FrancophonIA/ELRC3.0 huggingface dataset:
English: Pemetrexed medac is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Slovenian: Zdravilo Pemetreksed medac dajemo v kombinaciji s cisplatinom, drugim zdravilom proti raku, za zdravljenje malignega plevralnega mezotelioma, vrste raka, ki prizadene vrhnjo plast pljuč, bolnikom,
English: ** According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
Slovenian: ** V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998), alopecija mora biti poročana kot stopnja 1
English: White to light yellow powder.
Slovenian: Bel do svetlorumen prašek.
English: Each 1,000 mg vial contains approximately 108 mg sodium.
Slovenian: Pomožna snov z znanim učinkom Vsaka 1000 mg viala vsebuje približno 108 mg natrija.
English: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology
Slovenian: JMEN: Kaplan Meierjeva grafa preživetja brez napredovanja in skupnega preživetja za pemetreksed v primerjavi s placebom pri bolnikih z NSCLC, ki nima pretežno ploščatocelične histologije:
English: Pemetrexed/ cisplatin (N = 839)
Slovenian: Pemetreksed/cisplatin N = 839
English: Each 100 mg vial contains approximately 11 mg sodium.
Slovenian: Pomožna snov z znanim učinkom Vsaka 100 mg viala vsebuje približno 11 mg natrija.
English: This medicine contains 108 mg sodium (main component of cooking/table salt) in each 1,000 mg vial.
Slovenian: Zdravilo Pemetreksed medac 1.000 mg To zdravilo vsebuje 108 mg natrija (glavne sestavine kuhinjske soli) na 1.000 mg vialo.
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups ITT population and histology subgroups
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri zdravljenju prvega izbora nedrobnoceličnega karcinoma pljuč - NZ populacija in histološke podskupine
English: • Response rate (%)(95 % CI) • Stable disease (%)
Slovenian: • Stabilna bolezen (%)
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed medac.
Slovenian: Po zadnjem odmerku zdravila Pemetreksed medac morate še 21 dni jemati folno kislino.
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).
Slovenian: Študija je dosegla svojo primarno končno točko in pokazala statistično značilno izboljšanje preživetja brez napredovanja v skupini s pemetreksedom glede na skupino s placebom (n = 581, neodvisno pregledana populacija; mediana 4,0 mesece in 2,0 meseca) (razmerje tveganja = 0,60, 95 % CI:
English: Abbreviation: CI = confidence interval * p-value refers to comparison between arms ** In the pemetrexed/cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Slovenian: ** V veji zdravljenja s pemetreksedom/cisplatinom, randomizirani in zdravljeni (N = 225) ter s popolnim dopolnjevanjem (N = 167).
English: This medicine contains 54 mg sodium (main component of cooking/table salt) in each 500 mg vial.
Slovenian: Zdravilo Pemetreksed medac 500 mg To zdravilo vsebuje 54 mg natrija (glavne sestavine kuhinjske soli) na 500 mg vialo.
English: You will also receive an injection of Vitamin B12 (1,000 µg) in the week before administration of Pemetrexed medac and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed medac treatment).
Slovenian: (1000 µg), nato pa še približno na vsakih 9 tednov (ustrezno 3 ciklusom zdravljenja z zdravilom Pemetreksed medac).
English: Women must use effective contraception during treatment with Pemetrexed medac.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem s pemetreksedom.
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.
Slovenian: Multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija faze 3 (JMEN) je primerjala učinkovitost in varnost vzdrževalnega zdravljenja s pemetreksedom skupaj z najboljšo suportivno oskrbo (BSC) (n = 441) s placebom skupaj z BSC (n = 222) pri bolnikih z lokalno napredovalim (stopnja IIIB) ali metastatskim (stopnja IV) nedrobnoceličnim pljučnim karcinomom
English: − if you are breast-feeding; you must discontinue breast-feeding during treatment with
Slovenian: − če dojite, morate med zdravljenjem z zdravilom Pemetreksed medac dojenje prekiniti.
English: Pemetrexed should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Zdravilo Pemetreksed medac se daje kot 10-minutna intravenska infuzija prvi dan vsakega 21dnevnega ciklusa.
English: Pemetrexed medac 1,000 mg:
Slovenian: Pemetreksed medac 1000 mg:
English: You should not breast-feed while using Pemetrexed medac.
Slovenian: Med zdravljenjem z zdravilom Pemetreksed medac ne smete dojiti.
English: In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min), the concomitant administration of pemetrexed with NSAIDs (e.g. ibuprofen) or acetylsalicylic acid at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Slovenian: Pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina 45-79 ml/min) se moramo izogibati sočasnemu dajanju pemetrekseda z NSAID-i (denimo, ibuprofenom) ali acetilsalicilno kislino v visokih odmerkih 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.4).
English: Safety was assessed for patients who were randomised to receive pemetrexed (N = 800).
Slovenian: Varnost je bila ocenjena pri bolnikih, ki so bili naključno izbrani za prejemanje pemetrekseda
English: Czech Republic medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Slovenian: Češka medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: − nausea
Slovenian: − bruhanje
English: After reconstitution, each vial contains 25 mg/ml of pemetrexed.
Slovenian: Po rekonstituciji ena viala vsebuje 25 mg/ml pemetrekseda.
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.
Slovenian: Če se pri bolnikih razvijejo nehematološke toksičnosti ≥ stopnje 3 (z izjemo nevrološke toksičnosti),
English: Frequency* Event**
Slovenian: Pogostnost* Dogodek** Pemetreksed***
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1038/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1038/001
English: Of the 939 patients treated with pemetrexed plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Slovenian: Izmed 939 bolnikov, ki so bili zdravljeni z indukcijsko terapijo s pemetreksedom in cisplatinom, jih je bilo
English: Pemetrexed medac 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).
Slovenian: Zdravilo Pemetreksed medac je v kombinaciji s cisplatinom indicirano kot zdravljenje prvega izbora za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: Synthon Hispania SL C/Castelló n°1, Pol. Las Salinas 08830 Sant Boi de Llobregat Barcelona
Slovenian: 08830 Sant Boi de Llobregat Barcelona
English: What you need to know before you use Pemetrexed medac
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Pemetreksed medac Ne uporabljajte zdravila Pemetreksed medac:
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).
Slovenian: Od začetka indukcijskega zdravljenja prve izbire s pemetreksedom skupaj s cisplatinom je bilo mediano skupno preživetje bolnikov 16,9 meseca v kraku s pemetreksedom in 14,0 mesecev v kraku s placebom (razmerje tveganja = 0,78, 95 % CI = 0,64 - 0,96).
English: Package leaflet: Information for the user Pemetrexed medac 100 mg powder for concentrate for solution for infusion Pemetrexed medac 500 mg powder for concentrate for solution for infusion Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Navodilo za uporabo Pemetreksed medac 100 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed medac 500 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed medac 1000 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 100 mg powder for concentrate for solution for infusion Pemetrexed medac 500 mg powder for concentrate for solution for infusion Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion
Slovenian: Pemetreksed medac 100 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed medac 500 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed medac 1000 mg prašek za koncentrat za raztopino za infundiranje
English: Clinical efficacy
Slovenian: Klinična učinkovitost Mezoteliom
English: Pemetrexed medac 500 mg:
Slovenian: Pemetreksed medac 500 mg:
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).
Slovenian: Vključno z indukcijsko fazo je bila mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije 18,6 mesecev za skupino s pemetreksedom in 13,6 mesecev za skupino s placebom, razmerje tveganja = 0,71 (95% CI: 0,56 - 0,88, p = 0,002).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1038/003
English: Contraception in males and females Women of childbearing potential must use effective contraception during treatment with pemetrexed.
Slovenian: Ženske v rodni dobi morajo v času zdravljenja s pemetreksedom uporabljati učinkovito kontracepcijo
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).
Slovenian: Za bolnike z NSCLC , ki nima pretežno ploščatocelične histologije (n = 430, neodvisno pregledana populacija) je bila mediana preživetja brez napredovanja 4,4 mesece za skupino s pemetreksedom in 1,8 meseca za skupino s placebom, razmerje tveganja = 0,47, 95% CI:
English: Instructions for use, handling and disposal Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za uporabo, ravnanje z zdravilom in odlaganje Pri rekonstituciji in nadaljnjemu redčenju pemetrekseda za intravensko infundiranje uporabljajte aseptično metodo.
English: Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Slovenian: Zdravilo Pemetreksed medac je v kombinaciji s cisplatinom indicirano za zdravljenje bolnikov z neresektabilnim malignim plevralnim mezoteliomom, ki jih še nismo zdravili s kemoterapijo.
English: EXP Read the leaflet for the shelf life of the reconstituted product.
Slovenian: EXP Za informacije o roku uporabnosti pripravljenega zdravila preberite navodilo za uporabo.
English: Placebo*** (N = 402)
Slovenian: Placebo***
English: Pemetrexed medac contains sodium
Slovenian: Zdravilo Pemetreksed medac vsebuje natrij
English: How to use Pemetrexed medac
Slovenian: Kako uporabljati zdravilo Pemetreksed medac
English: Pemetrexed medac 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 5.1).
Slovenian: Zdravilo Pemetreksed medac je indicirano kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: − watery eyes
Slovenian: − solzne oči
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.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri < 1 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: povišanje GGT, bolečino v prsnem košu, aritmijo in motorično nevropatijo.
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.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri ≥ 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: okužbo brez nevtropenije, febrilno nevtropenijo, alergijsko reakcijo/preobčutljivost, povišan kreatinin, motorično nevropatijo, senzorično nevropatijo, multiformni eritem in bolečino v trebuhu.
English: Pemetrexed medac 100 mg:
Slovenian: Pemetreksed medac 100 mg:
English: PARAMOUNT: Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Slovenian: Kaplan Meierjev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
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, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri ≥ 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: febrilno nevtropenijo, infekcijo, znižane trombocite, diarejo, zaprtje, alopecijo, srbenje, vročino (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
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.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri ≥ 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: povišanje AST, povišanje ALT, okužbo, febrilno nevtropenijo, odpoved ledvic, pireksijo, dehidracijo, konjuktivitis in znižanje očistka kreatinina.
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 800 patients randomly assigned to receive single-agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N = 663) and continuation pemetrexed maintenance (PARAMOUNT: N = 539) studies.
Slovenian: Spodnja preglednica podaja pogostnost in izraženost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 800 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali pemetreksed kot edino zdravilo, in 402 bolnikov, ki so naključno prejemali placebo v študijah vzdrževalnega zdravljenja samo s pemetreksedom (JMEN:
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).
Slovenian: je bila 13,4 mesece za skupino s pemetreksedom in 10,6 mesecev za skupino s placebom, razmerje tveganja = 0,79 (95 % CI: 0,65 do 0,95; p = 0,01192).
English: − muscle weakness
Slovenian: − mišična oslabelost
English: − interstitial pneumonitis (scarring of the air sacs of the lung)
Slovenian: − intersticijska pljučnica (brazgotinjenje pljučnih mešičkov)
English: Pemetrexed medac 100 mg: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed medac 100 mg: Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Pemetrexed medac 100 mg
Slovenian: Zdravilo Pemetreksed medac 100 mg
English: To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration.
Slovenian: Režim premedikacije Da zmanjšamo incidenco in resnost kožnih reakcij, dajemo kortikosteroid dan pred dajanjem pemetrekseda, na dan dajanja pemetrekseda in naslednji dan. Kortikosteroid naj ustreza 4 mg deksametazona, danega peroralno dvakrat dnevno (glejte poglavje 4.4).
English: Nadir platelets < 50,000/mm³ with bleedinga, regardless of nadir ANC 50 % of previous dose (both pemetrexed and cisplatin)
Slovenian: Najnižje število trombocitov < 50.000/mm³ s krvavitvijoa, ne glede na najnižji ANC
English: Grade
Slovenian: Povišanje
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04 Pemetrexed medac is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Slovenian: Farmakoterapevtska skupina: antineoplastične učinkovine, analogi folne kisline, oznaka ATC: L01BA04
English: Pemetrexed medac 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed medac 500 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: − fatigue (tiredness)
Slovenian: − utrujenost (izčrpanost) − kožni izpuščaji
English: • HR (95 % CI)
Slovenian: (95 % IZ)
English: Pemetrexed medac 500 mg: Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed medac 500 mg: Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
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).
Slovenian: Za naključno izbrane bolnike, merjeno od začetka indukcijskega zdravljenja prve izbire s pemetreksedom in cisplatinom, je bilo mediano preživetje brez napredovanja bolezni po oceni raziskovalca 6,9 meseca za skupino, ki je prejemala pemetreksed, in 5,6 meseca za skupino, ki je prejemala placebo (razmerje tveganja = 0,59
English: Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed medac 1000 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 1000 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Pemetrexed medac 1,000 mg: Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed medac 1000 mg: Ena viala vsebuje 1000 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: odpoved ledvic, okužbo, pireksijo, febrilno nevtropenijo, povišane AST, ALT in GGT, koprivnico in bolečino v prsnem košu.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed medac 1000 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: Log Rank p-value* Median time to tumour progression (months) (95 % CI)
Slovenian: Mediana časa do napredovanja tumorja (meseci) (95 % IZ)
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Slovenian: Vnetje sluznice stopnje 3 ali 4 50 % predhodnega odmerka 100 % predhodnega odmerka a Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998) b Brez nevrološke toksičnosti
English: Cisplatin (N = 222)
Slovenian: (N = 222)
English: In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12.
Slovenian: V obeh vejah zdravljenja so bolniki, ki pred tem še niso prejeli kemoterapije, med celotno študijo prejemali dopolnilno folno kislino in vitamin B12.
English: Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pri rekonstituciji in nadaljnjemu redčenju pemetrekseda za intravensko infundiranje uporabljajte aseptično metodo.
English: Very common (may affect more than 1 in 10 people)
Slovenian: Med zdravljenjem s pemetreksedom se lahko pojavijo naslednji neželeni učinki: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: − Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving
Slovenian: − nekateri bolniki so med zdravljenjem z zdravilom Pemetreksed medac/obsevanjem doživeli vnetje sluznice požiralnika (grla)