FrancophonIA/ELRC3.0 huggingface dataset:
English: Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer therapy.
Slovenian: Edem (preveč tekočine v telesnih tkivih, kar povzroča oteklino) Nekateri bolniki so med prejemanjem pemetrekseda, običajno v kombinaciji z drugim zdravilom proti raku, doživeli srčno kap, možgansko kap ali "manjšo kap".
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed Pfizer 100 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje Pemetreksed Pfizer 1.000 mg prašek za koncentrat za raztopino za infundiranje
English: Clinically relevant CTC toxicities that were reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Slovenian: Klinično pomembne CTC toksičnosti, o katerih so poročali pri < 1 % bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo aritmijo in motorično nevropatijo.
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 skupini s pemetreksedom glede na skupino s placebom (N = 581, neodvisno pregledana populacija; mediana 4,0 mesece in 2,0 meseca) (razmerje tveganja = 0,60, 95 % CI: 0,490,73, p < 0,00001).
English: 50% of previous dose (both pemetrexed and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Slovenian: 50 % predhodnega odmerka (obehpemetrekseda in cisplatina) Ta merila ustrezajo Merilom pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998), definiciji za ≥ CTC stopnjo krvavitve 2
English: Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection 6.
Slovenian: Pemetreksed je inkompatibilen z vehikli, ki vsebujejo kalcij, vključno z raztopino Ringerjevega laktata za injiciranje in Ringerjevo raztopino za injiciranje.
English: Pemetrexed undergoes limited hepatic metabolism.
Slovenian: Pemetreksed je podvržen omejeni jetrni presnovi.
English: Rare cases of hepatitis, potentially serious, have been reported during clinical studies with pemetrexed.
Slovenian: Med kliničnimi študijami s pemetreksedom so poročali o redkih primerih potencialno resnega hepatitisa.
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 skupini, ki je prejemala pemetreksed, v primerjavi s skupino, 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: Pemetrexed Pfizer 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 Pfizer 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: Alkaline phosphatase, AST, and ALT ≤ 5-times upper limit of normal is acceptable if liver has tumour involvement.
Slovenian: Če so jetra tumorsko prizadeta, so sprejemljive vrednosti alkalne fosfataze, AST in ALT ≤ 5-kratnik zgornje meje normalnih vrednosti.
English: Pemetrexed Pfizer 1,000mg vial:
Slovenian: Pemetreksed Pfizer 1.000 mg:
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Slovenian: *** V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998), motnje okusa in alopecija morata biti poročana kot stopnja 1 ali 2.
English: Muscle weakness
Slovenian: Mišična oslabelost
English: Not known: frequency cannot be estimated from the available data
Slovenian: Pogostnost neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) Otekanje spodnjih udov z bolečino in rdečino Povečano izločanje urina
English: A multi-centre, randomised, double-blind, placebo-controlled Phase-3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed 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 pemetrexed in combination with cisplatin.
Slovenian: V multicentrični, randomizirani, dvojno slepi in s placebom nadzorovani študiji v tretji fazi (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 karcinomom pljuč, ki nima prevladujoče ploščatocelične histologije, ter pri katerih ni bilo napredka po 4 ciklih zdravljenja prve izbire z dubletami pemetrekseda v kombinaciji s cisplatinom.
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Slovenian: - če dojite, morate med zdravljenjem z zdravilom Pemetreksed Pfizer dojenje prekiniti.
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 kraku pemetreksed in 14,0 mesecev v kraku s placebom (razmerje tveganja = 0,78, 95 % IZ = 0,64-0,96).
English: **According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
Slovenian: **V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2.0; NCI 1998) mora biti alopecija poročana kot stopnja 1 ali 2.
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: xKaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
English: Conjunctivitis (inflamed eye) Upset stomach
Slovenian: Razdražen želodec
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion The 500 mg vial does not require any special storage conditions.
Slovenian: Pemetreksed Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje Za shranjevanje 500 mg viale niso potrebni posebni pogoji.
English: Pemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Slovenian: Zdravilo Pemetreksed Pfizer je v kombinaciji s cisplatinom indicirano za zdravljenje bolnikov z neresektabilnim malignim plevralnim mezoteliomom, ki jih še nismo zdravili s kemoterapijo.
English: • HR
Slovenian: • RT
English: The pharmacokinetic properties of pemetrexed are not influenced by concurrently administered cisplatin.
Slovenian: Na farmakokinetične lastnosti pemetrekseda sočasno dani cisplatin ne vpliva.
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion 18 months
Slovenian: Pemetreksed Pfizer 100 mg prašek za koncentrat za raztopino za infundiranje 18 mesecev
English: How to use Pemetrexed Pfizer
Slovenian: Kako uporabljati zdravilo Pemetreksed Pfizer
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: 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 skupino s pemetreksedom in 1,8 meseca za skupino s placebom, razmerje tveganja = 0,47, 95 % CI: 0,37-0,60, p = 0,00001).
English: Rash Alopecia
Slovenian: Izpuščaj Alopecija
English: In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12.
Slovenian: V obeh vejah zdravljenja so bolniki, ki pred tem še niso prejeli kemoterapije, prejemali dopolnilno folno kislino in vitamin B12.
English: Pemetrexed Pfizer 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 Pfizer je indicirano kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
English: Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion The 1,000 mg vial does not require any special storage conditions.
Slovenian: Pemetreksed Pfizer 1.000 mg prašek za koncentrat za raztopino za infundiranje Za shranjevanje 1.000 mg viale niso potrebni posebni pogoji.
English: Common Leucocytes decreased
Slovenian: Znižan hemoglobin Pogosto Znižani levkociti
English: What Pemetrexed Pfizer contains
Slovenian: Kaj vsebuje zdravilo Pemetreksed Pfizer
English: pemetrexed/cisplatin (N = 839)
Slovenian: Pemetreksed/cisplatin (N = 839)
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1,000 mg
Slovenian: prašek za koncentrat za raztopino za infundiranje 1.000 mg
English: 100% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Slovenian: 50% predhodnega odmerka 100% predhodnega odmerka Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2.0; NCI 1998) Brez nevrološke toksičnosti
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, povišan kreatinin, motorično nevropatijo, senzorično nevropatijo, multiformni eritem in bolečino v trebuhu.
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 skupino s pemetreksedom in 13,6 mesecev za skupino s placebom (razmerje tveganja = 0,71, 95 % CI: 0,56-0,88, p = 0,002).
English: pemetrexed / cisplatin (N = 168)
Slovenian: pemetreksed / cisplatin (N = 168)
English: Method of administration For Precautions to be taken before handling or administering Pemetrexed Pfizer, see section 6.6.
Slovenian: Za previdnostne varnostne ukrepe pri pripravi in dajanju zdravila Pemetreksed Pfizer glejte poglavje
English: Pemetrexed Pfizer 1,000mg powder for concentrate for solution for infusion 2 years
Slovenian: Pemetreksed Pfizer 1.000 mg prašek za koncentrat za raztopino za infundiranje 2 leti
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: Da zmanjšamo incidenco in resnost kožnih reakcij, dajemo 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: 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 dodelili v skupino, ki je prejemala pemetreksed, vključujejo: povišanje AST, povišanje ALT, okužbo, febrilno nevtropenijo, odpoved ledvic, pireksijo, dehidracijo, konjunktivitis in znižan očistek kreatinina.
English: Nephrogenic diabetes insipidus and renal tubular necrosis have been reported in post marketing setting with an unknown frequency.
Slovenian: V obdobju trženja so z neznano pogostnostjo poročali o nefrogenem diabetesu insipidusu in ledvični tubulni nekrozi.
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, pruritus/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, vročino (v odsotnosti nevtropenije), bolezni površine očesa (vključno s konjunktivitisom), povečano solzenje, omotico in motorično nevropatijo.
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 pemetreksed, vključujejo: povišanje GGT, bolečino v prsnem košu, aritmijo in motorično nevropatijo.
English: *p-value refers to comparison between arms.
Slovenian: Okrajšava: IZ = interval zaupanja *p-vrednost se nanaša na primerjavo med vejama zdravljenja.
English: Reconstitute 100 mg vials with 4.2 ml of sterile water for injections, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 100 mg viale rekonstituirajte s 4,2 ml sterilne vode za injekcije, da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first-line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59, 95% CI = 0.47-0.74).
Slovenian: Za naključno izbrane bolnike, merjeno od začetka zdravljenja s pemetreksedom in indukcijskim zdravljenjem prve izbire s cisplatinom, je bilo mediano preživetje brez napredovanja bolezni po oceni raziskovalca 6,9 meseca za skupino, ki je prejemala pemetreksed, in 5,6 meseca za skupino, ki je prejemala placebo (razmerje tveganja = 0,59 95 % IZ = 0,47-0,74).
English: A white to light yellow or green-yellow lyophilised powder.
Slovenian: Bel do svetlorumen ali zelenorumen liofilizirani prašek.
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Store the 100 mg vial below 30°C.
Slovenian: Pemetreksed Pfizer 100 mg prašek za koncentrat za raztopino za infundiranje 100 mg vialo shranjujte pri temperaturi do 30 °C.
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 skupino s pemetreksedom in 10,3 mesecev za skupino s placebom (razmerje tveganja = 0,70, 95 % CI: 0,56-0,88, p = 0,002).
English: Reconstitute 500 mg vials with 20 ml of sterile water for injections, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 500 mg viale rekonstituirajte z 20 ml sterilne vode za injekcije, da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: In clinical trials, cases of colitis (including intestinal and rectal bleeding, sometimes fatal, intestinal perforation, intestinal necrosis and typhlitis) have been reported uncommonly in patients treated with pemetrexed.
Slovenian: V kliničnih preskušanjih so pri bolnikih, ki so jih zdravili s pemetreksedom, občasno poročali o primerih kolitisa (vključno s črevesnimi krvavitvami in krvavitvami iz danke, ki so bile včasih usodne, črevesnimi perforacijami, črevesno nekrozo in vnetjem slepega črevesa).
English: Mesothelioma
Slovenian: Mezoteliom
English: Frequency Event*
Slovenian: Dogodek*
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion 2 years
Slovenian: Pemetreksed Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje 2 leti
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 500 mg
Slovenian: prašek za koncentrat za raztopino za infundiranje 500 mg
English: Reconstitute 1000 mg vials with 40 ml of sterile water for injections resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 1.000 mg viale rekonstituirajte s 40 ml sterilne vode za injekcije, da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Warnings and precautions Talk to your doctor or hospital pharmacist before receiving Pemetrexed Pfizer.
Slovenian: Pred začetkom uporabe zdravila Pemetreksed Pfizer se posvetujte z zdravnikom ali bolnišničnim farmacevtom.
English: Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident, and transient ischaemic attack, have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Slovenian: Občasno so v kliničnih študijah pemetrekseda, običajno ob sočasnem dajanju z drugo citotoksično učinkovino, poročali o resnih srčnožilnih in možganskožilnih dogodkih, vključno z miokardnim infarktom, angino pektoris, cerebrovaskularnim insultom in prehodnimi ishemičnimi atakami.
English: Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Slovenian: Pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov) Alergijske reakcije: kožni izpuščaji/pekoč ali zbadajoč občutek Okužba vključno s sepso
English: pemetrexed (N = 265)
Slovenian: Pemetreksed (N = 265)
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Slovenian: Po rekonstituciji ena viala vsebuje 25 mg/ml pemetrekseda.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 100 mg
Slovenian: prašek za koncentrat za raztopino za infundiranje 100 mg
English: 9 l/m2.
Slovenian: 100.000 celic/mm
English: Stomatitis/Pharyngitis Diarrhoea without colostomy
Slovenian: Diareja brez kolostomije
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Each vial contains 500 milligrams of pemetrexed (as pemetrexed ditromethamine).
Slovenian: Pemetreksed Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 500 miligramov pemetrekseda (v obliki ditrometaminijevega pemetrekseda).
English: Leucocytes decreased 53.0 14.9 16.6 Haemoglobin decreased 26.2 4.2 Platelets decreased
Slovenian: Znižani levkociti 53,0 Znižan hemoglobin Znižani trombociti
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomised and treated patients Fully supplemented patients
Slovenian: Učinkovitost pemetrekseda skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Store below 30°C.
Slovenian: Pemetreksed Pfizer 100 mg prašek za koncentrat za raztopino za infundiranje Shranjujte pri temperaturi do 30 °C.
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 AST, ALT in GGT, koprivnico in bolečino v prsnem košu.
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Each vial contains 100 milligrams of pemetrexed (as pemetrexed ditromethamine).
Slovenian: Pemetreksed Pfizer 100 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 100 miligramov pemetrekseda (v obliki ditrometaminijevega pemetrekseda).
English: Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed ditromethamine).
Slovenian: Pemetreksed Pfizer 1.000 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 1.000 miligramov pemetrekseda (v obliki ditrometaminijevega pemetrekseda).
English: 1050 Bruxelles
Slovenian: 500 mg
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion This medicinal product does not require any special storage conditions.
Slovenian: Pemetreksed Pfizer 500 mg prašek za koncentrat za raztopino za infundiranje Za shranjevanje zdravila niso potrebna posebna navodila.
English: Pancytopenia has been uncommonly reported during clinical trials with pemetrexed.
Slovenian: V kliničnih preskušanjih s pemetreksedom so redko poročali o pancitopeniji.
English: Common Neuropathy-sensory Taste disturbance
Slovenian: Pogosto Nevropatija - senzorna
English: Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion This medicinal product does not require any special storage conditions.
Slovenian: Pemetreksed Pfizer 1.000 mg prašek za koncentrat za raztopino za infundiranje Za shranjevanje zdravila niso potrebna posebna navodila.
English: Tabulated list of adverse reactions
Slovenian: V tabeli prikazani neželeni učinki