natgillin/translations-raw huggingface dataset:
The difference in the proportion of patients who maintained &lt; 400 copies/ml at week 48 was mainly influenced by the higher number of discontinuations in the tenofovir disoproxil fumarate treatment group.
Na razliku u udjelu pacijenata u kojih se zadržalo &lt; 400 kopija/ml u 48. tjednu uglavnom je utjecao veći broj prekida liječenja u skupini koja je primala tenofovirdizoproksilfumarat.
The difference was 5.28 points and statistically significant (p &lt; 0.0001).
Razlika je bila 5,28 bodova, što je bilo i statistički značajno (p &lt; 0,0001).
The differences observed were &lt; 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity (see section 4.5).
Opažene razlike bile su &lt; 10% i u većine su ispitanika prijavljene nuspojave bile blagog do umjerenog intenziteta (vidjeti dio 4.5).
The differences were statistically significant (p &lt; 0.001 and p=0.003, respectively).
Razlike su bile statistički značajne (p &lt; 0,001, odnosno p=0,003).
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p &lt; 0.001).
U bolesnika s psorijatičnim artritisom liječenih Enbrelom rezultat indeksa nesposobnosti je bio značajno bolji u svim vremenskim točkama određivanja u odnosu na placebo (p &lt; 0,001).
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p &lt; 0.001).
U bolesnika sa psorijatičnim artritisom liječenih etanerceptom rezultat indeksa nesposobnosti je bio značajno bolji u svim vremenskim točkama određivanja u odnosu na placebo (p &lt; 0,001).
The disease control rate (complete response or partial response or stable disease) was significantly higher in patients treated with Stivarga (41.0% vs.
Stopa kontrole bolesti (potpuni odgovor ili djelomični odgovor ili stabilna bolest) bila je znatno viša u bolesnika liječenih lijekom Stivarga (41,0% naspram 14,9%, p &lt; 0,000001, jednostrana).
the disease to which the product is intended to confer immunity is largely absent from the territory in question.
je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja. &gt;
The doctor has a more complete list of side effects for ProQuad and for the vaccine components for ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. and Varicella Vaccine live (Oka/Merck)).
Liječnik ima potpuniji popis nuspojava cjepiva ProQuad i sastojaka u cjepivu ProQuad (cjepivo protiv morbila, parotitisa i rubele proizvođača Merck &amp; Co., Inc. i živo cjepivo protiv varičele (Oka/Merck)).
The dosage may be increased every 4 weeks by 3 x 20 IU/kg and week if the increase of Hb is not adequate ( &lt; 0.25 g/dl per week).
Doza se može povećavati svaka 4 tjedna za 3 x 20 IU/kg tjel. mase tjedno, ako porast Hb nije zadovoljavajući ( &lt; 0,25 g/dl tjedno).
The dosage should therefore be reduced for patients with a creatinine clearance of &lt; 50 ml/minute.
Dozu stoga treba smanjiti u bolesnika s klirensom kreatinina &lt; 50 ml/minuti.
The dosage should, therefore, be reduced for patients with a creatinine clearance of &lt; 50 ml/minute.
Dozu stoga treba smanjiti u bolesnika s klirensom kreatinina &lt; 50 ml/minuti.
The dose may be increased after 4 weeks to 40 IU/kg, 3 times per week, if the increase in haemoglobin is not adequate ( &lt; 1 g/dl [0.62 mmol/l] within 4 weeks).
Doza se može nakon 4 tjedna povećati na 40 IU/kg, 3 puta tjedno, ako porast hemoglobina nije adekvatan ( &lt; 1 g/dl [0,62 mmol/l] unutar 4 tjedna).
The dose of cabazitaxel should be reduced from 25 mg/m2 to 20 mg/m2 for persistent grade &gt; 2 peripheral neuropathy (see section 4.2).
U slučaju perzistentne periferne neuropatije stupnja ≥ 2 dozu kabazitaksela potrebno je smanjiti s 25 mg/m2 na 20 mg/m2 (vidjeti dio 4.2).
The dose should be raised if there is adequate tolerance and the leucocyte cystine level remains &gt; 1 nmol hemicystine/mg protein.
Dozu treba povećati ako je tolerancija dobra, a razina cistina u leukocitima ostane &gt; 1 nmol hemicistina/mg proteina.
The dose should not be &lt; 2.2 mg/kg.
Doza ne bi trebala biti &lt; 2,2 mg/kg.
The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg) if bw &gt; 24 kg or dose volume in ml = 0.117 x bw (kg) if bw &lt; 24 kg)).
Volumen doze u mililitrima treba izračunati na temelju tjelesne težine svakog pojedinog bolesnika koristeći sljedeću formulu: Volumen doze u ml = 0,042 x TT bolesnika (kg) ako je TT &gt; 24 kg ili je volumen doze u ml = 0,117 x TT (kg) ako je TT &lt; 24 kg)).
The dose-response curve for tocilizumab flattens at higher exposure, resulting in smaller efficacy gains for each incremental increase in tocilizumab concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with &gt; 800 mg of tocilizumab.
Krivulja doza-odgovor za tocilizumab izravnava se pri višoj izloženosti, što rezultira manjim povećanjem djelotvornosti za svako dodatno povećanje koncentracije tocilizumaba tako da klinički značajna povećanja djelotvornosti nisu pokazana kod bolesnika liječenih s više od 800 mg tocilizumaba.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load &lt; 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Liječenje je trajalo 48 tjedana, a razdoblje naknadnog praćenja 6 mjeseci, osim u bolesnika inficiranih genotipovima 2 ili 3 i virusnim opterećenjem &lt; 800 000 IU/ml (Amplicor) koji su liječeni 24 tjedna i naknadno praćeni 6 mjeseci.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load &lt; 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Liječenje je trajalo 48 tjedana, a razdoblje naknadnog praćenja 6 mjeseci, osim u bolesnika inficiranih genotipovima 2 ili 3 i virusnim opterećenjem &lt; 800 000 IU/ml (Amplicor) koji su liječeni 24 tjedna i naknadno praćeni 6 mjeseci.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load &lt; 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Trajanje terapije je bilo 48 tjedana, a period naknadnog praćenja 6 mjeseci, osim u bolesnika inficiranih genotipovima 2 ili 3 i virusnim opterećenjem &lt; 800 000 IU/ml (Amplicor), koji su liječeni 24 tjedna, uz period naknadnog praćenja od 6 mjeseci.
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load &lt; 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Liječenje je trajalo 48 tjedana, a razdoblje praćenja 6 mjeseci, osim u bolesnika inficiranih genotipovima 2 ili 3 i virusnim opterećenjem &lt; 800 000 IU/ml (Amplicor), koji su liječeni 24 tjedna uz razdoblje praćenja od 6 mjeseci.
The duration of therapy with olaparib in patients who developed MDS/AML varied from &lt; 6 months to &gt; 2 years.
Trajanje terapije olaparibom kod bolesnica kod kojih se razvio MDS/AML kretalo se u rasponu od &lt; 6 mjeseci do &gt; 2 godine.
The duration of treatment should be based upon maintenance of response (serum uric acid levels &lt; 6 mg/dl) and clinical judgment.
Trajanje liječenja treba temeljiti na održavanju odgovora (serumske razine mokraćne kiseline &lt; 6 mg/dl) i na kliničkoj procjeni.
The effect of being homozygote (UGT1A9*3/*3, frequency &lt; 0.1%) is probably more marked, but has not been investigated.
Homozigotno svojstvo (UGT1A9*3/*3, učestalost &lt; 0,1%) je vjerojatno više izraženo, ali nije bilo istraženo.
The effect of hepatic impairment on the CL of nivolumab was evaluated in patients with mild hepatic impairment (total bilirubin 1.0 × to 1.5 × ULN or AST &gt; ULN as defined using the National Cancer Institute criteria of hepatic dysfunction; n = 92) compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN; n = 804) in the population PK analyses.
Učinak oštećenja jetrene funkcije na klirens nivolumaba ocjenjivao se u bolesnika s blagim oštećenjem jetrene funkcije (ukupni bilirubin 1,0 × do 1,5 × GGN ili AST &gt; GGN, prema kriterijima za disfunkciju jetre Nacionalnog instituta za rak; n = 92) u usporedbi s bolesnicima s normalnom jetrenom funkcijom (ukupni bilirubin i AST ≤ GGN; n = 804) u populacijskim PK analizama.
The effect of Lonsurf on overall survival was similar in patients &lt; 65 years and ≥65 years of age.
Učinak lijeka Lonsurf na ukupno preživljenje bio je sličan u bolesnika koji su &lt; 65 godina i ≥65 godina.
The effect of ocriplasmin (particularly in inducing resolution of vitreomacular adhesion or causing total posterior vitreous detachment [PVD]) is reduced in subjects with an epiretinal membrane (ERM) or a diameter of VMA &gt; 1500 microns (see section 5.1).
Učinak okriplazmina (osobito u indukciji uklanjanja vitreomakularne adhezije ili uzrokovanju potpunog stražnjeg odvajanja staklovine smanjen je u osoba s epiretinalnom membranom (ERM) ili s VMA promjera &gt; 1500 mikrona (vidjeti dio 5.1).
The effect of OPTISON on pulmonary haemodynamics was studied in a prospective, open-label study of 30 patients scheduled for pulmonary artery catheterisation, including 19 with an elevated baseline pulmonary arterial systolic pressure (PASP) ( &gt; 35 mmHg; mean 70.1±33.0 mmHg; range 36.0-176.0 mmHg) and 11 with a normal PASP (≤35 mmHg; mean 29.3±4.6 mmHg; range 22.0-35.0 mmHg).
Učinak OPTISONA na plućnu hemodinamiku proučavan je u prospektivnom otvorenom kliničkom ispitivanju u kojem je sudjelovalo 30 bolesnika naručenih za kateterizaciju plućne arterije, uključujući njih 19 s povišenim plućnim arterijskim sistoličkim tlakom (PAST) ( &gt; 35 mmHg; srednja vrijednost 70,1±33,0 mmHg; raspon 36,0-176,0 mmHg) i 11 s normalnim PAST-om (≤35 mmHg; srednja vrijednost 29,3±4,6 mmHg; raspon 22,0-35,0 mmHg).
The effect of renal impairment on the CL of nivolumab was evaluated in patients with mild (GFR &lt; 90 and ≥ 60 mL/min/1.73 m2; n = 379), moderate (GFR &lt; 60 and ≥ 30 mL/min/1.73 m2; n = 179), or severe (GFR &lt; 30 and ≥ 15 mL/min/1.73 m2; n = 2) renal impairment compared to patients with normal renal function (GFR ≥ 90 mL/min/1.73 m2; n = 342) in population PK analyses.
(GFR &lt; 90 i ≥ 60 ml/min/1,73 m2; n = 379), umjerenim (GFR &lt; 60 i ≥ 30 ml/min/1,73 m2; n = 179) ili teškim (GFR &lt; 30 i ≥ 15 ml/min/1,73 m2; n = 2) oštećenjem bubrežne funkcije u usporedbi s bolesnicima s normalnom bubrežnom funkcijom (GFR ≥ 90 ml/min/1,73 m2; n = 342) u populacijskim PK analizama.
The effect of renal impairment on the CL of nivolumab was evaluated in patients with mild (GFR &lt; 90 and ≥ 60 mL/min/1.73 m2; n = 379), moderate (GFR &lt; 60 and ≥ 30 mL/min/1.73 m2; n = 179), or severe (GFR &lt; 30 and ≥ 15 mL/min/1.73 m2; n = 2) renal impairment compared to patients with normal renal function (GFR ≥ 90 mL/min/1.73 m2; n = 342) in population PK analyses.
Učinak oštećenja bubrežne funkcije na klirens nivolumaba ocjenjivao se u bolesnika s blagim (GFR &lt; 90 i ≥ 60 ml/min/1,73 m2; n = 379), umjerenim (GFR &lt; 60 i ≥ 30 ml/min/1,73 m2; n = 179) ili teškim (GFR &lt; 30 i ≥ 15 ml/min/1,73 m2; n = 2) oštećenjem bubrežne funkcije u usporedbi s bolesnicima s normalnom bubrežnom funkcijom (GFR ≥ 90 ml/min/1,73 m2; n = 342) u populacijskim PK analizama.
The effect of renal impairment on the pharmacokinetics of elotuzumab was evaluated in patients with normal renal function (CrCl &gt; 90 mL/min; N = 8), severe renal impairment not requiring dialysis (CrCl &lt; 30 mL/min; N = 9), or end-stage renal disease requiring dialysis (CrCl &lt; 30 mL/min; N = 9).
Učinak oštećenja funkcije bubrega na farmakokinetiku elotuzumaba ocjenjivao se u bolesnika s normalnom funkcijom bubrega (CrCl &gt; 90 ml/min; N = 8), teškim oštećenjem funkcije bubrega koje nije zahtijevalo dijalizu (CrCl &lt; 30 ml/min; N = 9) ili onih u terminalnoj fazi bubrežne bolesti kojima je bila potrebna dijaliza (CrCl &lt; 30 ml/min; N = 9).
The effect on red blood cell (RBC) ( &lt; 2%) and platelet counts ( &lt; 10%) was less pronounced.
Učinak na broj eritrocita ( &lt; 2%) i trombocita ( &lt; 10%) bio je manje izražen.
The effect size of pitolisant compared with placebo based on a model for WRC based on BOCF with centre as a fixed effect was 0.581, 95%CI [0.493 to 0.686]; p &lt; 0.0001.
Opseg učinka pitolizanta u usporedbi s placebom prema modelu WRC-a na temelju početnog zapažanja prenesenog dalje (engl. baseline observation carried forward, BOCF) sa središtem kao fiksnim učinkom iznosio je 0,581, 95 %CI [0,493 do 0,686]; p &lt; 0,0001.
The effects of desloratadine in poor metabolisers &lt; 2 years of age have not been studied.
Nisu ispitivani učinci desloratadina u bolesnika mlađih od dvije godine koji sporo metaboliziraju desloratadin.
The effects of desloratadine in poor metabolizers &lt; 2 years of age have not been studied.
Nisu ispitivani učinci desloratadina u bolesnika mlađih od dvije godine koji sporo metaboliziraju desloratadin.
The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance &lt; 30 mL/min, see section 5.2).
Djelotvornost i sigurnost nisu u potpunosti procijenjeni kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina &lt; 30 ml/min, vidjeti dio 5.2).
The efficacy and safety of a daily dose of 0.25 mg/kg to 10 mg adefovir dipivoxil in children (aged from 2 to &lt; 18 years) were examined in a double-blind, randomised, placebo-controlled study in 173 paediatric patients (115 on adefovir dipivoxil, 58 on placebo) who had HBeAg positive chronic hepatitis B, serum ALT levels ≥ 1.5 x upper limit of normal (ULN) and compensated liver disease.
Djelotvornost i sigurnost dnevne doze od 0,25 mg/kg do 10 mg adefovirdipivoksila u djece (u dobi od 2 do &lt; 18 godina) ispitane su u dvostruko slijepom, randomiziranom, placebom kontroliranom ispitivanju u 173 pedijatrijskih pacijenata (115 na adefovirdipivoksilu, 58 na placebu) koji su imali HBeAg pozitivan kronični hepatitis B, serumske razine ALT-a ≥ 1,5 puta iznad gornje granice normale i kompenziranu bolest jetre.
The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly depressed patients ( &lt; 75years).
Djelotvornost i sigurnost primjene agomelatina (25 do 50 mg/dan) dokazana je kod starijih bolesnika koji boluju od depresije ( &lt; 75 godina).
The efficacy and safety of eluxadoline in IBS-D patients was established in two randomized, multi- center, multi-national, double-blind, placebo-controlled studies (Studies 1 &amp; 2).
Djelotvornost i sigurnost eluksadolina u bolesnika s dijagnozom IBS-D-a ustanovljene su u dva randomizirana, multicentrična, multinacionalna, dvostruko slijepa, placebom-kontrolirana ispitivanja (Ispitivanja 1 i 2).
The efficacy and safety of Lonsurf was compared between a high-exposure group ( &gt; median) and a low-exposure group (≤median) based on the median AUC value of trifluridine.
Djelotvornost i sigurnost Lonsurfa uspoređena je između skupine s visokom izloženosti ( &gt; medijana) i skupine s niskom izloženosti ( medijana) u odnosu na medijan AUC vrijenosti trifluridina.
The efficacy and safety of the recommended doses of alogliptin and metformin in a subgroup of patients with type 2 diabetes mellitus and ≥ 65 years old were reviewed and found to be consistent with the profile obtained in patients &lt; 65 years old.
Djelotvornost i sigurnost preporučenih doza alogliptina i metformina u podskupini bolesnika sa šećernom bolešću tipa 2 u dobi od ≥ 65 godina starosti su procijenjene i nađeno je da odgovaraju profilu dobivenom u bolesnika &lt; 65 godina starosti.
The efficacy and safety of the recommended doses of alogliptin and pioglitazone in a subgroup of patients with type 2 diabetes mellitus and ≥ 65 years old were reviewed and found to be consistent with the profile obtained in patients &lt; 65 years old.
Djelotvornost i sigurnost preporučenih doza alogliptina i metformina u podskupini bolesnika sa šećernom bolešću tipa 2 i dobi ≥ 65 godina starosti su procijenjene i nađeno je da odgovaraju profilu dobivenom u bolesnika &lt; 65 godina starosti.
The efficacy and safety of tolvaptan in those with a creatinine clearance &lt; 10 ml/min has not been evaluated and is therefore unknown.
Djelotvornost i sigurnost tolvaptana kod osoba sa klirensom kreatinina &lt; 10 ml/min nije procijenjena i stoga nije poznata.
The efficacy and safety of Vidaza was studied in an international, multicentre, controlled, open-label, parallel group Phase 3 study in patients 65 years and older with newly diagnosed de novo or secondary AML with &gt; 30% bone marrow blasts according to the WHO classification, who were not eligible for HSCT.
Djelotvornost i sigurnost Vidaze bila je ispitana u međunarodnom, multicentričnom, kontroliranom, otvorenom ispitivanju faze 3 na usporednim skupinama bolesnika u dobi od 65 i više godina s novodijagnosticiranom de novo ili sekundarnom AML s &gt; 30 % blasta u koštanoj srži prema klasifikaciji SZO-a, koji nisu zadovoljavali kriterije za THMS.
The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double-blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with &gt; 7.5 mg/day oral prednisone (or equivalent).
Djelotvornost i sigurnost primjene zoledronatne kiseline u liječenju i prevenciji osteoporoze povezane s dugotrajnim sistemskim liječenjem glukokortikoidima bila je procijenjena u randomiziranom, multicentričnom, dvostruko slijepom, stratificiranom ispitivanju s djelatnom kontrolom u 833 muškaraca i žena u dobi od 18 do 85 godina (srednja dob za muškarce 56,4 godine za žene 53,5 godina) liječenih sa &gt; 7,5mg/dan oralno primijenjenog prednizona (ili ekvivalenta).
The efficacy and safety of zoledronic acid in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double-blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with &gt; 7.5 mg/day oral prednisone (or equivalent).
Djelotvornost i sigurnost primjene zoledronatne kiseline u liječenju i prevenciji osteoporoze povezane s dugotrajnim sistemskim liječenjem glukokortikoidima bila je procijenjena u randomiziranom, multicentričnom, dvostruko slijepom, stratificiranom ispitivanju s djelatnom kontrolom u 833 muškaraca i žena u dobi od 18 do 85 godina (srednja dob za muškarce 56,4 godine, za žene 53,5 godina) liječenih sa &gt; 7,5mg/dan oralno primijenjenog prednizona (ili ekvivalenta).
The efficacy of alogliptin in patients with type 2 diabetes mellitus and ≥ 65 years old across a pooled analysis of five 26-week placebo-controlled studies was consistent with that in patients &lt; 65 years old.
Djelotvornost alogliptina u bolesnika sa šećernom bolešću tipa 2 i ≥ 65 godina starosti je u analizi objedinjenih podataka iz pet 26-tjednih placebom kontroliranih ispitivanja bila jednaka kao i u bolesnika &lt; 65 godina starosti.
The efficacy of Cymbalta 30-120 mg (flexible dosing) once a day in elderly patients ( &gt; 65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Djelotvornost lijeka Cymbalta u dozi od 30-120 mg (fleksibilno doziranje) jednom dnevno u starijih bolesnika ( &gt; 65 godina) s generaliziranim anksioznim poremećajem ocijenjena je u ispitivanju koje je pokazalo statistički značajno poboljšanje ukupnog broja bodova na HAM-A ljestvici u bolesnika liječenih duloksetinom u odnosu na one koji su uzimali placebo.
The efficacy of duloxetine 30-120 mg (flexible dosing) once a day in elderly patients ( &gt; 65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Djelotvornost duloksetina u dozi od 30-120 mg (fleksibilno doziranje) jednom dnevno u starijih bolesnika ( &gt; 65 godina) s generaliziranim anksioznim poremećajem ocijenjena je u ispitivanju koje je pokazalo statistički značajno poboljšanje ukupnog broja bodova na HAM-A ljestvici u bolesnika liječenih duloksetinom u odnosu na one koji su uzimali placebo.
The efficacy of Duloxetine Lilly 30-120 mg (flexible dosing) once a day in elderly patients ( &gt; 65 years) with generalised anxiety disorder was evaluated in a study that demonstrated statistically significant improvement in the HAM-A total score for duloxetine treated patients compared to placebo treated patients.
Djelotvornost lijeka Duloksetin Lilly u dozi od 30-120 mg (fleksibilno doziranje) jednom dnevno u starijih bolesnika ( &gt; 65 godina) s generaliziranim anksioznim poremećajem ocijenjena je u ispitivanju koje je pokazalo statistički značajno poboljšanje ukupnog broja bodova na HAM-A ljestvici u bolesnika liječenih duloksetinom u odnosu na one koji su uzimali placebo.
The efficacy of Enbrel was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis ( &lt; 3 years duration) who had never received treatment with methotrexate.
Djelotvornost Enbrela uspoređena je s metotreksatom u randomiziranom, aktivno kontroliranom ispitivanju s radiografskom ocjenom na slijepo kao primarnom mjerom ishoda, kod 632 odrasla bolesnika s aktivnim reumatoidnim artritisom ( &lt; 3 godine trajanja) koji nikada nisu bili liječeni metotreksatom.
The efficacy of etanercept was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis ( &lt; 3 years duration) who had never received treatment with methotrexate.
Djelotvornost etanercepta uspoređena je s metotreksatom u randomiziranom, aktivno kontroliranom ispitivanju s radiografskom ocjenom na slijepo kao primarnom mjerom ishoda kod 632 odrasla bolesnika s aktivnim reumatoidnim artritisom ( &lt; 3 godine trajanja) koji nikada nisu bili liječeni metotreksatom.
The efficacy of Humira was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or &gt; 20% BSA involvement or &gt; 10% BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Djelotvornost lijeka Humira ocjenjivala se u randomiziranom, dvostruko slijepom, kontroliranom ispitivanju provedenom u 114 pedijatrijskih bolesnika u dobi od 4 ili više godina s teškom kroničnom plak psorijazom (koja se definirala kao PGA rezultat od ≥ 4 ili zahvaćenost površine tijela od &gt; 20% ili zahvaćenost površine tijela od &gt; 10% s vrlo debelim lezijama ili PASI rezultat od ≥ 20 ili ≥ 10 uz klinički značajnu zahvaćenost lica, genitalija ili šaka/stopala) u kojih bolest nije bila dovoljno dobro kontrolirana topikalnom terapijom i helioterapijom ili fototerapijom.
The efficacy of IDELVION has been evaluated in a phase 3 study, in which a total of 27 male PTPs between 1 and 10 years (median age 6.0 years) with 12 patients &lt; 6 years, received IDELVION for prophylaxis and control of bleeding episodes.
Djelotvornost lijeka IDELVION je ocijenjena u ispitivanju faze 3, u kojoj je ukupno 27 prethodno liječenih muških bolesnika između 1. i 10. godine (medijan dobi 6,0 godina), s 12 bolesnika &lt; 6 godina, primilo lijek IDELVION u svrhu profilakse i kontrole epizoda krvarenja.