FrancophonIA/ELRC3.0 huggingface dataset:
English: Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Croatian: Koristiti aseptičku tehniku kod rekonstitucije i daljnjeg razrjeđivanja pemetrekseda za primjenu u intravenskoj infuziji.
English: Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Sandoz treatment.
Croatian: Kortikosteroidi: liječnik će Vam propisati tablete kortikosteroida (ekvivalentne dozi deksametazona od 4 mg dvaput na dan) koje ćete morati uzeti dan prije, na sam dan i dan nakon primjene lijeka Pemetrexed Sandoz.
English: Therefore, the use of pemetrexed in patients with creatinine clearance of < 45ml/min is not recommended (see section 4.2).
Croatian: Stoga se primjena pemetrekseda u bolesnika s klirensom kreatinina < 45 ml/min ne preporučuje (vidjeti dio 4.2).
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Sandoz.
Croatian: Morate nastaviti uzimati folatnu kiselinu još najmanje 21 dan nakon posljednje doze lijeka Pemetrexed Sandoz.
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 ne-infektivni poremećaji dermisa, hipodermisa i / ili potkožnog tkiva s nepoznatom učestalošću (npr. Akutni bakterijski dermo-hipodermitis, pseudocelulitis, dermatitis).
English: Alkaline phosphatase, AST, and ALT ≤ 5 times upper limit of normal is acceptable if liver has tumour involvement.
Croatian: Prihvatljive su vrijednosti alkalne fosfataze, AST-a i ALT-a od  5 puta iznad gornje granice normale ako je jetra zahvaćena tumorom.
English: The 1 year and 2 year survival rates for patients on pemetrexed were 58% and 32% respectively, compared to 45% and 21% for patients on placebo.
Croatian: Za bolesnike liječene lijekom pemetreksed stopa jednogodišnjeg preživljenja iznosila je 58%, a stopa dvogodišnjeg preživljenja 32%, u usporedbi s 45% odnosno 21% za bolesnike koji su primali placebo.
English: You will always receive Pemetrexed Sandoz by infusion into one of your veins.
Croatian: Lijek Pemetrexed Sandoz uvijek ćete primiti infuzijom u jednu od vena.
English: Manufacturer Ebewe Pharma Ges.m.b.H Nfg.KG
Croatian: Ebewe Pharma Ges.m.b.H Nfg.KG Mondseestrasse 11
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: Women must use effective contraception during treatment with Pemetrexed Sandoz.
Croatian: Žene moraju primjenjivati djelotvornu kontracepciju tijekom liječenja lijekom Pemetrexed Sandoz.
English: Prior chemotherapy did not include pemetrexed.
Croatian: Prethodna kemoterapija nije uključivala lijek pemetreksed.
English: • Hypernatraemia - increased sodium in blood
Croatian: • Hipernatremija- povećana koncentracije natrija u krvi
English: • Blood clots in the lung blood vessels (pulmonary embolism)
Croatian: • Krvni ugrušci u krvnim žilama u plućima (plućna embolija)
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Sandoz.
Croatian: Ako Vam se oko pluća nakupila tekućina, liječnik može odlučiti ukloniti tu tekućinu prije primjene lijeka Pemetrexed Sandoz.
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 StevensJohnsonov sindrom i toksičnu epidermalnu nekrolizu
English: • Hepatitis (inflammation of the liver) • Anaphylactic shock (severe allergic reaction)
Croatian: • Anafilaktički šok (teška alergijska reakcija)
English: filialas Šeimyniškių 3A,
Croatian: Sandoz Pharmaceuticals d.d. filialas Šeimyniškių 3A,
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Sandoz.
Croatian: Ako ste nedavno cijepljeni, obavijestite o tome svog liječnika jer to može izazvati štetne učinke uz primjenu lijeka Pemetrexed Sandoz.
English: Hepatic impairment: No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified.
Croatian: Bolesnici s oštećenjem jetre: Nije utvrđen odnos između vrijednosti AST-a (SGOT-a), ALT-a (SGPT-a) odnosno ukupnog bilirubina i farmakokinetike pemetrekseda.
English: What Pemetrexed Sandoz is and what it is used for
Croatian: Što je Pemetrexed Sandoz i za što se koristi
English: Renal impairment (standard Cockcroft and Gault formula or glomerular filtration rate measured Tc99m DPTA serum clearance method): Pemetrexed is primarily eliminated unchanged by renal excretion.
Croatian: Bolesnici s oštećenjem bubrega: (serumski klirens izračunat standardnom Cockcroftovom i Gaultovom formulom ili metodom mjerenja brzine glomerularne filtracije Tc99m-DPTA): Pemetreksed se prvenstveno eliminira putem bubrega u nepromijenjenom obliku.
English: • Low haemoglobin level (anaemia)
Croatian: • Niska razina hemoglobina (anemija)
English: organizačná zložka Galvaniho 15/C SK-821 04 Bratislava Tel: + 421 2 48 200 600 info@sandoz.sk
Croatian: Slovenská republika Sandoz d.d. organizačná zložka Galvaniho 15/C SK-821 04 Bratislava Tel: + 421 2 48 200 600 info@sandoz.sk
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 pacijenata zbog moguće pojave akutne tubularne nekroze, smanjenja funkcije bubrega te znakova i simptoma nefrogenog dijabetes insipidusa (npr. hipernatremija).
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 = 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: • Oedema (excess fluid in body tissue, causing swelling)
Croatian: • Edem (višak tekućine u tjelesnom tkivu koji izaziva oticanje)
English: The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment) (see section 2 “Pemetrexed Sandoz contains sodium”).
Croatian: Drugi sastojci su manitol (E421), kloridna kiselina (za podešavanje pH) i natrijev hidroksid (za podešavanje pH) (vidjeti dio 2 „Pemetrexed Sandoz sadrži natrij“)
English: • Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells)
Croatian: • Imunološki posredovana hemolitička anemija (razaranje crvenih krvnih stanica posredstvom protutijela) Hepatitis (upala jetre)
English: Do not use after the expiry date which is shown on the carton and label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici iza oznake Rok valjanosti ili EXP.
English: Warnings and precautions Talk to your doctor or pharmacist before receiving Pemetrexed Sandoz.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primite lijek Pemetrexed Sandoz.
English: What Pemetrexed Sandoz looks like and contents of the pack
Croatian: Kako Pemetrexed Sandoz izgleda i sadržaj pakiranja
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 taking Pemetrexed Sandoz.
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 Pemetrexed Sandoz.
English: • Inflammation of the skin, mainly of the lower limb with swelling, pain and redness
Croatian: • Upala kože, uglavnom donjeg ekstremiteta s oticanjem, boli i crvenilom
English: Do not use this medicine if you notice particles or a discolouration.
Croatian: Nemojte upotrebljavati ovaj lijek ako prije primjene uočite čestice u tekućini ili promjenu boje.
English: Randomised and treated patients Fully supplemented patients
Croatian: Bolesnici s potpunim bolesnici nadomjeskom
English: Pemetrexed Sandoz is a powder for concentrate for solution for infusion in a glass vial.
Croatian: Pemetrexed Sandoz je prašak za koncentrat za otopinu za infuziju u bočici.
English: What you need to know before you use Pemetrexed Sandoz
Croatian: Što morate znati prije nego počnete uzimati Pemetrexed Sandoz
English: Calculate the dose and the number of Pemetrexed Sandoz vials needed.
Croatian: Izračunajte dozu i potreban broj bočica lijeka Pemetrexed Sandoz.
English: Each pack of Pemetrexed Sandoz consists of one vial with protective plastic overwrap, containing 100 mg, 500 mg or 1000 mg of pemetrexed.
Croatian: Svako pakiranje lijeka Pemetrexed Sandoz sadrži jednu bočicu lijeka sa zaštitnim plastičnim omotom, koja sadrži 100 mg , 500 mg i 1000 mg pemetrekseda.
English: Marketing Authorisation Holder Sandoz GmbH
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Sandoz GmbH
English: When using Pemetrexed Sandoz in combination with cisplatin:
Croatian: Kad se Pemetrexed Sandoz primjenjuje u kombinaciji s cisplatinom:
English: Children and adolescents There is no relevant use of Pemetrexed Sandoz in the paediatric population.
Croatian: Nema relevantne primjene lijeka Pemetrexed Sandoz u pedijatrijskoj populaciji.
English: In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of nonsteroidal 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: • If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon)(may indicate a blood clot in the blood vessels of the lungs)
Croatian: ako iskusite iznenadni nedostatak zraka, osjećate intenzivnu bol u prsima ili iskašljavate krv (manje često) (može ukazivati na krvni ugrušak u krvnim žilama u plućima).
English: • Irritation of the skin and itching
Croatian: • Iritacija kože i svrbež
English: Pemetrexed*** (N = 800)
Croatian: pemetreksed*** (N=800)
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1,500 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: • Fast heart rate
Croatian: •Ubrzano kucanje srca
English: Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
Croatian: Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austrija
English: Other (N = 252)
Croatian: Drugi oblici (N=252)
English: Adenocarcinoma (N = 847)
Croatian: Adenokarcinom (N=847)
English: 50% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Croatian: 50% prethodne doze a Zajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998)
English: Concomitant administration of nephrotoxic drugs (e.g., aminoglycoside, loop diuretics, platinum compounds, cyclosporin) 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: 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: If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), Pemetrexed Sandoz 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 Pemetrexed Sandoz mora se prekinuti dok se vrijednosti ne vrate na razinu prije liječenja ili nižu.
English: Reconstituted and infusion solution
Croatian: Rekonstituirana otopina i otopina za infuziju
English: Other medicines and Pemetrexed Sandoz
Croatian: Drugi lijekovi i Pemetrexed Sandoz
English: Gemcitabine/ Cisplatin (N = 830)
Croatian: gemcitabin/ cisplatin (N = 830)
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: Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
Croatian: Otopine pemetrekseda za infuziju pripremljene na opisani način kompatibilne su s infuzijskim priborom i infuzijskim vrećicama od polivinilklorida i poliolefina.
English: Patients must receive adequate antiemetic 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: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
Croatian: Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austrija
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: 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: 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: Hyperpigmentation has been commonly reported.
Croatian: Prijavljeni su česti slučajevi hiperpigmentacije.
English: : + 359 2 970 47 47 regaffairs.bg@sandoz.com
Croatian: Teл.: + 359 2 970 47 47 regaffairs.bg@sandoz.com
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: Rare (may affect up to 1 in 1,000 people)
Croatian: Rijetke (mogu se javiti u do 1 na 1000 osoba)
English: • Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)
Croatian: • Kolitis (upala sluznice debelog crijeva koja može biti praćena krvarenjem iz crijeva ili završnog dijela debelog crijeva)
English: Pemetrexed Sandoz in combination with cisplatin
Croatian: Pemetrexed Sandoz u kombinaciji s cisplatinom
English: • Extremity pain, low temperature and discolouration have been reported.
Croatian: • Prijavljeni su bol u udovima, snižena temperatura i promjene boje.
English: Pemetrexed Sandoz is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Croatian: Pemetrexed Sandoz se također primjenjuje u kombinaciji s cisplatinom za početno liječenje bolesnika s uznapredovalim stadijem raka pluća.
English: Most of these events resolved after pemetrexed withdrawal.
Croatian: Nakon prekida primjene pemetrekseda, većina ovih pojava bi se povukla.
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: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 1000 mg
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 (HR) 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 pemetreksed i cisplatin u usporedbi s 5,1 mjeseci za gemcitabin i cisplatin (prilagođen omjer hazarda 1,04; 95% CI = 0,94-1,15), a stopa ukupnog odgovora bila je 30,6% (95% CI = 27,3-33,9) za pemetreksed i cisplatin u usporedbi s 28,2% (95% CI = 25,0-31,4) za gemcitabin i cisplatin.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Sandoz powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Croatian: Prije primjene lijeka Pemetrexed Sandoz bolnički ljekarnik, medicinska sestra ili liječnik će pomiješati Pemetrexed Sandoz prašak s otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%).
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 Sandoz.
Croatian: Ako ste primali ili ćete primati terapiju zračenjem, obavijestite o tome svog liječnika jer se uz primjenu lijeka Pemetrexed Sandoz mogu pojaviti rane ili kasne reakcije na zračenje.
English: Efficacy of Pemetrexed vs. Docetaxel in NSCLC - ITT population
Croatian: Djelotvornost pemetrekseda u odnosu na docetaksel kod NSCLC - ITT populacija pemetreksed docetaksel
English: N = 863 0.94a
Croatian: N=863 0,94
English: Pemetrexed Sandoz must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Croatian: Pemetrexed Sandoz se smije primjenjivati samo pod nadzorom liječnika koji je obučen za primjenu antitumorske kemoterapije.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 500 mg
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN POGLEDA
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/mm3, a broj trombocita  100 000 stanica/mm3.
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 pemetreksedom 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: 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/darbepoetin (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: Paediatric population: 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: Large cell (N = 153)
Croatian: Karcinom velikih stanica (N=153)
English: • Skin rash
Croatian: • Kožni osip
English: Contains mannitol (E421), hydrochloric acid and sodium hydroxide (for pH adjustment).
Croatian: Sadrži manitol (E421), kloridnu kiselinu i natrijev hidroksid (za podešavanje pH).
English: Sandoz S.p.A Largo Umberto Boccioni 1 I - 21040 Origgio/VA Tel: + 39 02 96541
Croatian: Sandoz S.p.A Largo Umberto Boccioni 1 I - 21040 Origgio/VA
English: For intravenous use after reconstitution and dilution.
Croatian: Primjena u venu nakon pripreme i razrjeđivanja.
English: Upon recovery, patients should be re-treated using the guidelines in Tables 1, 2, and 3, which are applicable for Pemetrexed Sandoz used as a single agent or in combination with cisplatin.
Croatian: Nakon oporavka bolesnika treba ponovno liječiti prema smjernicama za primjenu lijeka Pemetrexed Sandoz u monoterapiji ili u kombinaciji s cisplatinom, prikazanima u Tablicama 1, 2 i 3.
English: • Upset stomach
Croatian: • Bol u trbuhu