FrancophonIA/ELRC3.0 huggingface dataset:
English: Pemetrexed Accord is a powder for concentrate for solution for infusion in a glass vial.
Slovenian: Zdravilo Pemetreksed Accord je prašek za koncentrat za raztopino za infundiranje v stekleni viali.
English: Consistent with other pemetrexed studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Slovenian: V skladu z ostalimi študijami pemetrekseda so v študiji JMEN tudi opažali razliko v učinkovitosti glede na histologijo NSCLC.
English: Neuropathy-Sensory
Slovenian: Nevropatija - senzorna
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Accord 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 Pemetreksed Accord 500 mg/m2 TP, dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: Dose of Pemetrexed Accord (mg/m2)
Slovenian: Odmerek zdravila Pemetreksed Accord (mg/m2)
English: For instructions on reconstitution and dilution of Pemetrexed Accord before administration, see section 6.6.
Slovenian: Za informacije o rekonstituciji in redčenju zdravila Pemetreksed Accord pred uporabo glejte poglavje 6.6.
English: Pemetrexed/cisplati n
Slovenian: Pemetreksed/cisplati n
English: Pemetrexed is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Slovenian: Zdravilo Pemetreksed Accord (pemetreksed) je večtarčno protirakavo antifolatno zdravilo, ki deluje s porušenjem ključnih presnovnih procesov, odvisnih od folata, ki so nujni za podvajanje celic.
English: Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4 % versus 28.9 %, p<0.001), red blood cell transfusions (16.1 % versus 27.3 %, p< 0.001) and platelet transfusions (1.8 % versus 4.5 %, p=0.002).
Slovenian: Bolniki zdravljeni s pemetreksedom in cisplatinom so potrebovali manj transfuzij (16,4 % proti 28,9 %, p < 0,001), transfuzij rdečih krvničk (16,1 % proti 27,3 %, p < 0,001) in transfuzij krvnih ploščic (1,8 % proti 4,5 %, p = 0,002).
English: Time to treatment failure (TTTF - months) Median
Slovenian: RT (95 % IZ) Čas do neuspeha zdravljenja (Time to treatment failure, TTTF - meseci) Mediana
English: • Additional risk minimisation measures
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Navedba smiselno ni potrebna.
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Slovenian: 100 % predhodnega odmerka a Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998) b Brez nevrološke toksičnosti
English: Log Rank p-value* Overall response rate**
Slovenian: Log Rank p-vrednost* Skupna stopnja odziva** (95 % IZ)
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOSTATIK
English: Median overall survival in months (95 % CI)
Slovenian: Mediana skupnega preživetja v mesecih (95 % IZ)
English: - If you have any further questions, ask your doctor , pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the pemetrexed/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 s pemetreksedom/cisplatinom (212 bolnikov) v primerjavi z vejo zdravljenja s cisplatinom samim (218 bolnikov).
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
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: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosto (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: The recommended dose of Pemetrexed Accord 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 Pemetreksed Accord je 500 mg/m2 telesne površine (TP), dan kot intravenska infuzija v 10 minutah prvi dan vsakega 21-dnevnega ciklusa.
English: Pemetrexed Accord 1000 mg:
Slovenian: Pemetreksed Accord 1000 mg:
English: Pemetrexed Accord should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Slovenian: Zdravilo Pemetreksed Accord se daje kot 10-minutna intravenska infuzija prvi dan vsakega 21dnevnega ciklusa.
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu Randomizirani in zdravljeni
English: Rare (may affect up to 1 in 1,000 people)
Slovenian: Redko (pojavijo se lahko pri do 1 od 1000 bolnikov)
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN OTHER SPECIAL WARNING (S), IF NECESSARY CYTOTOXIC.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOSTATIK DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Table 2 - Dose modification table for Pemetrexed Accord (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b
Slovenian: Preglednica 2 - Preglednica za prilagajanje odmerkov zdravila Pemetreksed Accord (kot edine učinkovine ali v kombinaciji) in cisplatina - Nehematološke toksičnostia, b
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed 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 pemetrexed 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 pemetreksed 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 pemetreksed skupaj s cisplatinom proti 28,2 % (95 % IZ 25,0-31,4) za gemcitabin skupaj s cisplatinom.
English: (N = 1725) Adenocarcinoma (N=847)
Slovenian: Adenokarcinom (N = 847)
English: Pemetrexed Accord 500 mg:
Slovenian: Pemetreksed Accord 500 mg:
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n= 399, 9.3 versus 8.0 months, adjusted HR= 0.78; 95% CI= 0 .61-1.00, p= 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n= 172, 6.2 versus 7.4 months, adjusted HR= 1.56;95% CI = 1.08-2.26, p = 0.018).
Slovenian: Analiza vpliva histologije NSCLC glede učinka zdravljenja na skupno preživetje je bila prednostna za pemetreksed proti docetakselu pri tistih, ki nimajo pretežno luskaste histologije (n = 399, 9,3 proti 8,0 mesecev, prilagojen RT = 0,78; 95 % IZ = 0,61-1,00, p = 0,047) in je bila prednostna za docetaksel za luskasto celično histologijo karcinoma (n = 172, 6,2 proti 7,4 mesecev, prilagojen RT = 1,56; 95 % IZ = 1,082,26, p = 0,018).
English: 9 l/m2.
Slovenian:  100.000 celic/mm3.
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: Pemetrexed Accord 100 mg:
Slovenian: Pemetreksed Accord 100 mg:
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Slovenian: Spodnja preglednica podaja pogostnost in resnost neželenih učinkov, o katerih so poročali pri > 5 % od 265 bolnikov, ki so jih naključno razporedili, da so prejemali eno učinkovino pemetreksed z dopolniloma folno kislino in vitaminom B12, ter pri 276 bolnikih, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, docetaksel.
English: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival pemetrexed 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 pemetreksed v primerjavi s placebom pri bolnikih z NSCLC, ki nima pretežno ploščatocelične histologije:
English: Pemetrexed Accord in combination with cisplatin
Slovenian: Zdravilo Pemetreksed Accord v kombinaciji s cisplatinom
English: 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: 50 % of previous dose (both Pemetrexed Accord and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: 100 % predhodnega odmerka 50 % predhodnega odmerka a *Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998)
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n= 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n= 863) in overall survival (adjusted hazard ratio 0.94; 95% CI= 0.84-1.05).
Slovenian: Multicentrična, randomizirana, odprta študija faze 3 pemetrekseda skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri bolnikih, ki v preteklosti še niso prejemali kemoterapije, z lokalno napredovalim ali metastatskim (stopnja IIIb ali IV) nedrobnoceličnim karcinomom pljuč (NSCLC), je pokazala, da je pemetreksed skupaj s cisplatinom (Populacija z namenom zdraviti, [NZ] populacija n = 862) dosegla prvotno končno točko in pokazala podobno klinično učinkovitost, kot gemcitabin skupaj s cisplatinom (NZ n = 863) v skupnem preživetju (prilagojeno razmerje tveganja 0,94; 95 % IZ = 0,84-1,05).
English: There is no relevant use of Pemetrexed Accord in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Slovenian: Pri pediatrični populaciji se zdravila Pemetreksed Accord ne uporablja za zdravljenje malignega plevralnega mezotelioma in nedrobnoceličnega karcinoma pljuč.
English: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n= 283) and 7.9 months for patients treated with docetaxel (ITT n= 288).
Slovenian: Multicentrična, randomizirana študija faze 3 z znanim zdravilom, kjer so preskušali s pemetreksed v primerjavi z docetakselom pri bolnikih z lokalno napredovalim ali metastatskim NSCLC po predhodni kemoterapiji, je pokazala mediano časa preživetja 8,3 mesece pri bolnikih, zdravljenih s pemetreksedom (Populacija z namenom zdraviti n = 283), in 7,9 mesecev pri bolnikih, zdravljenih z docetakselom (NZ n = 288).
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Accord 100 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Accord 500 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Accord 1000 mg prašek za koncentrat za raztopino za infundiranje
English: EMPHACIS, a multicentre, randomised, single-blind phase 3 study of pemetrexed plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with pemetrexed and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone.
Slovenian: EMPHACIS, multicentrična, randomizirana, enojno slepa študija faze 3 pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri bolnikih z malignim plevralnim mezoteliomom, ki v preteklosti še niso prejemali kemoterapije, je pokazala, da so imeli bolniki, zdravljeni s pemetreksedom in cisplatinom, klinično pomembno prednost 2,8-mesečne mediane preživetja pred bolniki, ki so prejemali samo cisplatin.
English: What Pemetrexed Accord looks like and contents of the pack
Slovenian: Izgled zdravila Pemetreksed Accord in vsebina pakiranja.
English: Pemetrexed*** (N = 800)
Slovenian: Pemetreksed*** N = 800
English: 10.3 N = 10.3 N = 0.94a
Slovenian: 0,94a
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95 %CI=0.64-0.96, p=0.0195).
Slovenian: Po indukcijskem zdravljenju s pemetreksedom skupaj s cisplatinom (4 cikli) je bilo zdravljenje s pemetreksedom statistično boljše od placeba glede skupnega preživetja (mediana 13,9 mesecev v primerjavi z 11,0 meseci, razmerje tveganja = 0,78, 95 % CI=0,64-0,96, p=0,0195).
English: Table 3 - Dose modification table for Pemetrexed Accord (as single agent or in combination) and cisplatin - Neurotoxicity
Slovenian: Preglednica 3 - Preglednica za prilagajanje odmerkov zdravila Pemetreksed Accord (kot edine učinkovine ali v kombinaciji) in cisplatina - Nevrotoksičnost Stopnja CTC a *
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed 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: Multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija faze 3 (JMEN) je primerjala učinkovitost in varnost vzdrževalnega zdravljenja s pemetreksedom 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 (NSCLC), ki po 4 ciklih dvojne terapije prvega izbora s cisplatinom ali karboplatinom v kombinaciji z
English: Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and acetylsalicylic acid (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Slovenian: Bolniki z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina od 45 do 79 ml/min) naj se izogibajo jemanju nesteroidnih protivnetnih zdravil (NSAID), denimo, ibuprofena in acetilsalicilne kisline (> 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
English: Breast-feeding must be discontinued during Pemetrexed Accord treatment.
Slovenian: Dojenje morate med zdravljenjem z zdravilom Pemetreksed Accord prekiniti.
English: LIST OF EXCIPIENTS Mannitol, hydrochloric acid, sodium hydroxide (see package leaflet for further information).
Slovenian: SEZNAM POMOŽNIH SNOVI Manitol, klorovodikova kislina, natrijev hidroksid (za nadaljnje informacije glejte navodilo za uporabo).
English: Pemetrexed Accord 1000 mg contains approximately 108 mg sodium per vial.
Slovenian: Zdravilo Pemetreksed Accord 1000 mg vsebuje približno 108 mg natrija v eni viali.
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri zdravljenju prvega izbora nedrobnoceličnega karcinoma pljuč - NZ populacija in histološke podskupine
English: Pemetrexed Accord 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
Slovenian: Zdravilo Pemetreksed Accord je indicirano 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: Pemetrexed Accord 100 mg contains less than 1 mmol sodium (23 mg) sodium per vial, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo Pemetreksed Accord 100 mg vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni »brez natrija«.
English: Pemetrexed Accord 500 mg contains approximately 54 mg sodium per vial.
Slovenian: Zdravilo Pemetreksed Accord 500 mg vsebuje približno 54 mg natrija v eni viali.
English: Powder for concentrate for solution for infusion.
Slovenian: Prašek za koncentrat za raztopino za infundiranje.
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: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Predpisovanje in izdaja zdravila je na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Each vial contains approximately 108 mg sodium.
Slovenian: Ena viala vsebuje približno 108 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: 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 Accord contains sodium
Slovenian: Zdravilo Pemetreksed Accord vsebuje natrij
English: Pemetrexed Accord in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Slovenian: Zdravilo Pemetreksed Accord je v kombinaciji s cisplatinom indicirano kot zdravljenje prvega izbora za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: The median OS for the overall population (n = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI= 0.65-0.95, p = 0.01192).
Slovenian: Mediana skupnega preživetja za celotno populacijo (n = 663) je bila 13,4 mesece za skupino s pemetreksedom in 10,6 mesecev za skupino s placebom, razmerje tveganja = 0,79 (95 % CI: 0,65 do 0,95; p = 0,01192).
English: Breast-feeding must be discontinued during pemetrexed therapy (see section
Slovenian: Dojenje je treba med zdravljenjem s pemetreksedom prekiniti (glejte poglavje 4.3).
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Slovenian: - če dojite, morate med zdravljenjem z zdravilom Pemetreksed Accord dojenje prekiniti.
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Accord.
Slovenian: Po zadnjem odmerku zdravila Pemetreksed Accord morate še 21 dni jemati folno kislino.
English: Women must use effective contraception during treatment with Pemetrexed Accord.
Slovenian: Med zdravljenjem z zdravilom Pemetreksed Accord morajo ženske uporabljati učinkovito metodo kontracepcije.
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Slovenian: Ustrezno prostornino rekonstituirane raztopine pemetrekseda moramo še nadalje redčiti do 100 ml z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje brez konzervansa, damo jo kot intravensko infuzijo, ki teče 10 minut.
English: GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE Justification for not including Braille accepted.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: 50 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) Treatment with Pemetrexed Accord should be discontinued if a patient experiences any haematologic or non-haematologic Grade 3 or 4 toxicity after 2 dose reductions or immediately if Grade 3 or 4 neurotoxicity is observed.
Slovenian: Zdravljenje z zdravilom Pemetreksed Accord moramo prekiniti, če bolnik izkusi kakršnokoli hematološko ali nehematološko toksičnost stopnje 3 ali 4 po 2 znižanjih odmerka ali nemudoma, če opazimo nevrološko toksičnost stopnje 3 ali 4.