FrancophonIA/ELRC3.0 huggingface dataset:
English: The threshold for the elevated AFP study entry requirement for REACH-2 was determined based on the survival results from a pre-specified subgroup, exploratory analysis from REACH, a previously completed, supportive phase 3 clinical study in 565 HCC patients randomised (1:1) to either Cyramza plus BSC or placebo plus BSC that had disease progression on or after prior sorafenib therapy.
Slovenian: Meja za zahtevano zvišano vrednost AFP ob vstopu v študijo REACH-2 je bila določena glede na rezultate preživetja pri predhodno opredeljeni podskupini z eksplorativno analizo v študiji REACH, predhodno opravljeni podporni klinični študiji 3. faze pri 565 bolnikih s hepatocelularnim karcinomom, randomiziranih (1 : 1) na zdravilo Cyramza in najboljše podporno zdravljenje ali placebo in najboljše podporno zdravljenje, pri katerih je bolezen napredovala ob ali po predhodnem zdravljenju s sorafenibom.
English: Branchburg New Jersey NJ 08876
Slovenian: ImClone Systems LLC 33 ImClone Drive, Branchburg New Jersey NJ 08876
English: Efficacy results are shown in Table 8.
Slovenian: Rezultati učinkovitosti so prikazani v Tabeli 8.
English: Table 9: Summary of efficacy data - ITT population
Slovenian: Tabela 10: Povzetek podatkov o učinkovitosti - ITT populacija
English: Terminology Criteria for Adverse Events [NCI
Slovenian: Nacionalnega inštituta za rakava obolenja; National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE])
English: Post discontinuation systemic anti-cancer therapy was given to 47.9% of patients receiving Cyramza plus paclitaxel and 46.0% of patients receiving placebo plus paclitaxel.
Slovenian: Sistemsko zdravljenje proti raku po prekinitvi je prejelo 47,9 % bolnikov, ki so prejemali zdravilo Cyramza in paklitaksel ter 46,0 % bolnikov, ki so prejemali placebo in paklitaksel.
English: If you have liver cancer your doctor will monitor you for signs and symptoms of confusion and/or disorientation associated with chronic liver problems and will stop treatment with Cyramza if you develop these signs and symptoms.
Slovenian: Če imate raka jeter, vas bo vaš zdravnik spremljal glede znakov in simptomov zmedenosti in/ali dezorientiranosti, povezanih s kroničnimi težavami z jetri,
English: Ramucirumab should only be used in these patients if the potential benefits of treatment are judged to outweigh the potential risk of progressive hepatic failure.
Slovenian: Zdravilo pri teh bolnikih uporabite le, če presodite, da možne koristi zdravljenja odtehtajo možna tveganja progresivne jetrne odpovedi.
English: Cyramza may increase the risk of problems with wound healing.
Slovenian: Zdravilo Cyramza lahko poveča tveganje za težave pri celjenju ran.
English: Tables 6 and 7 below list the adverse drug reactions (ADRs) from placebo controlled phase III clinical trials associated with ramucirumab used either as a monotherapy treatment for gastric cancer and HCC or in combination with different chemotherapy regimens for the treatment of gastric cancer, mCRC and NSCLC.
Slovenian: V Tabelah 6 in 7 spodaj so navedeni neželeni učinki zdravila iz s placebom nadzorovanih kliničnih preskušanj 3. faze, povezani z ramucirumabom, ki so ga uporabljali kot monoterapijo za zdravljenje raka želodca in hepatocelularnega karcinoma ali v kombinaciji z različnimi kemoterapevtskimi režimi za zdravljenje raka želodca, metastatskega kolorektalnega raka in nedrobnoceličnega pljučnega raka.
English: Cyramza is used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults.
Slovenian: Zdravilo Cyramza se uporablja za zdravljenje napredovalega raka kolona ali rektuma (dela debelega črevesa) pri odraslih.
English: Each 50 ml vial contains approximately 85 mg sodium.
Slovenian: Ena 50-mililitrska viala vsebuje približno 85 mg natrija.
English: The one sub-group with HR > 1 was for patients with disease progression from start of first-line bevacizumab treatment of <3 months (HR 1.02 [95% CI: 0.68 to 1.55]).
Slovenian: RT > 1 je bila skupina bolnikov z napredovanjem bolezni od začetka zdravljenja prve izbire z bevacizumabom < 3 mesece (RT: 1,02 [95 % IZ: 0,68 do 1,55]).
English: In REACH-2, baseline patient demographics and disease characteristics were generally balanced between arms, except for AFP, which was lower in the placebo arm.
Slovenian: V študiji REACH-2 sta bili skupini zdravljenja uravnoteženi glede na izhodiščne demografske podatke bolnikov in lastnosti bolezni, razen glede vrednosti AFP, ki je bila nižja v skupini, ki je prejemala placebo.
English: There is no relevant use of ramucirumab in the paediatric population for the indications of advanced gastric cancer or gastro-oesophageal adenocarcinoma, adenocarcinoma of the colon and rectum, lung carcinoma, and hepatocellular carcinoma.
Slovenian: Smotrne uporabe ramucirumaba v pediatrični populaciji za indikacijo napredovali rak želodca ali adenokarcinom gastro-ezofagealnega prehoda, adenokarcinom kolona in rektuma, pljučni rak ter hepatocelularni karcinom ni.
English: The most frequent (≥1%) ADRs leading to discontinuation of one or more components of FOLFIRI were: neutropenia
Slovenian: Najpogostejši (≥ 1 %) neželeni učinki, zaradi katerih je prihajalo do prekinitve zdravljenja s shemo FOLFIRI, so bili:
English: The major efficacy outcome in REACH-2 was supported by a statistically significant improvement in progression free survival in Cyramza treated patients compared to placebo treated patients.
Slovenian: REACH-2 je bil podprt s statistično značilnim izboljšanjem preživetja brez napredovanja bolezni pri bolnikih, zdravljenih z zdravilom Cyramza, v primerjavi z bolniki, zdravljenimi s placebom.
English: Arterial blood clots can lead to serious conditions, including heart attack or stroke.
Slovenian: Krvni strdki v arterijah imajo lahko resne posledice, vključno s srčnim infarktom ali možgansko kapjo.
English: Parenteral medicinal products should be inspected visually for particulate matter prior to administration.
Slovenian: Parenteralna zdravila je treba pred uporabo vizualno pregledati, da ne vsebujejo trdnih delcev.
English: The target organs identified in repeated dose cynomolgus monkey toxicity studies were kidney (glomerulonephritis), bone (thickening and abnormal endochondral ossification of the epiphyseal growth plate) and female reproductive organs (decreased weight of ovaries and uterus).
Slovenian: Pri opicah vrste javanski makak so bili v študijah toksičnosti pri ponovljenih odmerkih kot ciljni organi določeni: ledvice (glomerulonefritis), kost (zadebelitev in osteohondropatija epifizealne rastne plošče) in reproduktivni organi samic (zmanjšana masa jajčnikov in maternice).
English: Chemical and physical in-use stability of Cyramza in sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 24 hours at 2 ºC to 8 ºC or for 4 hours at 25 ºC.
Slovenian: Dokazano je bilo, da je zdravilo Cyramza v 9 mg/ml (0,9 %) raztopini natrijevega klorida za injiciranje med uporabo kemično in fizikalno stabilno: 24 ur pri temperaturi 2 ºC do 8 ºC ali 4 ure pri temperaturi 25 ºC.
English: Efficacy results are shown in Table 11.
Slovenian: Rezultati učinkovitosti so prikazani v Tabeli 11.
English: There is insufficient data to evaluate the effects of ADAs on the efficacy or safety of ramucirumab.
Slovenian: Podatki za oceno učinkov protiteles na zdravila na učinkovitost ali varnost ramucirumaba niso zadostni.
English: Pack of 2 vials of 10 ml.
Slovenian: Pakiranje z 2 vialama z 10 ml.
English: gemcitabine (25%), taxane (24%), and bevacizumab (14%); 22% of patients received prior maintenance therapy.
Slovenian: Najpogostejša predhodna zdravljenja so vključevala pemetreksed (38 %), gemcitabin (25 %), taksan (24 %) in bevacizumab (14 %); 22 % bolnikov je prejemalo predhodno vzdrževalno zdravljenje.
English: Cyramza is used to treat liver cancer that is advanced or cannot be taken out by surgery, in adults who have been previously treated with another anticancer medicine (sorafenib) and who have an elevated level of a particular protein in the blood (alpha fetoprotein).
Slovenian: Zdravilo Cyramza se uporablja za zdravljenje raka jeter, ki je napredoval ali ga ni mogoče kirurško odstraniti, pri odraslih, ki so se predhodno zdravili z drugim zdravilom proti raku (sorafenibom) in ki imajo zvišane vrednosti določene beljakovine v krvi (alfa-fetoproteina).
English: Patients were randomised in a 1:1 ratio to receive Cyramza plus docetaxel (n=628) or placebo plus docetaxel (n=625).
Slovenian: Bolniki so bili randomizirani v razmerju 1 : 1 za prejemanje zdravila Cyramza in docetaksela (n = 628) ali placeba in docetaksela (n = 625).
English: In the RAISE study, in mCRC patients treated with ramucirumab plus FOLFIRI, the most frequent (≥1%) ADR that led to the discontinuation of ramucirumab was proteinuria (1.5%).
Slovenian: V študiji RAISE je bil pri bolnikih z metastatskim kolorektalnim rakom, ki so bili zdravljeni z ramucirumabom in shemo FOLFIRI, najpogostejši (≥ 1 %) neželeni učinek, zaradi katerega je prihajalo do prekinitve zdravljenja z ramucirumabom, proteinurija (1,5 %).
English: UNITED STATES
Slovenian: ZDA
English: b Includes: hypokalaemia and blood potassium decreased.
Slovenian: b Vključuje: hipokaliemijo in znižano raven kalija v krvi.
English: Efficacy results are shown in Table 9.
Slovenian: Rezultati učinkovitosti so prikazani v Tabeli 9.
English: If you experience an infusion-related reaction during Cyramza therapy, you will be given premedication for all future infusions.
Slovenian: Če se med zdravljenjem z zdravilom Cyramza pri vas pojavi reakcija, povezana z infuzijo, boste morda dobili premedikacijo za vsa prihodnja infundiranja.
English: Table 6: ADRs reported in patients treated with ramucirumab as monotherapy in phase 3 clinical trials (REGARD, REACH-2 and REACH patients with alpha fetoprotein ≥ 400 ng/ml)
Slovenian: Tabela 6: Neželeni učinki, o katerih so poročali pri bolnikih, ki so prejemali ramucirumab v monoterapiji v kliničnih preskušanjih 3. faze (bolniki iz študij REGARD in REACH-2 ter bolniki iz študije REACH z vrednostjo alfa-fetoproteina ≥ 400 ng/ml)
English: - blood clots in the arteries:arterial blood clots can lead to a heart attack or stroke.
Slovenian: - krvni strdki v arterijah: arterijski krvni strdki lahko povzročijo srčni infarkt ali možgansko kap.
English: Peripheral oedema Infusion-related reactionsa a Terms represent a group of events that describe a medical concept rather than a single event or preferred term.
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edem reakcije, povezane z infuzijoa a Izrazi zajemajo skupino dogodkov, ki opisujejo medicinski koncept in ne posameznega dogodka ali priporočenega izraza.
English: The recommended dose of docetaxel is 75 mg for every square metre (m²) of your body's surface area once every 3 weeks.
Slovenian: Priporočeni odmerek docetaksela je 75 mg na en kvadratni meter (m²) površine vašega telesa, enkrat na vsake 3 tedne.
English: The recommended dose of ramucirumab is 10 mg/kg on day 1 of a 21 day cycle, prior to docetaxel infusion.
Slovenian: Priporočeni odmerek ramucirumaba je 10 mg/kg na 1. dan 21-dnevnega cikla, pred infuzijo docetaksela.
English: Based on limited data from REGARD patients with HER2-positive gastric or GEJ adenocarcinoma and patients previously treated with trastuzumab (in RAINBOW), it is considered unlikely that Cyramza has a detrimental effect or that it has no effect in patients with HER2-positive gastric cancer.
Slovenian: HER2 ali z adenokarcinomom gastro-ezofagealnega prehoda ter bolnikov, ki so bili predhodno zdravljeni s trastuzumabom (v študiji RAINBOW), se šteje za malo verjetno, da bi zdravilo Cyramza imelo škodljiv učinek ali da ne bi imelo nobenega učinka pri bolnikih z rakom želodca, pozitivnim na gen HER2.
English: Based on PopPK, ramucirumab exposure in patients with mild hepatic impairment (total bilirubin >1.0-1.5 upper limit of normal (ULN) and any AST or total bilirubin ≤1.0 ULN and AST >ULN) or moderate hepatic impairment (total bilirubin > 1.5-3.0 ULN and any AST) was similar to patients with normal hepatic function (total bilirubin and AST ≤ ULN).
Slovenian: Na podlagi populacijske farmakokinetike je bila izpostavljenost ramucirumabu pri bolnikih z blago okvarjenim delovanjem jeter (celokupni bilirubin > 1,0-1,5-kratna zgornja meja normalne vrednosti (ULN) in kakršna koli vrednost AST ali celokupnega bilirubina ≤ 1,0 ULN in AST > ULN) ali zmerno okvarjenim delovanjem jeter (celokupni bilirubin > 1,5-3,0 ULN in kakršna koli vrednost
English: Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia have been reported in clinical studies.
Slovenian: V kliničnih študijah so poročali o resnih, včasih smrtnih arterijskih trombemboličnih dogodkih, vključno z miokardnim infarktom, srčnim zastojem, možganskožilnim dogodkom in možgansko ishemijo.
English: For HCC patients with evidence of portal hypertension or prior history of oesophageal variceal bleeding, screening for and treatment of oesophageal varices should be performed as per standard of care before starting ramucirumab treatment.
Slovenian: Pri bolnikih s hepatocelularnim karcinomom z dokazano portalno hipertenzijo ali anamnezo krvavitev iz varic požiralnika je treba v skladu s standardno oskrbo pred začetkom zdravljenja z ramucirumabom opraviti presejalno testiranje in zdravljenje varic požiralnika.
English: Dose level
Slovenian: 2 odmerni ravni.
English: Not known (frequency cannot be estimated from the available data): - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
Slovenian: - nenormalno strjevanje krvi v majhnih krvnih žilah Neznano (pogostnosti ni mogoče oceniti na podlagi razpoložljivih podatkov): - širitev in oslabitev stene krvnih žil ali raztrganje stene krvnih žil (anevrizme in disekcije arterij).
English: The median OS in patients with any grade neutropenia was greater in the ramucirumab arm (16.1 months) than in the placebo arm (12.6 months).
Slovenian: Porast medianega celokupnegapreživetja med bolniki z nevtropenijo in bolniki brez nevtropenije je bil večji v skupini z ramucirumabom (16,1 meseca) v primerjavi s skupino s placebom (12,6).
English: EORTC QLQ-C30, patients in the ramucirumab plus FOLFIRI treatment arm reported a transient decrease in QoL compared to the patients in the placebo plus FOLFIRI treatment arm in most of the scales.
Slovenian: V vprašalniku EORTC QLQ-C30 so bolniki v skupini zdravljenja z ramucirumabom in shemo FOLFIRI poročali o prehodnem upadu kakovosti življenja na večini lestvic v primerjavi z bolniki v skupini zdravljenja s placebom in shemo FOLFIRI.
English: Gastrointestinal haemorrhage eventsa,f Gastrointestinal perforationa
Slovenian: Bolezni prebavil stomatitis driska gastrointestinalne krvavitvea,f gastrointestinalne perforacijea
English: 5-FU infusion 2,400 mg/m2 over 46-48 hours
Slovenian: Infuzija 5-FU 2.400 mg/m2 v 46-48 urah
English: Patients who are treated with ramucirumab should have their blood pressure monitored.
Slovenian: Med zdravljenjem z ramucirumabom spremljajte krvni tlak bolnikov.
English: The correct amount of Cyramza needed to treat your disease will be calculated by your doctor or hospital pharmacist depending on your body weight.
Slovenian: Količina zdravila Cyramza, ki je potrebna za zdravljenje vaše bolezni, je odvisna od vaše telesne mase.
English: Tél: +33-(0) 1 55 49 34 34
Slovenian: Lilly France SAS Tél: +33-(0) 1 55 49 34 34
English: Symptoms may include a burning sensation in the mouth, ulceration, blisters or swelling.
Slovenian: Simptomi lahko vključujejo žgoč občutek v ustih, nastanek razjed ali mehurjev ali otekanje.
English: Gastrointestinal perforations (see section 4.4).
Slovenian: Gastrointestinalne perforacije (glejte poglavje 4.4).
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Ne stresajte viale.
English: The most serious adverse reactions associated with ramucirumab treatment (as a single agent or in combination with cytotoxic chemotherapy) were:
Slovenian: Povzetek varnostnega profila Najresnejši neželeni učinki, povezani z zdravljenjem z ramucirumabom (v monoterapiji ali v kombinaciji s citotoksično kemoterapijo) so bili:
English: A relevant exposure-efficacy association was observed for ramucirumab in REACH-2 (see section 5.2).
Slovenian: Za ramucirumab so v študiji REACH-2 opazili pomembno povezavo med izpostavljenostjo in učinkovitostjo (glejte poglavje 5.2).
English: Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
Slovenian: Zdravilo Cyramza je v kombinaciji s shemo FOLFIRI (irinotekan, folinska kislina in 5-fluorouracil) indicirano za zdravljenje odraslih bolnikov z metastatskim kolorektalnim rakom (mCRC), z napredovanjem bolezni ob ali po predhodnem zdravljenju z bevacizumabom, oksaliplatinom in fluoropirimidinom.
English: An increased incidence of stomatitis was reported in patients receiving ramucirumab in combination with chemotherapy as compared to patients treated with placebo plus chemotherapy.
Slovenian: O povečani incidenci stomatitisa so poročali pri bolnikih, ki so prejemali ramucirumab v kombinaciji s kemoterapijo, v primerjavi z bolniki, zdravljenimi s placebom in kemoterapijo.
English: Haematological criteria in Table 2 are not met
Slovenian: Hematološka merila v Tabeli 2 niso izpolnjena.
English: Your doctor will monitor your blood pressure and adjust your blood pressure medicine as needed during treatment with Cyramza.
Slovenian: Med zdravljenjem z zdravilom Cyramza bo vaš zdravnik spremljal vaš krvni tlak in po potrebi prilagodil vaša zdravila za krvni tlak.
English: 50 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
Slovenian: 50 ml raztopine v viali (iz stekla tipa I) z zamaškom iz klorobutilne gume, aluminijasto zaporko in polipropilenskim pokrovčkom.
English: Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome.
Slovenian: Trajno prekinite zdravljenje z ramucirumabom, če se pojavi raven beljakovin v urinu > 3 g/24 ur ali v primeru nefrotskega sindroma.
English: Inspect the content of the vials for particulate matter and discolouration (the concentrate for solution for infusion should be clear to slightly opalescent and colourless to slightly yellow without visible particles) prior to dilution.
Slovenian: Pred redčenjem preglejte vsebino vial in bodite pozorni na trdne delce in obarvanost (koncentrat za raztopino za infundiranje mora biti bister do rahlo opalescenten in brezbarven do nekoliko rumenkast brez vidnih delcev).
English: If a patient develops wound healing complications during therapy, ramucirumab should be discontinued until the wound is fully healed (see section 4.2).
Slovenian: Če se pri bolniku med zdravljenjem razvijejo zapleti v zvezi s celjenjem rane, prekinite zdravljenje z ramucirumabom, dokler rana ni povsem zaceljena (glejte poglavje 4.2).
English: Table 8: Summary of efficacy data - Intent to treat (ITT) population Cyramza plus paclitaxel N=330
Slovenian: Tabela 8: Povzetek podatkov o učinkovitosti - populacija, namenjena za zdravljenje (ITT) zdravilo Cyramza in paklitaksel N=330
English: There are limited data available about the use of Cyramza in patients with severely impaired kidney function.
Slovenian: Podatki o uporabi zdravila Cyramza pri bolnikih s hudo okvarjenim delovanjem ledvic so omejeni.
English: REVEL, a randomised, double-blind study of Cyramza plus docetaxel versus placebo plus docetaxel, was conducted in 1253 patients with locally advanced or metastatic squamous or non-squamous NSCLC with disease progression on or after one platinum-based therapy.
Slovenian: Študija REVEL, randomizirana, dvojno slepa študija učinka zdravila Cyramza in docetaksela v primerjavi z učinkom placeba in docetaksela, je bila opravljena s 1253 bolniki z lokalno napredovalim ali metastatskim ploščatoceličnim ali neploščatoceličnim NSCLC, z napredovanjem bolezni ob ali po enem zdravljenju na osnovi platine.
English: Cyramza plus paclitaxel arm was 27.9% and in the placebo plus paclitaxel arm was 16.1%.
Slovenian: Objektivna stopnja odziva v skupini z zdravilom Cyramza in paklitakselom je znašala 27,9 %, v skupini s placebom in paklitakselom pa 16,1 %.
English: Pack of 1 vial of 10 ml.
Slovenian: Pakiranje z 1 vialo z 10 ml.
English: Patients with recent serious pulmonary, gastrointestinal, or postoperative bleeding, evidence of CNS haemorrhage, tumour involvement of major airway or blood vessel, intra-tumour cavitation, and history of significant bleeding or uncontrolled thrombotic disorders were excluded.
Slovenian: Bolniki z nedavnimi resnimi pljučnimi krvavitvami, krvavitvami v prebavilih ali krvavitvami po kirurškem posegu, dokazi o krvavitvah v osrednjem živčnem sistemu, prepletenostjo tumorja z glavnimi dihalnimi potmi ali krvnimi žilami, kavitacijo znotraj tumorja in anamnezo pomembnih krvavitev ali nenadzorovanimi trombotskimi motnjami so bili izključeni.
English: Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.
Slovenian: Monoterapija z zdravilom Cyramza je indicirana za zdravljenje odraslih bolnikov z napredovalim ali neresektabilnim hepatocelularnim karcinomom, ki imajo vrednosti alfa-fetoproteina (AFP) v serumu ≥ 400 ng/ml in so se predhodno zdravili s sorafenibom.
English: The ORR was similar for both treatment arms (13.4% versus 12.5%, ramucirumab plus FOLFIRI versus placebo plus FOLFIRI, respectively).
Slovenian: Objektivna stopnja odziva je bila v obeh skupinah zdravljenja podobna (13,4 % pri ramucirumabu in shemi FOLFIRI v primerjavi z 12,5 % pri placebu in shemi FOLFIRI).
English: After dilution When prepared as directed, infusion solutions of Cyramza contain no antimicrobial preservatives.
Slovenian: Raztopine za infundiranje Cyramza, ki so pripravljene po navodilih, ne vsebujejo antimikrobnih konzervansov.
English: 2,000 mg/m2 over 46-48 hours
Slovenian: 2.000 mg/m2 v 46-48 urah
English: Patients should be monitored during the infusion for signs of hypersensitivity.
Slovenian: Med infundiranjem morate bolnike spremljati in biti pozorni na znake preobčutljivosti.
English: RAINBOW
Slovenian: Študija RAINBOW
English: Do not dilute with other solutions or co-infuse with other electrolytes or medicinal products.
Slovenian: NE redčite z drugimi raztopinami in ne infundirajte sočasno z drugimi elektroliti ali zdravili.
English: If particulate matter is identified, discard the infusion solution.
Slovenian: Če opazite trdne delce, zavrzite raztopino za infundiranje.
English: The HR of OS was 0.82 (95% CI: 0.67 to 1.0) in patients with a KRAS wild type tumour, and 0.89 (95% CI: 0.73 to 1.09) in patients with a KRAS mutant tumour.
Slovenian: RT za celokupno preživetje je znašal 0,82 (95 % IZ: 0,67 do 1,0) pri bolnikih s tumorjem divjega tipa KRAS in 0,89 (95 % IZ: 0,73 do 1,09) pri bolnikih s tumorjem mutantnega KRAS.
English: Ramucirumab should be permanently discontinued in the event of hepatic encephalopathy or hepatorenal syndrome (see section 4.2).
Slovenian: Ramucirumab je treba ob pojavu hepatične encefalopatije ali hepatorenalnega sindroma trajno ukiniti (glejte poglavje 4.2).
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaja
English: There is no data on overdose in humans.
Slovenian: 4.9 Preveliko odmerjanje Podatkov o prevelikem odmerjanju pri ljudeh ni.
English: The recommended dose of paclitaxel is 80 mg/m2 administered by intravenous infusion over approximately 60 minutes on days 1, 8 and 15 of a 28 day cycle.
Slovenian: Priporočeni odmerek paklitaksela je 80 mg/m2 in se daje z intravenskim infundiranjem, ki traja približno 60 minut, 1., 8. in 15. dan 28-dnevnega cikla.