FrancophonIA/ELRC3.0 huggingface dataset:
English: There are limited data in patients with malignant pleural mesothelioma treated with ALIMTA alone.
Slovenian: O bolnikih z malignim plevralnim mezoteliomom, zdravljenih samo z zdravilom ALIMTA, so na voljo le omejeni podatki.
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: 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).
Slovenian: 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).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila ALIMTA Vsebina pakiranja in dodatne informacije
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with ALIMTA.
Slovenian: - če dojite, morate med zdravljenjem z zdravilom ALIMTA dojenje prekiniti.
English: Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Slovenian: Redkeje opaženi učinki so StevensJohnsonov sindrom in toksična epidermalna nekroliza.
English: HR (95 % CI)
Slovenian: RT (95 % IZ)
English: ALIMTA 500 mg powder for concentrate for solution for infusion This medicinal product contains approximately 54 mg of sodium per vial.
Slovenian: ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje približno 54 mg natrija na vialo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia and anaemia.
Slovenian: Pričakovani zapleti prevelikega odmerjanja vključujejo zavrtje delovanja kostnega mozga, kar se kaže kot nevtropenija, trombocitopenija in anemija.
English: If you are concerned about any side effects, talk to your doctor.
Slovenian: Če ste zaradi kateregakoli neželenega učinka (neželenih učinkov) zaskrbljeni, se pogovorite z zdravnikom.
English: The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
Slovenian: Farmakokinetika pemetrekseda ostaja po večih ciklusih zdravljenja enaka.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za koncentrat za raztopino za infundiranje.
English: Squamous cell (N=473)
Slovenian: Luskaste celice (N = 473)
English: ALIMTA should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Zdravilo ALIMTA se daje kot 10-minutna intravenska infuzija prvi dan vsakega 21-dnevnega ciklusa.
English: - If you have further questions, please ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Further dilution by a healthcare provider is required prior to administration.
Slovenian: Pred dajanjem mora zdravstveni delavec raztopino še nadalje razredčiti.
English: Interactions common to all cytotoxics
Slovenian: Medsebojna delovanja, ki so skupna vsem citotoksičnim zdravilom:
English: After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Slovenian: Po rekonstituciji raztopina vsebuje 25 mg/ml pemetrekseda.
English: Very common
Slovenian: Zelo pogosto
English: 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.
Slovenian: 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).
English: Common SGPT (ALT) elevation
Slovenian: Pogosto Povišanje SGPT (ALT) Povišanje
English: Neutrophils/ Granulocytes decreased
Slovenian: Znižani nevtrofilci/ granulociti
English: Liver: abnormal blood tests
Slovenian: Sprememba okusa Jetra: nenormalne vrednosti krvnih testov
English: For instructions on reconstitution and dilution of ALIMTA before administration, see section 6.6.
Slovenian: Za informacije o rekonstituciji in redčenju zdravila ALIMTA pred uporabo glejte poglavje 6.6.
English: Caution should be made when these drugs are combined with pemetrexed.
Slovenian: Pri sočasnem dajanju teh zdravil s pemetreksedom je potrebna previdnost.
English: Nadir platelets <50,000 /mm3 regardless of nadir ANC
Slovenian: Najnižje število trombocitov < 50.000 /mm3 ne glede na najnižji ANC
English: A number of cases describing cellulitis, pseudocellulitis, dermatitis and dermo-hypodermitis have been reported with an unknown frequency.
Slovenian: Z neznano pogostnostjo so poročali o več primerih celulitisa, psevdocelulitisa, dermatitisa in dermohipodermitisa.
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Slovenian: Po rekonstituciji (glejte poglavje 6.6) vsebuje ena viala 25 mg/ml pemetrekseda.
English: The PFS and OS results in patients with squamous cell histology suggested no advantage for ALIMTA over placebo.
Slovenian: Rezultati preživetja brez napredovanja in skupnega preživetja pri bolnikih z luskasto celično histologijo ne kažejo prednosti za zdravilo ALIMTA nad placebom.
English: PC: SN:
Slovenian: SN:
English: You must continue taking the folic acid for 21 days after the last dose of ALIMTA.
Slovenian: Po zadnjem odmerku zdravila ALIMTA morate še 21 dni jemati folno kislino.
English: 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.
Slovenian: 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.
English: CTC a Grade
Slovenian: Stopnja CTC a *
English: Erythematous oedema mainly of the lower limbs has been reported with an unknown frequency.
Slovenian: Poročali so eritematoznem edemu, ki se je pojavljal predvsem v spodnjih okončinah, z neznano pogostnostjo.
English: ALIMTA contains sodium
Slovenian: Zdravilo ALIMTA vsebuje natrij
English: 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).
Slovenian: 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).
English: Median time to tumour progression (months) (95 % CI)
Slovenian: Mediana časa do napredovanja tumorja (meseci) (95 % IZ)
English: ALIMTA as single agent
Slovenian: ALIMTA kot samostojno zdravilo
English: Contraceptive measures or abstinence are recommended.
Slovenian: Priporočamo ukrepe prosti zanositvi ali vzdržnost.
English: 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.
Slovenian: Priporočeni odmerek zdravila ALIMTA je 500 mg/m2 telesne površine (TP), dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: If you are breast-feeding, tell your doctor.
Slovenian: Če dojite, to povejte zdravniku.
English: Pharyngitis
Slovenian: Faringitis
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for ALIMTA plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95% CI = 0.94-1.15), and overall response rate was 30.6% (95% CI = 27.3-33.9) for ALIMTA plus cisplatin versus 28.2% (95% CI = 25.0-31.4) for gemcitabine plus cisplatin.
Slovenian: Preživetje brez napredovanja (PBN) in celokupno razmerje odziva sta bila podobna med vejama zdravljenja: mediana PBN je bila 4,8 mesecev za zdravilom ALIMTA skupaj s cisplatinom proti 5,1 mesecev za gemcitabin skupaj s cisplatinom (prilagojeno razmerje tveganja 1,04; 95 % IZ 0,94-1,15) in celokupno razmerje odziva je bilo 30,6 % (95 % IZ 27,3-33,9) za zdravilom ALIMTA skupaj s cisplatinom proti 28,2 % (95 % IZ 25,0-31,4) za gemcitabin skupaj s cisplatinom.
English: Hair loss
Slovenian: Izguba las Zaprtje
English: There is no relevant use of ALIMTA in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Slovenian: Pri pediatrični populaciji se zdravila ALIMTA ne uporablja za zdravljenje malignega plevralnega mezotelioma in nedrobnoceličnega karcinoma pljuč.
English: Table 3 - Dose modification table for ALIMTA (as single agent or in combination) and cisplatin - Neurotoxicity
Slovenian: Preglednica 3 - Preglednica za prilagajanje odmerkov zdravila ALIMTA (kot edine učinkovine ali v kombinaciji) in cisplatina - Nevrotoksičnost
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of ALIMTA versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted 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 zdravilo ALIMTA 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 = 1,08-2,26, p = 0,018).
English: Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer's injection and Ringer's injection.
Slovenian: Pemetreksed je fizikalno nekompatibilen z vehikli ki vsebujejo kalcij, vključujoč raztopino Ringerjevega laktata ter Ringerjevo raztopino.
English: For the purpose of this table a cut off of 5 % was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Slovenian: Za namen te preglednice smo uporabili »cut off« 5 % za vključitev vseh dogodkov, kjer je poročevalec upošteval možno povezavo s pemetreksedom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 mg
English: In vitro studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Slovenian: Študije in vitro so pokazale, da se pemetreksed vede kot večtarčni antifolat z zaviranjem timidilatne sintaze (TS), dihidrofolatne reduktaze (DHFR) in glicinamidne ribonukleotidne formiltransferaze
English: For the purpose of this table a cut off of 5 % was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Slovenian: Za namen te preglednice smo uporabili »cut off« 5 % za vključitev vseh dogodkov, kjer je poročevalec upošteval možno povezavo s pemetreksedom ali cisplatinom.
English: In patients with mild to moderate renal insufficiency eligible for pemetrexed therapy NSAIDs with long elimination half-lives should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).
Slovenian: Pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic, ki jih lahko zdravimo s pemetreksedom, naj se jemanje NSAID-ov z dolgimi razpolovnimi časi izločanja prekine vsaj za 5 dni pred dajanjem pemetrekseda, na dan dajanja in še vsaj za 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
English: The European Medicines Agency has waived the obligation to submit the results of studies with ALIMTA in all subsets of the paediatric population in the granted indications (see Section 4.2).
Slovenian: ALIMTA za vse skupine pediatrične populacije za odobrene indikacije (glejte poglavje 4.2).
English: Efficacy of ALIMTA plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated
Slovenian: Učinkovitost zdravila ALIMTA skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu Randomizirani in zdravljeni
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: Do not use ALIMTA - if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of of this medicine (listed in section 6).
Slovenian: - če ste alergični na (preobčutljivi za) pemetreksed ali na katerokoli sestavino tega zdravila
English: Each vial contains approximately 54 mg sodium.
Slovenian: Ena viala vsebuje približno 54 mg natrija.
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Slovenian: Spodnja preglednica podaja pogostnost in izraženost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 800 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali pemetreksed kot edino zdravilo, in 402 bolnikov, ki so naključno prejemali placebo v študijah vzdrževalnega zdravljenja samo s pemetreksedom (JMEN: N=663) ter nadaljevalnega zdravljenja s pemetreksedom (PARAMOUNT: N=539).
English: Common ALT (SGPT) elevation
Slovenian: Pogosto Povišanje SGPT (ALT)
English: After reconstitution (see package leaflet), each vial contains 25 mg/ml of pemetrexed.
Slovenian: Po rekonstituciji (glejte navodilo za uporabo) ena viala vsebuje 25 mg/ml pemetrekseda.
English: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival ALIMTA versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Slovenian: JMEN: Kaplan Meier-jeva grafa preživetja brez napredovanja in skupnega preživetja za zdravilo ALIMTA v primerjavi s placebom pri bolnikih z NSCLC, ki nima pretežno ploščatocelične histologije:
English: ALIMTA 100 mg contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'
Slovenian: ALIMTA 100 mg vsebuje manj kot 1 mmol natrija (23 g) na vialo, kar v bistvu pomeni »brez natrija«.
English: In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min), the concomitant administration of pemetrexed with NSAIDs (e.g. ibuprofen) or acetylsalicylic acid at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Slovenian: Pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina 45 - 79 ml/min) se moramo izogibati sočasnemu dajanju pemetrekseda z NSAID-i (denimo, ibuprofenom) ali acetilsalicilno kislino v visokih odmerkih 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.4).
English: Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1000 bolnikov) Radiacijski izpuščaj (kožni izpuščaj kot pri hudi sončni opeklini), ki se lahko pojavi na koži, ki je bila v preteklosti izpostavljena obsevanju, in sicer od nekaj dni do več let po obsevanju.
English: HR
Slovenian: RT
English: Efficacy of ALIMTA + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Slovenian: Učinkovitost zdravila ALIMTA skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri zdravljenju prvega izbora nedrobnoceličnega karcinoma pljuč - NZ populacija in histološke podskupine
English: Unopened vial 3 years.
Slovenian: 3 leta.
English: Median overall survival (months) (95 % CI)
Slovenian: Mediana skupnega preživetja (meseci) (95 % IZ)
English: Following ALIMTA plus cisplatin induction (4 cycles), treatment with ALIMTA 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 z zdravilom ALIMTA skupaj s cisplatinom (4 cikli) je bilo zdravljenje z zdravilom ALIMTA 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: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed and 163 patients with mesothelioma randomised to receive single agent cisplatin.
Slovenian: Spodnja preglednica navaja pogostnost in hudost neželenih učinkov, o katerih so poročali pri > 5 % 168 bolnikov z mezoteliomom, ki so jih naključno razporedili, da so prejemali cisplatin in pemetreksed, ter pri 163 bolnikov z mezoteliomom, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, cisplatin.
English: Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Slovenian: Pri rekonstituciji in nadaljnjemu redčenju pemetrekseda za intravensko infundiranje uporabljajte aseptično metodo.
English: Overall response rate** (95 % CI)
Slovenian: Log Rank p-vrednost* Skupna stopnja odziva** (95 % IZ)
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in >5% of 839 patients with NSCLC who were randomized to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomized to receive cisplatin and gemcitabine.
Slovenian: Spodnja preglednica podaja pogostnost in resnost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 839 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali cisplatin in pemetreksed in 830 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali cisplatin in gemcitabin.
English: Pemetrexed*** (N =800)
Slovenian: Pemetreksed*** N = 800
English: MARKETING AUTHORISATION NUMBER EU/1/04/290/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/04/290/001
English: 50 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: 100 % predhodnega odmerka a Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998) b Brez nevrološke toksičnosti
English: Clinically relevant CTC toxicity that was reported in < 1% of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri < 1 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: alergijsko reakcijo/hipersenzitivnost, multiformni eritem, supraventrikularno aritmijo in pljučno embolijo.
English: Mannitol Hydrochloric acid Sodium hydroxide
Slovenian: 6.1 Seznam pomožnih snovi manitol klorovodikova kislina natrijev hidroksid
English: Leukocytes decreased
Slovenian: Znižani levkociti
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri < 1 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo supraventrikularne aritmije.
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with ALIMTA plus best supportive care (BSC) (n = 441) with that of placebo plus BSC (n = 222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first line doublet therapy containing Cisplatin or Carboplatin in combination with Gemcitabine, Paclitaxel, or Docetaxel.
Slovenian: JMEN Multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija faze 3 (JMEN) je primerjala učinkovitost in varnost vzdrževalnega zdravljenja z zdravilom ALIMTA skupaj z najboljšo suportivno oskrbo (BSC) (n = 441) s placebom skupaj z BSC (n = 222) pri bolnikih z lokalno napredovalim (stopnja IIIB) ali metastatskim (stopnja IV) nedrobnoceličnim pljučnim karcinomom
English: Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia (or pancytopenia) (see section 4.8).
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Pemetreksed lahko zavre delovanje kostnega mozga, kar se kaže kot nevtropenija, trombocitopenija in anemija (ali pancitopenija) (glejte poglavje 4.8).
English: Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection.
Slovenian: Pemetreksed je nekompatibilen z vehikli, ki vsebujejo kalcij, vključujoč raztopino Ringerjevega laktata ter Ringerjevo raztopino.
English: ALIMTA 500 mg contains approximately 54 mg sodium per vial.
Slovenian: ALIMTA 500 mg vsebuje približno 54 mg natrija v eni viali.
English: ALIMTA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Slovenian: ALIMTA je v kombinaciji s cisplatinom indicirana za zdravljenje bolnikov z neresektabilnim malignim plevralnim mezoteliomom, ki jih še nismo zdravili s kemoterapijo.
English: How to store ALIMTA
Slovenian: Shranjevanje zdravila ALIMTA