natgillin/translations-raw huggingface dataset:
Dose adjustment is recommended for patients with creatinine clearance &lt; 50 ml/min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Preporučuje se prilagoditi dozu bolesnicima s klirensom kreatinina &lt; 50 ml/min, uključujući bolesnike na hemodijalizi ili kontinuiranoj ambulantnoj peritonejskoj dijalizi (KAPD).
Dose adjustments are required for children aged from 2 months to &lt; 12 years and for adolescents aged 12 to &lt; 18 years with bodyweight &lt; 33 kg (see section 4.2).
Potrebne su prilagodbe doze u djece u dobi od navršena 2 mjeseca do &lt; 12 godina i u adolescenata u dobi od navršenih 12 do &lt; 18 godina koji imaju tjelesnu težinu &lt; 33 kg (vidjeti dio 4.2).
Dose increase for efficacy was allowed at the discretion of the investigators after three and six months of treatment if biochemical parameters showed a mean GH ≥2.5 µg/l and/or IGF-1 &gt; ULN (age and sex related).
Povećanje doze za djelotvornost bilo je dopušteno prema odluci ispitivača nakon tri i šest mjeseci liječenja ako su biokemijski parametri pokazali srednji GH ≥2,5 µg/l i/ili IGF-1 &gt; GGN (povezano s dobi i spolom).
Dose or dose interval adjustment is required in all patients with creatinine clearance &lt; 30 ml/min (see sections 4.2, 4.4 and 5.2).
PrilagoĎavanje doze ili intervala doziranja obavezno je za pacijente s klirensom kreatinina &lt; 30 ml/min (vidjeti dijelove 4.2, 4.4 i 5.2).
Dose reduction in patients with a creatinine clearance of &lt; 50 ml/min is necessary (see section 4.2).
Potrebno je smanjiti dozu u bolesnika s klirensom kreatinina &lt; 50 ml/min (vidjeti dio 4.2).
Dose reduction is required for patients with creatinine clearance &lt; 50 ml/min (see section 4.2).
U bolesnika s klirensom kreatinina od &lt; 50 ml/min nužno je smanjenje doze (vidjeti dio 4.2).
Dose reduction levels ( &gt; 75 years of age): Starting dose 20 mg; dose level -1 12 mg; dose level-2 8 mg on Days 1, 8, 15 and 22 of each 28-day treatment cycle.
Razine smanjenja doze (dob &gt; 75 godina): početna doza 20 mg; 1. razina doze 12 mg; 2. razina doze 8 mg 1., 8., 15. i 22. dana svakog 28- dnevnog ciklusa liječenja.
Dose reduction may be required in patients with severe renal impairment (GFR 29-15 ml/min) and an end stage renal disease (GFR &lt; 15 ml/min) or requiring dialysis.
U bolesnika s teškim oštećenjem funkcije bubrega (GFR 29-15 ml/min) i završnim stadijem bolesti bubrega (GFR &lt; 15 ml/min ili je potrebna dijaliza) može biti potrebno sniženje doze.
Dose reduction to 90 micrograms is recommended if the platelet count is &lt; 50,000/mm3.
Smanjenje doze na 90 mikrograma preporučuje se ako je razina trombocita &lt; 50 000/mm3.
Dose should be reduced for patients with mild (total bilirubin &gt; 1 to ≤1.5 x ULN or AST &gt; 1.5 x ULN), hepatic impairment (see sections 4.2 and 5.2).
Dozu treba smanjiti kod bolesnika s blagim (ukupan bilirubin &gt; 1 do ≤1,5 x GGN ili AST &gt; 1,5 x GGN) oštećenjem jetrene funkcije (vidjeti dijelove 4.2 i 5.2).
Dose-dependent, statistically significant reductions in mean IGF-I (p &lt; 0.0001), free IGF-I (p &lt; 0.05), IGFBP-3 (p &lt; 0.05) and ALS (p &lt; 0.05) were observed at all post-baseline visits in the pegvisomant treatment groups.
Na svim kontrolnim pregledima bolesnika iz skupina koje su primale pegvisomant opažena su statistički značajna, o dozi ovisna sniženja prosječnih vrijednosti IGF-1 (p &lt; 0,0001), slobodnog IGF-1 (p &lt; 0,05), IGFBP-3 (p &lt; 0,05) i ALS (p &lt; 0,05).
Doses &gt; 150 mg did not result in higher plasma concentrations in clinical trials and patients on doses &gt; 150 mg have been included in the analysis.
U kliničkim ispitivanjima doze &gt; 150 mg nisu rezultirale višom koncentracijom lijeka u plazmi, a bolesnici koji su primali doze &gt; 150 mg uključeni su u analizu.
Doses of simvastatin &gt; 40 mg should not be used with Lojuxta (see section 4.3).
Doze simvastatina &gt; 40 mg ne smiju se primjenjivati s Lojuxtom (vidjeti dio 4.3).
Dosing for nucleoside naive paediatric patients aged 2 to &lt; 18 years
Doziranje za pedijatrijske bolesnike u dobi od 2 to &lt; 18 godina koji prethodno nisu bili liječeni analozima nukleozida
Dosing for paediatric patients &lt; 40 kg is based on paediatric patients with aHUS.
Doziranje u pedijatrijskih bolesnika težine &lt; 40 kg temeljilo se na onom primjenjivanom u pedijatrijskih bolesnika s aHUS-om.
Dosing recommendations are not available for neonates with a gestational age &lt; 37 weeks.
Preporuke za doziranje nisu dostupne za novorođenčad s gestacijskom dobi &lt; 37 tjedana.
DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and Stevens-Johnson Syndrome has been rarely ( &lt; 0.1%) reported, and during post-marketing experience toxic epidermal necrolysis and acute generalised exanthematous pustulosis have been reported.
DRESS (osip izazvan lijekom s eozinofilijom i sistemskim simptomima) i Stevens-Johnsonov sindrom bili su rijetko ( &lt; 0,1%) prijavljivani, a tijekom postmarketinškog iskustva prijavljene su toksička epidermalna nekroliza i akutna generalizirana egzantematozna pustuloza.
Dronedarone reduced the incidence of cardiovascular hospitalisation or death from any cause by 24.2% when compared to placebo (p &lt; 0.0001).
Dronedaron je smanjio incidenciju hospitalizacije zbog kardiovaskularnih razloga odnosno smrti zbog bilo kojeg uzroka za 24,2% u usporedbi s placebom (p &lt; 0,0001).
Duaklir Genuair demonstrated a rapid onset of action within 5 minutes of the first inhalation relative to placebo (p &lt; 0.0001).
Duaklir Genuair pokazao je brzi nastup djelovanja unutar 5 minuta od prve inhalacije u odnosu na placebo (p &lt; 0,0001).
Duaklir Genuair reduced the use of rescue medication over 6 months compared to placebo (by 0.9 puffs per day [p &lt; 0.0001]), aclidinium (by 0.4 puffs/day [p &lt; 0.001]) and formoterol (by 0.2 puffs/day [p=0.062]).
Duaklir Genuair je smanjio uporabu lijekova za hitno ublažavanje simptoma tijekom 6 mjeseci u usporedbi s placebom (za 0,9 udisaja dnevno [p &lt; 0,0001]), aklidinijem (za 0,4 udisaja dnevno [p &lt; 0,001]) i formoterolom (za 0,2 udisaja dnevno[p=0,062]).
Due to limited clinical experience (see table and footnotes below) Cubicin should only be used in patients with any degree of renal impairment (CrCl &lt; 80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk.
Zbog ograničenog kliničkog iskustva (vidjeti tablicu i napomene niže), u bolesnika s oštećenjem bubrega bilo kojega stupnja (CrCl &lt; 80 ml/min) Cubicin se smije primjenjivati samo kada se smatra da očekivana klinička korist nadmašuje mogući rizik.
Due to protocol violation, two patients with historical K103N substitutions discontinued early with HIV-1 RNA &lt; 50 copies/mL.
Zbog kršenja protokola, dva pacijenta sa prethodnom supstitucijom K103N prekinula su terapiju ranije s HIV-1 RNK &lt; 50 kopija/ml.
Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, ribavirin dose adjustments are recommended in adult patients with creatinine clearance &lt; 50 mL/minute.
Zbog značajnih povećanja koncentracije ribavirina u plazmi, u bolesnika s umjerenim i teškim oštećenjem funkcije bubrega, preporučuje se prilagoditi dozu ribavirina u odraslih bolesnika s klirensom kreatinina &lt; 50 ml/min.
Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, Ribavirin Mylan dose adjustments are recommended in adult patients with creatinine clearance &lt; 50 mL/minute.
Zbog značajnih povećanja u koncentracijama ribavirina u plazmi u bolesnika s umjerenim i ozbiljnim oštećenjem bubrega, prilagodbe doze lijeka Ribavirin Mylan preporučuju se u odraslih bolesnika s klirensom kreatinina &lt; 50 ml/min.
Due to the active substance zidovudine, Trizivir is contraindicated in patients with abnormally low neutrophil counts ( &lt; 0.75 x 109/l), or abnormally low haemoglobin levels ( &lt; 7.5 g/dl or 4.65 mmol/l) (see section 4.4).
Zbog djelatne tvari zidovudina, Trizivir je kontraindiciran u bolesnika s abnormalno niskim brojem neutrofila ( &lt; 0,75 x 109/l) ili abnormalno niskim razinama hemoglobina ( &lt; 7,5 g/dl ili 4,65 mmol/l) (vidjeti dio 4.4).
Due to the hydrochlorothiazide component, Ifirmacombi is not recommended for patients with severe renal dysfunction (creatinine clearance &lt; 30 ml/min).
Zbog hidroklorotiazida u sastavu lijeka, Ifirmacombi se ne preporučuje bolesnicima s teško oštećenom funkcijom bubrega (klirens kreatinina &lt; 30 ml/min.).
Due to the hydrochlorothiazide component, Ifirmacombi is not recommended for patients with severe renal dysfunction (creatinine clearance &lt; 30 ml/min).
Zbog hidroklorotiazida u sastavu lijeka, Ifirmacombi se ne preporučuje bolesnicima s teško oštećenom funkcijom bubrega (klirens kreatinina &lt; ml/min.).
Due to the hydrochlorothiazide component, Irbesartan/Hydrochlorothiazide Teva is not recommended for patients with severe renal dysfunction (creatinine clearance &lt; 30 ml/min).
Zbog hidroklorotiazida u sastavu lijeka, Irbesartan/Hidroklorotiazid Teva ne preporučuje se bolesnicima s teško oštećenom funkcijom bubrega (klirens kreatinina &lt; 30 ml/min.).
Due to the lack of data in adolescents (age 15- &lt; 18), patients in this age group should be more closely monitored during treatment.
S obzirom na nedostatak podataka u adolescenata (u dobi od 15 do &lt; 18), bolesnici ove dobne skupine moraju se pažljivije pratiti tijekom liječenja.
Due to the much higher concentration of enoxaparin sodium in blood serum in patients with severe renal impairment (creatinine clearance &lt; 30 mL/min) dose adjustments are recommended in therapeutic and prophylactic dose ranges.
Zbog znatno više koncentracije enoksaparinnatrija u serumu bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina &lt; 30 ml/min) preporučuje se prilagodba doze u terapijskom i profilaktičkom rasponu doza.
Due to the risk of serious rhythm disturbances, Gilenya should not be used in patients with second degree Mobitz type II or higher AV block, sick-sinus syndrome, or sino-atrial heart block, a history of symptomatic bradycardia or recurrent syncope, or in patients with significant QT prolongation (QTc &gt; 470msec (female) or &gt; 450msec (male)).
Zbog rizika od ozbiljnih poremećaja srčanog ritma, Gilenya se ne smije primjenjivati u bolesnika s AV blokom drugog stupnja tipa Mobitz II ili višeg stupnja, sindromom bolesnog sinusa ili sinoatrijalnim blokom, simptomatskom bradikardijom ili rekurentnom sinkopom u anamnezi, ili u bolesnika sa značajnim produljenjem QT intervala (QTc &gt; 470 msek (žene) ili &gt; 450 msek (muškarci)).
Due to the significant impact of body weight on trastuzumab clearance and the use of a fixed dose for the subcutaneous administration the difference in exposure between subcutaneous and intravenous administration was dependent on body weight: in patients with a body weight &lt; 51 kg, mean steady state AUC of trastuzumab was about 80% higher after subcutaneous than after intravenous treatment whereas in the highest BW group ( &gt; 90 kg) AUC was 20% lower after subcutaneous than after intravenous treatment.
Zbog značajnog utjecaja tjelesne težine na klirens trastuzumaba i činjenice da se za supkutanu primjenu koristi fiksna doza, razlika u izloženosti između supkutane i intravenske primjene ovisila je o tjelesnoj težini: u bolesnica tjelesne težine &lt; 51 kg srednja vrijednost AUC-a trastuzumaba u stanju dinamičke ravnoteže bila je približno 80% viša nakon supkutane primjene nego nakon intravenske terapije, dok je u skupini s najvećom tjelesnom težinom ( &gt; 90 kg) AUC bio 20% niži nakon supkutane primjene u odnosu na intravensku terapiju.
Duloxetine Lilly 60 mg to 120 mg once daily demonstrated statistically significant superiority compared to placebo (p &lt; 0.001) on the prevention of relapse, as measured by time to relapse.
Duloksetin Lilly u dozi od 60 do 120 mg jednom dnevno bila je statistički značajno superiornija u odnosu na placebo (p &lt; 0,001) u prevenciji relapsa, mjereno vremenom do pojave relapsa.
Duloxetine Lilly must not be used in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min; see section 4.3).
Duloksetin Lilly se ne smije primjenjivati u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 30 ml/min; vidjeti dio 4.3).
Duloxetine Mylan must not be used in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min; see section 4.3).
Duloxetine Mylan se ne smije primjenjivati u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 30 ml/min; vidjeti dio 4.3).
Duloxetine Zentiva must not be used in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min; see section 4.3).
Duloxetine Zentiva se ne smije primjenjivati u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 30 ml/min; vidjeti dio 4.3).
Durable tumour &amp; symptomatic response (independent review)
Trajni tumorski odgovor i simptomatski odgovor (nezavisna procjena)
Durable tumour &amp; symptomatic response (investigator review)
Trajni tumorski odgovor i simptomatski odgovor (procjena ispitivača)
Duration of tumour &amp; symptomatic response (days) - independent review; median (min, max)
Trajanje tumora i simptomatski odgovor (dani) - nezavisna procjena; medijan (minimum, maksimum)
Duration of viral suppression prior to transplantation was the most predictive factor for pTVR in those who were HCV RNA &lt; LLOQ at the time of transplantation.
Trajanje virološke supresije prije transplantacije bilo je najjači prediktivni čimbenik za pTVR u onih koji su imali HCV RNK &lt; donje granice kvantifikacije u vrijeme transplantacije.
During 52 weeks of placebo-controlled double blind treatment, duloxetine-treated patients with recurrent MDD had a significantly longer symptom free period (p &lt; 0.001) compared with patients randomised to placebo.
Tijekom 52 tjedna placebom kontroliranog dvostruko slijepog ispitivanja, bolesnici s opetovanim velikim depresivnim poremećajem koji su primali duloksetin imali su značajno dulji period bez simptoma (p &lt; 0,001) u usporedbi s bolesnicima koji su primali placebo.
During a mean of 53 weeks of treatment with ambrisentan, none of the patients enrolled had a confirmed serum ALT &gt; 3xULN that required permanent discontinuation of treatment.
Tijekom srednjeg razdoblja od 53 tjedna liječenja ambrisentanom niti u jednog uključenog bolesnika nije potvrđen serumski ALT &gt; 3xGGN koji bi zahtijevao trajan prekid liječenja.
During clinical studies, increases in serum creatinine of &gt; 33% on ≥2 consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36% of patients.
Tijekom kliničkih ispitivanja u otprilike 36% bolesnika dogodila su se povišenja serumskog kreatinina za &gt; 33% kod ≥2 uzastopne provjere, katkada i iznad gornje granice normalnog raspona.
During clinical trials with Iblias in approximately 200 paediatric and adult patients diagnosed with severe haemophilia A (FVIII &lt; 1%) with previous exposure to factor VIII concentrates ≥ 50 ED, no case of inhibitor occurred.
Tijekom kliničkih ispitivanja s lijekom Iblias u otprilike 200 pedijatrijskih i odraslih bolesnika kojima je dijagnosticirana teška hemofilija A (FVIII &lt; 1%) s prethodnom izloženošću koncentratima faktora VIII ≥ 50 dana izloženosti nije došlo do pojave inhibitora.
During clinical trials with Kovaltry in approximately 200 paediatric and adult patients diagnosed with severe haemophilia A (FVIII &lt; 1 %) with previous exposure to factor VIII concentrates ≥ 50 ED, no case of inhibitor occurred.
Tijekom kliničkih ispitivanja s lijekom Kovaltry u otprilike 200 pedijatrijskih i odraslih bolesnika kojima je dijagnosticirana teška hemofilija A (FVIII &lt; 1%) s prethodnom izloženošću koncentratima faktora VIII ≥ 50 dana izloženosti nije došlo do pojave inhibitora.
During clinical trials with Kovaltry in approximately 200 paediatric and adult patients diagnosed with severe haemophilia A (FVIII &lt; 1%) with previous exposure to factor VIII concentrates ≥ 50 ED, no case of inhibitor occurred.
Tijekom kliničkih ispitivanja s lijekom Kovaltry u otprilike 200 pedijatrijskih i odraslih bolesnika kojima je dijagnosticirana teška hemofilija A (FVIII &lt; 1%) s prethodnom izloženošću koncentratima faktora VIII ≥ 50 dana izloženosti nije došlo do pojave inhibitora.
During clinical trials with Suprelorin 4.7 mg, the mean duration of testosterone suppression was 1.5 times longer among smaller size dogs ( &lt; 10 kg) compared with all larger dogs.
Tjekom kliničkih ispitivanja sa Superlorinom 4,7 mg srednje vrijeme supresije testosterona bilo je 1,5 puta dulje u manjih pasa ( &lt; 10 kg) u usporedbi sa većim psima.
During clinical trials, most of the smaller size dogs ( &lt; 10 kg) maintained suppressed levels of testosterone for more than 12 months following implantation.
Tijekom kliničkih ispitivanja, većina manjih pasa ( &lt; 10 kg) održali su nižu razinu testosterona duže od 12 mjeseci nakon implantacije.
During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts &lt; 10 x109/L).
Nakon stavljanja Kinereta u promet prijavljeni su slučajevi trombocitopenije, uključujući povremene prijave slučajeva koji su upućivali na tešku trombocitopeniju (tj. broj trombocita &lt; 10 x109/l).
During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts &lt; 10 x109/L).
Nakon stavljanja lijeka u promet prijavljeni su slučajevi trombocitopenije, uključujući povremene prijave slučajeva koji su upućivali na tešku trombocitopeniju (tj. broj trombocita &lt; 10 x109/l).
During routine laboratory monitoring in the tocilizumab 6 month controlled clinical trial SC-I, 19% of patients experienced sustained elevations in total cholesterol &gt; 6.2 mmol/l (240 mg/dl), with 9% experiencing a sustained increase in LDL to  4.1 mmol/l (160 mg/dl) on the subcutaneous weekly dose.
Prilikom rutinskog laboratorijskog praćenja u 6-mjesečnom kontroliranom kliničkom ispitivanju tocilizumaba SC-I, zabilježeno je trajno povišenje ukupne razine kolesterola &gt; 6,2 mmol/l (240 mg/dl) u 19% bolesnika koji su primali supkutanu dozu jedanput tjedno, pri čemu je u 9% bolesnika primijećeno trajno povišenje LDL-a na ≥ 4,1 mmol/l (160 mg/dl).
During routine laboratory monitoring in the tocilizumab all exposure population, elevation in ALT or AST ≥ 3xULN occurred in 3.7% and &lt; 1% of patients, respectively.
Prilikom rutinskog laboratorijskog praćenja cjelokupne populacije izložene tocilizumabu primijećena je povišena razina ALT-a odnosno AST-a ≥ 3 x iznad gornje granice normale u 3,7% odnosno &lt; 1% bolesnika.
During routine laboratory monitoring in the tocilizumab all exposure population, elevation in total cholesterol &gt; 1.5-2 x ULN occurred in one patient (0.5%) and elevation in LDL &gt; 1.5-2 x ULN in one patient (0.5%).
Prilikom rutinskog laboratorijskog praćenja cjelokupne populacije izložene tocilizumabu, kod jednoga je bolesnika (0,5%) primijećeno povišenje ukupne razine kolesterola &gt; 1,5-2 puta iznad gornje granice normale, a kod jednoga (0,5%) povišenje razine LDL-a &gt; 1,5-2 puta iznad gornje granice normale.
During the 12-week treatment period, patients treated with Fexeric had a significant decrease in serum phosphorus, compared to the placebo group (p &lt; 0.001 for treatment difference) (Table 3).
Tijekom 12-tjednog razdoblja liječenja, bolesnici koji su liječeni Fexericom imali su značajno smanjenje razine fosfora u serumu u usporedbi sa skupinom koja je uzimala placebo (p &lt; 0,001 za razliku u liječenju) (Tablica 3).
During the 24-week open-label Phase 3 clinical study in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) &gt; 3 x ULN was 14.7% (5/34).
Tijekom kliničkog ispitivanja faze III otvorenog tipa u trajanju od 24 tjedna u 34 bolesnika u dobi od 2 do manje od 6 godina (ispitivanje 7), incidencija bolesnika s povišenim transaminazama (ALT ili AST) &gt; 3 puta GGN iznosila je 14,7% (5/34).
During the 24-week, placebo-controlled, Phase 3 studies, the incidence of maximum transaminase (ALT or AST) levels &gt; 8, &gt; 5, and &gt; 3 x ULN were 0.8%, 2.0%, and 5.2%; and 0.5%, 1.9%, and 5.1% in lumacaftor/ivacaftor- and placebo-treated patients, respectively.
Tijekom placebom kontroliranih ispitivanja faze 3 u trajanju od 24 tjedna, incidencija maksimalnih razina transaminaza (ALT ili AST) &gt; 8, &gt; 5 i &gt; 3 x GGN bila je 0,8%, 2,0% i 5,2% u bolesnika liječenih lumakaftorom/ivakaftorom, odnosno 0,5%, 1,9% i 5,1% u bolesnika liječenih placebom.
During the 48-week placebo-controlled studies 1 and 2 in patients aged 6 years and older, the incidence of maximum transaminase (ALT or AST) &gt; 8, &gt; 5 or &gt; 3 x ULN was 3.7%, 3.7% and 8.3% in ivacaftor-treated patients and 1.0%, 1.9% and 8.7% in placebo-treated patients, respectively.
Tijekom placebom kontroliranih ispitivanja 1 i 2 u trajanju od 48 tjedana u bolesnika u dobi od 6 i više godina, incidencija najviših vrijednosti transaminaza (ALT ili AST) &gt; 8, &gt; 5 ili &gt; 3 puta GGN iznosila je 3,7%, 3,7% odnosno 8,3% u bolesnika liječenih ivakaftorom i 1,0%, 1,9% odnosno 8,7% u bolesnika koji su primali placebo.
During the 52-week double-blind treatment period (including the 24-week fixed-dose steroid phase and the 28-week steroid adjustment phase) the difference in rates between treatment groups represented a 50% (rate ratio 0.504, p &lt; 0.001) relative decrease in exacerbations for omalizumab patients.
Tijekom 52-tjednog razdoblja dvostruko slijepe terapije (uključujući 24-tjednu fazu primjene steroida u fiksnoj dozi i 28-tjednu fazu prilagođavanja doze steroida) razlika u stopama između terapijskih skupina bila je 50%-tno (omjer stopa 0,504, p &lt; 0,001) relativno smanjenje egzacerbacija kod bolesnika liječenih omalizumabom.
During the 52-week placebo- controlled double blind treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients experience a return of their depressive symptoms (p &lt; 0.001).
Tijekom 52 tjedna placebom kontrolirane dvostruko slijepe faze liječenja u 14,4% bolesnika liječenih duloksetinom te u 33,1% bolesnika koji su primali placebo došlo je do povratka simptoma depresije (p &lt; 0,001).
During the 52-week placebo-controlled double blind treatment phase 14.4% of the duloxetine-treated patients and 33.1% of the placebo-treated patients experience a return of their depressive symptoms (p &lt; 0.001).
Tijekom 52 tjedna placebom kontrolirane dvostruko slijepe faze liječenja u 14,4% bolesnika liječenih duloksetinom te u 33,1% bolesnika koji su primali placebo došlo je do povratka simptoma depresije (p &lt; 0,001).
During the controlled periods of the psoriasis and psoriatic arthritis clinical studies of ustekinumab, rash and urticaria have each been observed in &lt; 1% of patients (see section 4.4).
Tijekom kontroliranog razdoblja kliničkih ispitivanja psorijaze i psorijatičnog artritisa s ustekinumabom, osip i urtikarija pojedinačno su primijećeni kod &lt; 1% bolesnika (vidjeti dio 4.4).
During the Holter substudy in PLATO, more patients had ventricular pauses &gt; 3 seconds with ticagrelor than with clopidogrel during the acute phase of their ACS.
U podstudiji Holter studije PLATO, više je bolesnika imalo ventrikularne pauze &gt; 3 sekunde s tikagrelorom nego s klopidogrelom za vrijeme akutne faze njihovih akutnih koronarnih sindroma.
During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels &lt; 100 mg/dl [5.5 mmol/l], and post-prandial glucose levels &lt; 140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Tijekom početnih 18 tjedana i posljednjih 12 tjedana doza inzulina je bila stalna, ali se između 19. i 40. tjedna prilagođavala u cilju postizanja razine glukoze &lt; 100 mg/dl [5,5 mmol/l] preprandijalno i razine glukoze &lt; 140 mg/dl [7,8 mmol/l] postprandijalno.