FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms may include sweating or other signs of infection, such as headache, pain in the limbs or decreased appetite.
Croatian: Simptomi mogu uključivati znojenje ili druge znakove infekcije, poput glavobolje, bolova u rukama i nogama ili smanjenog teka.
English: Cyramza should not be administered or mixed with dextrose solutions.
Croatian: Cyramza se ne smije primjenjivati niti miješati s otopinama glukoze.
English: Dose reductions for individual components of FOLFIRI may be made for specific toxicities.
Croatian: Doze pojedinačnih sastavnica protokola FOLFIRI mogu se smanjiti u slučaju specifičnih toksičnosti.
English: There are no data on the effect of ramucirumab on human fertility.
Croatian: Nema podataka o učincima ramucirumaba na plodnost u ljudi.
English: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≥2 patients Patients with ECOG score ≥2 were excluded from the pivotal studies in all indications, therefore the safety and efficacy of Cyramza in this patient population is unknown.
Croatian: Bolesnici s ECOG statusom ≥ 2 nisu bili uključeni u pivotalna ispitivanja ni u jednoj indikaciji, stoga nisu poznate sigurnost i djelotvornost lijeka Cyramza u toj populaciji.
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).
Croatian: Stopa kontrole bolesti (potpun odgovor plus djelomičan odgovor plus stabilna bolest) bila je brojčano veća u bolesnika liječenih ramucirumabom plus protokolom FOLFIRI nego u onih koji su primali placebo plus FOLFIRI (74,1% naspram 68,8%).
English: No drug-drug interactions were observed between ramucirumab and paclitaxel.
Croatian: Nisu primijećene interakcije između ramucirumaba i paklitaksela.
English: There are no data regarding ramucirumab administration in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Nema podataka o primjeni ramucirumaba u bolesnika s teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.4 i 5.2).
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.
Croatian: U ispitivanju REACH-2 početne značajke bolesti i demografske značajke bolesnika u načelu su bile dobro ujednačene između liječenih skupina, uz izuzetak AFP-a, koji je bio niži u skupini koja je primala placebo.
English: Your doctor will make sure that if you already have high blood pressure, it is brought under control before starting Cyramza.
Croatian: Ako već imate visok krvni tlak, liječnik će se pobrinuti da ga stavi pod kontrolu prije početka liječenja lijekom Cyramza.
English: Cyramza may increase the risk of problems with wound healing.
Croatian: Cyramza može povećati rizik od problema povezanih s cijeljenjem rana.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničen recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: - have liver cancer and have had previous bleeding from enlarged veins in your food pipe (oesophagus) or have high blood pressure in the portal vein, which carries the blood from the bowel and spleen to the liver.
Croatian: - imate rak jetre i prethodno ste imali krvarenje iz proširenih vena u jednjaku ili ako imate visok krvni tlak u portalnoj veni, koja prenosi krv iz crijeva i slezene u jetru.
English: Based on PopPK, ramucirumab exposure was similar in patients with mild renal impairment (creatinine clearance [CrCl] ≥60 to <90 ml/min), moderate renal impairment (CrCl ≥30 to <60 ml/min) or severe renal impairment (CrCl 15 to 29 ml/min) as compared to patients with normal renal function (CrCl ≥90 ml/min).
Croatian: Na temelju populacijske farmakokinetike, izloženost ramucirumabu bila je slična u bolesnika s blagim oštećenjem bubrežne funkcije (klirens kreatinina [CrCl] ≥ 60 do < 90 ml/min), umjerenim oštećenjem bubrežne funkcije (CrCl ≥ 30 do <60 ml/min) ili teškim oštećenjem bubrežne funkcije (CrCl 15 do 29 ml/min) kao i u onih s normalnom bubrežnom funkcijom (CrCl ≥ 90 ml/min).
English: - Abnormal urine test (‘proteinuria'): Cyramza may increase the risk of developing or worsening of abnormal levels of protein in the urine.
Croatian: - odstupanja u nalazima mokraćnih pretraga („proteinurija“): Cyramza može povećati rizik od razvoja ili pogoršanja prekomjernih razina proteina u mokraći.
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.
Croatian: Na temelju ograničenih podataka iz ispitivanja REGARD prikupljenih u bolesnika s HER2 pozitivnim rakom želuca ili adenokarcinomom gastroezofagealnog spoja te u bolesnika prethodno liječenih trastuzumabom (u ispitivanju RAINBOW), nije vjerojatno da će Cyramza imati štetnoga učinka ili da neće imati učinka u bolesnika s HER2 pozitivnim rakom želuca.
English: Each 10 ml vial contains approximately 17 mg sodium.
Croatian: Jedna bočica od 10 ml sadrži približno 17 mg natrija.
English: Women of childbearing potential/Contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on Cyramza and should be informed of the potential hazard to the pregnancy and foetus.
Croatian: Ženama reproduktivne dobi treba savjetovati da izbjegavaju trudnoću tijekom liječenja lijekom Cyramza te ih treba upozoriti na moguće rizike za trudnoću i plod.
English: Patients were randomised in a 2:1 ratio to receive an intravenous infusion of Cyramza 8 mg/kg (n= 238) or placebo (n= 117) every 2 weeks.
Croatian: Bolesnici su bili randomizirani u omjeru 2:1 za primanje intravenske infuzije lijeka Cyramza u dozi od 8 mg/kg (n=238) ili placeba (n=117) svaka dva tjedna.
English: A relevant exposure-efficacy association was observed for ramucirumab in REACH-2 (see section 5.2).
Croatian: Zabilježena je značajna povezanost izloženosti i djelotvornosti vezano uz primjenu ramucirumaba u ispitivanju REACH-2 (vidjeti dio 5.2).
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.
Croatian: Bolesnici su morali imati progresiju bolesti tijekom ili unutar 4 mjeseca nakon posljednje doze prvolinijske terapije za metastatsku bolest ili tijekom adjuvantnog liječenja ili unutar 6 mjeseci nakon posljednje doze adjuvantne terapije te su morali imati funkcionalni ECOG status od 0-1.
English: Branchburg New Jersey NJ 08876
Croatian: ImClone Systems LLC 33 ImClone Drive, Branchburg New Jersey NJ 08876
English: Your doctor or nurse will check for side effects during your infusion.
Croatian: Liječnik ili medicinska sestra će Vas nadzirati tijekom infuzije kako bi uočili moguće nuspojave.
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.
Croatian: Glavni ishod za djelotvornost u ispitivanju REACH-2 poduprli su i podaci o statistički značajnom poboljšanju preživljenja bez progresije bolesti u bolesnika liječenih lijekom Cyramza u odnosu na one koji su primali placebo.
English: Criteria to be met prior to FOLFIRI are provided in Table 2.
Croatian: Kriteriji koji moraju biti zadovoljeni prije primjene protokola FOLFIRI navedeni su u Tablici 2.
English: Table 11: Summary of efficacy data - ITT population Cyramza plus docetaxel N=628
Croatian: Tablica 11: Sažetak podataka o djelotvornosti - ITT populacija Cyramza plus docetaksel N=628
English: Based on ramucirumab's mechanism of action, it is likely that in animals, ramucirumab will inhibit angiogenesis and result in adverse effects on fertility (ovulation), placental development, developing foetuses and postnatal development.
Croatian: S obzirom na mehanizam djelovanja, ramucirumab će u životinja vjerojatno inhibirati angiogenezu te tako imati štetne učinke na plodnost (ovulaciju), razvoj posteljice,
English: Table 7: ADRs reported in patients treated with ramucirumab in combination with chemotherapy in phase 3 clinical trials (RAINBOW, REVEL and RAISE)
Croatian: Tablica 7: Nuspojave na lijek prijavljene u bolesnika liječenih ramucirumabom u kombinaciji s kemoterapijom u sklopu kliničkih ispitivanja faze 3 (RAINBOW, REVEL i RAISE)
English: Eleven (2.2%) of ramucirumab treated patients and two (0.5%) of control treated patients developed ADAs.
Croatian: Protutijela na lijek razvila su se u jedanaest (2,2%) bolesnika liječenih ramucirumabom te u dva (0,5%) bolesnika liječena kontrolnim lijekom.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Croatian: 4.1 Terapijske indikacije Rak želuca
English: ADRs are listed below by MedDRA body system organ class.
Croatian: Nuspojave na lijek navedene su u nastavku sukladno MedDRA klasifikaciji organskih sustava.
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.
Croatian: Opći poremećaji i reakcije na mjestu primjene periferni edem reakcije na infuzijua a Navedeni pojmovi predstavljaju skupinu događaja koji opisuju određeni medicinski koncept, a ne samo jedan događaj ili preporučeni pojam.
English: To be included in the study, patients were required to have total bilirubin of ≤1.5 mg/dl and AST and ALT ≤3 times ULN, or ≤5 times ULN if liver metastases were present.
Croatian: Da bi bili uključeni u ispitivanje, bolesnici su morali imati vrijednost ukupnog bilirubina ≤ 1,5 mg/dl te AST i ALT ≤ 3 puta iznad GGN-a, ili ≤ 5 puta iznad
English: Parenteral medicinal products should be inspected visually for particulate matter prior to administration.
Croatian: Lijekove za parenteralnu primjenu treba prije primjene vizualno pregledati kako bi se utvrdila moguća prisutnost čestica.
English: No patients had neutralising antibodies to ramucirumab.
Croatian: Niti jedan bolesnik nije imao neutralizirajuća protutijela na ramucirumab.
English: Efficacy, as measured by improvements in OS, was associated with increasing ramucirumab exposure range produced by 8 mg/kg ramucirumab given every 2 weeks and by 10 mg/kg ramucirumab given every 3 weeks.
Croatian: Djelotvornost, koja se mjerila poboljšanjima OS-a bila je povezana s porastom raspona izloženosti ramucirumabu postignutim nakon primjene ramucirumaba u dozi od 8 mg/kg svaka 2 tjedna te u dozi od 10 mg/kg svaka 3 tjedna.
English: Cyramza in combination with paclitaxel
Croatian: Cyramza u kombinaciji s paklitakselom
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ºC to 8 ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Pripremljeni lijek ne bi se smio čuvati dulje od 24 sata na temperaturi od 2ºC do 8ºC, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
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).
Croatian: Cyramza se primjenjuje za liječenje raka jetre koji je uznapredovao ili se ne može kirurški odstraniti, u odraslih osoba koje su prethodno bile liječene drugim lijekom protiv raka (sorafenibom) i koje imaju povišene razine određenog proteina u krvi (alfa-fetoproteina).
English: Efficacy results are shown in Table 11.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 11.
English: 11% of patients treated with Cyramza and 6% of patients on placebo discontinued therapy due to adverse events.
Croatian: Jedanaest posto (11%) bolesnika liječenih lijekom Cyramza i 6% bolesnika koji su primali placebo prekinulo je liječenje zbog nuspojava.
English: Table 2: Criteria to be met prior to FOLFIRI administration Criteria
Croatian: Tablica 2: Kriteriji koji moraju biti zadovoljeni prije primjene protokola FOLFIRI Kriterij neutrofili
English: A total of 1072 patients were randomised (1:1) to receive either Cyramza (n=536) at 8 mg/kg or placebo (n=536), in combination with FOLFIRI.
Croatian: Ukupno su 1072 bolesnika randomizirana (1:1) da primaju ili lijek Cyramza (n=536) u dozi od 8 mg/kg ili placebo (n=536), oba u kombinaciji s protokolom FOLFIRI.
English: - have severe kidney problems.
Croatian: - imate teške bubrežne tegobe.
English: Ramucirumab is a human receptor-targeted antibody that specifically binds VEGF Receptor 2 and blocks binding of VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand stimulated activation of VEGF Receptor 2 and its downstream signalling components, including p44/p42 mitogen-activated protein kinases, neutralising ligand-induced proliferation and migration of human endothelial cells.
Croatian: Rezultat toga je da ramucirumab inhibira ligandom stimuliranu aktivaciju VEGF receptora 2 i sve ostale signalizacijske komponente koje se na njega nadovezuju (engl. downstream signalling components), uključujući mitogenima aktivirane proteinske kinaze p44/p42, neutralizirajući tako ligandom induciranu proliferaciju i migraciju humanih endotelnih stanica.
English: Cyramza can cause blood clots in your arteries.
Croatian: Cyramza može uzrokovati nastanak krvnih ugrušaka u arterijama.
English: No liver metastases: ALT/AST ≤3 x ULN Liver metastases: ALT/AST ≤5 x ULN
Croatian: Bez jetrenih metastaza: ALT/AST ≤ 3 x GGN
English: Each 50 ml vial contains approximately 85 mg sodium.
Croatian: Jedna bočica od 50 ml sadrži približno 85 mg natrija.
English: Add a sufficient quantity of sodium chloride 9 mg/ml (0.9%) solution for injection to the container to make the total volume 250 ml.
Croatian: Dodajte dovoljnu količinu otopine natrijeva klorida za injekcije od 9 mg/ml (0,9%) u spremnik kako biste dobili konačan ukupan volumen od 250 ml.
English: 5-FU infusion 2,400 mg/m2 over 46-48 hours
Croatian: infuzija 5-FU 2400 mg/m2 tijekom 46 - 48 sati
English: There is insufficient data to evaluate the effects of ADAs on the efficacy or safety of ramucirumab.
Croatian: Nema dovoljno podataka da bi se ocijenili učinci protutijela na lijek na djelotvornost ili sigurnost ramucirumaba.
English: Pack of 1 vial of 50 ml.
Croatian: Pakiranje s 1 bočicom od 50 ml.
English: Paclitaxel dose reductions may be applied based upon the grade of toxicity experienced by the patient.
Croatian: Doza docetaksela može se smanjivati u skladu sa stupnjem toksičnosti koja se razvije kod bolesnika.
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.
Croatian: Medijan dobi iznosio je 62 godine, a 40% bolesnika bilo je u dobi od ≥ 65 godina; 57% bolesnika bili su muškarci; 76% bolesnika bili su bijelci, a 20% Azijci; 49% bolesnika imalo je funkcionalni ECOG status od 0; 49% bolesnika imalo je tumor s mutacijom gena KRAS, a u 24% bolesnika progresija je nastupila < 6 mjeseci nakon početka prvolinijskog liječenja.
English: Hepatic encephalopathy or hepatorenal syndrome (see section 4.4).
Croatian: Jetrene encefalopatije ili hepatorenalnog sindroma (vidjeti dio 4.4).
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).
Croatian: Medijan OS-a u bolesnika s neutropenijom bilo kojeg stupnja bio je dulji u skupini koja je primala ramucirumab (16,1 mjesec) nego u bolesnika koji su primali placebo (12,6 mjeseci).
English: Excipients: histidine, histidine monohydrochloride, sodium chloride, glycine, polysorbate 80, water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: histidin, histidinklorid, natrijev klorid, glicin, polisorbat 80, voda za injekcije.
English: Palmar-plantar erthyrodysaesthesia syndromeg
Croatian: Poremećaji kože i potkožnog tkiva sindrom palmarno-plantarne eritrodizestezijeg
English: Patients were required to have ECOG PS 0 or 1 and to have disease progression within 6 months of the last dose of first-line therapy.
Croatian: Bolesnici su morali imati funkcionalni ECOG status od 0 ili 1 te progresiju bolesti unutar 6 mjeseci od posljednje doze prvolinijske terapije.
English: - severe bleeding in your gut: symptoms may include extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Croatian: - teško krvarenje u crijevima: simptomi mogu uključivati izrazit umor, slabost, omaglicu ili promjene u boji stolice.
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.
Croatian: Na temelju izračunatog volumena ramucirumaba, uklonite odgovarajući volumen otopine natrijeva klorida za injekcije od 9 mg/ml (0,9%) iz napunjena spremnika za intravensku infuziju od 250 ml.
English: The primary QoL analysis showed similar time to deterioration for all Lung Cancer Symptom Scale (LCSS) scores between treatment arms.
Croatian: Primarna analiza kvalitete života u obje je skupine pokazala slično vrijeme do pogoršanja prema svim ljestvicama za ocjenu simptoma kod raka pluća (engl.
English: Each 10 ml vial contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Croatian: Jedna bočica od 10 ml sadrži manje od 1 mmol (23 mg) natrija, tj. zanemarive količine natrija.
English: If there is medically significant hypertension that cannot be controlled safely with antihypertensive therapy, ramucirumab therapy should be permanently discontinued (see section 4.4).
Croatian: U slučaju medicinski značajne hipertenzije koja se ne može sigurno kontrolirati antihipertenzivima, liječenje ramucirumabom mora se trajno obustaviti (vidjeti dio 4.4).
English: Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level.
Croatian: Nakon što se razina proteina u mokraći vrati na < 2 g/24 sata, liječenje treba nastaviti smanjenom dozom.
English: The recommended dose of docetaxel is 75 mg for every square metre (m²) of your body's surface area once every 3 weeks.
Croatian: Preporučena doza docetaksela je 75 mg na svaki četvorni metar (m2) tjelesne površine jedanput svaka
English: Efficacy results are shown in Table 9.
Croatian: Rezultati za djelotvornost prikazani su u Tablici 9.
English: Tél: +33-(0) 1 55 49 34 34
Croatian: Lilly France SAS Tél: +33-(0) 1 55 49 34 34
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.
Croatian: U Tablicama 6 i 7 u nastavku navedene su nuspojave na lijek zabilježene u placebom kontroliranim kliničkim ispitivanjima faze III koje su bile povezane s primjenom ramucirumaba u monoterapiji za liječenje raka želuca i hepatocelularnog karcinoma ili u kombinaciji s različitim kemoterapijskim protokolima za liječenje raka želuca, metastatskog kolorektalnog raka i NSCLC-a.
English: There were no patients with Child-Pugh B or C liver cirrhosis enrolled in REGARD.
Croatian: U ispitivanje REGARD nisu bili uključeni bolesnici s cirozom jetre Child-Pugh B ili C.
English: Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia have been reported in clinical studies.
Croatian: U kliničkim su ispitivanjima prijavljeni ozbiljni arterijski tromboembolijski događaji, koji su ponekad imali smrtni ishod, uključujući infarkt miokarda, srčani zastoj, cerebrovaskularni incident i ishemiju mozga.
English: Common side effects (may affect up to 1 in 10 people): - hole in the wall of your gut: this is a hole that develops in the stomach, gut or bowel.
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): - pukotina u stijenci crijeva: radi se o pukotini koja nastaje u želucu, tankom crijevu ili debelom crijevu.
English: Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome.
Croatian: Liječenje ramucirumabom mora se trajno obustaviti ako je razina proteina u mokraći > 3 g/24 sata ili ako se razvije nefrotski sindrom.
English: Cyramza is administered as an intravenous infusion.
Croatian: Cyramza se primjenjuje u obliku intravenske infuzije.
English: e Includes: abdominal pain, abdominal pain lower, abdominal pain upper, and hepatic pain.
Croatian: e Uključuje: bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena i bol u jetri.
English: - A hole in the wall of your gut (‘gastrointestinal perforation'): Cyramza may increase the risk of developing a hole in the wall of your gut.
Croatian: - pukotina u stijenci crijeva („perforacija u probavnom sustavu“): Cyramza može povećati rizik od nastanka pukotine u stijenci crijeva.
English: Sites in East Asia administered a reduced dose of docetaxel at 60 mg/m2 every 21 days.
Croatian: Na ispitivačkim mjestima u Istočnoj Aziji primjenjivala se smanjena doza docetaksela od 60 mg/m2 svakih 21 dan.
English: In severe cases, symptoms may include breathing distress caused by narrowing of the airways, faster heartbeat, and feeling faint.
Croatian: U teškim slučajevima simptomi mogu uključivati otežano disanje zbog suženja dišnih putova, ubrzane otkucaje srca i nesvjesticu.
English: b Includes: hypokalaemia and blood potassium decreased.
Croatian: b Uključuje: hipokalijemiju i smanjenu razinu kalija u krvi.
English: Ramucirumab therapy should be temporarily discontinued if there are wound healing complications, until the wound is fully healed (see section 4.4).
Croatian: Liječenje ramucirumabom mora se privremeno prekinuti u slučaju komplikacija s cijeljenjem rane, sve dok rana posve ne zacijeli (vidjeti dio 4.4).
English: For East Asian patients, a reduced docetaxel starting dose of 60 mg/m2 on day 1 of a 21 day cycle should be considered.
Croatian: U bolesnika istočnoazijskog podrijetla treba razmotriti primjenu smanjene početne doze docetaksela od 60 mg/m2 1. dana 21-dnevnog ciklusa.
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).
Croatian: Na temelju populacijske farmakokinetike, izloženost ramucirumabu u bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin > 1,0-1,5 puta iznad gornje granice normale (GGN) i bilo koja vrijednost AST-a ili ukupni bilirubin ≤ 1,0 GGN i AST > GGN) ili umjerenim oštećenjem jetrene funkcije (ukupni bilirubin > 1,5-3,0 GGN i bilo koja vrijednost AST-a)
English: Hypertensiona,e
Croatian: Krvožilni poremećaji hipertenzijaa,e
English: Pack of 2 vials of 10 ml.
Croatian: Pakiranje s 2 bočice od 10 ml.
English: No dose modification.
Croatian: Nije potrebno prilagođavati dozu.
English: ≥1.5 x 109/L
Croatian: ≥ 1,5 x 109/l trombociti
English: It is unknown whether ramucirumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se ramucirumab u majčino mlijeko.
English: Patients were randomised in a 1:1 ratio to receive Cyramza plus docetaxel (n=628) or placebo plus docetaxel (n=625).
Croatian: Bolesnici su randomizirani u omjeru 1:1 za primanje lijeka Cyramza plus docetaksela (n=628) ili za primanje placeba plus docetaksela (n=625).