natgillin/translations-raw huggingface dataset:
The full EPAR and risk management plan summary for Incruse can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Incruse sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The geometric mean plasma Cmax was approximately 0.5 ng/ml (range 0 to 2.3), and the geometric mean plasma AUC was approximately 1.7 day* ng/ml (range &lt; LLOQ (lower limit of quantification) to 13.5).
Geometrično povprečje Cmax v plazmi je bilo približno 0,5 ng/ml (razpon 0 do 2,3) in geometrično povprečje AUC v plazmi je bilo približno 1,7 dan*ng/ml (razpon &lt; LLOQ (spodnja meja kvantifikacije) do 13,5).
The group of NS5A RAVs that conferred &gt; 100-fold shift and was observed in patients were the following substitutions in genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) or in genotype 1b (Y93H).
Skupino RAV NS5A, ki je doprinesla k &gt; 100-kratnemu premiku, in so jo opazili pri bolnikih, so bile naslednje substitucije v genotipu 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) ali genotipu 1b (Y93H).
The group with dapagliflozin sequentially added to saxagliptin and metformin achieved statistically significant (p-value &lt; 0.0001) greater reductions in HbA1c versus the group with placebo sequentially added to saxagliptin plus metformin group at 24 weeks (see table 4).
Skupina, ki je dobila dapagliflozin, zaporedno dodan saksagliptinu in metforminu, je po 24 tednih dosegla statistično značilno (vrednost p &lt; 0,0001) večje znižanje HbA1c kot skupina, ki je dobila placebo, zaporedno dodan saksagliptinu in metforminu (glejte preglednico 5).
The group with saxagliptin sequentially added to dapagliflozin and metformin achieved statistically significant (p-value &lt; 0.0001) greater reductions in HbA1c versus the group with placebo sequentially added to dapagliflozin plus metformin group at 24 weeks (see table 4).
Skupina, ki je dobila saksagliptin, zaporedno dodan dapagliflozinu in metforminu, je po 24 tednih dosegla statistično značilno (vrednost p &lt; 0,0001) večje znižanje HbA1c kot skupina, ki je dobila placebo, zaporedno dodan dapagliflozinu in metforminu (glejte preglednico 4).
The half life of tocilizumab in sJIA patients is up to 23 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 12 mg/kg for body weight &lt; 30 kg) at week 12.
Razpolovni čas tocilizumaba pri bolnikih s sJIA je v 12. tednu do 23 dni za obe skupini, ločeni glede na telesno maso (8 mg/kg tocilizumaba za bolnike s telesno maso ≥ 30 kg ali 12 mg/kg za bolnike s telesno maso &lt; 30 kg).
The half-life of lenalidomide increased from approximately 3.5 hours in subjects with creatinine clearance &gt; 50 mL/min to more than 9 hours in subjects with reduced renal function &lt; 50 mL/min.
Razpolovni čas lenalidomida se je povečal s približno 3,5 ure pri osebah, pri katerih je bil kreatininski očistek &gt; 50 ml/min, na več kot 9 ur pri osebah z okvarjenim delovanjem ledvic ( &lt; 50 ml/min).
The hard capsules are green/white hard gelatin capsules imprinted ‘TMZ’ on cap &amp; ‘5’ on body.
Trde kapsule so zeleno-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '5' na telesu.
The hard capsules are maroon/white, hard gelatin capsules, imprinted with ‘TMZ’ on cap &amp; ‘180’ on body.
Trde kapsule so temno rdeče-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '180' na telesu.
The hard capsules are pink/white hard gelatin capsules, imprinted ‘TMZ’ on cap &amp; ‘100’ on body.
Trde kapsule so roza-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '100' na telesu.
The hard capsules are transparent blue/white hard gelatin capsules, imprinted ‘TMZ’ on cap &amp; ‘140’ on body.
Trde kapsule so prozorno modro-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '140' na telesu.
The hard capsules are white/white, hard gelatin capsules imprinted with ‘TMZ’ on cap &amp; ‘250’ on body.
Trde kapsule so bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '250' na telesu.
The hardcapsules are yellow/ white hard gelatin capsules, imprinted ‘TMZ’ on cap &amp; ‘20’ on body.
Trde kapsule so rumeno-bele trde želatinske kapsule, z oznako 'TMZ' na kapici in oznako '20' na telesu.
The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR = 1.33 – 1.91) with a log-rank p &lt; 0.0001 in favour of the TMZ arm.
Količnik tveganja (KT) za skupno preživetje je bil 1,59 (95 % IZ za KT= 1,33 -1,91) z logaritmičnim rangom p &lt; 0,0001 v prid delu študije s TMZ.
The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR = 1.33 – 91) with a log-rank p &lt; 0.0001 in favour of the TMZ arm.
Količnik tveganja (KT) za skupno preživetje je bil 1,59 (95 % IZ za KT= 1,33 -1,91) z logaritmičnim rangom p &lt; 0,0001 v prid delu študije s TMZ.
The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33 -1.91) with a log-rank p &lt; 0.0001 in favour of the TMZ arm.
Količnik tveganja (KT) za skupno preživetje je bil 1,59 (95 % IZ za KT=1,33 -1,91) z logaritmičnim rangom p &lt; 0,0001 v prid delu študije s TMZ.
The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33-1.91) with a log-rank p &lt; 0.0001 in favour of the TMZ arm.
Količnik tveganja (KT) za skupno preživetje je bil 1,59 (95 % IZ za KT=1,33 -1,91) z logaritmičnim rangom p &lt; 0,0001 v prid delu študije s TMZ.
The hazard ratio (HR) for overall survival was 1.59 (95% CI for HR=1.33 -1.91) with a log-rank p &lt; 0.0001 in favour of the TMZ arm.
Količnik tveganja (KT) za skupno preživetje je bil 1,59 (95 % IZ za KT=1,33 -1,91) z logaritmičnim rangom p &lt; 0,0001 v korist kraka, ki je prejemal TMZ.
The hepatic safety of maraviroc in combination with other antiretroviral agents in HIV-1-infected subjects with HIV RNA &lt; 50 copies/mL, co-infected with Hepatitis C and/or Hepatitis B Virus was evaluated in a multicentre, randomized, double blinded, placebo-controlled study.
Z multicentrično, randomizirano, dvojno slepo, s placebom kontrolirano študijo je bila ocenjena jetrna varnost maraviroka v kombinaciji z drugimi protiretrovirusnimi zdravili pri preiskovancih, okuženih s virusom HIV-1 in HIV RNA &lt; 50 kopij/ml, sočasno okuženih z virusom hepatitisa C in/ali hepatitisa
The high volume of distribution (Vd) &gt; 2 l/kg bodyweight indicates good tissue penetration.
Velik volumen razporeditve (Vd) &gt; 2 l/kg telesne mase kaže, da se pradofloksacin dobro razporedi v tkivu.
The high volume of distribution (Vd) &gt; 4 l/kg body weight indicates good tissue penetration.
Velik volumen razporeditve (Vd) &gt; 4 l/kg telesne mase kaže, da se pradofloksacin dobro razporedi v tkivu.
The HR median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = &lt; 0.01 to 0.03).
Srednja časa do napredovanja bolezni sta bila v teh primarnih točkah ocene učinkovitosti pri TMZ od 0,7 do 2,1 meseca daljša kot pri prokarbazinu (vrednost p testa log rank = &lt; 0,01 do 0,03).
The immunogenicity and safety of ProQuad were evaluated in a clinical trial involving 799 subjects 4 through 6 years of age who had received Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. at least 1 month prior to study entry.
Imunogenost in varnost cepiva ProQuad so ocenjevali v kliničnem preskušanju s 799 otroci, starimi 4 do 6 let, ki so bili najmanj 1 mesec pred vstopom v študijo cepljeni s cepivom z živim virusom noric (Oka/Merck) in cepivom proti ošpicam, mumpsu in rdečkam izdelovalca Merck &amp; Co., Inc.
The immunogenicity of a single dose of an earlier formulation of ProQuad was comparable to the immunogenicity of a single dose of its individual component vaccines (Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc.), currently used in routine vaccination in some countries.
Imunogenost enkratnega odmerka predhodne oblike cepiva ProQuad je bila primerljiva z imunogenostjo enkratnega odmerka posameznih komponent cepiva (cepivo z živim virusom noric (Oka/Merck) ter cepivo proti ošpicam, mumpsu in rdečkam izdelovalca Merck &amp; Co., Inc.), ki se trenutno v nekaterih državah uporabljajo za rutinsko cepljenje.
The improved room temperature patch formulation showed better skin adhesion than the cold storage formulation with &gt; 90% of patches showing sufficient adhesion (i.e. &gt; 70% of the patch area adhering) compared to &lt; 83%.
Obliž, ki se ga shranjuje na sobni temperaturi, je imel boljši oprejem na koži kot obliž, ki se ga shranjuje na hladnem, saj je &gt; 90 % obližev, ki se jih shranjuje na sobni temperaturi, imelo zadosten oprijem (to je &gt; 70 % površine obliža oprijete) v primerjavi z &lt; 83 % obližev, ki se jih shranjuje na hladnem.
The improvement in the proportion of patients who achieved SVR was consistent across all subgroups in the randomisation strata (baseline platelet counts ( &lt; 50,000 vs. &gt; 50,000), viral load ( &lt; 800,000 IU/ml vs. ≥ 800,000 IU/ml) and genotype (2/3 vs.
Pri deležu bolnikov, ki so dosegli SVR je bilo izboljšanje konsistentno v vseh podskupinah randomizirane skupine bolnikov (število trombocitov v izhodišču ( &lt; 50.000 v primerjavi z &gt; 50.000), virusna obremenitev ( &lt; 800.000 IU/ml v primerjavi z ≥ 800.000 IU/ml) in genotip (2/3 v primerjavi z 1/4/6)).
The in vitro human plasma protein binding of rimonabant is high ( &gt; 99.9%) and non-saturable over a wide concentration range.
Vezava rimonabanta na človeške plazemske beljakovine je in vitro velika ( &gt; 99,9 %) in v širokem razponu koncentracij ne kaže saturacije.
The incidence in older, predominantly non-vaccinated children ( &gt; 5 years) did not change over the duration of the study.
Incidenca pri starejših, večinoma necepljenih otrocih (starejši od 5 let), se v času trajanja študije ni spremenila.
The incidence of a FEV1 reduction &gt; 15% from baseline after Rapiscan administration was assessed in three randomised, controlled clinical studies.
Incidenca zmanjšanja FEV1 &gt; 15% od izhodišča po dajanju zdravila Rapiscan je bila ocenjena v treh randomiziranih, nadziranih kliničnih študijah.
The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared to younger patients ( &lt; 65 years).
Incidenca neželenih učinkov vseh stopenj ter učinkov 3. ali 4. stopnje je bila pri starejših bolnikih podobna kot pri mlajših ( &lt; 65 let).
The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N = 519), and compared to patients who received &gt; 6 cycles of pemetrexed (N = 281).
Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N = 519) in jo primerjali z bolniki, ki so prejeli &gt; 6 ciklov pemetrekseda (N = 281).
The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N=519), and compared to patients who received &gt; 6 cycles of pemetrexed (N=281).
Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N = 519) in jo primerjali z bolniki, ki so prejeli &gt; 6 ciklov pemetrekseda (N = 281).
The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N=519), and compared to patients who received &gt; 6 cycles of pemetrexed (N=281).
Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N=519) in jo primerjali z bolniki, ki so prejeli &gt; 6 ciklov pemetrekseda (N=281).
The incidence of adverse reactions was evaluated for patients who received ≤6 cycles of pemetrexed maintenance (N=519), and compared to patients who received &gt; 6 cycles of pemetrexed (N=281).
Pojavnost neželenih učinkov so ocenili za bolnike, ki so prejeli ≤ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom (N=519) in jo primerjali z bolniki, ki so prejeli &gt; 6 ciklov pemetrekseda (N=281).
The incidence of all adverse events relating to liver and biliary systems was  1.5% in any treatment group and similar to placebo.
Incidenca vseh neželenih pojavov, povezanih s hepatobiliarnim sistemom, je bila v vseh zdravljenih skupinah &lt; 1,5 % in podobna, kot pri placebu.
The incidence of all adverse events relating to liver and biliary systems was  1.5% in any treatment group and similar to placebo.
Pogostnost vseh neželenih učinkov, povezanih z jetri in žolčnim sistemom je bila &lt; 1,5 % v katerikoli skupini zdravljenja in podobna pogostnosti pri placebu.
The incidence of all adverse events relating to liver and biliary systems was 1.5% in any treatment group and similar to placebo.
Incidenca vseh neželenih učinkov, povezanih z jetri in biliarnim sistemom je bila &lt; 1,5 % v vseh skupinah in podobna kot pri placebu.
The incidence of aminotransferase elevations (ALT/AST) &gt; 3 × ULN was 3.4% on macitentan 10 mg and 4.5% on placebo in a double-blind study in patients with PAH.
Incidenca zvišanja aminotransferaz (ALT/AST) &gt; 3 × ULN je bila v dvojno slepi študiji pri bolnikih s PAH 3,4 % pri macitentanu 10 mg in 4,5 % pri placebu.
The incidence of binding antibodies (excluding predose positive patients) was 1% as detected by the acid-dissociation ELISA and &lt; 1% as detected by the Biacore assay;
Incidenca protiteles, ki vežejo panitumumab (izključeni bolniki, pozitivni pred odmerkom) je bila s kislinsko-disociacijskim ELISA 1 % in s preizkusom »Biacore« &lt; 1 %.
The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients ( &lt; 65 years), with previously untreated or relapsed/refractory CLL.
Incidenca neželenih dogodkov krvi in limfatičnega sistema 3. ali 4. stopnje je bila pri bolnikih s KLL, ki predhodno še niso bili zdravljeni ali pri katerih se je bolezen ponovila oziroma se na predhodno zdravljenje niso odzvali, višja pri starejših bolnikih v primerjavi z mlajšimi bolniki ( &lt; 65 let).
The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p0.001; and 2% versus 10%, p0.001)
Med prejemnicami pegfilgrastima je bila tudi manjša incidenca hospitalizacij in intravensko uporabljene antiinfektivne terapije, povezanih s klinično diagnozo febrilne nevtropenije, kot med prejemnicami placeba (1 % v primerjavi s 14 %, p &lt; 0,001, ter 2 % v primerjavi z 10 %, p &lt; 0,001).
The incidence of infection was 38% in the Gazyvaro plus chlorambucil arm and 37% in the rituximab plus chlorambucil arm (with Grade 3-5 events reported in 12% and 14%, respectively and fatal events reported in &lt; 1% in both treatment arms).
Incidenca okužb je bila s kombinacijo zdravila Gazyvaro in klorambucila 38-% in s kombinacijo rituksimaba in klorambucila 37-% (neželene učinke od 3. do 5. stopnje so zabeležili pri 12 % bolnikov v prvi skupini in 14 % v drugi skupini, učinkov s smrtnim izidom pa je bilo v obeh skupinah &lt; 1 %).
The incidence of infections leading to dose interruptions was also numerically higher in patients weighing &lt; 30 kg treated with 10 mg/kg tocilizumab (21.4%) compared to patients weighing ≥30 kg, treated with 8 mg/kg tocilizumab (7.6%).
Incidenca okužb, ki so vodile v prekinitev odmerjanja, je bila prav tako številčno višja pri bolnikih s telesno maso &lt; 30 kg, ki so se zdravili z 10 mg/kg tocilizumaba (21,4 %) v primerjavi z bolniki s telesno maso ≥ 30 kg, ki so se zdravili z 8 mg/kg tocilizumaba (7,6 %).
The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is &lt; 1% of patients by the eighth cycle of MabThera (containing) treatment.
Incidenca simptomov in znakov, povezanih z infuzijo, se je z nadaljnjimi infuzijami precej zmanjšala in je bila do osmega cikla zdravljenja z zdravilom MabThera &lt; 1 %.
The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is &lt; 1% of patients by the eighth cycle of MabThera-containing treatment.
Incidenca simptomov in znakov, povezanih z infuzijo, se je z nadaljnjimi infuzijami precej zmanjšala in je bila do osmega cikla zdravljenja z zdravilom MabThera &lt; 1 %.
The incidence of infusion-related symptoms decreased substantially with subsequent intravenous infusions and is &lt; 1% of patients by the eighth cycle of MabThera (containing) treatment.
Incidenca simptomov in znakov, povezanih z infuzijo, se je z nadaljnjimi intravenskimi infuzijami precej zmanjšala in je bila do osmega cikla zdravljenja z zdravilom MabThera &lt; 1 %.
The incidence of life threatening (grade 4) haematologic effects was &lt; 1.0% and sepsis was reported in 1% of patients.
Incidenca smrtno nevarnih (4. stopnja) hematoloških učinkov je bila &lt; 1,0%, o sepsi pa so poročali pri 1% bolnikov.
The incidence of on treatment alanine aminotransferase (ALT) flares in the two treatment arms according to AASLD (American Association for the Study of Liver Diseases) definition (ALT elevation &gt; 2x baseline and &gt; 10x ULN) are further described in Table 3 below.
Incidence poslabšanj z zvišanjem alanin aminotransferaze (ALT) med zdravljenjem v obeh skupinah bolnikov glede na opredelitev Ameriškega združenja za proučevanje bolezni jeter AASLD (American Association for the Study of Liver Diseases) (zvišanje ALT &gt; 2x izhodiščna vrednost in &gt; 10x ULN) so podrobneje navedene v spodnji preglednici 3.
The incidence of patients with triglyceride elevations &gt; 5 x upper limit of normal (ULN) was 2.4% with Ilaris and 0.7% with triamcinolone acetonide.
Pri bolnikih z zdravilom Ilaris je bila pogostnost zvišanja na več kot 5-kratnik zgornje meje normalnih vrednosti 2,4 %, pri bolnikih s triamcinolon acetonidom pa 0,7 %.
The incidence of potentially clinically significant decreases in lymphocyte counts ( &lt; 0.5 x 109/L) ( &lt; 1%), neutrophil counts (≤1.0 x 109/L) ( &lt; 1%) and platelet counts (≤100 x 109/L) (≤1%) was similar in Plegridy-treated patients compared to placebo-treated patients.
Incidenca potencialno klinično pomembnega zmanjšanja števila limfocitov ( &lt; 0,5 x 109/l) ( &lt; 1 %), števila nevtrofilcev (≤ 1,0 x 109/l) ( &lt; 1 %) in števila trombocitov (≤ 100 x 109/l) (≤ 1 %) je bila pri bolnikih, zdravljenih z zdravilom Plegridy, podobna kot pri bolnikih, ki so prejemali placebo.
The incidence of potentially clinically significant decreases in RBC counts ( &lt; 3.3 x 1012/L) was similar in Plegridy-treated patients compared to placebo-treated patients.
Incidenca potencialno klinično pomembnih zmanjšanj števila rdečih krvnih celic ( &lt; 3,3 x 1012/l) je bila pri bolnikih, zdravljenih z zdravilom Plegridy, podobna kot pri bolnikih, ki so prejemali placebo.
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala &gt; 10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
The incidence of seizure events was low and comparable in patients receiving Plegridy (125 micrograms every 2 weeks) and placebo ( &lt; 1% in each group).
Incidenca epileptičnih napadov je bila nizka in primerljiva pri bolnikih, ki so prejemali zdravilo Plegridy (125 mikrogramov vsaka 2 tedna) in placebo ( &lt; 1 % v vsaki skupini).
The incidence of serious events related to depression and suicidal ideation were similar and low ( &lt; 1%) in both Plegridy 125 micrograms every 2 weeks and placebo-treated patients.
Incidenca resnih neželenih dogodkov, povezanih z depresijo in samomorilnimi mislimi, je bila podobna in nizka ( &lt; 1 %) za bolnike, zdravljene z zdravilom Plegridy 125 mikrogramov vsaka 2 tedna, in za bolnike, ki so prejemali placebo.
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Incidenca naslednjih neželenih učinkov (vse stopnje) - letargije, stomatitisa in nevtropenične okužbe - je bila pri bolnikih, starih 65 let ali več, &gt; 10 % večja kot pri mlajših bolnikih.
The incidence of these adverse reactions, possibly reflecting meningeal irritation, are headache (24%), nausea (18%), vomiting (17%), pyrexia (12%), neck stiffness (3%), neck pain (4%), back pain (7%), meningism ( &lt; 1%), convulsions (6%), hydrocephalus (2%), and CSF pleocytosis with or without altered state of consciousness (1%).
Ti neželeni učinki, ki so morda odraz draženja možganskih ovojnic, vključujejo glavobol (24%), slabost (18%), bruhanje (17%), povišano telesno temperaturo (12%), togost vratu (3%), bolečine v vratu ( 4%), bolečine v hrbtu (7%), meningizem ( &lt; 1%), konvulzije (6%), hidrocefalijo (2%) ter pleocitozo likvorja z motnjo zavesti ali brez nje (1%).
The incidence of thrombocytopenia was low ( &lt; 1% , grade 3/4 ) and was not different between treatment arms.
Incidenca trombocitopenije je bila nizka ( &lt; 1 % 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
The incidence of thrombocytopenia was low ( &lt; 1 %, grade 3/4) and was not different between treatment arms.
Incidenca trombocitopenije je bila nizka ( &lt; 1 % 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
The incidence of thrombocytopenia was low ( &lt; 1%, grade 3/4%) and was not different between treatment arms.
Incidenca trombocitopenije je bila nizka ( &lt; 1 % 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
The incidences of Abilify Maintena patients with prolactin levels &gt; 1 time the upper limit of normal range (ULN) was 1.9 % compared to 7.1 % for placebo patients.
Pojavnost bolnikov, zdravljenih z zdravilom Abilify Maintena in ravnmi prolaktina z &gt; 1-kratno zgornjo mejo normalnih vrednosti (ULN), je znašala 1,9 % v primerjavi s 7,1 % bolnikov, ki so prejemali placebo.
The increased risk of overall and major hypoglycemia was primarily observed in subjects with A1C &lt; 7% at baseline.
Večje tveganje za vse hipoglikemije in hujše hipoglikemije so ugotovili predvsem med preiskovanci, ki so imeli izhodiščno A1c &lt; 7 %.
The increases in BMD were significantly greater in the Aclasta-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p &lt; 0.03).
Po 12 mesecih je bilo povečanje mineralne gostote kosti ledvene hrbtenice in vratu stegnenice statistično značilno večje v skupini bolnikov, ki so prejemali zdravilo Aclasta, v primerjavi s tistimi, ki so prejemali risedronat (vse vrednosti p &lt; 0,03).
The increases in BMD were significantly greater in the zoledronic acid-treated group at the lumbar spine and femoral neck at 12 months compared to risedronate (all p &lt; 0.03).
Po 12 mesecih je bilo povečanje mineralne gostote kosti ledvene hrbtenice in vratu stegnenice statistično značilno večje v skupini bolnikov, ki so prejemali zoledronsko kislino, v primerjavi s tistimi, ki so prejemali risedronat (vse vrednosti p &lt; 0,03).
The initial dose of melphalan is reduced for elderly &gt; 75 years of age considering baseline bone marrow reserve and renal function.
Začetni odmerek melfalana je treba pri bolnikih, starejših od &gt; 75 let, zmanjšati, pri čemer upoštevamo izhodiščno rezervo kostnega mozga in funkcijo ledvic.
The INOmax group had significantly improved oxygenation as measured by PaO2, OI, and alveolar-arterial gradient (p &lt; 0.001 for all parameters).
Skupina, ki je prejemala zdravilo INOmax, je imela značilno izboljšano oksigenacijo, ki so jo izmerili kot PaO2, OI (kisikov indeks) in alveolo-arterijski gradient (p &lt; 0,001 za vse parametre).
The intranasal dosing of 110 micrograms once daily does not typically result in measurable plasma concentrations ( &lt; 10 pg/ml).
110 mikrogramov enkrat na dan plazemske koncentracije tipično niso bile merljive ( &lt; 10 pg/ml).