FrancophonIA/ELRC3.0 huggingface dataset:
English: In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
Croatian: U KLL-u je ukupna incidencija poremećaja živčanog sustava stupnja 3 ili 4 bila niska i u ispitivanju prve linije liječenja (4% R-FC, 4% FC) i u ispitivanju relapsirajuće/refraktorne bolesti (3% R-FC, 3% FC).
English: MabThera intravenous formulation was used at the standard dose of 375 mg/m2.
Croatian: MabThera u formulaciji za intravensku primjenu davala se u standardnoj dozi od 375 mg/m2 površine tijela.
English: Skin and subcutaneous tissue disorders alopecia
Croatian: Poremećaji kože i potkožnog tkiva alopecija svrbež urtikarija poremećaj kože
English: patients.
Croatian: DJECE
English: The majority of patients had received MabThera in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Croatian: Većina bolesnika primala je lijek MabThera u kombinaciji s kemoterapijom ili u postupku transplantacije hematopoetskih matičnih stanica.
English: collapse
Croatian: Cijepljenje
English: ORR, % CR,
Croatian: ORR je iznosio 38%
English: Angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction have occurred in patients treated with MabThera.
Croatian: U bolesnika liječenih lijekom MabThera pojavljivali su se angina pektoris, srčane aritmije poput undulacije i fibrilacije atrija, zatajenje srca i/ili infarkt miokarda.
English: The dose of 1600 mg of MabThera subcutaneous formulation was selected for the Part 2 of the study.
Croatian: Za 2. dio ispitivanja odabrana je doza supkutane formulacije lijeka MabThera od 1600 mg.
English: In CLL, the overall incidence of grade 3 or 4 cardiac disorders was low both in the first-line study (4% R-FC, 3% FC) and in the relapsed/refractory study (4% R-FC, 4% FC).
Croatian: U KLL-u je ukupna incidencija srčanih poremećaja stupnja 3 ili 4 bila niska i u ispitivanju prve linije liječenja (4% R-FC, 3% FC) i u ispitivanju relapsirajuće/refraktorne bolesti (4% R-FC, 4% FC).
English: virus.
Croatian: ciklusa.
English: Also do not breast-feed for 12 months after your last treatment with MabThera.
Croatian: Ne smijete dojiti dijete tijekom liječenja lijekom MabThera i još 12 mjeseci nakon posljednje primjene lijeka jer se MabThera može izlučiti u majčino mlijeko.
English: Cases of hepatitis B reactivation have been reported in patients receiving the MabThera intravenous formulation including fulminant hepatitis with fatal outcome.
Croatian: U osoba koje su primale formulaciju lijeka MabThera za intravensku primjenu prijavljeni su slučajevi reaktivacije hepatitisa B, uključujući fulminantni hepatitis sa smrtnim ishodom.
English: Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera.
Croatian: MabThera ili nekoliko mjeseci nakon liječenja lijekom MabThera.
English: België/Belgique/Belgien N.V. Roche S.A.
Croatian: België/Belgique/Belgien
English: The European Medicines Agency has waived the obligation to submit the results of studies with MabThera in all subsets of the paediatric population with follicular lymphoma and CLL.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka MabThera u svim podskupinama pedijatrijske populacije s folikularnim limfomom i KLL-om.
English: • Weight loss
Croatian: • probavne tegobe
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with MabThera resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 7).
Croatian: Terapija održavanja lijekom MabThera u bolesnika s prethodno neliječenim folikularnim limfomom dovela je do klinički i statistički značajnog poboljšanja u primarnoj mjeri ishoda, tj. preživljenju bez progresije bolesti (PFS) prema procjeni ispitivača, u usporedbi s opservacijskom skupinom (Tablica 7).
English: Further, a significantly higher proportion of patients achieved MCIDs for these scores (Table 14).
Croatian: Nadalje, značajno je veći udio bolesnika postigao
English: Table 2 Efficacy results for SABRINA (BO22334) (Intent to Treat Population) Pooled Stages 1 & 2 N = 410
Croatian: Tablica 2 Rezultati za djelotvornost u ispitivanju SABRINA (BO22334) (populacija s namjerom liječenja)
English: Methotrexate (MTX) naïve populations with rheumatoid arthritis The use of MabThera is not recommended in MTX-naïve patients since a favourable benefit risk relationship has not been established.
Croatian: Bolesnici s reumatoidnim artritisom koji prethodno nisu liječeni metotreksatom Primjena lijeka MabThera ne preporučuje se u bolesnika koji prethodno nisu bili liječeni metotreksatom jer nije utvrđen povoljan omjer koristi i rizika.
English: MabThera subcutaneous formulation MabThera intravenous formulation
Croatian: MabThera u formulaciji za supkutanu primjenu MabThera za intravensku primjenu
English: • A complex of symptoms occurring within a few weeks of an infusion of MabThera including allergic like reactions such as rash, itching, joint pain, swollen lymph glands and fever
Croatian: MabThera, a obuhvaćaju reakcije nalik alergijskima kao što su osip, svrbež, bol u zglobovima, otečeni limfni čvorovi i vrućica
English: MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a blue plastic flip-off disk.
Croatian: Kako MabThera 1600 mg otopina za supkutanu injekciju izgleda i sadržaj pakiranja MabThera je bistra do opalescentna, bezbojna do žućkasta tekućina spremna za uporabu, dostupna u obliku otopine za supkutanu injekciju u bezbojnoj staklenoj bočici s butilnim gumenim čepom zabrtvljenim aluminijskim prstenom i plavim plastičnim „flip-off“ poklopcem.
English: Results from trial BP22333 are presented in section 5.2.
Croatian: BP22333 prikazani su u dijelu 5.2. Ispitivanje BO22334 (SABRINA)
English: Since hypotension may occur during MabThera administration, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to giving MabThera.
Croatian: S obzirom da tijekom primjene lijeka MabThera može doći do hipotenzije, potrebno je razmotriti mogućnost izostavljanja antihipertenzivne terapije 12 sati prije davanja infuzije.
English: Cases of posterior reversible encephalopathy syndrome (PRES) / reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Croatian: Neurološki događaji Prijavljeni su slučajevi sindroma reverzibilne posteriorne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) odnosno sindroma reverzibilne posteriorne leukoencefalopatije (engl. reversible posterior leukoencephalopathy syndrome, RPLS).
English: • short term increase in the amount of some types of anti-bodies in the blood (called immunoglobulins - IgM), chemical disturbances in the blood caused by break-down of dying cancer cells
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): · kratkotrajno povišenje količine nekih vrsta protutijela u krvi (imunoglobulina - IgM), kemijski poremećaji krvi uzrokovani raspadanjem umirućih stanica raka · oštećenje živaca u rukama i nogama, paraliza lica
English: The recommended dosage of MabThera for the treatment of pemphigus vulgaris is 1000 mg administered as an IV infusion followed two weeks later by a second 1000 mg IV infusion in combination with a tapering course of glucocorticoids.
Croatian: Preporučena doza lijeka MabThera za liječenje običnog pemfigusa iznosi 1000 mg primijenjeno intravenskom infuzijom, a potom se nakon dva tjedna primjenjuje druga doza od 1000 mg intravenskom infuzijom u kombinaciji s glukokortikoidima čija se doza postupno smanjuje.
English: EFS - Event Free Survival TTP - Time to progression or death PFS - Progression-Free Survival TTF - Time to Treatment Failure OS rates - survival rates at the time of the analyses
Croatian: Time to progression or death) PFS - preživljenje bez progresije bolesti
English: Musculo skeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Croatian: Poremećaji mišićno-koštanog sustava artralgija/bol u kostima i mišićima,
English: Do not take MabThera if:
Croatian: Nemojte primati lijek MabThera
English: Keep the vial in the outer carton, in order to protect from light.
Croatian: Čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: The pre-specified primary analysis was conducted at a median observation time of 25 months from randomization, maintenance therapy with MabThera resulted in a clinically relevant and statistically significant improvement in the primary endpoint of investigator assessed progression-free survival (PFS) as compared to observation in patients with previously untreated follicular lymphoma (Table 4).
Croatian: Terapija održavanja lijekom MabThera u bolesnika s prethodno neliječenim folikularnim limfomom dovela je do klinički i statistički značajnog poboljšanja u primarnoj mjeri ishoda, tj. preživljenju bez progresije bolesti (PFS) prema procjeni ispitivača, u usporedbi s opservacijskom skupinom (Tablica 4).
English: Following induction of remission with other standard of care immunosuppressants, MabThera maintenance treatment should be initiated during the 4 week period that follows disease remission.
Croatian: terapiju održavanja lijekom MabThera treba započeti tijekom 4-tjednog razdoblja nakon nastupa remisije bolesti.
English: • feeling restless, problems falling asleep
Croatian: · nemir, teškoće s usnivanjem
English: late neutropenia2 Serum sickness-like reaction
Croatian: reakcija nalik serumskoj bolesti
English: Vascular disorders hypertension, orthostatic hypotension, hypotension vasculitis (predominatel y cutaneous), leukocytoclast ic vasculitis
Croatian: Krvožilni poremećaji hipertenzija, ortostatska hipotenzija, hipotenzija vaskulitis (pretežno kutani),
English: Patients treated with MabThera in combination with methotrexate had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Table 12).
Croatian: U bolesnika liječenih lijekom MabThera u kombinaciji s metotreksatom došlo je do značajno većeg smanjenja aktivnosti bolesti (DAS28, od engl.
English: Adverse reactions reported in MabThera intravenous formulation usage
Croatian: Nuspojave prijavljene kod primjene formulacije lijeka MabThera za intravensku primjenu
English: How to store MabThera
Croatian: Kako čuvati lijek MabThera
English: Each vial contains 1400 mg/11.7 mL rituximab.
Croatian: 1 bočica sadrži 1400 mg/11,7 ml rituksimaba.
English: PFS - Progression-Free Survival (proportion with event, disease progression/relapse or death from any cause) a - at end of Induction b - at time of final analysis (median follow-up 58 months)
Croatian: Progression-Free Survival) (udio bolesnika s događajem: progresija/relaps bolesti ili smrt zbog bilo kojeg uzroka)
English: MabThera subcutaneous formulation contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered substances when administered subcutaneously.
Croatian: (rHuPH20), enzim koji se koristi za povećanje disperzije i apsorpcije istodobno primijenjenih lijekova kada se oni primjenjuju supkutano.
English: At Week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
Croatian: ACR50 u usporedbi sa seronegativnim bolesnicima (p = 0,0312 i p = 0,0096) (Tablica 15).
English: Diluted medicinal product
Croatian: Razrijeđen lijek
English: At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, patients were randomly assigned to receive either MabThera (two 500 mg IV infusions separated by two weeks (on Day 1 and Day 15) followed by 500 mg IV every 6 months for
Croatian: Nakon postizanja remisije, a unutar najviše mjesec dana od primjene posljednje pulsne doze ciklofosfamida, bolesnici su bili randomizirani za primanje lijeka MabThera (dvije i.v. infuzije od 500 mg u razmaku od dva tjedna [1. dana i 15. dana], a zatim 500 mg i.v. svakih 6 mjeseci tijekom 18 mjeseci) ili azatioprina (primijenjenog peroralno u dozi od 2 mg/kg na dan tijekom 12 mjeseci, zatim u dozi od 1,5 mg/kg na dan tijekom 6 mjeseci i na kraju u dozi od 1 mg/kg na dan tijekom 4 mjeseca [prekid liječenja nakon ta 22 mjeseca]).
English: The rate of overall infections and serious infections was not increased after the development of low IgA, IgG or IgM.
Croatian: Stopa svih infekcija i ozbiljnih infekcija nije se povećala nakon nastupa niskih vrijednosti
English: Each vial contains 1600 mg/ 13.4 mL rituximab.
Croatian: 1 bočica sadrži 1600 mg/13,4 ml rituksimaba.
English: Cases of hepatitis B reactivation, including those with a fatal outcome, have been reported in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis patients receiving MabThera.
Croatian: Infekcije virusom hepatitisa B U bolesnika s reumatoidnim artritisom, granulomatozom s poliangitisom i mikroskopskim poliangitisom koji su primali lijek MabThera prijavljeni su slučajevi reaktivacije hepatitisa B, uključujući one sa smrtnim ishodom.
English: The majority of patients had received MabThera in combination with chemotherapy or as part of a haematopoetic stem cell transplant.
Croatian: Većina je bolesnika primala lijek MabThera u kombinaciji s kemoterapijom ili u sklopu presađivanja hematopoetskih matičnih stanica.
English: Rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris
Croatian: Reumatoidni artritis, granulomatoza s poliangitisom, mikroskopski poliangitis i obični pemfigus
English: FC) for the first-line study (Table 10a and Table 10b) and 552 patients (276 R-FC, 276 FC) for the relapsed/refractory study (Table 11) were analysed for efficacy.
Croatian: Analizom djelotvornosti obuhvaćeno je ukupno 810 bolesnika (403 R-FC, 407 FC) u ispitivanju prve linije liječenja (Tablica 10a i Tablica 10b) i 552 bolesnika (276 R-FC, 276 FC) u ispitivanju relapsirajuće/refraktorne bolesti (Tablica 11).
English: Complete response (CR/CRu) rate* 48% 67% 53% 67% chi-squared test p value odds ratio (95% CI)
Croatian: log-rang p-vrijednost omjer hazarda (95% CI) smanjenje rizika Stopa ukupnog odgovora* p-vrijednost iz hi-kvadrat testa omjer izgleda (95% CI) Stopa potpunog odgovora (CR/CRu)* p-vrijednost iz hi-kvadrat testa omjer izgleda (95% CI)
English: The most common infections in the MabThera group were herpes simplex and zoster infections, bronchitis, urinary tract infection, fungal infection and conjunctivitis.
Croatian: Najčešće infekcije u skupini koja je primala lijek MabThera bile su herpes simplex i herpes zoster, bronhitis,
English: The clinical experience of MabThera subcutaneous formulation in Non-Hodgkin's lymphoma is based on data from a phase III clinical trial (SABRINA BO22334) in patients with follicular lymphoma (FL) and a phase Ib dose-finding/dose-confirmation trial (SparkThera BP22333) in patients with FL.
Croatian: BO22334) u bolesnika s folikularnim limfomom (FL) te ispitivanja faze Ib namijenjenog utvrđivanju/potvrđivanju doze (SparkThera BP22333) u bolesnika s FL-om.
English: 4 see also section infusion-related reactions below.
Croatian: Vidjeti i dio o reakcijama povezanima s infuzijom u nastavku.
English: The frequencies of ADRs reported with MabThera alone or in combination with chemotherapy are summarised in Table 1.
Croatian: Učestalost nuspojava prijavljenih pri primjeni lijeka MabThera u monoterapiji ili u kombinaciji s kemoterapijom sažeta je u Tablici
English: This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphaetemia, acute renal failure, elevated lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Croatian: hipokalcijemijom, hiperfosfatemijom, akutnim zatajenjem bubrega, povišenom razinom laktat dehidrogenaze (LDH), kao i s akutnim zatajenjem dišnog sustava i smrću.
English: Patients achieving at least partial response (PR) were entered on the MabThera subcutaneous formulation maintenance therapy once every 8 weeks for 24 months.
Croatian: MabThera u formulaciji za supkutanu primjenu jedanput svakih 8 tjedana tijekom 24 mjeseca.
English: During the treatment course in studies with MabThera in combination with chemotherapy, grade 3/4 leucopoenia (R-CHOP 88% vs. CHOP 79%), neutropenia (R-CVP 24% vs. CVP 14%; R-CHOP 97% vs. CHOP 88%), were usually reported with higher frequencies when compared to chemotherapy alone.
Croatian: Za vrijeme liječenja u ispitivanjima lijeka MabThera u kombinaciji s kemoterapijom obično su s većom učestalošću u usporedbi s primjenom samo kemoterapije prijavljene: leukopenija stupnja 3/4 (R-CHOP 88% naspram CHOP 79%), neutropenija (R-CVP 24%
English: NAME OF THE MEDICINAL PRODUCT MabThera 1600 mg solution for subcutaneous injection
Croatian: NAZIV LIJEKA MabThera 1600 mg otopina za supkutanu injekciju
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 500 mg concentrate for solution for infusion Rituximab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MabThera 500 mg koncentrat za otopinu za infuziju rituksimab i.v.
English: The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is: 1400 mg once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 administrations in total).
Croatian: Preporučena doza lijeka MabThera u terapiji održavanja u bolesnika s relapsirajućim/refraktornim folikularnim limfomom koji su odgovorili na uvodno liječenje iznosi 375 mg/m površine tijela jedanput svaka 3 mjeseca (počevši 3 mjeseca nakon zadnje doze uvodne terapije) do progresije bolesti ili najdulje dvije godine (ukupno 8 infuzija).
English: Significant difference from placebo + MTX at the primary timepoint: ***p ≤ 0.0001
Croatian: † Ishod nakon 24 tjedna Značajna razlika u odnosu na placebo + metotreksat u trenutku primarne mjere ishoda: ***p ≤ 0,0001
English: NAME OF THE MEDICINAL PRODUCT MabThera 1400 mg solution for subcutaneous injection
Croatian: NAZIV LIJEKA MabThera 1400 mg otopina za supkutanu injekciju
English: PML).
Croatian: (PV).
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with CLL.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja rituksimaba u svim podskupinama pedijatrijske populacije s KLL-om.
English: Subcutaneous injections
Croatian: infiltracija pluća
English: MabThera intravenous formulation
Croatian: MabThera za intravensku primjenu
English: MabThera 1600 mg solution for subcutaneous injection rituximab
Croatian: MabThera 1600 mg otopina za supkutanu injekciju rituksimab
English: MabThera is associated with infusion/administration-related reactions, which may be related to release of cytokines and/or other chemical mediators.
Croatian: Primjena lijeka MabThera povezuje se s reakcijama na infuziju/primjenu, koje mogu biti povezane s otpuštanjem citokina i/ili drugih kemijskih medijatora.
English: InSparkThera, no severe administration-related reactions were reported.
Croatian: Nisu opažene ozbiljne reakcije povezane s infuzijom.
English: In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) (< 7 g/L) after induction treatment in both the observation and the MabThera groups.
Croatian: IgG-a nakon početne terapije bio je ispod donje granice normalnih vrijednosti (< 7 g/l) i u opservacijskoj skupini i u skupini koja je primala lijek MabThera.
English: At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of
Croatian: Kasnija analiza trajanja ukupnog preživljenja, provedena nakon medijana praćenja od 60 mjeseci, potvrdila je prednost liječenja R-CHOP-om u odnosu na liječenje CHOP-om (p = 0,0071),
English: The chemotherapy should be given after the MabThera infusion.
Croatian: Kemoterapiju treba dati nakon infuzije lijeka MabThera.
English: Very rare cases of PML have been reported during post-marketing use of the MabThera intravenous formulation in NHL (see section 4.8).
Croatian: Nakon stavljanja formulacije lijeka MabThera za intravensku primjenu u promet prijavljeni su vrlo rijetki slučajevi PML-a u bolesnika s NHL-om (vidjeti dio 4.8).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MabThera 100 mg concentrate for solution for infusion Rituximab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MabThera 100 mg koncentrat za otopinu za infuziju rituksimab i.v.
English: lung infiltration,
Croatian: gljivična infekcija,
English: • If you are having MabThera with chemotherapy MabThera will be given to you on the same day as your chemotherapy.
Croatian: Koliko ćete lijeka primiti i koliko često · Lijek MabThera primit ćete istoga dana kad i kemoterapiju.
English: cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month timepoint.
Croatian: U bolesnika s granulomatozom s poliangitisom i mikroskopskim poliangitisom broj perifernih B stanica smanjio se na < 10 stanica/µl nakon dvije tjedne infuzije rituksimaba u dozi od 375 mg/m2 i održao na toj razini u većine bolesnika do trenutka mjere ishoda nakon 6 mjeseci.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rituximab in all subsets of the paediatric population with follicular lymphoma.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja rituksimaba u svim podskupinama pedijatrijske populacije s folikularnim limfomom.
English: The percentage of patients reporting ADRs upon re-treatment with further courses of MabThera was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
Croatian: Postotak bolesnika koji su prijavili nuspojave nakon ponovnog liječenja dodatnim ciklusima lijeka MabThera bio je sličan postotku bolesnika koji su prijavili nuspojave nakon početnog liječenja
English: For subjects in the middle and low BSA tritiles, average Ctrough values following intravenous dosing were approximately 12% and 26% lower compared to the subcutaneous regimen.
Croatian: U ispitanika sa srednjom i malom površinom tijela (srednja i donja trećina), prosječne vrijednosti Ctrough nakon intravenske primjene bile su približno
English: For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Croatian: Unaprijed utvrđena primarna analiza provedena je nakon medijana promatranja od 25 mjeseci od randomizacije.
English: MabThera 1400 mg solution for subcutaneous injection rituximab
Croatian: MabThera 1400 mg otopina za supkutanu injekciju rituksimab
English: Very Rare
Croatian: Manje često
English: • memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare,
Croatian: - smetenost, gubitak pamćenja ili poteškoće s razmišljanjem
English: 84.9% (n = 174)
Croatian: Procjena jednim brojem 84,9% (n = 174)
English: The geometric mean Ctrough (CV%) values at
Croatian: Geometrijska srednja vrijednost Cthrough (CV%) u 5. ciklusu (prije primjene doze u 6. ciklusu)