natgillin/translations-raw huggingface dataset:
Plasma aztreonam concentrations in paediatric patients aged 3 months to &lt; 6 years are comparable to those observed for children &gt; 6 years, adolescents and adults.
Koncentracije aztreonama u plazmi u pedijatrijskih bolesnika u dobi od 3 mjeseca do &lt; 6 godina usporedive su s onima opaženima u djece u dobi &gt; 6 godina, adolescenata i odraslih.
Plasma concentrations following continuous (≥ 48 h) IT infusion (≤ 21.6 μg/day) appear to be relatively low and typically undetectable (i.e., about 80% of plasma samples collected from pain patients contain no quantifiable medicinal product; &lt; 0.04 ng/ml).
Plazmatske koncentracije nakon neprekinute (≥ 48 h) intratekalne infuzije (≤ 21,6 μg/dan) čini se da su relativno niske i u pravilu se ne mogu detektirati (tj. oko 80% uzoraka plazme uzetih od bolesnika s bolovima ne sadrže mjerljivu količinu lijeka; &lt; 0,04 ng/ml).
Plasma concentrations of intact orlistat were non-measurable ( &lt; 5 ng/ml) eight hours following oral administration of orlistat.
Koncentracija nepromijenjenog orlistata u plazmi nije se mogla odrediti ( &lt; 5 ng/ml) osam sati nakon peroralne primjene orlistata.
Plasma concentrations of intact orlistat were non-measurable ( &lt; 5 ng/ml) 8 hours following oral administration of orlistat 360 mg.
Osam sati nakon peroralne primjene 360 mg orlistata, koncentracije intaktnog orlistata u plazmi nisu bile mjerljive ( &lt; 5 ng/ml).
Plasma protein binding is high ( &gt; 96%).
Vezanje proteina plazme je visoko ( &gt; 96%).
Plasma protein binding is high ( &gt; 98%).
Vezanje proteina plazme je visoko ( &gt; 98%).
Plasma protein binding of decitabine is negligible ( &lt; 1%).
Vezanje decitabina na proteine plazme zanemarivo je ( &lt; 1%).
Plasma protein binding of varenicline is low ( &lt; 20%) and independent of both age and renal function.
Stupanj vezanja vareniklina za proteine u plazmi je nizak (≤ 20%), a ne ovisi ni o dobi ni o bubrežnoj funkciji.
Plasma Uric Acid &lt; 6 mg/dl for at Least 80% of the Time During Months 3 and 6
Plazmatske razine mokraćne kiseline &lt; 6 mg/dl najmanje 80% vremena tijekom 3. i
platelet &lt; 50 x 109/L
ili trombociti &lt; 50 x 109/l
Platelet count &lt; 10 x 109/L or evidence of bleeding with thrombocytopenia (see section 4.4)
Broj trombocita &lt; 10 x 109/l ili dokaz krvarenja uz trombocitopeniju (vidjeti dio 4.4)
Platelet count &lt; 25,000/mm3 Hemoglobin &lt; 8 g/dl
&lt; 25 000/mm3 Hemoglobin &lt; 8 g/dl
Platelet count &lt; 25 x 109/l
Broj trombocita &lt; 25 x 109/l
Platelet count &gt; 75,000/microlitre
Broj trombocita &gt; 75 000/mikrolitra
platelet counts &lt; 100,000/mm3 (monotherapy) and &lt; 150,000/mm3 (consolidation treatment)
bolesnicima s brojem trombocita &lt; 100 000/mm3 (monoterapija) i &lt; 150 000/mm3 (konsolidacijska terapija)
Platelet counts &gt; 75,000/µl should be avoided.
Broj trombocita &gt; 75 000/µl treba izbjegavati.
Platelet counts ≤100x109/l at baseline to &gt; 50% increase or &gt; 100x109/l post baseline
Broj trombocita ≤ 100x109/l za početne vrijednosti do &gt; 50% povećanje ili
Platelet inhibition was readily reversed, with a return of platelet function towards baseline ( &gt; 50 % platelet aggregation) 4 hours after stopping a continuous infusion of 2.0 microgram/kg/min.
Inhibicija trombocita brzo se poništila, pri čemu se &gt; 50 % funkcije trombocita vratila na početne vrijednosti 4 sata nakon prestanka kontinuirane infuzije od 2,0 mikrograma/kg/min.
Platelets &lt; 25 x 109/l thrombocytopenia
Broj trombocita &lt; 25 x 109/l trombocitopenija
Platelets &lt; 50 x 109/l thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion
Broj trombocita &lt; 50 x 109/l trombocitopenija komplicirana krvarenjem ili zahtijeva transfuziju krvi ili trombocita
Platelets &lt; 50×109/L
trombociti &lt; 50×109/l
Platelets &lt; 80,000/mm3 Haemoglobin &lt; 4.5 g/dl
Trombociti &lt; 80 000/mm3 Hemoglobin &lt; 4,5 g/dl
PLATO Major Fatal/life-threatening: Fatal bleeding, OR any intracranial bleeding, OR intrapericardial with cardiac tamponade, OR with hypovolaemic shock or severe hypotension requiring pressors/inotropes or surgery OR clinically apparent with &gt; 50 g/L decrease in haemoglobin or ≥4 red cell units transfused.
PLATO Velika Fatalna/opasna po život: Fatalna krvarenja, ILI bilo koje intrakranijalno krvarenje, ILI intraperikardijalno krvarenje sa srčanom tamponadom, ILI sa hipovlemijskim šokom ili teškom hipotenzijom koja zahtijeva lijekove za povišenje krvnog tlaka ili operaciju, ILI klinički vidljivo sa smanjenjem hemoglobina od &gt; 50 g/l ili transfuzijom ≥4 jedinice eritrocita
Plegridy also significantly reduced the risk of relapse by 39% (p=0.0003), the risk of sustained disability progression confirmed at 12 weeks by 38% (p=0.0383) and at 24 weeks (post-hoc analysis) by 54% (p=0.0069), the number of new or newly enlarging T2 lesions by 67% (p &lt; 0.0001), the number of Gd-enhancing lesions by 86% (p &lt; 0.0001) and the number of new T1
Plegridy je također značajno smanjio rizik od relapsa za 39% (p = 0,0003), rizik od kontinuirane progresije onesposobljenosti potvrđen nakon 12 tjedna za 38% (p=0,0383) i nakon 24 tjedna (post-hoc analiza) za 54% (p=0,0069), broj novih ili novo povećanih T2 lezija za 67% (p &lt; 0,0001), broj Gd pozitivnih lezija za 86% (p
Plegridy also significantly reduced the risk of relapse by 39% (p=0.0003), the risk of sustained disability progression confirmed at 12 weeks by 38% (p=0.0383) and at 24 weeks (post-hoc analysis) by 54% (p=0.0069), the number of new or newly enlarging T2 lesions by 67% (p &lt; 0.0001), the number of Gd-enhancing lesions by 86% (p &lt; 0.0001) and the number of new T1 hypointense lesions compared to placebo by 53% (p &lt; 0.0001).
Plegridy je također značajno smanjio rizik od relapsa za 39% (p = 0,0003), rizik od kontinuirane progresije onesposobljenosti potvrđen nakon 12 tjedna za 38% (p=0,0383) i nakon 24 tjedna (post-hoc analiza) za 54% (p=0,0069), broj novih ili novo povećanih T2 lezija za 67% (p &lt; 0,0001), broj Gd pozitivnih lezija za 86% (p &lt; 0,0001) i broj novih T1 hipointenzivnih lezija za 53% (p &lt; 0,0001) u usporedbi s placebom.
Pleural and pericardial effusions as well as complications of fluid retention occurred in &lt; 1% of patients receiving Tasigna.
Pleuralni i perikardijalni izljevi, kao i komplikacije vezane uz retenciju tekućine pojavile su se u &lt; 1% bolesnika liječenih Tasignom.
Pleural and pericardial effusions, regardless of causality, occurred in 2% and &lt; 1% of patients, respectively, receiving Tasigna 300 mg twice daily.
Pleuralni, odnosno perikardijalni izljevi, neovisno o uzroku, pojavili su se u 2%, odnosno &lt; 1% bolesnika liječenih Tasignom 300 mg dva puta na dan.
Polypropylene tablet containers with tamper evident polyethylene closure containing 250 &amp; 500 film- coated tablets per tablet container.
Polipropilenski spremnici za tablete s polietilenskim zatvaračem s evidencijom otvaranja sadrže 250 i 500 filmom obloženih tableta po spremniku za tablete.
Polypropylene tablet containers with tamper evident polyethylene closure containing 250 &amp; 500 tablets per tablet container.
Svaka filmom obložena tableta sadrži 228 mg bezvodne laktoze po tableti.
Ponatinib is highly bound ( &gt; 99%) to plasma proteins in vitro.
Ponatinib se izrazito veže na proteine plazme ( &gt; 99%) u in vitro uvjetima.
Pooled Stages 1 &amp; 2
Objedinjeni dijelovi 1 &amp; 2
Population pharmacokinetic analysis demonstrated that the mean plasma clearance value after subcutaneous bolus administration was approximately 14% higher in men than in women and approximately 10% higher in subjects &lt; 65 years than in subjects  65 years.
Farmakokinetičke analize na populaciji pokazale su da je prosječna vrijednost klirensa u plazmi nakon supkutane bolusne injekcije bila za približno 14% viša u muškaraca nego u žena te približno 10% viša u ispitanika mlađih od 65 godina i onih starijih od 65 godina.
Population pharmacokinetic analysis with a BMI as covariate showed that patients with a BMI &gt; 30 kg/m2 dosed more frequently.
Populacijska farmakokinetička analiza s indeksom tjelesne mase kao kovarijantom pokazala je da su bolesnici s indeksom tjelesne mase &gt; 30 kg/m2 češće uzimali lijek.
Population pharmacokinetic data derived from studies in dogs with a predominantly older population with heavier dogs as compared to the experimental studies (mean 9 years of age) showed that the mean elimination half-life was 39 days with a small sub-population ( &lt; 5%) having an elimination half-life of more than 80 days and correspondingly an increased exposure was recorded in these individuals.
Populacijski farmakokinetički podaci dobiveni iz studija na psima starije populacije težih pasa u usporedbi s eksperimentalnim studijama (prosječene starosti od 9 godina) pokazali su da je srednji poluživot eliminacije bio 39 dana, a poluživot eliminacije male podpopulacije ( &lt; 5%) bio je dulji od 80 dana pa je prema tome u tih jedinki zabilježena povišena izloženost.
Population pharmacokinetic data from adult and paediatric patients suggest that patients with stable moderate renal impairment (creatinine clearance 30 – &lt; 60 ml/min) receiving a 50% dose reduction achieve similar clofarabine exposure to those with normal renal function receiving a standard dose.
Populacijski farmakokinetički podaci prikupljeni u odraslih i pedijatrijskih bolesnika ukazuju na to da se primjenom 50% niže doze u bolesnika sa stabilnim umjerenim oštećenjem bubrežne funkcije (klirens kreatinina 30 - &lt; 60 ml/min) postiže izloženost klofarabinu slična onoj u bolesnika s normalnom bubrežnom funkcijom kod primjene standardne doze.
Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus &lt; 1% for placebo) (see section 4.4).
Tromboza portalne vene bio je najčešći TED u obje terapijske skupine (2% u bolesnika koji su primali eltrombopag u odnosu na &lt; 1% za placebo) (vidjeti dio 4.4).
Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus &lt; 1% for placebo).
Tromboza portalne vene bila je najčešći TED u obje terapijske skupine (2% u bolesnika koji su primali eltrombopag u odnosu na &lt; 1% za placebo).
Posaconazole is highly protein bound ( &gt; 98 %), predominantly to serum albumin.
Posakonazol se u visokom postotku veže za proteine ( &gt; 98%), uglavnom za serumski albumin.
Posaconazole is highly protein bound ( &gt; 98 %), predominantly to serum albumin.
Posakonazol se visokom postotku veže za proteine ( &gt; 98%), uglavnom za serumski albumin.
Posaconazole is slowly absorbed and slowly eliminated with a large apparent volume of distribution (1,774 litres) and is highly protein bound ( &gt; 98 %), predominantly to serum albumin.
Posakonazol se polako apsorbira i sporo eliminira uz velik prividan volumen distribucije (1774 litre) te se u visokom postotku veže za proteine ( &gt; 98%), uglavnom za serumski albumin.
positive &lt; baseline
pozitivne &lt; početnih pozitivne &gt; početnih
Post-exposure prevention of influenza in infants less than 1 year of age during a pandemic: Simulation of once daily dosing of 3mg/kg in infants &lt; 1 year shows an exposure in the same range or higher than for once daily dosing of 75 mg in adults.
Prevencija gripe nakon izloženosti virusu dojenčadi mlađe od 1 godine tijekom pandemije: Simulacija doziranja od 3 mg/kg jednom dnevno u dojenčadi &lt; 1 godine pokazuje izloženost u istom rasponu ili višu kao jednom dnevno doziranje od 75 mg u odraslih.
Post-exposure prevention of influenza in infants less than 1 year of age during a pandemic: Simulation of once daily dosing of 3mg/kg in infants &lt; 1 year shows an exposure in the same range or higher than for once daily dosing of 75 mg in adults.
Prevencija gripe nakon izloženosti virusu u dojenčadi mlađe od 1 godine tijekom pandemije: Simulacija doziranja od 3 mg/kg jednom dnevno u dojenčadi &lt; 1 godine pokazuje izloženost u istom rasponu ili višu kao doziranje od 75 mg jednom dnevno u odraslih.
PR = progesterone receptor a ER/PR-negative or Grade 3 or tumor size &gt; 5 cm
ER = estrogenski receptor PR = progesteronski receptor a ER/PR-negativni ili gradus 3 ili veličina tumora &gt; 5 cm
PR intervals of &gt; 200 msec were seen in 3% of subjects in the active control group (moxifloxacin) and 5% in the placebo arm.
PR-intervali &gt; 200 ms opaženi su u 3% ispitanika u skupini koja je primala aktivni kontrolni lijek (moksifloksacin) te u 5% ispitanika u skupini koja je primala placebo.
Pramipexole is bound to plasma proteins to a very low ( &lt; 20 %) extent, and little biotransformation is seen in man.
Pramipeksol se u vrlo maloj mjeri veže na proteine plazme ( &lt; 20%) te se slabo biotransformira u ljudi.
Pramipexole is bound to plasma proteins to a very low ( &lt; 20%) extent, and little biotransformation is seen in man.
Pramipeksol se u vrlo maloj mjeri veže na proteine plazme ( &lt; 20%), te se malo biotransformira u ljudi.
Pramipexole is bound to plasma proteins to a very low ( &lt; 20%) extent, and little biotransformation is seen in man.
Pramipeksol se u vrlo maloj mjeri veže na proteine plazme ( &lt; 20%), te se vrlo malo biotransformira u ljudi.
Prasugrel should be used with caution in patients with a body weight of &lt; 60 kg due to the potential risk of bleeding in this population (see section 4.4).
Prasugrel treba primjenjivati uz oprez u bolesnika tjelesne težine manje od 60 kg zbog mogućeg rizika od krvarenja u ovoj populaciji (vidjeti dio 4.4).
Prasugrel should be used with caution in patients ≥ 75 years old and in patients weighing &lt; 60 kg (see sections 4.2, 4.4 and 4.8).
Prasugrel treba primjenjivati uz oprez u bolesnika u dobi od ≥ 75 godina te u bolesnika tjelesne težine &lt; 60 kg (vidjeti dijelove 4.2, 4.4 i 4.8).
Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance &lt; 60 ml/min) (see section 4.3.)
Pravafenix je kontraindiciran u bolesnika s umjerenim do teškim oštećenjem bubrega (definirano kao klirens kreatinina &lt; 60 ml/min) (vidjeti dio 4.3.).
Pre-planned interim analyses of both studies showed that lenalidomide/dexamethasone was statistically significantly superior (p &lt; 0.00001) to dexamethasone alone for the primary efficacy endpoint, TTP (median follow-up duration of 98.0 weeks).
Prethodno planirane međuanalize za oba ispitivanja pokazale su da je kombinacija lenalidomida/deksametazona statistički značajno superiornija (p &lt; 0,00001) u odnosu na sam deksametazon za primarni ishod, vrijeme do napredovanja bolesti (medijan vremena praćenja u trajanju od 98 tjedana).
Pre-specified subgroup analyses for both PFS and OS according to age ( &lt; 65 and ≥65 years), gender, race, ECOG PS (0 or ≥1), number of organs involved, liver metastases only, site of primary tumour (colon or rectum), carcinoembryonic antigen levels ( &lt; 200 μg/L, ≥200 μg/L), all showed a treatment effect favouring Cyramza plus FOLFIRI treatment over placebo plus FOLFIRI.
Sve unaprijed određene analize podskupina za PFS i OS – prema dobi ( &lt; 65 i ≥ 65 godina), spolu, rasi, funkcionalnom ECOG statusu (0 ili ≥ 1), broju zahvaćenih organa, metastazama samo u jetri, sijelu primarnog tumora (kolon ili rektum) i vrijednostima karcinoembrijskog antigena ( &lt; 200 µg/l, ≥ 200 µ/l) – pokazale su da se bolji terapijski učinak ostvaruje lijekom Cyramza plus protokolom FOLFIRI nego placebom plus protokolom FOLFIRI.
Pre-specified subgroup analyses of the primary endpoint by baseline CRP (≥ 1 mg/dL vs &lt; 1 mg/dL) demonstrated higher flare rates in placebo + MTX vs golimumab + MTX treated subjects among subjects with baseline CRP ≥ 1 mg/dL (87% vs 40% p = 0.0068).
Prethodno definirane analize primarne mjere ishoda podskupine prema početnim vrijednostima CRP-a (≥ 1 mg/dl naspram &lt; 1 mg/dl) pokazale su više stope razbuktavanja bolesti u skupini ispitanika koja je primala placebo + MTX nego u onoj koja je primala Simponi + MTX među ispitanicima s početnim vrijednostima CRP-a ≥ 1 mg/dl (87% naspram 40%, p=0,0068).
Pre-switching rates (Cycles 1-4) for serious adverse events, grade 3 adverse events and treatment discontinuations due to adverse events were low ( &lt; 5%) and similar to post-switching rates (Cycles 5- 8).
Stope ozbiljnih štetnih događaja, štetnih događaja 3. stupnja i prekida liječenja zbog štetnih događaja zabilježene prije prelaska (1.-4. ciklus) bile su niske ( &lt; 5%) i slične onima primijećenima nakon prelaska (5.-8. ciklus).
pre-vaccination titer &lt; 1:4
titar prije cijepljenja &lt; 1:4
Predominantly patients with a plasma HIV-1 viral load of 50 copies/ml or higher, women with CD4 counts &gt; 250 cells/mm3 had a 12 fold higher risk of symptomatic hepatic adverse reactions compared to women with CD4 counts &lt; 250 cells/mm3 (11.0 % versus 0.9 %).
U retrospektivnom pregledu uglavnom bolesnika s HIV-1 virusnim opterećenjem od 50 kopija/ml ili više u plazmi, žene s brojem CD4 &gt; 250 stanica/mm3 imaju 12 puta viši rizik simptomatskih jetrenih nuspojava u usporedbi sa ženama s brojem CD4 &lt; 250 stanica/mm3 (11,0% naspram 0,9%).
Premature rupture of the membranes &gt; 30 weeks of gestation
Prijevremena ruptura vodenjaka &gt; 30 gestacijskog tjedna
Preparation of the 50 mg/m2 infusion for paediatric patients &gt; 3 months of age (using a 70-mg vial)
Priprema doze od 50 mg/m2 u infuziji za pedijatrijske bolesnike u dobi od &gt; 3 mjeseca (iz bočice od 70 mg)
Preparation of the 50 mg/m2 infusion for paediatric patients &gt; 3 months of age (using a 50-mg vial)
Priprema doze od 50 mg/m2 u infuziji za pedijatrijske bolesnike u dobi od &gt; 3 mjeseca (iz bočice od 50 mg)
Preparation of the 70 mg/m2 infusion for paediatric patients &gt; 3 months of age (using a 70-mg vial)
Priprema doze od 70 mg/m2 u infuziji za pedijatrijske bolesnike u dobi od &gt; 3 mjeseca (iz bočice od 70 mg)
Preparation of the 70 mg/m2 infusion for paediatric patients &gt; 3 months of age (using a 50-mg vial)
Priprema doze od 70 mg/m2 u infuziji za pedijatrijske bolesnike u dobi od &gt; 3 mjeseca (iz bočice od 50 mg)
PRES, also known as RPLS, has been reported in patients treated with lenvatinib ( &lt; 1%; see section 4.8, Description of selected adverse reactions).
U bolesnika liječenih lenvatinibom zabilježen je PRES, poznat i kao RPLS ( &lt; 1%; vidjeti dio 4.8 Opis odabranih nuspojava).
Prescribing physicians should ensure that adult and adolescent patients with IgE below 76 IU/ml and children (6 to &lt; 12 years of age) with IgE below 200 IU/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
Kod odraslih bolesnika i adolescenata s IgE nižim od 76 IU/ml te kod djece (6 do &lt; 12 godina starosti) s IgE nižim od 200 IU/ml liječnici propisivači moraju nedvojbeno utvrditi in vitro reaktivnost (RAST) na cjelogodišnji alergen prije početka terapije.
Prescription of nitric oxide should be supervised by a physician experienced in cardiothoracic anaesthesia &amp; intensive care.
Propisivanje dušikovog (II) oksida treba nadzirati liječnik s iskustvom u kardiotorakalnoj anesteziji i intenzivnoj skrbi.
Preterm infants ( &lt; 37 weeks gestation)
Prijevremeno rođena dojenčad ( &lt; 37 tjedana gestacije)
Prevenar 13 non-inferiority (lower bound of the 95% CI for the difference in percentage of responders at 0.35 µg/ml between groups was &gt; -10%) was demonstrated for all 7 common serotypes, except for serotype 6B in study 006 and serotypes 6B and 9V in study 004, which missed by a small margin.
Neinferiornost Prevenara 13 (donja granica 95 %-tnog CI za razliku između skupina u postotku ispitanika s odgovorom od 0,35 µg/ml iznosila je &gt; -10 %) dokazana je za svih 7 čestih serotipova, osim za serotip 6B u ispitivanju 006 i serotipove 6B i 9V u ispitivanju 004, za koje se zamalo postigla.
Prevention of VTE - Patients with body weight &lt; 50 kg are at increased risk of bleeding.
Prevencija VTE – bolesnici tjelesne težine &lt; 50 kg imaju povišeni rizik od nastupa krvarenja.
Prevention of VTE and Treatment of UA/NSTEMI and STEMI - Patients with body weight &lt; 50 kg are at increased risk of bleeding.
Prevencija VTE i liječenje UA/NSTEMI i STEMI – bolesnici tjelesne težine &lt; 50 kg imaju povišeni rizik od nastupa krvarenja.
Previous Treatment Pegasys 180 mcg &amp;
Prethodna terapija Pegasys 180 mikrograma i
PREZISTA used in combination with cobicistat or low dose ritonavir once daily in ART-experienced patients should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/ml or CD4+ cell count &lt; 100 cells x 106/l (see section 4.2).
PREZISTA koja se uzima u kombinaciji s kobicistatom ili niskom dozom ritonavira jedanput na dan, u ART-om prethodno liječenih bolesnika, ne smije se primjenjivati kod onih bolesnika koji imaju jednu ili više mutacija povezanih s rezistencijom na darunavir (DRV-RAM, od engl. darunavir resistance associated mutations) ili HIV-1 RNK ≥ 100 000 kopija/ml ili broj CD4+ stanica &lt; 100 stanica x 106/l (vidjeti dio 4.2).
PREZISTA/ritonavir in combination with other antiretroviral agents (see section 4.2 for dosage recommendations per body weight).
&lt; 15 kg koji su primali lijek PREZISTA/ritonavir u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 4.2 za preporuke o doziranju prema tjelesnoj težini).
Primary endpoint (patients with IGF-1 &lt; lower limit of normal (LLN) were not considered “responders”).
Mjera primarnog ishoda (bolesnici s IGF-1 ispod donje granice normale (DGN) nisu se smatrali bolesnicima s odgovorom).
Primary endpoint was the proportion of patients reaching HbA1c &lt; 7% without confirmed or severe hypoglycaemia.
Primarna mjera ishoda bila je udio bolesnika koji su postigli HbA1c od &lt; 7% bez potvrđene ili teške hipoglikemije.
Primary SEGA volume was reduced at month 6 compared to baseline (p &lt; 0.001 [see Table 5]).
Nakon 6 mjeseci liječenja, volumen primarne SEGA-e bio je manji od početnog (p &lt; 0,001 [vidjeti Tablicu 5.]).
Primary SEGA volume was reduced at month 6 compared to baseline (p &lt; 0.001 [see Table 7]).
Nakon 6 mjeseci liječenja, volumen primarne SEGA-e bio je manji od početnog (p &lt; 0,001 [vidjeti Tablicu 7.]).
Prior to authorisation, serious events occurred in &lt; 1% of patients, with only Basedow’s disease (also known as Graves’ disease), hyperthyroidism, and hypothyroidism occurring in more than 1 patient.
Prije dobivanja odobrenja za stavljanje lijeka u promet, ozbiljni su se događaji javili u &lt; 1% bolesnika, a u više od 1 bolesnika javili su se samo Basedowljeva bolest (poznata i kao Gravesova bolest), hipertireoza i hipotireoza.
Prior to enrolment, patients had to have documented CD20+ CLL, and one or both of the following measures of coexisting medical conditions: comorbidity score (CIRS) of greater than 6 or reduced renal function as measured by CrCl &lt; 70 mL/min.
Prije uključivanja u ispitivanje bolesnici su morali imali dokumentiran KLL pozitivan na CD20 te ispunjavati jedan ili oba uvjeta za istodobno postojeće bolesti: rezultat bodovanja komorbiditeta (CIRS) veći od 6 ili smanjenu funkciju bubrega određenu vrijednošću CrCl &lt; 70 ml/min.
Prior to study participation, patients were well treated with standard of care therapy which included ACE inhibitors/ARBs ( &gt; 99%), beta blockers (94%), mineralocorticoid antagonists (58%) and diuretics (82%).
Prije sudjelovanja u ispitivanju bolesnici su bili dobro liječeni standardnom terapijom koja je uključivala ACE inhibitore/ARB-ove ( &gt; 99%), beta blokatore (94%), mineralokortikoidne antagoniste (58%) i diuretike (82%).
Proactive skin treatment including skin moisturiser, sun screen (SPF &gt; 15 UVA and UVB), topical steroid cream (not stronger than 1% hydrocortisone) and an oral antibiotic (e.g. doxycycline) may be useful in the management of dermatologic reactions.
Proaktivno liječenje kože koje uključuje primjenu sredstava za ovlaživanje kože, sredstva za zaštitu od sunca (SPF &gt; 15 UVA i UVB), topikalnih steroidnih krema (ne jačih od 1% hidrokortizona) i oralnih antibiotika (npr. doksiciklina) može biti korisno u liječenju dermatoloških reakcija.