FrancophonIA/ELRC3.0 huggingface dataset:
English: Major response at 84 months (%) * p<0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): WBC < 10 x 109/l, platelet < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (3665%) or minimal (66-95%).
Croatian: L <10 x 109/l, trombociti <450 x 109/l, mijelociti+metamijelociti <5% u krvi, nema blasta i promijelocita u krvi, bazofili < 20%, nema ekstramedularne zahvaćenosti
English: − if you have recently received or are about to receive a vaccine against yellow fever.
Croatian: • ako ste nedavno primili ili ćete uskoro primiti cjepivo protiv žute groznice.
English: − infection including sepsis
Croatian: • infekcija, uključujući sepsu
English: • Median (m)
Croatian: • medijan (m)
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka)
English: − thirst and increased water consumption
Croatian: • žeđ i povećan unos vode
English: In the absence of other compatibility studies this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima.
English: − if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na pemetreksed ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Infection (sepsis) may be severe and could lead to death.
Croatian: Infekcija (sepsa) može biti vrlo teška i može imati smrtni ishod.
English: Survival Time (months)
Croatian: Vrijeme preživljenja (mjeseci)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 November 2015
Croatian: Datum prvog odobrenja: 27. studeni 2015.
English: If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Croatian: Ako niste sigurni, upitajte svog liječnika ili ljekarnika je li koji od Vaših lijekova NSAIL.
English: • 95 % CI for median
Croatian: • 95 % CI za medijan
English: Any diarrhoea requiring hospitalisation (irrespective of grade) or grade 3 or 4 diarrhoea
Croatian: Svaki proljev koji zahtijeva hospitalizaciju (bez obzira na stupanj) ili proljev stupnja 3 ili 4
English: Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.
Croatian: Razgovarajte s Vašim liječnikom kada je sigurno ponovno započeti dojenje nakon dovršetka liječenja.
English: 67801 Blansko Czech Republic Tel.: +420 516 427 311 Fax: +420 516 417 350
Croatian: 67801 Blansko Češka Republika Tel.: +420 516 427 311 Fax: +420 516 417 350
English: − increased skin pigmentation
Croatian: • pojačana pigmentacija kože
English: − anaphylactic shock (severe allergic reaction)
Croatian: • anafilaktički šok (teška alergijska reakcija)
English: PFS data were partially confirmed by an independent review (400/1,725 patients were randomly selected for review).
Croatian: Podaci za PFS djelomično su potvrđeni neovisnom procjenom (400/1725 bolesnika bilo je nasumce odabrano za procjenu).
English: Based on the planned date of your infusion of Pemetrexed medac and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Croatian: Ovisno o planiranom datumu primjene infuzije lijeka Pemetrexed medac i/ili Vašoj bubrežnoj funkciji, liječnik Vam mora reći koje lijekove možete uzimati i kada ih možete uzimati.
English: • Median
Croatian: • medijan
English: − hypernatraemia - increased sodium in blood
Croatian: • hipernatremija - povećana razina natrija u krvi
English: Your doctor will discuss with you the potential risk of taking Pemetrexed medac during pregnancy.
Croatian: Liječnik će s Vama razgovarati o mogućem riziku primjene lijeka Pemetrexed medac u trudnoći.
English: Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
Croatian: Pemetreksed se ne smije primjenjivati tijekom trudnoće osim ako je to doista nužno i tek nakon što se pažljivo razmotre potrebe majke i rizik za fetus (vidjeti dio 4.4).
English: • 95 % CI for HR
Croatian: • 95 % CI za HR
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka pemetreksed u svim podskupinama pedijatrijske populacije u odobrenim indikacijama (vidjeti dio 4.2).
English: In particular, tell your doctor if you are using medicines for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Croatian: Osobito, obavijestite svog liječnika ako koristite lijekove protiv bolova ili upale (otekline), poput lijekova iz skupine takozvanih „nesteroidnih protuupalnih lijekova“ (NSAIL), uključujući lijekove koje ste nabavili bez liječničkog recepta (poput ibuprofena).
English: C/ Castello, nº1, Pol. Las Salinas,
Croatian: C/ Castello, nº1, Pol.
English: − taste change
Croatian: • promjena okusa
English: It is a white to light yellow powder.
Croatian: To je bijeli do svijetložuti prašak.
English: Event*
Croatian: Događaj*
English: • Response rate (%)(95 % CI) • Stable disease (%)
Croatian: • stopa odgovora (%)(95 % CI) • stabilna bolest (%)
English: The use of Pemetrexed medac should be avoided during pregnancy.
Croatian: Primjena lijeka Pemetrexed medac mora se izbjegavati tijekom trudnoće.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed medac has finished.
Croatian: Cisplatin se također primjenjuje infuzijom u jednu od vena i daje se približno 30 minuta nakon završetka infuzije lijeka Pemetrexed medac.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/001 Pemetrexed medac 100 mg EU/1/15/1038/002 Pemetrexed medac 500 mg EU/1/15/1038/003 Pemetrexed medac 1,000 mg
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1038/001 Pemetrexed medac 100 mg EU/1/15/1038/002 Pemetrexed medac 500 mg EU/1/15/1038/003 Pemetrexed medac 1000 mg
English: Reconstituted and infusion solutions: The product should be used immediately.
Croatian: Rekonstituirana otopina i otopina za infuziju: Lijek se mora odmah upotrijebiti.
English: The other ingredients are mannitol, hydrochloric acid and sodium hydroxide, please see section 2 “Pemetrexed medac contains sodium”.
Croatian: Drugi sastojci su manitol, kloridna kiselina i natrijev hidroksid, vidjeti dio 2 „Pemetrexed medac sadrži natrij“.
English: Each pack consists of one vial containing 100 , 500 or 1,000 mg of pemetrexed.
Croatian: Svako pakiranje sadrži jednu bočicu koja sadrži 100, 500 ili 1000 mg pemetrekseda.
English: You must take at least 5 doses during the seven days before the first dose of Pemetrexed medac.
Croatian: Morate uzeti barem 5 doza tijekom 7 dana prije prve doze lijeka Pemetrexed medac.
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed medac.
Croatian: Prije svake infuzije uzet će Vam se uzorak krvi kako bi se provjerilo jesu li Vam funkcija jetre i bubrega dovoljno dobre i imate li dovoljno krvnih stanica da biste primili lijek Pemetrexed medac.
English: < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and not known (cannot be estimated from available data).
Croatian: Procjena učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: − low white blood cells
Croatian: • nizak broj bijelih krvnih stanica
English: Warnings and precautions Talk to your doctor or pharmacist before using Pemetrexed medac if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primite Pemetrexed medac:
English: − you currently have or have previously had problems with your kidneys, as you may not be able to receive Pemetrexed medac.
Croatian: • ako trenutno imate ili ste prethodno imali problema s bubrezima, jer možda nećete smjeti primati lijek Pemetrexed medac.
English: You will always receive Pemetrexed medac by infusion into one of your veins.
Croatian: Pemetrexed medac uvijek ćete primiti infuzijom u jednu od vena.
English: You will also receive an injection of Vitamin B12 (1,000 µg) in the week before administration of Pemetrexed medac and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed medac treatment).
Croatian: Također ćete dobiti injekciju vitamina B12 (1000 mikrograma) u tjednu prije primjene lijeka Pemetrexed medac i zatim otprilike svakih 9 tjedana (što odgovara 3 ciklusa liječenja lijekom Pemetrexed medac).
English: − pancytopenia-combined low counts of white cells, red cells and platelets
Croatian: • pancitopenija - udruženi nizak broj bijelih krvnih stanica, crvenih krvnih stanica i krvnih pločica
English: − fever or infection (common): if you have a temperature of 38 °C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
Croatian: • vrućicu ili infekciju (često): ako Vam je tjelesna temperatura 38°C ili viša, ako se znojite ili imate druge znakove infekcije (jer broj bijelih krvnih stanica može biti niži od normalnog, što je vrlo česta pojava).
English: How to store Pemetrexed medac Contents of the pack and other information
Croatian: Kako čuvati Pemetrexed medac Sadržaj pakiranja i druge informacije
English: − pain, redness, swelling or sores in your mouth
Croatian: • bol, crvenilo, oteklina ili ranice u ustima
English: This is equivalent to 2.70% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 2,70% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m² infused over a 10-minute period.
Croatian: 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.
English: − immune-mediated haemolytic anaemia (antibody-mediated destruction of red blood cells)
Croatian: • imunološki posredovana hemolitička anemija (razaranje crvenih krvnih stanica posredstvom protutijela)
English: − hair loss
Croatian: • gubitak kose
English: What Pemetrexed medac is and what is it used for Pemetrexed medac is a medicine used in the treatment of cancer.
Croatian: Što je Pemetrexed medac i za što se koristi Pemetrexed medac je lijek koji se koristi za liječenje raka.
English: ITT population (N = 1,725)
Croatian: ITT populacija (N = 1725)
English: Patients with renal impairment (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method)
Croatian: Bolesnici s oštećenjem funkcije bubrega (serumski klirens izračunat standardnom Cockcroftovom i Gaultovom formulom ili metodom mjerenja brzine glomerularne filtracije Tc99m-DPTA)
English: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤ 6 cycles: 3.3 %, > 6 cycles: 6.4 %: p = 0.046).
Croatian: Zabilježeno je značajno povećanje incidencije neutropenije stupnja 3/4, koja je mogla biti povezana s lijekom, pri duljoj izloženosti pemetreksedu (≤ 6 ciklusa: 3,3%, > 6 ciklusa: 6,4%; p = 0,046).
English: Concomitant use contraindicated: Yellow fever vaccine: risk of fatal generalised vaccine disease (see section 4.3).
Croatian: Kontraindicirana je istodobna primjena cjepiva protiv žute groznice zbog rizika od smrtonosne generalizirane vakcinalne bolesti (vidjeti dio 4.3).
English: − allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Croatian: • alergijska reakcija: ako dobijete osip na koži (vrlo često) / osjećaj pečenja ili bockanja (često) ili vrućicu (često).
English: − you have been recently vaccinated, as this can possibly cause bad effects with Pemetrexed medac.
Croatian: • ako ste nedavno cijepljeni, jer to može izazvati štetne učinke uz primjenu lijeka Pemetrexed medac.
English: Patients must also receive an intramuscular injection of vitamin B12 (1,000 µg) in the week preceding the first dose of pemetrexed and once every three cycles thereafter.
Croatian: Bolesnici moraju također primiti i intramuskularnu injekciju vitamina B12 (1000 mikrograma) u tjednu prije prve doze pemetrekseda te nakon toga jedanput svaka tri ciklusa.
English: − radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation
Croatian: • radijacijski „recall“ dermatitis (kožni osip poput teških opeklina od sunca) koji se može pojaviti na koži prethodno izloženoj zračenju, više dana ili više godina nakon zračenja.
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis)
Croatian: Obratite se liječniku ako dobijete težak osip, svrbež ili mjehuriće na koži (StevensJohnsonov sindrom ili toksična epidermalna nekroliza).
English: White to light yellow powder.
Croatian: Bijeli do svijetložuti prašak.
English: Your doctor will prescribe you steroid tablets (equivalent to 4 mg of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed medac treatment.
Croatian: Vaš liječnik će Vam propisati tablete kortikosteroida (ekvivalentne dozi deksametazona od 4 mg dvaput na dan) koje ćete morati uzeti dan prije, na sam dan i dan nakon primjene lijeka Pemetrexed medac.
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed medac.
Croatian: Morate nastaviti uzimati folatnu kiselinu još najmanje 21 dan nakon posljednje doze lijeka Pemetrexed medac.
English: − fast heart rate
Croatian: • ubrzano kucanje srca
English: The recommend dose of Pemetrexed medac is 500 mg for every square metre of your body's surface area.
Croatian: Preporučena doza lijeka Pemetrexed medac je 500 mg po svakom kvadratnom metru Vaše površine tijela.
English: A total of 213 patients (48.3 %) completed ≥ 6 cycles and a total of 103 patients (23.4 %) completed ≥ 10 cycles of treatment with pemetrexed.
Croatian: (48,3%) završilo ≥ 6 ciklusa, dok su 103 bolesnika (23,4%) završila ≥ 10 ciklusa liječenja pemetreksedom.
English: What you need to know before you use Pemetrexed medac
Croatian: Što morate znati prije nego počnete primati Pemetrexed medac
English: − if you have pain, redness, swelling or sores in your mouth (very common)
Croatian: • ako imate bolove, crvenilo, oteklinu ili ranice u ustima (vrlo često).
English: This is equivalent to 5.40% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 5,40% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Prior to each chemotherapy administration blood chemistry tests should be collected to evaluate renal and hepatic function.
Croatian: Prije svake kemoterapije moraju se provesti biokemijske pretrage krvi kako bi se ocijenila funkcija bubrega i jetre.
English: Vitamin supplementation
Croatian: Vitaminska nadoknada
English: The 1 year and 2 year survival rates for patients on pemetrexed were 58 % and 32 % respectively, compared to 45 % and 21 % for patients on placebo.
Croatian: Za bolesnike liječene pemetreksedom stopa jednogodišnjeg preživljenja iznosila je 58%, a stopa dvogodišnjeg preživljenja 32%, u usporedbi sa 45% odnosno 21% za bolesnike koji su primali placebo.
English: − allergic reaction: skin rash / burning or prickling sensation
Croatian: • alergijska reakcija: kožni osip / osjećaj pečenja ili bockanja
English: − conjunctivitis (inflamed eye)
Croatian: • konjunktivitis (upala oka)
English: − you have an accumulation of fluid around your lungs, as your doctor may decide to remove the fluid before giving you Pemetrexed medac.
Croatian: • ako imate nakupljenu tekućinu oko pluća, liječnik može odlučiti ukloniti tu tekućinu prije primjene lijeka Pemetrexed medac.
English: Treatment with pemetrexed 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.
Croatian: Liječenje pemetreksedom se mora obustaviti ako se u bolesnika pojavi bilo kakva hematološka ili nehematološka toksičnost stupnja 3 ili 4 nakon dvaju sniženja doze, odnosno odmah ako se ustanovi neurotoksičnost stupnja 3 ili 4.
English: Pemetrexed can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
Croatian: Pemetrexed medac Vam se može propisati ako imate rak pluća u uznapredovaloj fazi ako je Vaša bolest reagirala na liječenje ili ostala većim dijelom nepromijenjena nakon početne kemoterapije.
English: Women must use effective contraception during treatment with Pemetrexed medac.
Croatian: Žene moraju primjenjivati djelotvornu kontracepciju tijekom liječenja lijekom Pemetrexed medac.
English: Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section 4.2).
Croatian: Davanjem deksametazona (ili ekvivalentnog lijeka) prije početka liječenja pemetreksedom mogu se smanjiti incidencija i težina kožnih reakcija (vidjeti dio 4.2).
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „ Rok valjanosti“.
English: • HR (95 % CI) Response (n: qualified for response)
Croatian: • HR (95 % CI) Odgovor (n: broj bolesnika u kojih se mogao ocijeniti odgovor)
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10 %.
Croatian: Kratice: ALT = alanin aminotransferaza; AST = aspartat aminotransferaza; CTCAE = Zajednička terminologija za nuspojave; NCI = Nacionalni institut za rak; SGOT = serumska glutamat-oksaloctena aminotransferaza; SGPT = serumska glutamat piruvična aminotransferaza.
English: When prepared as directed, reconstituted and infusion solutions of pemetrexed contain no antimicrobial preservatives.
Croatian: Kada se pripremaju prema uputama, rekonstituirana otopina i otopina za infuziju pemetrekseda ne sadrže antimikrobne konzervanse.
English: For instructions on reconstitution and dilution of Pemetrexed medac before administration, see section 6.6.
Croatian: Za uputu o rekonstituciji i razrjeđivanju lijeka Pemetrexed medac prije primjene, vidjeti dio 6.6.
English: For precautions to be taken before handling or administering Pemetrexed medac, see section 6.6.
Croatian: Za mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Pemetrexed medac vidjeti dio 6.6.
English: What Pemetrexed medac looks like and contents of the pack Pemetrexed medac is a powder for concentrate for solution for infusion in a glass vial with rubber stopper.
Croatian: Kako Pemetrexed medac izgleda i sadržaj pakiranja Pemetrexed medac je prašak za koncentrat za otopinu za infuziju u staklenoj bočici s gumenim čepom.
English: Type I glass vial with rubber (bromobutyl rubber coated with fluoropolymer) stopper containing 100, 500 or 1,000 mg of pemetrexed.
Croatian: I s gumenim (bromobutilna guma obložena fluoropolimerom) čepom, koja sadrži 100, 500 ili 1000 mg pemetrekseda.
English: Calculate the dose and the number of Pemetrexed medac vials needed.
Croatian: Izračunajte dozu i potreban broj bočica lijeka Pemetrexed medac.
English: − If you have further questions, ask your doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: 75 % of previous dose (both pemetrexed and cisplatin)
Croatian: 75% prethodne doze (pemetrekseda i cisplatina)
English: Dose for cisplatin (mg/m²)
Croatian: Doza cisplatina (mg/m²)
English: − oedema (excess fluid in body tissue, causing swelling)
Croatian: • edem (višak tekućine u tjelesnom tkivu koji izaziva oticanje)
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 - 1,000 µg) on a daily basis.
Croatian: Bolesnici moraju svakodnevno peroralno uzimati folatnu kiselinu ili multivitaminski pripravak koji sadrži folatnu kiselinu (350 - 1000 mikrograma).
English: • HR (95 % CI)
Croatian: • medijan • HR (95 % CI)
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Croatian: Analiza osjetljivosti glavnih ishoda djelotvornosti obuhvaćala je i populaciju koja je ispunila kriterije protokola za uključenje u ispitivanje (PQ= protocol qualified).
English: Other medicines and Pemetrexed medac
Croatian: Drugi lijekovi i Pemetrexed medac
English: What Pemetrexed medac is and what it is used for What you need to know before you use Pemetrexed medac How to use Pemetrexed medac Possible side effects
Croatian: Što je Pemetrexed medac i za što se koristi Što morate znati prije nego počnete primati Pemetrexed medac
English: Less toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was administered.
Croatian: Manja toksičnost te smanjenje hematološka i nehematološka toksičnost stupnja 3/4, poput neutropenije, febrilne neutropenije i infekcija praćenih neutropenijom stupnja ¾ prijavljene su kada je primijenjeno prethodno liječenje folatnom kiselinom i vitaminom B12.
English: − blood clots in the lung blood vessels (pulmonary embolism)
Croatian: • krvni ugrušci u krvnim žilama u plućima (plućna embolija)
English: When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature (2 °C - 8 °C).
Croatian: Kada se pripreme prema uputama, rekonstituirana otopina pemetrekseda i otopina pemetrekseda za infuziju su fizikalno i kemijski stabilne 24 sata ako se čuvaju u hladnjaku (2 °C - 8 °C).
English: Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
Croatian: Žene u reproduktivnoj dobi dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja pemetreksedom (vidjeti dio 4.6).
English: The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N = 519), and compared to patients who received > 6 cycles of pemetrexed (N = 281).
Croatian: Incidencija nuspojava ocijenjena je u bolesnika koji su primili ≤ 6 ciklusa pemetrekseda kao terapije održavanja (N = 519) te je uspoređena s bolesnicima koji su primili > 6 ciklusa pemetrekseda (N = 281).
English: Synthon Hispania SL C/Castelló n°1, Pol. Las Salinas 08830 Sant Boi de Llobregat Barcelona
Croatian: Las Salinas, Sant Boi de Llobregat 08830 Barcelona, Španjolska