FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore concluded that the benefits of Galantamine Stada do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Slovenian: Odbor CHMP je zato sklenil, da koristi zdravila Galantamine Stada ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z zdravilom v zadevnih državah članicah ne odobri.
English: Galantamine Stada is a generic medicine based on a ‘reference medicine', Reminyl.
Slovenian: Galantamine Stada je generično zdravilo, ki temelji na „referenčnem zdravilu“, zdravilu Reminyl.
English: By blocking this enzyme, galantamine allows levels of acetylcholine to be increased in the parts of the brain associated with intellectual function.
Slovenian: Z zaviranjem tega encima galantamin omogoči dvig ravni acetilholina v tistih delih možganov, ki so povezani z intelektualnimi sposobnostmi.
English: What is Galantamine Stada?
Slovenian: Kaj je zdravilo Galantamine Stada?
English: The grounds for the referral were that bioequivalence studies, to show that Galantamine Stada produces the same levels of active substance in the body as Reminil, had not been conclusive.
Slovenian: Razlog za napotitev je bilo dejstvo, da študije bioekvivalence, ki naj bi dokazale, da zdravilo Galantamine Stada ustvari enake koncentracije zdravilne učinkovine v telesu kot zdravilo Reminyl, niso bile prepričljive.
English: In patients with Alzheimer's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).Galantamine works by blocking acetylcholinesterase, an enzyme that breaks down acetylcholine.
Slovenian: Pri bolnikih z Alzheimerjevo boleznijo nekatere živčne celice v možganih odmrejo, kar se odraža v nizkih ravneh živčnega prenašalca acetilholina (kemične snovi, ki omogoča medsebojno komunikacijo živčnih celic).
English: Galantamine Stada is a medicine that contains the active substance galantamine.
Slovenian: Galantamine Stada je zdravilo, ki vsebuje zdravilno učinkovino galantamin.
English: EMA/83112/2012
Slovenian: Vprašanja in odgovori o zdravilu Galantamine Stada in povezanih imenih (galantamin 8, 16 in 24 mg tablete s podaljšanim sproščanjem) EMA/83112/2012
English: The Safety Information Communication should contain the following:
Slovenian: Dopis o varnostnih informacijah mora vsebovati:
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Topotecan Eagle are provided with a Safety Information Communication.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob začetku trženja zdravila vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali in/ali predpisovali zdravilo Topotekan Eagle, prejeli dopis o varnostnih informacijah.
English: The anticipated effects of overdose (e.g. bone marrow suppression).
Slovenian: • pričakovane učinke prevelikega odmerjanja (npr. supresija kostnega mozga);
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of a Safety Information Communication with the national competent authority, including the need and the timing of any follow-up Safety Communication Information, as well as the distribution list of such information.
Slovenian: Imetnik dovoljenja za promet z zdravilom se bo, preden da zdravilo v promet, v vsaki državi članici s pristojnim nacionalnim organom dogovoril o vsebini in obliki dopisa o varnostnih informacijah, vključno s potrebo po morebitnih naknadnih dopisih o varnostnih informacijah in njihovo časovno uskladitvijo ter seznamom prejemnikov tega dopisa.
English: The risk of medication error due to the higher concentration than the dilution concentration of the originator, with potentially life-threatening consequences.
Slovenian: • navedbe glede tveganja za napačno zdravljenje zaradi večje koncentracije v primerjavi z razredčeno koncentracijo originatorskega zdravila, z možnimi življenjsko nevarnimi
English: Reference to the vial collar as visual reminder of this difference and the instruction that it must
Slovenian: • sklic na obroček na viali kot vidni opomnik te razlike ter navodilo, da se ga ne sme nikoli
English: An encouragement of reporting of actual medication errors and any safety events that might be
Slovenian: • spodbudo k poročanju o dejanskih napakah pri zdravljenju ter vseh varnostnih ukrepih, ki bi bili lahko posledica napake pri zdravljenju;
English: Annex
Slovenian: DODATEK
English: • Information on crisis or infections
Slovenian: • Informacije pri krizi ali okužbi
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
English: • Key signs and symptoms of serious adverse reactions
Slovenian: • Bistvene znake in simptome resnih neželenih učinkov
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, opisanimi v nadaljevanju:
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo pred sprostitvijo vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Siklos, dobili informacije za zdravnika, ki bodo vsebovale naslednje:
English: • Information on growth follow-up of treated children for their parents
Slovenian: • Informacije o spremljanju rasti zdravljenih otrok za njihove starše
English: • When to seek urgent attention from the health care provider
Slovenian: • Kdaj poiskati nujno zdravstveno pomoč
English: • Need for periodic blood counts and dose adjustment
Slovenian: • Zahteva po periodičnem preverjanju krvne slike in prilagoditvi odmerka
English: • Growth follow-up of treated children
Slovenian: • Spremljanje rasti zdravljenih otrok
English: • Need for periodic blood counts
Slovenian: • Potreba po periodičnem preverjanju krvne slike
English: • Patient information pack
Slovenian: • Informativni komplet za bolnika
English: The treatment guide for physicians should contain the following key elements:
Slovenian: Vodnik za zdravljenje za zdravnika mora vsebovati:
English: The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Slovenian: Pred prihodom zdravila na tržišče v vsaki državi članici se bo imetnik dovoljenja za promet dogovoril glede vsebine in oblike izobraževalnega gradiva z nacionalnim organom, pristojnim za zdravila.
English: • Management of adverse drug reactions
Slovenian: • Načrt upravljanja z neželenimi učinki zdravila
English: • Treatment guide for physicians
Slovenian: • Vodnik za zdravljenje za zdravnika
English: This summary was last updated in 02-2016.
Slovenian: Povzetek je bil nazadnje posodobljen 06-2015.
English: The full EPAR for Clopidogrel Teva Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel HCS je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: • peripheral arterial disease (problems with blood flow in the arteries);
Slovenian: • bolnikom s periferno arterijsko boleznijo (težavami s pretokom krvi v arterijah);
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Teva Pharma is used together with aspirin, the dose of which should not be higher than 100 mg.
Slovenian: Pri akutnem koronarnem sindromu in atrijski fibrilaciji se zdravilo Clopidogrel HCS uporablja skupaj z aspirinom, katerega odmerek ne sme biti višji od 100 mg.
English: The standard dose of Clopidogrel Teva Pharma is one 75-mg tablet once a day.
Slovenian: Običajni odmerek zdravila Clopidogrel HCS je ena 75-miligramska tableta enkrat dnevno.
English: This means that Clopidogrel Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
English: For more information about treatment with Clopidogrel Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Clopidogrel HCS preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: • recently had a myocardial infarction (heart attack).
Slovenian: • bolnikom, ki so nedavno doživeli miokardni infarkt (srčni napad).
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST-segment-elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Slovenian: Temu sledi običajni 75-miligramski odmerek enkrat na dan za najmanj štiri tedne (pri miokardnem infarktu z elevacijo spojnice ST) ali največ 12 mesecev (pri nestabilni angini pektoris ali pri miokardnem infarktu brez zobca Q).
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Slovenian: Uporablja se pri bolnikih, ki imajo vsaj en dejavnik tveganja za dogodke, kot so srčni napad ali kap, ki ne smejo jemati antagonistov vitamina K (drugih zdravil, ki preprečujejo krvne strdke) in pri katerih je tveganje za krvavitve majhno.
English: Clopidogrel Teva Pharma can be started between a few days and 35 days after the attack;
Slovenian: Zdravilo se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Teva Pharma.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel HCS.
English: Because Clopidogrel Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Clopidogrel HCS generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Teva Pharma.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel HCS, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What are the benefit and risk of Clopidogrel Teva Pharma?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel HCS?
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel HCS primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Slovenian: • bolnikom z atrijsko fibrilacijo (nerednim hitrim krčenjem srčnih preddvorov), pri katerih se mora dajati skupaj z aspirinom.
English: Because Clopidogrel Teva Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Slovenian: Ker je zdravilo Clopidogrel HCS generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
English: In acute coronary syndrome, treatment generally starts with a loading dose of four 75-mg tablets.
Slovenian: Pri akutnem koronarnem sindromu se zdravljenje načeloma uvede z udarnim odmerkom štirih tablet.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel HCS on 21 September 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel HCS, veljavno po vsej Evropski uniji, izdala 28. oktobra 2010.
English: Clopidogrel Teva Pharma can be started between seven days and six months after the stroke;
Slovenian: Zdravilo se lahko začne jemati od sedem dni po kapi do šest mesecev po njej;
English: Clopidogrel Teva Pharma is used to prevent problems caused by blood clots in adults who have:
Slovenian: Zdravilo Clopidogrel HCS se uporablja pri odraslih za preprečevanje težav, ki jih povzročajo krvni strdki.
English: The Committee recommended that Clopidogrel Teva Pharma be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Clopidogrel HCS izda dovoljenje za promet.
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Slovenian: Clopidogrel HCS je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
English: The active substance in Clopidogrel Teva Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Clopidogrel HCS, klopidogrel, je zaviralec agregacije trombocitov.
English: Why has Clopidogrel Teva Pharma been approved?
Slovenian: Zakaj je bilo zdravilo Clopidogrel HCS odobreno?
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Slovenian: • bolnikom, ki so nedavno doživeli ishemično kap (kap, ki jo povzroči prekinitev dotoka krvi v del možganov).
English: 1 Previously known as Clopidogrel HCS.
Slovenian: Clopidogrel HCS
English: Clopidogrel Teva Pharma is a ‘generic medicine'.
Slovenian: Zdravilo Clopidogrel HCS je generično zdravilo.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Slovenian: • bolnikom z akutnim koronarnim sindromom (bolezenskim stanjem, za katerega je značilen zmanjšan dotok krvi v srce) , pri katerih se mora zdravilo dajati skupaj z aspirinom (drugim zdravilom za preprečevanje krvnih strdkov), vključno z bolniki, ki jim je bil vstavljen stent (kratka cevka, nameščena v arteriji, da prepreči njeno zamašitev).
English: Other information about Clopidogrel Teva Pharma:
Slovenian: Druge informacije o zdravilu Clopidogrel HCS
English: Clopidogrel Teva Pharma clopidogrel
Slovenian: klopidogrel
English: What is Clopidogrel Teva Pharma used for?
Slovenian: Za kaj se zdravilo Clopidogrel HCS uporablja?
English: How has Clopidogrel Teva Pharma been studied?
Slovenian: Kako je bilo zdravilo Clopidogrel HCS raziskano?
English: How does Clopidogrel Teva Pharma work?
Slovenian: Kako zdravilo Clopidogrel HCS deluje?
English: How is Clopidogrel Teva Pharma used?
Slovenian: Kako se zdravilo Clopidogrel HCS uporablja?
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Slovenian: Lahko se uporablja tudi pri bolnikih, ki nimajo nenormalnega zapisa na EKG, če imajo nestabilno angino pektoris (hudo obliko bolečine v prsih) ali so doživeli miokardni infarkt brez zobca Q.
English: What is Clopidogrel Teva Pharma?
Slovenian: Kaj je zdravilo Clopidogrel HCS?
English: Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Slovenian: Bolnike je treba med zdravljenjem skrbno nadzorovati glede morebitnega pojava resnih ali oportunističnih okužb.
English: Adopted at the 2-5 May 2017 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 2. in 5. majem 2017
English: Brentuximab vedotin - Cytomegalovirus (CMV) reactivation (EPITT no 18789)
Slovenian: Brentuksimab vedotin - reaktivacija citomegalovirusa (CMV) (EPITT št. 18789)
English: Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes) and herpes zoster, Cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with brentuximab vedotin.
Slovenian: Pri bolnikih, ki so prejemali brentuksimab vedotin, so poročali o resnih okužbah, kot so pljučnica, stafilokokna bakteriemija, sepsa/septični šok (vključno s smrtnim izidom) in herpes zoster, okužbi s citomegalovirusom (CMV) (reaktivaciji), ter o oportunističnih okužbah, kot sta pljučnica, ki jo povzroča Pneumocystis jiroveci, in ustna kandidiaza.
English: Uncommon side effects (affects less than 1 in 100 people) - new or recurring cytomegalovirus (CMV) infection
Slovenian: Občasni (pojavijo se pri manj kot 1 osebi od 100): - nova ali ponavljajoča se okužba s citomegalovirusom (CMV)
English: Frequency ‘uncommon': Cytomegalovirus infection or reactivation
Slovenian: Pogostnost „občasna“: Okužba s citomegalovirusom ali reaktivacija okužbe stran 2/2
English: Date of first authorisation: 18 September 2015
Slovenian: Datum pridobitve dovoljenja za promet: 18. september 2015
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča mora biti raztopina uporabljena takoj.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Tega zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
English: • Infection including sepsis
Slovenian: • Okužba vključno s sepso
English: Not known: frequency cannot be estimated from the available data
Slovenian: Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: *Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Slovenian: *Definicija pogostnosti: Zelo pogosto - ≥ 10 %; Pogosto - > 5 % in < 10 %.
English: Between-patient variability in clearance is moderate at 19.3 %.
Slovenian: Variabilnost med bolniki v očistku je zmerna, 19,3 %.
English: Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe tega zdravila, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: Zahteve za predložitev redno posodobljenih poročil o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, to povejte svojemu zdravniku.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Vse neporabljeno zdravilo ali odpadke je treba zavreči v skladu z lokalnimi zahtevami.
English: It is not known whether pemetrexed is excreted in human milk, and adverse reactions on the suckling child cannot be excluded.
Slovenian: Ni znano, ali se pemetreksed izloča v materino mleko, in neželenih reakcij za dojenčka ne moremo izključiti.
English: Elderly: In clinical studies, there has been no indication that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Slovenian: Starejši: V kliničnih študijah ni kazalo, da bi bili bolniki, stari 65 let ali več, bolj izpostavljeni tveganju za neželene učinke v primerjavi z bolniki, mlajšimi od 65 let.
English: 1526 Ljubljana Slovenia
Slovenian: 1526 Ljubljana Slovenija
English: Your doctor will use this body surface area to work out the right dose for you.
Slovenian: Vaš zdravnik bo uporabil to izračunano površino vašega telesa za določitev pravega odmerka za vas.
English: Based on the planned date of your infusion of Pemetrexed Sandoz 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.
Slovenian: Na podlagi načrtovanega datuma vaše infuzije zdravila Pemetreksed Sandoz in/ali glede na delovanje vaših ledvic, vam mora vaš zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
English: 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.
Slovenian: Če ni uporabljena takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik in to običajno ne sme biti dlje kot 24 ur pri temperaturi od 2 °C do 8 °C, razen če je rekonstitucija/redčenje potekalo v nadzorovanih in preverjeno aseptičnih pogojih.
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Slovenian: Pogostnosti so določene kot: zelo pogosto (≥1/10), pogosto ( 1/100 do < 1/10), občasno (≥1/1000 do < 1/100), redko (≥1/10.000 do < 1/1000), zelo redko (<1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
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).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s pemetreksedom za vse skupine pediatrične populacije za odobrene indikacije (glejte poglavje 4.2).
English: Pack of 1 vial with protective plastic overwrap.
Slovenian: Pakiranje z 1 vialo z zaščitnim plastičnim ovojem.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovernega za sprostitev zadevne serije.
English: The total bilirubin should be ≤ 1.5 times upper limit of normal.
Slovenian: Celotni bilirubin mora biti  1,5-kratnika zgornje meje normalnih vrednosti.
English: If you have heart disease or a history of heart disease, please tell your doctor.
Slovenian: Če imate bolezen srca ali če ste v preteklosti imeli bolezen srca, prosimo, povejte to svojemu zdravniku.
English: Do not use after the expiry date which is shown on the carton and label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake EXP.
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.
Slovenian: Stopnji preživetja pri 1 in pri 2 letih pri bolnikih, ki so prejemali pemetreksed sta bili 58 % in 32 %, v primerjavi s 45 % in 21 % pri bolnikih, ki so prejemali placebo.