FrancophonIA/ELRC3.0 huggingface dataset:
English: Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.
Slovenian: Zdravilo Cyramza je v kombinaciji z docetakselom indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, z napredovanjem bolezni po kemoterapiji na osnovi platine.
English: Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome (see section 4.2).
Slovenian: Trajno prekinite zdravljenje z ramucirumabom, če se pojavi raven beljakovin v urinu > 3 g/24 ur ali v primeru nefrotskega sindroma (glejte poglavje 4.2).
English: Ramucirumab should be permanently discontinued if medically significant hypertension cannot be controlled with antihypertensive therapy (see section 4.2).
Slovenian: Trajno prekinite zdravljenje z ramucirumabom, če zdravstveno pomembne hipertenzije ni mogoče nadzirati z antihipertenzivnim zdravljenjem (glejte poglavje 4.2).
English: Blood counts and coagulation parameters should be monitored in patients with conditions predisposing to bleeding, and in those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding.
Slovenian: Pri bolnikih, ki so nagnjeni h krvavitvam in pri bolnikih, ki se zdravijo z antikoagulanti ali z drugimi sočasnimi zdravili, ki povečajo tveganje za krvavitve, je treba spremljati krvno sliko in koagulacijske parametre.
English: Hypokalaemiaa,b Hyponatraemiaa Hypoalbuminaemiaa
Slovenian: Presnovne in prehranske motnje hipokaliemijaa,b hiponatriemijaa hipoalbuminemijaa
English: If Grade 4 diarrhoea does not resolve to Grade ≤1, withhold 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1.
Slovenian: Če se diareja razreda 4 ne izboljša do razreda ≤ 1, prekinite dajanje 5-FU in irinotekana za največ 28* dni do izboljšanja neželenega učinka do razreda ≤ 1.
English: Post discontinuation systemic anticancer therapy was given to 54% of patients receiving Cyramza plus FOLFIRI and 56% of patients receiving placebo plus FOLFIRI.
Slovenian: Sistemsko zdravljenje raka je po prekinitvi prejelo 54 % bolnikov, ki so prejemali zdravilo Cyramza in shemo FOLFIRI, in 56 % bolnikov, ki so prejemali placebo in shemo FOLFIRI.
English: Dose modifications of each component of FOLFIRI should be made independently and are provided in Table 4.
Slovenian: Odmerek vsake komponente sheme FOLFIRI je treba prilagoditi neodvisno.
English: Symptoms include severe abdominal pain, being sick (vomiting), fever or chills.
Slovenian: Simptomi vključujejo hude bolečine v trebuhu, slabost (bruhanje), vročino ali mrzlico.
English: Ramucirumab therapy should be temporarily discontinued if the urine protein level is ≥2 g/24 hours.
Slovenian: Začasno prekinite zdravljenje z ramucirumabom, če raven beljakovin v urinu znaša ≥ 2 g/24 ur.
English: No formal studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of ramucirumab.
Slovenian: Formalne študije, ki bi ocenjevale učinek jetrne okvare na farmakokinetiko ramucirumaba, niso bile opravljene.
English: Placebo plus FOLFIRI N=536
Slovenian: Placebo in FOLFIRI N = 536
English: Cyramza at 8 mg/kg or placebo was administered by intravenous infusion every 2 weeks (on days 1 and 15) of a 28-day cycle.
Slovenian: Zdravilo Cyramza v odmerku 8 mg/kg ali placebo sta bila dana z intravenskim infundiranjem vsaka 2 tedna (1. in 15. dan) 28-dnevnega cikla.
English: Symptoms may include: increased muscle tension, back pain, chest pain and/or tightness, chills, flushing, difficulty in breathing, wheezing, and feeling of tingling or numbness in hands or feet.
Slovenian: povečano napetost mišic, bolečine v hrbtu, bolečine in/ali tiščanje v prsnem košu, mrzlico, zardevanje, težave z dihanjem, sopenje in občutke mravljinčenja ali otopelosti v dlaneh in stopalih.
English: The disease control rate (complete response plus partial response plus stable disease) was numerically higher in patients on the ramucirumab plus FOLFIRI arm as compared to the placebo plus FOLFIRI arm (74.1% versus 68.8%, respectively).
Slovenian: (popoln odziv in delni odziv in stabilna bolezen) je bila številčno višja pri bolnikih, ki so se zdravili v skupini z ramucirumabom in shemo FOLFIRI, v primerjavi s skupino s placebom in shemo FOLFIRI (74,1 % v primerjavi z 68,8 %).
English: It is recommended to reduce the docetaxel dose by 10 mg/m2 for all following cycles.
Slovenian: Pri vseh naslednjih ciklih je priporočljivo zmanjšati odmerek docetaksela za 10 mg/m2.
English: Vials contain either 100 mg or 500 mg as a 10 mg/ml solution of ramucirumab.
Slovenian: Viale vsebujejo bodisi 100 mg ali 500 mg ramucirumaba v obliki raztopine 10 mg/ml.
English: Median age was 62 years and 40% of patients were ≥65 years; 57% of patients were male; 76% were White and 20% Asian; 49% had ECOG PS 0; 49% of patients had KRAS mutant tumours; and 24% of patients had TTP <6 months after commencing first-line treatment.
Slovenian: Mediana starost je bila 62 let in 40 % bolnikov je bilo starih ≥ 65 let; 57 % bolnikov je bilo moškega spola; 76 % bolnikov je bilo belcev in 20 % bolnikov je bilo azijske rase; 49 % bolnikov je imelo indeks stanja zmogljivosti ECOG 0; 49 % bolnikov je imelo tumorje z mutantnim KRAS; pri 24 %
English: RAINBOW, a global, randomised, double-blind, study of Cyramza plus paclitaxel versus placebo plus paclitaxel, was conducted in 665 patients with locally recurrent and unresectable or metastatic gastric cancer (including GEJ adenocarcinoma) following platinum- and fluoropyrimidine-containing chemotherapy, with or without anthracycline.
Slovenian: RAINBOW, globalna, randomizirana, dvojno slepa študija z zdravilom Cyramza in paklitakselom v primerjavi s placebom in paklitakselom, je bila opravljena s 665 bolniki z lokalno recidivnim in neoperabilnim ali metastatskim rakom želodca (vključno z adenokarcinomom gastro-ezofagealnega prehoda) po zdravljenju s kemoterapijo, ki je vsebovala platino in fluoropirimidin, z ali brez antraciklina.
English: Placebo plus docetaxel N=625
Slovenian: Placebo in docetaksel N = 625
English: 1,600 mg/m2 over 46-48 hours
Slovenian: 1.600 mg/m2 v 46-48 urah
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ne stresajte viale.
English: The recommended dose of ramucirumab is 8 mg/kg every 2 weeks administered by intravenous infusion, prior to FOLFIRI administration.
Slovenian: Priporočeni odmerek ramucirumaba je 8 mg/kg vsaka 2 tedna, dan z intravensko infuzijo pred dajanjem sheme FOLFIRI.
English: Store in a refrigerator (2 ºC - 8 ºC).
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 ºC-8 ºC).
English: Tel. +370 (5) 2649600
Slovenian: Eli Lilly Lietuva Tel. +370 (5) 2649600
English: Cyramza is given in combination with docetaxel, another anti-cancer medicine, for the treatment of adult patients with advanced stage of lung cancer whose disease has worsened after treatment with medicines to treat cancer.
Slovenian: Zdravilo Cyramza se daje v kombinaciji z docetakselom, drugim zdravilom proti raku, za zdravljenje odraslih bolnikov z napredovalo stopnjo pljučnega raka, pri katerih se je bolezen po zdravljenju z zdravili za zdravljenje raka poslabšala.
English: Time and dose dependency
Slovenian: Odvisnost odmerka od časa
English: The pharmacokinetics of paclitaxel were not affected when co-administered with ramucirumab and the pharmacokinetics of ramucirumab were not affected when co-administered with paclitaxel.
Slovenian: Ko so paklitaksel dajali sočasno z ramucirumabom, ni prišlo do vpliva na farmakokinetiko paklitaksela in ko so ramucirumab dajali sočasno s paklitakselom, ni prišlo do vpliva na farmakokinetiko ramucirumaba.
English: - If you get any side effects, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
English: Cyramza has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Cyramza nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: - Abnormal tube-like connections or passageways inside the body (‘fistula'): Cyramza may increase the risk of abnormal tube-like connections or passageways inside the body between internal organs and skin or other tissues.
Slovenian: Zdravilo Cyramza lahko poveča tveganje za nastanek nenormalnih cevi podobnih povezav ali prehodov med notranjimi organi in kožo ali drugimi tkivi v telesu.
English: The primary endpoint was overall survival (OS) and the secondary endpoints included progression free survival (PFS) and overall response rate (ORR).
Slovenian: Primarni opazovani dogodek je bilo celokupno preživetje, sekundarni opazovani dogodki pa so vključevali preživetje brez napredovanja bolezni in skupno stopnjo odziva.
English: Cyramza is used for the treatment of advanced stomach cancer (or cancer of the junction between the oesophagus and the stomach) in adults whose disease has worsened after treatment with medicines to treat cancer and for whom treatment of Cyramza in combination with paclitaxel is not suitable.
Slovenian: Zdravilo Cyramza uporabljamo za zdravljenje napredovalega raka želodca (ali raka prehoda med požiralnikom in želodcem) pri odraslih, pri katerih je bolezen po zdravljenju z zdravili proti raku napredovala in pri katerih zdravljenje z zdravilom Cyramza v kombinaciji s paklitakselom ni ustrezno.
English: Days 8 and 15: ≥75 x 109/L
Slovenian: 8. in 15. dan: ≥ 75 x 109/l
English: A treatment effect on PFS was observed for all exposure levels produced by 8 mg/kg ramucirumab given every 2 weeks.
Slovenian: Učinek na preživetje brez napredovanja bolezni so opazili pri vseh ravneh izpostavljenosti, ki jih povzroči odmerek ramucirumaba 8 mg/kg, dan vsaka 2 tedna.
English: Symptoms included rigors/tremors, back-pain/spasms, chest pain and/or tightness, chills, flushing, dyspnoea, wheezing, hypoxia, and paraesthesia.
Slovenian: Simptomi so vključevali otrplost/tresavico, bolečine/krče v hrbtu, bolečino in/ali tiščanje v prsih, mrzlico, zardevanje, dispnejo, piskajoče dihanje, hipoksijo in parestezijo.
English: EU/1/14/957/001 - 1 vial of 10 ml.
Slovenian: EU/1/14/957/001- 1 viala po 10 ml
English: c Based on study REACH-2 and REACH (single-agent ramucirumab in HCC).
Slovenian: c Na podlagi študij REACH-2 in REACH (ramucirumab v monoterapiji pri hepatocelularnem karcinomu).
English: Haematological criteria in Table 2 are not met and fever resolved
Slovenian: Hematološka merila v Tabeli 2 niso izpolnjena in vročina je minila.
English: The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
Slovenian: Priporočeni odmerek ramucirumaba v monoterapiji je 8 mg/kg vsaka 2 tedna.
English: Includes: anal haemorrhage, diarrhoea haemorrhage, gastric haemorrhage, gastrointestinal haemorrhage, haematemesis, haematochezia, haemorrhoidal haemorrhage, Mallory-Weiss syndrome, melaena, oesophageal haemorrhage, rectal haemorrhage, and upper gastrointestinal haemorrhage.
Slovenian: Vključuje: analno krvavitev, krvavitev ob driski, krvavitev v želodcu, gastrointestinalno krvavitev, hematemezo, hematohezijo, krvavitev iz hemoroidov, Mallory-Weissov sindrom, meleno,
English: you should not breast-feed your baby during treatment with Cyramza and for at least 3 months after you receive the last dose.
Slovenian: Ni znano, če to zdravilo prehaja v materino mleko, zato med zdravljenjem z zdravilom Cyramza in še najmanj 3 mesece po prejemu zadnjega odmerka zdravila otroka ne smete dojiti.
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
English: After dilution and preparation, the medicine must be used immediately.
Slovenian: Zdravilo je treba uporabiti takoj po redčenju in pripravi.
English: In case of empty intravenous infusion container usage Aseptically transfer the calculated volume of ramucirumab into an empty intravenous infusion container.
Slovenian: Aseptično prenesite izračunano prostornino ramucirumaba v prazen vsebnik za intravensko infuzijo.
English: Sodium restricted diet
Slovenian: Dieta z omejenim vnosom natrija
English: There have been no studies performed with other routes of administration.
Slovenian: Z drugimi načini dajanja zdravila niso opravili študij.
English: Dose modification at day 1 of cycle subsequent to ADR
Slovenian: Prilagajanje odmerka na 1. dan cikla po pojavu neželenega učinka zdravila
English: If particulate matter or discolouration is identified, discard the vial.
Slovenian: V kolikor opazite trdne delce in obarvanost, zavrzite vialo.
English: Talk to your doctor or nurse before you are given Cyramza if you:
Slovenian: Opozorila in previdnostni ukrepi Preden prejmete zdravilo Cyramza se posvetujte z zdravnikom, če:
English: Objective response rate [ORR(complete response [CR] + partial response [PR])] was significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (Odds ratio 2.140; 95% CI: 1.499 to 3.160; p=0.0001).
Slovenian: Objektivna stopnja odziva (popolni odziv + delni odziv) je bila statistično bistvena boljša pri bolnikih, ki so prejemali zdravilo Cyramza in paklitaksel, v primerjavi z bolniki, ki so prejemali placebo in paklitaksel (razmerje obetov 2,140; 95-odstotni interval zaupanja: 1,499 do 3,160; p=0,0001).
English: Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).
Slovenian: Monoterapija z zdravilom Cyramza je indicirana za zdravljenje odraslih bolnikov z napredovalim rakom želodca ali adenokarcinomom gastro-ezofagealnega prehoda z napredovalo boleznijo po predhodni kemoterapiji s platino ali fluoropirimidinom, za katere zdravljenje v kombinaciji s paklitakselom ni primerno (glejte poglavje 5.1).
English: During each infusion, your doctor or nurse will check for side effects.
Slovenian: Vaš zdravnik ali medicinska sestra bosta med vsako vašo infuzijo pozorna na neželene učinke.
English: An improvement in PFS was also associated with increasing ramucirumab exposure for advanced gastric cancer, NSCLC, and mCRC.
Slovenian: Izboljšanje preživetja brez napredovanja bolezni je bilo povezano tudi z naraščajočo izpostavljenostjo ramucirumabu pri napredovalem raku želodca, nedrobnoceličnem pljučnem raku in metastatskem kolorektalnem raku.
English: Patients were also excluded if they had experienced any of: an ATE, Grade 4 hypertension, Grade 3 proteinuria, a grade 3-4 bleeding event, or bowel perforation during first-line bevacizumab therapy.
Slovenian: arterijski trombotski dogodek, hipertenzija stopnjer 4, proteinurija stopnje 3, krvavitev 3-4 ali perforacija prebavil med zdravljenjem prve izbire z bevacizumabom.
English: Comorbidities associated with advanced age, performance status and the likely tolerability to chemotherapy should therefore be thoroughly evaluated prior to the initiation of treatment in the elderly (see sections 4.2 and 5.1).
Slovenian: Sočasne bolezni, povezane z višjo starostjo, stanjem zmogljivosti in prenašanjem kemoterapije, je zato treba pri starejših pred začetkom zdravljenja temeljito oceniti
English: Cyramza is administered as an intravenous infusion.
Slovenian: Zdravilo Cyramza se daje v obliki intravenske infuzije.
English: There was an increase in median survival of 2.3 months in favour of the Cyramza plus paclitaxel arm: 9.63 months in the Cyramza plus paclitaxel arm and 7.36 months in the placebo plus paclitaxel arm.
Slovenian: V skupini z zdravilom Cyramza in paklitakselom se je povečalo mediano preživetje za 2,3 meseca: 9,63 meseca v skupini z zdravilom Cyramza in paklitakselom ter 7,36 meseca v skupini s placebom in paklitakselom.
English: Patients may be at increased risk for the development of fistula when treated with Cyramza.
Slovenian: Pri bolnikih, ki so zdravljeni z zdravilom Cyramza, lahko obstaja povečano tveganje za nastanek fistule.
English: FOLFIRI chemotherapy is given by intravenous infusion, after the Cyramza infusion has finished.
Slovenian: Če prejemate zdravilo Cyramza v kombinaciji s shemo FOLFIRI Kemoterapija FOLFIRI se daje z intravensko infuzijo po zaključku infuzije zdravila Cyramza.
English: Odd ratio
Slovenian: Odmerna raven
English: The European Medicines Agency has waived the obligation to submit the results of studies with Cyramza in all subsets of the paediatric population in gastric adenocarcinoma, in adenocarcinoma of the colon and rectum, in lung carcinoma, and liver cancer (see section 4.2 for information on paediatric use).
Slovenian: Cyramza za vse podskupine pediatrične populacije za adenokarcinom želodca, adenokarcinom kolona in rektuma, za pljučni rak ter za rak jeter (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: How to store Cyramza
Slovenian: Shranjevanje zdravila Cyramza
English: In case of pre-filled intravenous infusion container usage Based on the calculated volume of ramucirumab, remove the corresponding volume of sodium chloride 9 mg/ml (0.9%) solution for injection from the pre-filled 250 ml intravenous container.
Slovenian: Če uporabljate vnaprej napolnjene vsebnike za intravensko infuzijo Glede na izračunano prostornino ramucirumaba odvzemite ustrezno prostornino 9 mg/ml (0,9 %)
English: Patients were required to have experienced disease progression during, or within 4 months after the last dose of, first-line therapy for metastatic disease, or during adjuvant treatment or within 6 months after the last dose of adjuvant therapy, and had ECOG PS 0-1.
Slovenian: Vključili so bolnike, pri katerih je bolezen napredovala v času zdravljenja prve izbire ali v 4 mesecih po zadnjem odmerku zdravljenja pri metastatski bolezni, ali med dopolnilnim zdravljenjem ali v 6 mesecih po zadnjem odmerku dopolnilnega zdravljenja, ter ki so imeli status zmogljivosti 0-1 po ECOG. Za vključitev v študijo so morali bolniki imeti skupni bilirubin ≤ 1,5 mg/dl ter vrednosti AST in ALT ≤ 3-kratna vrednost ULN,
English: Only use sodium chloride 9 mg/ml (0.9%) solution for injection as a diluent.
Slovenian: Kot redčilo uporabljajte le 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
English: There have been no formal studies with Cyramza in patients with hepatic impairment.
Slovenian: Formalnih študij z zdravilom Cyramza pri bolnikih z okvarjenim delovanjem jeter niso izvedli.
English: Do not freeze or shake the infusion solution.
Slovenian: Ne zamrzujte in ne pretresajte raztopine za infundiranje.
English: Cyramza as a single agent The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
Slovenian: Zdravilo Cyramza v monoterapiji Priporočeni odmerek ramucirumaba kot monoterapije je 8 mg/kg vsaka 2 tedna.
English: A second dose reduction (see Table 3) is recommended if a urine protein level ≥2 g/24 hours reoccurs.
Slovenian: Priporočljivo je ponovno znižanje odmerka (glejte Tabelo 3), če se znova pojavi raven beljakovin v urinu ≥ 2 g/24 ur.
English: Česká republika ELI LILLY ČR, s.r.o.
Slovenian: ELI LILLY ČR, s.r.o.
English: Fatiguea,i Mucosal inflammationd Peripheral oedema 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 utrujenosta,i vnetje sluzniced periferni edem a Izrazi zajemajo skupino dogodkov, ki opisujejo medicinski koncept in ne posameznega dogodka ali priporočenega izraza.
English: i Based on study RAINBOW (ramucirumab plus paclitaxel) and study REVEL (ramucirumab plus docetaxel).
Slovenian: i Na podlagi študije RAINBOW (ramucirumab in paklitaksel) in študije REVEL (ramucirumab in docetaksel).
English: Overall survival was statistically significantly improved in patients receiving Cyramza as compared with patients receiving placebo (hazard ratio [HR] 0.776; 95%CI: 0.603 to 0.998; p= 0.0473), corresponding to a 22% reduction in the risk of death and an increase in median survival to 5.2 months for Cyramza from3.8 months for placebo.
Slovenian: Celokupno preživetje je bilo statistično bistveno boljše pri bolnikih, ki so prejemali zdravilo Cyramza, v primerjavi z bolniki, ki so prejemali placebo (razmerje tveganja: 0,776; 95-odstotni interval zaupanja: 0,603 do 0,998; p = 0,0473), kar ustreza 22-odstotnemu zmanjšanju tveganja smrti ter povečanju v medianem preživetju na 5,2 meseca za zdravilo Cyramza s 3,8 meseca za placebo.
English: Few between-arm differences were reported after the first month of treatment.
Slovenian: V prvem mesecu zdravljenja so poročali o redkih razlikah med obema skupinama.
English: In addition, patients were either Barcelona Clinic Liver Cancer (BCLC) stage B and no longer amenable to locoregional therapy, or were BCLC stage C. Patients with brain metastases, leptomeningeal disease, uncontrolled spinal cord compression, a history of or current hepatic encephalopathy or clinically meaningful ascites, severe variceal bleeding in the 3 months prior to treatment, or gastric or oesophageal varices at high risk of bleeding were excluded from the study.
Slovenian: Bolniki z možganskimi metastazami, leptomeningealno boleznijo, nenadzorovano kompresijo hrbtenjače, z anamnezo hepatične encefalopatije ali klinično pomembnega ascitesa ali s trenutno hepatično encefalopatijo ali klinično pomembnim ascitesom, hudo krvavitvijo iz varic v zadnjih treh mesecih pred zdravljenjem ali varicami v želodcu ali požiralniku z velikim tveganjem za krvavitev so bili iz študije izključeni.
English: Cases of gastrointestinal perforation have been reported in patients treated with ramucirumab.
Slovenian: Pri bolnikih, zdravljenih z ramucirumabom, so poročali o primerih gastrointestinalnih perforacij.
English: If Grade 3 mucositis/stomatitis does not resolve to Grade ≤1,
Slovenian: Če sta se stomatitis/mukozitis izboljšala do razreda ≤ 1,
English: Hepatic encephalopathyc
Slovenian: Bolezni živčevja glavobol hepatična encefalopatijac
English: A second dose reduction is recommended if a urine protein level ≥2 g/24 hours reoccurs.
Slovenian: Priporočljivo je ponovno znižanje odmerka, če se znova pojavi raven beljakovin v urinu ≥ 2 g/24 ur.
English: Sites in East Asia administered a reduced dose of docetaxel at 60 mg/m2 every 21 days.
Slovenian: V centrih v Vzhodni Aziji so dajali manjši odmerek docetaksela 60 mg/m2
English: Ramucirumab should be permanently discontinued in patients who experience Grade 3 or 4 bleeding (see section 4.2).
Slovenian: Trajno prekinite zdravljenje z ramucirumabom pri bolnikih, pri katerih se pojavi krvavitev stopnje 3 ali 4 (glejte poglavje 4.2).
English: The blood pressure of patients should be monitored prior to each ramucirumab administration and treated as clinically indicated.
Slovenian: Pred vsakim dajanjem ramucirumaba spremljajte krvni tlak in ukrepajte glede na klinično indikacijo.
English: Hazard ratio (95% CI) Stratified log-rank p-value Abbreviations: CI = confidence interval
Slovenian: Razmerje tveganja (95 % IZ) p vrednost za stratificiran test log-rank Okrajšave: IZ = interval zaupanja
English: (n= 39) suggested a survival benefit in such patients (HR 0.679, 95% CI 0.327, 1.419) and demonstrated a benefit for progression free survival (PFS) (HR 0.399, 95% CI 0.194, 0.822).
Slovenian: Naknadne analize nestratificirane podskupine bolnikov iz študije RAINBOW, ki so bili predhodno zdravljeni s trastuzumabom (n=39) kažejo na korist za preživetje teh bolnikov (razmerje tveganja: 0,679, 95-% interval zaupanja 0,327, 1,419) in so dokazale korist za preživetje brez napredovanja bolezni (PFS) (razmerje tveganja: 0,399, 95-% interval zaupanja 0,194, 0,822).
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenijaa nevtropenijaa