FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 2 mg prucalopride (as succinate).
Slovenian: Ena filmsko obložena tableta vsebuje 2 mg prukaloprida (v obliki sukcinata).
English: Each film-coated tablet contains 2 mg prucalopride (as succinate)
Slovenian: Ena filmsko obložena tableta vsebuje 2 mg prukaloprida (v obliki sukcinata)
English: Pollakiuria
Slovenian: Plodnost
English: EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/002 (28 tablets) EU/1/09/581/008 (84 tablets)
Slovenian: EU/1/09/581/004 (7 tablet) EU/1/09/581/006 (14 tablet) EU/1/09/581/002 (28 tablet) EU/1/09/581/008 (84 tablet)
English: OTHER
Slovenian: A.
English: Very common
Slovenian: Pogosti omotica
English: EU/1/09/581/002 (28 tablets) EU/1/09/581/004 (7 tablets) EU/1/09/581/006 (14 tablets) EU/1/09/581/008 (84 tablets)
Slovenian: EU/1/09/581/002 (28 tablet) EU/1/09/581/004 (7 tablet) EU/1/09/581/006 (14 tablet) EU/1/09/581/008 (84 tablet)
English: EU/1/09/581/001 (28 tablets) EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/007 (84 tablets)
Slovenian: EU/1/09/581/001 (28 tablet) EU/1/09/581/003 (7 tablet) EU/1/09/581/005 (14 tablet) EU/1/09/581/007 (84 tablet)
English: How to store Resolor
Slovenian: Shranjevanje zdravila Resolor
English: EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/001 (28 tablets) EU/1/09/581/007 (84 tablets)
Slovenian: EU/1/09/581/003 (7 tablet) EU/1/09/581/005 (14 tablet) EU/1/09/581/001 (28 tablet) EU/1/09/581/007 (84 tablet)
English: Do not take Resolor: - if you are allergic to prucalopride or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Resolor: - če ste alergični na prukaloprid ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste na dializi, - če imate perforacijo ali obstrukcijo črevesne stene, hudo vnetje črevesa, kot so Crohnova bolezen, ulcerativni kolitis in toksični megakolon/megarektum.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE
English: 10 bottles Zero days
Slovenian: 10 vialami Nič dni.
English: An updated version of the Risk Management Plan will be submitted to National Competent Authorities within 3 months of the Commission Decision for this procedure, to reflect the updated information on the paediatric population as agreed by CHMP.
Slovenian: Posodobljena različica načrta za obvladovanje tveganja, ki odraža posodobljene informacije glede pediatrične populacije, kot je bilo dogovorjeno s CHMP, bo predložena pristojnim nacionalnim organom v roku 3 mesecev od sklepa Evropske komisije za ta postopek.
English: National Competent Authorities (NCAs), coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders (MAHs):
Slovenian: Nacionalni pristojni organi, ki jih koordinira referenčna država članica, kjer je to možno, bodo zagotovili, da bodo imetniki dovoljenja za promet z zdravilom izpolnili naslednje pogoje:
English: Conditions of the marketing authorisations
Slovenian: Pogoji dovoljenja za promet z zdravilom
English: The overall response rate was 14.1%.
Slovenian: Skupna stopnja odziva je bila 14,1 %.
English: Pack of 1 vial is available in a box.
Slovenian: Na voljo je pakiranje z 1 vialo v škatli.
English: Response (n: qualified for response)
Slovenian: Odziv (n: ustrezen za odziv)
English: *Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Slovenian: *Definicija pogostnosti: zelo pogosto (> 10 %); pogosto (> 5 % in < 10 %).
English: ITT population and histology subgroups
Slovenian: Populacija NZ in histološke podskupine
English: This is equivalent to 2.7% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 2,7 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: *p-value refers to comparison between arms.
Slovenian: *Vrednost p se nanaša na primerjavo med vejama zdravljenja.
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, se posvetujte z zdravnikom.
English: Based on the planned date of your infusion of Pemetrexed Krka 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 Krka in/ali glede na delovanje vaših ledvic vam mora zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
English: Each box contains one vial.
Slovenian: V vsaki škatli je ena viala.
English: Randomised and treated patients
Slovenian: Randomizirani in zdravljeni bolniki
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) - Not known (cannot be estimated from the available data)
Slovenian: Ocena pogostnosti: - zelo pogosti (≥ 1/10), - pogosti (≥ 1/100 do < 1/10), - občasni (≥ 1/1.000 do < 1/100), - redki (≥ 1/10.000 do < 1/1.000), - zelo redki (< 1/10.000), - neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The reporting rates shown are according to CTCAE version 3.0.
Slovenian: Prikazana pogostnost navedb je skladna s CTCAE (verzija 3.0).
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 z zdravilom Pemetreksed Krka za vse skupine pediatrične populacije za odobrene indikacije (glejte poglavje 4.2).
English: The total bilirubin should be ≤ 1.5-times upper limit of normal.
Slovenian: Celotni bilirubin mora biti  1,5-kratnik zgornje meje normalnih vrednosti.
English: *p-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test.
Slovenian: *Vrednosti p < 0,05 pri primerjavi pemetrekseda/cisplatina in gemcitabina/cisplatina z uporabo Fisherjevega natančnega testa (Fisher Exact test).
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Slovenian: Okrajšave: ALT = alaninska aminotransferaza; AST = aspartatna aminotransferaza; CTCAE = skupna merila za terminologijo neželenih učinkov (Common Terminology Criteria for Adverse Events); NCI = Nacionalni inštitut za rakava obolenja; SGOT = serumska glutamat oksalocetna aminotransferaza; SGPT = serumska glutamat piruvična aminotransferaza.
English: Do not use Pemetrexed Krka - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Pemetreksed Krka: - če ste alergični na pemetreksed ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Date of first authorisation: 22.
Slovenian: Datum prve odobritve: 22. maj 2018
English: There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other antimetabolites, is suspected to cause serious birth defects when administered during pregnancy.
Slovenian: Podatkov o uporabi pemetrekseda pri nosečnicah ni, a za pemetreksed, kot za druge anti-metabolite, sumimo, da povzroča resne prirojene okvare, če ga dajemo med nosečnostjo.
English: KRKA Farmacêutica, Sociedade Unipessoal Lda.
Slovenian: Portugal KRKA Farmacêutica, Sociedade Unipessoal Lda.
English: Driving and using machines Pemetrexed Krka may make you feel tired.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pemetreksed Krka lahko povzroči, da se boste počutili utrujene.
English: Calculate the dose and the number of Pemetrexed Krka vials needed.
Slovenian: Izračunajte odmerek in število potrebnih vial zdravila Pemetreksed Krka.
English: Pemetrexed + Cisplatin Gemcitabine + Cisplatin
Slovenian: Pemetreksed + cisplatin Gemcitabin + cisplatin
English: ** which is derived from the term “renal/genitourinary other”.
Slovenian: **Izhaja iz izraza “ledvice/sečila drugo”.
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be ≤ 3-times upper limit of normal.
Slovenian: Alkalna fosfataza (AF), aspartatna aminotransferaza (AST ali SGOT) in alaninska aminotransferaza (ALT ali SGPT) morajo biti  3-kratnik zgornje meje normalnih vrednosti.
English: See section 2 "Pemetrexed Krka contains sodium".
Slovenian: Glejte poglavje 2 "Zdravilo Pemetreksed Krka vsebuje natrij".
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Krka during pregnancy.
Slovenian: Z zdravnikom se pogovorite o možnem tveganju pri prejemanju zdravila Pemetreksed Krka v času nosečnosti.
English: Patients must also receive an intramuscular injection of vitamin B12 (1,000 micrograms) in the week preceding the first dose of pemetrexed and once every three cycles thereafter.
Slovenian: Bolniki morajo prejeti tudi intramuskularno injekcijo vitamina B12 (1.000 mikrogramov) v tednu pred prvim odmerkom pemetrekseda in enkrat vsake tri cikle zatem.
English: 75% of previous dose
Slovenian: 75 % predhodnega odmerka 75 % predhodnega odmerka
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 Krka.
Slovenian: Pred vsako infuzijo vam bomo odvzeli vzorce krvi za vrednotenje delovanja vaših ledvic in jeter ter oceno, ali imate dovolj krvnih celic za prejemanje zdravila Pemetreksed Krka.
English: Of the randomised patients, 44.9% had a complete/partial response and 51.9% had a response of stable disease to pemetrexed plus cisplatin induction.
Slovenian: Izmed naključno izbranih bolnikov jih je 44,9 % doseglo popoln/delen odziv in 51,9 % jih je doseglo odziv stabilne bolezni na pemtreksed in indukcijsko zdravilo cisplatina.
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), analogi folne kisline, oznaka ATC: L01BA04.
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Slovenian: Analiza primarne učinkovitosti je bila osnovana na populaciji NZ. Analize občutljivosti glavnih končnih točk učinkovitosti so ocenili tudi pri s protokolom kvalificirani (PK) populaciji.
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the pemetrexed arm versus 21.7% on the placebo arm.
Slovenian: V času te končne analize preživetja je bilo živih ali ni bilo na voljo za nadaljnje spremljanje 28,7 % bolnikov v kraku s pemetreksedom v primerjavi z 21,7 % v kraku s placebom.
English: Upon recovery, patients should be re-treated using the guidelines in Tables 1, 2, and 3, which are applicable for Pemetrexed Krka used as a single agent or in combination with cisplatin.
Slovenian: Po okrevanju bolnike ponovno zdravimo z uporabo smernic v Preglednicah 1, 2 in 3, ki veljajo za zdravilo Pemetreksed Krka, če jo uporabljamo kot edino učinkovino ali v kombinaciji s cisplatinom.
English: Chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at 2°C to 8°C (and 25°C).
Slovenian: Po pripravi je kemijska in fizikalna uporabnost rekonstituiranih raztopin pemetrekseda in raztopin pemetrekseda za infundiranje 24 ur pri temperaturi 2 °C do 8 °C (in 25 °C).
English: **In the pemetrexed/cisplatin arm, randomized and treated (N=225) and fully supplemented (N=167).
Slovenian: **V veji zdravljenja s pemetreksidom/cisplatinom, randomizirani in zdravljeni (N = 225) ter s popolnim dopolnjevanjem (N = 167).
English: The dose of Pemetrexed Krka is 500 milligrams for every square metre of your body's surface area.
Slovenian: Odmerek zdravila Pemetreksed Krka je 500 miligramov za vsak kvadratni meter površine vašega telesa.
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm
Slovenian: Pred začetkom kateregakoli cikla kemoterapije morajo bolniki izpolnjevati naslednja merila: absolutno število nevtrofilcev (ANC) mora biti  1500 celic/mm
English: ****Combined term includes increased serum/blood creatinine, decreased glomerular filtration rate, renal failure and renal/genitourinary- other.
Slovenian: ****Skupni izraz vključuje povišan kreatinin v serumu/krvi, znižano stopnjo glomerulne filtracije, ledvično odpoved in ledvice/sečila - drugo.
English: a Statistically significant for non-inferiority, with the entire confidence interval for HR well below the 1.17645 non-inferiority margin (p < 0.001).
Slovenian: Statistično pomembna za prednost, s celotnim intervalom zaupanja za RT znatno pod mejo prednosti 1,17645 (p < 0,001).
English: What Pemetrexed Krka is and what it is used for
Slovenian: Kaj je zdravilo Pemetreksed Krka in za kaj ga uporabljamo
English: You will always receive Pemetrexed Krka by infusion into one of your veins.
Slovenian: Zdravilo Pemetreksed Krka boste vedno prejeli v obliki infuzije v veno.
English: If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive Pemetrexed Krka.
Slovenian: Če imate ali ste imeli težave z ledvicami, se pogovorite z zdravnikom ali bolnišničnim farmacevtom, ker morda ne boste mogli prejeti zdravila Pemetreksed Krka.
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Pemetrexed Krka.
Slovenian: Če se vam okrog pljuč nabira tekočina, se bo zdravnik morda odločil tekočino pred dajanjem zdravila Pemetreksed Krka odstraniti.
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).
Slovenian: Znatno povečanje pojavnosti nevtropenije stopnje 3/4, ki je lahko povezano s preučevanim zdravilom, so opazili pri dolgotrajnejši izpostavljenosti pemetreksedu (≤ 6 ciklov: 3,3 %, > 6 ciklov: 6,4 %: p = 0,046).
English: All patients included in this study had an ECOG performance status 0 or 1.
Slovenian: Vsi bolniki, vključeni v to študijo, so imeli stanje zmogljivosti po ECOG 0 ali 1.
English: You must contact your doctor immediately if you notice any of the following: - 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).
Slovenian: Če opazite katerega od spodaj naštetih učinkov, morate nemudoma poklicati zdravnika: - Povišana telesna temperatura ali okužba (pogosto): če se pojavi temperatura 38 ºC ali višja, znojenje ali drugi znaki okužbe (ker imate lahko manj belih krvničk kot normalno, kar je zelo pogosto).
English: It is a white to either light yellow or green yellow lyophilized cake or powder.
Slovenian: Je bela do bodisi svetlo rumena ali zeleno rumena liofilizirana pogača ali prašek.
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Pemetrexed Krka.
Slovenian: Če ste bili nedavno cepljeni, prosimo, povejte to zdravniku saj lahko to ob jemanju zdravila Pemetreksed Krka povzroča škodljive učinke.
English: What Pemetrexed Krka is and what it is used for What you need to know before you use Pemetrexed Krka How to use Pemetrexed Krka Possible side effects
Slovenian: Kaj je zdravilo Pemetreksed Krka in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Pemetreksed Krka Kako uporabljati zdravilo Pemetreksed Krka Možni neželeni učinki
English: a
Slovenian: I
English: Frequency Event*
Slovenian: Pogostnost Dogodek*
English: Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Krka treatment.
Slovenian: Kortikosteroidi: zdravnik vam bo predpisal tablete steroidov (ustrezno 4 miligramom deksametazona dvakrat dnevno), ki jih boste morali jemati dan pred zdravljenjem z zdravilom Pemetreksed Krka, na dan zdravljenja in na dan po zdravljenju z zdravilom Pemetreksed Krka.
English: VIAL LABEL
Slovenian: ETIKETA ZA VIALO
English: ***Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
Slovenian: ***Skupna preglednica neželenih učinkov združuje rezultate študije vzdrževalnega zdravljenja s pemetreksedom JMEN (N = 663) in študije nadaljevalnega vzdrževalnega zdravljenja s pemetreksedom PARAMOUNT (N = 539).
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).
Slovenian: Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N = 519) in jo primerjali z bolniki, ki so prejeli > 6 ciklov pemetrekseda (N = 281).
English: Use an inactivated vaccine where it exists (poliomyelitis) (see section
Slovenian: Uporabite inaktivirano cepivo, če to obstaja (poliomielitis) (glejte poglavje 4.4).
English: Treatment with Pemetrexed Krka 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.
Slovenian: Zdravljenje z zdravilom Pemetreksed Krka moramo prekiniti, če bolnik izkusi kakršnokoli hematološko ali nehematološko toksičnost stopnje 3 ali 4 po 2 znižanjih odmerka ali nemudoma, če opazimo nevrološko toksičnost stopnje 3 ali 4.
English: Patients randomised to maintenance treatment were required to have an ECOG performance status 0 or 1.
Slovenian: Bolniki, ki so bili naključno izbrani za vzdrževalno zdravljenje, so morali imeti stanje zmogljivosti po ECOG 0 ali 1.
English: 3 and platelets should be ≥ 100,000 cells/mm Creatinine clearance should be ≥ 45 ml/min.
Slovenian:  100.000 celic/mm Očistek kreatinina mora biti  45 ml/min.
English: Children and adolescents There is no relevant use of Pemetrexed Krka in the paediatric population
Slovenian: Otroci in mladostniki Zdravilo Pemetreksed Krka ni primerno za uporabo pri pediatrični populaciji.
English: • Response rate (%) (95% CI)
Slovenian: • Stopnja odziva (%) (95 % IZ)
English: These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/or abnormal baseline liver function tests.
Slovenian: Te razlike so bile verjetno posledica različnih populacij bolnikov, saj so v študijah faze 2 sodelovali bolniki, ki še niso prejemali kemoterapije, in tudi bolnice s karcinomom dojke, ki so v preteklosti prejemale kemoterapijo, s predhodno obstoječimi zasevki v jetrih in/ali nenormalnimi izhodiščnimi vrednostmi testov jetrnega delovanja.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Krka has finished.
Slovenian: Cisplatin tudi dajemo v obliki infuzije v veno, približno 30 minut po zaključku infuzije zdravila Pemetreksed Krka.
English: Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Krka and should therefore use effective contraception during treatment with Pemetrexed Krka and for up to 6 months afterwards.
Slovenian: Moškim odsvetujemo, da bi v času zdravljenja z zdravilom Pemetreksed Krka ter do 6 mesecev po zdravljenju s tem zdravilom spočeli otroka, zato naj v času zdravljenja z zdravilom Pemetreksed Krka ter do 6 mesecev po zdravljenju s tem zdravilom uporabljajo učinkovito kontracepcijo.
English: Pemetrexed Krka 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.
Slovenian: Zdravnik vam lahko predpiše zdravilo Pemetreksed Krka, če imate pljučni rak v napredovalem stadiju in če se vaša bolezen odziva na zdravljenje oz. če po začetni kemoterapiji ostaja večinoma nespremenjena.
English: Efficacy of pemetrexed vs. docetaxel in NSCLC - ITT population
Slovenian: Učinkovitost pemetrekseda v primerjavi z docetakselom pri NSCLC - populacija NZ
English: 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/mm
Slovenian: Pri bolnikih moramo biti med zdravljenjem pozorni na morebiten pojav mielosupresije, pemetrekseda pa bolnikom ne smemo dajati, dokler se absolutno število nevtrofilcev (ANC) ne povrne na  1.500 celic/mm
English: ITT population (N=1725)
Slovenian: Populacija NZ (N = 1725)
English: A Phase 2 study of pemetrexed in 31 solid tumour patients with stable third-space fluid demonstrated no difference in pemetrexed dose normalized plasma concentrations or clearance compared to patients without third-space fluid collections.
Slovenian: V študiji pemetrekseda so v fazi II pri 31 bolnikih s solidnim tumorjem in stabilno tekočino tretjega prostora pokazali, da ni razlike med normalno koncentracijo v plazmi ali očistkom, doseženo glede na odmerek pemetrekseda, v primerjavi z bolniki brez zaloge tekočine tretjega prostora.
English: What you need to know before you use Pemetrexed Krka
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Pemetreksed Krka
English: Excipient with known effect Each vial contains approximately 11 mg (0.48 mmol) sodium.
Slovenian: Pomožna snov z znanim učinkom: Ena viala vsebuje približno 11 mg (0,48 mmol) natrija.
English: - If you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon) (may indicate a blood clot in the blood vessels of the lungs).
Slovenian: - Če doživite nenadno težko dihanje, močno bolečino v prsih ali kašelj s krvavim izmečkom (občasno) (lahko kaže na krvni strdek v krvnih žilah v pljučih).
English: 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).
Slovenian: Klinično pomembne laboratorijske toksičnosti stopenj 3 in 4 so bile podobne pri integriranih rezultatih faze 2 treh študij pemetrekseda kot edine učinkovine (N = 164) in faze 3 študije pemetrekseda kot edine učinkovine, opisane zgoraj, z izjemo nevtropenije (12,8 % oziroma 5,3 %) in povišanja alaninske aminotransferaze (15,2 % oziroma 1,9 %).
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking Pemetrexed Krka.
Slovenian: Dopolnjevanje vitaminov: zdravnik vam bo predpisal peroralno folno kislino (vitamin) ali multivitaminski pripravek, ki jo vsebuje (350 do 1000 mikrogramov), ki ga boste morali med prejemanjem zdravila Pemetreksed Krka jemati enkrat dnevno.
English: 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.
Slovenian: Priporočeni odmerek cisplatina je 75 mg/m2 TP, infundiran v dveh urah približno 30 minut po zaključku infuzije pemetrekseda prvi dan vsakega 21-dnevnega cikla.