FrancophonIA/ELRC3.0 huggingface dataset:
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
Croatian: * Za sve stupnjeve toksičnosti vidjeti Nacionalnog Instituta za rak CTC NCI verziju 2
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (n=441) with that of placebo plus BSC (n=222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first line doublet therapy containing Cisplatin or Carboplatin in combination with Gemcitabine, Paclitaxel, or Docetaxel.
Croatian: U multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (JMEN) uspoređivala se djelotvornost i sigurnost liječenja lijekom pemetreksed kao terapijom održavanja uz najbolju potpornu njegu (eng. best supportive care, BSC) (n = 441) s djelotvornošću i sigurnošću primjene placeba uz BSC (n = 222) u bolesnika s lokalno uznapredovalim (stadij IIIB) ili metastatskim (stadij IV) rakom pluća nemalih stanica (NSCLC) u kojih nije došlo do progresije nakon 4 ciklusa prve linije dvojne terapije cisplatinom ili karboplatinom u kombinaciji s gemcitabinom, paklitakselom ili docetakselom.
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio=0.78, 95 %CI=0.640.96, p=0.0195).
Croatian: Nakon uvodnog liječenja lijekom pemetreksed i cisplatinom (4 ciklusa), liječenje lijekom pemetreksed bilo je statistički značajno bolje od placeba s obzirom na OS (medijan 13,9 mjeseci naspram 11,0 mjeseci, omjer hazarda = 0,78, 95% CI = 0,64-0,96, p = 0,0195).
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated patients
Croatian: Djelotvornost lijeka pemetreksed + cisplatin u odnosu na monoterapiju cisplatinom u bolesnika s malignim pleuralnim mezoteliomom Randomizirani i liječeni
English: Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Croatian: Pemetreksed u kombinaciji s cisplatinom indiciran je u prvoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice (vidjeti dio 5.1).
English: Nadir platelets <50,000 /mm 3 regardless of nadir ANC
Croatian: Najniži broj trombocita < 50 000 /mm3 bez obzira na najniži ABN
English: Pemetrexed/ cisplatin (N=839)
Croatian: Pemetreksed/ Cisplatin (N = 839)
English: - If you get any side effects, talk to your doctor or nurse or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, medicinsku sestru ili ljekarnika.
English: Survival Time (months) Median (m) 95 % CI for median HR 95 % CI for HR Non-inferiority p-value (HR)
Croatian: 95% CI za HR p-vrijednost za neinferiornost (HR)
English: Table 1 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Haematologic toxicities
Croatian: Tablica 1 - Tablica za prilagodbu doze pemetrekseda (u monoterapiji ili u kombinaciji) i cisplatina - hematološka toksičnost
English: There were no clinically relevant differences observed for the safety profile of pemetrexed plus cisplatin within the histology subgroups.
Croatian: Nisu uočene klinički značajne razlike u sigurnosnom profilu lijeka pemetreksed u kombinaciji s cisplatinom unutar podskupina prema histološkom tipu.
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR=0.78; 95 % CI = 0 .61-1.00, p=0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n=172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95 % CI = 1.08-2.26, p = 0.018).
Croatian: Analiza utjecaja histologije NSCLC-a na učinak liječenja na ukupno preživljenje pokazuje prednost lijeka pemetreksed u odnosu na docetaksel u tumora kod kojih histološki ne prevladavaju skvamozne stanice (n=399, 9,3 naspram 8,0 mjeseci, prilagođeni omjer hazarda (engl. hazard ratio) HR = 0,78; 95% CI = 0,61-1,00, p = 0,047) i prednost docetaksela u slučaju tumora kod kojih histološki prevladavaju skvamozne stanice (n=172, 6,2 naspram 7,4 mjeseci, prilagođeni
English: The median OS for the overall population (n=663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio=0.79 (95% CI=0.65-0.95, p=0.01192).
Croatian: Medijan ukupnog preživljenja za ukupnu populaciju (n = 663) iznosio je 13,4 mjeseci u skupini koja je primala lijek pemetreksed i 10,6 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,79 (95% CI = 0,65-0,95, p = 0,01192).
English: For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Croatian: U ovu su tablicu uključene sve nuspojave čija je učestalost bila najmanje 5% i za koje je ispitivač procijenio da bi mogle biti povezane s primjenom pemetrekseda i cisplatina.
English: Common (may affect up to 1 in 10 people) - Allergic reaction: skin rash / burning or prickling sensation - Infection including sepsis - Fever - Dehydration - Kidney failure - Irritation of the skin and itching - Hives - Increased skin pigmentation - Chest pain - Muscle weakness - Conjunctivitis (inflamed eye) - Upset stomach - Pain in the abdomen - Taste change - Liver: abnormal blood tests - Watery eyes - Dizziness
Croatian: alergijska reakcija: kožni osip / osjećaj pečenja ili bockanja infekcija uključujući sepsu vrućica dehidracija zatajenje bubrega iritacija kože i svrbež koprivnjača pojačana pigmentacija kože bol u prsima slabost mišića konjunktivitis (upala oka)
English: Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin- Non-haematologic toxicitiesa,b
Croatian: Tablica 2 - Tablica za prilagodbu doze pemetrekseda (u monoterapiji ili u kombinaciji) i cisplatina - nehematološka toksičnost a,b
English: Armisarte 25 mg/ml sterile concentrate pemetrexed
Croatian: Armisarte 25 mg/ml sterilni koncentrat pemetreksed i.v.
English: EMPHACIS, a multicentre, randomised, single-blind phase 3 study of pemetrexed plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with pemetrexed and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone.
Croatian: EMPHACIS, multicentrično, randomizirano, jednostruko slijepo ispitivanje faze III lijeka pemetreksed i cisplatina u odnosu na monoterapiju cisplatinom u bolesnika s malignim pleuralnim mezoteliomom koji nisu ranije primali kemoterapiju, pokazalo je da je u bolesnika liječenih lijekom pemetreksed i cisplatinom medijan preživljenja bio 2,8 mjeseci dulji nego u bolesnika liječenih samo cisplatinom, što se smatra klinički značajnom razlikom.
English: This routinely involves blood tests, including checks on your liver and kidney function.
Croatian: To uključuje rutinske provjere krvnih testova,
English: Armisarte may make you feel tired.
Croatian: Armisarte može izazvati umor.
English: Infection (sepsis) may be severe and could lead to death - If you start feeling chest pain (common) or having a fast heart rate (uncommon) - If you have pain, redness, swelling or sores in your mouth (very common) - Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Croatian: Infekcija (sepsa) može biti vrlo teška i potencijalno smrtonosna - ako počnete osjećati bolove u prsima (često) ili ubrzano kucanje srca (manje često)
English: radiation therapy - Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) - Interstitial pneumonitis (scarring of the air sacs of the lung) - Oedema (excess fluid in body tissue, causing swelling) - Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer therapy - Pancytopenia- combined low counts of white cells, red cells and platelets - Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)
Croatian: edem (višak tekućine u tjelesnom tkivu koji izaziva oticanje) neki su bolesnici doživjeli srčani udar, moždani udar ili „mali moždani udar“ pri primjeni lijeka pemetreksed, obično u kombinaciji s nekim drugim protutumorskim lijekom pancitopenija - nizak broj bijelih krvnih stanica, crvenih krvnih stanica i krvnih pločica radijacijski pneumonitis (stvaranje ožiljaka na mjehurićima u plućima (alveolama) povezano s terapijom zračenjem) može se pojaviti u bolesnika koji su zračeni prije, tijekom ili nakon liječenja lijekom pemetreksed prijavljeni su bol u udovima, snižena temperatura i promjene boje krvni ugrušci u krvnim žilama u plućima (plućna embolija) Rijetke (mogu se javiti u do 1 na 1000 osoba)
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95 % CI=0.47-0.74).
Croatian: Prema procjeni ispitivača medijan PFS-a randomiziranih bolesnika, mjeren od početka prve linije uvodnog liječenja lijekom pemetreksed i cisplatinom, iznosio je 6,9 mjeseci za skupinu koja je primala lijek pemetreksed i 5,6 mjeseci za skupinu s placebom (omjer hazarda = 0,59 95% CI = 0,47
English: Armisarte 25 mg/ml concentrate for solution for infusion
Croatian: Armisarte 25 mg/ml koncentrat za otopinu za infuziju
English: Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Croatian: Pemetreksed u kombinaciji s cisplatinom je indiciran za liječenje bolesnika s neoperabilnim malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju.
English: For patients with NSCLC other than predominantly squamous cell histology (n=430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio=0.47 (95% CI=0.37-0.60, p=0.00001).
Croatian: U bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (n=430, neovisno procijenjena populacija), medijan PFS-a bio je 4,4 mjeseci u skupini koja je primala lijek pemetreksed te 1,8 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,47 (95% CI = 0,37-0,60, p = 0,00001).
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n=862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n=863) in overall survival (adjusted hazard ratio 0.94; 95 % CI=0.84-1.05).
Croatian: Multicentrično, randomizirano, otvoreno ispitivanje faze III lijeka pemetreksed i cisplatina u odnosu na gemcitabin i cisplatin u bolesnika s lokalno uznapredovalim ili metastatskim (stadij IIIB ili IV) rakom pluća nemalih stanica (NSCLC) koji prethodno nisu primali kemoterapiju pokazalo je da su pemetreksed i cisplatin (ITT populacija, n = 862) ostvarili primarni ishod ispitivanja i pokazali sličnu kliničku djelotvornost kao gemcitabin i cisplatin (ITT n = 863) s obzirom na ukupno preživljenje
English: Your dose may be changed or treatment delayed depending on results from these tests.
Croatian: Ovisno o rezultatu tih testova, Vaša doza lijeka može biti promijenjena ili liječenje odgođeno.
English: Skin reactions have been reported in patients not pre-treated with a corticosteroid.
Croatian: U bolesnika koji prije početka liječenja nisu uzimali kortikosteroid prijavljene su kožne reakcije.
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio=0.78, 95 % CI=0.64-0.96).
Croatian: Medijan OS od početka prve linije uvodnog liječenja lijekom pemetreksed i cisplatinom iznosio je 16,9 mjeseci u skupini koja je primala lijek pemetreksed te 14,0 mjeseci u skupini koja je primala placebo (omjer hazarda = 0,78, 95% CI = 0,64-0,96).
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (n=359) with that of placebo plus BSC (n=180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of pemetrexed in combination with cisplatin.
Croatian: U multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (PARAMOUNT) uspoređivala se djelotvornost i sigurnost liječenja lijekom pemetreksed kao terapije održavanja uz BSC (n = 359) s djelotvornošću i sigurnošću primjene placeba uz BSC (n = 180) u bolesnika s lokalno uznapredovalim (stadij IIIB) ili metastatskim (stadij IV) NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice u kojih nije došlo do progresije nakon 4 ciklusa prve linije dvojne terapije lijekom pemetreksed u kombinaciji s cisplatinom.Od 939 bolesnika liječenih uvodnom terapijom lijekom pemetreksed i cisplatinom, 539 bolesnika randomizirano je u skupinu koja je primala terapiju održavanja pemetreksedom ili placebo.
English: During the study, low-dose folic acid and vitamin B12 supplementation was introduced to patients therapy to reduce toxicity.
Croatian: Tijekom ispitivanja bolesnici su radi ublažavanja toksičnosti primali niske doze nadomjeska folatne kiseline i vitamina B12.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n=581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio=0.60, 95% CI=0.49-0.73, p<0.00001).
Croatian: Ispitivanje je ispunilo primarni ishod i pokazalo statistički značajno poboljšanje PFS-a u skupini koja je primala lijek pemetreksed u odnosu na skupinu koja je primala placebo (n=581, neovisno procijenjena populacija; medijan od 4 odnosno 2 mjeseca) (omjer hazarda = 0,60, 95% CI = 0,49-0,73,
English: (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: CTCa Grade
Croatian: CTC a stupanj
English: Armisarte 25 mg/ml concentrate for solution for infusion pemetrexed
Croatian: Armisarte 25 mg/ml koncentrat za otopinu za infuziju pemetreksed
English: 50% of previous dose 100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Croatian: 100% prethodne doze a Zajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998) b Osim neurotoksičnosti
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio=0.71 (95 % CI=0.56-0.88, p=0.002).
Croatian: Uključujući fazu uvodnog liječenja, medijan ukupnog preživljenja u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice bio je 18,6 mjeseci u skupini koja je primala lijek pemetreksed te 13,6 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,71 (95% CI = 0,56-0,88, p = 0,002).
English: Colourless glass vial (type I) with type I rubber (bromobutyl) serum stopper and an aluminium cap with polypropylene disk.
Croatian: I gumenim bromobutilnim serumskim čepom i aluminijskim zatvaračem s polipropilenskim diskom.
English: Breast-feeding must be discontinued during Armisarte treatment.
Croatian: Tijekom liječenja lijekom Armisarte dojenje se mora prekinuti.
English: For the purpose of this table, a cutoff of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Croatian: U ovu su tablicu uključene sve nuspojave čija je učestalost bila najmanje 5% i za koje je ispitivač procijenio da bi mogle biti povezane s primjenom pemetrekseda.
English: Cytotoxic Must only be diluted in 5% glucose solution.
Croatian: Mora se razrijediti isključivo u otopini 5% - tne glukoze.
English: One ml contains 25 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedan ml sadrži 25 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: Pemetrexed in combination with cisplatin The recommended dose of pemetrexed is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Croatian: Preporučena doza pemetrekseda je 500 mg/m2 tjelesne površine, a primjenjuje se u obliku intravenske infuzije tijekom 10 minuta, prvog dana svakog 21-dnevnog ciklusa.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n=481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio=0.70 (95 % CI = 0.56-0.88, p = 0.002).
Croatian: Medijan ukupnog preživljenja u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (n = 481) bio je 15,5 mjeseci u skupini koja je primala lijek pemetreksed i 10,3 mjeseca u skupini koja je primala placebo, omjer hazardaomjer hazarda = 0,70 (95% CI = 0,56-0,88, p = 0,002).
English: One ml of concentrate contains 25 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedan ml koncentrata sadrži 25 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: One vial of 4 ml contains 100 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedna bočica od 4 ml sadrži 100 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: Not known (frequency cannot be estimated from the available data) - Lower limb swelling with pain and redness - Inflammation of the skin, mainly of the lower limb with swelling, pain and redness - Increased urine output - Thirst and increased water consumption - Hypernatraemia - increased sodium in blood
Croatian: Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) - Oticanje donjih udova praćeno boli i crvenilom - Upala kože koja se uglavnom javlja na donjim udovima, a praćena je oticanjem, boli i crvenilom
English: The median time from the start of pemetrexed plus cisplatin induction therapy to the start of maintenance treatment was 2.96 months on both the pemetrexed arm and the placebo arm. Randomised patients received maintenance treatment until disease progression.
Croatian: Medijan vremena od početka uvodnog liječenja lijekom pemetreksed i cisplatinom do početka terapije održavanja iznosio je
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis) - 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) - 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) - 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 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: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n=472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio=0.64, 95 % CI=0.51-0.81, p=0.0002).
Croatian: Ispitivanje je ispunilo primarni ishod i pokazalo statistički značajno poboljšanje PFS-a u skupini koja je primala lijek pemetreksed u odnosu na skupinu koja je primala placebo (n = 472, neovisno procijenjena populacija; medijan od 3,9 odnosno 2,6 mjeseci) (omjer hazarda = 0,64, 95% CI = 0,51
English: Time to treatment failure (TTTF - months)
Croatian: Log-rang p-vrijednost* Vrijeme do prestanka odgovora na liječenje (mjeseci)
English: IV
Croatian: HR
English: definition of ≥CTC Grade 2 bleeding.
Croatian: Ovi kriteriji odgovaraju definiciji krvarenja stupnja ≥ 2 prema Zajedničkim kriterijima toksičnosti
English: One vial of 34 ml contains 850 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedna bočica od 34 ml sadrži 850 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04.
Croatian: Farmakoterapijska skupina: antineoplastici, analozi folatne kiseline, ATK oznaka: L01BA04 Pemetreksed je protutumorski lijek s višestrukim antifolatnim djelovanjem koji djeluje tako da prekida ključne metaboličke procese ovisne o folatima neophodne za umnažanje stanica.
English: One vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedna bočica s 34 ml koncentrata sadrži 850 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia, mucositis, sensory polyneuropathy and rash.
Croatian: Prijavljeni simptomi predoziranja uključuju neutropeniju, anemiju, trombocitopeniju, mukozitis,
English: One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedna bočica s 4 ml koncentrata sadrži 100 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: Pemetrexed at a dose of 500 mg/m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Croatian: U 64 bolesnika s malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju lijek pemetreksed ispitan je u dozi od 500 mg/m2 u monoterapiji.
English: One vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedna bočica s 20 ml koncentrata sadrži 500 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: One vial of 20 ml contains 500 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedna bočica od 20 ml sadrži 500 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: One vial of 40 ml contains 1000 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedna bočica od 40 ml sadrži 1000 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid).
Croatian: Jedna bočica s 40 ml koncentrata sadrži 1000 mg pemetrekseda (u obliku pemetrekseddikiseline).
English: ≥ 50,000 /mm3
Croatian: Najniži ABN < 500 /mm3 i najniži broj trombocita ≥ 50 000 /mm3
English: Hemoglobin decreased
Croatian: nizak broj bijelih krvnih stanica niska razina hemoglobina (anemija)
English: N=863 0.94a
Croatian: N=862 10,3
English: An insufficient number of patients has been studied with creatinine clearance of below 45 ml/min.
Croatian: U kliničkim ispitivanjima nije sudjelovao dovoljan broj bolesnika s klirensom kreatinina manjim od 45 ml/min pa se primjena pemetrekseda ne preporučuje u bolesnika s klirensom kreatinina