natgillin/translations-raw huggingface dataset:
At 96 weeks, virologic suppression in the dolutegravir group (80%) was superior to the DRV/r group (68%), (adjusted treatment difference [DTG-(DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.2]).
U 96. tjednu, virološka supresija u dolutegravir skupini (80%) bila je superiorna u odnosu na DRV/r skupinu (68 %) (prilagođena razlika između liječenja [DTG-(DRV+RTV)]: 12,4%; 95% CI: [4,7; 20,2]).
At 96-weeks, in treatment-experienced patients, Grade 2 or higher laboratory abnormalities that represent a worsening Grade from baseline of AST, ALT or total bilirubin occurred in 29 %, 34 % and 13 %, respectively, of co-infected subjects treated with ISENTRESS as compared to 11 %, 10 % and 9 % of all other subjects treated with ISENTRESS.
96 tjedana su u prethodno liječenih bolesnika odstupanja u laboratorijskim nalazima AST-a, ALT-a i ukupnog bilirubina 2. ili višeg stupnja koja su predstavljala pogoršanje u odnosu na početne vrijednosti zabilježena u 29%, 34% odnosno 13% ispitanika s istodobnom infekcijom koji su liječeni lijekom ISENTRESS, u usporedbi s 11%, 10% odnosno 9% svih ostalih ispitanika koji su liječeni lijekom ISENTRESS.
At a dose higher than the recommended dose for adult patients, a case of fatal cardiac failure occurred in the setting of life-threatening cytokine release syndrome (CRS) and tumour lysis syndrome (TLS), see section 4.4.
Pri dozi višoj od preporučene doze za odrasle bolesnike, došlo je do slučaja srčanog zatajenja sa smrtnim ishodom u okviru po život opasnog sindroma otpuštanja citokina (CRS) i sindroma lize tumora (TLS), vidjeti dio 4.4.
At a dose of 0.25 mg per injection repeated injections every 24 hours will maintain the effect of cetrorelix.
Pri dozi od 0,25 mg po injekciji, injekcije ponavljane svaka 24 sata održavati će učinak cetroreliksa.
At a dose of 10 mg/kg, mean Vss averaged between 133 (SD 24) ml/kg after multiple dosing, corresponding to a value of approximately 10 l for a 75 kg person.
U dozi od 10 mg/kg, prosječna srednja vrijednost Vss je bila između 133 (SD 24) ml/kg nakon višekratnog doziranja što odgovara vrijednosti od približno 10 l za osobu težine 75 kg.
At a dose of 100 mg/day, 71% of patients developed an ISR compared to 28% of the placebo treated patients.
Pri dozi od 100 mg/dnevno, 71% bolesnika imalo je ISR u usporedbi s 28% bolesnika koji su primali placebo.
At a dose of 1–2 mg/kg body weight, robenacoxib tablets produced a marked inhibition of COX-2 activity in cats and had no effect on COX-1 activity.
Pri dozi od 1 - 2 mg/kg tjelesne težine tablete robenakoksiba uzrokovale su značajnu inhibiciju aktivnosti COX-2 u mačaka i nisu imale učinka na aktivnost COX-1.
At a dose of 20 mg Levitra film-coated tablets, elderly ( 65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (<65 years old).
Uz Levitra filmom obložene tablete od 20 mg, stariji (u dobi od ≥ 65 godina) bolesnici imali su veću učestalost glavobolja (16,2% nasuprot 11,8%) i omaglice (3,7% nasuprot 0,7%) nego mlađi bolesnici (u dobi od < 65 godina).
At a dose of 2200 mg/m2 given on days 1, 3 and 5 every 21 days, 2 patients developed a significant grade 3 ascending sensory neuropathy.
Pri primjeni dnevne doze od 2200 mg/m2 1., 3. i 5. dan terapijskoga ciklusa ponavljanoga svakih 21 dan, 2 bolesnika razvila su klinički značajnu senzornu neuropatiju uzlaznoga tipa 3. stupnja.
At a dose of 60 mg/kg, female rats had significant post- implantation foetal loss and a reduced number of live foetuses.
Pri dozi od 60 mg/kg, ženke štakora su imale značajan postimplantacijski gubitak fetusa te smanjeni broj živih fetusa.
At a follow-up visit 1 to 3 days after the second injection of each treatment cycle, perform a penile modeling procedure (as described below) on the flaccid penis to stretch and elongate the plaque that Xiapex has disrupted:
Na kontrolnom posjetu 1 do 3 dana nakon druge injekcije svakog ciklusa liječenja, provedite postupak modeliranja penisa (kako je opisano niže) na opuštenom penisu kako bi se plak razgrađen Xiapexom rastegnuo i produljio:
At a maternally toxic dose of 1000 mg/kg/day (approximately 49 times the MRHD on a mg/m2 basis), decreased fetal body weight occurred with no signs of teratogenicity.
Pri dozama toksičnim za majke od 1000 mg/kg/dan (približno 49 puta veća doza od MRHD na bazi mg/m2), tjelesna težina fetusa se smanjila ali bez znakova teratogenosti.
At a maternally toxic dose of 1000 mg/kg/day (approximately 49 times the MRHD on a mg/m2 basis), decreased fetal body weight occurred with no signs of teratogenicity.
Pri dozama toksičnim za majke od 1000 mg/kg/dan (približno 49 puta veća doza od od MRHD na bazi mg/m2), tjelesna težina fetusa se smanjila ali bez znakova teratogenosti.
At a rate of rise in haemoglobin of > 2 g/dl (> 1.25 mmol/l) per month the Retacrit dose should be reduced by about 25-50%.
Kod porasta hemoglobina za >2 g/dl (> 1,25 mmol/l) mjesečno, potrebno je smanjiti dozu Retacritom za 25-50%.
At a survival update with a median duration of follow-up of 14.7 months, median Overall Survival (OS) was 17.5 months (95% CI:13.7, not estimable ).
U trenutku ažuriranja podataka o preživljenju nakon medijana praćenja od 14,7 mjeseci, medijan ukupnog preživljenja (engl. overall survival, OS) iznosio je 17,5 mjeseci (95% CI: 13,7; ne može se procijeniti).
At adult age (Day 69 post partum) no effects of bosentan were detected at 1.3 (males) and 2.6 (females) times the therapeutic exposure in children with PAH.
U odrasloj dobi (69. postpartalni dan) nisu zabilježeni učinci bosentana pri izloženosti 1,3 puta (mužjaci) i 2,6 puta (ženke) većoj od terapijske izloženosti u djece s PAH-om.
At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QT corrected (QTc) interval.
Pri svim ispitivanim dozama, palonosetron nije izazvao klinički značajno produljenje QTc intervala.
At all evaluation time points after the initial few months of treatment, a higher proportion of patients treated with ZYTIGA remained alive, compared with the proportion of patients treated with placebo (see Figure 4).
U svim vremenskim točkama u kojima su ocjenjivani rezultati nakon prvih mjeseci liječenja, preživio je veći udio bolesnika liječenih lijekom ZYTIGA u odnosu na udio bolesnika koji su primali placebo (vidjeti Sliku 4).
At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec.
U svim vremenskim točkama nakon doze 8. dana, prosječna promjena u duljini QTcF intervala u odnosu na početnu iznosila je 4 -6 msek, uz gornju granicu 95% raspona pouzdanosti od <7 msek.
At all post-injection days, p≤0.024 in TG-MV-006, p≤0.009 in TG-MV-007, p<0.001 in integrated data
U sv im danima nakon injekcije p≤0.024 u TG-MV-006, p≤0.009 u TG-MV-007, p<0.001 u integriranim podacima
At an initial visit, the patient’s clinical status, alcohol dependence, and level of alcohol consumption (based on patient reporting) should be evaluated.
Za vrijeme prvog posjeta trebalo bi procijeniti bolesnikov klinički status, ovisnost o alkoholu te razinu konzumacije alkohola (na temelju bolesnikova izvješća).
At an interim analysis of the on-going registry, data from 96 patients with severe VOD were available.
Prilikom međuanalize aktivnog registra bili su dostupnbi podaci za 96 bolesnika s teškom veno-okluzivnom bolešću.
At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to the physician assessment and the patient’s response.
Doza se u svakom trenutku može smanjiti (na 4,5 mg dnevno) ili povećati (do 36 mg dnevno) ovisno o procjeni liječnika i odgovoru bolesnika.
At any time, the patient’s assigned dose could be reduced based on tolerability.
U bilo kojem trenutku bolesnikova doza mogla se smanjiti u skladu s podnošljivošću.
At any visit, the mean diurnal IOP values measured over the 12-month study period differed by no more than 1.3 mmHg throughout the day and were never greater than 18.0 mmHg.
Pri svakom pregledu, srednje dnevne vrijednosti očnog tlaka izmjerene u razdoblju 12-mjesečnog ispitivanja razlikovale su se najviše 1,3 mmHg kroz dan i nikada nisu bile veće od 18,0 mmHg.
At application site: Bleeding, warmth, discoloration, ulcer, haemorrhage, swelling
Na mjestu primjene: krvarenje, toplina, promjena boje, čir, krvarenje, otok
At application site: Erythema, irritation, pain, pruritus, oedema, exfoliation, scab
Na mjestu primjene: eritem, nadraženost, bol, pruritus, edem, eksfolijacija, krasta
At application site: Induration, vesicles, paraesthesia, hyperalgesia, erosion, discomfort, discharge
Na mjestu primjene: otvrdnuće, vezikule, parestezija, hiperalgezija, erozija, nelagoda, iscjedak
At application site: Pustules
Na mjestu primjene: pustule
At approximately 25 days after the first dose, re-evaluate the dog and measure the Na⁺/K⁺ ratio.
Otprilike 25 dana nakon prve doze, procijenite stanje psa i izmjerite odnos Na⁺/K⁺.
At approximately twice therapeutic concentrations, sunitinib has been shown to prolong the QTcF Interval (Frederica’s Correction).
Pri koncentracijama približno dvostruko većima od terapijskih uočeno je da sunitinib produljuje QTcF-interval (korekcija prema Fridericiji).
At approximately twice therapeutic concentrations, the maximum QTcF interval change from baseline was 15.4 msec (90% CI:
Pri približno dvostrukim terapijskim koncentracijama najveća je promjena QTcF-intervala u odnosu na početne vrijednosti iznosila 15,4 msek (90% CI: 22,4 msek).
At baseline 52% of patients had high disease activity (SELENA SLEDAI score >10), 59% of patients had mucocutaneous, 60% had musculoskeletal, 16% had haematological, 11% had renal and 9% had vascular organ domain involvement (BILAG A or B at baseline).
Na početku ispitivanja je 52% bolesnika imalo visoki stupanj aktivnost bolesti (SELENA SLEDAI rezultat >10), u 59% bolesnika zahvaćene su bile koža i sluznice, u 60% bolesnika mišićno-koštani sustav, u 16% hematološki sustav, u 11% bubrezi, te u 9% vaskularni sustav (BILAG A ili B ishodišno).
At baseline a total of 165 women (69) had a T-score below –2.5, and 112 (47) reported at least one fracture after menopause.
Pri uključivanju u ispitivanje ukupno 165 žena (69%) imalo je T-vrijednost nižu od -2,5 a 112 žena (47%) prijavile su najmanje jedan prijelom nakon menopauze.
At baseline the median platelet count was 20,000/µl, haemoglobin was 8.4 g/dL, ANC was
Na početku je medijan broja trombocita bio 20 000/μl, hemoglobin je bio 8,4 g/dL, ABN je bio 0,58 x 109/L, a apsolutni broj retikulocita bio je 24,3 x 109/L.
At baseline, 39.2% of patients had Rai Stage IV, 45.1% had bulky disease (≥ 5 cm), 35.3% had deletion 17p and 31.4% had deletion 11q.
Na početku je 39,2% bolesnika imalo Rai stadij IV, 45,1% imalo je veliku tumorsku masu (≥ 5 cm), 35,3% imalo je deleciju 17p i 31,4% imalo je deleciju 11q.
At baseline, 53% of patients had bulky disease (≥ 5 cm), 21% had high-risk score by Simplified MIPI, 60% had extranodal disease and 54% had bone marrow involvement at screening.
Na početku, 53% bolesnika imalo je veliku tumorsku masu (≥ 5 cm), 21% imalo je skor visokog rizika prema Pojednostavljenom MIPI indeksu, 60% imalo je ekstranodalnu bolest i 54% imalo je zahvaćenost koštane srži pri probiru.
At baseline, 55% of patients in the siltuximab arm and 65% of patients in the placebo arm had received prior systemic therapies for MCD and 30% of patients in the siltuximab arm and 31% in the placebo arm were using corticosteroids.
Na početku je 55% bolesnika u skupini liječenoj siltuksimabom i 65% bolesnika u placebo skupini, primilo prethodne sistemske terapije za MCD i 30% bolesnika u skupini liječenoj siltuksimabom, te 31% u placebo skupini koristilo je kortikosteroide.
At baseline, 56% of patients had at least one tumour ≥ 5 cm, 26% had del11q.
Na početku, 56% bolesnika imalo je barem jedan tumor ≥ 5 cm, 26% imalo je del11q.
At baseline, 57% of patients randomised to tenofovir disoproxil fumarate versus 60% of patients randomised to emtricitabine plus tenofovir disoproxil fumarate treatment group had previously been treated with lamivudine.
Na početku je 57% pacijenata randomizirano na tenofovirdizoproksilfumarat nasuprot 60% pacijenata randomiziranih na emtricitabin u kombinaciji s tenofovirdizoproksilfumaratom, a koji su bili prethodno liječeni lamivudinom.
At baseline, 58% of patients had at least one tumour ≥5 cm.
Na početku, 58% bolesnika imalo je barem jedan tumor ≥5 cm.
At baseline, 71% of subjects in the eltrombopag group and 69% in the placebo group reported any bleeding (WHO Grades 1-4).
Na početku je 71% ispitanika u eltrombopag skupini te 69% u placebo skupini prijavilo bilo kakvo krvarenje (WHO stadij 1-4).
At baseline, 76% of patients were refractory to the last line of treatment, 64% were refractory to both a PI and IMiD, 60% were refractory to alkylating agents, 36% were refractory to pomalidomide and 17% were refractory to carfilzomib.
Na početku ispitivanja, 76% bolesnika bilo je refraktorno na posljednju liniju liječenja, njih 64% bilo je refraktorno i na inhibitor proteasoma i na imunomodulator, 60% ih je bilo refraktorno na alkilirajuće lijekove, 36% na pomalidomid, a 17% na karfilzomib.
At baseline, 80 patients (33%) had eGFRCG < 50 mL/min and 162 patients had eGFRCG ≥ 50 mL/min.
Na početku je 80 bolesnika (33%) imalo eGFRCG < 50 ml/min, a 162 bolesnika su imala eGFRCG  50 ml/min.
At baseline, 97% of patients were refractory to the last line of treatment, 95% were refractory to both, a proteasome inhibitor (PI) and immunomodulatory agent (IMiD), 77% were refractory to alkylating agents, 63% were refractory to pomalidomide and 48% of patients were refractory to carfilzomib.
Na početku ispitivanja, 97% bolesnika bilo je refraktorno na posljednju liniju liječenja, njih 95% bilo je refraktorno i na inhibitor proteasoma i na imunomodulator, 77% ih je bilo refraktorno na alkilirajuće lijekove, 63% na pomalidomid, a 48% na karfilzomib.
At baseline, mean predicted FEV1 was 73% (range: 32.5% to 105.5%) and mean age was 31 years (range: 6 to 68 years).
Na početku je prosječni predviđeni FEV1 iznosio 73% (raspon: od 32,5% do 105,5%), a prosječna dob je bila 31 godina (raspon: od 6 do 68 godina).
At baseline, mean predicted FEV1 was 84.2% (range: 44.0% to 133.8%) and mean age was 9 years (range: 6 to 12 years); 8 (30.8%) of patients in the placebo group and 4 (15.4%) of patients in the ivacaftor group had an FEV1 less than 70% predicted at baseline.
Na početku je prosječni predviđeni FEV1 iznosio 84,2% (raspon: 44,0% do 133,8%), a prosječna dob bila je 9 godina (raspon: 6 do 12 godina); 8 (30,8%) bolesnika u skupini koja je primala placebo i 4 (15,4%) bolesnika u skupini koja je primala ivakaftor imalo je FEV1 na početku manji od 70% predviđenog.
At baseline, median eGFR was 56 mL/min, and 33% of patients had an eGFR from 30 to 49 mL/min.
Medijan eGFRCG na početku iznosio je 56 ml/min, a 33% bolesnika imalo je eGFR od 30 do 49 ml/min.
At baseline, median patient age was 35 years, 16% were female, 32% non- white, 7% had hepatitis C co-infection and 4% were CDC Class C, these characteristics were similar between treatment groups.
Na početku ispitivanja medijan dobi bolesnika iznosio je 35 godina, 16% bolesnika bile su žene, 32% bolesnika nisu bili bijelci, 7% bolesnika imalo je istodobnu infekciju hepatitisom C, a 4% bolesnika imalo je HIV infekciju kategorije C prema CDC klasifikaciji; ove značajke bile su slične u obje liječene skupine.
At baseline, median patient age was 35 years, 16% were female, 32% non-white, 7% had hepatitis C co- infection and 4% were CDC Class C, these characteristics were similar between treatment groups.
Na početku ispitivanja medijan dobi bolesnika iznosio je 35 godina, 16% bolesnika bile su žene, 32% bolesnika nisu bili bijelci, 7% bolesnika imalo je istodobnu infekciju hepatitisom C, a 4% bolesnika imalo je HIV infekciju kategorije C prema CDC klasifikaciji; ove značajke bile su slične u obje liječene skupine.
At baseline, median patient age was 48 years, 23% were female, 29% non-white, and 20% had hepatitis B and/or C co-infection.
Na početku je ispitivanja medijan dobi bolesnika iznosio 48 godina, 23% bolesnika bile su žene, 29% bolesnika nije bilo bijele rase, a
At baseline, median plasma HIV-1 RNA was 4.7 log10 copies/mL, median CD4+ cell count was 456 cells/mm3 (range: 95-1,110), and median CD4+% was 23% (range: 7-45%).
Na početku je medijan HIV-1 RNK u plazmi bio 4,7 log10 kopija/ml, medijan broja CD4+ stanica bio je 456 stanica/mm3 (raspon: 95-1110) i medijan postotka CD4+ bio je 23% (raspon: 7-45%).
At baseline, more than 70% of ITP patients in each treatment group reported any bleeding (WHO Grades 1-4) and more than 20% reported clinically significant bleeding (WHO Grades 2-4), respectively.
Na početku ispitivanja više od 70% bolesnika s ITP-om u svakoj ispitivanoj skupini prijavilo je bilo koji oblik krvarenja (WHO stadij 1-4), a više od 20% je prijavilo klinički značajno krvarenje (WHO stupanj 2-4).
At baseline, participants had a median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9 to 6.4% in the insulin glargine group, and 6.2% to 6.6% in the standard care group throughout the duration of follow-up.
Sudionici su na početku ispitivanja imali medijan vrijednosti HbA1c od 6,4%, dok se medijan vrijednosti HbA1c tijekom liječenja kretao u rasponu od 5,9 6,4% u skupini koja je primala inzulin glargin te od 6,2 6,6% u skupini koja je primala standardno liječenje tijekom čitavoga razdoblja praćenja.
At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to
Na početku ispitivanja bolesnici su imali umjereni stupanj nesposobnosti s prosječnom ocjenom na upitniku HAQ od 1,4 do 1,5.
At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5. Treatment with etanercept 25 mg resulted in substantial improvement at
Na početku ispitivanja bolesnici su imali umjereni stupanj nesposobnosti, s prosječnom ocjenom na upitniku HAQ od 1,4 do 1,5.
At baseline, patients had average estimated glomerular filtration rate (eGFR) of 82 mL/min/1.73m2 (CKD-EPI) with 79% having hypertension and a mean TKV of 1692 mL (height adjusted 972 mL/m).
Na početku je bolesnicima prosječna procijenjena brzina glomerularne filtracije (eGFR) bila 82 ml/min/1,73m2 (KBB-EPI), a njih 79% imalo je hipertenziju i srednju vrijednost UVB-a od 1692 ml (972 ml/m prilagođenoj prema visini).
At baseline, patients had idiopathic (31 patients [86%]) or familial (5 patients [14%]) PAH, and were in WHO functional class II (n = 23 patients, 64%) or class III (n = 13 patients, 36%).
Na početku studije, bolesnici su imali idiopatsku (31 bolesnik [86%]) ili obiteljsku (5 bolesnika [14%]) PAH i bili su funkcionalnog stupnja II (n = 23 bolesnika [64%]) ili III (n = 13 bolesnika [36%]) prema WHO.
At baseline, the majority of enrolled patients (80%) were being treated with a stable dose of a specific therapy for PAH, either an ERA (15%) or a PDE-5 inhibitor (32%) or both an ERA and a PDE-5 inhibitor (33%).
Na početku je većina uključenih bolesnika (80%) liječena stabilnom dozom lijekova za PAH, bilo ERA-ima (15%) ili inhibitorima PDE-5 (32%) ili kombinacijom ERA-a i inhibitora PDE-5 (33%).
At baseline, the median serum IgM value was 3.5 g/dL, and 60% of patients were anemic (haemoglobin ≤ 11 g/dL or 6.8 mmol/L).
Na početku, medijan vrijednosti serumskog IgM bio je 3,5 g/dl i 60% bolesnika imalo je anemiju (hemoglobin ≤ 11 g/dl ili 6,8 mmol/l).
At baseline, the patients had, on average, 23 HDDs per month (11% of patients had fewer than 14 HDDs per month) and consumed 106 g/day.
Pri početnim vrijednostima bolesnici su imali prosječno 23 DTPP-a mjesečno (11% bolesnika imalo je manje od 14 DTPP-a mjesečno) i konzumiralo je
At birth, one dose of hepatitis B immunoglobulin (within 24 hours).
Odmah nakon rođenja, jedna doza imunoglobulina protiv hepatitisa B (unutar 24 sata).
At body weight ≥ 100 kg, the predicted mean (± SD) steady- state AUC, Cmin and Cmax of tocilizumab were 50000 ± 16800 μg•h/mL, 24.4 ± 17.5 μg/mL, and 226 ± 50.3 μg/mL, respectively, which are higher than mean exposure values for the patient population (i.e. all body weights) reported above.
tjelesnu težinu ≥ 100 kg predviđene srednje vrijednosti (± SD) AUC-a, Cmin odnosno Cmax tocilizumaba u stanju dinamičke ravnoteže bile su 50000± 16800 μg•sat/ml, 24,4 ± 17,5 μg/ml odnosno 226 ± 50,3 μg/ml, što je veće od srednjih vrijednosti izloženosti za populaciju bolesnika (tj sve tjelesne težine) gore navedenih.
At body weight ≥ 100 kg, the predicted mean (± SD) steady-state AUC, Cmin and Cmax of tocilizumab were 50000 ± 16800 μg•h/mL, 24.4 ± 17.5 μg/mL, and 226 ± 50.3 μg/mL, respectively, which are higher than mean exposure values for the patient population (i.e. all body weights) reported above.
Uz tjelesnu težinu ≥ 100 kg predviđene srednje vrijednosti (± SD) AUC-a, Cmin odnosno Cmax tocilizumaba u stanju dinamičke ravnoteže bile su 50000 ± 16800 μg•sat/ml, 24,4 ± 17,5 μg/ml odnosno 226 ± 50,3 μg/ml, što je veće od srednjih vrijednosti izloženosti za populaciju bolesnika (tj sve tjelesne težine) gore navedenih.
At both week 24 and week 120, responder rates were higher for patients on 3 or more active substances (in vitro) in their background regimen.
I u tjednu 24 i u tjednu 120, stope odgovora bile su više kod bolesnika koji su u osnovnom liječenju uzimali 3 ili više djelatnih tvari (in vitro).
at both Week 8 and Week 30)
8. i u 30. tjednu)a
at both Week 8 and Week 30)a
8. i u 30. tjednu)a
At clinical cutoff, 1337 deaths were reported.
Pri kliničkom razgraničenju (engl. clinical cutoff) prijavljeno je 1337 smrti.
At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments.
Na temelju in vitro ispitivanja, vezanje dasatiniba u klinički značajnim koncentracijama za proteine plazme iznosilo je oko 96%.
At clinically relevant exposures, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Pri klinički značajnim izloženostima, ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak po pitanju reproduktivne toksičnosti (vidjeti dio 5.3).
At day 100 of gestation, depletion of B-cells relating to the pharmacological activity of ofatumumab were observed in foetal cord blood and foetal splenic tissues.
Stotog dana gestacije, u fetalnoj krvi pupkovine i fetalnom tkivu slezene zabilježeno je smanjenje broja B-stanica povezano s farmakološkom aktivnošću ofatumumaba.
At day 15, the median change from baseline in the number of joints with active arthritis and limited range of motion were -67% and -73% for Ilaris (N=43), respectively, compared to a median change of 0% and 0% for placebo (N=41).
Nakon 15 dana, medijan promjene od početne vrijednosti u broju zglobova s aktivnim artritsom i ograničenim rasponom pokreta bio je -67% odnosno -73% za Ilaris (N=43), u usporedi s medijanom promjene od 0% odnosno 0% za placebo (N=41).
At Day 15, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline was 2.51 percentage points in the pooled Trials 1 and 2 (P<0.0001).
U objedinjenim ispitivanjima 1 i 2, terapijska razlika između lumakaftora 400 mg/ivakaftora 250 mg svakih 12 sati i placeba za srednju vrijednost apsolutne promjene (95% CI) u ppFEV1 iznosila je 15. dana u odnosu na početnu vrijednost 2,51 postotnih bodova (P < 0,0001).
At day 42, 100% of subjects aged 18-60 years and 96.4% of subjects aged >60 years had a titre of at least 1:80.
Četrdeset i drugog dana, 100% ispitanika od 18 do 60 godina, te 96,4% ispitanika starijih od 60 godina imalo je titar od najmanje 1:80.
At day 42, the anti-HA antibody responses were as follows:
Odgovor anti- HA protutijela 42. dana navodi se u nastavku:
At day 42, the anti-HA antibody responses were as follows:
Odgovori anti-HA protutijela 42. dana navode se u nastavku:
At day 42, the anti-HA antibody responses were as follows:
Odgovori anti-HA protutijela 42. dana su bili sljedeći:
At day 42, the neutralising antibody responses were as follows:
Odgovori neutralizirajućih protutijela 42. dana bili su sljedeći: