FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Vendar pa bolnikov z okvarjenim delovanjem jeter, ki se kaže kot bilirubin > 1,5-kratnik zgornje meje normalnih vrednosti in/ali aminotransferaza > 3,0-kratnik zgornje meje normalnih vrednosti (brez zasevkov v jetrih) ali > 5,0-kratnik zgornje meje normalnih vrednosti (z zasevki v jetrih), niso posebej preučevali.
English: • Low haemoglobin level (anaemia)
Slovenian: • Nizka raven hemoglobina (anemija)
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.
Slovenian: Dopolnjevanje vitaminov: vaš zdravnik vam bo predpisal peroralno folno kislino (vitamin) ali multivitaminski pripravek, ki jo vsebuje (350 do 1000 mikrogramov), ki ga boste morali med prejemanjem zdravila Pemetreksed Sandoz jemati enkrat dnevno.
English: Pemetrexed Sandoz can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
Slovenian: Zdravnik vam lahko predpiše zdravilo Pemetreksed Sandoz, če imate pljučni rak v napredovalem stadiju in če se vaša bolezen odziva na zdravljenje oz. če po začetni kemoterapiji ostaja večinoma nespremenjena.
English: • Loss of sensation
Slovenian: • Izguba občutka
English: 3 B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
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.
Slovenian: Bolniki z okvarjenim delovanjem ledvic (po standardni formuli Cockcrofta in Gaulta ali hitrost glomerulne filtracije, izmerjena z metodo Tc99m-DPTA serumskega očistka): pemetreksed se primarno izloča nespremenjen preko ledvic.
English: What Pemetrexed Sandoz is and what it is used for
Slovenian: Kaj je zdravilo Pemetreksed Sandoz in za kaj ga uporabljamo
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.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina  80 ml/min) lahko visoki odmerki nesteroidnih protivnetnih zdravil (NSAID-i, denimo ibuprofen > 1600 mg dnevno) in acetilsalicilna kislina v visokih odmerkih ( 1,3 g dnevno) zmanjšajo eliminacijo pemetrekseda in tako lahko povečajo pojavnost neželenih učinkov pemetrekseda.
English: For intravenous use after reconstitution and dilution.
Slovenian: Za intravensko uporabo po pripravi in redčenju.
English: Contains mannitol (E421), hydrochloric acid and sodium hydroxide (for pH adjustment).
Slovenian: Vsebuje manitol (E421), klorovodikovo kislino in natrijev hidroksid (za uravnavanje pH).
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Pemetrexed Sandoz and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Sandoz treatment).
Slovenian: V tednu pred dajanjem zdravila Pemetreksed Sandoz boste prejeli tudi injekcijo vitamina B12 (1000 mikrogramov), nato pa še približno na vsakih 9 tednov (ustrezno 3 ciklusom zdravljenja z zdravilom Pemetreksed Sandoz).
English: • Acute renal failure
Slovenian: • Akutna odpoved ledvic
English: What you need to know before you use Pemetrexed Sandoz
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Pemetreksed Sandoz
English: Pemetrexed Sandoz must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Slovenian: Zdravilo Pemetreksed Sandoz smemo dajati le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije za zdravljenje raka.
English: The resulting solution is clear and ranges in colour from colourless to pale yellow without adversely affecting product quality.
Slovenian: Raztopina, ki jo dobite, je bistra, brezbarvna do rumena, barve v tem razponu ne vplivajo na kakovost zdravila.
English: 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a
Slovenian: Farmakokinetične lastnosti pemetrekseda po dajanju ene učinkovine so vrednotili pri 426 bolnikih z različnimi malignimi trdnimi tumorji v razponu odmerkov od 0,2 do 838 mg/m2, infundiranih v 10 minutah.
English: Concomitant administration of nephrotoxic drugs (e.g., aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed.
Slovenian: Sočasno dajanje nefrotoksičnih zdravil (denimo aminoglikozidov, diuretikov zanke, spojin platine, ciklosporina) lahko potencialno povzroči zakasnjeni očistek pemetrekseda.
English: **Refer to NCI CTCAE Criteria (Version 3.0; NCI 2003) for each grade of toxicity.
Slovenian: ** Glejte CTC Nacionalnega inštituta za rakava obolenja (verzija 3.0; NCI 2003), za vsako stopnjo toksičnosti.
English: Pemetrexed Sandoz is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Slovenian: Pemetreksed Sandoz se daje tudi v kombinaciji s cisplatinom, za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega raka.
English: • Liver: abnormal blood tests
Slovenian: •Jetra: nenormalne vrednosti krvnih testov
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.
Slovenian: Pred začetkom kateregakoli ciklusa kemoterapije morajo bolniki izpolnjevati naslednja merila: absolutno število nevtrofilcev (ANC) mora biti  1500 celic/mm3 ter število trombocitov
English: When using Pemetrexed Sandoz in combination with cisplatin:
Slovenian: Kadar uporabljamo zdravilo Pemetreksed Sandoz v kombinaciji s cisplatinom:
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).
Slovenian: Če vam krvavijo dlesni, krvavite iz nosu ali ustne votline, ali se pojavi kakršnakoli krvavitev, ki se noče ustaviti, rdečkasto ali rožnato obarvan urin, nepričakovane podplutbe (ker imate lahko manj trombocitov, kot je normalno, kar je zelo pogosto).
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.
Slovenian: Pri bolnikih moramo biti med zdravljenjem pozorni na morebiten pojav mielosupresije, pemetrekseda pa bolnikom ne smemo dajati, dokler se absolutno število nevtrofilcev (ANC) ne povrne na  1500 celic/mm3 ter število trombocitov na  100.000 celic/mm3.
English: Vomiting Anorexia Constipation Stomatitis/ Pharyngitis
Slovenian: Slabost Bruhanje Anoreksija Zaprtje Stomatitis/ Faringitis
English: 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.
Slovenian: Priporočeni odmerek pemetrekseda je 500 mg/m2 telesne površine (TP), dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: Pemetrexed*** (N = 800)
Slovenian: Pemetreksed*** (N = 800)
English: Docetaxel (N = 276)
Slovenian: Docetaksel (N = 276)
English: • Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)
Slovenian: • Kolitis (vnetje sluznice debelega črevesa, ki ga lahko spremlja krvavitev iz črevesa ali danke)
English: Pemetrexed Sandoz in combination with cisplatin
Slovenian: Pemetreksed Sandoz v kombinaciji s cisplatinom
English: Pemetrexed Sandoz.
Slovenian: Pemetreksed Sandoz.
English: Pemetrexed Sandoz is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Slovenian: Zdravilo Pemetreksed Sandoz je namenjeno tudi zdravljenju bolnikov z napredovalim stadijem pljučnega raka, katerih bolezen se širi po tem, ko je bila že uporabljena druga začetna kemoterapija.
English: Pemetrexed Sandoz as single agent In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Pemetreksed Sandoz kot samostojno zdravilo Pri bolnikih, pri katerih zdravimo nedrobnocelični pljučni karcinom po predhodni kemoterapiji, je priporočeni odmerek pemetrekseda 500 mg/m2 TP, dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: Adenocarcinoma (N = 847)
Slovenian: Adenokarcinom (N = 847)
English: AST (SGOT) elevation
Slovenian: Povišanje SGOT (AST)
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”).
Slovenian: Pomožne snovi so manitol (E421), klorovodikova kislina (za uravnavanje pH) in natrijev hidroksid (za uravnavanje pH) (glejte poglavje 2: Zdravilo Pemetreksed Sandoz vsebuje natrij).
English: • 95% CI for HR
Slovenian: 95 % IZ za RT
English: Breast-feeding must be discontinued during Pemetrexed Sandoz treatment.
Slovenian: Dojenje morate med zdravljenjem z zdravilom Pemetreksed Sandoz prekiniti.
English: Marketing Authorisation Holder Sandoz GmbH
Slovenian: Imetnik dovoljenja za promet z zdravilom Sandoz GmbH
English: 5 D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Sandoz and cisplatin is documented in Table 3.
Slovenian: Priporočene prilagoditve odmerkov zdravila Pemetreksed Sandoz in cisplatina v primeru nevrološke toksičnosti so navedene v Preglednici 3.
English: • Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection(since you might have less white blood cells than normal which is very common).
Slovenian: Če opazite katerega od spodaj naštetih učinkov, morate nemudoma poklicati svojega zdravnika: Povišana telesna temperatura ali okužba (pogosto): če se pojavi temperatura 38ºC ali višja, znojenje ali drugi znaki okužbe (ker imate lahko manj belih krvničk kot normalno, kar je zelo pogosto).
English: • Increased skin pigmentation
Slovenian: • Solzne oči • Povečana pigmentiranost kože
English: Pemetrexed Sandoz 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 Sandoz dajemo v kombinaciji s cisplatinom, drugim zdravilom proti raku, za zdravljenje malignega plevralnega mezotelioma, vrste raka, ki prizadene vrhnjo plast pljuč, bolnikom, ki pred tem še niso prejemali kemoterapije.
English: It is a white to pale yellow lyophilised powder.
Slovenian: Je bel do sivo bel ali svetlo rumen liofiliziran prašek.
English: • Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Slovenian: Alergijska reakcija: če se pojavi izpuščaj (zelo pogosto) / pekoč ali zbadajoč občutek (pogosto), ali povišana telesna temperatura (pogosto).
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.
Slovenian: Če ste imeli ali če boste imeli zdravljenje z obsevanjem, prosimo, povejte to svojemu zdravniku, saj ob jemanju zdravila Pemetreksed Sandoz lahko pride do zgodnje ali pozne reakcije na obsevanje.
English: After reconstitution and infusion:
Slovenian: Rekonstituirana raztopina in raztopina za infundiranje:
English: 2 A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJE
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).
Slovenian: Bolniki zdravljeni s pemetreksedom in cisplatinom so potrebovali manj transfuzij (16,4 % proti 28,9 %, p < 0,001), transfuzij rdečih krvničk (16,1 % proti 27,3 %, p < 0,001) in transfuzij krvnih ploščic (1,8 % proti 4,5 %, p = 0,002).
English: • 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).
Slovenian: Če ste utrujeni, omotični, se hitro zadihate, ste bledi (ker imate morda manj hemoglobina, kot je normalno, kar je zelo pogosto).
English: Pemetrexed is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Slovenian: Pemetreksed Sandoz (pemetreksed) je večtarčno protirakavo antifolatno zdravilo, ki deluje s porušenjem ključnih presnovnih procesov, odvisnih od folata, ki so nujni za podvajanje celic.
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Sandoz.
Slovenian: V sedmih dneh pred prvim odmerkom zdravilom Pemetreksed Sandoz morate vzeti vsaj 5 odmerkov.
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Slovenian: Po rekonstituciji vsebuje (glejte poglavje 6.6) ena viala 25 mg/ml pemetrekseda.
English: Pemetrexed Sandoz should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Zdravilo Pemetreksed Sandoz se daje kot 10-minutna intravenska infuzija prvi dan vsakega 21dnevnega ciklusa.
English: Chemical and physical in-use stability of reconstituted solutions of Pemetrexed Sandoz has been demonstrated for 4 days at 2°C to 8°C and for 4 days below 25°C.
Slovenian: Kemična in fizikalna stabilnost rekonstituirane raztopine zdravila Pemetreksed Sandoz med uporabo je dokazana za 4 dni pri temperaturi 2°C do 8°C in 4 dni pri temperaturi do 25°C.
English: Nephrogenic diabetes insipidus and renal tubular necrosis were also reported in post marketing setting with pemetrexed alone or with other chemotherapeutic agents.
Slovenian: V obdobju po prihodu zdravila na trg so poročali tudi o nefrogenem diabetesu insipidus in ledvični tubulni nekrozi s pemetreksedom samim ali v povezavi z drugimi kemoterapevtiki.
English: Chemical and physical in-use stability of infusion solutions of Pemetrexed Sandoz has been demonstrated for 4 days at 2°C to 8°C and for 2 days below 25°C.
Slovenian: Kemična in fizikalna stabilnost raztopine za infundiranje zdravila Pemetreksed Sandoz med uporabo je dokazana za 4 dni pri temperaturi 2°C do 8°C in 2 dni pri temperaturi do 25°C.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Slovenian: Za informacije o rekonstituciji in redčenju zdravila Pemetreksed Sandoz pred uporabo glejte poglavje 6.6.
English: Efficacy of Pemetrexed vs. Docetaxel in NSCLC - ITT population
Slovenian: Učinkovitost pemetrekseda v primerjavi z docetakselom pri NSCLC - Populacija NZ pemetreksed docetaksel
English: • Kidney: abnormal blood tests
Slovenian: • Ledvice: nenormalne vrednosti krvnih testov
English: 1 SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalcev, odgovornih za sproščanje serije
English: Very common Alopecia
Slovenian: Alopecija Zelo pogosto Utrujenost
English: The use of calcium folinate / folinic acid in the management of pemetrexed overdose should be considered.
Slovenian: Pri zdravljenju prevelikega odmerjanja pemetrekseda velja razmisliti o uporabi kalcijevega folinata / folinične kisline.
English: 4 C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Time to treatment failure (TTTF - months)
Slovenian: RT (95 % IZ) Čas do neuspeha zdravljenja (Time to treatment failure, TTTF - meseci) Mediana
English: Dose of Pemetrexed (mg/m2)
Slovenian: Odmerek pemetrekseda (mg/m2)
English: Nadir platelets < 50,000/mm3 with bleedinga, regardless of nadir ANC
Slovenian: Najnižje število trombocitov < 50.000 /mm3 s krvavitvijoa, ne glede na najnižji ANC
English: Pemetrexed Sandoz is a powder for concentrate for solution for infusion in a glass vial.
Slovenian: Zdravilo Pemetreksed Sandoz je prašek za koncentrat za raztopino za infundiranje v stekleni viali.
English: Paediatric population: There is no relevant use of pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Slovenian: Pediatrična populacija: Pri pediatrični populaciji se zdravila Pemetreksed Sandoz ne uporablja za zdravljenje malignega plevralnega mezotelioma in nedrobnoceličnega karcinoma pljuč.
English: Gemcitabine/ Cisplatin (N = 830)
Slovenian: Gemcitabin/cisplatin (N = 830)
English: • HR (95% CI)
Slovenian: RT (95 % IZ)
English: White to off-white or pale yellow lyophilised powder.
Slovenian: Bel do sivo bel ali svetlorumen liofilizirani prašek.
English: 100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Slovenian: 100% predhodnega odmerka a Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998) b Brez nevrološke toksičnosti
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 hazard ratio (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).
Slovenian: Analiza vpliva histologije NSCLC glede učinka zdravljenja na skupno preživetje je bila prednostna za pemetreksed proti docetakselu pri tistih, ki nimajo pretežno luskaste histologije (N = 399, 9,3 proti 8,0 mesecev, prilagojen RT = 0,78; 95% IZ = 0,61-1,00, p = 0,047) in je bila prednostna za docetaksel za luskasto celično histologijo karcinoma (N = 172, 6,2 proti 7,4 mesecev, prilagojen RT = 1,56; 95 % IZ = 1,082,26, p = 0,018).
English: • If you start feeling chest pain (common) or having a fast heart rate (uncommon).
Slovenian: Če se pojavi bolečina v prsnem košu (pogosto) ali hitro bitje srca (občasno).
English: • Lower limb swelling with pain and redness
Slovenian: • Otekanje spodnjih okončin z bolečino in pordelostjo
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.
Slovenian: Spodnja preglednica podaja pogostnost in resnost neželenih učinkov, o katerih so poročali pri > 5 % od 265 bolnikov, ki so jih naključno razporedili, da so prejemali eno učinkovino pemetreksed z dopolniloma folno kislino in vitaminom B12, ter pri 276 bolnikih, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, docetaksel.
English: Pemetrexed Sandoz 100 mg contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free'.
Slovenian: Pemetreksed Sandoz 100 mg vsebuje manj kot 1 mmol natrija (23 mg) v eni viali, kar v bistvu pomeni “brez natrija”.
English: Nadir platelets < 50,000/mm3 regardless of nadir ANC
Slovenian: Najnižje število trombocitov < 50.000 /mm3 ne glede na najnižji ANC
English: Rare (may affect up to 1 in 1,000 people)
Slovenian: Redko (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: A multi-centre, randomised, open-label Phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent-To-Treat [ITT] population N = 283) and 7.9 months for patients treated with docetaxel (ITT N = 288).
Slovenian: Multicentrična, randomizirana študija faze 3 z znanim zdravilom, kjer so preskušali pemetreksed v primerjavi z docetakselom pri bolnikih z lokalno napredovalim ali metastatskim NSCLC po predhodni kemoterapiji, je pokazala mediano časa preživetja 8,3 mesece pri bolnikih, zdravljenih s pemetreksedom (Populacija z namenom zdraviti N = 283), in 7,9 mesecev pri bolnikih, zdravljenih z docetakselom (NZ N = 288).
English: 6 A. LABELLING
Slovenian: A. OZNAČEVANJE
English: Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1).
Slovenian: Pemetreksed Sandoz je indiciran kot monoterapija za zdravljenje lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega karcinoma, ki nima pretežno ploščatocelične histologije pri bolnikih, pri katerih bolezen ni napredovala neposredno po kemoterapiji na osnovi platine (glejte poglavje 5.1).
English: • Hair loss
Slovenian: • Izguba las
English: 10-minute period.
Slovenian: 2 leti
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=0.64-0.96, p=0.0195).
Slovenian: Po indukcijskem zdravljenju s pemetreksedom skupaj s cisplatinom (4 cikli) je bilo zdravljenje s pemetreksedom statistično boljše od placeba glede skupnega preživetja (mediana 13,9 mesecev v primerjavi z 11,0 meseci, razmerje tveganja = 0,78, 95 % CI=0,64-0,96, p=0,0195).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1000 mg
English: A multi-centre, 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 (HR) 0.94; 95% CI= 0.84-1.05).
Slovenian: Multicentrična, randomizirana, odprta študija faze 3pemetreksedaskupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri bolnikih, ki v preteklosti še niso prejemali kemoterapije, z lokalno napredovalim ali metastatskim (stopnja IIIb ali IV) nedrobnoceličnim karcinomom pljuč (NSCLC), je pokazala, da je pemetreksedskupaj s cisplatinom (Populacija z namenom zdraviti, [NZ] populacija n=862) dosegla prvotno končno točko in pokazala podobno klinično učinkovitost, kot gemcitabin skupaj s cisplatinom (NZ n=863) v skupnem preživetju (prilagojeno razmerje tveganja 0,94; 95% IZ=0,84-1,05).