FrancophonIA/ELRC3.0 huggingface dataset:
English: • Unusual bruising or bleeding, such as a cut, that takes longer than usual to stop bleeding; or internal bleeding such as coughing up blood, vomiting up blood, dark tarry stools, or bright red blood in your stools; or bleeding in the brain leading to sudden numbness or paralysis on one side of the face, legs or arms, sudden severe headache or trouble seeing or difficulty speaking or swallowing
Croatian: • Neuobičajeno stvaranje modrica ili krvarenje, poput posjekotina kojima za prestanak krvarenja treba duže nego je očekivano; ili unutarnje krvarenje poput iskašljavanja krvi, povraćanja krvi, tamne stolice nalik katranu ili svijetlo crvene krvi u stolici; ili krvarenje u mozgu koje dovodi do iznenadne utrnulosti ili paralize na jednoj strani lica, nogu ili ruku, iznenadne jake glavobolje ili poteškoća s vidom, govorom ili gutanjem
English: Appropriate dose reduction for the starting dose of lenalidomide in patients with baseline renal impairment should be considered according to the recommendations in the lenalidomide summary of product characteristics.
Croatian: Potrebno je razmotriti odgovarajuće smanjenje početne doze lenalidomida u bolesnika koji na početku terapije imaju oštećenje bubrega, u skladu s preporukama u sažetku opisa svojstava lijeka za lenalidomid.
English: Kaplan-Meier curve of overall survival in relapsed multiple myeloma study 2011-003
Croatian: Slika 4. Kaplan-Meierova krivulja sveukupnog preživljenja dobivenog analizom kod recidivirajućeg multiplog mijeloma u ispitivanju 2011-003
English: HR (95% CI); 1-sided p-valueb
Croatian: HR (95% CI); jednostrana p-vrijednostb
English: Kyprolis, as a single agent, was administered intravenously over 30 minutes at 20 mg/m2 on days 1 and 2 and at 27 mg/m2 on days 8, 9, 15 and 16 of cycle 1.
Croatian: Kyprolis je, kao monoterapija, primijenjen intravenski tijekom 30 minuta u dozi od 20 mg/m2 1. i 2. dan, te u dozi od 27 mg/m2 8., 9., 15. i 16. dan 1. ciklusa.
English: Week 3
Croatian: Tjedan 3.
English: • Yellowing of your skin and eyes (jaundice), abdominal pain or swelling, nausea or vomiting, which could be symptoms of liver problems including liver failure.
Croatian: • Žuta boja kože i očiju (žutica), bolovi u trbuhu ili oticanje trbuha, mučnina ili povraćanje, što mogu biti simptomi problema s jetrom, uključujući zatajenje jetre.
English: Week 1
Croatian: Tjedan 1.
English: • Fever, chills or shaking, joint pain, muscle pain, facial flushing, or swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing (angioedema), weakness, shortness of breath, low blood pressure, fainting, chest tightness, or chest pain can occur as a reaction to the infusion
Croatian: • Kao reakcija na infuziju mogu se javiti vrućica, zimica ili tresavica, bol u zglobovima, bol u mišićima, navala crvenila ili oticanje lica, usana, jezika i/ili grla koje može dovesti do otežanog disanja ili gutanja (angioedem), slabost, nedostatak zraka, nizak krvni tlak, nesvjestica, stezanje u prsnom košu ili bol u prsnom košu
English: Patients being treated with Kyprolis should be advised not to drive or operate machines in the event that they experience any of these symptoms.
Croatian: U slučaju da se u bolesnika liječenih lijekom Kyprolis javi bilo koji od ovih simptoma, treba ih savjetovati da ne upravljaju vozilima ili strojevima.
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 bolesnika)
English: • Changes to blood tests (decreased blood levels of sodium, magnesium, protein, calcium or phosphate, increased blood levels of calcium, uric acid, potassium, bilirubin or c-reactive protein)
Croatian: • Promjene krvnih pretraga (smanjena razina natrija, magnezija, proteina, kalcija ili fosfata u krvi,
English: Deep vein thrombosis Hypotension Flushing
Croatian: Duboka venska tromboza Hipotenzija
English: Kyprolis will be given to you together with lenalidomide and dexamethasone, or only with dexamethasone.
Croatian: Kyprolis će se u Vas primijeniti zajedno s lenalidomidom i deksametazonom, ili samo s deksametazonom.
English: • Feeling confused
Croatian: • Osjećaj smetenosti
English: Week 4
Croatian: Tjedan 4.
English: Hypertensive crises (hypertensive urgency or hypertensive emergency) have occurred following administration of Kyprolis.
Croatian: Nakon primjene lijeka Kyprolis bilo je pojava hipertenzivne krize (hipertenzivne urgencije ili hipertenzivne hitnosti).
English: Patients with moderate or severe hepatic impairment were excluded from Kyprolis studies in combination with either lenalidomide and dexamethasone or dexamethasone alone.
Croatian: Bolesnici s umjerenim ili teškim oštećenjem jetre bili su isključeni iz ispitivanja kombinacije lijeka Kyprolis bilo s lenalidomidom i deksametazonom bilo samo s deksametazonom.
English: Together with Kyprolis you will also be given either lenalidomide and dexamethasone, or only dexamethasone.
Croatian: Zajedno s lijekom Kyprolis, također ćete primati ili lenalidomid i deksametazon ili samo deksametazon.
English: Dexamethasone (mg)
Croatian: Deksametazon (mg) a.
English: Acute respiratory distress syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving Kyprolis.
Croatian: U bolesnika liječenih lijekom Kyprolis bilo je pojava akutnog respiratornog distres sindroma (ARDS), akutnog respiratornog zatajenja te akutne difuzne infiltrativne plućne bolesti poput pneumonitisa i intersticijske bolesti pluća.
English: In patients who received prior lenalidomide (38%), median PFS was 12.9 months in the Kd arm versus 7.3 months in the Vd arm (HR = 0.69, 95% CI: 0.52, 0.92), ORR was 70.1% versus 59.3%.
Croatian: U bolesnika koji su prethodno liječeni lenalidomidom (38%), medijan PFS-a bio je 12,9 mjeseci za Kd skupinu naspram 7,3 mjeseci za Vd skupinu (HR = 0,69, 95% CI: 0,52, 0,92), vrijednost ORR bila je 70,1% naspram 59,3%.
English: In study PX-171-009 the incidence of venous thromboembolic events was 15.6% in the KRd arm and 9.0% in the Rd arm. Grade ≥ 3 venous thromboembolic events were reported in 5.6% of patients in the KRd arm and 3.9% of patients in the Rd arm.
Croatian: U ispitivanju PX-171-009, incidencija događaja venske tromboembolije bila je 15,6% u KRd skupini te 9,0% u Rd skupini.
English: Liver enzymes and bilirubin should be monitored at treatment initiation and monthly during treatment with carfilzomib, regardless of baseline values.
Croatian: Bez obzira na početne vrijednosti, jetreni enzimi i bilirubin trebaju se pratiti na početku liječenja i tijekom liječenja karfilzomibom na mjesečnoj razini.
English: When combined with dexamethasone, Kyprolis is administered intravenously as a 30 minute infusion on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15, and 16) followed by a 12-day rest period (days 17 to 28) as shown in table 2.
Croatian: U kombinaciji s deksametazonom, Kyprolis se primjenjuje intravenski kao infuzija u trajanju od 30 minuta, tijekom dva uzastopna dana, svaki tjedan kroz period od tri tjedna (1., 2., 8., 9., 15. i 16. dan), nakon čega slijedi period mirovanja od 12 dana (17. do 28. dan), kako je prikazano u tablici 2. Svaki period od 28 dana smatra se jednim terapijskim ciklusom.
English: Kaplan-Meier curve of progression-free survival in relapsed multiple myelomaa
Croatian: Slika 1. Kaplan-Meierova krivulja preživljenja bez progresije bolesti kod recidivirajućeg multiplog mijelomaa
English: Week 2
Croatian: Tjedan 2.
English: Patients treated with KRd reported improved Global Health Status, with higher Global Health Status/Quality of Life (QoL) scores compared with Rd over 18 cycles of treatment (multiplicity unadjusted 1-sided p-value = 0.0001) measured with the EORTC QLQ-C30, an instrument validated in multiple myeloma.
Croatian: Quality of Life) u usporedbi s Rd liječenjem kroz 18 ciklusa liječenja (jednostrana p-vrijednost bez korekcije za multiplicitet = 0,0001), kako je izmjereno pomoću EORTC QLQ-C30, upitnika koji je validiran za multipli mijelom.
English: When Kyprolis is combined with dexamethasone alone, dexamethasone is administered as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28 day cycles.
Croatian: U slučaju kombinacije lijeka Kyprolis i samo deksametazona, deksametazon se primjenjuje peroralno ili intravenski u dozi od 20 mg 1., 2., 8., 9., 15., 16., 22. i 23. dan ciklusa od 28 dana.
English: A statistically significant advantage in OS was observed in patients in the Kd arm compared to patients in the Vd arm (HR = 0.791; 95% CI: 0.65, 0.96; p-value = 0.010) (see figure 4).
Croatian: Statistički značajna prednost u ukupnom preživljenju (OS) je bila opažena kod bolesnika u Kd skupini u usporedbi s bolesnicima u Vd skupini (HR = 0,791; 95% CI: 0,65, 0,96; p-vrijednost = 0,010). (vidjeti sliku 4).
English: • Bleeding in the lungs
Croatian: • Krvarenje u plućima
English: Cases of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism with fatal outcomes, have been reported in patients who received Kyprolis.
Croatian: Slučajevi venske tromboembolije, uključujući duboku vensku trombozu i plućnu emboliju sa smrtnim ishodom, prijavljeni su u bolesnika u kojih je primjenjivan lijek Kyprolis.
English: Common (≥ 1/100 to < 1/10)
Croatian: Vrlo često (≥ 1/10) Često (≥ 1/100 i
English: The demographics and baseline characteristics for study 2011-003 were well-balanced between the two arms, including prior treatment with bortezomib (54%), prior treatment with lenalidomide (38%), lenalidomide refractory (25%), age (65 years, range 30-89 years), gender (51% male), ECOG performance status (45% with performance status 1), high risk genetic mutations, consisting of the genetic subtypes t(4;14) or t(14;16) in 10% or more of screened plasma cells, or deletion 17p in ≥ 20%
Croatian: Demografske i početne karakteristike u ispitivanju 2011-003 bile su dobro uravnotežene između dvije skupine, uključujući prethodno liječenje bortezomibom (54%), prethodno liječenje lenalidomidom (38%), bez odgovora na liječenje lenalidomidom (25%), dob (65 godina, raspon od 30 - 89 godina), spol (51% muškarci), ECOG izvedbeni status (45% s izvedbenim statusom 1), visokorizične genetičke mutacije koje uključuju genetičke podtipove t(4;14) ili t(14;16) u 10% ili više provjerenih plazma stanica, ili delecija 17p u ≥ 20% plazma stanica (23%), genetičke mutacije nepoznatog rizika što je uključivalo ispitanike s rezultatima koji nisu prikupljeni ili nisu analizirani (9%) i početni ISS stadij bolesti III (24%).
English: • Kidney problems, including kidney failure or if you have ever received dialysis
Croatian: • Problemi s bubrezima, uključujući zatajenje bubrega ili ako ste ikada primali dijalizu
English: • A history of blood clots in your veins
Croatian: • Krvni ugrušci u venama u povijesti bolesti
English: However, higher subject incidence of hepatic function abnormalities, ≥ grade 3 adverse events and serious adverse events have been reported in patients with mild or moderate baseline hepatic impairment compared with patients with normal hepatic function (see sections 4.4 and 5.2).
Croatian: Međutim, u bolesnika s blagim ili umjerenim početnim oštećenjem jetre prijavljena je veća incidencija abnormalnosti jetrene funkcije, nuspojava stupnja ≥ 3 i ozbiljnih nuspojava, u usporedbi s bolesnicima s normalnom funkcijom jetre (vidjeti dijelove 4.4 i 5.2).
English: Acute onset of chills, hypotension, renal insufficiency, thrombocytopenia and lymphopenia has been reported following a dose of 200 mg of Kyprolis administered in error.
Croatian: trombocitopenija i limfopenija prijavljeni su nakon što je greškom primijenjena doza lijeka Kyprolis od 200 mg.
English: • Runny nose, nasal congestion or sneezing
Croatian: • Curenje nosa, začepljen nos ili kihanje
English: Paraesthesia Hypoaesthesia
Croatian: Parestezija Hipoestezija
English: Multi-organ dysfunction syndrome
Croatian: Sindrom višestrukog organskog zatajenja
English: In patients who received prior bortezomib (54%), median PFS was 15.6 months in the Kd arm versus 8.1 months in the Vd arm (HR = 0.56, 95% CI: 0.44, 0.73), ORR was 71.2% versus 60.3%.
Croatian: U bolesnika koji su prethodno liječeni bortezomibom (54%), medijan PFS-a bio je 15,6 mjeseci za Kd skupinu naspram 8,1 mjeseci za Vd skupinu (HR = 0,56, 95% CI: 0,44, 0,73), vrijednost ORR bila je 71,2% naspram 60,3%.
English: No starting dose adjustment for Kyprolis is recommended in patients with baseline mild, moderate, or severe renal impairment or patients on chronic dialysis based on available pharmacokinetic data (see section 5.2).
Croatian: Na temelju dostupnih farmakokinetičkih podataka, ne preporučuje se prilagodba početne doze za Kyprolis u bolesnika koji na početku terapije imaju blago, umjereno ili teško oštećenje bubrega ili u bolesnika na kroničnoj dijalizi (vidjeti dio 5.2).
English: Each mL of reconstituted solution contains 7 mg of sodium.
Croatian: Pomoćna tvar s poznatim učinkom Svaki ml rekonstituirane otopine sadrži 7 mg natrija.
English: New or worsening cardiac failure (e.g. congestive cardiac failure, pulmonary oedema, decreased ejection fraction), myocardial ischaemia and infarction have occurred following administration of Kyprolis.
Croatian: Nakon primjene lijeka Kyprolis pojavili su se novo ili pogoršanje postojećeg zatajenja srca (npr. kongestivno zatajenje srca, edem pluća, smanjena istisna frakcija), ishemija te infarkt miokarda.
English: Please refer to the current lenalidomide summary of product characteristics.
Croatian: Molimo, pogledajte važeći sažetak opisa svojstava lijeka za lenalidomid.
English: Monkeys administered a single bolus intravenous dose of carfilzomib at 3 mg/kg (which corresponds to 36 mg/m2 and is similar to the recommended dose in humans of 27 mg/m2 based on BSA) experienced hypotension, increased heart rate, and increased serum levels of troponin T. The repeated bolus intravenous administration of carfilzomib at ≥ 2 mg/kg/dose in rats and 2 mg/kg/dose in monkeys using dosing schedules similar to those used clinically resulted in mortalities that were due to toxicities occurring in the cardiovascular (cardiac failure, cardiac fibrosis, pericardial fluid accumulation, cardiac haemorrhage/degeneration), gastrointestinal (necrosis/haemorrhage), renal (glomerulonephropathy, tubular necrosis, dysfunction), and pulmonary (haemorrhage/inflammation) systems.
Croatian: Opetovana intravenska bolus primjena karfilzomiba pri ≥ 2 mg/kg/dozi u štakora i pri 2 mg/kg/dozi u majmuna, uz raspored doziranja sličan onome koji se koristi i klinički, rezultirala je smrtnim ishodima koji su bili posljedica toksičnosti u kardiovaskularnom (zatajenje srca, fibroza srca, nakupljanje tekućine u perikardu, krvarenje/degeneracija srca), probavnom (nekroza/krvarenje), bubrežnom (glomerulonefropatija, nekroza tubula, oštećenje funkcije) i plućnom (krvarenje/upala) sustavu.
English: Do not administer as an intravenous push or bolus.
Croatian: Ne smije se primjenjivati kao intravenska doza ili bolus injekcija.
English: Kyprolis contains sodium
Croatian: Kyprolis sadrži natrij
English: How to store Kyprolis
Croatian: Kako čuvati Kyprolis
English: Kyprolis 60 mg powder for solution for infusion Each vial contains 60 mg of carfilzomib.
Croatian: Kyprolis 60 mg prašak za otopinu za infuziju Svaka bočica sadrži 60 mg karfilzomiba.
English: Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome (TTP/HUS) have been reported in patients who received Kyprolis.
Croatian: U bolesnika u kojih je primjenjivan lijek Kyprolis prijavljeni su slučajevi trombotične mikroangiopatije, uključujuči trombotičnu trombocitopeničnu purpuru i hemolitično-uremični sindrom (TTP/HUS).
English: • Infusion reaction
Croatian: • Reakcije povezane s infuzijom
English: Fatigue, dizziness, fainting, blurred vision, somnolence and/or a drop in blood pressure have been observed in clinical trials.
Croatian: U kliničkim ispitivanjima opaženi su umor, omaglica, nesvjestica, zamagljen vid, somnolencija i/ili smanjenje krvnog tlaka.
English: Kyprolis and dexamethasone
Croatian: Kyprolis i deksametazon
English: • Perforation of the digestive system
Croatian: • Puknuće (perforacija) probavnog sustava
English: Evaluate as appropriate.
Croatian: Procijenite bolesnika prema potrebi.
English: Excipients: Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Croatian: Pomoćne tvari: natrijev sulfobutileter betadeks, bezvodna citratna kiselina (E330), natrijev hidroksid.
English: In study 2011 003 the incidence of venous thromboembolic events was 12.5% in the Kd arm and 3.3% in the bortezomib plus dexamethasone (Vd) arm. Grade ≥ 3 venous thromboembolic events were reported in 3.5% of patients in the Kd arm and 1.8% of patients in the Vd arm.
Croatian: U ispitivanju 2011-003, incidencija događaja venske tromboembolije bila je 12,5% u Kd skupini te 3,3% u skupini liječenoj bortezomibom i deksametazonom (Vd skupina).
English: How to use Kyprolis
Croatian: Kako uzimati Kyprolis
English: Kaplan-Meier curve of overall survival in relapsed multiple myelomaa
Croatian: Slika 2. Kaplan-Meierova krivulja sveukupnog preživljenja dobivenog analizom kod recidivirajućeg multiplog mijelomaa
English: Kyprolis 30 mg powder for solution for infusion Each vial contains 30 mg of carfilzomib.
Croatian: Kyprolis 30 mg prašak za otopinu za infuziju Svaka bočica sadrži 30 mg karfilzomiba.
English: LIST OF EXCIPIENTS Betadex sulfobutyl ether sodium, anhydrous citric acid (E330), sodium hydroxide.
Croatian: POPIS POMOĆNIH TVARI Natrijev sulfobutileter betadeks, bezvodna citratna kiselina (E330), natrijev hidroksid.
English: sometimes spreading across to the neck and shoulders, sometimes with a fever
Croatian: • Oticanje ovojnice srca (perikarditis), simptomi uključuju bol iza prsne kosti koja se ponekad širi na vrat i ramena, ponekad uz vrućicu
English: Kyprolis 10 mg powder for solution for infusion Kyprolis 30 mg powder for solution for infusion Kyprolis 60 mg powder for solution for infusion carfilzomib
Croatian: Kyprolis 10 mg prašak za otopinu za infuziju Kyprolis 30 mg prašak za otopinu za infuziju Kyprolis 60 mg prašak za otopinu za infuziju karfilzomib
English: Discard unused portions in accordance with local requirements.
Croatian: Baciti neiskorišteni dio lijeka u skladu s lokalnim zahtjevima.
English: Pneumonia Respiratory tract infection
Croatian: Pneumonija Infekcija dišnog sustava
English: Dyspnoea was reported in approximately 30% of subjects in clinical studies with Kyprolis.
Croatian: U kliničkim ispitivanjima lijeka Kyprolis dispneja je prijavljena u otprilike 30% ispitanika.
English: Febrile neutropenia HUS
Croatian: Febrilna neutropenija
English: • Feeling weak
Croatian: • Osjećaj slabosti
English: Third Kyprolis dose reduction
Croatian: Treće smanjenje doze lijeka Kyprolis
English: Kyprolis in combination with lenalidomide and dexamethasonea
Croatian: Kyprolis u kombinaciji s lenalidomidom i deksametazonom
English: Cases of haemorrhage (e.g. gastrointestinal, pulmonary and intracranial haemorrhage) have been reported in patients treated with Kyprolis, often associated with thrombocytopenia.
Croatian: U bolesnika liječenih lijekom Kyprolis prijavljeni su slučajevi krvarenja (npr. gastrointestinalno, pulmonalno ili intrakranijalno krvarenje), često povezani s trombocitopenijom.
English: For men taking Kyprolis
Croatian: Za muškarce koji uzimaju Kyprolis
English: Non-haematologic toxicity (renal)
Croatian: Nehematološka toksičnost (bubrežna)
English: First Kyprolis dose reduction
Croatian: Prvo smanjenje doze lijeka Kyprolis
English: PFS months median (95% CI) HR (95% CI); 1-sided p-valueb
Croatian: PFS u mjesecima, medijan (95% CI) HR (95% CI); jednostrana p-vrijednostb
English: Progression/Death, n (%) Median PFS, mo HR (KRd/Rd) (95% CI) p-value (1-sided)
Croatian: Progresija/smrt,n (%) Medijan PFS-a, mj HR (KRd/Rd) (95% CI) p-vrijednost (jednostrana)
English: Uric acid lowering medicinal products should be considered in patients at high risk for TLS.
Croatian: U bolesnika s visokim rizikom od TLS-a treba razmotriti primjenu lijekova za sniženje mokraćne kiseline.
English: Dose modifications during Kyprolis treatment
Croatian: Tablica 3. Prilagodba doze pri liječenju lijekom Kyprolis
English: Kyprolis Dose
Croatian: Doza lijeka Kyprolis
English: Hypertension, including hypertensive crisis and hypertensive emergency, has been observed with Kyprolis.
Croatian: Prilikom primjene lijeka Kyprolis bila je opažena hipertenzija, uključujući hipertenzivnu krizu i hitnost.
English: Pneumonitis
Croatian: Trombocitopenija
English: OS months median (95% CI) HR (95% CI); 1-sided p-valueb
Croatian: OS u mjesecima, medijan (95% CI) HR (95% CI); jednostrana p-vrijednostb
English: Progression/Death, n (%) Median PFS, mo HR (Kd/Vd) (95% CI) p-value (1-sided)
Croatian: Progresija/smrt,n (%) Medijan PFS-a, mj HR (Kd/Vd) (95% CI) p-vrijednost (jednostrana)
English: 15 mg/m2 dose cycle 1, day 1 for mild, moderate, severe renal impairment and chronic dialysis versus normal renal function were 124.36%, 111.07%, 84.73% and 121.72%, respectively.
Croatian: Omjer geometrijskih sredina za AUClast pri dozi od 15 mg/m2 1. dana 1. ciklusa iznosio je 124,36% za blago, 111,07% za umjereno i 84,73% za teško oštećenje bubrega, te 121,72% za kroničnu dijalizu, naspram normalne funkcije bubrega.
English: 10 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a light blue plastic flip off cap.
Croatian: Prozirna staklena bočica (staklo tipa I) od 10 ml, zatvorena čepom (elastomer obložen fluoropolimerom) i zatvaračem (aluminij) sa svijetloplavim plastičnim poklopcem.
English: Cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving Kyprolis.
Croatian: U bolesnika liječenih lijekom Kyprolis prijavljeni su slučajevi sindroma posteriorne reverzibilne encefalopatije (PRES, od engl. posterior reversible encephalopathy syndrome).
English: • Fluid in the lungs
Croatian: • Tekućina u plućima
English: • Bone pain, muscle pain, chest pain
Croatian: • Bol u kostima, bol u mišićima, bol u prsnom košu
English: Give an additional 250 mL to 500 mL of intravenous fluids as needed following Kyprolis administration in cycle 1.
Croatian: Nakon primjene lijeka Kyprolis u 1. ciklusu, prema potrebi intravenski primijenite dodatnih 250 ml ili 500 ml tekućine.
English: Kύπρος
Croatian: Κύπρος
English: 50 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with a purple plastic flip off cap.
Croatian: Prozirna staklena bočica (staklo tipa I) od 50 ml, zatvorena čepom (elastomer obložen fluoropolimerom) i zatvaračem (aluminij) s ljubičastim plastičnim poklopcem.
English: Stop Kyprolis for grade 3 or 4 cardiac events until recovery and consider whether to restart Kyprolis at 1 dose level reduction based on a benefit/risk assessment (see section 4.2).
Croatian: U slučaju srčanih događaja 3. ili 4. stupnja prekinite primjenu lijeka Kyprolis do oporavka i razmotrite ponovno uvođenje lijeka Kyprolis uz smanjenje doze za 1 razinu, ovisno o procjeni koristi i rizika (vidjeti dio 4.2).
English: Second Kyprolis dose reduction
Croatian: Drugo smanjenje doze lijeka Kyprolis
English: The geometric mean ratios in AUClast at the 27 mg/m2 dose cycle 1, day 16 and at the 56 mg/m2 dose cycle 2, day 1 for ESRD versus normal renal function were 139.72% and 132.75%, respectively.
Croatian: Omjer geometrijskih sredina za AUClast iznosio je 139,72% pri dozi od 27 mg/m2 16. dana 1. ciklusa odnosno 132,75% pri dozi od 56 mg/m2 1. dana 2. ciklusa za ZSBB naspram normalne funkcije bubrega.
English: 30 mL type I clear glass vial, closed with fluoropolymer laminated elastomeric stopper and aluminium seal with an orange plastic flip off cap.
Croatian: Prozirna staklena bočica (staklo tipa I) od 30 ml, zatvorena čepom (elastomer obložen fluoropolimerom) i zatvaračem (aluminij) s narančastim plastičnim poklopcem.
English: Acute kidney injury Renal failure Renal impairment Decreased creatinine renal clearance
Croatian: Zatajenje bubrega Oštećenje bubrega Smanjen bubrežni klirens kreatinina