FrancophonIA/ELRC3.0 huggingface dataset:
English: A phase 2 study of pemetrexed in 31 solid tumour patients with stable third space fluid demonstrated no difference in pemetrexed dose normalized plasma concentrations or clearance compared to patients without third space fluid collections.
Slovenian: V študiji pemetrekseda so v fazi II pri 31 bolnikih s solidnim tumorjem in stabilno tekočino tretjega prostora pokazali, da ni razlike med normalno koncentracijo v plazmi ali očistkom, doseženo glede na odmerek pemetrekseda, v primerjavi z bolniki brez zaloge tekočine tretjega prostora.
English: A hospital pharmacist, nurse or doctor will have mixed the ALIMTA powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Slovenian: Bolnišnični farmacevt, medicinska sestra ali zdravnik bo prašek ALIMTA, preden ga boste prejeli, zmešal z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1500 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 ≥ 100.000 celic/mm3.
English: Therefore, caution should be made when administering higher doses of NSAIDs or acetylsalicylic acid, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/min).
Slovenian: Zato je pri dajanju visokih odmerkov NSAID-ov ali acetilsalicilne kisline sočasno s pemetreksedom bolnikom z normalnim delovanjem ledvic (očistek kreatinina ≥ 80 ml/min) potrebna previdnost.
English: Limited clinical data from a separate randomized, 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 = 540).
Slovenian: 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).
English: Frequency Event*
Slovenian: Pogostnost Dogodek *
English: Taste disturbance
Slovenian: Motnje okusa
English: When using ALIMTA in combination with cisplatin:
Slovenian: Kadar uporabljamo zdravilo ALIMTA v kombinaciji s cisplatinom:
English: Pemetrexed is primarily eliminated unchanged by renal excretion.
Slovenian: Pemetreksed se primarno izloča nespremenjen preko ledvic.
English: Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Slovenian: Vse neporabljeno zdravilo ali odpadke je treba zavreči v skladu z lokalnimi zahtevami.
English: Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving treatment.
Slovenian: Zato moramo bolnike pred prejemanjem terapije in/ali po njej ustrezno hidrirati, prejeti morajo zadostno antiemetično zdravljenje.
English: Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n = 164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8 % versus 5.3 %, respectively) and alanine aminotransferase elevation (15.2 % versus 1.9 %, respectively).
Slovenian: Klinično pomembne laboratorijske toksičnosti stopenj 3 in 4 so bile podobne pri integriranih rezultatih faze 2 treh študij pemetrekseda kot edine učinkovine (n = 164) in faze 3 študije pemetrekseda kot edine učinkovine, opisane zgoraj, z izjemo nevtropenije (12,8 % oziroma 5,3 %) in povišanja alaninske aminotransferaze (15,2 % oziroma 1,9 %).
English: As a result there is sufficient evidence suggesting a causal relationship between the use of pemetrexed and infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue including acute bacterial dermo-hypodermitis, cellulitis, pseudocellulitis and dermatitis.
Slovenian: Obstaja torej dovolj dokazov, ki kažejo na vzročno povezavo med uporabo pemetrekseda ter infektivnimi in neinfektivnimi motnjami dermisa, hipodermisa in/ali podkožja, vključno z akutnim bakterijskim dermohipodermitisom, celulitisom, psevdocelulitisom in dermatitisom.
English: Uncommon ( may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: You must contact your doctor immediately if you notice any of the following: 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: Povišana telesna temperatura ali okužba (pogosto): če se pojavi temperatura 38 ºC ali višja, znojenje ali drugi znaki okužbe (ker imate lahko manj belih krvničk kot normalno, kar je zelo pogosto).
English: Gemcitabine/ cisplatin (N = 830)
Slovenian: Gemcitabin/cisplatin N = 830
English: Administration of pemetrexed to pregnant mice resulted in decreased foetal viability, decreased foetal weight, incomplete ossification of some skeletal structures and cleft palate.
Slovenian: Dajanje pemetrekseda brejim mišim je povzročilo zmanjšano preživetje plodov, zmanjšano maso plodov, nepopolno okostenevanje določenih struktur okostja in shize neba.
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
Slovenian: Obvestite zdravnika, če se pojavijo hud izpuščaj, srbenje ali mehurčki (StevensJohnsonov sindrom ali toksična epidermalna nekroliza).
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of ALIMTA and then approximately every 9 weeks (corresponding to 3 courses of ALIMTA treatment).
Slovenian: V tednu pred dajanjem zdravila ALIMTA boste prejeli tudi injekcijo vitamina B12 (1000 mikrogramov), nato pa še približno na vsakih 9 tednov (ustrezno 3 ciklusom zdravljenja z zdravilom ALIMTA).
English: Concomitant administration of substances that are also tubularly secreted (e.g. probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Slovenian: Sočasno dajanje snovi, ki se tudi izločajo s tubulno sekrecijo (denimo, probenecid, penicilin), lahko potencialno povzroči zakasnjeni očistek pemetrekseda.
English: ALIMTA in combination with cisplatin
Slovenian: ALIMTA v kombinaciji s cisplatinom
English: 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 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: Hrvatska Eli Lilly Hrvatska d.o.o.
Slovenian: Eli Lilly Hrvatska d.o.o.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pemetrexed, the scientific conclusions of the CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za pemetreksed je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Data from the originator medicinal product identified 141 cases of pigmentation disorders such as hyperpigmentation (n=48) and pigmentation disorders NEC (n=80) corresponding mostly to blackish or increased pigmentation, positive de-challenge and positive re-challenge in a number of cases was also described.
Slovenian: Na podlagi podatkov o originatorskem zdravilu so prepoznali 141 primerov motenj pigmentacije, kot so hiperpigmentacija (n = 48) in motnje pigmentacije, ki niso uvrščene drugje (n = 80), ki so ustrezale predvsem črnkasti ali povečani pigmentaciji; pri številnih primerih so opisali tudi izzvenenje simptomov po prekinitvi zdravljenja in njihov vnovični pojav ob ponovni uvedbi zdravljenja.
English: You must take at least 5 doses during the seven days before the first dose of ALIMTA.
Slovenian: V sedmih dneh pred prvim odmerkom zdravilom ALIMTA morate vzeti vsaj 5 odmerkov.
English: Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
Slovenian: Raztopine pemetrekseda za infundiranje, pripravljene, kot je navedeno zgoraj, so skladne s seti za dajanje in infuzijskimi vrečkami iz polivinilklorida in prevlečenimi s poliolefinom.
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 ALIMTA.
Slovenian: Dopolnjevanje vitaminov: 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 ALIMTA jemati enkrat dnevno.
English: Pemetrexed has a steady-state volume of distribution of 9 l/m2.
Slovenian: Pemetreksed ima volumen porazdelitve v stanju dinamičnega ravnovesja 9 l/m2.
English: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Slovenian: Kot pri drugih potencialno toksičnih učinkovinah za zdravljenje raka je potrebna previdnost pri ravnanju z raztopinami pemetrekseda za infundiranje ter pripravi teh raztopin.
English: Of the 939 patients treated with ALIMTA plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Slovenian: Izmed 939 bolnikov, ki so bili zdravljeni z zdravilom ALIMTA in indukcijskim zdravilom cisplatina, je bilo naključno izbranih za vzdrževalno zdravljenje s pemetreksedom ali s placebom.
English: LIST OF EXCIPIENTS Mannitol, hydrochloric acid, sodium hydroxide (see package leaflet for further information).
Slovenian: Manitol, klorovodikova kislina, natrijev hidroksid (za nadaljnje informacije glejte navodilo za uporabo).
English: There were no clinically relevant differences observed for the safety profile of ALIMTA within the histology subgroups.
Slovenian: Za varnostni profil zdravila ALIMTA niso opazili nobenih klinično pomembnih razlik znotraj histoloških podskupin.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj(a) za promet z zdravilom
English: Patients received a median of 4 cycles of maintenance treatment with ALIMTA and 4 cycles of placebo.
Slovenian: Bolniki so prejeli mediano 4 cikle vzdrževalnega zdravljenja z zdravilom ALIMTA in 4 cikle placeba.
English: ≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with ALIMTA.
Slovenian: Skupno 213 bolnikov (48,3 %) je zaključilo ≥ 6 ciklov in skupno 103 bolniki (23,4 %) so zaključili ≥ 10 ciklov zdravljenja z zdravilom ALIMTA.
English: During the study, low-dose folic acid and vitamin B12 supplementation was introduced to patients' therapy to reduce toxicity.
Slovenian: V trajanju študije so bolnikom uvedli v terapijo nizke odmerke dopolnilne folne kisline in vitamina B12, za zmanjšanje toksičnosti.
English: Chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature.
Slovenian: Kemijsko in fizikalno obstojnost za uporabo pripravljenih raztopin pemetrekseda in raztopin pemetrekseda za infundiranje so pokazali za 24 ur v hladilniku.
English: The other ingredients are mannitol, hydrochloric acid and sodium hydroxide
Slovenian: Pomožne snovi so manitol, klorovodikova kislina in natrijev hidroksid.
English: 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 pre-treatment with folic acid and vitamin B12 was administered.
Slovenian: 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.
English: The relative treatment effect of ALIMTA was internally consistent across subgroups (including disease stage, induction response, ECOG PS, smoking status, gender, histology and age) and similar to that observed in the unadjusted OS and PFS analyses.
Slovenian: ALIMTA je bil notranje konsistenten med podskupinami (vključno s stopnjo bolezni, odzivom na indukcijsko zdravljenje, stanjem zmogljivosti po ECOG, kajenjem, spolom, histologijo in starostjo) in podoben tistemu, ki so ga opazili pri neprilagojenih analizah skupnega preživetja in preživetja brez napredovanja bolezni.
English: Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Slovenian: Imunsko pogojena hemolitična anemija (propad rdečih krvnih celic, ki ga povzročijo protitelesa)
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
English: Each vial contains approximately 11 mg sodium.
Slovenian: Ena viala vsebuje približno 11 mg natrija.
English: ALIMTA (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: ALIMTA (pemetreksed) je večtarčno protirakavo antifolatno zdravilo, ki deluje s porušenjem ključnih presnovnih procesov, odvisnih od folata, ki so nujni za podvajanje celic.
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Slovenian: Bolniki morajo dnevno jemati peroralno folno kislino ali multivitaminski pripravek, ki jo vsebuje (350 do 1000 mikrogramov).
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the ALIMTA arm versus 21.7% on the placebo arm.
Slovenian: V času te končne analize preživetja je bilo živih ali ni bilo na voljo za nadaljnje spremljanje 28,7 % bolnikov v kraku
English: Infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue have been reported with an unknown frequency (e.g. acute bacterial dermo-hypodermitis, pseudocellulitis, dermatitis).
Slovenian: Poročali so o infektivnih in neinfektivnih boleznih dermisa, hipodermisa in/ali podkožja z neznano pogostnostjo (npr. akutni bakterijski dermohipodermitis, psevdocelulitis, dermatitis).
English: 95 % CI for HR
Slovenian: 95 % IZ za RT
English: Increased skin pigmentation
Slovenian: Solzne oči Povečana pigmentiranost kože
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: You will always receive ALIMTA by infusion into one of your veins.
Slovenian: Zdravilo ALIMTA boste vedno prejeli v obliki infuzije v veno.
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** which is derived from the term “renal/genitourinary other”.
Slovenian: *Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti, razen izraza “znižan očistek kreatinina”.
English: Progression-Free Survival
Slovenian: Preživetje brez napredovanja
English: To be taken into consideration by patients on a controlled sodium diet.
Slovenian: Ta podatek naj upoštevajo bolniki na dieti z nadzorovanim vnosom natrija.
English: The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N=519), and compared to patients who received > 6 cycles of pemetrexed (N=281).
Slovenian: Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N=519) in jo primerjali z bolniki, ki so prejeli > 6 ciklov pemetrekseda
English: 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).
Slovenian: Odmerke v naslednjih ciklusih nižamo na podlagi najnižjega ANC, števila trombocitov ter največje nehematološke toksičnosti iz prejšnjega ciklusa (glejte poglavje 4.2).
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: Driving and using machines ALIMTA may make you feel tired.
Slovenian: ALIMTA lahko povzroči, da se boste počutili utrujene.
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: What you need to know before you use ALIMTA
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo ALIMTA Ne uporabljajte zdravila ALIMTA
English: Docetaxel N = 276
Slovenian: Docetaksel N = 276
English: Prior to each chemotherapy administration blood chemistry tests should be collected to evaluate renal and hepatic function.
Slovenian: Pred vsakim dajanjem kemoterapije opravimo tudi teste biokemije seruma za vrednotenje ledvičnega in jetrnega delovanja.
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1500 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: Cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to their pemetrexed therapy.
Slovenian: Poročali so o primerih radiacijske pljučnice pri bolnikih, ki so jih zdravili z radiacijo pred, med ali po zdravljenju s pemetreksedom.
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: 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.
Slovenian: Priporočeni odmerek cisplatina je 75 mg/m2 TP, infundiran v dveh urah približno 30 minut po zaključku infuzije pemetrekseda prvi dan vsakega 21-dnevnega ciklusa.
English: During post marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
Slovenian: V nadzoru po uvedbi zdravila na trg so pri bolnikih, ki so jih zdravili s pemetreksedom, poročali o naslednjih neželenih učinkih:
English: ALIMTA 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 ALIMTA 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: Consistent with other ALIMTA studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Slovenian: V skladu z ostalimi študijami zdravila ALIMTA, so v študiji JMEN tudi opažali razliko v učinkovitosti glede na histologijo NSCLC.
English: Do not use this medicine after the expiry date which is stated on the label and carton This medicine does not require any special storage conditions.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature.
Slovenian: Po pripravi po navodilih so kemijsko in fizikalno obstojnost za uporabo pripravljenih raztopin pemetrekseda in raztopin pemetrekseda za infundiranje pokazali za 24 ur v hladilniku.
English: 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).
Slovenian: 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).
English: Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis
Slovenian: Bulozna stanja (bolezni s kožnimi mehurji), vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo
English: Section 4.8 of the SmPC is being updated accordingly together with consequential changes in the Package leaflet.
Slovenian: Poglavje 4.8 povzetka glavnih značilnosti zdravila se posodobi skladno s tem, posledično pa se spremeni tudi navodilo za uporabo.
English: Each pack of ALIMTA consists of one ALIMTA vial.
Slovenian: Vsako pakiranje zdravila ALIMTA vsebuje eno vialo zdravila ALIMTA.
English: Other (N=252)
Slovenian: Drugo (N = 252)
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),
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: ALIMTA 100 mg powder for concentrate for solution for infusion This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree'.
Slovenian: ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje manj kot 1 mmol (23 g) natrija na vialo, kar v bistvu pomeni »brez natrija«.
English: N=863 0.94
Slovenian: N = 863 0,94a