FrancophonIA/ELRC3.0 huggingface dataset:
English: An improvement in PFS was also associated with increasing ramucirumab exposure for advanced gastric cancer, NSCLC, and mCRC.
Croatian: Poboljšanje PFS-a bilo je također povezano s porastom raspona izloženosti ramucirumabu kod bolesnika s uznapredovalim rakom želuca, rakom pluća nemalih stanica i metastatskim kolorektalnim rakom.
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.
Croatian: Preporučena doza paklitaksela je 80 mg/m2, a primjenjuje se intravenskom infuzijom tijekom približno 60 minuta 1., 8. i 15. dana 28-dnevnog ciklusa.
English: FOLFIRI chemotherapy is given by intravenous infusion, after the Cyramza infusion has finished.
Croatian: Kada primate lijek Cyramza u kombinaciji s kemoterapijom FOLFIRI Kemoterapija FOLFIRI primjenjuje se intravenskom infuzijom nakon završetka infuzije lijeka Cyramza.
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.
Croatian: Dostupni su vrlo ograničeni podaci o djelotvornosti i sigurnosti u tih bolesnika, pa se kod njih ramucirumab smije primjenjivati samo ako se prosudi da mogući korisni učinci liječenja nadmašuju mogući rizik od progresivnog zatajenja jetre.
English: Cyramza will be permanently stopped if you experience a severe infusion-related reaction.
Croatian: Primjena lijeka Cyramza trajno će se obustaviti ako nastupi teška reakcija na infuziju.
English: Ramucirumab therapy should be temporarily discontinued in the event of severe hypertension, until controlled with medical management.
Croatian: Liječenje ramucirumabom mora se privremeno prekinuti u slučaju teške hipertenzije, sve dok se ona liječenjem ne stavi pod kontrolu.
English: Cyramza is given in combination with paclitaxel, another anti-cancer medicine, 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.
Croatian: Cyramza se daje u kombinaciji s paklitakselom, još jednim lijekom protiv raka, za liječenje uznapredovalog raka želuca (ili raka na spoju između jednjaka i želuca) u odraslih osoba kod kojih se bolest pogoršala nakon terapije lijekovima za liječenje raka.
English: Chemotherapy-related gastrointestinal toxicity
Croatian: ≥ 100 x 109/l gastrointestinalna toksičnost povezana s kemoterapijom
English: Following the dose regimen of 8 mg/kg every 2 weeks, the geometric means of ramucirumab Cmin prior to administration of the fourth and seventh dose of ramucirumab given as a single agent in advanced gastric cancer patients' serum were 49.5 μg/ml (range of 6.3-228 μg/ml) and 74.4 μg/ml (range of 13.8-234 μg/ml), respectively.
Croatian: Nakon režima doziranja od 8 mg/kg svaka 2 tjedna, geometrijska srednja vrijednost Cmin prije primjene četvrte i sedme doze ramucirumaba u monoterapiji u serumu bolesnika s uznapredovalim rakom želuca iznosila je 49,5 μg/ml (raspon: 6,3-228 μg/ml) odnosno 74,4 μg/ml (raspon: 13,8-234 μg/ml).
English: Days 8 and 15: ≥75 x 109/L
Croatian: 1. dan: ≥ 100 x 109/l 8. i 15. dan: ≥ 75 x 109/l bilirubin
English: In the REACH-2 study for HCC, a relevant exposure-efficacy association was observed for ramucirumab which showed that only patients with above-median exposure experienced an improvement in OS, compared to placebo, and these exposure-efficacy relationships remained after attempts to adjust for other prognostic factors.
Croatian: U REACH-2 ispitivanju kod HCC-a, zabilježena je značajna povezanost izloženosti i djelotvornosti vezano uz primjenu ramucirumaba, što je pokazalo da je samo kod bolesnika s izloženošću ramucirumabu višom od medijana vrijednosti došlo do poboljšanja OS-a, u odnosu na placebo.
English: A hospital pharmacist, nurse or doctor will have diluted the contents of the vial with sodium chloride 9 mg/ml
Croatian: medicinska sestra ili liječnik će prije primjene razrijediti sadržaj bočice otopinom natrijeva klorida od
English: Cyramza will be permanently stopped if you experience severe bleeding.
Croatian: Primjena lijeka Cyramza trajno će se obustaviti ako kod Vas nastupi teško krvarenje.
English: How you are given Cyramza
Croatian: Kako ćete primati lijek Cyramza
English: Haematological criteria in Table 2 are met and fever resolved
Croatian: Zadovoljeni su hematološki kriteriji iz Tablice 2, a vrućica se povukla
English: Cyramza contains sodium
Croatian: Cyramza sadrži natrij
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.
Croatian: Prije razrjeđivanja pregledajte sadržaj bočice kako biste provjerili sadrži li čestice i je li promijenio boju (koncentrat za otopinu za infuziju mora biti bistar do blago opalescentan te bezbojan do blijedo žut i ne smije sadržavati vidljive čestice).
English: Symptoms included rigors/tremors, back-pain/spasms, chest pain and/or tightness, chills, flushing, dyspnoea, wheezing, hypoxia, and paraesthesia.
Croatian: Simptomi su uključivali tresavicu/tremor, bol u leđima/grčeve, bol i/ili stezanje u prsištu, zimicu, crvenilo praćeno osjećajem vrućine, dispneju, piskanje pri disanju, hipoksiju i paresteziju.
English: For patients with TTP ≥6 months after commencing first-line treatment the HR of OS was 0.86 (95% CI: 0.73 to 1.01), and 0.86 (95% CI: 0.64 to 1.13) in patients with TTP <6 months after commencing first-line treatment.
Croatian: U bolesnika kojima je bolest progredirala ≥ 6 mjeseci nakon početka prvolinijskog liječenja, HR za OS iznosio je 0,86 (95% CI: 0,73 do 1,01), dok je u bolesnika kojima je bolest progredirala < 6 mjeseci nakon početka prvolinijskog liječenja iznosio 0,86 (95% CI: 0,64 do 1,13).
English: Symptomatic treatment should be instituted promptly if stomatitis occurs.
Croatian: U slučaju razvoja stomatitisa potrebno je odmah uvesti simptomatsko liječenje.
English: Progression-free survival was statistically significantly improved in patients receiving Cyramza as compared with patients receiving placebo (HR 0.483; 95%CI: 0.376 to 0.620; p<0.0001), corresponding to a 52% reduction in the risk of progression or death and an increase in median PFS to 2.1 months for Cyramza from 1.3 months for placebo.
Croatian: Preživljenje bez progresije bolesti statistički se značajno poboljšalo u bolesnika koji su primali lijek Cyramza u odnosu na one koji su primali placebo (HR 0,483; 95% CI: 0,376 do 0,620; p=0,0001) te se rizik od progresije ili smrti smanjio za 52%, a medijan PFS-a produljio na 2,1 mjesec uz primjenu lijeka Cyramza u odnosu na 1,3 mjeseca uz placebo.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
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).
Croatian: Monoterapija lijekom Cyramza indicirana je za liječenje uznapredovalog raka želuca ili adenokarcinoma gastroezofagealnog spoja u odraslih bolesnika kod kojih je došlo do progresije bolesti nakon prethodne kemoterapije platinom ili fluoropirimidinom, a za koje nije prikladno liječenje u kombinaciji s paklitakselom (vidjeti dio 5.1).
English: The pharmacokinetics of irinotecan and its active metabolite, SN-38, were not affected when co-administered with ramucirumab.
Croatian: Istodobna primjena ramucirumaba nije utjecala na farmakokinetiku irinotekana ni njegova aktivnog metabolita SN-38.
English: Infusion-related reactions were reported in clinical studies with ramucirumab.
Croatian: U kliničkim ispitivanjima ramucirumaba prijavljene su reakcije na infuziju.
English: g Based on study RAISE (ramucirumab plus FOLFIRI).
Croatian: g Na temelju podataka iz ispitivanja RAISE (ramucirumab plus FOLFIRI).
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.
Croatian: U bolesnika koji su primali ramucirumab u kombinaciji s kemoterapijom prijavljena je povećana incidencija stomatitisa u usporedbi s bolesnicima koji su primali placebo plus kemoterapiju.
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.
Croatian: Ukupno preživljenje statistički se značajno poboljšalo u bolesnika koji su primali lijek Cyramza u odnosu na one koji su primali placebo (omjer hazarda [HR] 0,776; 95% CI: 0,603 do 0,998; p=0,0473) što odgovara smanjenju rizika od smrti za 22%, te produljenju medijana preživljenja na 5,2 mjeseca uz primjenu lijeka Cyramza u odnosu na 3,8 mjeseci uz placebo.
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.
Croatian: Cyramza se primjenjuje u kombinaciji s docetakselom, još jednim lijekom protiv raka, za liječenje odraslih bolesnika s uznapredovalim rakom pluća koji se pogoršao nakon terapije lijekovima za liječenje raka.
English: DO NOT FREEZE OR SHAKE the infusion solution.
Croatian: Otopina za infuziju ne smije se zamrzavati niti tresti.
English: Do not freeze or shake the infusion solution.
Croatian: Otopina za infuziju NE SMIJE SE ZAMRZAVATI NITI TRESTI.
English: Paclitaxel dose adjustments
Croatian: Prilagodba doze paklitaksela
English: i Based on study RAINBOW (ramucirumab plus paclitaxel) and study REVEL (ramucirumab plus docetaxel).
Croatian: Na temelju podataka iz ispitivanja RAINBOW (ramucirumab plus paklitaksel) i REVEL (ramucirumab plus docetaksel).
English: Paclitaxel and docetaxel are also given by a drip into a vein (intravenous infusion) over a period of approximately 60 minutes.
Croatian: Kada primate lijek Cyramza u kombinaciji s paklitakselom ili docetakselom Paklitaksel i docetaksel također se daju ukapavanjem u venu (intravenskom infuzijom) tijekom razdoblja od približno 60 minuta.
English: Tel: + 46-(0) 8 7378800
Croatian: Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800
English: In case of empty intravenous infusion container usage Aseptically transfer the calculated volume of ramucirumab into an empty intravenous infusion container.
Croatian: Aseptičkom tehnikom prebacite izračunati volumen ramucirumaba u prazan spremnik za intravensku infuziju.
English: Ramucirumab has not been studied in patients with severe hepatic impairment (total bilirubin >3.0 ULN and any AST).
Croatian: Ramucirumab nije ispitivan u bolesnika s teškim oštećenjem jetrene funkcije (ukupni bilirubin
English: Gastric cancer and gastro-oesophageal junction (GEJ) adenocarcinoma
Croatian: Rak želuca i adenokarcinom gastroezofagealnog spoja
English: Figure 8: Kaplan-Meier curves of Overall Survival for Cyramza versus placebo in REACH-2
Croatian: Slika 8: Kaplan-Meierove krivulje ukupnog preživljenja uz lijek Cyramza u odnosu na placebo u ispitivanju REACH-2
English: Table 3: Ramucirumab dose reductions for proteinuria Initial ramucirumab dose First dose reduction to Second dose reduction to
Croatian: Tablica 3: Smanjenje doze ramucirumaba kod proteinurije
English: See prescribing information for paclitaxel, for components of FOLFIRI and for docetaxel, as applicable, for premedication requirements and additional information.
Croatian: Za zahtjeve za premedikacijom i dodatne informacije, vidjeti Sažetke opisa svojstava lijeka za paklitaksel, sastavnice protokola FOLFIRI i docetaksel (prema potrebi).
English: There have been no formal studies with Cyramza in patients with hepatic impairment.
Croatian: Nisu provedena službena ispitivanja lijeka Cyramza u bolesnika s oštećenjem jetrene funkcije.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava trombocitopenijaa neutropenijaa
English: You may be given another medicine to reduce the risk of an infusion-related reaction before you receive Cyramza.
Croatian: Prije nego što primite lijek Cyramza, možda ćete primiti još jedan lijek koji će smanjiti rizik od pojave reakcije na infuziju.
English: Symptoms include severe abdominal pain, being sick (vomiting), fever or chills.
Croatian: Simptomi uključuju jaku bol u trbuhu, povraćanje, vrućicu ili zimicu.
English: Talk to your doctor or nurse before you are given Cyramza if you:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite lijek Cyramza ako: - imate bilo koju bolest koja povećava rizik od krvarenja.
English: Female fertility is likely to be compromised during treatment with ramucirumab based on studies in animals (see section 5.3).
Croatian: postoji vjerojatnost štetnog utjecaja liječenja ramucirumabom na plodnost žena (vidjeti dio 5.3).
English: Vials contain either 100 mg or 500 mg as a 10 mg/ml solution of ramucirumab.
Croatian: 100 mg ili 500 mg u obliku otopine ramucirumaba od 10 mg/ml.
English: For patients with NSCLC, ramucirumab is contraindicated where there is tumour cavitation or tumour involvement of major vessels (see section 4.4).
Croatian: Ramucirumab je kontraindiciran u bolesnika s NSCLC-om kojima je tumor kavitirao ili zahvatio velike krvne žile (vidjeti dio 4.4).
English: Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1).
Croatian: Cyramza je u kombinaciji s paklitakselom indicirana za liječenje uznapredovalog raka želuca ili adenokarcinoma gastroezofagealnog spoja u odraslih bolesnika kod kojih je došlo do progresije bolesti nakon prethodne kemoterapije platinom i fluoropirimidinom (vidjeti dio 5.1).
English: After dilution and preparation, the medicine must be used immediately.
Croatian: Lijek se mora primijeniti odmah nakon razrjeđivanja i pripreme.
English: ADRs of haemangioma and thrombotic microangiopathy were reported in ramucirumab clinical trials at a frequency of common (1.5%) and rare (0.03%), respectively, and through post-marketing reporting.
Croatian: U kliničkim ispitivanjima ramucirumaba prijavljeni su hemangiom, s čestom učestalošću (1,5%), te trombotska mikroangiopatija, čija je učestalost bila rijetka (0,03%).
English: d Based on study REVEL (ramucirumab plus docetaxel).
Croatian: d Na temelju podataka iz ispitivanja REVEL (ramucirumab plus docetaksel).
English: Placebo plus paclitaxel N=335
Croatian: Placebo plus paklitaksel N=335
English: One ml of concentrate contains 10 mg ramucirumab.
Croatian: Jedan ml koncentrata sadrži 10 mg ramucirumaba.
English: Cyramza will be permanently stopped if you develop a fistula.
Croatian: Primjena lijeka Cyramza trajno će se obustaviti ako nastane fistula.
English: For patients treated with Cyramza plus paclitaxel the median duration of therapy was 19 weeks, and for patients treated with placebo plus paclitaxel the median duration of therapy was 12 weeks.
Croatian: 19 tjedana, dok je u bolesnika koji su primali placebo plus paklitaksel medijan trajanja liječenja iznosio 12 tjedana.
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]).
Croatian: Jedina podskupina u kojoj je HR bio > 1 bila je podskupina bolesnika u kojih je progresija bolesti nastupila < 3 mjeseca nakon početka prvolinijskog liječenja bevacizumabom (HR 1,02 [95% CI:
English: In RAINBOW, the incidences of Grade ≥3 hypertension, neutropenia, and leukopenia were increased with higher ramucirumab exposure.
Croatian: U ispitivanju RAINBOW se s povećanjem izloženosti ramucirumabu povećavala i incidencija hipertenzije, neutropenije i leukopenije ≥ 3. stupnja.
English: Ramucirumab therapy should be temporarily discontinued for at least 4 weeks prior to elective surgery.
Croatian: Elektivni kirurški zahvat ili otežano cijeljenje rana Liječenje ramucirumabom mora se privremeno prekinuti najmanje 4 tjedna prije elektivnog kirurškog zahvata.
English: NSCLC patients with recent pulmonary bleeding (>2.5 ml or bright red blood) as well as patients with evidence of baseline tumour cavitation, regardless of histology, or those with any evidence of tumour invasion or encasement of major blood vessels have been excluded from clinical trials (see section 4.3).
Croatian: (> 2,5 ml ili svjetlocrvena krv), bolesnici u kojih su na početku ispitivanja postojali dokazi kavitacije tumora, neovisno o histološkom tipu, kao ni bolesnici u kojih su na početku ispitivanja postojali bilo kakvi dokazi da je tumor prodro ili okružio velike krvne žile (vidjeti dio 4.3).
English: Days 8 and 15: ≥1.0 x 109/L
Croatian: 1. dan: ≥ 1,5 x 109/l 8. i 15. dan: ≥ 1,0 x 109/l trombociti
English: A second reduction of 15 mg/m2 is recommended if these toxicities persist or reoccur.
Croatian: Ako navedene toksičnosti potraju ili se ponovno pojave, preporučuje se drugo smanjenje doze za 15 mg/m2.
English: Baseline demographics and disease characteristics were balanced.
Croatian: Skupine su bile ujednačene s obzirom na početne demografske značajke i značajke bolesti.
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.
Croatian: Rak pluća nemalih stanica Cyramza je u kombinaciji s docetakselom indicirana za liječenje lokalno uznapredovalog ili metastatskog raka pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) u odraslih bolesnika kod kojih je došlo do progresije bolesti nakon prethodne kemoterapije utemeljene na platini.
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.
Croatian: U ispitivanje nisu bili uključeni bolesnici s nedavnim ozbiljnim plućnim krvarenjem, krvarenjem u probavnom sustavu ili poslijeoperacijskim krvarenjem, bolesnici s dokazima krvarenja u središnjem živčanom sustavu (SŽS), bolesnici u kojih je tumor zahvatio glavni dišni put ili veliku krvnu žilu, bolesnici s intratumorskom kavitacijom te bolesnici koji su u anamnezi imali značajno krvarenje ili nekontrolirane trombotske poremećaje.
English: Docetaxel dose adjustments
Croatian: Prilagodbe doze docetaksela
English: - develop high blood pressure, until it is controlled with anti-hypertensive medicine - develop wound healing problems, until the wound is healed - will undergo planned surgery, four weeks prior to surgery
Croatian: Liječenje lijekom Cyramza privremeno će se prekinuti ako: - razvijete visok krvni tlak, sve dok se on ne stavi pod kontrolu lijekovima za liječenje visokog krvnog tlaka - se pojave problemi s cijeljenjem rana, sve dok rana potpuno ne zacijeli
English: Ramucirumab should be temporarily discontinued for severe hypertension until controlled with medical management.
Croatian: Primjena ramucirumaba mora se privremeno prekinuti u slučaju teške hipertenzije, sve dok se ona liječenjem ne stavi pod kontrolu.
English: Cmin prior to administration of the second, fourth and seventh dose of ramucirumab were 23.5 μg/ml (range of 2.9-76.5 μg/ml), 44.1 μg/ml (range of 4.2-137 μg/ml) and 60.2 μg/ml (range of
Croatian: Geometrijska srednja vrijednost Cmin ramucirumaba u serumu bolesnika s HCC-om iznosila je 23,5 μg/ml (raspon: 2,9-76,5 μg/ml) prije primjene druge doze, 44,1 μg/ml (raspon: 4,2-137 μg/ml) prije primjene četvrte doze te 60,2 μg/ml (raspon: 18,3-123 μg/ml) prije primjene sedme doze.
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.
Croatian: RAINBOW, globalno, randomizirano, dvostruko slijepo ispitivanje lijeka Cyramza plus paklitaksela naspram placeba plus paklitaksela, provedeno je u 665 bolesnika s lokalno recidivirajućim i neoperabilnim ili metastatskim rakom želuca (uključujući adenokarcinom gastroezofagealnog spoja)
English: Only use sodium chloride 9 mg/ml (0.9%) solution for injection as a diluent.
Croatian: Kao sredstvo za razrjeđivanje se smije koristiti samo otopina natrijeva klorida za injekcije od 9 mg/ml (0,9%).
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.
Croatian: hematemezu, hematoheziju, hemoroidalno krvarenje, Mallory-Weissov sindrom, melenu, ezofagealno krvarenje, rektalno krvarenje i krvarenje u gornjem dijelu probavnog sustava.
English: Cyramza 10 mg/ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA Cyramza 10 mg/ml koncentrat za otopinu za infuziju
English: There was an increase in median PFS of 1.5 months in favour of the Cyramza plus paclitaxel arm: 4.4 months in the Cyramza plus paclitaxel arm and 2.9 months in the placebo plus paclitaxel arm.
Croatian: Primijećeno je produljenje medijana PFS-a od 1,5 mjeseci u korist skupine liječene lijekom Cyramza plus paklitakselom: 4,4 mjeseca u skupini liječenoj lijekom Cyramza plus paklitakselom te 2,9 mjeseci u skupini koja je primala placebo plus paklitaksel.
English: Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level (see Table 3).
Croatian: Ako razina proteina u mokraći ponovno poraste na ≥ 2 g/24 sata, preporučuje se još jedno smanjenje doze (vidjeti Tablicu 3).
English: Withhold 5-FU for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 dose levels for 5-FU.
Croatian: Odgoditi primjenu 5-FU za najviše 28* dana, dok se nuspojava ne ublaži do ≤ 1. stupnja, a zatim smanjiti dozu 5-FU za 2 razine.
English: See docetaxel prescribing information for specific dosing advice.
Croatian: Za specifične savjete za doziranje docetaksela, vidjeti Sažetak opisa svojstava lijeka za docetaksel.
English: Ramucirumab should be permanently discontinued if medically significant hypertension cannot be controlled with antihypertensive therapy (see section 4.2).
Croatian: Primjena ramucirumaba mora se trajno obustaviti ako se medicinski značajna hipertenzija ne može kontrolirati antihipertenzivnom terapijom
English: EU/1/14/957/001-003
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/957/001-003
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).
Croatian: Post hoc analize nestratificirane podskupine bolesnika iz ispitivanja RAINBOW koji su prethodno bili liječeni trastuzumabom (n = 39) ukazale su na moguće povoljne učinke na preživljenje tih bolesnika (HR 0,679, 95% CI 0,327; 1,419) i pokazale su povoljne učinke na preživljenje bez progresije bolesti (PFS) (HR 0,399, 95% CI 0,194;
English: One ml of concentrate for solution for infusion contains 10 mg ramucirumab.
Croatian: Jedan ml koncentrata za otopinu za infuziju sadrži 10 mg ramucirumaba.