FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no clinically relevant differences observed for the safety profile of ALIMTA plus cisplatin within the histology subgroups.
Croatian: Nisu uočene klinički značajne razlike u sigurnosnom profilu lijeka ALIMTA u kombinaciji s cisplatinom unutar podskupina prema histološkom tipu.
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Croatian: Kratice: CI = interval pouzdanosti; ITT = populacija svih uključenih bolesnika; N = ukupan broj bolesnika.
English: EMPHACIS, a multicentre, randomised, single-blind phase 3 study of ALIMTA plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with ALIMTA 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 ALIMTA 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 ALIMTA i cisplatinom medijan preživljenja bio 2,8 mjeseci dulji nego u bolesnika liječenih samo cisplatinom, što se smatra klinički značajnom razlikom.
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 prijavitelj procijenio da bi mogle biti povezane s primjenom pemetrekseda i cisplatina.
English: The median OS for the overall population (n = 663) was 13.4 months for the ALIMTA 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 ALIMTA i 10,6 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,79 (95% CI = 0,65-0,95, p = 0,01192).
English: MARKETING AUTHORISATION NUMBER EU/1/04/290/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/290/001
English: In patients with mild to moderate renal insufficiency eligible for pemetrexed therapy NSAIDs with long elimination half-lives should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).
Croatian: U bolesnika s blagim do umjerenim zatajenjem bubrega koji mogu biti liječeni pemetreksedom, uzimanje nesteroidnih protuupalnih lijekova s dugim poluvremenom eliminacije mora se prekinuti najmanje 5 dana prije, na sam dan i najmanje 2 dana nakon primjene pemetrekseda (vidjeti dio 4.5).
English: The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is not fully defined.
Croatian: Nije sasvim jasno kako na pemetreksed utječu tekućine u transcelularnom prostoru, primjerice pleuralni izljev ili ascites.
English: The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leukopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, and stomatitis.
Croatian: Najčešće prijavljene nuspojave povezane s primjenom pemetrekseda, kako u monoterapiji tako i u kombinaciji s drugim lijekovima, su supresija koštane srži, koja se očituje kao anemija, neutropenija, leukopenija ili trombocitopenija; i gastrointestinalna toksičnost, koja se očituje kao anoreksija,
English: Median time to tumour progression (months) (95 % CI)
Croatian: Log-rang p-vrijednost* Medijan vremena do progresije tumora (mjeseci) (95% CI)
English: ALIMTA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Croatian: ALIMTA je u kombinaciji s cisplatinom indicirana za liječenje bolesnika s neoperabilnim malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju.
English: ALIMTA 100 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 100 mg of pemetrexed.
Croatian: ALIMTA 100 mg prašak za koncentrat za otopinu za infuziju Staklena (tip I) bočica s gumenim čepom, koja sadrži 100 mg pemetrekseda.
English: Loss of sensation
Croatian: Gubitak teka
English: Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia (or pancytopenia) (see section 4.8).
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Pemetreksed može suprimirati funkciju koštane srži, što se očituje neutropenijom, trombocitopenijom i anemijom (ili pancitopenijom) (vidjeti dio 4.8).
English: Clinically relevant toxicity that was reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Croatian: Klinički značajne toksičnosti prijavljene u < 1% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsima, aritmiju i motoričku neuropatiju.
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Croatian: Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih da primaju pemetreksed ubrajaju se: neutropenijska vrućica, infekcija, snižen broj trombocita, proljev, konstipacija, alopecija, pruritus/svrbež, vrućica (bez neutropenije), površinske bolesti oka (uključujući konjunktivitis), pojačano suzenje, omaglica i motorička neuropatija.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika na dijeti s ograničenim unosom natrija.
English: ALIMTA + cisplatin
Croatian: ALIMTA + cisplatin gemcitabin + cisplatin
English: *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Croatian: *** Prema CTC NCI (v2.0; NCI 1998), poremećaj osjeta okusa i alopecija prijavljuju se isključivo kao nuspojave stupnja 1 ili 2.
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Croatian: Klinički značajni oblici toksičnosti prema CTC kriterijima prijavljeni u < 1% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed uključuju aritmiju i motoričku neuropatiju.
English: The recommended dose of ALIMTA 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: ALIMTA u kombinaciji s cisplatinom Preporučena doza lijeka ALIMTA je 500 mg/m2 tjelesne površine, a primjenjuje se u obliku intravenske infuzije tijekom 10 minuta, prvog dana svakog 21-dnevnog ciklusa.
English: Squamous cell (N=473)
Croatian: Karcinom skvamoznih stanica (N=473)
English: ALIMTA 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Croatian: ALIMTA 500 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrija).
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Croatian: Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala pemetreksed, ubrajaju se: infekcija bez neutropenije, neutropenijska vrućica, alergijska reakcija/preosjetljivost, povišene vrijednosti kreatinina, motorička neuropatija, senzorna neuropatija, multiformni eritem i bol u abdomenu.
English: For patients with NSCLC other than predominantly squamous cell histology (n = 430, independently reviewed population) median PFS was 4.4 months for the ALIMTA 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 ALIMTA te 1,8 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,47 (95% CI = 0,37-0,60, p = 0,00001).
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 ALIMTA plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the ALIMTA 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 ALIMTA i cisplatinom, iznosio je 6,9 mjeseci za skupinu koja je primala lijek ALIMTA i 5,6 mjeseci za skupinu s placebom (omjer hazarda = 0,59 95% CI = 0,47-0,74).
English: Table 2 - Dose modification table for ALIMTA (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b Dose of ALIMTA (mg/m2)
Croatian: Potom se liječenje može nastaviti prema smjernicama u Tablici 2. Tablica 2 - Tablica za prilagodbu doze lijeka ALIMTA (u monoterapiji ili u kombinaciji) i cisplatina - nehematološka toksičnost a,b
English: ALIMTA 500 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 500 mg of pemetrexed.
Croatian: ALIMTA 500 mg prašak za koncentrat za otopinu za infuziju Staklena (tip I) bočica s gumenim čepom, koja sadrži 500 mg pemetrekseda.
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with ALIMTA 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 ALIMTA in combination with cisplatin.
Croatian: U multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (PARAMOUNT) uspoređivala se djelotvornost i sigurnost liječenja lijekom ALIMTA 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 ALIMTA u kombinaciji s cisplatinom.Od 939 bolesnika liječenih uvodnom terapijom lijekom ALIMTA i cisplatinom, 539 bolesnika randomizirano je u skupinu koja je primala terapiju održavanja pemetreksedom ili placebo.
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 ALIMTA treatment.
Croatian: 4 mg dvaput na dan) koje ćete morati uzeti dan prije, na sam dan i dan nakon primjene lijeka
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Croatian: *** Prema CTC NCI (v2.0; NCI 1998), poremećaj osjeta okusa i alopecija prijavljuju se isključivo kao nuspojave stupnja 1 ili 2
English: ALIMTA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Croatian: ALIMTA 100 mg: Jedna bočica sadrži 100 milligrama pemetrekseda (u obliku pemetrekseddinatrija).
English: Oedema (excess fluid in body tissue, causing swelling)Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving ALIMTA usually in combination with another anticancer therapy.
Croatian: Neki su bolesnici doživjeli srčani udar, moždani udar ili „mali moždani udar“ pri primjeni lijeka ALIMTA, obično u kombinaciji s nekim drugim protutumorskim lijekom.
English: Each vial contains approximately 11 mg sodium.
Croatian: Pomoćne tvari s poznatim učinkom Jedna bočica sadrži približno 11 mg natrija.
English: Kidney: abnormal blood tests
Croatian: Bubrezi: poremećeni rezultati krvnih pretraga
English: *P-values <0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Croatian: * P-vrijednosti < 0,05 za usporedbu kombinacija pemetreksed/cisplatin i gemcitabin/cisplatin uz primjenu Fisherova egzaktnog testa.
English: ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section
Croatian: ALIMTA je indicirana kao monoterapija u drugoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice
English: Therefore patients should be cautioned against driving or operating machines if this event occurs.
Croatian: Ipak, prijavljeno je da pemetreksed može izazvati umor pa se bolesnike mora upozoriti da u tom slučaju ne upravljaju vozilima niti rukuju strojevima.
English: From the start of ALIMTA plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the ALIMTA 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 ALIMTA i cisplatinom iznosio je 16,9 mjeseci u skupini koja je primala lijek ALIMTA te 14,0 mjeseci u skupini koja je primala placebo (omjer hazarda = 0,78, 95% CI = 0,64-0,96).
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA 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 ALIMTA 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: 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
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland B.V.
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 prijavitelj procijenio da bi mogle biti povezane s primjenom pemetrekseda.
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the ALIMTA 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 ALIMTA te 13,6 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,71 (95% CI = 0,56-0,88, p = 0,002).
English: ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion
Croatian: ALIMTA 100 mg prašak za koncentrat za otopinu za infuziju ALIMTA 500 mg prašak za koncentrat za otopinu za infuziju
English: Breast-feeding must be discontinued during ALIMTA treatment.
Croatian: Tijekom liječenja lijekom ALIMTA dojenje se mora prekinuti.
English: ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: ALIMTA 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: ALIMTA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Croatian: ALIMTA 500 mg: Jedna bočica sadrži 500 milligrama pemetrekseda (u obliku pemetrekseddinatrija).
English: Polyglutamation is a time- and concentration-dependent process that occurs in tumour cells and, to a lesser extent, in normal tissues.
Croatian: koji se odvija u tumorskim stanicama i, u manjoj mjeri, u zdravim tkivima.
English: Clinically relevant CTC toxicity that was reported in < 1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Croatian: Klinički značajni oblici toksičnost prema CTC kriterijima prijavljeni u < 1% bolesnika randomiziranih da primaju pemetreksed uključuju: alergijske reakcije/reakcije preosjetljivosti, multiformni eritem,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/290/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/290/001
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity In the event of neurotoxicity, the recommended dose adjustment for ALIMTA and cisplatin is documented in Table 3.
Croatian: 50% prethodne doze a Zajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998) Liječenje lijekom ALIMTA se mora obustaviti ako se u bolesnika pojavi bilo kakva hematološka ili nehematološka toksičnost stupnja 3 ili 4 nakon dvaju sniženja doze, odnosno odmah ako se ustanovi neurotoksičnost stupnja 3 ili 4.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the ALIMTA 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 ALIMTA i 10,3 mjeseca u skupini koja je primala placebo, omjer hazarda = 0,70 (95% CI = 0,56-0,88, p = 0,002).
English: **According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
Croatian: * Za sve stupnjeve toksičnosti vidjeti Nacionalnog Instituta za rak CTC NCI verziju 2 ** Prema CTC NCI (v2.0; NCI 1998), alopecija se prijavljuje isključivo kao nuspojava stupnja 1 ili 2.
English: Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Lijekove za parenteralnu primjenu potrebno je vizualno pregledati prije primjene kako bi se utvrdilo da ne sadrže čestice i da nisu promijenili boju.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12.
Croatian: U obje skupine ti su bolesnici koji prethodno nisu primali kemoterapiju dobivali potpun nadomjestak folatne kiseline i vitamina B12.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/290/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/290/002
English: Efficacy of ALIMTA plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated
Croatian: Rezultati tih analiza djelotvornosti su sažeti u tablici koja slijedi: Djelotvornost lijeka ALIMTA + cisplatina u odnosu na monoterapiju cisplatinom u bolesnika s malignim pleuralnim mezoteliomom Randomizirani i liječeni
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Croatian: 265 bolesnika randomiziranih u skupinu koja je primala samo pemetreksed te nadomjestak folatne kiseline i vitamina B12 i 276 bolesnika randomiziranih u skupinu koja je primala samo docetaksel.
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) Intersticijski pneumonitis (stvaranje ožiljaka na mjehurićima u plućima (alveolama))
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Croatian: Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih da primaju cisplatin i pemetreksed ubrajaju se: povišene vrijednosti AST-a, povišene vrijednosti ALT-a, infekcija, neutropenijska vrućica, zatajenje bubrega, vrućica, dehidracija, konjuktivitis i smanjen klirens kreatinina.
English: ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed
Croatian: ALIMTA 100 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: 50% of previous dose (both ALIMTA and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI
Croatian: 100% prethodne doze a Zajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998) b Osim neurotoksičnosti
English: 1998) definition of ≥CTC Grade 2 bleeding
Croatian: Ovi kriteriji odgovaraju definiciji krvarenja stupnja ≥ 2 prema Zajedničkim kriterijima toksičnosti
English: Hemoglobin decreased Neutrophils/ Granulocytes decreased Leukocytes Decreased Platelets Decreased
Croatian: Poremećaji krvi i limfnog sustava vrlo često snižen hemoglobin snižen broj neutrofila/ granulocita snižen broj leukocita snižen broj trombocita
English: The recommended dose of cisplatin is 75 mg/m2 BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Croatian: Preporučena doza cisplatina je 75 mg/m2 tjelesne površine, a primjenjuje se infuzijom u trajanju od dva sata, približno
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the ALIMTA 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 ALIMTA 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: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrija).