FrancophonIA/ELRC3.0 huggingface dataset:
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 navaja pogostnost in resnost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5 % od 800 bolnikov z nedrobnoceličnim pljučnim rakom, ki so naključno prejemali pemetreksed kot edino zdravilo, ter pri 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 navaja 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 pljučnim rakom, ki so naključno prejemali cisplatin in pemetreksed, ter pri 830 bolnikov z nedrobnoceličnim pljučnim rakom, ki so naključno prejemali cisplatin in gemcitabin.
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 5% glucose intravenous infusion and administered as an intravenous infusion over 10 minutes.
Slovenian: Ustrezno prostornino rekonstituirane raztopine pemetrekseda se mora še nadalje redčiti do 100 ml s 50 mg/ml (5,0 %) raztopino glukoze za intravensko infundiranje, daje se jo kot intravenska infuzija, ki teče 10 minut.
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (excess fluid in body tissue, causing swelling).
Slovenian: Edem (preveč tekočine v telesnih tkivih, kar povzroča oteklino).
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 NSAIDs 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: Table 1 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin- Haematologic toxicities
Slovenian: Preglednica 1 - Preglednica za prilagajanje odmerkov pemetrekseda (kot edine učinkovine ali v kombinaciji) in cisplatina - hematološka toksičnost
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed Fresenius Kabi.
Slovenian: V sedmih dneh pred prvim odmerkom zdravila Pemetreksed Fresenius Kabi morate vzeti vsaj 5 odmerkov.
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 navaja 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 bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, docetaksel.
English: *P-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Slovenian: *p-vrednosti < 0,05 v primerjavi pemetreksed/cisplatin proti gemcitabin/cisplatin, z uporabo Fisherjevega Exact testa.
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 - best supportive care) (n = 441) s placebom skupaj z BSC (n = 222) pri bolnikih z lokalno napredovalim (stopnja IIIB) ali metastatskim (stopnja IV) nedrobnoceličnim pljučnim rakom (NSCLC), ki po 4 ciklih dvojne terapije prve izbire s cisplatinom ali karboplatinom v kombinaciji z gemcitabinom, paklitakselom ali docetakselom, ni napredoval.
English: Due to the increased thrombotic risk in patients with cancer, the use of anticoagulation treatment is frequent.
Slovenian: Medsebojna delovanja, ki so skupna vsem citotoksičnim zdravilom Zaradi povečanega tveganja za trombozo pri bolnikih z rakavim obolenjem pogosto uporabljamo antikoagulacijsko zdravljenje.
English: Do not use Pemetrexed Fresenius Kabi if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na pemetreksed ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Creatinine clearance decreased**
Slovenian: Bolezni sečil Zelo pogosti Povišan kreatinin Znižan očistek kreatinina**
English: PARAMOUNT: Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Slovenian: PARAMOUNT: Kaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z nedrobnoceličnim pljučnim rakom, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
English: Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin-Non-haematologic toxicities a, b
Slovenian: Preglednica 2 - Preglednica za prilagajanje odmerkov zdravila Pemetreksed Fresenius Kabi (kot edine učinkovine ali v kombinaciji) in cisplatina - nehematološka toksičnost a, b
English: When prepared as directed, chemical and physical in-use stability of reconstituted solution of pemetrexed was demonstrated for 24 hours at refrigerated temperature.
Slovenian: Po pripravi po navodilih sta kemična in fizikalna stabilnost med uporabo rekonstituirane raztopine pemetrekseda dokazani za 24 ur, ohlajenega na temperaturo v hladilniku.
English: Pemetrexed*** (N =800)
Slovenian: Pogostnost* Dogodek** pemetreksed*** (N = 800)
English: Pemetrexed / Cisplatin (N = 168)
Slovenian: pemetreksed/ cisplatin (N = 168)
English: Pemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion Pemetrexed Fresenius Kabi 500 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Fresenius Kabi 100 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Fresenius Kabi 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Slovenian: Od začetka indukcijskega zdravljenja prve izbire s pemetreksedom skupaj s cisplatinom je bilo mediano skupno preživetje bolnikov 16,9 meseca v veji s pemetreksedom in 14,0 mesecev v veji s placebom (razmerje tveganja = 0,78, 95 % IZ = 0,64-0,96).
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomised and treated patients
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu
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 (NSAIDs - non steroidal anti-inflammatory drugs), kot sta ibuprofen in acetilsalicilna kislina (> 1,3 g dnevno) 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4.5).
English: Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Slovenian: Zdravilo Pemetreksed Fresenius Kabi je v kombinaciji s cisplatinom indicirano za zdravljenje bolnikov z neresektabilnim malignim plevralnim mezoteliomom, ki še niso bili zdravljeni s kemoterapijo.
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Fresenius Kabi.
Slovenian: Po zadnjem odmerku zdravila Pemetreksed Fresenius Kabi morate še 21 dni jemati folno kislino.
English: For patients with NSCLC other than predominantly squamous cell histology (n = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p = 0.00001).
Slovenian: Za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije (n = 430, neodvisno pregledana populacija) je bila mediana preživetja brez napredovanja 4,4 mesece za vejo s pemetreksedom in 1,8 meseca za vejo s placebom, razmerje tveganja = 0,47, 95% IZ: 0,37-0,60, p = 0,00001).
English: Each vial contains 500 mg of pemetrexed (as pemetrexed diacid).
Slovenian: Ena viala vsebuje 500 mg pemetrekseda (kot pemetreksed diacid).
English: Time to treatment failure (TTTF - months) ▪ Median ▪ HR (95% CI)
Slovenian: Čas do neuspeha zdravljenja (Time to treatment failure, TTTF - meseci)
English: Constipation Stomatitis/
Slovenian: Bruhanje Vnetje sluznice/ stomatitis
English: Each vial contains 100 mg of pemetrexed (as pemetrexed diacid).
Slovenian: Ena viala vsebuje 100 mg pemetrekseda (kot pemetreksed diacid).
English: Pemetrexed + cisplatin
Slovenian: Prednost p- vrednost pemetreksed + cisplatin gemcitabin + cisplatin
English: Nadir ANC < 500 /mm and nadir platelets
Slovenian: Najnižji ANC < 500 /mm in najnižje število trombocitov ≥ 50.000 /mm
English: Pemetrexed Fresenius Kabi 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 Fresenius Kabi je v kombinaciji s cisplatinom indicirano kot zdravljenje prve izbire za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: Powder for concentrate for solution for infusion.
Slovenian: prašek za koncentrat za raztopino za infundiranje 1 viala
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60, 95% CI = 0.49-0.73, p < 0.00001).
Slovenian: Študija je dosegla svojo primarno končno točko in pokazala statistično značilno izboljšanje preživetja brez napredovanja v veji s pemetreksedom glede na vejo s placebom (n = 581, neodvisno pregledana populacija; mediana 4,0 mesece in 2,0 meseca) (razmerje tveganja = 0,60, 95 % IZ: 0,49-0,73, p < 0,00001).
English: Pemetrexed / Cisplatin (N = 226)
Slovenian: Parameter učinkovitosti pemetreksed/ cisplatin (N = 226)
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: okužbo brez nevtropenije, febrilno nevtropenijo, alergijsko reakcijo/preobčutljivost, povišane vrednosti kreatinina, motorično nevropatijo, senzorično nevropatijo, multiformni eritem in bolečino v trebuhu.
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson
Slovenian: Obvestite zdravnika, če se pojavijo hud izpuščaj, srbenje ali mehurčki (StevensJohnsonov sindrom ali toksična epidermalna nekroliza).
English: Common SGPT (ALT) elevation
Slovenian: Povišanje SGPT (ALT)
English: Time to treatment failure (months) (95% CI)
Slovenian: Log rank p-vrednost* Čas do neuspeha zdravljenja (meseci) (95 % IZ)
English: Neutrophils decreased
Slovenian: Znižani trombociti
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
Slovenian: Mediana skupnega preživetja za celotno populacijo (n = 663) je bila 13,4 mesece za vejo s pemetreksedom in 10,6 mesecev za vejo s placebom, razmerje tveganja = 0,79 (95 % IZ: 0,65 do 0,95; p = 0,01192).
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: znojenje ali drugi znaki okužbe (ker imate lahko manj belih krvnih celic kot normalno, kar je zelo pogosto).
English: Women must use effective contraception during treatment with Pemetrexed Fresenius Kabi.
Slovenian: Med zdravljenjem z zdravilom Pemetreksed Fresenius Kabi morajo ženske uporabljati učinkovito metodo kontracepcije.
English: Pemetrexed Fresenius Kabi is indicated as monotherapy for the second 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 Fresenius Kabi je indicirano kot monoterapija za zdravljenje druge izbire za bolnike z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: Constipation Common Dyspepsia
Slovenian: Zelo pogosti Diareja Navzea
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Slovenian: Vključno z indukcijsko fazo je bila mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije 18,6 mesecev za vejo s pemetreksedom in 13,6 mesecev za vejo s placebom (razmerje tveganja = 0,71, 95% IZ: 0,56-0,88, p = 0,002).
English: Clinically relevant toxicity that was reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri < 1 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: povišanje vrednosti GGT, bolečino v prsnem košu, aritmijo in motorično nevropatijo.
English: White to off-white lyophilised powder or solid.
Slovenian: prašek za koncentrat za raztopino za infundiranje bel do belkast liofiliziran prašek ali trdna snov
English: To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration.
Slovenian: Za zmanjšanje incidence in resnosti kožnih reakcij, se daje kortikosteroid dan pred dajanjem pemetrekseda, na dan dajanja pemetrekseda in naslednji dan. Kortikosteroid naj ustreza 4 mg deksametazona, danega peroralno dvakrat dnevno (glejte poglavje 4.4).
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
Slovenian: Študija je dosegla svoj primarni ciljni učinek in dokazala statistično pomembno izboljšanje preživetja brez napredovanja bolezni v veji, ki je prejemala pemetreksed, v primerjavi z vejo, ki je prejemala placebo (n = 472, neodvisno pregledana populacija; mediano 3,9 meseca in 2,6 meseca) (razmerje tveganja=0,64, 95 % IZ = 0,51-0,81, p = 0,0002).
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: febrilno nevtropenijo, infekcijo, znižane trombocite, diarejo, zaprtje, alopecijo, srbenje, povišano telesno temperaturo (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Slovenian: Mediana skupnega preživetja za bolnike z NSCLC, ki nima pretežno ploščatocelične histologije (n = 481) je bila 15,5 mesecev za vejo s pemetreksedom in 10,3 mesecev za vejo s placebom (razmerje tveganja = 0,70, 95% IZ: 0,56-0,88, p = 0,002).
English: Reconstitute each 500 mg vial with 20 ml of 5% glucose intravenous infusion resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: Rekonstituirajte 500 mg viale z 20 ml 50 mg/ml (5,0 %) raztopino glukoze za intravensko infundiranje, tako da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Nadir platelets < 50,000/mm with bleeding a,
Slovenian: Najnižje število trombocitov < 50.000 /mm s krvavitvijo a, ne glede na najnižji ANC
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with ALIMTA plus BSC (n = 359) with that of placebo plus BSC (n = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of ALIMTA in combination with cisplatin.
Slovenian: V multicentrični, randomizirani, dvojno slepi in s placebom nadzorovani študiji faze 3 (PARAMOUNT) so primerjali učinkovitost in varnost nadaljevanja vzdrževalnega zdravljenja s pemetreksedom in najboljšo podporno oskrbo (n = 359) s placebom in najboljšo podporno oskrbo (n = 180) pri bolnikih z lokalno napredovanim (faza IIIB) ali metastatskim (faza IV) nedrobnoceličnim pljučnim rakom, ki nima prevladujoče ploščatocelične histologije, ter pri katerih ni bilo napredka po 4 ciklih dvojne terapije prve izbire s pemetreksedom v kombinaciji s cisplatinom.
English: 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Slovenian: BSA, infundiran v dveh urah približno 30 minut po zaključku infuzije pemetrekseda prvi dan vsakega 21-dnevnega cikla.
English: Reconstitute 100-mg vials with 4.2 ml of 5% glucose intravenous infusion resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: Rekonstituirajte 100 mg viale s 4,2 ml 50 mg/ml (5,0 %) raztopino glukoze za intravensko infundiranje, tako da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Slovenian: Klinično pomembne toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno razporedili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: povišanje vrednosti AST, povišanje vrednosti ALT, okužbo, febrilno nevtropenijo, odpoved ledvic, pireksijo, dehidracijo, konjuktivitis in znižanje očistka kreatinina.
English: 50 % of previous dose a
Slovenian: 100 % predhodnega odmerka 50 % predhodnega odmerka a
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: Bolniki z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina 45-79 ml/min) se morajo izogibati sočasnemu dajanju pemetrekseda z NSAIDs (npr. ibuprofen) 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: Median time to tumour progression (months) (95% CI)
Slovenian: Log rank p-vrednost* Mediana časa do napredovanja tumorja (meseci) (95 % IZ)
English: NeuropathySensory
Slovenian: Nevropatijasenzorična
English: CLINICAL PARTICULARS
Slovenian: CITOTOKSIČNO ZDRAVILO
English: How to store Pemetrexed Fresenius Kabi
Slovenian: Shranjevanje zdravila Pemetreksed Fresenius Kabi
English: What Pemetrexed Fresenius Kabi contains
Slovenian: Kaj vsebuje zdravilo Pemetreksed Fresenius Kabi
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1 % in ≤ 5 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: odpoved ledvic, okužbo, pireksijo, febrilno nevtropenijo, povišane vrednosti AST, ALT in GGT (GGT - gamma glutamyl transferase), koprivnico in bolečino v prsnem košu.
English: Common Neuropathysensory
Slovenian: Zelo pogosti Nevropatijasenzorična
English: if you are breast-feeding; you must discontinue breast-feeding during treatment with Pemetrexed Fresenius Kabi.
Slovenian: • če dojite, morate med zdravljenjem z zdravilom Pemetreksed Fresenius Kabi dojenje prekiniti.
English: Patients should discontinue therapy if Grade 3 or 4 neurotoxicity is observed.
Slovenian: Če opazimo nevrološko toksičnost stopnje 3 ali 4, se zdravljenje prekine.
English: NSCLC, second-line treatment
Slovenian: NSCLC (NSCLC - non small cell lung cancer), zdravljenje druge izbire