natgillin/translations-raw huggingface dataset:
Patients randomised to maintenance treatment were required to have an ECOG performance status 0 or 1.
Bolniki, ki so bili naključno izbrani za vzdrževalno zdravljenje so morali imeti indeks zmogljivosti po ECOG 0 ali 1.
Owing to the possibility of pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment.
Zaradi možnosti, da zdravljenje s pemetreksedom povzroči trajno neplodnost, naj se moški pred začetkom zdravljenja posvetujejo o shranjevanju semena.
• Response rate (%) (95% CI)
• Stopnja odzivnosti (%) (95% IZ)
Due to the gastrointestinal toxicity of pemetrexed given in combination with cisplatin, severe dehydration has been observed.
Kot posledico toksičnosti pemetrekseda v kombinaciji s cisplatinom za prebavila so opažali hudo dehidracijo.
Rare cases of bullous conditions have been reported including Stevens-Johnson syndrome and Toxic epidermal necrolysis which in some cases were fatal.
Poročali so o redkih primerih buloznih stanj, kot sta Stevens-Johnsonov sindrom in toksična epidermalna nekroliza, ki so bila v nekaterih primerih usodna.
The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 5% glucose solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Ustrezno prostornino rekonstituirane raztopine pemetrekseda moramo še nadalje redčiti do 100 ml s 5-odstotno raztopino glukoze za injiciranje brez konzervansa; damo jo kot intravensko infuzijo, ki teče 10 minut.
Uncommon cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Poročali so o občasnih primerih akutne odpovedi ledvic s pemetreksedom samim ali v povezavi z drugimi kemoterapevtiki (glejte poglavje 4.4).
At least five doses of folic acid must be taken during the seven days preceding the first dose of pemetrexed, and dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
V sedmih dneh pred prvim odmerkom pemetrekseda morajo vzeti vsaj pet odmerkov folne kisline, odmerjanje pa morajo nadaljevati ves čas zdravljenja in še 21 dni po zadnjem odmerku pemetrekseda.
For instructions on reconstitution and dilution of Pemetrexed Pfizer before administration, see section 6.6
Za informacije o rekonstituciji in redčenju zdravila Pemetreksed Pfizer pred uporabo glejte poglavje 6.6.
Patients receiving pemetrexed should be monitored before each dose with a complete blood count, including a differential white cell count (WCC) and platelet count.
Bolnikom, ki prejemajo pemetreksed, moramo pred vsakim odmerkom odvzeti kri za popolno krvno sliko, vključno z diferencialno belo krvno sliko (WCC) in številom trombocitov.
Administration of pemetrexed to pregnant mice resulted in decreased foetal viability, decreased foetal weight, incomplete ossification of some skeletal structures, and cleft palate.
Dajanje pemetrekseda brejim mišim je povzročilo zmanjšano preživetje plodov, zmanjšano maso plodov, nepopolno okostenevanje določenih struktur okostja in shize neba.
Limited clinical data from a separate randomised, Phase-3, controlled trial, suggest that efficacy data (overall survival, progression-free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (N = 41) and patients who did not receive previous docetaxel treatment (N =
Omejeni klinični podatki iz ločeno randomiziranih, kontroliranih preskušanj faze 3, nakazujejo, da so podatki o učinkovitosti (skupno preživetje, preživetje brez napredovanja) za pemetreksed podobni med bolniki, ki so bili predhodno zdravljeni z doksatakselom (n = 41) in bolniki, ki niso prejeli predhodnega zdravljenja z doksatakselom (n = 540).
Oral folic acid and intramuscular vitamin B12 supplementation do not affect the pharmacokinetics of pemetrexed.
Peroralno jemanje folne kisline in intramuskularno dopolnjevanje z vitaminom B12 ne vplivata na farmakokinetiko pemetrekseda.
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Neporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Dose for cisplatin (mg/m2)
Odmerek cisplatina (mg/m
First-line doublet therapy containing pemetrexed was not included.
Dvojne terapije prvega izbora s pemetreksedom niso vključili.
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.
Pred začetkom kateregakoli ciklusa kemoterapije morajo bolniki izpolnjevati naslednja merila: absolutno število nevtrofilcev (ANC) mora biti ≥ 1500 celic/mm
Grade 3-4 toxicity
Toksičnost stopnje 3-4
What you need to know before you use Pemetrexed Pfizer 3.
Kaj morate vedeti, preden boste uporabili zdravilo Pemetreksed Pfizer
Prior to each chemotherapy administration, blood chemistry tests should be collected to evaluate renal and hepatic function.
Pred vsakim dajanjem kemoterapije opravimo tudi teste biokemije seruma za vrednotenje ledvičnega in jetrnega delovanja.
Preparation and administration precautions
Opozorila in previdnostni ukrepi
• 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).
• 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).
Consistent with other pemetrexed studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
V skladu z ostalimi študijami pemetrekseda, so v študiji JMEN tudi opažali razliko v učinkovitosti glede na histologijo NSCLC.
• Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
• Alergijska reakcija: če se pojavi izpuščaj (zelo pogosto) / pekoč ali zbadajoč občutek (pogosto) ali povišana telesna temperatura (pogosto).
Hair loss
Izguba las
You will also receive an injection of vitamin B12 (1,000 micrograms) in the week before administration of Pemetrexed Pfizer and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed Pfizer treatment).
V tednu pred dajanjem zdravila Pemetreksed Pfizer boste prejeli tudi injekcijo vitamina B12 (1.000 mikrogramov), nato pa še približno na vsakih 9 tednov (ustrezno 3 ciklusom zdravljenja z zdravilom Pemetreksed Pfizer).
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C.
Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, je za čase shranjevanja in pogoje pred uporabo odgovoren uporabnik in naj ne bi presegali 24 ur pri 2 do 8 °C.
Concomitant administration of nephrotoxic medicinal products (e.g., aminoglycoside, loop diuretics, platinum compounds, ciclosporin) could potentially result in delayed clearance of pemetrexed.
Sočasno dajanje nefrotoksičnih zdravil (denimo, aminoglikozidov, diuretikov zanke, spojin platine, ciklosporina) lahko potencialno povzroči zakasnjeni očistek pemetrekseda.
Contraceptive measures or abstinence are recommended.
Priporočamo ukrepe proti zanositvi ali vzdržnost.
Chemical and physical in-use stability of reconstituted and infusion solutions of Pemetrexed Pfizer were demonstrated for 24 hours at refrigerated temperature and 25°C.
Rekonstituirane raztopine in raztopine za infundiranje Kemijsko in fizikalno stabilnost rekonstituiranih raztopin in raztopin za infundiranje zdravila Pemetreksed Pfizer med uporabo so dokazali za 24 ur pri temperaturi shranjevanja v hladilniku in pri 25 °C.
During the study, low-dose folic acid and vitamin B12 supplementation was introduced to patients' therapy to reduce toxicity.
V trajanju študije so bolnikom uvedli v terapijo nizke odmerke dopolnilne folne kisline in vitamin B12, za zmanjšanje toksičnosti.
**Refer to NCI CTCAE Criteria (Version 3.0; NCI 2003) for each grade of toxicity.
**Glejte CTC Nacionalnega inštituta za rakava obolenja (verzija 3.0; NCI 2003), za vsako stopnjo toksičnosti.
Pemetrexed Pfizer is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Pemetreksed Pfizer je namenjen tudi zdravljenju bolnikov z napredovalim stadijem pljučnega raka, katerih bolezen napreduje po tem, ko je bila že uporabljena druga začetna kemoterapija.
You will always receive Pemetrexed Pfizer by infusion into one of your veins.
Zdravilo Pemetreksed Pfizer boste vedno prejeli v obliki infuzije v veno.
Extremity pain, low temperature and discolouration have been reported.
Poročali so tudi o bolečinah v okončinah, nizki temperaturi in bledosti okončin.
Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
Ženske v rodni dobi morajo v času zdravljenja s pemetreksedom uporabljati učinkovito kontracepcijo (glejte poglavje 4.6).
In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acid at higher doses (≥ 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
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.
Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter.
Spolno zrelim moškim odsvetujemo zaploditev otroka v času zdravljenja in še 6 mesecev zatem.
Any Grade 3 or 4 toxicities except mucositis
Katerekoli toksičnosti stopnje 3 ali 4, razen vnetja sluznice
Time to treatment failure (months) (95% CI)
Čas do neuspeha zdravljenja (meseci) (95% IZ)
Less toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities, such as neutropenia, febrile neutropenia, and infection with Grade 3/4 neutropenia, were reported when pretreatment with folic acid and vitamin B12 was administered.
Poročali so o povprečno manjši toksičnosti ter znižanju hematoloških in nehematoloških toksičnosti stopnje 3/4, denimo nevtropeniji, febrilni nevtropeniji ter okužbi z nevtropenijo stopnje 3/4, kadar so pred zdravljenjem dajali folno kislino in vitamin B12.
Pemetrexed Pfizer must only be reconstituted with sterile water for injections.
Zdravilo Pemetreksed Pfizer lahko pripravite samo s sterilno vodo za injekcije.
Efficacy of pemetrexed vs. docetaxel in NSCLC - ITT population pemetrexed docetaxel
Učinkovitost pemetrekseda v primerjavi z docetakselom pri NSCLC - Populacija NZ pemetreksed docetaksel
All patients were diagnosed with Stage IIIB or IV NSCLC and had received prior platinum-based chemotherapy.
Vsi bolniki so imeli diagnozo nedrobnoceličnega pljučnega karcinoma IIIB ali IV. stopnje in so predhodno prejemali kemoterapijo na osnovi platine.
The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
Farmakokinetika pemetrekseda ostaja po več ciklusih zdravljenja enaka.
Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent-to-treat; N = total population size.
Okrajšave: IZ = interval zaupanja; RT = razmerje tveganja; NZ = namen zdraviti; N = velikost populacije.
Patients with renal impairment (Standard Cockcroft and Gault formula or glomerular filtration rate measured Tc99m DPTA serum clearance method)
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.
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 Pfizer.
Če ste imeli ali če boste imeli zdravljenje z obsevanjem, prosimo, da to poveste zdravniku, saj ob uporabi zdravila Pemetreksed Pfizer lahko pride do zgodnje ali pozne reakcije na obsevanje.
During post-marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
V nadzoru po uvedbi zdravila na trg so pri bolnikih, ki so jih zdravili s pemetreksedom, poročali o naslednjih neželenih učinkih:
Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Dojenje je treba med zdravljenjem s pemetreksedom prekiniti (glejte poglavje 4.3).
The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality.
Raztopina, ki jo dobite, je bistra, brezbarvna do rumena ali zeleno-rumena, barve v tem razponu ne vplivajo na kakovost zdravila.
Rare cases of radiation recall have been reported in patients who have received radiotherapy previously (see section 4.4).
Poročali so o redkih primerih radiacijskega izpuščaja pri bolnikih, ki so se v preteklosti zdravili z radioterapijo (glejte poglavje 4.4).
Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia, and anaemia (or pancytopenia) (see section 4.8).
Pemetreksed lahko zavre delovanje kostnega mozga, kar se kaže kot nevtropenija, trombocitopenija in anemija (ali pancitopenija) (glejte poglavje 4.8).
docetaxel (N = 276)
Docetaksel (N = 276)
Serious renal events, including acute renal failure, have been reported with pemetrexed alone or in association with other chemotherapeutic agents.
Poročali so o resnih ledvičnih primerih, vključno z akutno ledvično odpovedjo, s pemetreksedom samim ali v povezavi z drugimi kemoterapevtiki.
Women of childbearing potential must use effective contraception during treatment with pemetrexed.
Ženske v rodni dobi morajo v času zdravljenja s pemetreksedom uporabljati učinkovito kontracepcijo.
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.
Priporočeni odmerek cisplatina je 75 mg/m2 TP, infundiran v dveh urah približno 30 minut po zaključku infuzije pemetrekseda prvi dan vsakega 21dnevnega ciklusa.
• Non-inferiority p-value (HR)
• Prednostna p-vrednost (RT)
Pemetrexed Pfizer is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Pemetreksed Pfizer se v kombinaciji s cisplatinom daje tudi za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega raka.
All patients were diagnosed with locally advanced or metastatic non-small cell lung cancer and received prior chemotherapy.
Vsi bolniki so imeli postavljeno diagnozo lokalno napredovalega ali metastatskega nedrobnoceličnega karcinoma pljuč ter so v preteklosti prejemali kemoterapijo.
Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Okrajšave: IZ = interval zaupanja; NZ = namen zdraviti; N = velikost populacije.
Patients with hepatic impairment
Bolniki z okvarjenim delovanjem jeter
Frequency Event**
Pogostnost Dogodek**
Dose reductions for subsequent cycles are based on nadir ANC, platelet count, and maximum non-haematologic toxicity seen from the previous cycle (see section 4.2).
Odmerke v naslednjih ciklusih nižamo na podlagi najnižjega ANC, števila trombocitov ter največje nehematološke toksičnosti iz prejšnjega ciklusa (glejte poglavje 4.2).
Increases in adverse reactions (all grades) were observed with longer exposure.
Pri dolgotrajnejši izpostavljenosti so opažali zvečanje neželenih učinkov (vseh stopenj).
This suggests that pemetrexed may impair male fertility.
To kaže, da pemetreksed lahko okvari moško plodnost.
Patients also required lower administration of erythropoietin/darbopoietin (10.4% versus 18.1%, p < 0.001), G-CSF/GM-CSF (3.1% versus 6.1%, p = 0.004), and iron preparations (4.3% versus 7.0%, p = 0.021).
Bolniki so potrebovali tudi nižje odmerjanje eritropoetin/darbopoetina (10,4 % proti 18,1 %, p < 0,001), G-CSF/GM-CSF (3,1 % proti 6,1 %, p = 0,004) in pripravkov z železom (4,3 % proti 7,0 %, p = 0,021).
Pemetrexed is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Pemetreksed je večtarčno antifolatno zdravilo proti raku, ki deluje tako, da ruši ključne od folata odvisne presnovne procese, ki so nujni za podvajanje celic.
Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and toxic epidermal necrolysis
Bulozna stanja (bolezni s kožnimi mehurji), vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo
*Refer to National Cancer Institute CTC version 2 for each grade of toxicity.
*Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti.
NSCLC, maintenance treatment JMEN
NSCLC, vzdrževalno zdravljenje
Pemetrexed was not mutagenic in either the in vitro chromosome aberration test in Chinese hamster ovary cells, or the Ames test. Pemetrexed has been shown to be clastogenic in the in vivo micronucleus test in the mouse.
Pemetreksed ni bil mutagen niti v testu kromosomskih aberacij in vitro na celicah jajčnika kitajskih hrčkov niti v testu Ames.
Pharmacotherapeutic group: antineoplastic agents, folic acid analogues.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, analogi folne kisline.
Cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during, or subsequent to their pemetrexed therapy.
Poročali so o primerih radiacijske pljučnice pri bolnikih, ki so jih zdravili z radiacijo pred, med ali po zdravljenju s pemetreksedom.
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.
Mediana časa od začetka zdravljenja s pemetreksedom in indukcijskim zdravilom cisplatina do začetka vzdrževalnega zdravljenja je bila 2,96 meseca tako v skupini s pemetreksedom, kot v skupini s placebom.
• 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).
• Če ste utrujeni, omotični, se hitro zadihate, ste bledi (ker imate morda manj hemoglobina, kot je normalno, kar je zelo pogosto).
If you are breast-feeding, tell your doctor.
Če dojite, to povejte svojemu zdravniku.
Skin reactions have been reported in patients not pre-treated with a corticosteroid.
Pri bolnikih, ki pred zdravljenjem niso prejemali kortikosteroidov, so poročali o kožnih reakcijah.
Neutrophils/Granulocytes decreased
Znižani nevtrofilci/ granulociti
Caution should be made when these medicinal products are combined with pemetrexed.
Pri sočasnem dajanju teh zdravil s pemetreksedom je potrebna previdnost.
Non-small cell lung cancer
Nedrobnocelični karcinom pljuč
UNIQUE IDENTIFIER- 2D BARCODE
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
Rarely seen events include Stevens-Johnson syndrome and toxic epidermal necrolysis.
Redkeje opaženi učinki so Stevens- Johnsonov sindrom in toksična epidermalna nekroliza.
Your height and weight are measured to work out the surface area of your body.
Za izračun površine vašega telesa izmerimo vašo telesno višino in maso.
Common Dehydration
Pogosto Dehidracija
METHOD OF ADMINISTRATION Reconstitute and dilute before use See leaflet.
Pred uporabo rekonstituirajte in razredčite.
Pemetrexed Pfizer 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.
Zdravilo Pemetreksed Pfizer 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.
• If you start feeling chest pain (common) or having a fast heart rate (uncommon).
• Če se pojavi bolečina v prsnem košu (pogosto) ali hitro bitje srca (občasno).
The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to
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.
• 95% CI for HR
• 95 % IZ za RT
In the event of neurotoxicity, the recommended dose adjustment for pemetrexed and cisplatin is documented in Table 3.
Priporočene prilagoditve odmerkov pemetrekseda in cisplatina v primeru nevrološke toksičnosti so navedene v Preglednici 3.
Adjusted hazard ratio (HR) (95% CI)
Prilagojeno razmerje tveganja (RT) (95 % IZ)
Concomitant use not recommended
Odsvetovana sočasna uporaba
Type I glass vial with bromobutyl rubber stopper containing 100 mg, 500 mg or 1,000 mg of pemetrexed
Steklena viala tipa I z bromobutilno gumijasto zaporko, ki vsebuje 100 mg, 500 mg ali 1.000 mg pemetrekseda.
Nephrogenic diabetes insipidus and renal tubular necrosis were also reported in post marketing setting with pemetrexed alone or with other chemotherapeutic agents.
V obdobju trženja so poročali tudi o nefrogenem diabetesu insipidusu in ledvični tubulni nekrozi s pemetreksedom samim ali v povezavi z drugimi kemoterapevtiki.
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).
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).
Other medicines and Pemetrexed Pfizer
Druga zdravila in zdravilo Pemetreksed Pfizer
pemetrexed*** (N = 800)
Dogodek** Pemetreksed*** (N = 800)
There is no relevant use of pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Pri pediatrični populaciji se pemetrekseda ne uporablja za zdravljenje malignega plevralnega mezotelioma in nedrobnoceličnega karcinoma pljuč.
Uncommon cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to their pemetrexed therapy (see section 4.4).
Poročali so o občasnih primerih radiacijske pljučnice pri bolnikih, ki so jih zdravili z radiacijo pred, med ali po njihovem zdravljenju s pemetreksedom (glejte poglavje 4.4).
The PFS and OS results in patients with squamous cell histology suggested no advantage for pemetrexed over placebo.
Rezultati preživetja brez napredovanja in skupnega preživetja pri bolnikih z luskasto celično histologijo ne kažejo prednosti za pemetreksed nad placebom.
Dose adjustments
Prilagajanja odmerkov
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.
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.
Liver: abnormal blood tests
Jetra: nenormalne vrednosti krvnih testov Solzne oči
NSCLC, first-line treatment
NSCLC, zdravljenje prvega izbora
Nadir platelets < 50,000/mm3 with bleedinga, regardless of nadir ANC
Najnižje število trombocitov < 50.000/mm 3 s krvavitvijo a, ne glede na najnižji ANC