natgillin/translations-raw huggingface dataset:
The pharmacokinetics of ribavirin are altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Farmakokinetika ribavirina je spremenjena pri bolnikih z motnjami delovanja ledvic zaradi zmanjšanja navideznega očistka kreatinina pri teh bolnikih (glejte poglavje 5.2).
The pharmacokinetics of rilpivirine and tenofovir disoproxil fumarate in children and adolescents are under investigation.
Farmakokinetika rilpivirina in dizoproksiltenofovirijevega fumarata pri otrocih in mladostnikih se preučuje.
The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Farmakokinetike rilpivirina niso proučevali pri bolnikih z ledvično insuficienco.
The pharmacokinetics of riluzole have been evaluated in healthy male volunteers after single oral administration of 25 to 300 mg and after multiple-dose oral administration of 25 to 100 mg bid.
Farmakokinetiko riluzola so ovrednotili pri zdravih moških prostovoljcih po enkratni peroralni uporabi odmerkov od 25 do 300 mg in po večkratni peroralni uporabi odmerkov od 25 do 100 mg dvakrat na dan.
The pharmacokinetics of rimonabant are similar in female and male patients.
Farmakokinetika rimonabanta je pri bolnicah in bolnikih podobna.
The pharmacokinetics of robenacoxib do not differ between male and female dogs, and are linear over the range 0.5–8 mg/kg.
Farmakokinetika robenakoksiba se med psicami in psi ne razlikuje ter je pri odmerkih od 0,5 do 8 mg/kg telesne mase linearna.
The pharmacokinetics of robenacoxib injection do not differ between male and female cats and dogs, and are linear over the range of 0.25–4 mg/kg in dogs.
Farmakokinetika injiciranega robenakoksiba se med mačkami in psi ženskega in moškega spola ne razlikuje ter je pri psih pri odmerkih 0,25 - 4 mg/kg linearna.
The pharmacokinetics of silodosin is linear throughout this dose range.
Farmakokinetika silodozina je v celotnem navedenem odmernem intervalu linearna.
The pharmacokinetics of sirolimus were similar in various populations with renal function ranging from normal to absent (dialysis patients).
Farmakokinetika sirolimusa je bila podobna pri različnih skupinah ledvičnih bolnikov, od tistih z normalnim delovanjem ledvic do tistih s popolno ledvično odpovedjo (bolniki na dializi).
The pharmacokinetics of sirolimus were similar in various populations, with renal function ranging from normal to absent (dialysis patients).
Farmakokinetika sirolimusa je bila podobna pri različnih skupinah ledvičnih bolnikov, od tistih z normalnim delovanjem ledvic do tistih s popolno ledvično odpovedjo (bolniki na dializi).
The pharmacokinetics of SIRTURO in paediatric patients have not been evaluated.
Farmakokinetike zdravila SIRTURO pri pediatričnih bolnikih niso proučevali.
The pharmacokinetics of sofosbuvir and GS-331007 in paediatric subjects have not been established (see section 4.2).
Farmakokinetike sofosbuvirja in GS-331007 pri pediatričnih osebah niso ugotavljali (glejte poglavje 4.2).
The pharmacokinetics of sofosbuvir was studied in HCV negative patients with mild (eGFR ≥ 50 and
Farmakokinetiko sofosbuvirja so preučili pri bolnikih, negativnih za HCV, z blago (eGFR ≥ 50 in
The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥ 50 and
Farmakokinetiko sofosbuvirja so preučili pri bolnikih, negativnih za HCV, z blago (eGFR ≥ 50 in
The pharmacokinetics of sofosbuvir were studied in HCV negative subjects with mild (eGFR ≥50 and
Farmakokinetiko sofosbuvirja so preučili pri osebah, negativnih za HCV, z blago (eGFR ≥ 50 in
The pharmacokinetics of sofosbuvir, GS-331007 and velpatasvir in paediatric patients have not been established (see section 4.2).
Farmakokinetike sofosbuvirja, GS-331007 in velpatasvirja pri pediatričnih bolnikih niso ugotavljali (glejte poglavje 4.2).
The pharmacokinetics of Soliris have been studied in aHUS patients with a range of renal impairment and age.
Farmakokinetika zdravila Soliris je bila ocenjena pri bolnikih z aHUS na podlagi obsega ledvične okvare in starosti.
The pharmacokinetics of sonidegib were examined in subjects with mild (Child-Pugh class A; n=8), moderate (Child-Pugh class B; n=8) or severe (Child-Pugh class C; n=9) hepatic impairment and in 8 healthy subjects with normal hepatic function.
Farmakokinetiko sonidegiba so proučevali pri osebah z blago okvaro jeter (Child-Pugh stopnje A; n=8), z zmerno okvaro jeter (Child-Pugh stopnje B; n=8) oziroma s hudo okvaro jeter (Child-Pugh stopnje C; n=9) in pri 8 zdravih osebah z normalnim delovanjem jeter.
The pharmacokinetics of strontium and ranelic acid have been assessed in healthy young men and healthy postmenopausal women, as well as during long- term exposure in men with osteoporosis and postmenopausal osteoporotic women including elderly women.
Farmakokinetiko stroncija in ranelske kisline so proučevali pri zdravih mladih moških in zdravih ženskah v obdobju po menopavzi ter dolgoročno pri moških z osteoporozo ter ženskah z osteoporozo v obdobju po menopavzi, vključno pri starejših ženskah.
The pharmacokinetics of sufentanil after sublingual administration can be described as a three- compartment model with first-order absorption.
Farmakokinetiko sufentanila po podjezični aplikaciji je možno opisati kot tripredalčni model z absorpcijo prve stopnje.
The pharmacokinetics of sunitinib were evaluated in 135 healthy volunteers and 266 patients with solid tumours.
Farmakokinetiko sunitiniba so ocenili pri 135 zdravih prostovoljcih in 266 bolnikih s čvrstimi tumorji.
The pharmacokinetics of tacrolimus after topical application are similar to those reported in adults, with minimal systemic exposure and no evidence of accumulation (see above).
Farmakokinetika takrolimusa po lokalni uporabi je primerljiva s tisto, ki je opisana za odrasle, in sicer minimalna sistemska izpostavljenost ter odsotnost znakov [sistemskega] kopičenja (glejte zgoraj).
The pharmacokinetics of tedizolid were evaluated in adolescent subjects (12 to 17 years; n=20) following administration of a single oral or IV dose of Sivextro 200 mg.
Farmakokinetiko tedizolida so ocenili pri mladostnikih (od 12 do 17 let, n = 20) po uporabi enkratnega 200 mg peroralnega ali intravenskega odmerka zdravila Sivextro.
The pharmacokinetics of telavancin have not been evaluated in severe hepatic impairment (Child-Pugh class C).
Farmakokinetika telavancina ni bila ocenjena pri hujši jetrni okvari (Child–Pugh razred C).
The pharmacokinetics of telavancin in patients below 18 years of age have not been established (see section 4.2).
Farmakokinetika telavancina pri bolnikih, mlajših od 18 let, še ni bila preučena (glejte poglavje 4.2).
The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Farmakokinetika telmisartana se pri starejših ne razlikuje od tiste pri mlajših od 65 let.
The pharmacokinetics of tenofovir have been studied in patients with hepatic impairment and no dose adjustment is required in these patients.
Farmakokinetične lastnosti tenofovirja so proučevali pri bolnikih z jetrno okvaro in ugotovili, da pri teh bolnikih prilagoditev odmerka ni potrebna.
The pharmacokinetics of tenofovir have not been specifically studied in different ethnic groups.
Farmakokinetike tenofovira niso posebej preučevali pri različnih etničnih skupinah.
The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co- administration with duloxetine (60 mg twice daily).
Sočasno dajanje duloksetina (60 mg dvakrat na dan) ni značilno vplivalo na farmakokinetiko teofilina, substrata CYP1A2.
The pharmacokinetics of tocilizumab was determined using a population pharmacokinetic analysis on a database composed of 188 patients with pJIA.
Farmakokinetiko tocilizumaba so proučili s populacijsko farmakokinetično analizo podatkovne baze 188 bolnikov s pJIA.
The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with 162 mg subcutaneous every week, 162 mg subcutaneous every other week, and or 4 or 8 mg/kg intravenous every 4 weeks for 24 weeks.
Farmakokinetiko tocilizumaba so proučili s populacijsko farmakokinetično analizo podatkov 3552 bolnikov z revmatoidnim artritisom, ki so se zdravili s 162 mg subkutano vsak teden, 162 mg subkutano vsak drugi teden in 4 ali 8 mg/kg intravensko vsake 4 tedne 24 tednov.
The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg tocilizumab every 4 weeks for 24 weeks or with 162 mg tocilizumab given subcutaneously either once a week or every other week for 24 weeks.
Farmakokinetiko tocilizumaba so proučili s populacijsko farmakokinetično analizo podatkov 3552 bolnikov z revmatoidnim artritisom, ki so 24 tednov na 4 tedne dobivali enourno infuzijo 4 ali 8 mg/kg tocilizumaba, ali 24 tednov 162 mg tocilizumaba subkutano bodisi enkrat tedensko ali vsak drugi teden.
The pharmacokinetics of topotecan given as a 30 minute infusion for 5 days were evaluated in two studies.
Farmakokinetiko topotekana, danega v obliki 30-minutne infuzije v času 5 dni, so ovrednotili v dveh študijah.
The pharmacokinetics of topotecan was generally unchanged when coadministered with ranitidine.
Farmakokinetika topotekana se med sočasno uporabo z ranitidinom na splošno ni spremenila.
The pharmacokinetics of trastuzumab at a dose of 600 mg administered three-weekly by the subcutaneous route was compared to the intravenous route (8 mg/kg loading dose, 6 mg/kg maintenance every three weeks) in the phase III study BO22227.
Farmakokinetiko trastuzumaba v fiksnem odmerku 600 mg, dajano trikrat na teden subkutano, so primerjali z intravenskim dajanjem (uvajalni odmerek 8 mg/kg, vzdrževalni odmerek 6 mg/kg vsake 3 tedne) v fazi III študije BO22227.
The pharmacokinetics of trastuzumab at a dose of 600 mg administered three-weekly by the subcutaneous route was compared to the intravenous route (8 mg/kg loading dose, 6 mg/kg maintenance every three weeks) in the phase III study BO22227.
Farmakokinetiko trastuzumaba v odmerku 600 mg, dajano trikrat na teden subkutano, so primerjali z intravenskim dajanjem (uvajalni odmerek 8 mg/kg, vzdrževalni odmerek 6 mg/kg vsake 3 tedne) v fazi III študije BO22227.
The pharmacokinetics of trastuzumab emtansine and DM1-containing catabolites were evaluated after the administration of 3.6 mg/kg of trastuzumab emtansine to metastatic HER2+ breast cancer patients with normal hepatic function (n=10), mild (Child-Pugh A; n=10) and moderate (Child-Pugh B; n=8) hepatic impairment.
Farmakokinetika trastuzumaba emtanzina in DM1 vsebujočih presnovkov je bila ocenjena po dajanju 3,6 mg trastuzumaba emtanzina na kg telesne mase bolnikom s HER2+ metastatskim rakom dojk z normalnim delovanjem jeter (n = 10), blago (razred A po Child-Pughovi lestvici; n = 10) in zmerno (razred B po Child-Pughovi lestvici, n = 8) jetrno okvaro.
The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumor types, and healthy volunteers, in 18 Phase I, II and III trials receiving Herceptin IV.
Farmakokinetika trastuzumaba je bila ocenjena z analizo populacijskega farmakokinetičnega modela z uporabo združenih podatkov 1582 preizkušancev, vključno z bolniki s HER2-pozitivnim metastatskim rakom dojk (metastatic breast cancer – MBC), zgodnjim rakom dojk (early breast cancer – EBC), napredovalim rakom želodca (advanced gastric cancer – AGC) ali drugimi vrstami tumorjev in zdravimi prostovoljci, ki so v 18 kliničnih preskušanjih faze I, II in III prejemali zdravilo Herceptin v iv. obliki.
The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn’s disease.
Pri bolnikih s psoriatičnim artritisom sočasna uporaba MTX, NSAID in peroralnih kortikosteroidov ali predhodna izpostavljenost zaviralcem TNFα ni vplivala na farmakokinetiko ustekinumaba.
The pharmacokinetics of ustekinumab were generally comparable between Asian and non-Asian patients with psoriasis.
Ni znano, ali se ustekinumab sistemsko absorbira po zaužitju.
The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a clearance of approximately 13.2 l/h. and plasma half-life of approximately 19 days.
Za farmakokinetiko vandetaniba v odmerku 300 mg pri bolnikih z MTC sta značilna očistek, ki je približno 13,2 l/h, in plazemski razpolovni čas, ki je približno 19 dni.
The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Farmakokinetiko velpatasvirja so preučili z enkratnim 100-miligramskim odmerkom velpatasvirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi Cockcroft- Gault).
The pharmacokinetics of Vipdomet in children and adolescents < 18 years old has not been established.
Farmakokinetika zdravila Vipdomet pri otrocih in mladostnikih, mlajših od 18 let, ni bila raziskana.
The pharmacokinetics of Viraferon and ribavirin (dose-normalized) are similar in adults and children or adolescents.
Farmakokinetika zdravila Rebetol in interferona alfa-2b (z normaliziranim odmerkom) je podobna pri odraslih in otrocih ali mladostnikih.
The pharmacokinetics of Viraferon were studied in healthy volunteers following single 5 million IU/m2 and 10 million IU doses administered subcutaneously, at 5 million IU/m2 administered intramuscularly and as a 30-minute intravenous infusion.
Farmakokinetiko zdravila Viraferon so raziskovali pri zdravih prostovoljcih po enkratnih subkutanih odmerkih po 5 milijonov i.e./m2 in 10 milijonov i.e., po intramuskularnem dajanju 5 milijonov i.e./m2 in po 30-minutni intravenski infuziji.
The pharmacokinetics of ViraferonPeg have not been evaluated in patients with severe hepatic dysfunction.
Pri bolnikih s hudo jetrno okvaro farmakokinetike zdravila ViraferonPeg niso ocenjevali.
The pharmacokinetics were similar in all solid tumours populations tested and in healthy volunteers.
Farmakokinetika je bila pri vseh testiranih populacijah s čvrstimi tumorji in pri zdravih prostovoljcih podobna.
The pharmacokinetics, efficacy and safety of Envarsus and tacrolimus immediate-release capsules , both in combination with corticosteroids was compared in 117 liver transplant recipients, of whom 88 received treatment with Envarsus.
Farmakokinetiko, učinkovitost in varnost zdravila Envarsus in kapsulami takrolimusa s takojšnjim sproščanjem, oboje v kombinaciji s kortikosteroidi, so primerjali pri 117 bolnikih po presaditvi jeter, od katerih jih je 88 prejemalo zdravilo Envarsus.
The pharmacokinetics, safety and activity of saquinavir have been evaluated in an open label, multicenter study in 18 children aged 4 months to less than 6 years old in which saquinavir (50 mg/kg bid up to the adult dose of 1000 mg bid) was administered in combination with ritonavir oral solution (3 mg/kg bid for body weight from 5 to <15 kg, 2.5 mg/kg bid for body weight from 15 to 40 kg and 100 mg bid for body weight >40 kg) plus ≥2 background ARVs.
Farmakokinetiko, varnost in učinkovitost sakvinavirja so ovrednotili v odprti, multicentrični študiji pri 18 otrocih, starih od 4 mesece do manj kot 6 let, pri katerih je bil sakvinavir (50 mg/kg dvakrat na dan do odmerka za odrasle 1000 mg dvakrat na dan) dan v kombinaciji s peroralno raztopino ritonavirja (3 mg/kg dvakrat na dan pri telesni masi od 5 do <15 kg, 2,5 mg/kg dvakrat na dan pri telesni masi od 15 do 40 kg in 100 mg dvakrat na dan pri telesni masi >40 kg) in še z ≥ 2 antiretrovirusnima zdraviloma.
The pharmacokinetics, safety, tolerability and efficacy of PREZISTA/ritonavir twice daily in combination with other antiretroviral agents in 21 ART-experienced HIV-1 infected paediatric patients aged 3 to < 6 years and weighing 10 kg to < 20 kg was evaluated in an open-label, Phase II trial, ARIEL.
Farmakokinetiko, varnost, prenosljivost in učinkovitost zdravil PREZISTA/ritonavir dvakrat na dan v kombinaciji z drugimi protiretrovirusnimi zdravili pri 21 s HIV-1 okuženih pediatričnih bolnikih, ki že imajo izkušnje z ART, starih 3 do < 6 let in s telesno maso 10 kg do < 20 kg, so ocenili v odprtem preskušanje faze II, ARIEL.
The pharmacokinetics, safety, tolerability and efficacy of rilpivirine 25 mg once daily, in combination with an investigator-selected BR containing two NRTIs, was evaluated in trial TMC278-C213, a single-arm, open-label Phase 2 trial in antiretroviral treatment-naïve HIV-1 infected adolescent subjects weighing at least 32 kg.
Farmakokinetiko, varnost, prenosljivost in učinkovitost zdravljenja s 25 mg rilpivirina enkrat na dan, v kombinaciji z BR po izboru raziskovalca, ki je vsebovala 2 NRTI, so ocenili v odprti študiji faze 3 z eno preiskovano skupino TMC278-C213 pri zdravljenju mladostnikov, okuženih s HIV-1, ki še niso prejemali protiretrovirusnih zdravil in s telesno maso najmanj 32 kg.
The pharmacologic effects of beta2-adrenoceptor agonist drugs, including vilanterol trifenatate, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cyclic AMP).
Farmakološke učinke agonistov adrenergičnih receptorjev beta2, vključno z vilanterolijevim trifenatatom, je mogoče vsaj deloma pripisati stimulaciji znotrajcelične adenilat-ciklaze, tj. encima, ki katalizira pretvorbo adenozin trifosfata (ATP) v ciklični 3’, 5’-adenozin monofosfat (ciklični AMP).
The pharmacological activity is initiated by photoactivation of temoporfin with non-thermal light at 652 nm following intravenous administration.
Farmakološka aktivnost se prične s fotoaktivacijo temoporfina, injiciranega v žilo, z lučjo, ki ne oddaja toplote, z valovno dolžino 652 nm.
The pharmacological effects after inhalation of Ventavis are:
Farmakološki učinki po inhaliranju zdravila Ventavis
The pharmacological effects of beta2-adrenoceptor agonists are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3’, 5’-adenosine monophosphate (cyclic monophosphate).
Farmakološko delovanje agonistov adrenergičnih receptorjev beta-2 je vsaj deloma mogoče pripisati stimulaciji znotrajcelične adenilat-ciklaze, encima, ki katalizira pretvorbo adenozin-trifosfata (ATP) v ciklični adenozin-3',5'-monofosfat (ciklični monofosfat).
The pharmacological effects of beta2-adrenoceptor agonists, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3’, 5’-adenosine monophosphate (cyclic AMP).
Farmakološko delovanje agonistov beta-2 adrenergičnih receptorjev, med katere sodi tudi indakaterol, je vsaj deloma mogoče pripisati stimulaciji znotrajcelične adenilat-ciklaze, encima, ki katalizira pretvorbo adenozin-trifosfata (ATP) v ciklični adenozin-3’,5’-monofosfat (ciklični AMP).
The pharmacological mode of action of delamanid involves inhibition of the synthesis of the mycobacterial cell wall components, methoxy-mycolic and keto-mycolic acid.
Farmakološki način delovanja delamanida vključuje zaviranje sinteze sestavin celične stene mikobakterij, metoksi-mikolične in keto-mikolične kisline.
The pharmacy preparation should be preferred to home preparation.
Priprava v lekarni je prednostna pred pripravo doma.
The Phase 1 and 2 studies assessed the safety of idelalisib in a total of 535 subjects with haematologic malignancies, including 399 subjects who received idelalisib (any dose) as a single agent and 136 subjects who received idelalisib in combination with an anti-CD20 monoclonal antibody (rituximab or ofatumumab).
V študijah 1. in 2. faze so ocenili varnost idelaliziba pri skupaj 535 osebah s hematološkimi malignostmi, vključno s 399 osebami, ki so prejemale idelalizib (kateri koli odmerek) kot edino zdravilo, in 136 osebami, ki so idelalizib prejemale v kombinaciji z monoklonskim protitelesom proti CD20 (rituksimabom ali ofatumumabom).
The Phase 1 pharmacokinetics showed proportionality within the dose interval (0.5 – 8 mg) as reflected in Cmax values.
Farmakokinetika 1. faze je pokazala sorazmernost znotraj razpona odmerka (0,5–8 mg), kar se kaže z vrednostmi Cmax.
The Phase 3 clinical study was a randomised, open-label active comparator study comparing the efficacy of colistimethate sodium 1,662,500 IU dry powder for inhalation to tobramycin nebuliser solution for inhalation, 300 mg/5 ml, in 380 subjects with documented cystic fibrosis complicated by chronic pulmonary infection with Pseudomonas aeruginosa.
Klinična študija faze 3 je bila randomizirana odprta študija z aktivno primerjavo, v kateri so primerjali učinkovitost 1.662.500 i.e. suhega praška za inhaliranje natrijevega kolistimetata s 300 mg/5 ml raztopine tobramicina v nebulatorju pri 380 osebah z dokumentirano cistično fibrozo in zapletom zaradi kronične pljučne okužbe z bakterijo Pseudomonas aeruginosa.
The phase 3 studies conducted with ZYTIGA excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class (NYHA) III or IV heart failure (study 301) or Class II to IV heart failure (study 302) or cardiac ejection fraction measurement of < 50%.
Bolniki z nenadzorovano hipertenzijo, klinično pomembno srčno boleznijo, kot so miokardni infarkt ali arterijski trombotični dogodki v zadnjih 6 mesecih, hudo nestabilno angino pektoris, srčnim popuščanjem stopnje III ali IV (študija 301) ali srčnim popuščanjem razreda II do IV (študija 302) po klasifikaciji Newyorškega združenja za srce (NYHA - New York Heart Association) ali vrednostjo iztisnega deleža srca < 50% niso bili vključeni v študije faze III z zdravilom ZYTIGA.
The Phase 3 studies were all conducted with peginterferon alfa-2a in combination with INCIVO and ribavirin.
Vse študije faze III so bile izvedene z uporabo peginterferona alfa-2a v kombinaciji z zdravilom INCIVO in ribavirinom.
The Phase 3 trials of lumacaftor/ivacaftor included 81 patients with ppFEV1 <40 at baseline.
V preskušanja 3. faze lumakaftorja/ivakaftorja je bilo vključenih 81 bolnikov s ppFEV1 <40 v izhodišču.
The Phase II and III clinical studies involving 1,410 patients with CKD Stage 5 on dialysis treated with BindRen for up to one year constituted the safety population.
Klinične študije II. in III. faze, v katerih je sodelovalo 1.410 bolnikov s KBL 5. faze na dializi, zdravljenimi z zdravilom BindRen do enega leta, je predstavljalo varnostno populacijo.
The phase II pivotal study evaluated the safety of Odomzo in a total of 229 adult patients with locally advanced or metastatic BCC.
V ključni študiji faze II so ocenjevali varnost zdravila Odomzo pri skupaj 229 odraslih bolnikih z lokalno napredovalim ali metastatskim bazalnoceličnim karcinomom.
The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n=102), leflunomide 5 mg (n=95), 10 mg (n=101) or 25 mg/day (n=104).
V preskušanju II. faze, raziskave YU203, so 402 preiskovanca z aktivnim revmatoidnim artritisom randomizirano razvrstili na placebo (n = 102), leflunomid 5 mg (n = 95), 10 mg (n = 101) ali 25 mg/dan (n = 104).
The phase III trial (study 008) enrolled women without pre-screening for the presence of HPV infection, i.e. regardless of baseline cytology and HPV serological and DNA status.
V preskušanje III. faze (študija 008) so bile vključene ženske pri katerih presejanje za prisotnost okužbe s HPV ni bilo izvedeno, to je ne glede na citološki izvid ob izhodišču in ne glede na HPV serološki in DNA status.
The Philadelphia-chromosome is found in some ALL patients and is present in most patients with CML.
Kromosom Philadelphia je prisoten pri vseh bolnikih z ALL in pri večini bolnikov s KML.