natgillin/translations-raw huggingface dataset:
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.
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.
You must take at least 5 doses during the seven days before the first dose of ALIMTA.
V sedmih dneh pred prvim odmerkom zdravilom ALIMTA morate vzeti vsaj 5 odmerkov.
Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags.
Raztopine pemetrekseda za infundiranje, pripravljene, kot je navedeno zgoraj, so skladne s seti za dajanje in infuzijskimi vrečkami iz polivinilklorida in prevlečenimi s poliolefinom.
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.
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.
Pemetrexed has a steady-state volume of distribution of 9 l/m2.
Pemetreksed ima volumen porazdelitve v stanju dinamičnega ravnovesja 9 l/m2.
As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Kot pri drugih potencialno toksičnih učinkovinah za zdravljenje raka je potrebna previdnost pri ravnanju z raztopinami pemetrekseda za infundiranje ter pripravi teh raztopin.
Of the 939 patients treated with ALIMTA plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
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.
LIST OF EXCIPIENTS Mannitol, hydrochloric acid, sodium hydroxide (see package leaflet for further information).
Manitol, klorovodikova kislina, natrijev hidroksid (za nadaljnje informacije glejte navodilo za uporabo).
There were no clinically relevant differences observed for the safety profile of ALIMTA within the histology subgroups.
Za varnostni profil zdravila ALIMTA niso opazili nobenih klinično pomembnih razlik znotraj histoloških podskupin.
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj(a) za promet z zdravilom
Patients received a median of 4 cycles of maintenance treatment with ALIMTA and 4 cycles of placebo.
Bolniki so prejeli mediano 4 cikle vzdrževalnega zdravljenja z zdravilom ALIMTA in 4 cikle placeba.
≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with ALIMTA.
Skupno 213 bolnikov (48,3 %) je zaključilo ≥ 6 ciklov in skupno 103 bolniki (23,4 %) so zaključili ≥ 10 ciklov zdravljenja z zdravilom ALIMTA.
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 vitamina B12, za zmanjšanje toksičnosti.
Chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature.
Kemijsko in fizikalno obstojnost za uporabo pripravljenih raztopin pemetrekseda in raztopin pemetrekseda za infundiranje so pokazali za 24 ur v hladilniku.
The other ingredients are mannitol, hydrochloric acid and sodium hydroxide
Pomožne snovi so manitol, klorovodikova kislina in natrijev hidroksid.
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.
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.
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.
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.
Immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Imunsko pogojena hemolitična anemija (propad rdečih krvnih celic, ki ga povzročijo protitelesa)
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.
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
Each vial contains approximately 11 mg sodium.
Ena viala vsebuje približno 11 mg natrija.
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.
ALIMTA (pemetreksed) je večtarčno protirakavo antifolatno zdravilo, ki deluje s porušenjem ključnih presnovnih procesov, odvisnih od folata, ki so nujni za podvajanje celic.
Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Bolniki morajo dnevno jemati peroralno folno kislino ali multivitaminski pripravek, ki jo vsebuje (350 do 1000 mikrogramov).
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.
V času te končne analize preživetja je bilo živih ali ni bilo na voljo za nadaljnje spremljanje 28,7 % bolnikov v kraku
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).
Poročali so o infektivnih in neinfektivnih boleznih dermisa, hipodermisa in/ali podkožja z neznano pogostnostjo (npr. akutni bakterijski dermohipodermitis, psevdocelulitis, dermatitis).
95 % CI for HR
95 % IZ za RT
Increased skin pigmentation
Solzne oči Povečana pigmentiranost kože
** 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.
You will always receive ALIMTA by infusion into one of your veins.
Zdravilo ALIMTA boste vedno prejeli v obliki infuzije v veno.
*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”.
*Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti, razen izraza “znižan očistek kreatinina”.
Progression-Free Survival
Preživetje brez napredovanja
To be taken into consideration by patients on a controlled sodium diet.
Ta podatek naj upoštevajo bolniki na dieti z nadzorovanim vnosom natrija.
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).
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
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).
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).
Driving and using machines ALIMTA may make you feel tired.
ALIMTA lahko povzroči, da se boste počutili utrujene.
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).
What you need to know before you use ALIMTA
Kaj morate vedeti, preden boste uporabili zdravilo ALIMTA Ne uporabljajte zdravila ALIMTA
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.
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.
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.
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.
Concomitant administration of nephrotoxic drugs (e.g. aminoglycoside, loop diuretics, platinum compounds, cyclosporin) 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.
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 21-dnevnega ciklusa.
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:
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.
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.
Consistent with other ALIMTA studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
V skladu z ostalimi študijami zdravila ALIMTA, so v študiji JMEN tudi opažali razliko v učinkovitosti glede na histologijo NSCLC.
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.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
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.
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.
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).
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
Section 4.8 of the SmPC is being updated accordingly together with consequential changes in the Package leaflet.
Poglavje 4.8 povzetka glavnih značilnosti zdravila se posodobi skladno s tem, posledično pa se spremeni tudi navodilo za uporabo.
Each pack of ALIMTA consists of one ALIMTA vial.
Vsako pakiranje zdravila ALIMTA vsebuje eno vialo zdravila ALIMTA.
Other (N=252)
Drugo (N = 252)
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),
Nadir platelets <50,000/mm3 with bleedinga, regardless of nadir ANC
Najnižje število trombocitov < 50.000 /mm3 s krvavitvijoa, ne glede na najnižji ANC
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'.
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«.
N=863 0.94
N = 863 0,94a
There are limited data in patients with malignant pleural mesothelioma treated with ALIMTA alone.
O bolnikih z malignim plevralnim mezoteliomom, zdravljenih samo z zdravilom ALIMTA, so na voljo le omejeni podatki.
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).
Patients treated with ALIMTA 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 z zdravilom ALIMTA 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).
Contents of the pack and other information
Shranjevanje zdravila ALIMTA Vsebina pakiranja in dodatne informacije
- if you are breast-feeding; you must discontinue breast-feeding during treatment with ALIMTA.
- če dojite, morate med zdravljenjem z zdravilom ALIMTA dojenje prekiniti.
Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Redkeje opaženi učinki so StevensJohnsonov sindrom in toksična epidermalna nekroliza.
HR (95 % CI)
RT (95 % IZ)
ALIMTA 500 mg powder for concentrate for solution for infusion This medicinal product contains approximately 54 mg of sodium per vial.
ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje približno 54 mg natrija na vialo.
The median time from the start of ALIMTA 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 z zdravilom ALIMTA in indukcijskim zdravilom cisplatina do začetka vzdrževalnega zdravljenja je bila 2,96 meseca tako v skupini s pemetreksedom, kot v skupini s placebom.
In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of ALIMTA 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 zdravila ALIMTA 500 mg/m2 TP, dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia and anaemia.
Pričakovani zapleti prevelikega odmerjanja vključujejo zavrtje delovanja kostnega mozga, kar se kaže kot nevtropenija, trombocitopenija in anemija.
If you are concerned about any side effects, talk to your doctor.
Če ste zaradi kateregakoli neželenega učinka (neželenih učinkov) zaskrbljeni, se pogovorite z zdravnikom.
The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
Farmakokinetika pemetrekseda ostaja po večih ciklusih zdravljenja enaka.
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA Prašek za koncentrat za raztopino za infundiranje.
Squamous cell (N=473)
Luskaste celice (N = 473)
ALIMTA should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Zdravilo ALIMTA se daje kot 10-minutna intravenska infuzija prvi dan vsakega 21-dnevnega ciklusa.
- If you have further questions, please ask your doctor or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
Further dilution by a healthcare provider is required prior to administration.
Pred dajanjem mora zdravstveni delavec raztopino še nadalje razredčiti.
Interactions common to all cytotoxics
Medsebojna delovanja, ki so skupna vsem citotoksičnim zdravilom:
After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Po rekonstituciji raztopina vsebuje 25 mg/ml pemetrekseda.
Very common
Zelo pogosto
A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the ALIMTA/cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Z uporabo Lestvice simptomov pljučnega raka (Lung Cancer Symptom Scale) so pokazali statistično značilno izboljšanje klinično pomembnih simptomov (bolečina in dispneja), povezanih z malignim plevralnim mezoteliomom v veji zdravljenja z zdravilom ALIMTA/cisplatinom (212 bolnikov) v primerjavi z vejo zdravljenja s cisplatinom samim (218 bolnikov).
Common SGPT (ALT) elevation
Pogosto Povišanje SGPT (ALT) Povišanje
Neutrophils/ Granulocytes decreased
Znižani nevtrofilci/ granulociti
Liver: abnormal blood tests
Sprememba okusa Jetra: nenormalne vrednosti krvnih testov
For instructions on reconstitution and dilution of ALIMTA before administration, see section 6.6.
Za informacije o rekonstituciji in redčenju zdravila ALIMTA pred uporabo glejte poglavje 6.6.
Caution should be made when these drugs are combined with pemetrexed.
Pri sočasnem dajanju teh zdravil s pemetreksedom je potrebna previdnost.
Nadir platelets <50,000 /mm3 regardless of nadir ANC
Najnižje število trombocitov < 50.000 /mm3 ne glede na najnižji ANC
A number of cases describing cellulitis, pseudocellulitis, dermatitis and dermo-hypodermitis have been reported with an unknown frequency.
Z neznano pogostnostjo so poročali o več primerih celulitisa, psevdocelulitisa, dermatitisa in dermohipodermitisa.
After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Po rekonstituciji (glejte poglavje 6.6) vsebuje ena viala 25 mg/ml pemetrekseda.
The PFS and OS results in patients with squamous cell histology suggested no advantage for ALIMTA over placebo.
Rezultati preživetja brez napredovanja in skupnega preživetja pri bolnikih z luskasto celično histologijo ne kažejo prednosti za zdravilo ALIMTA nad placebom.
You must continue taking the folic acid for 21 days after the last dose of ALIMTA.
Po zadnjem odmerku zdravila ALIMTA morate še 21 dni jemati folno kislino.
The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leukopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, and stomatitis.
Neželeni učinki, o katerih so pri uporabi pemetrekseda, tako v primeru monoterapije kot v kombinaciji z drugimi zdravili, najpogosteje poročali, so bili povezani z zavrtjem delovanja kostnega mozga, kar se je izrazilo kot anemija, nevtropenija, levkopenija, trombocitopenija; in s toksičnostjo za prebavila, kar se je izrazilo kot anoreksija, slabost, bruhanje, diareja, zaprtje, faringitis, mukozitis in stomatitis.
CTC a Grade
Stopnja CTC a *
Erythematous oedema mainly of the lower limbs has been reported with an unknown frequency.
Poročali so eritematoznem edemu, ki se je pojavljal predvsem v spodnjih okončinah, z neznano pogostnostjo.
ALIMTA contains sodium
Zdravilo ALIMTA vsebuje natrij
ALIMTA 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).
ALIMTA je indicirana 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).
Median time to tumour progression (months) (95 % CI)
Mediana časa do napredovanja tumorja (meseci) (95 % IZ)
ALIMTA as single agent
ALIMTA kot samostojno zdravilo
Contraceptive measures or abstinence are recommended.
Priporočamo ukrepe prosti zanositvi ali vzdržnost.
The recommended dose of ALIMTA is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Priporočeni odmerek zdravila ALIMTA je 500 mg/m2 telesne površine (TP), dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
If you are breast-feeding, tell your doctor.
Če dojite, to povejte zdravniku.