natgillin/translations-raw huggingface dataset:
In controlled clinical studies, use of NeoRecormon and other erythropoiesis-stimulating agents (ESAs) have shown:
Kontrolirane klinične študije so pri dajanju zdravila NeoRecormon in drugih zdravil za stimulacijo eritropoeze pokazale:
In controlled clinical trials (4 – 8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
V nadzorovanih kliničnih preskušanjih (ki so trajala od 4 do 8 tednov) se je od začetka do končnega cilja preskušanja skupna ocena HAM-A izboljšala za najmanj 50 % pri 52 % bolnikov, ki so prejemali pregabalin, in pri 38 % bolnikov, ki so prejemali placebo.
In controlled clinical trials (4-8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
V nadzorovanih kliničnih preskušanjih (ki so trajala od 4 do 8 tednov) se je od začetka do končnega cilja preskušanja skupna ocena HAM-A izboljšala za najmanj 50% pri 52% bolnikov, ki so prejemali pregabalin, in pri 38% bolnikov, ki so prejemali placebo.
In controlled clinical trials conducted world–wide, indinavir was administered alone or in combination with other antiretroviral agents (zidovudine, didanosine, stavudine, and/or lamivudine) to approximately 2,000 patients, the majority of whom were adult Caucasian males (15 % females).
V kontroliranih kliničnih raziskavah po vsem svetu so uporabljali indinavir sam ali v kombinaciji z drugimi protiretrovirusnimi zdravili (zidovudinom, didanozinom, stavudinom in/ali lamivudinom) pri približno 2.000 bolnikih, med katerimi je bila večina moških belcev (15 % žensk).
In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score.
V kontroliranem kliničnem preskušanju periferne nevropatske bolečine je 35% bolnikov, ki so prejemali pregabalin, in 18% bolnikov, ki so prejemali placebo, izkusilo 50%-no izboljšanje v točkovanju bolečine.
In controlled clinical trials, 23.8% of patients in the Provenge group required opioids (a single dose of pethidine) on the day of infusion for infusion reactions compared with 2.4% of patients in control group (see sections 4.2 and 4.4).
V kontroliranih kliničnih preskušanjih so bili pri 23,8 % bolnikov, zdravljenih z zdravilom Provenge, potrebni opioidi (enojni odmerek pethidina) na dan infundiranja zaradi reakcije na infuzijo v primerjavi z 2,4 % bolnikov v kontrolni skupini (glejte poglavji 4.2 in 4.4).
In controlled clinical trials, 23.8% of patients treated with Provenge required opioids (a single dose of pethidine) on the day of infusion for infusion reactions (see sections 4.4 and 4.8).
V kontroliranih kliničnih preskušanjih so bili pri 23,8 % bolnikov, zdravljenih z zdravilom Provenge, potrebni opioidi (enojni odmerek pethidina) na dan infundiranja zaradi reakcije na infuzijo (glejte poglavji 4.4 in 4.8).
In controlled clinical trials, 71.2% of patients in the Provenge group developed an acute infusion reaction.
V kontroliranih kliničnih preskušanjih se je pri 71,2 % bolnikov v skupini z zdravilom Provenge razvila akutna reakcija na infundiranje.
In controlled clinical trials, at the recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to placebo.
V kontroliranih kliničnih preskušanjih s priporočenim odmerkom 5 mg na dan incidenca zaspanosti ni bila večja kot s placebom.
In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Rasilez.
V kontroliranih kliničnih preskušanjih je bila uporaba zdravila Rasilez občasno povezana s klinično pomembnimi spremembami standardnih laboratorijskih parametrov.
In controlled clinical trials, infection occurred in 27.5% of subjects in the Provenge group and 27.7% of subjects in the control group.
V kontroliranih kliničnih preskušanjih se je okužba pojavila pri 27,5 % oseb v skupini z zdravilom Provenge in pri 27,7 % oseb v kontrolni skupini.
In controlled clinical trials, infusion associated reactions (IARs) were defined as any adverse event occurring during or within 24 hours of LEMTRADA infusion.
V kontroliranih kliničnih preskušanjih so z infuzijo povezane reakcije opredelili kot vse neželene dogodke v 24 urah po infundiranju zdravila LEMTRADA.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 microgram/mL even at maximum doses.
V nadzorovanih kliničnih preskušanjih največje koncentracije metformina v plazmi (Cmax) tudi pri največjih odmerkih niso presegle 4 mikrogramov/ml.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 g/ml, even at maximum doses.
V kontroliranih kliničnih preskušanjih, celo pri največjih dovoljenih odmerkih, maksimalna koncentracija metformina v plazmi (Cmax) ni presegla 4 µg/ml.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed µg/ml, even at maximum doses.
V kontroliranih kliničnih preskušanjih najvišje koncentracije metformina v plazmi (Cmax) niso presegale 4 µg/ml niti pri najvišjih odmerkih.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed µg/ml, even at maximum doses.
V kontroliranih kliničnih preskušanjih, celo pri največjih dovoljenih odmerkih, maksimalna koncentracija metformina v plazmi (Cmax) ni presegla 4 μg/ml.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed µg/mL, even at maximum doses.
V nadzorovanih kliničnih preskušanjih največja koncentracija metformina v plazmi (Cmax) tudi pri največjih odmerkih ni presegla 5 μg/ml.
In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of TRAVATAN has been reported in 0.4% of patients.
V kontroliranih kliničnih preskušanjih so pri 0,4% bolnikov poročali o potemnitvi kože okoli očesa, potemnitvi kože vek ali obojega ob uporabi zdravila TRAVATAN.
In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of travoprost has been reported in 0.2% of patients.
V kontroliranih kliničnih preskušanjih so poročali o potemnitvi kože okrog očesa in/ali potemnitvi kože vek ob uporabi travoprosta pri 0,2% bolnikov.
In controlled clinical trials, the dosing interval range was 1 – 15 weeks (see section 5.1).
V kontroliranih kliničnih preskušanjih je razpon intervala odmerjanja 1–15 tednov (glejte poglavje 5.1).
In controlled clinical trials, the incidence of diarrhoea in Rasilez HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
V kontroliranih preskušanjih je bila incidenca driske pri uporabi zdravila Rasilez HCT 1,3 % v primerjavi z 1,4 % pri uporabi samo aliskirena oziroma z 1,9 % pri uporabi samo hidroklorotiazida.
In controlled clinical trials, the incidence of diarrhoea in Riprazo HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
V kontroliranih preskušanjih je bila incidenca driske pri uporabi zdravila Riprazo HCT 1,3 % v primerjavi z 1,4 % pri uporabi samo aliskirena oziroma z 1,9 % pri uporabi samo hidroklorotiazida.
In controlled clinical trials, the incidence of diarrhoea in Sprimeo HCT-treated patients was 1.3% compared to 1.4% for aliskiren- or 1.9% for hydrochlorothiazide-treated patients.
V kontroliranih preskušanjih je bila incidenca driske pri uporabi zdravila Sprimeo HCT 1,3 % v primerjavi z 1,4 % pri uporabi samo aliskirena oziroma z 1,9 % pri uporabi samo hidroklorotiazida.
In controlled clinical trials, the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
V nadzorovanih kliničnih preskušanjih je bila pojavnost srčnega popuščanja pri bolnikih, zdravljenih s pioglitazonom, enaka kot pri bolnikih, zdravljenih s placebom, z metforminom in s sulfonilsečnino, vendar pa je bila pri kombiniranem zdravljenju z insulinom večja.
In controlled Phase 3 trials of Humira in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of Humira-treated patients and 1.8% of control-treated patients.
V kontroliranih preskušanjih faze 3 z zdravilom Humira pri bolnikih s psoriazo s plaki in s trajanjem kontrolnega obdobja od 12 do 24 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 1,8 % bolnikov, zdravljenih z zdravilom Humira, in pri 1,8 % bolnikov v kontrolni skupini.
In controlled Phase 3 trials of Humira in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of Humira-treated patients and 1.8% of control-treated patients.
V kontroliranih preskušanjih faze 3 z zdravilom Humira pri bolnikih s psoriazo v plakih in s trajanjem kontrolnega obdobja od 12 do 24 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 1,8 % bolnikov, zdravljenih z zdravilom Humira, in pri 1,8 % bolnikov v kontrolni skupini.
In controlled Phase 3 trials of Humira in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of Humira-treated patients and 1.6% of control-treated patients.
V kontroliranih preskušanjih faze 3 z zdravilom Humira pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom s trajanjem kontrolnega obdobja od 4 do 104 tedne, so se zvišanja ALT ≥ 3 x ULN (Upper Limits of Normal – zgornja normalna meja) pojavila pri 3,7 % bolnikov, zdravljenih z zdravilom Humira, in pri 1,6 % bolnikov v kontrolni skupini.
In controlled Phase 3 trials of Humira in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of Humira-treated patients and 1.6% of control-treated patients.
V kontroliranih preskušanjih faze 3 z zdravilom Humira pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom s trajanjem kontrolnega obdobja od 4 do 104 tedne, so se zvišanja ALT ≥ 3 x ULN (Upper Limits of Normal – zgornja normalna meja) pojavila pri 3,7% bolnikov, zdravljenih z zdravilom Humira, in pri 1,6 % bolnikov v kontrolni skupini.
In controlled Phase IIb and/or III trials in RA, PsA, AS, nr-Axial SpA, severe persistent asthma, and Phase II/III trials in UC, no patients treated with golimumab developed anaphylactic reactions.
V kontroliranih preskušanjih faze IIb in/ali faze III pri bolnikih z RA, PsA, AS, nr-aksialnim SpA, hudo persistentno astmo in preskušanjih faze II/III pri bolnikih z UK se niso pri nobenem bolniku, zdravljenem z golimumabom, pojavile anafilaktične reakcije.
In controlled studies in thrombocytopenic patients with HCV (n=1,439), 38 out of 955 subjects (4%) treated with eltrombopag experienced a TEE and 6 out of 484 subjects (1%) in the placebo group experienced TEEs.
V nadzorovanih študijah pri trombocitopeničnih bolnikih s HCV (n = 1439), so se trombembolični dogodki pojavili pri 38 od 955 (4 %) bolnikih, ki so prejemali eltrombopag in pri 6 od 484 (1 %) bolnikih, ki so prejemali placebo.
In controlled studies in thrombocytopenic patients with HCV (n=1439), 38 out of 955 subjects (4%) treated with eltrombopag experienced a TEE and 6 out of 484 subjects (1%) in the placebo group experienced TEEs.
V nadzorovanih študijah pri trombocitopeničnih bolnikih s HCV (n = 1439), so se trombembolični dogodki pojavili pri 38 od 955 (4 %) bolnikih, ki so prejemali eltrombopag in pri 6 od 484 (1 %) bolnikih, ki so prejemali placebo.
In controlled studies in thrombocytopenic patients with HCV receiving interferon therapy (n=1,439), progression of pre-existing baseline cataract(s) or incident cataracts was reported in 8% of the eltrombopag group and 5% of the placebo group.
V nadzorovanih študijah pri trombocitopeničnih bolnikih s HCV, ki so prejemali zdravljenje z interferonom (n = 1439), so poročali o napredovanju obstoječe katarakte v izhodišču ali pojavu katarakte pri 8 % v skupini, ki je prejemala eltrombopag in 5 % v skupini, ki je prejemala placebo.
In controlled studies in thrombocytopenic patients with HCV receiving interferon-based therapy (n=1,439), 38 out of 955 subjects (4%) treated with eltrombopag and 6 out of 484 subjects (1%) in the placebo group experienced thromboembolic events (TEEs).
V nadzorovanih študijah pri trombocitopeničnih bolnikih s HCV, ki so bili zdravljeni z interferonom (n = 1439), so se trombembolični dogodki pojavili pri 38 od 955 (4 %) bolnikih, ki so prejemali eltrombopag in pri 6 od 484 (1 %) bolnikih, ki so prejemali placebo.
In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication (34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)], normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16- 18 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
V nadzorovanih študijah je enoletno zdravljenje z lamivudinom znatno zavrlo replikacijo HBV DNA [pri 34 do 57 % bolnikov je bila pod mejo dokazljivosti s testom (Abbott Genostics hibridizacijski test v raztopini, LLOD < 1,6 pg/ml)], normaliziralo aktivnost ALT (pri 40 do 72 % bolnikov), sprožilo serokonverzijo HBeAg (izginotje HBeAg ter pojav protiteles HBeAb z izginotjem HBV DNA z običajnimi testi pri 16 do 18 % bolnikov), izboljšalo histološko sliko (pri 38 do 52 % bolnikov se je Knodell-ov histološki indeks aktivnosti HAI znižal za ≥ 2 točki) in zmanjšalo progresijo fibroze (pri 3 do 17 % bolnikov) in progresijo v cirozo.
In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication [34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)}, normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 16- 18 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
V nadzorovanih študijah je enoletno zdravljenje z lamivudinom znatno zavrlo replikacijo HBV DNA [pri 34 do 57 % bolnikov je bila pod mejo dokazljivosti s testom (Abbott Genostics hibridizacijski test v raztopini, LLOD < 1,6 pg/ml)], normaliziralo aktivnost ALT (pri 40 do 72 % bolnikov), sprožilo serokonverzijo HBeAg (izginotje HBeAg ter pojav protiteles HBeAb z izginotjem HBV DNA z običajnimi testi pri 16 do 18 % bolnikov), izboljšalo histološko sliko (pri 38 do 52 % bolnikov se je Knodell-ov histološki indeks aktivnosti HAI znižal za ≥ 2 točki) in zmanjšalo progresijo fibroze (pri 3 do 17 % bolnikov) in progresijo v cirozo.
In controlled studies, 1158 patients (34.7%) treated with Praluent were ≥65 years of age and 241 patients (7.2%) treated with Praluent were ≥75 years of age.
V kontroliranih študijah je bilo 1158 bolnikov (34,7 %), zdravljenih z zdravilom Praluent, starih ≥ 65 let, 241 bolnikov (7,2 %) zdravljenih z zdravilom Praluent, pa je bilo starih ≥ 75 let.
In controlled studies, the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively.
V nadzorovanih študijah se je plazemska koncentracija karbamazepin epoksida z majhno variabilnostjo povečala za povprečno 37 %, 62 % in 98 % pri odmerkih brivaracetama 50 mg/dan, 100 mg/dan in 200 mg/dan.
In controlled trials in susceptible animals mortality was less than 1%.
V kontrolnih poskusih pri dovzetnih živalih je umrljivost znašala manj kot 1 %.
In controlled trials in susceptible animals, mortality was less than 1%.
Med nadzorovanimi preskusi na občutljivih živalih je bila smrtnost manjša od 1 %.
In controlled trials of Humira (initial doses of 160 mg at Week 0 and 80 mg at Week 2, followed by 40 mg every week starting at Week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of Humira-treated patients and 0.6% of control-treated patients.
V kontroliranih preskušanjih z zdravilom Humira (v začetnem odmerku 160 mg, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu) pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 0,3% bolnikov, zdravljenih z zdravilom Humira, in pri 0,6% bolnikov v kontrolni skupini.
In controlled trials, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo which resolved in a majority of cases with continued dosing.
V nadzorovanih kontroliranih preskušanjih je zamegljen vid navajal večji delež bolnikov, ki so dobivali pregabalin, kot bolnikov, ki so dobivali placebo; med nadaljnjo uporabo je zamegljen vid v večini primerov izginil.
In COPD patients both systemic exposure and total urinary excretion of glycopyrronium at pharmacokinetic steady state increased about dose-proportionally over the (delivered) dose range of 44 to 176 µg.
Pri bolnikih s KOPB sta se tako sistemska izpostavljenost glikopironiju kot njegovo celotno izločanje z urinom v farmakokinetičnem stanju dinamičnega ravnovesja povečevala sorazmerno s prejetim odmerkom v okviru odmerjanja od 44 µg do 176 µg.
In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) glycopyrronium bromide can be used at the recommended dose.
Pri bolnikih s KOPB in blago oziroma zmerno okvaro ledvic (z ocenjeno hitrostjo glomerulne filtracije, eGFR ≥30 ml/min/1,73 m2) je glikopironijev bromid mogoče uporabljati v priporočenem odmerku.
In COPD, Aerivio Spiromax is used in adults who have had exacerbations (flare–ups) of the disease in the past and have significant symptoms despite regular treatment.
Pri KOPB se zdravilo Aerivio Spiromax uporablja pri odraslih s poslabšanji (izbruhi) bolezni v preteklosti, ki imajo izrazite simptome kljub rednemu zdravljenju.
In COPD, Airexar Spiromax is used in adults who have had exacerbations (flare–ups) of the disease in the past and have significant symptoms despite regular treatment.
Pri KOPB se zdravilo Airexar Spiromax uporablja pri odraslih s poslabšanji (izbruhi) bolezni v preteklosti, ki imajo izrazite simptome kljub rednemu zdravljenju.
In corifollitropin alfa, a peptide (a short chain of amino acids) is attached to the FSH to prolong its activity in the body.
V korifolitropinu alfa je na FSH vezan peptid (kratka veriga aminokislin), da se podaljša njegovo delovanje v telesu.
In course 1 the incidence was 20 %, by courses 4 the incidence was 8 %.
V 1. ciklusu je bila incidenca 20 %, do 4. ciklusa pa se je zmanjšala na 8 %.
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast- enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2 ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
Pri magnetnoresonančnem slikanju lobanje se lahko, če močan klinični sum na lezijo ne izgine kljub enkratnem odmerku kontrastnega sredstva ali kadar lahko natančnejša informacija o številu, velikosti ali obsegu lezij vpliva na obravnavanje ali zdravljenje bolnika, pri osebah z normalnim delovanjem ledvic v 30 minutah po prvem injiciranju uporabi druga bolusna injekcija z odmerkom 0,2 ml/kg (100 mikromolov/kg), ker lahko poveča diagnostični izkoristek pregleda.
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast- enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
Pri magnetnoresonančnem slikanju lobanje se lahko, če močan klinični sum na lezijo ne izgine kljub enkratnem odmerku kontrastnega sredstva ali kadar lahko natančnejša informacija o številu, velikosti ali obsegu lezij vpliva na obravnavanje ali zdravljenje bolnika, pri osebah z normalnim delovanjem ledvic v 30 minutah po prvem injiciranju uporabi druga bolusna injekcija z odmerkom 0,2 ml/kg (100 mikromolov/kg), ker lahko poveča diagnostični izkoristek pregleda.
In Crohn’s disease studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of STELARA. (see section 4.4).
V študijah psoriatičnega artritisa sočasna uporaba MTX ni vplivala na varnost in učinkovitost zdravila STELARA (glejte poglavje 4.4).
In Crohn’s disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Pri Crohnovi bolezni je malo izkušenj s ponovnim dajanjem zdravila po ponovitvi znakov in simptomov bolezni, primerjalnih podatkov o koristih ali tveganjih drugih možnosti nadaljnjega zdravljenja pa ni.
In Crohn’s disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Pri Crohnovi bolezni je malo izkušenj s ponovnim dajanjem zdravila po ponovitvi znakov in simptomov bolezni, primerjalnih podatkov o razmerju med koristmi in tveganji drugih možnosti nadaljnjega zdravljenja pa ni.
In Crohn’s disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Pri Crohnovi bolezni je malo izkušenj s ponovno uporabo zdravila po ponovitvi znakov in simptomov bolezni, primerjalnih podatkov o razmerju med koristmi in tveganji drugih možnosti nadaljnjega zdravljenja pa ni.
In Crohn’s disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with anti-TNF-alfa therapy, Entyvio still offers a benefit for patients because of its different mechanism of action and safety profile.
Glede Crohnove bolezni je odbor CHMP menil, da je sicer čas, potreben za izboljšanje simptomov, lahko daljši, obseg učinka pa omejen v primerjavi z zdravljenjem z zaviralci TNF-alfa, vendar ima zdravilo Entyvio zaradi drugačnega mehanizma delovanja ter varnostnega profila kljub temu koristi za bolnike.
In Crohn’s disease, the effects of Stelara in reducing symptoms in patients in whom other treatments had failed or who could not receive them were considered important, also given the unmet medical need of these patients.
Pri Crohnovi bolezni so bili učinki zdravila Stelara pri zmanjševanju simptomov bolezni pri bolnikih, pri katerih druga zdravljenja niso bila uspešna ali teh niso mogli prejemati, pomembni glede na to, da ni drugih zdravil, primernih za te bolnike.
In Crohn’s disease, treatment is started with Stelara concentrate.
Pri Crohnovi bolezni se zdravljenje začne z zdravilom Stelara v obliki koncentrata.
In CRVO and BRVO retinal ischaemia occurs and signals the release of VEGF which in turn destabilises the tight junctions, and promotes endothelial cell proliferation.
Pri CRVO in BRVO se pojavi ishemija mrežnice in spodbuja sproščanje VEGF, ki nato destabilizira tesne stike med endotelijskimi celicami in spodbuja njihovo proliferacijo.