natgillin/translations-raw huggingface dataset:
In clinical studies, &gt; 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
U kliničkim je ispitivanjima &gt; 90 % bolesnika imalo odgovor na ove doze i postiglo oporavak neutropenije u medijanu od 2 dana.
In clinical studies, &gt; 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
U kliničkim je ispitivanjima &gt; 90% bolesnika odgovorilo na ove doze, s medijanom vremena potrebnog za korekciju neutropenije od 2 dana.
In clinical studies, dosing with 30 MU (300 micrograms)/day on 1 to 7 days per week was required to maintain the ANC &gt; 2.0 x 109/l, with the median dose frequency being 3 days per week.
U kliničkim je ispitivanjima za održavanje ukupnog broja neutrofila na vrijednostima &gt; 2,0 x 109/l bila potrebna doza od 30 MU (300 mikrograma)/dan tijekom 1 do 7 dana na tjedan, s medijanom broja doza od 3 na tjedan.
In clinical studies, dosing with 30 MU/day (300 micrograms/day) on 1 - 7 days per week was required to maintain the ANC &gt; 2.0 x 109/L, with the median dose frequency being 3 days per week.
U kliničkim je ispitivanjima bila potrebna primjena doze od 30 MU/dan (300 mikrograma/dan) 1 do 7 dana tjedno kako bi se održao ABN &gt; 2,0 x 109/l, uz medijan učestalosti doziranja od 3 dana tjedno.
In clinical studies, dosing with 30 MU/day (300 μg/day) on 1 - 7 days per week was required to maintain the ANC &gt; 2.0 x 109/l, with the median dose frequency being 3 days per week.
U kliničkim je ispitivanjima bilo potrebno primjenjivati dozu od 30 MU na dan (300 μg/dan) tijekom 1 - 7 dana tjedno da bi se apsolutni broj neutrofila održao na &gt; 2,0 x 109/l, uz medijan učestalosti doziranja 3 dana tjedno.
In clinical studies, granulocytopenia was only uncommonly severe ( &lt; 0.5x109/L) and not associated with infections.
U kliničkim ispitivanjima granulocitopenija je bila manje često teška ( &lt; 0,5x109/l) i nije bila povezana s infekcijama.
In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated paediatric patients (MTPs, defined as having ≤4 exposure days) with residual FVIII:C &lt; 2 IU/dl.
U kliničkim ispitivanjima, Helixate NexGen se upotrebljavao za liječenje krvarenja u 37 prethodno neliječenih bolesnika (PNB) te 23 minimalno liječena pedijatrijska bolesnika (MLB, definirani kao izloženi lijeku ≤4 dana) s rezidualnim FVIII C &lt; 2 IU/dl.
In clinical studies, hypertension adverse events occurred in approximately 20% of subjects and approximately 6% of subjects had grade ≥ 3 hypertension events, but hypertensive crises occurred in &lt; 0.5% of subjects.
U kliničkim ispitivanjima, hipertenzivni štetni događaji javili su se u otprilike 20% ispitanika i otprilike 6% ispitanika imalo je događaj hipertenzije 3. ili višeg stupnja, dok se hipertenzivna kriza javila u &lt; 0,5% ispitanika.
In clinical studies, marked increases in plasma CPK to &gt; 5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in Cubicin-treated patients (1.9%) than in those that received comparators (0.5%).
U kliničkim su ispitivanjima, izraženi porasti CPK u plazmi do &gt; 5x gornje granice normale bez mišićnih simptoma, bili češći u bolesnika liječenih Cubicinom (1,9%) nego u onih koji su primali lijekove usporedbe (0,5%).
In clinical studies, no dosage adjustment was required in elderly ( &gt; 65 years) patients exposed to pomalidomide.
U kliničkim ispitivanjima nije bila potrebna prilagodba doze u starijih (u dobi &gt; 65 godina) bolesnika izloženih pomalidomidu.
In clinical studies, NO2 levels &gt; 3 ppm or methaemoglobin levels &gt; 7 % were treated by reducing the dose of, or discontinuing, INOmax.
U kliničkim ispitivanjima razine NO2 &gt; 3 ppm ili methemoglobina &gt; 7% liječene su smanjenjem doze ili prekidom davanja INOmax-a.
In clinical studies, patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) or receiving dialysis were at greater risk of developing hypocalcaemia in the absence of calcium supplementation.
U slučaju izostanka nadopune kalcija, bolesnici s teškim oštećenjem funkcije bubrega (klirens kreatinina &lt; 30 ml/min) ili bolesnici koji su na dijalizi u kliničkim su ispitivanjima imali povećan rizik za razvijanje hipokalcijemije.
In clinical studies, the incidence of important elevations in creatine phosphokinase (CK ≥ 3 times the ULN, &lt; 5 times the ULN) was 1.92% for patients treated with Pravafenix.
U kliničkim ispitivanjima incidencija značajnih povišenja kreatin fosfokinaze (KF ≥ 3puta GGN, &lt; 5 puta GGN) bila je kod 1,92% bolesnika liječenih Pravafenixom.
In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR &lt; 30 mL/min/1.73 m2) (see section 5.2).
U klinička je ispitivanja bio uključen ograničen broj bolesnika s teškim oštećenjem bubrežne funkcije (koje se definiralo kao eGFR &lt; 30 ml/min/1,73 m2) (vidjeti dio 5.2).
In clinical trials first degree AV block (PR prolongation &gt; 220 msec) developed in 3% of patients within 2 hours of Rapiscan administration; transient second degree AV block with one dropped beat was observed in one patient receiving Rapiscan.
U kliničkim ispitivanjima AV blok prvog stupnja (produženi PR interval &gt; 220 msek) razvio se u 3% bolesnika unutar 2 sata od primjene Rapiscana; prolazni AV blok drugog stupnja s neprovedenim jednim QRS-om primijećen je kod jednog bolesnika koji je primio Rapiscan.
In clinical trials in children 6 to &lt; 12 years of age, the most commonly reported adverse reactions were headache, pyrexia and upper abdominal pain.
U kliničkim ispitivanjima u djece od 6 do &lt; 12 godina starosti najčešće zabilježene nuspojave bile su glavobolja, vrućica i bol u gornjem dijelu abdomena.
In clinical trials non-cutaneous malignancies were reported in 1% (6/586) of patients with dabrafenib monotherapy, and 1% (3/209) of patients in study MEK115306 and &lt; 1% (3/350) of patients in study MEK116513 with dabrafenib in combination with trametinib.
U kliničkim ispitivanjima zloćudne bolesti koje nisu zahvatile kožu prijavljene su u 1% (6/586) bolesnika s monoterapijom dabrafenibom, i u 1% (3/209) bolesnika u ispitivanju MEK115306 i u &lt; 1% (3/350) bolesnika u studiji MEK116513 s dabrafenibom u kombinaciji s trametinibom.
In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to &lt; 1/10)).
U kliničkim ispitivanjima u bolesnika s nedostatkom faktora VII, stvaranje protutijela na NovoSeven i FVII jedina je prijavljena nuspojava (učestalost: često (≥ 1/100 i &lt; 1/10)).
In clinical trials these patients were defined by an endogenous serum LH level &lt; 1.2 IU/l.
U kliničkim ispitivanjima te su pacijentice definirane razinom endogenog LH u serumu &lt; 1,2 IU/l.
In clinical trials these patients were defined by an endogenous serum LH level &lt; 1.2 IU/L.
U kliničkim se ispitivanjima to stanje kod pacijentica definiralo razinom endogenog LH u serumu od &lt; 1,2 IU/l.
In clinical trials these patients were defined by an endogenous serum LH level &lt; 1.2 IU/l.
U kliničkim ispitivanjima ti su bolesnici definirani endogenom razinom LH u serumu &lt; 1,2 IU/l.
In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p &lt; 0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9%, respectively).
U kliničkim ispitivanjima u kojima se valsartan uspoređivao s ACE inhibitorom, incidencija suhog kašlja bila je značajno (p &lt; 0,05) niža u bolesnika liječenih valsartanom, nego u onih liječenih ACE inhibitorom (2,6% naspram 7,9%).
In clinical trials with oral olanzapine, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF &lt; 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
U kliničkim ispitivanjima s oralnim olanzapinom klinički značajna produljenja QTc-intervala (Fridericia QT korekcija [QTcF] ≥ 500 milisekundi [ms] u bilo kojem trenutku nakon početka liječenja u bolesnika koji su na početku liječenja olanzapinom imali vrijednost QTcF &lt; 500 ms) bila su manje česta (0,1% do 1%) i bez značajnih razlika u povezanim srčanim događajima u usporedbi s placebom.
In clinical trials with vedolizumab at doses ranging from 2 to 10 mg/kg, &gt; 95% saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut immune surveillance was observed in patients.
U kliničkim ispitivanjima vedolizumaba u dozama od 2 do 10 mg/kg kod bolesnika je uočeno zasićenje receptora α4β7 veće od 95% na podskupinu cirkulirajućih limfocita uključenih u imunološki nadzor crijeva.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 micromol/l or &gt; 3.0 mg/dl were excluded.
Bolesnici s vrijednošću kreatinina u serumu &gt; 265 mikromola/l ili &gt; 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa zoledronatnom kiselinom.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 µmol/l or &gt; 3.0 mg/dl were excluded.
Bolesnici s vrijednošću kreatinina u serumu &gt; 265 μmol/l ili &gt; 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa zoledronatnom kiselinom.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 µmol/l or &gt; 3.0 mg/dl were excluded.
Bolesnici s vrijednošću kreatinina u serumu &gt; 265 μmol/l ili &gt; 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 µmol/l or &gt; 3.0 mg/dl were excluded.
Bolesnici s vrijednošću kreatinina u serumu većom od 265 μmol/l ili 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja zoledronatne kiseline.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 μmol/l or &gt; 3.0 mg/dl were excluded.
Bolesnici s vrijednošću kreatinina u serumu većom od 265 μmol/l ili 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa zoledronatnom kiselinom.
In clinical trials with zoledronic acid, patients with serum creatinine &gt; 265 μmol/l or &gt; 3.0 mg/dl were excluded.
U kliničkim ispitivanjima Zoledronatne kiseline bolesnici s vrijednošću kreatinina u serumu &gt; 265 μmol/l ili &gt; 3,0 mg/dl bili su isključeni iz ispitivanja.
In clinical trials with Zometa, patients with serum creatinine
Bolesnici s vrijednošću kreatinina u serumu &gt; 265 μmol/l ili
In clinical trials, 51 adolescents with CF (≥ 12 to &lt; 18 years old) received Quinsair 240 mg twice daily and 6 adolescents with CF received Quinsair 120 mg (n = 3) or 240 mg (n = 3) once daily.
U kliničkim ispitivanjima, 51 adolescent s CF (u dobi od ≥ 12 do &lt; 18 godina) primala su Quinsair 240 mg dva puta na dan i 6 adolescenata s CF primala su Quinsair 120 mg (n = 3) ili 240 mg (n = 3) jedan puta na dan.
In clinical trials, a higher incidence of severe liver injury with fatal outcome was observed in Japanese patients (~1.5%) treated with Stivarga compared with non- Japanese patients ( &lt; 0.1%).
U kliničkim ispitivanjima, viša incidencija teškog oštećenja jetre sa smrtnim ishodom uočena je u japanskih bolesnika (~1,5%) koji su bili liječeni lijekom Stivarga u usporedbi s bolesnicima koji nisu japanskog podrijetla ( &lt; 0,1%).
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF &lt; 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
U kliničkim ispitivanjima, klinički značajna produljenja QTc (Fridericia QT korekcija [QTcF] ≥500 milisekundi [msek] bilo kada nakon početne vrijednosti u bolesnika s početnom vrijednošću QTcF &lt; 500 milisekundi) bila su manje česta (0,1% do 1%) u bolesnika liječenih olanzapinom, bez značajnih razlika u povezanim kardijalnim događajima u usporedbi s placebom.
In clinical trials, clinically meaningful QTc prolongations (Fridericia QT correction [QTcF] ≥ 500 milliseconds [msec] at any time post baseline in patients with baseline QTcF &lt; 500 msec) were uncommon (0.1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo.
U kliničkim ispitivanjima, klinički značajna produljenja QTc intervala (Fridericia QT korekcija [QTcF] ≥ 500 milisekundi [ms] bilo kada nakon početne vrijednosti u bolesnika s početnom vrijednošću QTcF &lt; 500 ms) bila su manje česta (0,1 % do 1 %) u bolesnika liječenih olanzapinom, bez značajnih razlika u povezanim kardijalnim događajima u usporedbi s placebom.
In clinical trials, decreased systolic blood pressure ( &gt; 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure ( &gt; 25 mm Hg) was observed in 4% of patients within 45 minutes of Rapiscan administration.
U kliničkim ispitivanjima sniženje sistoličkog krvnog tlaka ( &gt; 35 mm Hg) primijećeno je u 7% bolesnika, a sniženje dijastoličkog krvnog tlaka ( &gt; 25 mm Hg) primijećeno je u 4% bolesnika unutar 45 minuta od primjene Rapiscana.
In clinical trials, M-M-RVAXPRO was administered to 1965 children (see section 5.1), and the general safety profile was comparable to the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc.
U kliničkim ispitivanjima M-M-RVAXPRO je bio primijenjen u 1965 djece (vidjeti dio 5.1), a opći sigurnosni profil mogao se usporediti s prethodnim kombiniranim cjepivom protiv morbila, parotitisa i rubele proizvođača Merck &amp; Co., Inc.
In clinical trials, patients were defined by an endogenous serum LH level &lt; 1.2 IU/l as measured in a central laboratory.
U kliničkim ispitivanjima, pacijentice su bile definirane razinama endogenog LH u serumu &lt; 1,2 IU/l kako je izmjereno u središnjem laboratoriju.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level &lt; 1.2 IU/L as measured in a central laboratory.
U kliničkim ispitivanjima pacijentice s teškim nedostatkom FSH i LH definirane su razinom endogenog LH u serumu &lt; 1,2 IU/l, kako je izmjereno u središnjem laboratoriju.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level &lt; 1.2 IU/l as measured in a central laboratory.
U kliničkim ispitivanjima, pacijentice s teškim nedostatkom FSH i LH definirane su razinom endogenog LH u serumu &lt; 1,2 IU/l, kako je izmjereno u središnjem laboratoriju.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level &lt; 1.2 IU/L as measured in a central laboratory.
U kliničkim se ispitivanjima teški nedostatak FSH i LH kod pacijentica definirao razinom endogenog LH u serumu &lt; 1,2 IU/l na temelju mjerenja u središnjem laboratoriju.
In clinical trials, rapid tapering (over periods &lt; 1 month) resulted in recurrence of diarrhoea or colitis in some patients.
U kliničkim je ispitivanjima brzo smanjenje doza (u razdoblju &lt; 1 mjeseca) u nekih bolesnika dovelo do ponovne pojave proljeva ili kolitisa.
In clinical trials, smaller bleeding sites ( &lt; 10 cm2) used 0.5 g to 1 g on average.
U kliničkim ispitivanjima, za manja mjesta krvarenja ( &lt; 10 cm2) prosječno se koristi od 0,5 g do 1 g.
In clinical trials, these patients were defined by an endogenous serum LH level &lt; 1.2 IU/l.
U kliničkim ispitivanjima, ove pacijentice definirane su razinom endogenog LH u serumu &lt; 1,2 IU/l.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN
Iz pivotalnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje bolesnika s adenokarcinomom želuca, isključeni su bolesnici s ALT i/ili AST više od 1,5 puta većim od GGN te alkalnom fosfatazom više od 2,5 puta većom od GGN i bilirubinom više od 1 puta većim od GGN.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Iz ključnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje bolesnika s adenokarcinomom želuca, isključeni su bolesnici s ALT i/ili AST više od 1,5 puta većim od GGN te alkalnom fosfatazom više od 2,5 puta većom od GGN i bilirubinom više od 1 puta većim od GGN; za te bolesnike nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST &gt; 1.5 × ULN associated with alkaline phosphatase &gt; 2.5 × ULN, and bilirubin &gt; 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Iz ključnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje bolesnika s adenokarcinomom želuca, isključeni su bolesnici s ALT i/ili AST &gt; 1,5 x GGN te alkalnom fosfatazom &gt; 2,5 x GGN i bilirubinom &gt; 1 x GGN; za te bolesnike nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours &gt; 2 cm in diameter (see sections 4.4 and 5.1).
u kombinaciji s neoadjuvantnom kemoterapijom nakon koje slijedi adjuvantna terapija lijekom Herceptin za lokalno uznapredovalu (uključujući upalnu) bolest ili tumore promjera &gt; 2 cm (vidjeti dijelove 4.4 i 5.1).
In contrast, starting passage with mutants with mutation Q148H (fold change 1), a variety of raltegravir associated secondary mutations accumulated with a consequent increase of fold change to values &gt; 10.
Nasuprot tome, ako je pasaža započela s mutantima koji su imali mutaciju Q148H (vrijednost promjene 1), akumulirao se niz različitih sekundarnih mutacija povezanih s primjenom raltegravira, što je za posljedicu imalo porast vrijednosti promjene na &gt; 10.
In contrast, starting with mutants harbouring mutation Q148H (FC 1), a variety of secondary mutations were seen with a consequent increase of FC to values &gt; 10.
Nasuprot tome, ako je pasaža započela s mutantima koji su imali mutaciju Q148H (FC 1), primijećen je niz sekundarnih mutacija i posljedičan porast vrijednosti FC na &gt; 10.
In contrast, the administration of eltrombopag 2 hours before or 4 hours after a high-calcium meal or with low-calcium food [ &lt; 50 mg calcium] did not alter plasma eltrombopag exposure to a clinically significant extent (see sections 4.2 and 5.2).
Nasuprot tome, primjena eltrombopaga 2 sata prije ili 4 sata nakon obroka s visokim udjelom kalcija ili s hranom s niskim udjelom kalcija [ &lt; 50 mg kalcija] nije promijenila plazmatsku razinu eltrombopaga u klinički značajnoj mjeri (vidjeti dijelove 4.2 i 5.2).
In controlled clinical studies, 10 patients (0.5%) experienced a seizure out of 2051 patients treated with a daily dose of 160 mg enzalutamide, whereas one patient ( &lt; 0.1%) receiving placebo and one patient (0.3%) receiving bicalutamide, experienced a seizure.
U kontroliranim kliničkim ispitivanjima, 10 bolesnika (0,5%) od 2051 liječenih dnevnom dozom od 160 mg enzalutamida imalo je napadaje, dok je napadaje imao jedan bolesnik ( &lt; 0,1%) koji je primao placebo i jedan bolesnik (0,3%) koji je primao bikalutamid.
In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication (34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD &lt; 1.6pg/ml)], normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16- 18 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
U kontroliranim ispitivanjima jednogodišnja terapija lamivudinom značajno je smanjila replikaciju HBV DNK [34-57 % bolesnika bilo je ispod granice detekcije laboratorijskog testa (Abbott Genostics hibridizacijski test u otopini, LLOD &lt; 1,6 pg/ml)}, normalizirala razinu ALT (40-72% bolesnika), potakla serokonverziju HBeAg (nestanak HBeAg i pojavu HBeAb protutijela uz gubitak HBV DNK [uobičajenim testovima], 16-18 % bolesnika), poboljšala histološke nalaze (u 38-52 % bolesnika Knodellov histološki indeks aktivnosti [HAI] smanjio se za ≥ 2 boda) i usporila progresiju fibroze (u 3-17% bolesnika) te progresiju u cirozu
In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication [34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD &lt; 1.6pg/ml)}, normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16- 18 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
U kontroliranim ispitivanjima jednogodišnja terapija lamivudinom značajno je smanjila replikaciju HBV DNK [34-57 % bolesnika bilo je ispod granice detekcije laboratorijskog testa (Abbott Genostics hibridizacijski test u otopini, LLOD &lt; 1,6 pg/ml)}, normalizirala razinu ALT (40-72% bolesnika), potakla serokonverziju HbeAg (nestanak HbeAg i pojavu HbeAb protutijela uz gubitak HBV DNK [uobičajenim testovima], 16-18 % bolesnika), poboljšala histološke nalaze (u 38-52 % bolesnika Knodellov histološki indeks aktivnosti [HAI] smanjio se za ≥ 2 boda) i usporila progresiju fibroze (u 3-17% bolesnika) te progresiju u cirozu.
In DVT and PE treatment, patients receiving fondaparinux 5 mg (body weight &lt; 50 kg), 7.5 mg (body weight 50-100 kg inclusive) and 10 mg (body weight &gt; 100 kg) once daily, the body weight-adjusted doses provide similar exposure across all body weight categories.
U liječenju DVT i PE, u bolesnika koji su primali fondaparinuks u dozi od 5 mg (tjelesna težina &lt; 50 kg), 7,5 mg (tjelesna težina 50 – 100 kg) ili 10 mg (tjelesna težina &gt; 100 kg), doza prilagođena tjelesnoj težini omogućuje sličnu izloženost u svim težinskim kategorijama.
In each Phase III study and the pooled analysis, the time to achieve ≥ 15 letters (3-line) improvement in BCVA cumulative response curves were significantly different with OZURDEX compared to sham (p &lt; 0.001) with OZURDEX treated patients achieving a 3-line improvement in BCVA earlier than sham treated patients.
U svakoj studiji faze III i u analizi objedinjenih podataka, kumulativne krivulje odgovora za vrijeme postizanja poboljšanja od ≥ 15 slova (3 retka) u BCVA bile su značajno drugačije kod bolesnika liječenih lijekom OZURDEX u usporedbi s placebo postupkom (p &lt; 0,001), s tim da su bolesnici liječeni lijekom OZURDEX postigli poboljšanje od 3 retka u BCVA ranije nego bolesnici liječeni placebo postupkom.
In elderly patients ( &gt; 75 years) there is limited clinical experience.
Kod starijih osoba ( &gt; 75 godina) kliničko iskustvo je ograničeno.