natgillin/translations-raw huggingface dataset:
50% of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) 
50% prethodne doze a Zajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998)
Concomitant administration of nephrotoxic drugs (e.g., aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed. 
Istodobna primjena s nefrotoksičnim lijekovima (npr. aminoglikozidom, diureticima Henleove petlje, spojevima platine, ciklosporinom) može rezultirati odgođenim klirensom pemetrekseda.
The separation between the treatment arms was achieved by improvement in lung function in the pemetrexed/cisplatin arm and deterioration of lung function over time in the control arm. 
Skupine su se razlikovale i po tome što se u bolesnika liječenih kombinacijom pemetreksed/cisplatin funkcija pluća poboljšala, dok se u kontrolnoj skupini s vremenom pogoršavala.
If patients develop non-haematologic toxicities ≥ Grade 3 (excluding neurotoxicity), Pemetrexed Sandoz should be withheld until resolution to less than or equal to the patient's pre-therapy value. 
Razvije li se u bolesnika nehematološka toksičnost stupnja ≥ 3 (osim neurotoksičnosti), primjena lijeka Pemetrexed Sandoz mora se prekinuti dok se vrijednosti ne vrate na razinu prije liječenja ili nižu.
Reconstituted and infusion solution 
Rekonstituirana otopina i otopina za infuziju
Other medicines and Pemetrexed Sandoz 
Drugi lijekovi i Pemetrexed Sandoz
Gemcitabine/ Cisplatin (N = 830) 
gemcitabin/ cisplatin (N = 830)
Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single-agent pemetrexed studies (N = 164) and the Phase 3 single-agent pemetrexed study described above, with the exception of neutropenia (12.8 % versus 5.3 %, respectively) and alanine aminotransferase elevation (15.2 % versus 1.9 %, respectively). 
Klinički značajni oblici toksičnosti stupnja 3 i 4 utvrđeni laboratorijskim pretragama bili su podjednaki u objedinjenim rezultatima triju ispitivanja faze II pemetrekseda u monoterapiji (n = 164) i rezultatima gore opisanog kliničkog ispitivanja faze III pemetrekseda u monoterapiji, s iznimkom neutropenije (12,8% naspram 5,3%) i povišenih vrijednosti alanin aminotransferaze (15,2% naspram 1,9%).
Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags. 
Otopine pemetrekseda za infuziju pripremljene na opisani način kompatibilne su s infuzijskim priborom i infuzijskim vrećicama od polivinilklorida i poliolefina.
Patients must receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving cisplatin (see also cisplatin Summary of Product Characteristics for specific dosing advice). 
Prije i/ili nakon primjene cisplatina bolesnici moraju primiti odgovarajući antiemetik i primjerenu hidrataciju (vidjeti i posebne preporuke za doziranje u Sažetku opisa svojstava lijeka za cisplatin).
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria 
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austrija
Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups 
Djelotvornost pemetrekseda+ cisplatina u odnosu na gemcitabin + cisplatin u prvoj liniji liječenja raka pluća nemalih stanica - ITT populacija i podskupine prema histološkom tipu
However, patients with hepatic impairment, such as bilirubin > 1.5 times the upper limit of normal and/or aminotransferase >3.0 times the upper limit of normal (hepatic metastases absent) or > 5.0 times the upper limit of normal (hepatic metastases present), have not been specifically studied. 
Međutim, nisu posebno ispitivani bolesnici s oštećenjem jetre u kojih je vrijednost bilirubina bila > 1,5 puta iznad gornje granice normale i/ili vrijednost aminotransferaza > 3,0 puta iznad gornje granice normale (bez metastaza u jetri) odnosno > 5,0 puta iznad gornje granice normale (uz metastaze u jetri).
It is not known whether pemetrexed is excreted in human milk, and adverse reactions on the suckling child cannot be excluded. 
Nije poznato izlučuje li se pemetreksed u majčino mlijeko pa se mogu isključiti nuspojave na dojenče.
Hyperpigmentation has been commonly reported. 
Prijavljeni su česti slučajevi hiperpigmentacije.
: + 359 2 970 47 47 regaffairs.bg@sandoz.com 
Teл.: + 359 2 970 47 47 regaffairs.bg@sandoz.com
• If you experience bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common). 
ako imate krvarenje iz desni, nosa ili usta ili bilo kakvo krvarenje koje ne prestaje, crvenkastu ili ružičastu boju mokraće, neočekivane modrice (jer broj krvnih pločica može biti niži od normalnog, što je vrlo česta pojava).
Rare (may affect up to 1 in 1,000 people) 
Rijetke (mogu se javiti u do 1 na 1000 osoba)
• Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) 
• Kolitis (upala sluznice debelog crijeva koja može biti praćena krvarenjem iz crijeva ili završnog dijela debelog crijeva)
Pemetrexed Sandoz in combination with cisplatin 
Pemetrexed Sandoz u kombinaciji s cisplatinom
• Extremity pain, low temperature and discolouration have been reported. 
• Prijavljeni su bol u udovima, snižena temperatura i promjene boje.
Pemetrexed Sandoz is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer. 
Pemetrexed Sandoz se također primjenjuje u kombinaciji s cisplatinom za početno liječenje bolesnika s uznapredovalim stadijem raka pluća.
Most of these events resolved after pemetrexed withdrawal. 
Nakon prekida primjene pemetrekseda, većina ovih pojava bi se povukla.
Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent-to-treat; N = total population size. 
Kratice: CI = interval pouzdanosti; HR = omjer hazarda; ITT = populacija svih uključenih bolesnika;N = ukupan broj bolesnika.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 mg 
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 1000 mg
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 (HR) 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. 
Preživljenje bez progresije bolesti (PFS) i stopa ukupnog odgovora bili su podjednaki između terapijskih skupina: medijan PFS-a iznosio je 4,8 mjeseci za pemetreksed i cisplatin u usporedbi s 5,1 mjeseci za gemcitabin i cisplatin (prilagođen omjer hazarda 1,04; 95% CI = 0,94-1,15), a stopa ukupnog odgovora bila je 30,6% (95% CI = 27,3-33,9) za pemetreksed i cisplatin u usporedbi s 28,2% (95% CI = 25,0-31,4) za gemcitabin i cisplatin.
A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Sandoz powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you. 
Prije primjene lijeka Pemetrexed Sandoz bolnički ljekarnik, medicinska sestra ili liječnik će pomiješati Pemetrexed Sandoz prašak s otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%).
If you have had or are going to have radiation therapy, please tell your doctor, as there may be an early or late radiation reaction with Pemetrexed Sandoz. 
Ako ste primali ili ćete primati terapiju zračenjem, obavijestite o tome svog liječnika jer se uz primjenu lijeka Pemetrexed Sandoz mogu pojaviti rane ili kasne reakcije na zračenje.
Efficacy of Pemetrexed vs. Docetaxel in NSCLC - ITT population 
Djelotvornost pemetrekseda u odnosu na docetaksel kod NSCLC - ITT populacija pemetreksed docetaksel
Pemetrexed Sandoz must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. 
Pemetrexed Sandoz se smije primjenjivati samo pod nadzorom liječnika koji je obučen za primjenu antitumorske kemoterapije.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg 
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 500 mg
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 
POSEBNO UPOZORENJE DA LIJEK TREBA ČUVATI IZVAN POGLEDA
Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1,500 cells/mm3 and platelet count returns to ≥ 100,000 cells/mm3. 
U bolesnika se tijekom liječenja moraju pratiti pokazatelji mijelosupresije i pemetreksed se ne smije davati sve dok apsolutni broj neutrofila (ABN) ne bude ≥ 1500 stanica/mm3, a broj trombocita  100 000 stanica/mm3.
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). 
Bolesnici liječeni pemetreksedom i cisplatinom trebali su manje transfuzija (16,4% naspram 28,9%, p < 0,001), transfuzija eritrocita (16,1% naspram 27,3%, p < 0,001) i transfuzija trombocita (1,8% naspram 4,5%, p = 0,002).
Patients also required lower administration of erythropoietin/darbopoietin (10.4% versus 18.1%, p < 0.001), G-CSF/GM-CSF (3.1% versus 6.1%, p = 0.004), and iron preparations (4.3% versus 7.0%, p = 0.021). 
U tih je bolesnika također rjeđe trebalo primijeniti eritropoetin/darbepoetin (10,4% naspram 18,1%, p<0,001), G-CSF/GM-CSF (3,1% naspram 6,1%, p = 0,004) i pripravke željeza (4,3% naspram 7,0%, p = 0,021).
Paediatric population: There is no relevant use of pemetrexed in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer. 
Nema relevantne primjene pemetrekseda u pedijatrijskoj populaciji za indikaciju malignog pleuralnog mezotelioma i raka pluća nemalih stanica.
Large cell (N = 153) 
Karcinom velikih stanica (N=153)
• Skin rash 
• Kožni osip
Contains mannitol (E421), hydrochloric acid and sodium hydroxide (for pH adjustment). 
Sadrži manitol (E421), kloridnu kiselinu i natrijev hidroksid (za podešavanje pH).
Sandoz S.p.A Largo Umberto Boccioni 1 I - 21040 Origgio/VA Tel: + 39 02 96541 
Sandoz S.p.A Largo Umberto Boccioni 1 I - 21040 Origgio/VA
For intravenous use after reconstitution and dilution. 
Primjena u venu nakon pripreme i razrjeđivanja.
Upon recovery, patients should be re-treated using the guidelines in Tables 1, 2, and 3, which are applicable for Pemetrexed Sandoz used as a single agent or in combination with cisplatin. 
Nakon oporavka bolesnika treba ponovno liječiti prema smjernicama za primjenu lijeka Pemetrexed Sandoz u monoterapiji ili u kombinaciji s cisplatinom, prikazanima u Tablicama 1, 2 i 3.
• Upset stomach 
• Bol u trbuhu
Pemetrexed Sandoz is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy. 
Pemetrexed Sandoz se primjenjuje u kombinaciji s cisplatinom, još jednim protutumorskim lijekom, za liječenje zloćudnog pleuralnog mezotelioma, oblika raka koji zahvaća plućne ovojnice, u bolesnika koji prethodno nisu primali kemoterapiju.
Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Sandoz and should therefore use effective contraception during treatment with Pemetrexed Sandoz and for up to 6 months afterwards. 
Muškarcima se savjetuje da ne začinju djecu tijekom liječenja i do 6 mjeseci nakon završetka liječenja lijekom Pemetrexed Sandoz.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg 
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU JEDINICA LIJEKA 100 mg
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). 
Bolesnici s blagim do umjerenim zatajenjem bubrega (klirens kreatinina od 45 do 79 ml/min) moraju izbjegavati uzimanje nesteroidnih protuupalnih lijekova (NSAIL-a) poput ibuprofena i acetilsalicilatne kiseline (> 1,3 g na dan) 2 dana prije, na sam dan i 2 dana nakon primjene pemetrekseda (vidjeti dio 4.5).
* Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased”. 
* Za sve stupnjeve toksičnosti vidjeti CTC NCI verziju 2, osim za izraz „smanjen klirens kreatinina“ ** Izveden iz izraza „ostali bubrežni/genitourinarni poremećaji“.
**Refer to NCI CTCAE Criteria (Version 3.0; NCI 2003) for each grade of toxicity. 
** Za sve stupnjeve toksičnosti vidjeti NCI CTCAE (verzija 3.0; NCI 2003).
Pemetrexed Sandoz usually in combination with another anticancer therapy. 
Pemetrexed Sandoz, obično u kombinaciji s nekim drugim protutumorskim lijekom.
The recommended dose of cisplatin is 75 mg/m2 BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle. 
75 mg/m2 tjelesne površine, a primjenjuje se infuzijom u trajanju od dva sata, približno 30 minuta nakon završetka infuzije pemetrekseda, prvog dana svakog 21-dnevnog ciklusa.
426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a 
Farmakokinetička svojstva pemetrekseda nakon primjene u monoterapiji ispitana su u 426 onkoloških bolesnika s različitim solidnim tumorima, pri dozama od 0,2 do 838 mg/m2 primijenjenima u infuziji tijekom 10 minuta.
Pemetrexed Sandoz is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used. 
Pemetrexed Sandoz se također primjenjuje u bolesnika s uznapredovalim rakom pluća u kojih je bolest napredovala nakon primjene neke druge početne kemoterapije.
In vitro studies have shown that pemetrexed behaves as a multi-targeted 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. 
Ispitivanja in vitro pokazala su da pemetreksed djeluje antifolatno na više načina, inhibirajući timidilat sintetazu (TS), dihidrofolat reduktazu (DHFR) i glicinamid ribonukleotid formiltransferazu (GARFT),
• If you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common). 
ako osjetite umor, nesvjesticu, nedostatak zraka ili ste blijedi (jer razina hemoglobina može biti niža od normalne, što je vrlo česta pojava).
There are limited data in patients with malignant pleural mesothelioma treated with pemetrexed alone. 
Podaci o bolesnicima s malignim pleuralnim mezoteliomom liječenima samo lijekom pemetreksed su ograničeni.
Nadir platelets < 50,000/mm3 with bleedinga, regardless of nadir ANC 
Najniži broj trombocita < 50 000/mm3 uz krvarenjea, bez obzira na najniži ABN
System organ class 
Organski Sustav
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6. 
Za upute o rekonstituciji i razrjeđivanju lijeka Pemetrexed Sandoz prije primjene, vidjeti dio 6.6.
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. 
Tablica koja slijedi prikazuje učestalost i težinu nuspojava za koje se smatra da bi mogle biti povezane s ispitivanim lijekom, a koje su zabilježene u > 5% od 800 bolesnika randomiziranih da primaju samo pemetreksed i 402 bolesnika randomizirana da primaju placebo u ispitivanju monoterapije pemetreksedom kao terapije održavanja (JMEN: N= 663) i ispitivanja kontinuirane terapije održavanja pemetreksedom (PARAMOUNT: N=539).
Pemetrexed Sandoz contains sodium 
Pemetrexed Sandoz sadrži natrij
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 hazard ratio (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). 
Analiza utjecaja histologije NSCLC-a na učinak liječenja na ukupno preživljenje pokazuje prednost pemetrekseda u odnosu na docetaksel u tumora kod kojih histološki ne prevladavaju skvamozne stanice (N=399, 9,3 naspram 8,0 mjeseci, prilagođeni omjer hazarda (engl. hazard ratio) HR = 0,78; 95% CI = 0,61-1,00, p = 0,047) i prednost docetaksela u slučaju tumora kod kojih histološki prevladavaju skvamozne stanice (N=172, 6,2 naspram 7,4 mjeseci, prilagođeni HR = 1,56; 95% CI = 1,08-2,26, p = 0,018).
Intravenous use after reconstitution and dilution 
Primjena u venu nakon pripreme i razrjeđivanja
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva često osip/
Pemetrexed + Cisplatin Gemcitabine + Cisplatin 
ITT populacija i histološke podskupine pemetreksed + cisplatin gemcitabin + cisplatin
A multi-centre, 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 (HR) 0.94; 95% CI= 0.84-1.05). 
Multicentrično, randomizirano, otvoreno ispitivanje fazeIIIpemetrekseda i cisplatina u odnosu na gemcitabin i cisplatin u bolesnika s lokalno uznapredovalim ili metastatskim (stadijIIIB ili IV) rakom pluća nemalih stanica (NSCLC) koji prethodno nisu primali kemoterapiju pokazalo je da su pemetreksed i cisplatin (ITT populacija,N=862) ostvarili primarniishod ispitivanja i pokazali sličnu kliničku djelotvornost kao gemcitabin i cisplatin (ITT N = 863) s obzirom na ukupno preživljenje (prilagođeni omjer rizika 0,94; 95% CI = 0,84-1,05).
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). 
Nakon uvodnog liječenja pemetreksedom i cisplatinom (4 ciklusa), liječenje pemetreksedom bilo je statistički značajno bolje od placeba s obzirom na OS (medijan 13,9 mjeseci naspram 11,0 mjeseci, omjer hazarda = 0,78, 95% CI = 0,64-0,96, p = 0,0195).
Pemetrexed Sandoz 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). 
Pemetrexed Sandoz je indiciran kao monoterapija u terapiji održavanja lokalno uznapredovalog ili metastatskog raka pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice u bolesnika u kojih bolest nije napredovala neposredno nakon kemoterapije na bazi platine (vidjeti dio 5.1).
A multi-centre, 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. 
U multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (JMEN) uspoređivala se djelotvornost i sigurnost liječenja pemetreksedom kao terapijom održavanja uz najbolju potpornu njegu (eng. best supportive care, BSC) (N = 441) s djelotvornošću i sigurnošću primjene placeba uz BSC (N = 222) u bolesnika s lokalno uznapredovalim (stadij IIIB) ili metastatskim (stadij IV) rakom pluća nemalih stanica (NSCLC) u kojih nije došlo do progresije nakon 4 ciklusa prve linije dvojne terapije cisplatinom ili karboplatinom u kombinaciji s gemcitabinom, paklitakselom ili docetakselom.
Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Neurotoxicity 
Tablica 3 - Tablica za prilagodbu doze lijeka Pemetrexed Sandoz (u monoterapiji ili u kombinaciji) i cisplatina - neurotoksičnost
Fisher's exact p-value* < 0.001 
Fisherova egzaktna p-vrijednost
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution / dilution has taken place in controlled and validated aseptic conditions. 
Ukoliko razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima, te ukoliko se lijek ne primijeni odmah, vrijeme i način čuvanja prije primjene je odgovornost korisnika i normalno ne smije biti duže od 24 sata pri 2°C do 8C.
***Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies. 
(JMEN) (N=663) i kontinuirane terapije održavanja pemetreksedom (PARAMOUNT) (N=539).
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. 
U tablici koja slijedi navedena je učestalost i težina nuspojava koje su prijavljene u > 5% od 265 bolesnika randomiziranih u skupinu koja je primala samo pemetreksed te nadomjestak folatne kiseline i vitamina B12 i 276 bolesnika randomiziranih u skupinu koja je primala samo docetaksel.
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). 
U bolesnika s blagim do umjerenim zatajenjem bubrega (klirens kreatinina od 45 do 79 ml/min) mora se izbjegavati istodobna primjena NSAIL-a (npr. ibuprofena) ili viših doza acetilsalicilatne kiseline dva dana prije, na sam dan i dva dana nakon primjene pemetrekseda (vidjeti dio 4.4).
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 randomised to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomised to receive cisplatin and gemcitabine. 
Tablica koja slijedi prikazuje učestalost i težinu nuspojava za koje se smatra da bi mogle biti povezane s ispitivanim lijekom, a koje su prijavljene u > 5% od 839 bolesnika s rakom pluća nemalih stanica randomiziranih da primaju cisplatin i pemetreksed i 830 bolesnika s rakom pluća nemalih stanica randomiziranih da primaju cisplatin i gemcitabin.
Further dilution by a healthcare provider is required prior to administration. 
Zdravstveni radnika mora dodatno razrijediti otopinu prije primjene.