natgillin/translations-raw huggingface dataset:
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This may result in lowered pharmacodynamic responses in heavy patients ( &gt; 95 kg).
To može dovesti do smanjenih farmakodinamičkih odgovora u bolesnika s velikom tjelesnom težinom ( &gt; 95 kg).
This medicinal product has not been studied in severe renal impairment (CrCl &lt; 30 ml/min or eGFR &lt; 30 ml/min/1.73 m2) or end-stage renal disease (ESRD).
Ovaj lijek se nije ispitivao kod bolesnika s teškim oštećenjem funkcije bubrega (CrCl &lt; 30 ml/min ili eGFR &lt; 30 ml/min/1,73 m2), kao ni onih u terminalnoj fazi bubrežne bolesti.
This medicinal product must not be used in patients with moderate to severe renal impairment (patients with creatinine clearance
Ovaj lijek se ne smije primjenjivati u bolesnika s umjerenim do teškim oštećenjem bubrežne funkcije (bolesnici s klirensom kreatinina [CrCl] &lt; 60 ml/min ili procijenjenom brzinom glomerularne filtracije
This medicine should not be used in children and adolescents ( &lt; 18 years) because the safety and efficacy have not yet been fully established.
Ovaj lijek ne smiju uzimati djeca ni adolescenti ( &lt; 18 godina) jer sigurnost i djelotvornost lijeka nisu još u potpunosti utvrđene.
This reduction in urinary CTx levels was significantly correlated with the primary efficacy endpoint SMPR (Kendall-tau-b (p &lt; 0.001)).
Ovo smanjivanje razina CTx u urinu bitno korelira s primarnom mjerom ishoda djelotvornosti SMPR (Kendall-tau-b (p &lt; 0,001)).
This study also included patients with classic containing CNV with a visual acuity score &gt; 70 letters (20/40).
U ispitivanju su sudjelovali i bolesnici s klasičnim CNV-om i vidnom oštrinom &gt; 70 znakova (20/40).
This study evaluated non-splenectomised patients with ITP and platelet counts &lt; 50 x 109/l.
Ova je studija ocjenjivala nesplenektomirane bolesnike s ITP-om i brojem trombocita &lt; 50 x 109/l.
This study included patients of all three resistance categories (MDRH &amp; R-, pre-XDR- and XDR-TB).
U ovo ispitivanje uključeni su bolesnici sve tri kategorije rezistencije (MDRH &amp; R-, pre-XDR- i XDR-TB).
This study involved 423 patients with chronic renal impairment (estimated glomerular filtration rate &lt; 50 ml/min).
U to su ispitivanje uključena 423 bolesnika s kroničnim oštećenjem funkcije bubrega (procijenjena brzina glomerularne filtracije &lt; 50 ml/min).
This subject harboured &lt; 1% HCV S282T at baseline and developed S282T ( &gt; 99%) at 4 weeks post-treatment which resulted in a 13.5-fold change in sofosbuvir EC50 and reduced viral replication capacity.
Taj je ispitanik na početku nosio &lt; 1% S282T HCV-a i razvio S282T ( &gt; 99%) 4 tjedna nakon liječenja, što je promijenilo vrijednost EC50 sofosbuvira 13,5 puta i smanjilo kapacitet umnažanja virusa.
This translates to a reduction in the rate of moderate to severe exacerbations of 25% (95% CI: 19% to 31%; p &lt; 0.001) compared with placebo, 12% compared with salmeterol (95% CI: 5% to 19%, p=0.002) and 9% compared with FP (95% CI: 1% to 16%, p=0.024).
To je odgovaralo smanjenju stope umjerenih do teških egzacerbacija od 25% (95% CI: 19% do 31%; p &lt; 0,001) u usporedbi s placebom, 12% u usporedbi sa salmeterolom (95% CI: 5% do 19%, p=0,002) i 9% u usporedbi s FP-om (95% CI: 1% do 16%, p=0,024).
This was achieved in 28.7% of the patients in the group receiving daily methylnaltrexone 12 mg (p &lt; 0.001 vs. placebo), in 14.9% of those receiving it every other day (p=0.012 vs. placebo), and in 6.2% of the placebo treated patients.
Ovo je postignuto u 28,7% bolesnika u skupini koja je svakodnevno primala metilnaltrekson u dozi od 12 mg (p &lt; 0,001 naspram placeba), u 14,9% bolesnika u skupini koja je primala metilnaltrekson svaki drugi dan (p &lt; 0,012 naspram placeba) i u 6,2% bolesnika koji su primali placebo.
This was achieved in 59% of the patients in the group receiving daily methylnaltrexone 12 mg (p &lt; 0.001 vs. placebo), in 61% of those receiving it every other day (p &lt; 0.001 vs. placebo), and in 38% of the placebo treated patients.
Ovo je postignuto u 59% bolesnika u skupini koja je svakodnevno primala metilnaltrekson u dozi od 12 mg (p &lt; 0,001 naspram placeba), u 61% bolesnika u skupini koja je primala metilnaltrekson svaki drugi dan (p &lt; 0,001 naspram placeba) i u 38% bolesnika koji su primali placebo.
Three ( &lt; 1%) out of 409 patients in the degarelix group and four (2%) out of 201 patients in the leuprorelin 7.5 mg group, had a QTcF ≥ 500 msec.
Tri ( &lt; 1%) bolesnika od ukupno 409 u skupini koja je primala degareliks i četiri bolesnika (2%) od ukupno 201 u skupini koja je primala leuprorelin 7,5 mg, imali su QTcF ≥ 500 ms.
Three ( &lt; 1%) out of 409 patients in the degarelix group and four (2%) out of 201 patients in the leuprorelin 7.5 mg group, had a QTcF ≥ 500 msec.
Tri ( &lt; 1%) bolesnika od ukupno 409 u skupini koja je primala degareliks i četiri bolesnika (2%) od ukupno 201 u skupini koja je primala leuprorelin 7,5 mg, imali su QTcF ≥500 ms.
Three of 8 (37.5%) paediatric patients &lt; 7 years of age experienced at least one infusion related reaction over a mean observation time of 4.2 years.
Kod 3 od 8 (37,5 %) pedijatrijskih bolesnika mlađih od 7 godina uočena je barem jedna reakcija povezana s infuzijom tijekom srednjeg vremena promatranja od 4,2 godine.
Three of the five subjects had no detectable anti-porcine Factor VIII titres post-treatment ( &lt; 0.6 BU/mL based on the last reported result), two subjects had a detectable anti-porcine Factor VIII titre (≥ 0.6 BU/mL).
Tri od pet ispitanika nisu imala mjerljive titre protu-svinjskog faktor VIII inhibitora nakon liječenja ( &lt; 0,6 BU/ml na temelju zadnjeg zabilježenog rezultata), dva ispitanika imala su mjerljiv titar protu-svinjskog faktor VIII inhibitora (≥0,6 BU/ml).
thrombocytopenia ( &lt; 100,000 cells/mm3) prothrombin time &gt; 1.2 times control, or International Normalized Ratio (INR)  2.0 severe hypertension (systolic blood pressure &gt; 200 mm Hg or diastolic blood pressure
trombocitopenijom ( &lt; 100 000 stanica/mm3) s protrombinskim vremenom &gt; 1,2 puta u odnosu na kontrolnu vrijednost ili INR ≥ 2,0 s teškom hipertenzijom (sistolički krvni tlak &gt; 200 mm Hg ili dijastolički krvni tlak
thrombocytopenia ( &lt; 100,000 cells/mm3) prothrombin time &gt; 1.2 times control, or International Normalized Ratio (INR)  2.0 severe hypertension (systolic blood pressure &gt; 200 mm Hg or diastolic blood pressure
trombocitopenijom ( &lt; 100000 stanica/mm3) s protrombinskim vremenom &gt; 1,2 puta u odnosu na kontrolnu vrijednost ili INR ≥ 2,0 s teškom hipertenzijom (sistolički krvni tlak &gt; 200 mm Hg ili dijastolički krvni tlak
Thrombocytopenia ( &lt; 25x109/l or requiring platelet transfusion) occurred at a median of 5-6 days in 98% of patients.
Trombocitopenija ( &lt; 25x109/l ili potreba za transfuzijom trombocita) se pojavila u medijanu od 5-6 dana u 98% bolesnika.
Thrombocytopenia ( &lt; 80 x 109/l), anaemia (haemoglobin &lt; 4.5 g/dl)3
trombocitopenija ( &lt; 80 x 109/l), anemija (hemoglobin &lt; 4,5 g/dl)3
Thrombocytopenia (platelets &lt; 100,000/mm3)
Trombocitopenija (trombociti &lt; 100 000/mm³)
Thrombocytopenia: Severe (platelets less than 25 x 109/l) in 25 % of patients (8 % of courses); moderate (platelets between 25.0 and 50.0 x 109/l) in 25 % of patients (15 % of courses).
Trombocitopenija: teška trombocitopenija (broj trombocita &lt; 25 x 109/l) zabilježena je u 25% bolesnika (8% ciklusa), a umjerena (broj trombocita između 25,0 i 50,0 x 109/l) u 25% bolesnika (15% ciklusa).
Thrombocytopenia: Severe (platelets less than 25 x 109/l) in 25 % of patients (8 % of courses); moderate (platelets between 25.0 and 50.0 x 109/l) in 25 % of patients (15 % of courses).
Trombocitopenija: Teška trombocitopenija (broj trombocita &lt; 25,0 x 109/l) zabilježena je u 25% bolesnika (8% ciklusa), a umjerena (broj trombocita između 25,0 i 50,0 x 109/l) u 25% bolesnika (15% ciklusa).
Through 48 weeks of treatment, the proportion of patients in the tipranavir with ritonavir arm compared to the comparator PI/ritonavir arm with HIV-1 RNA &lt; 400 copies/ml was 30% and 14% respectively, and with HIV-1 RNA &lt; 50 copies/ml was 23% and 10% respectively.
Tijekom 48 tjedana liječenja udio bolesnika s HIV-1 RNA &lt; 400 kopija/ml u skupini koja je dobivala tipranavir s ritonavirom iznosio je 30%, a za kontrolni IP/ritonavir skupinu 14% dok je udio bolesnika s HIV-1 RNA &lt; 50 kopija/ml iznosio 23% za ispitivanu i 10% za kontrolnu skupinu.
Through 48 weeks of treatment, the proportion of patients in the tipranavir with ritonavir arm compared to the comparator PI/ritonavir arm with HIV-1 RNA &lt; 400 copies/ml was 30% and 14% respectively, and with HIV-1 RNA &lt; 50 copies/ml was 23% and 10% respectively.
Tijekom 48 tjedana liječenja udio bolesnika s HIV-1 RNA &lt; 400 kopija/ml u skupini koja je dobivala tipranavir s ritonavirom iznosio je 30%, a za kontrolnu IP/ritonavir skupinu 14% dok je udio bolesnika s HIV-1 RNA &lt; 50 kopija/ml iznosio 23% za ispitivanu i 10% za kontrolnu skupinu.
Through week 24 8.1 &lt; 0.0001 6.1 (4.7, 11.4) (-1.4, 13.5)
Do 24. tjedna 8,1 &lt; 0,0001 6,1 0,1092 (4,7; 11,4) (-1,4; 13,5)
Through week 96, fewer patients in the rilpivirine arm with baseline viral load ≤ 100,000 copies/mL had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load &gt; 100,000 copies/mL (30/262).
Do 96. tjedna u skupini koja je primala rilpivirin, manji je broj pacijenata s početnim virusnim opterećenjem ≤ 100 000 kopija/ml razvio supstitucije povezane s rezistencijom i/ili fenotipsku rezistenciju na rilpivirin (7/288) nego pacijenata s početnim virusnim opterećenjem
Ticagrelor and the active metabolite is extensively bound to human plasma protein ( &gt; 99.0%).
Tikagrelor i aktivni metabolit se opsežno vežu za proteine ljudske plazme ( &gt; 99,0%).
Time to initiation of cytotoxic chemotherapy: The median time to initiation of cytotoxic chemotherapy was 25.2 months for patients receiving ZYTIGA and 16.8 months for patients receiving placebo (HR = 0.580; 95% CI: [0.487; 0.691], p &lt; 0.0001).
Vrijeme do početka citotoksične kemoterapije: Medijan vremena do početka citotoksične kemoterapije iznosio je 25,2 mjeseca za bolesnike koji uzimaju lijek ZYTIGA, a za bolesnike koji uzimaju placebo iznosio je 16,8 mjeseci (HR=0,580; 95% CI: [0,487; 0,691], p &lt; 0,0001).
Time to opiate use for cancer pain: The median time to opiate use for prostate cancer pain at the time of final analysis was 33.4 months for patients receiving ZYTIGA and was 23.4 months for patients receiving placebo (HR = 0.721; 95% CI: [0.614; 0.846], p &lt; 0.0001).
Vrijeme do primjene opioidnih lijekova za bol karcinomskog porijekla: Medijan vremena do primjene opioidnih lijekova za bol karcinomskog porijekla u vrijeme završne analize bio je 33,4 mjeseca za bolesnike koji uzimaju lijek ZYTIGA, a za bolesnike koji uzimaju placebo iznosio je 23,4 mjeseca (HR=0,721; 95% CI: [0,614; 0,846], p &lt; 0,0001).
Time-to-event analysis (95% CI) [median no. of months] Hazard p-value Xofigo Placebo &lt; ratio
Analiza vremena do događaja (95% CI) [medijan br. mjeseci] Omjer p-vrijednost Xofigo Placebo hazarda &lt; 1 u
TIMI Major Bleed: Clinically apparent with &gt; 50 g/l decrease in haemoglobin or intracranial haemorrhage.
Veliko TIMI (Thrombolysis in Myocardial Infarction) krvarenje: Klinički vidljiva, sa smanjenjem hemoglobina &gt; 50 g/l ili intrakranijalnim krvarenjem.
TIMI Major: Clinically apparent with &gt; 50 g/L decrease in haemoglobin or intracranial haemorrhage.
Značajno prema TIMI kriterijima: klinički značajno krvarenje uz smanjenje hemoglobina za &gt; 50 g/l ili intrakranijalno krvarenje
Tipranavir is extensively bound to plasma proteins ( &gt; 99.9%).
Tipranavir se ekstenzivno veže na proteine plazme ( &gt; 99,9%).
Tipranavir maintains significant antiviral activity ( &lt; 4-fold resistance) against the majority of HIV-1 clinical isolates showing post-treatment decreased susceptibility to the currently approved protease inhibitors: amprenavir, atazanavir, indinavir, lopinavir, ritonavir, nelfinavir and saquinavir.
Tipranavir održava značajnu antivirusnu aktivnost ( &lt; 4-struka otpornost) protiv većine HIV-1 kliničkih izolata koji pokazuju smanjenu osjetljivost na trenutno odobrene inhibitore proteaze: amprenavir, atazanavir, indinavir, lopinavir, ritonavir, nelfinavir i sakvinavir.
TMA-event free status was defined as the absence for at least 12 weeks of the following: decrease in platelet count of &gt; 25% from baseline, PE/PI, and new dialysis.
Stanje bez TMA incidenta definiralo se kao najmanje 12 tjedana bez smanjenja broja trombocita za &gt; 25% u odnosu na početnu vrijednost, bez PE/PI terapije i nove dijalize.
To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels ( &gt; 6 g/l).
Kako bi se smanjila stopa infekcije, možda bude potrebno povisiti doziranje s ciljem postizanja viših najnižih koncentracija ( &gt; 6 g/l).
Toddlers (6- &lt; 36 months)
Mala djeca (6- &lt; 36 mjeseci)
Tolcapone does not distribute widely into tissues due to its high plasma protein binding ( &gt; 99.9 %).
Tolkapon se ne distribuira u tkiva zbog njegova visoka vezivanja na proteine plazme ( &gt; 99,9 %).
Tolvaptan was superior to placebo (p &lt; 0.0001) for both periods in both studies.
Tolvaptan je bio bolji od placeba (p &lt; 0,0001) tijekom oba perioda u oba ispitivanja.
Toremifene binds extensively ( &gt; 99.5%) to serum proteins, mainly to albumin.
Toremifen se opsežno veže na proteine seruma ( &gt; 99,5%), uglavnom na albumin.
Torsade de pointes has been observed in &lt; 0.1% of sunitinib-exposed patients.
Torsade de pointes su opažene u &lt; 0,1% bolesnika izloženih sunitinibu.
Total bilirubin: &gt; 1.5-3.0 ULN AST: any
Ukupni bilirubin: &gt; 1,5-3,0 GGN AST: bilo koja vrijednost
Total bilirubin: &gt; 3-10 ULN AST: any
Ukupni bilirubin: &gt; 3-10 GGN AST: bilo koja vrijednost
Total bilirubin: &gt; 1.5-3.0 ULN AST: any
Ukupni bilirubin: &gt; 1,5- - 3,0 GGN AST: bilo koji
Total bilirubin: &gt; 1.5-3.0 ULN AST: any
Ukupni bilirubin: &gt; 1,5-3,0 GGN AST: bilo koji
Total bilirubin: &gt; 1.5–3.0 ULN AST: any
Ukupni bilirubin: &gt; 1,5-3,0 GGN AST: bilo koja vrijednost
Total bilirubin: &gt; 1.5–3.0 ULN AST: any
Ukupni bilirubin: &gt; 1,5-3,0 GGN AST: bilo koji
Total bilirubin: &gt; 3-10 ULN
Ukupni bilirubin: &gt; 3-10 GGN AST: bilo koji
Total bilirubin: &gt; 3-10 ULN AST: any
Ukupni bilirubin: &gt; 3-10 GGN AST: bilo koji
Total bilirubin: &gt; 3–10 ULN AST: any
Ukupni bilirubin: &gt; 3-10 GGN AST: bilo koja vrijednost
Total bilirubin: &gt; 3–10 ULN AST: any
Ukupni bilirubin: &gt; 3-10 GGN AST: bilo koji
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% on average in mild (CrCl = 50 to &lt; 80 ml/min), 64% in moderate (CrCl = 30 to
U osoba s poremećajem bubrežne funkcije ukupni klirens paliperidona bio je smanjen za prosječno 32% kod blagog (CrCl = 50 do
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% on average in mild (CrCl = 50 to &lt; 80 ml/min), 64% in moderate (CrCl = 30 to &lt; 50 ml/min), and 71% in severe (CrCl = 10 to &lt; 30 ml/min) renal impairment, corresponding to an average increase in exposure (AUCinf) of 1.5, 2.6, and 4.8-fold, respectively, compared to healthy subjects.
U osoba s poremećajem bubrežne funkcije ukupni klirens paliperidona bio je smanjen za prosječno 32% kod blagog (CrCl = 50 do &lt; 80 ml/min), 64% kod umjerenog (CrCl = 30 do &lt; 50 ml/min) te 71% kod teškog (CrCl = 10 do &lt; 30 ml/min) oštećenja bubrega, što odgovara prosječnom porastu izloženosti (AUCinf) za 1,5; 2,6 odnosno 4,8 puta u odnosu na zdrave ispitanike.
Total dose recovery is low after a 10-day collection period ( &lt; 50%) following administration of a single oral dose of radiolabelled trametinib as a solution, due to the long elimination half-life.
Nakon primjene jedne radioaktivno označene doze trametiniba u obliku otopine, pronađena je mala količina ukupne doze nakon 10-dnevnog razdoblja prikupljanja ( &lt; 50%), što je posljedica dugog poluvijeka eliminacije.
Total lymphocyte counts &lt; 0.8x109 cells/L ([Common Terminology Criteria for Adverse Events – CTCAE] Grade 2; at least one measurement) occurred in 4% of placebo-treated and 5% of Zinbryta-treated patients in the SELECT study, and 9% of the interferon beta-1a (intramuscular)-treated and 8% of Zinbryta-treated patients in the DECIDE study.
Ukupni broj limfocita &lt; 0,8x109 stanica/L ([Zajednički kriteriji terminologije za nuspojave (Common Terminology Criteria for Adverse Events - CTCAE)] 2. stupnja; pri najmanje jednom mjerenju) zabilježen je u 4% bolesnika kojima je davan placebo i 5% bolesnika liječenih Zinbrytom u ispitivanju SELECT te u 9% bolesnika liječenih interferonom beta-1a (intramuskularno) i 8% bolesnika liječenih Zinbrytom u ispitivanju DECIDE.
Total plasma clearance of telmisartan after oral administration is &gt; 1500 ml/min.
Ukupni plazmatski klirens telmisartana nakon peroralne primjene je &gt; 1 500 ml/min.
Total plasma clearance of telmisartan after oral administration is &gt; 1500 ml/min.
Ukupni plazmatski klirens telmisartana nakon peroralne primjene je &gt; 1500 ml/min.
Trabectedin must not be used in patients with CPK &gt; 2.5 x ULN (see section 4.2).
Trabektedin se ne smije koristiti kod bolesnika s CPK-om &gt; 2,5 x GGN (vidjeti dio 4.2).
Trametinib should be interrupted in patients who have an asymptomatic, absolute decrease of &gt; 10% in LVEF compared to baseline and the ejection fraction is below the institution’s lower limit of normal (LLN) (see section 4.4).
Liječenje trametinibom treba prekinuti u bolesnika koji imaju asimptomatsko, apsolutno smanjenje ejekcijske frakcije lijeve klijetke (engl. left ventricular ejection fraction, LVEF) za &gt; 10% u odnosu na početnu vrijednost i u kojih je vrijednost ejekcijske frakcije ispod donje granice normale (DGN) za određenu ustanovu (vidjeti dio 4.4).
Transaminase elevations generally occurred early in the course of treatment (of the patients who experienced transaminase elevations of any grade, &gt; 80% experienced their first event within the first 3 months).
Porast transaminaza većinom se javljao na početku liječenja (od bolesnika koji su imali porast transaminaza bilo kojeg stupnja, &gt; 80% imalo je prvi događaj unutar prvih 3 mjeseca).
Transfer to Xultophy from doses of basal insulin &lt; 20 and &gt; 50 units has not been studied.
Prelazak s doza bazalnog inzulina &lt; 20 i &gt; 50 jedinica na lijek Xultophy nije ispitivan.
Transient elevations in total bilirubin &gt; 3 x ULN (mostly indirect) occurred in 17 (27.0%) subjects; 15 of these subjects were receiving atazanavir.
U 17 ispitanika (27,0%) je zabilježeno prolazno povišenje ukupnog bilirubina &gt; 3 x GGN (većinom indirektnog), a 15 od tih ispitanika je uzimalo atazanavir.
Transient local injection site reactions, which are restricted to a slight swelling ( &lt; 2 cm diameter), may uncommonly occur and disappear within 1 day.
Prolazne lokalne reakcije na mjestu injekcije, koje su ograničene na blago oticanje ( &lt; 2 cm dijametralno) rijetko se mogu pojaviti te nestaju u roku od jednog dana.
Transient local injection site reactions, which are restricted to a slight swelling ( &lt; 2 cm diameter), may uncommonly occur and disappear within 1 day.
Prolazne lokalne reakcije na mjestu injiciranja, koje su ograničene na blago oticanje ( &lt; 2 cm dijametralno) se mogu pojaviti te nestati u roku od jednog dana.
Transient thrombocytopenia (platelets &lt; 100 x 109/L) following filgrastim administration and leukapheresis was observed in 35 % of subjects studied.
Prolazna trombocitopenija (trombociti &lt; 100 x 109/l) nakon primjene filgrastima i nakon leukafereze zabilježena je u 35 % ispitanika.