natgillin/translations-raw huggingface dataset:
The rates of discontinuation due to adverse events in the subgroup of patients &gt; 65 years old were 8.8% in the CT arm and 50.0% in the CT + BV arm.
Stope prekida ispitivanja zbog nuspojava u podskupini bolesnica starijih od 65 godina iznosile su 8,8% u skupini KT te 50,0% u skupini KT+BV.
The recommended dosage for babies and children aged 2 months to &lt; 3 years is a total of 2 injections of 0.25 ml each:
Preporučena doza za dojenčad i djecu u dobi od 2 mjeseca do &lt; 3 godine je ukupno 2 injekcije, svaka od po 0,25 ml:
The recommended dose in adolescents aged 12 to &lt; 18 years is 50 mg given every 12 hours.
Preporučena doza u adolescenata u dobi od 12 do &lt; 18 godina je 50 mg koja se daje svakih 12 sati.
The recommended dose in children aged 8 to &lt; 12 years is 1.2 mg/kg given every 12 hours intravenously to a maximum dose of 50 mg every 12 hours.
Preporučena doza u djece u dobi od 8 to &lt; 12 godina je 1,2 mg/kg koja se daje svakih 12 sati u venu u najvećoj dozi od 50 mg svakih 12 sati.
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 2 - 12 years, is 24 mg/m² body surface area up to a maximum single dose of 20 mg adalimumab (for patients aged 2 - &lt; 4) and up to a maximum single dose of 40 mg adalimumab (for patients aged 4-12) administered every other week via subcutaneous injection.
Preporučena doza lijeka Humira za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom u dobi 2-12 godina je 24 mg/m² tjelesne površine do maksimalne pojedinačne doze od 20 mg adalimumaba (za bolesnike u dobi od 2 do manje od 4 godine) i do maksimalne pojedinačne doze od 40 mg adalimumaba (za bolesnike u dobi od 4 do 12 godina) primijenjene svaki drugi tjedan supkutanom injekcijom.
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 2 - 12 years, is 24 mg/m² body surface area up to a maximum single dose of 20 mg adalimumab (for patients aged 2- &lt; 4) and up to a maximum single dose of 40 mg adalimumab (for patients aged 4-12) administered every other week via subcutaneous injection.
Preporučena doza lijeka Humira za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom u dobi 2-12 godina je 24 mg/m² tjelesne površine do maksimalne pojedinačne doze od 20 mg adalimumaba (za bolesnike u dobi od 2 do manje od 4 godine) i do maksimalne pojedinačne doze od 40 mg adalimumaba (za bolesnike u dobi od 4 do 12 godina) primijenjene svaki drugi tjedan supkutanom injekcijom.
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 2- 12 years, is 24 mg/m² body surface area up to a maximum single dose of 20 mg adalimumab (for patients aged 2- &lt; 4) and up to a maximum single dose of 40 mg adalimumab (for patients aged 4-12) administered every other week via subcutaneous injection.
Preporučena doza lijeka Humira za bolesnike s poliartikularnim juvenilnim idiopatskim artritisom u dobi 2-12 godina je 24 mg/m² tjelesne površine do maksimalne pojedinačne doze od 20 mg adalimumaba (za bolesnike u dobi od 2 do manje od 4 godine) i do maksimalne pojedinačne doze od 40 mg adalimumaba (za bolesnike u dobi od 4 do 12 godina) primijenjene svaki drugi tjedan supkutanom injekcijom.
The recommended doses in children and adolescent patients are based on a population pharmacokinetic analysis of data obtained from 112 immunocompromised paediatric patients aged 2 to &lt; 12 years and 26 immunocompromised adolescent patients aged 12 to &lt; 17 years.
Preporučene doze u djece i adolescenata temelje se na populacijskoj farmakokinetičkoj analizi podataka prikupljenih u 112 imunokompromitiranih pedijatrijskih bolesnika u dobi od 2 do &lt; 12 godina i 26 imunokompromitiranih adolescentnih bolesnika u dobi 12 do &lt; 17 godina.
The recommended intravenous dose regimen for patients with creatinine clearance &gt; 50 mL/min is shown by infection type in Table 1.
Preporučeni režim intravenskog doziranja u bolesnika s klirensom kreatinina &gt; 50 ml/min prikazan je prema vrsti infekcije u tablici 1.
The recommended starting dose in elderly patients ( &gt; 60 years) is 2.5 - 5 mg.
Preporučena početna doza u starijih bolesnika ( &gt; 60 godina) iznosi 2,5 do 5 mg.
The recommended starting dose in infants ( &lt; 6 months of age) presenting with rapidly progressive LAL deficiency is 1 mg/kg administered as an intravenous infusion once weekly.
Preporučena početna doza za dojenčad ( &lt; 6 mjeseci starosti) s kliničkom slikom brzo progresivnog nedostatka LAL-a je 1 mg/kg primijenjeno kao intravenska infuzija jednom tjedno.
The recommended starting dose of filgrastim is 0.1 MIU (1 μg)/kg/day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μg)/kg/day until a normal neutrophil count is reached and can be maintained (ANC &gt; 2.0 x 109/L).
Preporučena početna doza je 0,1 MIU (1 μg)/kg/dan svakoga dana u supkutanoj injekciji, i može se titrirati do najviše 0,4 MIU (4 μg)/kg/dan, do postizanja normalnog broja neutrofila, koji će biti moguće i održavati (ABN &gt; 2,0 x 109/l).
The recommended starting dose of filgrastim is 0.1 MU (1 micrograms)/kg/day with titration up to a maximum of 0.4 MU (4 micrograms)/kg/day until a normal neutrophil count is reached and can be maintained (ANC &gt; 2.0 x 109/l).
Preporučena početna doza filgrastima je 0,1 MU (1 mikrogram)/kg/dan , i može se povisiti do najviše 0,4 MU (4 mikrograma)/kg/dan do postizanja normalnog broja neutrofila koji će biti moguće održavati (ABN &gt; 2,0 x109/l).
The recommended starting dose of filgrastim is 0.1 MU/kg/day (1 micrograms/kg/day) given daily with titration up to a maximum of 0.4 MU/kg/day (4 micrograms/kg/day) until a normal neutrophil count is reached and can be maintained (ANC &gt; 2.0 x 109/L).
Preporučena početna doza filgrastima je 0,1 MU/kg/dan (1 mikrograma/kg/dan) primijenjena svakodnevno uz titraciju do najviše 0,4 MU/kg/dan (4 mikrograma/kg/dan) dok se ne postigne normalan broj neutrofila koji je moguće održati (ABN &gt; 2,0 x 109/l).
The recommended starting dose of filgrastim is 0.1 MU/kg/day (1 μg/kg/day), with titration up to a maximum of 0.4 MU/kg/day (4 μg/kg/day) until a normal neutrophil count is reached and can be maintained (ANC &gt; 2.0 x 109/l).
Preporučena početna doza filgrastima je 0,1 MU/kg na dan (1 μg/kg na dan) uz postupno povećanje do najviše 0,4 MU/kg na dan (4 μg/kg na dan) sve dok se ne postigne normalni broj neutrofila koji se može i održati (ANC &gt; 2,0 x 109/l).
The recommended starting dose of Grastofil is 0.1 MU/kg/day (1 micrograms/kg/day) with titration up to a maximum of 0.4 MU/kg/day (4 micrograms/kg/day) until a normal neutrophil count is reached and can be maintained (ANC &gt; 2.0 x 109/L).
Preporučena početna doza Grastofila je 0,1 MU/kg/dan (1 mikrograma/kg/dan) uz titraciju do najviše 0,4 MU/kg/dan (4 mikrograma/kg/dan) dok se ne postigne normalan broj neutrofila koji je moguće održati (ABN &gt; 2,0 x 109/l).
The recommended starting dose of Jakavi in myelofibrosis is 15 mg twice daily for patients with a platelet count between 100,000/mm3 and 200,000/mm3 and 20 mg twice daily for patients with a platelet count of &gt; 200,000/mm3.
Preporučena početna doza Jakavija za mijelofibrozu je 15 mg dvaput na dan za bolesnike s brojem trombocita između 100 000/mm3 i 200 000/mm3, te 20 mg dvaput na dan za bolesnike s brojem trombocita od &gt; 200 000/mm3.
The recommended starting dose of Renvela tablets for adults and older people ( &gt; 65 years) is one to two tablets of 800 mg with each meal, 3 times a day.
Preporučena početna doza Renvela tableta za odrasle i starije osobe ( &gt; 65 godina) je jedna do dvije tablete od 800 mg uz svaki obrok 3 puta na dan.
The recommended starting dose of Sevelamer carbonate Zentiva tablets for adults and older people ( &gt; 65 years) is one to two tablets of 800 mg with each meal, 3 times a day.
Preporučena početna doza Sevelamer carbonate Zentiva tableta za odrasle i starije osobe ( &gt; 65 godina) je jedna do dvije tablete od 800 mg uz svaki obrok 3 puta na dan.
The recommended starting dose of Tasermity for adults and the elderly ( &gt; 65 years) is one or two tablets with each meal 3 times a day.
Preporučena početna doza lijeka Tasermity za odrasle i starije osobe ( &gt; 65 godina) je jedna do dvije tablete uz svaki obrok 3 puta na dan.
The recommended weight-based paediatric dose is dependent upon the patient’s age, with different recommended doses for children from 3 to &lt; 8 years of age and children 8 years or older.
Preporučena pedijatrijska doza na osnovi težine ovisi o dobi bolesnika, s različitim preporučenim dozama za djecu od 3 do &lt; 8 godina starosti i djecu od 8 i više godina starosti.
The reduction in B-CAP and C-CAP was greatest in children &lt; 36 months of age (vaccine efficacy of 20.6% (95% CI: 6.5; 32.6) and 24.2% (95% CI: 7.4; 38.0) respectively).
Smanjenje pojave B-CAP odnosno C-CAP bilo je najveće u djece u dobi &lt; 36 mjeseci (djelotvornost cjepiva iznosila je 20,6% (95% CI: 6,5; 32,6) odnosno 24,2% (95% CI: 7,4; 38,0)).
The reduction in diastolic blood pressure &lt; 90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3 % of patients respectively.
Sniženje dijastoličkog krvnog tlaka &lt; 90 mmHg bilo je postignuto kod 71,6%, 74,8%, 82,1%, 85,3% bolesnika, po istom redoslijedu.
The reduction in diastolic blood pressure &lt; 90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3% of patients respectively.
Sniženje dijastoličkog krvnog tlaka &lt; 90 mmHg bilo je postignuto kod 71,6%, 74,8%, 82,1%, 85,3% bolesnika, po istom redoslijedu.
The reductions in HbA1c and superiority vs sitagliptin observed after 26 weeks of liraglutide treatment (1.2 mg and 1.8 mg) were sustained after 52 weeks of treatment (­1.29% and ­1.51% vs ­0.88%, p0.0001).
Smanjenje HbA1c i superiornost naspram sitagliptina opažena nakon 26 tjedana liječenja liraglutidom (1,2 mg i 1,8 mg) zadržala se i nakon 52 tjedna liječenja (-1,29% i -1,51% naspram -0,88%, p &lt; 0,0001).
The regimen 3 mg/kg/day during 6 months (selected at the end of the phase II part of the study) presented 60.4% of success versus 3.6% in the placebo arm (p value &lt; 0.0001).
Režim 3 mg/kg/dnevno tijekom 6 mjeseci (odabran na kraju II faze studije) pokazao je 60,4% uspješnosti u odnosu na 3,6% uspješnosti na placebu studije (p-vrijednost &lt; 0,0001).
The relative contribution of the inhibitors to inactivation of reteplase decreases as follows: C1-inactivator &gt; 2- antiplasmin &gt; 2-antitrypsin.
Relativni udio inhibitora u inaktivaciji reteplaze smanjuje se na sljedeći način: C1-inaktivator &gt; 2- antiplazmin &gt; 2-antitripsin.
The renal excretion of verteporfin and its metabolite is minimal ( &lt; 1% of the verteporfin dose) and thus, clinically significant changes in verteporfin exposure in patients with renal impairment are unlikely.
Izlučivanje verteporfina i njegovih metabolita putem bubrega je minimalno ( &lt; 1% doze verteporfina) te stoga klinički značajne promjene u izloženosti verteporfinu u bolesnika s oštećenjem bubrega nisu vjerojatne.
The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations ( &lt; 1%).
Prijavljeni događaji bili su uglavnom prolazni, blagog do umjerenog intenziteta, i zbog njih je liječenje prekinulo svega nekoliko bolesnika ( &lt; 1%).
The reported incidence of life-threatening (grade 4) cases was &lt; 1%.
Zabilježena incidencija životno opasnih slučajeva (stupanj 4) bila je &lt; 1%.
The reporting rate is classified as very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
Učestalost prijavljivanja definirana je kao vrlo često (≥ 1/10), često (≥ 1/100 do &lt; 1/10), manje često (≥ 1/1000 do &lt; 1/100), rijetko (≥ 1/10 000 do &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The reporting rate is classified as very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated form the available data).
Stopa prijavljivanja definirana je kao vrlo često (≥ 1/10), često (≥ 1/100 i &lt; 1/10), manje često (≥ 1/1000 i &lt; 1/100), rijetko (≥ 1/10 000 i &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
The reporting rate is classified as very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Stopa prijavljivanja definirana je kao vrlo često (≥ 1/10), često (≥ 1/100 i &lt; 1/10), manje često (≥ 1/1000 i &lt; 1/100), rijetko (≥ 1/10 000 i &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
The respective odds ratios were 2.92 (p=0.0087), 4.32 (p=0.0004) and 5.75 (p &lt; 0.0001).
Odgovarajući omjeri vjerojatnosti bili su 2,92 (p = 0,0087), 4,32 (p = 0,0004) i 5,75 (p &lt; 0,0001).
The respective odds ratios were 2.92 (p=0.0087), 4.32 (p=0.0004) and 5.75 (p &lt; 0.0001).
Odgovarajući omjeri šansi bili su 2,92 (p = 0,0087), 4,32 (p = 0,0004) i 5,75 (p &lt; 0,0001).
The response rate (confirmed undetectable viral load &lt; 50 HIV-1 RNA copies/ml) at week 96 was comparable between the rilpivirine arm and the efavirenz arm.
Stopa odgovora (potvrđeno nemjerljivo virusno opterećenje &lt; 50 HIV-1 RNA kopija/ml) u 96. tjednu bila je usporediva između skupine liječene rilpivirinom i skupine liječene efavirenzom.
The response rate in the 0.1% tacrolimus group (71.6%) was significantly higher than that in the topical corticosteroid based treatment group (50.8%; p &lt; 0.001; Table 1).
Stopa odgovora u skupini koja je primala 0,1% takrolimusa (71,6%) bila je značajno viša od onog u skupini koja je primala liječenje na temelju topikalnih kortikosteroida (50,8%; p &lt; 0,001; Tablica 1).
The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA &lt; 400 copies/ml at 48 weeks was 60 % (95 %, C.I. 47, 72), and 53 % (C.I. 40, 66) based on percentage of patients with plasma HIV-RNA &lt; 50 copies/ml.
Stopa ispitanika koji su odgovorili na liječenje, prema NC=F analizi postotka bolesnika koji su imali &lt; 400 HIV-RNK kopija/ml plazme nakon 48 tjedana, bila je 60% (95%, C.I. 47, 72) te 53% (C.I. 40, 66), izračunato prema postotku bolesnika s &lt; 50 HIV-RNK kopija/ml plazme.
The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p &lt; 0.001).
Stope odgovora za sposobnost postizanja odnosno održavanja erekcije bile su 76% odnosno 59% uz vardenafil u usporedbi s 41% odnosno 22% uz placebo u bolesnika koji su dovršili tri mjeseca liječenja, a što je bilo klinički i statistički značajno (p &lt; 0,001).
The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p &lt; 0.001).
Stope odgovora za sposobnost postizanja odnosno održavanja erekcije bile su 76% odnosno 59% uz vardenafil u usporedbi s 41% odnosno 22% uz placebo u bolesnika koji su dovršili tri mjeseca liječenja, što je bilo klinički i statistički značajno (p &lt; 0,001).
The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p &lt; 0.001).
Stope odgovora za sposobnost postizanja odnosno održavanja erekcije bile su 76% odnosno 59% uz vardenafil u usporedbi s 41% odnosno 22% uz placebo u bolesnika koji su dovršili tri mjeseca liječenja, što je bio klinički i statistički značajan (p &lt; 0,001).
The response rates observed for patients ≥ 65 years of age were similar to that of patients &lt; 65 years of age, across treatment groups.
Stope odgovora opažene za bolesnike u dobi ≥ 65 godina bile su slične onima u bolesnika u dobi &lt; 65 godina u svim terapijskim skupinama.
The results from both clinical studies demonstrated that Mirvaso was significantly more effective (p &lt; 0.001) in the reduction of facial erythema of rosacea than vehicle gel when applied once daily for 29 days (primary endpoint, see Table 2).
Rezultati oba klinička ispitivanja pokazali su da je Mirvaso značajno učinkovitiji (p &lt; 0,001) u smanjenju eritema lica uzrokovanog rozacejom nego podloga gela kada se primjenjuje jednom dnevno tijekom 29 dana (primarni ishod, vidjeti Tablicu 2.).
The results indicate that as renal function decreases ( &lt; 50 mL/min), the total lenalidomide clearance decreases proportionally resulting in an increase in AUC.
Rezultati pokazuju da se ukupni klirens lenalidomida smanjuje proporcionalno smanjenju bubrežne funkcije ( &lt; 50 mL/min), što rezultira porastom u AUC-u.
The results of summary of PID at 60 minutes (SPID0-60) showed that all strengths of Instanyl had significantly higher mean SPID0-60 scores compared with placebo (p0.001) demonstrating better pain relief of Instanyl compared to placebo during 60 minutes.
Rezultati sumarne RIB nakon 60 minuta (SRIB0-60) pokazuju da sve jačine Instanyla imaju značajno višu srednju SRIB0-60 u usporedbi s placebom (p &lt; 0,001), ukazujući na bolju kontrolu boli Instanylom u usporedbi s placebom tijekom 60 minuta.
The results of these simulations indicate that at least 95% of patients will reach concentrations that are &lt; 1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Rezultati tih simulacija pokazuju da će najmanje 95% bolesnika postići koncentracije &lt; 1 µg/ml (približno 3% vrijednosti Cmin,ss predviđene za populaciju ili ispiranje od približno 97%) do 7. mjeseca.
The results of these simulations indicate that at least 95% of patients will reach concentrations that are &lt; 1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Rezultati tih simulacija ukazuju da će najmanje 95% bolesnika postići koncentracije &lt; 1 µg/ml (približno 3% vrijednosti Cmin,ss predviđene za populaciju ili ispiranje od približno 97%) do 7. mjeseca.
The results of this multicentre, double-blind, randomised trial showed that tacrolimus ointment, 0.03% and 0.1%, is significantly more effective (p &lt; 0.001 for both) than 1% hydrocortisone acetate ointment (Table 2).
Rezultati ovog multicentričnog, dvostruko slijepog, randomiziranog ispitivanja pokazali su da je takrolimus mast, kako od 0,03% tako i od 0,1%, značajno djelotvornija (p &lt; 0,001 za obje jačine) nego mast s 1% hidrokortizon acetata (Tablica 2).
The results of this study demonstrated that daily dosing with 10 or 20 mg/kg/day of Kuvan plus phenylalanine -restricted diet led to statistically significant improvements in dietary phenylalanine tolerance compared with dietary phenylalanine restriction alone while maintaining blood phenylalanine levels within the target range (≥120 to &lt; 360 µmol/l).
Rezultati ovog ispitivanja pokazali su da je svakodnevno davanje Kuvana u dozi od 10 ili 20 mg/kg na dan uz prehranu siromašnu fenilalaninom dovelo do statistički značajnog poboljšanja u toleranciji na fenilalanin unesen hranom u usporedbi sa samo prehranom siromašnom fenilalaninom, pri čemu je koncentracija fenilalanina u krvi bila održana unutar ciljnog raspona (od ≥120 do &lt; 360 µmol/l).
The results of this study demonstrated that sunitinib had an effect on QTc interval (defined as a mean placebo-adjusted change of &gt; 10 msec with a 90% CI upper limit &gt; 15 msec) at therapeutic concentration (Day 3) using the within-day baseline correction method, and at greater than therapeutic concentration (Day 9) using both baseline correction methods.
Rezultati tog ispitivanja pokazali su da sunitinib ima učinak na QTc-interval (definiran kao prosječna, za placebo korigirana promjena od &gt; 10 msek, uz gornju granicu 90%-tnog intervala pouzdanosti od &gt; 15 msek); utjecaj se iskazuje pri terapijskoj koncentraciji (3. dana) uz primjenu unutardnevne metode korekcije u odnosu na početne vrijednosti te pri koncentraciji većoj od terapijske (9. dana) uz primjenu obje metode korekcije u odnosu na početne vrijednosti.
The retigabine AUC was increased by approximately 50% in volunteers with moderate hepatic impairment (Child-Pugh score 7 to 9) and by approximately 100% in volunteers with severe hepatic impairment (Child-Pugh score &gt; 9), relative to healthy volunteers.
U usporedbi sa zdravim dobrovoljcima, AUC retigabina je bio povišen za oko 50% u dobrovoljaca s umjerenim oštećenjem jetre (Child-Pugh zbroj bodova 7 do 9) te za oko 100% u dobrovoljaca s teškim oštećenjem jetre (Child-Pugh zbroj bodova &gt; 9).
The retigabine AUC was increased by approximately 50% in volunteers with moderate hepatic impairment (Child-Pugh score 7 to 9) and by approximately 100% in volunteers with severe hepatic impairment (Child-Pugh score &gt; 9), relative to healthy volunteers.
U usporedbi sa zdravim dobrovoljcima, AUC retigabina je bio povišen za oko 50% u dobrovoljaca s umjerenim oštećenjem jetre (Child-Pugh zbroj bodova 7 do 9), te za oko 100% u dobrovoljaca s teškim oštećenjem jetre (Child-Pugh zbroj bodova &gt; 9).
The REYATAZ/ritonavir arm showed similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA &lt; 50 copies/ml at week 48 (Table 5).
U skupini koja je primala REYATAZ/ritonavir utvrđena je antivirusna djelotvornost slična (neinferiorna) onoj u skupini koja je primala lopinavir/ritonavir, što je procijenjeno na temelju udjela bolesnika s HIV RNK &lt; 50 kopija/ml u 48. tjednu (tablica 5).
The risk of hepatic damage in patients with severely reduced renal function (i.e. eGFR &lt; 20) may be increased; these patients should be carefully monitored for hepatic toxicity.
Rizik od oštećenja jetre u bolesnika s jako smanjenom bubrežnom funkcijom (tj. eGFR &lt; 20) može biti povećan; ove bolesnike treba pažljivo nadzirati zbog pojave hepatotoksičnosti.
The robustness and consistency of the primary analysis were supported by the: change in primary SEGA volume as per local investigator assessment (p &lt; 0.001), with 75.0% and 39.3% of patients experiencing reductions of ≥30% and ≥50%, respectively change in total SEGA volume as per independent central review (p &lt; 0.001) or local investigator assessment (p &lt; 0.001).
Robustnost i dosljednost primarne analize bili su potkrijepljeni: promjenom u primarnom volumenu SEGA-e prema procjeni lokalnog ispitivača (p &lt; 0,001), pri čemu je u 75,0% bolesnika došlo do smanjenja ≥30%, a u 39,3% bolesnika došlo je do smanjenja ≥50% promjenom u ukupnom volumenu SEGA-e prema neovisnom centralnom očitanju (p &lt; 0,001) ili prema procjeni lokalnog ispitivača (p &lt; 0,001).
The safety and appropriate dose of Sovaldi have not been established in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] &lt; 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Sigurnost i odgovarajuća doza Sovaldija nisu ustanovljene u bolesnika s teškim oštećenjem bubrega (procjena brzine glomerularne filtracije [eGFR] &lt; 30 ml/min/1,73 m2) ili završnim stadijem bolesti bubrega koje zahtijeva hemodijalizu (vidjeti dio 5.2).
The safety and efficacy have not been established in patients with moderate or severe renal impairment (CrCl &lt; 50 ml/min) or in patients on haemodialysis.
Djelotvornost i sigurnost primjene u bolesnika s umjerenim do teškim oštećenjem funkcije bubrega (CrCl &lt; 50 ml/min) ili u bolesnika na hemodijalizi nije utvrđena.
The safety and efficacy of ATryn in children and adolescents ( &lt; 18 years) have not been established.
Sigurnost i djelotvornost lijeka ATryn u djece i adolescenata ( &lt; 18 godina) nisu ustanovljene.