natgillin/translations-raw huggingface dataset:
In a pooled analysis of patients who received ledipasvir/sofosbuvir in Phase 3 studies (ION-3, ION-1 and ION-2), 37 patients (29 with genotype 1a and 8 with genotype 1b) qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA &gt; 1,000 IU/mL.
U analizi objedinjenih podataka pacijenata koji su primali ledipasvir/sofosbuvir u ispitivanjima faze 3 (ION-3, ION-1 i ION-2), 37 pacijenata (29 s genotipom 1a i 8 s genotipom 1b) zadovoljilo je mjerila za analizu rezistencije zbog virološkog neuspjeha ili ranog prekida primjene lijeka tijekom ispitivanja i imalo je HCV RNK &gt; 1000 IU/ml.
In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was similar in patients ≥ 65 years old treated with 25 mg alogliptin (3.8%) to that in patients &lt; 65 years old (3.6%).
U analizi objedinjenih podataka iz 12 ispitivanja, ukupna incidencija svih epizoda hipoglikemije bila je u bolesnika s ≥ 65 godina starosti liječenih s 25 mg alogliptina (3,8%) slična kao i u onih &lt; 65 godina starosti (3,6%).
In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was similar in patients ≥ 65 years old treated with 25 mg alogliptin (3.8%) to that in patients &lt; 65 years old (3.6%).
U analizi objedinjenih podataka iz 12 ispitivanja, ukupna incidencija svih epizoda hipoglikemije bila je u bolesnika u dobi od ≥ 65 godina starosti liječenih s 25 mg alogliptina (3,8%) slična kao i u onih &lt; 65 godina starosti (3,6%).
In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was similar in patients ≥ 65 years old treated with 25 mg alogliptin (3.8%) to that in patients &lt; 65 years old (3.6%).
U analizi objedinjenih podataka iz 12 ispitivanja, ukupna incidencija svih epizoda hipoglikemije bila je u bolesnika ≥ 65 godina starosti koji su liječeni s 25 mg alogliptina (3,8%) slična kao i u onih &lt; 65 godina starosti (3,6%).
In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Enurev Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p &lt; 0.001).
U objedinjenoj analizi prvih 6 mjeseci liječenja u 6- i 12-mjesečnom ispitivanju, u usporedbi s placebom Enurev Breezhaler statistički značajno je produljio vrijeme do prve umjerene ili teške egzacerbacije i smanjio stopu umjerenih ili teških egzacerbacija KOPB-a (0,53 egzacerbacija na godinu u usporedbi s 0,77 egzacerbacija na godinu, p &lt; 0,001).
In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Seebri Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p &lt; 0.001).
U objedinjenoj analizi prvih 6 mjeseci liječenja u 6- i 12-mjesečnom ispitivanju, u usporedbi s placebom Seebri Breezhaler statistički značajno je produljio vrijeme do prve umjerene ili teške egzacerbacije i smanjio stopu umjerenih ili teških egzacerbacija KOPB-a (0,53 egzacerbacija na godinu u usporedbi s 0,77 egzacerbacija na godinu, p &lt; 0,001).
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).
U objedinjenoj analizi jednogodišnjih ispitivanja M2-124 i M2-125 roflumilast od 500 mikrograma jedanput na dan značajno je poboljšao plućnu funkciju u usporedbi s placebom, prosječno za 48 ml (predbronhodilatacijski FEV1, primarni ishod, p &lt; 0,0001), te za 55 ml (postbronhodilatacijski FEV1, 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).
U skupnoj analizi dvije studije, postotak bolesnika koji su primali &gt; 7,5 mg/dan prednizona (ili ekvivalenta) na početku ispitivanja, čija je prosječna doza kortikosteroida bila smanjena za barem 25%, na dozu ekvivalentnu ≤7,5 mg prednizona dnevno, tijekom 40. do 52. tjedna, iznosio je 17,9% u skupini koja je primala lijek Benlysta, te 12,3% u skupini koja je primala placebo (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.
U populacijskoj farmakokinetičkoj analizi, bolesnici s početnom koncentracijom ukupnog bilirubina od 1-2 mg/dl (n=19) imali su prosječne koncentracije ukupnog SN-38 u stanju dinamičke ravnoteže koje su se povećale za 37% (0,98 [95%CI: 0,94-1,02] odnosno 1,29 [95%CI: 1,11-1,5] ng/ml) u usporedbi s bolesnicima s početnom koncentracijom bilirubina &lt; 1 mg/dl (n=329); međutim, nije bilo utjecaja povišenih koncentracija ALT/AST na koncentracije ukupnog 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).
U post-hoc analizi u žena &gt; 75 godina zabilježeno je smanjenje relativnog rizika od 62% s lijekom Prolia (1,4%-tno smanjenje apsolutnog rizika, p &lt; 0,01).
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).
U pre- i postnatalnom razvojnom ispitivanju, kanagliflozin primijenjen ženkama štakora od gestacijskog dana 6 do dana dojenja 20 rezultiralo je smanjenim tjelesnim težinama i muške i ženske maldunčadi pri toksičnim dozama za majku &gt; 30 mg/kg/dan (izloženosti ≥ 5,9 puta izloženosti kanagliflozinu u ljudi pri MHRD).
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).
U pre- i postnatalnom razvojnom ispitivanju, kanagliflozin primijenjen ženkama štakora od gestacijskog dana 6 do dana dojenja 20 rezultiralo je smanjenim tjelesnim težinama i muške i ženske mladunčadi pri toksičnim dozama za majku &gt; 30 mg/kg/dan (izloženosti ≥ 5,9 puta izloženosti kanagliflozinu u ljudi pri MHRD).
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.
U unaprijed zadanoj analizi objedinjenih podataka iz Ispitivanja 1 i 2 u 1. godini incidencija novonastale šećerne bolesti (NODM), definirane kao uzimanje antidijabetičkog lijeka ≥ 30 dana ili ≥ 2 vrijednosti glukoze u plazmi natašte &gt; 126 mg/dl (7,0 mmol/l) nakon presađivanja, iznosila je 5% uz belatacept i 10% uz ciklosporin.
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).
U prospektivnoj, randomiziranoj, dvostruko slijepoj, placebom kontroliranoj studiji provedenoj na 314 bolesnika s rakom pluća koji su primali kemoterapiju koja sadrži platinu postojalo je znatno smanjenje potreba za transfuzijom (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).
U prospektivnoj, randomiziranoj, dvostruko slijepoj, placebom kontroliranoj studiji provedenoj na 344 anemična bolesnika s limfoproliferativnim malignomima koji su primali kemoterapiju, zabilježeno je znatno smanjenje potreba za transfuzijom i poboljšanje hemoglobinskog odgovora (p &lt; 0,001).
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.
U randomiziranom kliničkom ispitivanju na 114 pedijatrijskih bolesnika u dobi od 2 do 18 godina s kroničnom bolesti bubrega, koji jesu ili nisu na dijalizi, imaju anemiju (hemoglobin &lt; 10,0 g/dl) i nisu bili liječeni lijekovima koji stimuliraju eritropoezu, bolesnici su dobivali darbepoetin alfa jednom tjedno (n = 58) ili jednom svaka dva tjedna (n=56) u svrhu korekcije anemije.
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.
U randomiziranom komparativnom ispitivanju faze III, provedenom na 52 pedijatrijska bolesnika, 27 bolesnika je primalo terapiju razburikazom u preporučenoj dozi od 0,20 mg/kg/dan intravenski, tijekom 4 do 7 dana ( &lt; 5 godina: n=11; 6-12 godina: n=11; 13-17 godina: n=5), a 25 bolesnika primalo je alopurinol u dnevnim oralnim dozama tijekom 4 do 8 dana.
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.
U randomiziranom, dvostruko slijepom ispitivanju na ukupno 667 bolesnika na visoko emetogenoj kemoterapiji koja je uključivala cisplatin ≥60 mg/m2, ciklofosfamid &gt; 1500 mg/m2 i dakarbazin, uspoređivan je palonosetron 250 mikrograma i 750 mikrograma s ondansetronom 32 mg primijenjeno intravenski na dan 1.
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.
U randomiziranom, dvostruko slijepom ispitivanju na ukupno 667 bolesnika na visoko emetogenoj kemoterapiji koja je uključivala cisplatin ≥60 mg/m2, ciklofosfamid &gt; 1500 mg/m2 i dakarbazin, uspoređivan je palonozetron 250 mikrograma i 750 mikrograma s ondanzetronom 32 mg primijenjeno intravenski na dan 1.
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.
U randomiziranom dvostruko slijepom kliničkom ispitivanju bolesnika s potvrđenom dijagnozom akutne simptomatske DVT, fondaparinuks u dozi od 5 mg (tjelesna težina &lt; 50 kg), 7,5 mg (tjelesna težina 50 kg, 100 kg) ili 10 mg (tjelesna težina &gt; 100 kg) primijenjen s.c. jednom na dan uspoređivao se s enoksaparinnatrijem u dozi od 1 mg/kg primijenjenim s.c. dvaput na dan.
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).
U retrospektivnoj analizi ispitivanja MOTIVATE, u kojoj se koristio osjetljiviji test za probir na tropizam (Trofile ES), stopa odgovora ( &lt; 50 kopija/ml u 48. tjednu) bolesnika u kojih je na početku ispitivanja otkriven samo CCR5-tropni virus iznosila je 48,2% u bolesnika liječenih maravirokom i OBT-om (n=328) te 16,3% u onih liječenih kombinacijom placebo + OBT (n=178).
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 %).
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%).
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 %).
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%).
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.
U analizi podataka o sigurnosti lijeka iz kliničkih ispitivanja te spontanih prijava nakon stavljanja lijeka u promet, apsces na mjestu injekcije prijavljen je rijetko (≥ 1/10 000 i &lt; 1/1000).
In a second multicentre, randomised, double-blind, parallel-group, clinical study, the aprepitant regimen was compared with standard therapy in 848 adult patients (652 females, 196 males) receiving a chemotherapy regimen that included any intravenous dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin; cyclophosphamide intravenously ( &lt; 1,500 mg/m2); or cytarabine intravenously ( &gt; 1 g/m2).
U drugom multicentričnom, randomiziranom, dvostruko slijepom kliničkom ispitivanju s paralelnim skupinama, režim liječenja aprepitantom uspoređen je sa standardnom terapijom u 848 odrasih bolesnika (652 žene, 196 muškaraca) koji su primali kemoterapiju koja je obuhvaćala intravensku primjenu bilo koje doze oksaliplatina, karboplatina, epirubicina, idarubicina, ifosfamida, irinotekana, daunorubicina, doksorubicina; intravenski ciklofosfamid ( &lt; 1500 mg/m2); ili intravenski citarabin ( &gt; 1 g/m2).
In a second multicentre, randomised, double-blind, parallel-group, clinical study, the aprepitant regimen was compared with standard therapy in 848 adult patients (652 females, 196 males) receiving a chemotherapy regimen that included any intravenous dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin; cyclophosphamide intravenously ( &lt; 1,500 mg/m2); or cytarabine intravenously ( &gt; 1 g/m2).
U drugom multicentričnom, randomiziranom, dvostruko slijepom kliničkom ispitivanju s paralelnim skupinama, režim liječenja aprepitantom uspoređen je sa standardnom terapijom u 848 odrasla bolesnika (652 žene, 196 muškaraca) koji su primali kemoterapiju koja je obuhvaćala intravensku primjenu bilo koje doze oksaliplatina, karboplatina, epirubicina, idarubicina, ifosfamida, irinotekana, daunorubicina, doksorubicina; intravenski ciklofosfamid ( &lt; 1500 mg/m2); ili intravenski citarabin ( &gt; 1 g/m2).
In a second multicentre, randomised, double-blind, parallel-group, clinical study, the aprepitant regimen was compared with standard therapy in 848 adult patients (652 females, 196 males) receiving a chemotherapy regimen that included any intravenous dose of oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin; cyclophosphamide intravenously ( &lt; 1,500 mg/m2); or cytarabine intravenously ( &gt; 1 g/m2).
U drugom multicentričnom, randomiziranom, dvostruko slijepom kliničkom ispitivanju s paralelnim skupinama, režim liječenja aprepitantom uspoređen je sa standardnom terapijom u 848 odraslih bolesnika (652 žene, 196 muškaraca) koji su primali kemoterapiju koja je obuhvaćala intravensku primjenu bilo koje doze oksaliplatina, karboplatina, epirubicina, idarubicina, ifosfamida, irinotekana, daunorubicina, doksorubicina; intravenski ciklofosfamid ( &lt; 1500 mg/m2); ili intravenski citarabin ( &gt; 1 g/m2).
In a separate trial, 224 patients with genotype 2 or 3 received peginterferon alfa-2b, 1.5 microgram/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 8).
U odvojenom su ispitivanju 224 bolesnika inficirana virusom genotipa 2 ili 3 tijekom 6 mjeseci primala peginterferon alfa-2b supkutano u dozi od 1,5 mikrograma/kg jedanput na tjedan, u kombinaciji s ribavirinom u peroralnoj dozi od 800 mg – 1400 mg (na temelju tjelesne težine; samo su tri bolesnika koja su težila &gt; 105 kg primila dozu od 1400 mg) (Tablica 8).
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).
U drugom su ispitivanju 224 bolesnika s genotipom 2 ili 3 tijekom 6 mjeseci supkutano primala PegIntron u dozi od 1,5 mikrograma/kg jedanput na tjedan, u kombinaciji s ribavirinom peroralno u dozi od 800-1400 mg (na temelju tjelesne težine, samo su tri bolesnika koja su težila &gt; 105 kg primila dozu od 1400 mg) (Tablica 10).
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 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).
U drugom su ispitivanju 224 bolesnika s genotipom 2 ili 3 tijekom 6 mjeseci supkutano primala ViraferonPeg u dozi od 1,5 mikrograma/kg jedanput na tjedan, u kombinaciji s ribavirinom peroralno u dozi od 800-1400 mg (na temelju tjelesne težine, samo su tri bolesnika koja su težila &gt; 105 kg primila dozu od 1400 mg) (Tablica 10).
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.
U ispitivanju primjene jedne doze (6 ispitanika/skupina), srednje vrijednosti AUC-a MPA u plazmi ispitanika s teškim kroničnim oštećenjem bubrega (brzina glomerularne filtracije &lt; 25 ml/min/1,73 m2) bile su 28 - 75% više u odnosu na srednje vrijednosti koje su primijećene kod normalnih, zdravih ispitanika ili ispitanika s blažim stupnjevima bubrežnog oštećenja.
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.
U ispitivanju jedne doze (6 ispitanika/skupina), srednje vrijednosti AUC-a MPA u plazmi ispitanika s teškim kroničnim oštećenjem bubrega (brzina glomerularne filtracije &lt; 25 ml•min-1•1,73 m-2) bile su 28-75 % više u odnosu na srednje vrijednosti koje su primijećene kod normalnih, zdravih ispitanika ili ispitanika s blažim stupnjevima bubrežnog oštećenja.
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.
U ispitivanju jedne doze (6 ispitanika/skupina), srednje vrijednosti AUC-a MPA u plazmi ispitanika s teškim kroničnim oštećenjem bubrega (brzina glomerularne filtracije &lt; 25 ml•min-1•1,73 m-2) bile su 28-75 % više u odnosu na srednje vrijednosti koje su primijećene kod normalnih, zdravih ispitanika ili ispitanika s blažim stupnjevima bubrežnog oštećenja.
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.
U ispitivanju primjene jedne doze (6 ispitanika/skupina), srednje vrijednosti AUC-a MPA u plazmi ispitanika s teškim kroničnim oštećenjem bubrega (brzina glomerularne filtracije &lt; 25 ml/min/1,73 m2) bile su 28 - 75% više u odnosu na srednje vrijednosti koje su primijećene kod normalnih, zdravih ispitanika ili ispitanika s blažim stupnjevima bubrežnog oštećenja.
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).
U ispitivanju koje je uključivalo davanje jedne doze Galafolda u ispitanika koji nisu imali Fabryjevu bolest s različitim stupnjevima bubrežne insuficijencije, izloženosti su se povećale 4,3 puta u ispitanika s teškim oštećenjem bubrega (GFR &lt; 30 ml/min/1,73 m2).
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.
U ispitivanju jednokratne doze, AUC retigabina je bio povišen za oko 30% u dobrovoljaca s blagim oštećenjem bubrega (klirens kreatinina 50 do 80 ml/min), te za oko 100% u dobrovoljaca s umjerenim do teškim oštećenjem bubrega (klirens kreatinina &lt; 50 ml/min) u usporedbi sa zdravim dobrovoljcima.
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.
U malog broja bolesnika ( &lt; 10 %) za ispravljanje neutropenije bile su nužne doze do 1,0 MIU (10 mikrograma)/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.
U malog broja bolesnika ( &lt; 10 %) za ispravljanje neutropenije bile su nužne doze do 1,0 MIU (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.
U malog broja bolesnika ( &lt; 10%) su za korekciju neutropenije bile nužne doze do 1,0 MU (10 mikrograma)/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.
Malom broju bolesnika ( &lt; 10%), bile su potrebne doze do 1,0 MU/kg/dan (10 mikrograma/kg/dan) kako bi se postigao obrat neutropenije.
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.
U malog broja bolesnika ( &lt; 10 %) bile su potrebne doze do 1,0 MU/kg na dan (10 μg/kg na dan) da bi se postigao oporavak neutropenije.