natgillin/translations-raw huggingface dataset:
Statistically greater proportions of patients achieved blood pressure control ( &lt; 140/90 mmHg) with Copalia HCT (71%) compared to each of the three dual combination therapies (45-54%) (p &lt; 0.0001).
Statistički veći udjeli bolesnika postigli su kontrolu krvnog tlaka ( &lt; 140/90 mmHg) s Copalia HCT-om (71%) u usporedbi s primjenom bilo koje od tri dvojne kombinacijske terapije (45-54%) (p &lt; 0,0001).
Statistically greater proportions of patients achieved blood pressure control ( &lt; 140/90 mmHg) with Dafiro HCT (71%) compared to each of the three dual combination therapies (45-54%) (p &lt; 0.0001).
Statistički veći udjeli bolesnika postigli su kontrolu krvnog tlaka ( &lt; 140/90 mmHg) s Dafiro HCT-om (71%) u usporedbi s primjenom bilo koje od tri dvojne kombinacijske terapije (45-54%) (p &lt; 0,0001).
Statistically significant (p &lt; 0.001) changes from baseline HbA1c relative to placebo of -0.57% and -0.70% were observed for 100 mg and 300 mg, respectively (see sections 4.2 and 4.8).
Statistički značajne (p &lt; 0,001) promjene početne vrijednosti HbA1c u odnosu na placebo od -0,57% i -0,70% uočene su uz 100 mg odnosno 300 mg (vidjeti dijelove 4.2 i 4.8).
Statistically significant (p &lt; 0.001) changes from baseline HbA1c relative to placebo of -0.57% and -0.70% were observed for 100 mg once daily and 300 mg once daily, respectively (see sections 4.2 and 4.8).
Statistički značajne (p &lt; 0,001) promjene početne vrijednosti HbA1c u odnosu na placebo od -0,57% i -0,70% uočene su uz 100 mg jedanput na dan odnosno 300 mg jedanput na dan (vidjeti dijelove 4.2 i 4.8).
Statistically significant differences are marked (*p &lt; 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Označene su statistički značajne razlike (*p &lt; 0,05) između dva liječenja (4 mg zoledronatne kiseline nasuprot placebu)
Statistically significant differences are marked (*p &lt; 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Označene su statistički značajne razlike (*p &lt; 0,05) između dvije terapije (zoledronatna kiselina u dozi od 4 mg nasuprot placebu)
Statistically significant differences are marked (*p &lt; 0.05) for between treatment comparisons (zoledronic acid versus placebo)
Označene su statistički značajne razlike (*p &lt; 0,05) između dvije terapije (4 mg zoledronatne kiseline nasuprot placebu)
Statistically significant differences are marked (*p &lt; 0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Označene su statistički značajne razlike (*p &lt; 0,05) između dva liječenja (4 mg zoledronatne kiseline nasuprot placebu)
Statistically significant differences are marked (*p &lt; 0.05) for between treatment comparisons (4 mg zoledronic acid vs. placebo)
Označene su statistički značajne razlike (*p &lt; 0,05) između dvije terapije usporedbe (4 mg zoledronatne kiseline naspram placeba)
Statistically significant differences are marked (*p &lt; 0.05) for between treatment comparisons (zoledronic acid versus placebo)
Označene su statistički značajne razlike (*p &lt; 0,05) između dvije terapije (zoledronatne kiseline nasuprot placebu)
Statistically significant differences from placebo (p &lt; 0.05) were observed for improvements in the total signs and symptoms score for all dose groups compared to placebo.
Statistički značajne razlike u odnosu na placebo (p &lt; 0,05) opažene su u vidu poboljšanja ukupnog broja bodova za simptome i znakove u svim doznim skupinama u usporedbi s placebom.
Statistically significant improvements in haemoglobin levels were observed with tocilizumab compared with DMARDs (p &lt; 0.0001) at week 24.
U 24. tjednu opaženo je statistički značajno poboljšanje u vrijednostima hemoglobina kod bolesnika liječenih tocilizumabom u usporedbi s bolesnicima liječenima DMARD lijekovima (p &lt; 0,0001).
Statistically significant increases in femoral neck BMD and total hip BMD (p &lt; 0,001) were observed after 12 months.
Nakon 12 mjeseci uočeno je statistički značajno povećanje BMD-a vrata bedrene kosti i ukupnog BMD-a kuka (p &lt; 0,001).
Statistically significant responses in DAS28 were also observed at weeks 14 and 24 (p &lt; 0.05).
U 14. i 24. tjednu bili su primijećeni i statistički značajni odgovori DAS28 (p &lt; 0,05).
Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to &lt; 18 years) with body weight ≥ 35 kg and in 23 HIV- 1 infected children aged 2 to &lt; 12 years.
Farmakokinetika tenofovira u stanju dinamičke ravnoteže ocjenjivala se u 8 adolescentnih bolesnika zaraženih virusom HIV-1 (u dobi od 12 do &lt; 18 godina) tjelesne težine ≥ 35 kg te 23 djece zaražene virusom HIV-1 u dobi od 2 do &lt; 12 godina.
Steady-state systemic exposure in adolescent patients of bodyweight &gt; 55 kg, as assessed by AUC (0-24), was comparable to that noted for the same doses in the adult population.
Sustavna izloženost u stanju dinamičke ravnoteže u adolescenata tjelesne težine &gt; 55 kg, procijenjena na temelju AUC(0-24), bila je usporediva s izloženošću u odraslih ispitanika kod primjene iste doze.
Stevens-Johnson Syndrome (rare; &lt; 0.1%) and toxic epidermal necrolysis (very rare; &lt; 0.01%) have been reported during clinical development with INTELENCE.
Stevens-Johnsonov sindrom ( rijetko &lt; 0,1%) i toksična epidermalna nekroliza (vrlo rijetko &lt; 0,01%) su prijavljeni tijekom kliničkog razvoja INTELENCEa.
STOCRIN has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts &lt; 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens.
STOCRIN nije adekvatno ispitan u bolesnika s uznapredovalom HIV bolešću odnosno u bolesnika s &lt; 50 CD4 stanica/mm3, ili u onih u kojih nije uspjelo liječenje protokolima s inhibitorom proteaze (IP).
STOCRIN has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts &lt; 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens.
STOCRIN nije adekvatno ispitan u bolesnika s uznapredovalom HIV bolešću, odnosno u bolesnika s &lt; 50 CD4 stanica/mm3, ili u onih u kojih nije uspjelo liječenje protokolima s inhibitorom proteaze (IP).
Storage, Use, Handling &amp; Disposal of Topotecan Hospira Storage
Čuvanje, upotreba, rukovanje i odlaganje Topotecana Hospira Čuvanje
Streptococcus A,B,C,G: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
Streptococcus A,B,C,G: S ≤ 0,5 mg/l i R &gt; 0,5 mg/l
Streptococcus pneumoniae: S ≤ 0.5 mg/L and R &gt; 0.5 mg/L
Streptococcus pneumoniae: S ≤0,5 mg/l i R &gt; 0,5 mg/l
Streptococcus spp. other than S. pneumoniae S  0.25 mg/L and R  0.5 mg/L
Streptococcus spp., s iznimkom S. pneumoniae S 0,25 mg/l i R &gt; 0,5 mg/l
Stribild met the non-inferiority criteria in achieving HIV-1 RNA &lt; 50 copies/mL when compared to efavirenz/emtricitabine/tenofovir disoproxil fumarate and when compared to atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate.
U usporedbi sa skupinom efavirenz / emtricitabin / tenofovirdizoproksilfumarat i skupinom atazanavir/ritonavir + emtricitabin / tenofovirdizoproksilfumarat, Stribild je ispunio kriterije neinferiornosti u postizanju vrijednosti HIV-1 RNK &lt; 50 kopija/ml.
Stribild should not be initiated in patients with creatinine clearance &lt; 70 mL/min.
Stribild se ne smije započeti u pacijenata s klirensom kreatinina &lt; 70 ml/min.
Strimvelis is not intended for use in patients &gt; 65 years of age, and has not been studied in this age group.
Strimvelis nije namijenjen za primjenu u bolesnika u dobi od &gt; 65 godina i nije se ispitivao u toj dobnoj skupini.
Stronghold 15 mg spot-on for cats and dogs &lt; 2.5 kg Stronghold 30 mg spot-on for dogs 2.6–5.0 kg Stronghold 45 mg spot-on for cats 2.6–7.5 kg Stronghold 60 mg spot-on for cats 7.6–10.0 kg Stronghold 60 mg spot-on for dogs 5.1–10.0 kg Stronghold 120 mg spot-on for dogs 10.1–20.0 kg Stronghold 240 mg spot-on for dogs 20.1–40.0 kg Stronghold 360 mg spot-on for dogs 40.1–60.0 kg
Stronghold 15 mg otopina za nakapavanje na kožu za mačke i pse ≤ 2,5 kg Stronghold 30 mg otopina za nakapavanje na kožu za pse 2,6 – 5,0 kg Stronghold 45 mg otopina za nakapavanje na kožu za mačke 2,6 – 7,5kg Stronghold 60 mg otopina za nakapavanje na kožu za mačke 7,6 – 10,0 kg Stronghold 60 mg otopina za nakapavanje na kožu za pse 5,1 – 10,0 kg Stronghold 120 mg otopina za nakapavanje na kožu za pse 10,1 – 20,0 kg Stronghold 240 mg otopina za nakapavanje na kožu za pse 20,1 – 40,0 kg Stronghold 360 mg otopina za nakapavanje na kožu za pse 40,1 – 60,0 kg
Stronghold 15 mg spot-on solution for cats and dogs &lt; 2.5 kg Selamectin
Stronghold 15 mg otopina za nakapavanje na kožu za mačke i pse &lt; 2,5 kg Selamektin
Stronghold 15 mg spot-on solution for cats and dogs &lt; 2.5 kg Stronghold 30 mg spot-on solution for dogs 2.6–5.0 kg Stronghold 45 mg spot-on solution for cats 2.6–7.5 kg Stronghold 60 mg spot-on solution for cats 7.6–10.0 kg Stronghold 60 mg spot-on solution for dogs 5.1–10.0 kg Stronghold 120 mg spot-on solution for dogs 10.1–20.0 kg Stronghold 240 mg spot-on solution for dogs 20.1–40.0 kg Stronghold 360 mg spot-on solution for dogs 40.1–60.0 kg
Stronghold 15 mg otopina za nakapavanje na kožu za mačke i pse ≤ 2,5 kg Stronghold 30 mg otopina za nakapavanje na kožu za pse 2,6 – 5,0 kg Stronghold 45 mg otopina za nakapavanje na kožu za mačke 2,6 – 7,5kg Stronghold 60 mg otopina za nakapavanje na kožu za mačke 7,6 – 10,0 kg Stronghold 60 mg otopina za nakapavanje na kožu za pse 5,1 – 10,0 kg Stronghold 120 mg otopina za nakapavanje na kožu za pse 10,1 – 20,0 kg Stronghold 240 mg otopina za nakapavanje na kožu za pse 20,1 – 40,0 kg Stronghold 360 mg otopina za nakapavanje na kožu za pse 40,1 – 60,0 kg
Studies in rats indicated that &gt; 90% of the administered PEG was eliminated in 3 months following a single dose, with the urine being the main route of excretion.
Ispitivanja u štakora pokazala su da se &gt; 90% jednokratno primijenjenog PEG-a eliminira unutar 3 mjeseca mokraćom, koja je i glavni put izlučivanja.
Studies including patients with renal insufficiency (creatinine clearance &lt; 30 ml/min for the monotherapy, and &lt; 60 ml/min for the combination regimen) have not been conducted and therefore Yondelis must not be used in this patient population (see section 4.4).
Ispitivanja koja obuhvaćaju bolesnike s bubrežnom insuficijencijom (klirens kreatinina &lt; 30 ml/min za monoterapiju i &lt; 60 ml/min za kombinirani režim) nisu provedena i stoga se Yondelis ne smije primjenjivati u toj populaciji bolesnika (vidjeti dio 4.4).
Studies using systemic administration of levofloxacin show that the pharmacokinetics of levofloxacin are affected by renal impairment; with decreasing renal function (estimated creatinine clearance &lt; 50 ml/min), renal elimination and clearance are decreased, and elimination half-life increased.
Ispitivanja u kojima se koristila sistemska primjena levofloksacina pokazala su da oštećenje bubrega utječe na farmakokinetiku levofloksacina; smanjenjem bubrežne funkcije (procijenjen klirens kreatinina &lt; 50 ml/min), bubrežna eliminacija i klirens se smanjuju a poluvijek eliminacije produljuje.
Study 2 shows that 37% of the patients treated with linaclotide compared with 19% of the patients treated with placebo showed response to IBS degree of relief (p &lt; 0.0001) and 55% of the patients treated with linaclotide compared with 42% of the patients treated with placebo showed response to abdominal pain/discomfort (p=0.0002).
Ispitivanje 2 je pokazalo da je 37% bolesnika liječenih linaklotidom u usporedbi s 19% bolesnika liječenih placebom pokazalo odgovor s obzirom na stupanj olakšanja IBS-a (p &lt; 0,0001), dok je 55% bolesnika liječenih linaklotidom u usporedbi s 42% bolesnika liječenih placebom pokazalo odgovor s obzirom na bolove/nelagodu u abdomenu (p= 0,0002).
Study AIT07 was a multicentre, open-label, randomised, phase II/III study that included 128 patients (1 to &lt; 18 years) treated with imatinib in combination with chemotherapy.
Ispitivanje AIT07 bilo je multicentrično, otvoreno, randomizirano ispitivanje faze II/III u kojem je sudjelovalo 128 bolesnika (od 1 do &lt; 18 godina) liječenih imatinibom u kombinaciji s kemoterapijom.
Study RO-2455-404-RD was a one year study in COPD patients with a baseline (pre-bronchodilator) FEV1 &lt; 50% of predicted normal and a history of frequent exacerbations.
Ispitivanje RO-2455-404-RD bilo je jednogodišnje ispitivanje u bolesnika s KOPB-om s početnim (predbronhodilatacijski) FEV1 &lt; 50% od predviđene normalne vrijednosti i učestalim egzacerbacijama u anamnezi.
Study SC-I was a randomized, double-blind, double-dummy non- inferiority study administered to patients stratified by body weight ( &lt; 60 kg, 60 to 100 kg, &gt; 100 kg) that compared the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis (RA), receiving background methotrexate (MTX), and experiencing an inadequate response to MTX (MTX-IR).
Ispitivanje SC-I bilo je randomizirano, dvostruko slijepo, dvostruko maskirano ispitivanje neinferiornosti u bolesnika stratificiranih prema tjelesnoj težini ( &lt; 60 kg, 60 do 100 kg, &gt; 100 kg), u kojemu se uspoređivala djelotvornost i sigurnost abatacepta primijenjenog supkutano i intravenski u ispitanika s reumatoidnim artritisom koji su primali osnovnu terapiju metotreksatom (MTX) na koju nisu dovoljno dobro odgovorili (engl. inadequate response to MTX, MTX-IR).
Study UV I Treatment Placebo Adalimumab
Ispitivanje UV I Liječenje Placebo Adalimumab
Study UV II Treatment Placebo Adalimumab
Ispitivanje UV II Liječenje Placebo Adalimumab
Subcutaneous use &lt; SC &gt;
Potkožna primjena &lt; s.c. &gt;
Subcutaneous Xolair or placebo were administered as add-on therapy to &gt; 1,000 micrograms beclomethasone dipropionate (or equivalent) plus a long-acting beta2-agonist.
Supkutani Xolair ili placebo primjenjivani su kao dodatna terapija uz &gt; 1000 mikrograma beklometazon-dipropionata (ili ekvivalenta) s dugodjelujućim beta2-agonistom.
Subgroup analyses for overall survival and progression free survival according to age ( &lt; 65; ≥65), gender, ECOG PS, primary site of disease, time from first diagnosis of metastatic disease, prior anticancer treatment, prior treatment lines for metastatic disease, and KRAS mutation showed a treatment effect favouring the regorafenib regimen over the placebo regimen.
Analize podgrupe na ukupno preživljenje i preživljenje bez progresije bolesti prema dobi ( &lt; 65; ≥65), spolu, ECOG PS, primarnom mjestu bolesti, vremenu od postavljanja dijagnoze metastatske bolesti, prethodnom antineoplastičnom liječenju, prethodnoj liniji liječenja metastatske bolesti i KRAS mutaciji, pokazale su prednost učinka liječenja regorafenibom u odnosu na placebo.
Subgroup analysis also showed that 29% of obese women (BMI ≥ 30) and 43% of normal weight women (BMI &lt; 30) showed a marked or better improvement.
Analiza podskupina pokazala je također da je 29% pretilih žena (indeks tjelesne mase ≥ 30) i 43% žena normalne težine (indeks tjelesne mase &lt; 30) pokazalo znatno poboljšanje ili čak bolje od toga.
Subjects (%) achieving: HbA1c &lt; 7%
Ispitanici (%) koji postižu: HbA1c &lt; 7
Subjects (%) achieving: HbA1c &lt; 7%
Ispitanici (%) koji su postigli: HbA1c &lt; 7
Subjects (%) achieving: HbA1c &lt; 7%
Ispitanici (%) u kojih je postignut: HbA1c &lt; 7
Subjects (%) achieving: HbA1c &lt; 7%
Ispitanici (%) u kojih je: HbA1c &lt; 7
Subjects (%) achieving: HbA1c &lt; 7% (LOCF)d
Ispitanici (%) u kojih je: HbA1c &lt; 7% (LOCF)d
Subjects &lt; 40 kg
Osobe &lt; 40 kg
Subjects must have been naïve to tenofovir disoproxil fumarate, but could have received interferon based regimens ( &gt; 6 months prior to screening) or any other non-tenofovir disoproxil fumarate containing oral anti-HBV nucleoside/nucleotide therapy ( &gt; 16 weeks prior to screening).
Ispitanici nisu smjeli biti prethodno liječeni tenofovirdizoproksilfumaratom, ali su mogli primati režime na bazi interferona ( &gt; 6 mjeseci prije probira) ili neku drugu peroralnu terapiju nukleozidima/nukleotidima za HBV koja nije sadržavala tenofovirdizoproksilfumarat ( &gt; 16 tjedana prije probira).
Subjects received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for subjects weighing &lt; 75 kg or 1,200 mg for subjects weighing ≥75 kg).
Ispitanici su primali 400 mg sofosbuvira i ribavirin na temelju tjelesne težine (1000 mg za ispitanike tjelesne težine &lt; 75 kg ili 1200 mg za ispitanike tjelesne težine ≥ 75 kg).
Subjects were diagnosed with chronic ITP for at least 1 year and were refractory or relapsed to at least one prior ITP therapy or unable to continue other ITP treatments for a medical reason and had platelet count &lt; 30,000/µl.
Ispitanicima je dijagnosticiran kronični ITP najmanje 1 godinu i bili su refraktorni ili imali relaps na najmanje jednoj prethodnoj terapiji za ITP ili nisu mogli nastaviti druge terapije za ITP iz medicinskog razloga te su imali broj trombocita &lt; 30 000/µl.
Subjects were either not on antiretroviral therapy with a CD4+ cell count &gt; 500 cells/mm3 or had virologically suppressed HIV-1 with a CD4+ cell count &gt; 200 cells/mm3.
Ispitanici ili nisu primali antiretrovirusnu terapiju i imali su broj CD4+ stanica &gt; 500 stanica/mm3 ili su imali virološki potisnut HIV-1 i broj CD4+ stanica &gt; 200 stanica/mm3.
Subjects were grouped according to baseline creatinine clearance ( &gt; 80 ml/min as normal function; 50-80 ml/min as mild impairment; 30-49 ml/min as moderate impairment;
Ispitanici su bili grupirani prema početnom klirensu kreatinina (normalna funkcija pri &gt; 80 ml/min, blago oštećenje pri 50-80 ml/min, umjereno oštećenje pri
Subjects were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level ( &lt; 6 log10 IU/mL versus ≥6 log10 IU/mL).
Ispitanici su bili randomizirani u omjeru 1:1 i stratificirani prema cirozi (prisutna naspram odsutna), genotipu HCV-a (2 naspram 3) i početnoj razini HCV RNK ( &lt; 6 log10 IU/ml naspram ≥ 6 log10 IU/ml).
Subjects were randomized in a 2:1 ratio and stratified based on cirrhosis/fibrosis and baseline HCV-RNA ( &lt; 800,000 IU/mL vs. ≥ 800,000 IU/mL).
Ispitanici su randomizirani u omjeru 2:1 i stratificirani na temelju ciroze/fibroze i početne vrijednosti HCV-RNK ( &lt; 800 000 IU/ml naspram ≥ 800 000 IU/ml).
Subjects were stratified by lactate dehydrogenase (LDH) level ( &gt; the upper limit of normal (ULN) versus ≤ULN) and BRAF mutation (V600E versus V600K).
Ispitanici su bili stratificirani prema razini laktat dehidrogenaze (LDH) ( &gt; gornje granice normale (GGN) naspram  GGN) i BRAF mutaciji (V600E naspram V600K).
Subjects were stratified by lactate dehydrogenase (LDH) level ( &gt; the upper limit of normal (ULN) versus ULN) and BRAF mutation (V600E versus V600K).
Ispitanici su bili stratificirani prema razini laktat dehidrogenaze (LDH) ( &gt; gornje granice normale (GGN) naspram  GGN) i BRAF mutaciji (V600E naspram V600K).
Subjects who had been in the placebo group in the short-term study were randomly reassigned to sildenafil treatment; subjects weighing ≤ 20 kg entered the medium or high dose groups (1:1), while subjects weighing &gt; 20 kg entered the low, medium or high dose groups (1:1:1).
Ispitanici koji su bili u skupini koja je primala placebo u kratkotrajnom ispitivanju, bili su ponovno randomizirani za liječenje sildenafilom; ispitanici tjelesne težine ≤ 20 kg uključeni su u skupine sa srednjom ili visokom dozom (1:1), a ispitanici tjelesne težine &gt; 20 kg uključeni su u skupine s niskom, srednjom ili visokom dozom (1:1:1).
Subjects with &gt; 1 log10 change from baseline in plasma HIV- 1 RNA
Ispitanici s promjenom HIV-1 RNK u plazmi &gt; 1 log10 od početnih vrijednosti
Subjects with an eGFR &lt; 30 ml/min/1.73 m2 were excluded from the study.
Iz ovog ispitivanja isključeni su ispitanici s eGFR &lt; 30 ml/min/1,73m2.
Subjects with ESRD (CrCl &lt; 15 ml/min) have not been investigated.
Ispitanici s završnim stadijem bolesti bubrega (CrCl &lt; 15 ml/min) nisu bili ispitivani.
Subjects with severe renal impairment (creatinine clearance &lt; 30mL/min) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with severe renal impairment and healthy volunteers.
U osoba s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 30 ml/min) nisu pronađeni dokazi povećane sistemske izloženosti umeklidinijevu bromidu (Cmax i AUC) niti dokazi promijenjenog vezanja za proteine u ispitanika s teškim oštećenjem bubrežne funkcije u odnosu na zdrave dobrovoljce.
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. &gt;
Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
Substitutions such as D168V or A, and R155K were usually associated with large reductions in susceptibility to simeprevir in vitro (FC in EC50 &gt; 50), whereas other substitutions such as Q80K or R, S122R, and D168E displayed in vitro low level resistance (FC in EC50 between 2 and 50).
Supstitucije poput D168V ili A i R155K bile su obično povezane sa velikim smanjenjima osjetljivosti na simeprevir in vitro (promjena EC50 &gt; 50 puta), dok su druge supstitucije poput Q80K ili R, S122R i D168E pokazale nisku razinu rezistencije in vitro (promjena EC50 između 2 i 50 puta).
Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for &gt; 14 days) and survival with no proven or probable IFI for 180 days after HSCT.
Uspjeh je definiran kao sposobnost nastavljanja profilakse ispitivanim lijekom 100 dana nakon HSCT-a (bez prekida &gt; 14 dana) i preživljenje bez dokazane ili vjerojatne invazivne gljivične infekcije 180 dana nakon HSCT-a.
Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61 % achieved in a study performed in naïve patients with a ribavirin dose &gt; 10.6 mg/kg, p &lt; 0.01).
Bolju djelotvornost pokazala je kombinacija pegiliranog interferona i ribavirina (postignuta je stopa trajnog terapijskog odgovora od 61% u ispitivanju bolesnika koji prethodno nisu bili liječeni, uz ribavirin u dozi od &gt; 10,6 mg/kg, p &lt; 0,01).
Supportive analyses from Study 2 (CAMMS32400507) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (48% reduction, p=0.0121), and significantly fewer relapses that led to steroid treatment (56% reduction, p &lt; 0.0001) or to hospitalization (55 % reduction, p=0.0045) compared to IFNB-1a.
Suportivne analize iz Ispitivanja 2 (CAMMS32400507) pokazale su da je primjena lijeka LEMTRADA u dozi od 12 mg/dan značajno smanjila broja bolesnika liječenih lijekom LEMTRADA u kojih je došlo do ozbiljnih relapsa (smanjenje za 48%, p=0,0121) kao i broj relapsa koji iziskuju liječenje steroidima (smanjenje za 56% p &lt; 0,0001) ili hospitalizaciju (smanjenje za 55%, p=0,0045) u usporedbi s IFNB-1a.
Sustained remission* (DAS28(ESR) &lt; 2.6 at both Week 40 and Week 52)
Održana remisija* (DAS28(ESR) &lt; 2,6 u 40. i 52. tjednu)
Sustained severe lymphopenia ( &lt; 500/mm3), was not observed in clinical studies with Zinbryta.
Trajna teška limfopenija ( &lt; 500/mm3) nije bila opažena u kliničkim ispitivanjima Zinbryte.
SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts &lt; 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens.
SUSTIVA nije adekvatno ispitana u bolesnika s uznapredovalom HIV bolešću, odnosno u bolesnika s brojem CD4 &lt; 50 stanica/mm3 ili u onih u kojih nije uspjelo liječenje protokolima s inhibitorom proteaze (IP).