.
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 Pemetrexed Pfizer.
Croatian: Ako ste primali ili ćete primati terapiju zračenjem, obavijestite o tome svog liječnika jer se uz primjenu lijeka Pemetreksed Pfizer mogu pojaviti rane ili kasne reakcije na zračenje.
English: However, patients with hepatic impairment, such as bilirubin > 1.5times 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: 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 pemetrekseda nad placebom.
English: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), pemetrexed 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 pemetrekseda mora se prekinuti dok se vrijednosti ne vrate na razinu prije liječenja ili nižu.
English: Pemetrexed is transported into cells by both the reduced folate carrier and membrane folate binding protein transport systems.
Croatian: Pemetreksed se u stanice prenosi i nosačima reduciranih folata i prijenosnim sustavom membranskih proteina koji vežu folate.
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 pri primjeni pemetrekseda samog ili u kombinaciji s drugim kemoterapeuticima (vidjeti dio 4.4).
English: Pemetrexed Pfizer is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Croatian: Pemetreksed Pfizer se također primjenjuje u kombinaciji s cisplatinom za početno liječenje bolesnika s uznapredovalim stadijem raka pluća.
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 5% glucose solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Croatian: Odgovarajući volumen rekonstituirane otopine pemetrekseda mora se dodatno razrijediti 5%-tnom otopinom glukoze za injekciju, bez konzervansa, do ukupnog volumena od 100 ml i primijeniti kao intravenska infuzija tijekom 10 minuta.
English: Pemetrexed is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Croatian: Pemetreksed je protutumorski lijek s višestrukim antifolatnim djelovanjem koji djeluje tako da prekida ključne metaboličke procese ovisne o folatima neophodne za umnažanje stanica.
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1,500 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/mm a broj trombocita ≥ 100 000 stanica/mm
English: Upon recovery, patients should be re-treated 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.