natgillin/translations-raw huggingface dataset:
Patients were between 18 and 70 years of age and had active psoriatic arthritis ( 3 swollen joints and  3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
Bolesnici su bili u dobi od 18 do 70 godina te su imali aktivni psorijatični artritis ( &gt; 3 otečena zgloba i &gt; 3 bolna zgloba) u najmanje jednom od sljedećih oblika: (1) zahvaćenost distalnih interfalangealnih prostora (DIP), (2) poliartikularni artritis (izostanak reumatoidnih čvorića te prisutnost psorijaze), (3) artritis mutilans, (4) asimetrični psorijatični artritis ili (5) spondilitisu slična ankiloza.
Patients were excluded if they had severe hepatic impairment, severe renal impairment (creatinine clearance &lt; 30ml/min), low body weight ( &lt; 50kg), active cancer, symptomatic PE or a recent history of DVT/PE ( &lt; 6 months) or superficial-vein thrombosis ( &lt; 90 days), or superficial-vein thrombosis associated with sclerotherapy or a complication of an IV line, or they were at high risk of bleeding.
Isključeni su i bolesnici s teškim oštećenjem funkcije jetre, teškim oštećenjem funkcije bubrega (kreatinin klirens &lt; 30 ml/min), malom tjelesnom težinom ( &lt; 50 kg), aktivnom malignom bolešću, simptomatskom PE ili anamnezom nedavno preboljele DVT/PE ( &lt; 6 mjeseci), trombozom površinske vene ( &lt; 90 dana), ili pak trombozom površinske vene kao posljedicom skleroterapije ili postavljenog venskog puta ili koji su imali povišeni rizik od krvarenja.
Patients were instructed to maintain a low-fat diet ( &lt; 20% calories from fat) and their lipid-lowering therapies at study entry, including apheresis if applicable, from 6 weeks prior to baseline through at least Week 26.
Pri uključivanju u ispitivanje, bolesnici su dobili upute da se od 6 tjedana prije početka ispitivanja do najmanje 26. tjedna pridržavaju dijete s niskim udjelom masti ( &lt; 20% kalorija iz masti) te da uzimaju svoju uobičajenu terapiju za snižavanje lipida, uključujući aferezu ako je primjenjivo.
Patients were randomised to receive either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or fluconazole (800 mg intravenous loading dose followed by 400 mg intravenous daily), and were stratified by APACHE II score (≤20 and &gt; 20) and the presence or absence of neutropaenia.
Bolesnici su bili randomizirani tako da su primali anidulafungin (intravenski u udarnoj dozi od 200 mg, nakon koje je slijedila intravenska doza od 100 mg na dan) ili flukonazol (intravenski u udarnoj dozi od 800 mg, nakon koje je slijedila intravenska doza od 400 mg na dan) i pri tom su stratificirani prema APACHE II ocjenskoj ljestvici (20 i &gt; 20) i prisutnosti odnosno odsutnosti neutropenije.
Patients were required to be &gt; 18 years of age with active RA diagnosed according to ACR criteria who had at least 8 tender and 6 swollen joints at baseline.
Bolesnici su morali imati više od 18 godina, aktivan RA dijagnosticiran prema ACR kriterijima te najmanje 8 bolno osjetljivih i 6 otečenih zglobova na početku liječenja.
Patients were required to have a baseline HIV-1 RNA concentration of at least 1500 copies/ml, were stratified by age (2 to &lt; 6 years, 6 to &lt; 12 years and 12 to 18 years) and randomized to receive one of two tipranavir with ritonavir dose regimens: 375 mg/m2/150 mg/m2 dose, compared to the 290 mg/m2/115 mg/m2 dose, plus background therapy of at least two non- protease inhibitor antiretroviral medicinal products, optimized using baseline genotypic resistance testing.
Morali su imati početnu vrijednost HIV-1 RNA najmanje 1 500 kopija/ml, stratificirani su po dobi (od 2 do &lt; 6 godina, od 6 do &lt; 12 godina, te od 12 do 18 godina) i randomizirani na jedan od dvaju režima tipranavira s ritonavirom: doza od 375 mg/m2/150 mg/m2 ili 290 mg/m2/115 mg/m2, plus osnovna terapija s najmanje dva neproteazna antiretrovirusna lijeka, koji su bili optimizirani pomoću početnog testiranja genotipske rezistencije.
Patients were required to have a baseline HIV-1 RNA concentration of at least 1500 copies/ml, were stratified by age (2 to &lt; 6 years, 6 to &lt; 12 years and 12 to 18 years) and randomized to receive one of two tipranavir with ritonavir dose regimens: 375 mg/m2/150 mg/m2 dose, compared to the 290 mg/m2/115 mg/m2 dose, plus background therapy of at least two non- protease inhibitor antiretroviral medicinal products, optimized using baseline genotypic resistance testing.
Morali su imati početnu vrijednost HIV-1 RNA najmanje 1500 kopija/ml, stratificirani su po dobi (od 2 do &lt; 6 godina, od 6 do &lt; 12 godina, te od 12 do 18 godina) i randomizirani na jedan od dvaju režima tipranavira s ritonavirom: doza od 375 mg/m2/150 mg/m2 ili 290 mg/m2/115 mg/m2, plus osnovna terapija s najmanje dva neproteazna antiretrovirusna lijeka, koji su bili optimizirani pomoću početnog testiranja genotipske rezistencije.
Patients were stratified according to region, iNHL subtype (follicular versus non-follicular), rituximab-refractory type (whether refractory to prior rituximab monotherapy or rituximab in combination with chemotherapy) and the number of prior therapies (≤2 versus &gt; 2).
Bolesnici su bili stratificirani prema regiji, podtipu iNHL-a (folikularni ili nefolikularni), tipu refraktornosti na rituksimab (je li bolest bila refraktorna na prethodno liječenje rituksimabom u monoterapiji ili u kombinaciji s kemoterapijom) te broju prethodnih terapija (≤ 2 naspram &gt; 2).
Patients were stratified according to their baseline haemoglobin (≤ 10 g/dl, &gt; 10 to ≤ 13 g/dl and
Bolesnici su podijeljeni u skupine prema početnoj razini hemoglobina (≤ 10 g/dl, &gt; 10 do
Patients were stratified at randomisation by age ( 75 vs. &gt; 75 years) and stage (ISS; Stages I and II vs. stage III).
Bolesnici su bili stratificirani prema dobi ( 75 naspram &gt; 75 godina) i stadiju bolesti (ISS; stupnjevi I i II naspram stupnja III).
Patients were stratified at randomization by age (≤75 versus &gt; 75 years), stage (ISS Stages I and II versus Stage III), and country.
Prilikom randomizacije, bolesnici su bili stratificirani prema dobi (≤ 75 naspram &gt; 75 godina), stadiju bolesti (ISS stadij I i II naspram stadij III) te zemlji.
Patients were stratified at screening based on plasma HIV-1 RNA levels &lt; 100,000 and ≥ 100,000 copies/mL.
Bolesnici su odabrani na temelju probira temeljenog na razini HIV-1 RNK &lt; 100 000 i ≥100 000 kopija/ml u plazmi.
Patients were stratified by hemoglobin level (≤13 g/dL vs. &gt; 13 g/dL for males and ≤11.5 g/dL vs &gt; 11.5 g/dL for females) and corrected serum calcium (≥10 mg/dL vs. &lt; 10 mg/dL).
Stratificirani su prema razini hemoglobina (≤13 g/dl naspram &gt; 13 g/dl za muškarce i ≤11,5 g/dl naspram &gt; 11,5 g/dl za žene) i korigiranom kalciju u serumu (≥10 mg/dl naspram &lt; 10 mg/dl).
Patients were stratified with respect to duration of glucocorticoid use prior to randomisation (≤ 3 months versus &gt; 3 months).
Bolesnici su bili stratificirani obzirom na duljinu primjene glukokortikosteroida prije randomizacije (≤3 mjeseca naspram &gt; 3 mjeseca).
Patients were stratified with respect to duration of glucocorticoid use prior to randomisation (≤ 3 months versus &gt; 3 months).
Bolesnici su stratificirani s obzirom na duljinu primjene glukokortikoida prije randomizacije (≤ 3 mjeseca u odnosu na &gt; 3 mjeseca).
Patients were to have at least one risk factor (including age, hypertension, diabetes, prior cerebrovascular accident, left atrium diameter ≥50 mm or LVEF &lt; 0.40) together with AF/AFL and sinus rhythm both documented within the last 6 months.
Bolesnici su morali imati barem jedan faktor rizika (uključujući dob, hipertenziju, dijabetes, pretrpljen cerebrovaskularni incident, promjer lijevog atrija ≥ 50 mm ili ejekcijsku frakciju lijeve klijetke (LVEF)
Patients were virologically suppressed (HIV-1 RNA &lt; 50 copies/mL) for at least 6 months before switching.
U bolesnika je virus bio suprimiran (HIV-1 RNK &lt; 50 kopija/ml) tijekom najmanje 6 mjeseci prije prebacivanja.
Patients who are considered to be at risk of TLS (e.g. patients with a high tumour burden and/or a high circulating lymphocyte count
U bolesnika koji se smatraju rizičnima za razvoj sindroma lize tumora (npr. bolesnici s velikim tumorskim opterećenjem i/ili velikim brojem cirkulirajućih limfocita [ &gt; 25 x 109/l] i/ili oštećenjem bubrežne funkcije
Patients who had 3 consecutive sUA levels &gt; 6.0 mg/dL were withdrawn.
Bolesnici kojima je u tri uzastopna mjerenja razina mokraćne kiseline u serumu bila veća od 6,0 mg/dl bili su isključeni iz ispitivanja.
Patients who had a QTcF &gt; 500 msec at screening, had a recent history of myocardial infarction within 6 months before randomization, had symptomatic congestive heart failure, or had any other overt CV disease were excluded from the clinical studies.
U klinička ispitivanja nisu bili uključeni bolesnici koji su imali QTcF &gt; 500 ms pri probiru, u nedavnoj anamnezi infarkt miokarda unutar 6 mjeseci prije randomizacije, simptomatsko kongestivno zatajenje srca ili bilo koju drugu očitu kardiovaskularnu bolest.
Patients who had missing data at follow-up Week 12 were considered responders if their next available HCV RNA value was &lt; LLOQ.
Za bolesnike za koje su nedostajali podaci u 12. tjednu praćenja smatralo se da su odgovorili na liječenje ako im je sljedeća dostupna razina HCV RNK bila &lt; LLOQ.
Patients who had the following were excluded from the trial: creatinine clearance rates &lt; 15 mL/min, NYHA Class III to IV congestive heart failure, myocardial infarction within the last 4 months or those with left ventricular ejection fraction (LVEF) &lt; 40%.
Iz ispitivanja su bili isključeni bolesnici sa sljedećim: brzina klirensa kreatinina &lt; 15 ml/min, kongestivno zatajenje srca NYHA razreda III do IV, infarkt miokarda unutar posljednja 4 mjeseca ili oni s istisnom frakcijom lijevog ventrikula &lt; 40%.
Patients who had the following were excluded from the trial: creatinine clearance rates &lt; 50 mL/min, NYHA Class III to IV congestive heart failure, or myocardial infarction within the last 4 months, disease progression during the treatment with a bortezomib-containing regimen, or progression during the first 3 months of initiating treatment with lenalidomide and dexamethasone, or progression at any time during treatment with lenalidomide and dexamethasone if this was the subject’s most recent line of therapy.
Iz ispitivanja su bili isključeni bolesnici sa sljedećim: brzina klirensa kreatinina &lt; 50 ml/min, kongestivno zatajenje srca NYHA razreda III do IV ili infarkt miokarda unutar posljednja 4 mjeseca, progresija bolesti tijekom liječenja režimom koji sadrži bortezomib, ili progresija bolesti tijekom prva tri mjeseca od inicijacije liječenja lenalidomidom i deksametazonom, ili progresija bolesti u bilo kojem trenutku liječenja lenalidomidom ili deksametazonom ako je to bila posljednja linija liječenja.
Patients who have baseline neutrophil counts &lt; 1500 cells/mm3.
Bolesnici s početnim brojem neutrofila &lt; 1500 stanica/mm3.
Patients who reach an absolute QT interval value &gt; 500 msec must be reassessed and immediate action must be taken to correct concomitant risk factors, if any, while the risk/benefit of continuing versus suspending TRISENOX therapy must be considered.
Bolesnici koji postignu apsolutnu vrijednost QT intervala &gt; 500 ms moraju se ponovno podvrgnuti pregledu te je potrebno hitno djelovati kako bi se korigirali istodobni čimbenici rizika, ako postoje, te je potrebno razmotriti omjer rizika/dobrobiti nastavka liječenja naspram prekida terapijom TRISENOXA.
Patients whose menstrual bleeding became normal (PBAC &lt;
Bolesnice čije je menstrualno krvarenje postalo normalno (PBAC
Patients with a baseline eGFR 45 mL/min/1.73 m2 to &lt; 60 mL/min/1.73 m2 treated with canagliflozin 100 mg and 300 mg exhibited mean improvements in percent change in body weight relative to placebo of -1.8% and -2.0%, respectively.
Bolesnici s početnom vrijednosti eGFR 45 mL/min/1,73 m2 do &lt; 60 mL/min/1,73 m2 koji su liječeni kanagliflozinom od 100 mg i 300 mg pokazali su poboljšanja srednje vrijednosti postotka promjene tjelesne težine u odnosu na placebo od -1,8% odnosno -2,0%.
Patients with a baseline viral load &gt; 100,000 HIV-1 RNA copies/ml who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
Bolesnici s početnim virusnim opterećenjem &gt; 100 000 HIV-1 RNK kopija/ml koji su imali virološki neuspjeh pokazali su veću stopu rezistencije koja se pojavila uz liječenje na klasu nenukleozidnih inhibitora reverzne transkriptaze (NNRTI).
Patients with a CrCl &lt; 30 mL/min were excluded from the study (see section 5.1).
Bolesnici koji su imali CrCl &lt; 30 ml/min nisu bili uključeni u ispitivanje (vidjeti dio 5.1).
Patients with a dipstick of ≥2+ for protein or a UPCR &gt; 1 or a protein/creatinine ratio (PCR) &gt; 100 mg/mmol should undergo a 24-hour urine collection.
U bolesnika s rezultatima analize pomoću test trakica ≥ 2+ za proteine ili s omjerom proteina i kreatinina u mokraći &gt; 1 ili s omjerom proteina i kreatinina &gt; 100 mg/mmol treba izvršiti 24-satno prikupljanje mokraće.
Patients with a high tumour burden and/or a high circulating lymphocyte count ( &gt; 25 x 109/L) and/or renal impairment (CrCl &lt; 70 mL/min) are considered at risk of TLS and should receive prophylaxis.
Bolesnici s velikim tumorskim opterećenjem i/ili velikim brojem cirkulirajućih limfocita ( &gt; 25 x 109/l) i/ili oštećenjem bubrežne funkcije (CrCl &lt; 70 ml/min) smatraju se rizičnima za razvoj sindroma lize tumora i stoga bi trebali primiti profilaksu.
Patients with a high tumour burden and/or a high circulating lymphocyte count ( &gt; 25 x 109/L) and/or renal impairment (CrCl &lt; 70 mL/min) are considered at risk of TLS and should receive prophylaxis.
Bolesnici s velikim tumorskim opterećenjem i/ili velikim brojem cirkulirajućih limfocita ( &gt; 25 x 109/l) i/ili oštećenjem bubrežne funkcije (klirens kreatinina [CrCl] &lt; 70 ml/min) smatraju se rizičnima za razvoj sindroma lize tumora i stoga bi trebali primiti profilaksu.
Patients with a high tumour burden and/or high circulating lymphocyte count in CLL [ &gt; 25 x 109/L] may be at increased risk of severe IRRs.
Bolesnici s KLL-om koji imaju veliko tumorsko opterećenje i/ili velik broj limfocita u cirkulaciji ( &gt; 25 x 109/l) mogu imati povećan rizik od teških reakcija na infuziju.
Patients with a low body weight ( &lt; 60 kg) are more likely to experience higher plasma concentrations of posaconazole and should be closely monitored for adverse events.
U bolesnika male tjelesne težine ( &lt; 60 kg) postoji veća vjerojatnost viših plazmatskih koncentracija posakonazola pa se ti bolesnici moraju pomno nadzirati zbog mogućih nuspojava.
Patients with a platelet count of 100,000/mm3 to 200,000/mm3 before starting Jakavi had a higher frequency of grade 3 or 4 thrombocytopenia compared to patients with platelet count &gt; 200,000/mm3 (64.2% versus 38.5%).
Bolesnici s brojem trombocita od 100 000/mm3 do 200 000/mm3 prije početka liječenja Jakavijem imali su veću učestalost trombocitopenije stupnja 3 ili 4 u usporedbi s bolesnicima s razinom trombocita &gt; 200 000/mm3 (64,2% u odnosu na 38,5%).
Patients with a smaller VMA diameter at baseline (≤ 1500 microns) were more likely to achieve VMA resolution at Day 28 compared with those who had a diameter &gt; 1500 microns.
U bolesnika s manjim promjerom VMA na početku ispitivanja (≤ 1500 mikrona) postojala je veća sklonost povlačenja VMA do 28. dana nego u onih s promjerom VMA &gt; 1500 mikrona.
Patients with additional risk of endometrial cancer, e.g. patients suffering from hypertension or diabetes, having high BMI ( &gt; 30) or history of hormone replacement therapy should be closely monitored (see also section 4.8).
Bolesnice s dodatnim rizikom od raka endometrija, primjerice bolesnice koje boluju od hipertenzije ili dijabetesa, osobe s visokim BMI ( &gt; 30) ili anamnezom hormonske nadomjesne terapije se mora pomno nadzirati (vidjeti također dio 4.8).
Patients with ALT &gt; 3 x ULN and bilirubin &gt; 2 x ULN were not studied (see section 4.4).
Bolesnici s ALT &gt; 3 x GGN i bilirubinom &gt; 2 x GGN nisu bili ispitani (vidjeti dio 4.4).
Patients with ALT and AST values &gt; 2xULN at baseline were also excluded.
U ispitivanje nisu bili uključeni ni bolesnici koji su na početku ispitivanja imali vrijednosti ALT-a i AST-a ≥ 2 x GGN.
Patients with ALT or AST &gt; 2 times the ULN prior to treatment were not included in clinical studies; treatment initiation is not recommended in patients with ALT or AST &gt; 2 times the ULN.
Bolesnici koji su imali ALT ili AST &gt; 2 puta GGN prije liječenja nisu bili uključeni u klinička ispitivanja; ne preporučuje se započeti liječenje u bolesnika s ALT ili AST &gt; 2 puta GGN.
Patients with ALT or AST &gt; 3 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Bolesnici s vrijednostima ALT ili AST &gt; 3 x GGN imali su veću incidenciju neutropenije i febrilne neutropenije 4. stupnja.
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts &lt; 50,000/μl were excluded.
Bolesnici koji su na početku ispitivanja imali perifrenu neuropatiju stupnja ≥ 2 ili s brojem trombocita &lt; 50 000/μl bili su isključeni.
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts &lt; 50,000/μl were excluded.
Bolesnici s osnovnom perifrenom neuropatijom stupnja ≥ 2 ili s brojem trombocita &lt; 50 000/µl bili su isključeni.
Patients with baseline HbA1c &gt; 10% to ≤ 12%
Bolesnici s početnom vrijednosti HbA1c &gt; 10% do ≤ 12
Patients with baseline neutrophil counts of &lt; 1.5 x 109/L and/or thrombocyte counts of &lt; 100 x 109/L should not be treated with capecitabine.
Bolesnike s početnim brojem neutrofila &lt; 1,5 x 109/l i/ili brojem trombocita &lt; 100 x 109/l ne bi trebalo liječiti kapecitabinom.
Patients with BCR-ABL &gt; 10% at 3 months
Bolesnici koji su imali BCR- ABL &gt; 10% u 3. mjesecu
Patients with BMI &gt; 30 kg/m2
Bolesnici s indeksom tjelesne mase &gt; 30 kg/m2
Patients with body weight &lt; 60 kg
Bolesnici s tjelesnom težinom &lt; 60 kg
Patients with body weight &lt; 60 kg
Bolesnici tjelesne težine &lt; 60 kg
Patients with body weight &gt; 100 kg
Bolesnici tjelesne težine &gt; 100 kg
Patients with both CIRS &gt; 6 and CrCl &lt; 70 mL/min are more at risk of infections, including severe infections (see section 4.8).
Rizik od infekcija, uključujući ozbiljne infekcije, veći je u bolesnika koji imaju CIRS rezultat &gt; 6 i CrCl &lt; 70 ml/min (vidjeti dio 4.8).
Patients with cardiac disease or risk factors such as a baseline LVEF value of &lt; 45% by multigated radionuclide (MUGA) scan, clinically significant cardiovascular abnormalities (equal to New York Heart Association [NYHA] grade 3 or 4), myocardial infarction within the last 6 months, severe arrhythmia, uncontrolled hypertension, uncontrolled angina, or prior cumulative doses of doxorubicin or equivalent exceeding 450 mg/m2 should receive careful risk versus benefit consideration before receiving treatment with Pixuvri.
Kod bolesnika sa srčanom bolešću ili s postojećim kardiološkim faktorom rizika, kao što je početna vrijednost LVEF &lt; 45% utvrđena pomoću MUGA-snimanja radionuklidima (MUltiGAted radionuclide), klinički značajnim kardiovaskularnim poremećajem (stupnja 3 ili 4 prema New York Heart Association [NYHA]), infarktom miokarda u zadnjih 6 mjeseci, teškom aritmijom, nekontroliranom hipertenzijom, nekontroliranom anginom pektoris ili ranijom terapijom kumulativnim dozama doksorubicina ili njegovog ekvivalenta koja prelazi 450 mg/m2, potrebno je pažljivo procjeniti odnos rizika i korist od terapije prije samog započinjanja liječenja Pixuvriom.
Patients with chronic renal failure, patients with creatinine clearance &lt; 50 ml/minute and/or on haemodialysis.
Bolesnici s kroničnim zatajenjem bubrega, bolesnici s klirensom kreatinina &lt; 50 i/ili na hemodijalizi
Patients with chronic renal failure, patients with creatinine clearance &lt; 50 ml/minute and/or on haemodialysis.
Bolesnici s kroničnim zatajenjem bubrega, bolesnici s klirensom kreatinina &lt; 50 ml/min i/ili na hemodijalizi.
Patients with creatinine clearance &lt; 30 ml/min and dialysis patients:
Pacijenti s klirensom kreatinina &lt; 30 ml/min i pacijenti na dijalizi:
Patients with creatinine clearance &lt; 50 ml/minute must not be treated with PegIntron in combination with ribavirin (bitherapy or tritherapy) (see section 4.3).
Bolesnici s klirensom kreatinina &lt; 50 ml/min ne smiju se liječiti lijekom PegIntron u kombinaciji s ribavirinom (dvojna ili trojna terapija) (vidjeti dio 4.3).
Patients with creatinine clearance &lt; 50 ml/minute must not be treated with PegIntron in combination with ribavirin (see ribavirin SmPC).
Bolesnici s klirensom kreatinina &lt; 50 ml/min ne smiju se liječiti lijekom PegIntron u kombinaciji s ribavirinom (vidjeti Sažetak opisa svojstava lijeka za ribavirin).
Patients with creatinine clearance &lt; 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (bitherapy or tritherapy) (see section 4.3).
Bolesnici s klirensom kreatinina &lt; 50 ml/min ne smiju se liječiti lijekom ViraferonPeg u kombinaciji s ribavirinom (dvojna ili trojna terapija) (vidjeti dio 4.3).
Patients with creatinine clearance &lt; 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SmPC).
Bolesnici s klirensom kreatinina &lt; 50 ml/min ne smiju se liječiti lijekom ViraferonPeg u kombinaciji s ribavirinom (vidjeti Sažetak opisa svojstava lijeka za ribavirin).
Patients with creatinine clearance &lt; 50 ml/min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
Bolesnici s klirensom kreatinina &lt; 50 ml/min imaju povećan rizik od krvarenja i treba ih liječiti uz oprez (vidjeti dio 4.2, 4.3 i 5.2).
Patients with creatinine clearance &gt; 60 ml/min have been included in efficacy/safety studies of topotecan.
Bolesnici s klirensom kreatinina većim od 60 ml/min uključeni su u ispitivanja djelotvornosti/sigurnosti topotekana.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of &lt; 2.
Eastern Cooperative Oncology Group) funkcionalnog stanja na početku liječenja bila 2, incidencija ozbiljnih infekcija bila je veća u odnosu na bolesnike s ECOG funkcionalnim stanjem &lt; 2.
Patients with ECOG performance status at baseline of 2 experienced a higher incidence of serious infections compared to patients with ECOG performance status of &lt; 2.
Incidencija ozbiljnih infekcija bila je veća u bolesnika početnog ECOG funkcionalnog stanja 2 u usporedbi s bolesnicima ECOG funkcionalnog stanja &lt; 2.
Patients with ECOG PS &gt; 1, significant hepatic or renal co-morbidities were not included in the study.
U ispitivanje nisu bili uključeni bolesnici s ECOG statusom &gt; 1, značajnim jetrenim ili bubrežnim bolestima.
Patients with eGFR 45 mL/min/1.73 m2 to &lt; 60 mL/min/1.73 m2
Bolesnici s eGFR 45 mL/min/1,73 m2 do &lt; 60 mL/min/1,73 m2
Patients with elevated liver enzymes &gt; 2 ULN were excluded from the main trials.
Bolesnici s povišenim vrijednostima jetrenih enzima &gt; 2 iznad gornje granice normalnih vrijednosti bili su isključeni iz glavnih ispitivanja.
Patients with elevated liver enzymes &gt; 2 ULN were excluded in controlled clinical trials investigating the VTE prevention following elective hip or knee replacement surgery.
Bolesnici s povišenim vrijednostima jetrenih enzima &gt; 2 iznad gornje granice normalnih vrijednosti bili su isključeni iz kontroliranih kliničkih ispitivanja prevencije VTE-a nakon elektivnog kirurškog zahvata ugradnje endoproteze kuka ili koljena.
Patients with elevated liver enzymes &gt; 2 ULN were excluded in the main trials.
Bolesnici s povišenim vrijednostima jetrenih enzima ≥ 2 iznad gornje granice normalnih vrijednosti bili su isključeni iz glavnih ispitivanja.