natgillin/translations-raw huggingface dataset:
In a pooled analysis of the one-year studies M2-124 and M2-125, roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 48 ml (pre-bronchodilator FEV1, primary endpoint, p &lt; 0.0001), and by 55 ml (post-bronchodilator FEV1, p &lt; 0.0001).
V analizi združenih podatkov iz enoletnih študij M28124 in M28125 je roflumilast 500 mikrogramov enkrat na dan pomembno izboljšal pljučno funkcijo v primerjavi s placebom, v povprečju za 48 ml (FEV1 pred bronhodilatatorjem, primarni klinični izid, p &lt; 0,0001) in za 55 ml (FEV1 po bronhodilatatorju, p &lt; 0,0001).
In a pooled analysis of the two studies, the percentage of patients receiving &gt; 7.5 mg/day prednisone (or equivalent) at baseline, whose average corticosteroid dose was reduced by at least 25% to a dose equivalent to prednisone ≤7.5 mg/day during Weeks 40 through 52, was 17.9% in the group receiving Benlysta and 12.3% in the group receiving placebo (p=0.0451).
V kumulativni analizi obeh študij je bil odstotek bolnikov, ki so izhodiščno prejemali &gt; 7,5 mg/dan prednizona (ali enakovredno) in se jim je povprečni odmerek kortikosteroida v obdobju od 40. do 52. tedna zmanjšal za vsaj 25 % na odmerek, enakovreden ≤7,5 mg/dan prednizona, 17,9 % med prejemniki zdravila Benlysta in 12,3 % med prejemniki placeba (p = 0,0451).
In a population pharmacokinetic analysis, patients with baseline total bilirubin concentrations of 1-2 mg/dl (n=19) had average steady state concentrations for total SN-38 that were increased by 37% (0.98 [95%CI: 0.94-1.02] and 1.29 [95%CI: 1.11-1.5] ng/ml, respectively) compared to patients with baseline bilirubin concentrations of &lt; 1 mg/dl (n=329); however, there was no effect of elevated ALT/AST concentrations on total SN-38 concentrations.
V populacijski farmakokinetični analizi so imeli bolniki z izhodiščno koncentracijo skupnega bilirubina 1– 2 mg/dl (n=19) povprečno koncentracijo skupnega SN-38 v dinamičnem ravnovesju višjo za 37 % (0,98 [95- odstotni IZ: 0,94 –1,02] oziroma 1,29 [95-odstotni IZ: 1,11 – 1,5] ng/ml) v primerjavi z bolniki z izhodiščno koncentracijo bilirubina &lt; 1 mg/dl (n=329), vendar pa zvišane koncentracije ALT/AST niso vplivale na skupne koncentracije SN-38.
In a post-hoc analysis in women &gt; 75 years, a 62% relative risk reduction was observed with Prolia (1.4% absolute risk reduction, p &lt; 0.01).
V post hoc analizi pri ženskah, starih &gt; 75 let, so pri zdravljenju z zdravilom Prolia ugotovili 62 % relativno zmanjšanje tveganja (1,4 % absolutno zmanjšanje tveganja, p &lt; 0,01).
In a post-hoc analysis of the combined dataset, the median time to worsening pain ( &gt; 4-point worst pain score) in patients with mild or no pain at baseline was delayed for XGEVA compared to zoledronic acid (198 versus 143 days) (p = 0.0002).
V post hoc analizi kombiniranega nabora podatkov je bil mediana čas do poslabšanja bolečin ( &gt; 4-točkovna najslabša ocena bolečin) pri bolnikih, ki izhodiščno niso imeli bolečin ali so imeli blage, z zdravilom XGEVA daljši kot z zoledronsko kislino (198 dni v primerjavi s 143 dnevi, p = 0,0002).
In a pre- and postnatal development study, canagliflozin administered to female rats from gestation day 6 to lactation day 20 resulted in decreased body weights in male and female offspring at maternally toxic doses &gt; 30 mg/kg/day (exposures ≥ 5.9 times the human exposure to canagliflozin at the MHRD).
Kanagliflozin, ki so ga v študiji prenatalnega in postnatalnega razvoja dajali samicam od 6. dneva brejosti do 20. dneva laktacije, je v odmerkih &gt; 30 mg/kg/dan, ki so bili toksični za samico (≥ 5,9-krat večja izpostavljenost, kot pri ljudeh pri MHRD) povzročil zmanjšano telesno maso mladičev moškega in ženskega spola.
In a prespecified exploratory analysis, 60 of 73 MRD evaluable patients with CR/CRh* (82.2%) also had a MRD response (defined as MRD by PCR &lt; 1 x 10-4).
V vnaprej opredeljeni eksploratorni analizi je imelo 60 od 73 bolnikov z minimalno rezidualno boleznijo, ki so bili primerni za analizo in so imeli CR/CRh* (82,2 %), tudi odziv minimalne rezidualne bolezni (opredeljen kot minimalna rezidualna bolezen s PCR &lt; 1 x 10-4).
In a prespecified pooled analysis of Studies 1 and 2 at Year 1, the incidence of new onset diabetes mellitus (NODM), defined as use of an antidiabetic agent for ≥ 30 days or ≥ 2 fasting plasma glucose values &gt; 126 mg/dl (7.0 mmol/l) post-transplantation, was 5% with belatacept and 10% with ciclosporin.
Pri vnaprej določenih združenih analizah Študij 1 in 2 je bila v 1. letu pojavnost novo nastale sladkorne bolezni, opredeljene kot uporaba antidiabetika za ≥ 30 dni ali ≥ 2 vrednosti glukoze v plazmi na tešče &gt; 126 mg/dl (7,0 mmol/l) po presaditvi, pri uporabi belatacepta 5 %, pri uporabi ciklosporina pa 10 %.
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p &lt; 0.001).
V prospektivni, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 314 bolnikih z rakom na pljučih, ki so dobivali kemoterapijo s platino, so ugotovili značilno zmanjšanje potreb po transfuziji (p &lt; 0,001).
In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p &lt; 0.001).
V prospektivni, randomizirani, dvojno slepi s placebom kontrolirani študiji pri 344 anemičnih bolnikih z limfoproliferativnimi malignomi, ki so dobivali kemoterapijo, so ugotovili značilno zmanjšanje potreb po transfuziji in boljši odziv hemoglobina (p &lt; 0,001).
In a radiolabeled metabolism study, the primary route of excretion was via the faeces with minimal excretion via urine ( &lt; 1%).
V študiji presnove z radioizotopom je bila primarna pot izločanja z blatom in minimalna ekskrecija z urinom ( &lt; 1 %).
In a randomised clinical study 114 paediatric patients aged 2 to 18 with chronic kidney disease receiving or not receiving dialysis who were anaemic (haemoglobin &lt; 10.0 g/dl) and not being treated with an ESA were administered darbepoetin alfa weekly (n = 58) or once every two weeks (n = 56) for the correction of anaemia.
V randomizirani klinični študiji je 114 pediatričnih bolnikov, starih od 2 do 18 let s kronično boleznijo ledvic in zdravljenih ali nezdravljenih z dializo, ki so bili anemični (hemoglobin &lt; 10,0 g/dl) in niso prejemali ESA, za korekcijo anemije dobivalo darbepoetin alfa vsak teden (n = 58) ali vsaka dva tedna (n = 56).
In a randomised comparative phase III study, performed in 52 paediatric patients, 27 patients were treated with rasburicase at the recommended dose of 0.20 mg/kg/day, intravenously, for 4 to 7 days ( &lt; 5 years: n=11; 6-12 years: n=11; 13-17 years: n=5), and 25 patients with allopurinol daily oral doses for 4 to 8 days.
V primerjalni randomizirani študiji tretje faze delani pri 52 pediatričnih bolnikih, so pri 27 bolnikih, ki so bili zdravljeni z razburikazo uporabili priporočene odmerke 0,20 mg/kg/dan, intravensko, od 4 do 7 dni ( &lt; 5 let: n=11, 6-12 let, n=11; 13-17 let: n=5) in 25 bolnikov z dnevno dozo alopurinola od 4 do 8 dni.
In a randomised, double-blind study with a total of 667 patients receiving highly emetogenic chemotherapy that included cisplatin ≥ 60 mg/m2, cyclophosphamide &gt; 1,500 mg/m2 and dacarbazine, palonosetron 250 micrograms and 750 micrograms were compared with ondansetron 32 mg administered intravenously on Day 1.
V randomizirani, dvojno slepi študiji, v kateri je sodelovalo 667 bolnikov, ki so prejemali visoko emetogeno kemoterapijo, ki je vključevala cisplatin &gt; 60 mg/m2, ciklofosfamid &gt; 1500 mg/m2 in dakarbazin, so primerjali odmerka 250 mikrogramov in 750 mikrogramov palonosetrona v primerjavi z ondansetronom 32 mg, danim prvi dan kemoterapije.
In a randomised, double-blind, clinical trial in patients with a confirmed diagnosis of acute symptomatic DVT, fondaparinux 5 mg (body weight &lt; 50 kg), 7.5 mg (body weight  50 kg,  100 kg) or 10 mg (body weight &gt; 100 kg) SC once daily was compared to enoxaparin sodium 1 mg/kg SC twice daily.
V randomiziranem, dvojno slepem kliničnem preskušanju pri bolnikih s potrjeno diagnozo akutne simptomatske DVT so fondaparinuks v odmerkih 5 mg (telesna masa &lt; 50 kg), 7,5 mg (telesna masa ≥ 50 kg, ≤ 100 kg) ali 10 mg (telesna masa &gt; 100 kg) s.c. enkrat na dan primerjali z natrijevim enoksaparinatom v odmerku 1 mg/kg s.c. dvakrat na dan.
In a randomized phase II study (BO20924) a total of 154 patients aged ≥ 6 months to &lt; 18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by Maintenance Vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months.
V randomizirani študiji faze II (BO20924) je skupno 154 bolnikov, starih ≥ 6 mesecev do &lt; 18 let, z novo diagnosticiranim metastatskim rabdomiosarkomom in ostalimi mehkotkivnimi sarkomi prejemalo standardno zdravljenje (indukcijo IVADo/IVA z lokalnim zdravljenjem ali brez njega, ki ji je sledilo vzdrževalno zdravljenje z vinorelbinom in ciklofosfamidom) z bevacizumabom ali brez njega (2,5 mg/kg/teden) v približno 18-mesečnem obdobju celotnega zdravljenja.
In a retrospective analysis of the MOTIVATE studies with a more sensitive assay for screening of tropism (Trofile ES), the response rates ( &lt; 50 copies/mL at week 48) in patients with only CCR5-tropic virus detected at baseline was 48.2% in those treated with maraviroc + OBT (n=328), and 16.3% in those treated with placebo + OBT (n=178).
V retrospektivni analizi študij MOTIVATE z občutljivejšim preskusom presejalnega testa tropizma (Trofile ES), je bil delež odziva 48,2 % pri bolnikih ( &lt; 50 kopij/ml po 48 tednih), pri katerih so ob začetku raziskave ugotovili samo CCR5-tropni virus in so jih zdravili z maravirokom + OOT (n=328), pri bolnikih, ki so prejemali samo OOT (n=178), pa je bil delež odziva 16,3%.
In a retrospective review of 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 %).
V retrospektivnem pregledu podatkov, ki je večinoma zajel bolnike z virusnim bremenom s HIV-1 v plazmi 50 kopij/ml ali več, je bilo tveganje simptomatskih neželenih jetrnih reakcij pri ženskah s številom celic CD4 &gt; 250 celic/mm3 12-krat večje, kot pri ženskah s številom celic CD4 &lt; 250 celic/mm3 (11,0 % proti 0,9 %).
In a retrospective review of 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 %).
V retrospektivnem pregledu, ki je večinoma zajel bolnike z virusnim bremenom s HIV-1 v plazmi 50 kopij/ml ali več, je bilo pri ženskah s številom celic CD4 &gt; 250 celic/mm3 tveganje simptomatskih neželenih jetrnih dogodkov 12-krat večje kot pri ženskah s številom celic CD4 &lt; 250 celic/mm3 (11,0 % v primerjavi z 0,9 %).
In a retrospective review of 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 %).
V retrospektivnem pregledu, ki je večinoma zajel bolnike z virusnim bremenom s HIV-1 v plazmi 50 kopij/ml ali več, je bilo pri ženskah s številom celic CD4 &gt; 250 celic/mm3 tveganje simptomatskih neželenih jetrnih dogodkov 12-krat večje kot pri ženskah s številom celic CD4 &lt; 250 celic/mm3 (11,0 % v primerjavi z 0,9 %).
In a review of safety data from clinical trials and spontaneous postmarketing reports, injection site abscess was rarely (≥ 1/10,000 to &lt; 1/1,000) reported.
Pri pregledu podatkov o varnosti iz kliničnih študij in spontanih poročil v obdobju trženja so o abcesu na mestu injiciranja poročali redko (≥ 1/10.000 do &lt; 1/1.000).
In a separate study (MenACWY-TT-085) a single dose of Nimenrix was administered to 194 Lebanese adults 56 years of age and older (including 133 aged 56-65 years and 61 aged &gt; 65 years).
V ločeni študiji (MenACWY-TT-085) je en odmerek cepiva Nimenrix prejelo 194 odraslih Libanoncev, starih 56 let ali več (od tega jih je bilo 133 starih od 56 do 65 let in 61 starih &gt; 65 let).
In a separate trial, 224 patients with genotype 2 or 3 received PegIntron, 1.5 micrograms/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing &gt; 105 kg, received the 1,400 mg dose) (Table 10).
V ločenem preskušanju je 224 bolnikov z genotipom 2 ali 3 prejemalo zdravilo PegIntron v odmerku 1,5 mikrograma/kg subkutano enkrat na teden v kombinaciji z ribavirinom od 800 mg do 1.400 mg peroralno 6 mesecev (glede na telesno maso, samo 3 bolniki s telesno maso &gt; 105 kg so prejeli odmerek 1.400 mg) (preglednica 10).
In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 years) with schizophrenia, the frequency and type of undesirable effects were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving oral aripiprazole than in adults receiving oral aripiprazole (and more frequently than placebo): somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, &lt; 1/10).
V kratkotrajnem, s placebom nadzorovanem kliničnem preskušanju, ki je vključevalo 302 mladostnika (13-17 let) s shizofrenijo, so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih neželenih učinkov, ki so bili pri mladostnikih, ki so prejemali oralni aripiprazol, pogostejši kot pri odraslih, ki so prejemali oralni aripiprazol (in pogostejši kot pri placebu): Somnolenca/sedacija in ekstrapiramidne motnje so bili zelo pogosti (≥ 1/10), suha usta, povečan apetit in ortostatska hipotenzija pa pogosti (≥ 1/100, &lt; 1/10) neželeni učinki.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate &lt; 25 mL./min/1.73 m2) were 28 – 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija &lt; 25 ml/min/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 % večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate &lt; 25 mL/min/1.73 m2) were 28 – 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija &lt; 25 ml/min/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 % večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate &lt; 25 mL/min/1.73 m2) were 28-75 % higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija &lt; 25 ml/min/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 % večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate &lt; 25 mL/min/1.73 m2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija &lt; 25 ml/mim/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 % večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate &lt; 25 mL•min-1•1.73 m-2) were 28-75 % higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija &lt; 25 ml/min/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 % večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate &lt; 25mL/min/1.73 m2) were 28 – 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija &lt; 25 ml/min/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 % večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate &lt; 25°mL/min/1.73°m2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
V študiji enkratnega odmerjanja (6 oseb/skupino) je bil pri bolnikih s hudo kronično ledvično okvaro (glomerulna filtracija &lt; 25 ml/mim/1,73 m2) srednji AUC mikofenolne kisline v plazmi za 28 do 75 % večji kot pri bolnikih z blažjimi stopnjami ledvične okvare ali pri zdravih prostovoljcih.
In a single dose study with Galafold in non-Fabry subjects with varying degrees of renal insufficiency, exposures were increased by 4.3-fold in subjects with severe renal impairment (GFR &lt; 30 mL/min/1.73 m2).
V študiji s enkratnim odmerkom zdravila Galafold pri bolnikih, ki nimajo Fabryjeve bolezni in imajo različno stopnjo ledvične insuficience, se je pri osebah s hudo okvaro ledvic (GFR &gt; 30 ml/min/1,73 m2) izpostavljenost povečala za 4,3-krat.
In a single-dose study, retigabine AUC was increased by approximately 30% in volunteers with mild renal impairment (creatinine clearance 50 to 80 ml/min) and by approximately 100% in volunteers with moderate to severe renal impairment (creatinine clearance &lt; 50 ml/min), relative to healthy volunteers.
V študiji enega odmerka se je AUC retigabina v primerjavi z zdravimi prostovoljci pri prostovoljcih z blago okvaro ledvic (očistek kreatinina od 50 do 80 ml/min) povečala za približno 30 % in pri prostovoljcih z zmerno do hudo okvaro ledvic (očistek kreatinina &lt; 50 ml/min) za približno 100 %.
In a small number of patients ( &lt; 10 %), doses up to 1.0 MIU (10 μg)/kg/day were required to achieve reversal of neutropenia.
Pri manjšem številu bolnikov (manj od 10 %) so bili za ustavitev napredovanja nevtropenije potrebni odmerki do 1,0 x 106i.e. (10 μg)/kg/dan.
In a small number of patients ( &lt; 10%), doses up to 1.0 MIU (10 μg)/kg/day were required to achieve reversal of neutropenia.
Pri manjšem številu bolnikov (manj od 10%) so bili za ustavitev napredovanja nevtropenije potrebni odmerki do 1,0 x 106i.e. (10 μg)/kg/dan.
In a small number of patients ( &lt; 10%), doses up to 1.0 MU (10 micrograms)/kg/day were required to achieve reversal of neutropenia.
Pri majhnem številu bolnikov ( &lt; 10 %) so bili za odpravo nevtropenije potrebni odmerki do 1,0 M e. (10 mikrogramov)/kg/dan.
In a small number of patients ( &lt; 10%), doses up to 1.0 MU/kg/day (10 micrograms/kg/day) were required to achieve reversal of neutropenia.
Pri majhnem številu bolnikov ( &lt; 10 %) so bili za dosego odpravljene nevtropenije potrebni odmerki do 1,0 M e./kg/dan (10 mikrogramov/kg/dan).
In a small number of patients ( &lt; 10%), doses up to 1.0 MU/kg/day (10 micrograms/kg/day) were required to achieve reversal of neutropenia.
Pri majhnem številu bolnikov ( &lt; 10 %) so bili za odpravo nevtropenije potrebni odmerki do 1,0 M e./kg/dan (10 mikrogramov/kg/dan).
In a small number of patients ( &lt; 10%), doses up to 1.0 MU/kg/day (10 micrograms/kg/day) were required to achieve reversal of neutropenia.
Pri majhnem številu bolnikov ( &lt; 10%) so bili za dosego odpravljene nevtropenije potrebni odmerki do 1,0 M e./kg/dan (10 mikrogramov/kg/dan).
In a small number of patients ( &lt; 10%), doses up to 1.0 MU/kg/day (10 μg/kg/day) were required to achieve reversal of neutropenia.
Pri majhnem številu bolnikov ( &lt; 10 %) so bili za odpravo nevtropenije potrebni odmerki do 1,0 M e./kg/dan (10 µg/kg/dan).
In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST &gt; 1,5-kratna ULN hkrati z alkalno fosfatazo &gt; 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
In a smaller group (n=36) of mixed type 1 and 2 subjects treated with EXUBERA for &gt; 36 months, cessation of therapy resulted in a mean FEV1 increase of 0.036L over the subsequent 6 months.
V manjši mešani skupini (n=36) bolnikov s tipom 1 in tipom 2, zdravljenih z zdravilom EXUBERA &gt; 36 mesecev dolgo, je prekinitev zdravljenja povzročila povprečno zvečanje FEV1 za 0,036 L v naslednjih 6 mesecih.
In a study comparing 1 dose (N=1114) to 2 doses (N=1102) of Varicella Vaccine live (Oka/Merck), the estimated vaccine efficacy against all severities of varicella disease for the 10-year observation period was 94% for 1 dose and 98% for 2 doses (p &lt; 0.001).
V študiji, ki je primerjala 1 odmerek (n = 1.114) z 2 odmerkoma (n = 1.102) cepiva z živim virusom noric (Oka/Merck), je ocenjena učinkovitost cepiva proti vsem stopnjam noric v 10-letnem opazovalnem obdobju znašala 94 % za 1 odmerek in 98 % za 2 odmerka (p &lt; 0,001).
In a study comparing canagliflozin 300 mg once daily to sitagliptin 100 mg in triple therapy with metformin and a sulphonylurea, canagliflozin demonstrated non-inferior (p &lt; 0.05) and superior (p &lt; 0.05) reduction in HbA1c relative to sitagliptin.
V študiji, v kateri so primerjali odmerek 300 mg kanagliflozina enkrat na dan z odmerkom 100 mg sitagliptina pri trotirnem zdravljenju z metforminom in sulfonilsečnino, so dokazali neinferiornost (p &lt; 0,05) kanagliflozina in superiorno zmanjšanje odstotka HbA1c (p &lt; 0,05) v primerjavi s sitagliptinom.
In a study comparing canagliflozin 300 mg to sitagliptin 100 mg in triple therapy with metformin and a sulphonylurea, canagliflozin demonstrated non-inferior (p &lt; 0.05) and superior (p &lt; 0.05) reduction in HbA1c relative to sitagliptin.
V študiji, v kateri so primerjali odmerek 300 mg kanagliflozina z odmerkom 100 mg sitagliptina pri trotirnem zdravljenju z metforminom in sulfonilsečnino, so dokazali neinferiornost (p &lt; 0,05) kanagliflozina in superiorno zmanjšanje odstotka HbA1c (p &lt; 0,05) v primerjavi s sitagliptinom.