natgillin/translations-raw huggingface dataset:
In 119 imiquimod-treated female patients, the combined total clearance rate was 60% as compared to 20% in 105 vehicle-treated patients (95% CI for rate difference: 20% to 61%, p<0.001).
Pri 119 bolnicah, zdravljenih z imikvimodom, je bil delež bolnic s popolno odstranitvijo bradavic 60%, pri 105 bolnicah, zdravljenih z nosilcem, pa 20% (95% interval zaupanja (IZ) razlike med očistkoma: 20% do 61%, p<0,001).
In 12 dogs suffering from atopic dermatitis, after topical application on the skin at the recommended therapeutic dosage for 28 to 70 consecutive days, no noticeable effect on the systemic cortisol level was observed.
Pri 12 psih, obolelih za atopičnim dermatitisom, po lokalnemi nanosu predpisanega odmerka na kožo v obdobju od 28 do 70 zaporednih dni ni bilo opaznega učinka na sistemsko raven kortizola.
In 12 patients who required major surgery during the study, control of blood loss was also rated as good or excellent by the patients’ doctors.
Tudi pri 12 bolnikih, ki so med študijo potrebovali večji kirurški poseg, so njihovi zdravniki ocenili, da je bil nadzor nad izgubo krvi dober ali odličen.
In 12 patients with available data the AUC and Cmax were approximately equivalent to those observed for the 20 mg/kg dose group in the pivotal trial.
Pri 12 bolnikih z razpoložljivimi podatki sta bila AUC in Cmax približno enakovredna tistim, opaženim pri skupinah, ki so prejemale odmerke 20 mg/kg v osrednji raziskavi.
In 13 treatment-naïve subjects on a stable dolutegravir plus abacavir/lamivudine regimen, dolutegravir concentration in CSF averaged 18 ng/mL (comparable to unbound plasma concentration, and above the IC50).
Pri 13 predhodno še nezdravljenih osebah je bila pri stabilnem režimu zdravljenja s kombinacijo dolutegravirja plus abakavirja/lamivudina povprečna koncentracija dolutegravirja v cerebrospinalni tekočini 18 ng/ml (to je primerljivo z nevezano koncentracijo v plazmi ter presega IC 50).
In 157 imiquimod-treated male patients, the combined total clearance rate was 23% as compared to 5% in 161 vehicle-treated patients (95%CI for rate difference: 3% to 36%, p<0.001).
Pri 157 moških bolnikih, zdravljenih z imikvimodom, je bil delež bolnikov s popolno odstranitvijo bradavic 23%, pri 161 bolnikih, zdravljenih z nosilcem, pa 5% (95% interval zaupanja razlike med očistkoma: 3% do 36%, p<0,001).
In 190 subjects evaluable for objective tumour response, 55 subjects had GCTB surgery, out of which 40 subjects had complete resections.
Od 190 bolnikov, ocenljivih glede objektivnega odziva tumorja, jih je 55 imelo kirurški poseg gigantocelularnega kostnega tumorja, od teh pa 40 popolno resekcijo.
In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 3 months after the first dose.
V 2 kliničnih preskušanjih je 1035 oseb dobilo drugi odmerek cepiva ProQuad približno 3 mesece po prvem cepljenju.
In 2 controlled clinical studies in patients with HCV, ALT or AST  3 x ULN was reported in 34% and 38% of the eltrombopag and placebo groups, respectively.
V dveh nadzorovanih kliničnih študijah pri bolnikih s HCV, so poročali o ALT ali AST  3 x zgornja meja normalne vrednosti pri 34 % v skupini, ki sta prejemali eltrombopag in 38 % v skupini, ki sta prejemali placebo.
In 2 controlled clinical studies in thrombocytopenic patients with HCV, hepatic decompensation (ascites, hepatic encephalopathy, variceal haemorrhage, spontaneous bacterial peritonitis) was reported more frequently in the eltrombopag arm (11%) than in the placebo arm (6%).
V dveh nadzorovanih kliničnih študijah pri trombocitopeničnih bolnikih s HCV so o jetrni dekompenzaciji (ascites, jetrna encefalopatija, krvavitev varic, spontani bakterijski peritonitis) bolj pogosto poročali v skupini, ki sta prejemali eltrombopag (11 %) kot v skupini, ki sta prejemali placebo (6 %).
In 2 controlled clinical studies, 171 chronic paediatric ITP patients were treated with eltrombopag.
V 2 nadzorovanih kliničnih študijah so z eltrombopagom zdravili 171 pediatričnih bolnikov s kronično ITP.
In 2 large randomized, parallel group, double-blind, dose-confirmatory trials, patients undergoing elective major orthopaedic surgery (one for knee replacement surgery and one for hip replacement surgery) received Pradaxa 75 mg or 110 mg within 1-4 hours of surgery followed by 150 mg or 220 mg daily thereafter, haemostasis having been secured, or enoxaparin 40 mg on the day prior to surgery and daily thereafter.
V dveh velikih, randomiziranih, dvojno slepih preskušanjih za potrditev odmerka z vzporednima skupinama so bolniki po večji ortopedski operaciji (v prvem preskušanju po vstavitvi umetnega kolena in v drugem umetnega kolka) prejeli zdravilo Pradaxa po 75 mg ali 110 mg 1 do 4 ure po posegu in nato 150 mg ali 220 mg na dan ob zagotovljeni hemostazi, ali enoksaparin po 40 mg na dan pred operacijo in nato vsak dan po njej.
In 2 of 14 subjects who had acute HIV infection at study enrollment, the K65R mutation was detected in the HIV of 1 of 5 subjects in the tenofovir disoproxil 245 mg (as fumarate) group and the M184V mutation (associated with resistance to emtricitabine) was detected in the HIV of 1 of 3 subjects in the Truvada group.
Pri 2 od 14 oseb, ki so imele akutno okužbo s HIV ob vključitvi v študijo, je bila v HIV zaznana mutacija K65R pri 1 od 5 oseb v skupini, ki je prejemala dizoproksiltenofovirat 245 mg (v obliki fumarata), in zaznana je bila mutacija M184V (povezana z rezistenco na emtricitabin) pri 1 od 3 oseb v skupini, ki je prejemala zdravilo Truvada.
In 2 out of 30 dogs in the clinical trial infertility was not achieved until approximately 12 weeks after initial treatment, but in most cases these animals are not capable of successfully siring offspring.
Dva od 30 psov v kliničnih preskusih nista postala neplodna do približno 12 tednov po prvi uporabi Suprelorina, vendar v večini primerov te živali niso bile sposobne uspešno zaploditi zaroda.
In 2 out of 30 dogs in the clinical trial infertility was not achieved until approximately 12 weeks after initial treatment, but in most cases these animals are not capable of successfully siring offspring.
Dva od 30 psov v kliničnih preskusih nista postala neplodna do približno 12 tednov po prvi uporabi zdravila, vendar v večini primerov te živali niso bile sposobne uspešno zaploditi zaroda.
In 2 Phase 1 studies, it was concluded that the potential for iron overload is minimal and no dose-dependent effects were observed in healthy volunteers.
V dveh študijah faze 1 so ugotovili, da je možnost za prenasičenost z železom minimalna in da pri zdravih prostovoljcih niso opazili učinkov, odvisnih od odmerka.
In 2 phase III clinical trials decreased LVEF has been reported in 6 to 8% of patients treated with trametinib in combination with dabrafenib.with most cases being asymptomatic and reversible.
V dveh kliničnih študijah faze III so o zmanjšanju iztisnega deleža levega prekata poročali pri 6 do 8 % bolnikov, ki so prejemali trametinib v kombinaciji z dabrafenibom, pri čemer je bila večina teh bolnikov brez simptomov, navedene motnje pa so bile reverzibilne.
In 2 pivotal, double-blind, placebo-controlled, clinical trials, a total of 424 patients with euvolaemic or hypervolaemic hyponatraemia (serum sodium <135 mEq/l) due to a variety of underlying causes (heart failure [HF], liver cirrhosis, SIADH and others) were treated for 30 days with tolvaptan (n=216) or placebo (n=208) at an initial dose of 15 mg/day.
V 2 osrednjih, dvojno slepih, s placebom nadziranih kliničnih preskušanjih so v obdobju 30 dni s tolvaptanom (n = 216) ali placebom (n = 208) z začetnim odmerkom 15 mg/dan zdravili skupno 424 bolnikov z euvolemično ali hipervolemično hiponatriemijo (natrij v serumu < 135 mEq/l) zaradi številnih različnih vzrokov (srčno popuščanje [SP], ciroza jeter, SIADH in drugi vzroki).
In 2 placebo-controlled studies the incidence of local injection site reactions with mepolizumab 100 mg subcutaneous and placebo was 8% and 3%, respectively.
V dveh s placebom kontroliranih študijah je bila pojavnost lokalnih reakcij na mestu injiciranja med subkutano uporabo 100 mg mepolizumaba 8 % in med uporabo placeba 3 %.
In 2 randomised, double-blind studies encompassing a total of 1,094 adult patients receiving chemotherapy that included cisplatin  70 mg/m2, aprepitant in combination with an ondansetron/dexamethasone regimen (see section 4.2) was compared with a standard regimen (placebo plus ondansetron 32 mg intravenously administered on Day 1 plus dexamethasone 20 mg orally on Day 1 and 8 mg orally twice daily on Days 2 to 4).
V 2 randomiziranih, dvojno slepih študijah, ki sta skupaj zajeli 1.094 odraslih bolnikov na kemoterapiji, ki je vključevala cisplatin  70 mg/m2, so primerjali aprepitant v kombinaciji z ondansetronom/deksametazonom (glejte poglavje 4.2) in standardno terapijo (placebo in ondansetron 32 mg intravensko 1. dan ter deksametazon 20 mg peroralno 1. dan in 8 mg peroralno dvakrat na dan od 2. do 4. dne).
In 2 studies (XM22-02 and XM22-03) in patients with breast cancer receiving chemotherapy consisting of doxorubicin and docetaxel, mean maximum blood concentrations of 227 and 262 ng/ml were reached after median times to maximum concentration (tmax) of 44 and 48 hours.
V 2 študijah (XM22-02 and XM22-03) pri bolnikih z rakom dojke, ki so prejemali kemoterapijo, sestavljeno iz doksorubicina in docetaksela, sta bili povprečni največji koncentraciji v krvi 227 in 262 ng/ml doseženi po medianem času do maksimalne koncentracije (tmax) 44 in 48 ur.
In 2 studies in healthy subjects the median times to the peak plasma concentrations were 1 and 3 hours after dosing.
V dveh študijah pri zdravih osebah so bile največje koncentracije v plazmi dosežene v povprečju eno oziroma 3 ure po prejemu odmerka.
In 2 studies, treatment was continued in patients whose psoriasis improved with Taltz given every 2 weeks for 12 weeks.
V dveh študijah se je zdravljenje nadaljevalo pri bolnikih, pri katerih se je psoriaza izboljšala v
In 2% and 0.3% of the simeprevir-treated patients grade 3 or 4 ‘blood bilirubin increased’ was reported, respectively (pooled phase 3 studies).
Pri 2% oziroma 0,3% bolnikov, ki so prejemali simeprevir, so poročali o zvečani koncentraciji bilirubina v krvi stopnje 3 oziroma 4 (združeni podatki iz študij faze 3).
In 2-year controlled clinical trials in MS patients, an infusion-related event was defined as an adverse event occurring during the infusion or within 1 hour of the completion of the infusion.
V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS so dogodek, povezan z infuzijo, opredelili kot neželen dogodek, ki se pojavi med infundiranjem ali v eni uri od zaključenega infundiranja.
In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients.
V dveletnih kontroliranih kliničnih preskušanjih pri bolnikih z MS je bila stopnja okužbe približno 1,5 na leto na bolnika, tako pri bolnikih zdravljenih z natalizumabom, kot pri bolnikih, zdravljenih s placebom.
In 20 HIV infected subjects receiving 200 mg emtricitabine daily as hard capsules, steady-state plasma emtricitabine peak concentrations (Cmax), trough concentrations (Cmin) and area under the plasma concentration time curve over a 24-hour dosing interval (AUC) were 1.8±0.7 µg/ml, 0.09±0.07 µg/ml and 10.0±3.1 µg·h/ml, respectively.
Pri 20 bolnikih z okužbo z virusom HIV, ki so prejemali 200 mg emtricitabina dnevno v obliki trdih kapsul, so bile koncentracije dinamičnega ravnovesja plazemskega emtricitabina sledeče: najvišja (Cmax) 1,8 ± 0,7 µg/ml, najnižja (Cmin) 0,09 ± 0,07 µg/ml in površina pod časovno krivuljo plazemske koncentracije v 24-urnem dozirnem intervalu (AUC), 10,0 ± 3,1 µg·h/ml.
In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo.
V 20 s placebom kontroliranih študijah, ki so se izvajale za številne terapevtske indikacije, je bilo skupaj 2.486 bolnikov zdravljenih z bosentanom v dnevnih odmerkih v razponu od 100 mg do 2.000 mg in 1.838 bolnikov s placebom.
In 2016 the CVMP considered that data submitted allowed BTVPUR AlSap 1-8 to convert to a BTVPUR vaccine based on three possible serotypes with one or two serotypes selected depending on the need.
Leta 2016 je odbor CVMP menil, da je na podlagi predloženih podatkov mogoče zdravilo BTVPUR AlSap 1–8 spremeniti v cepivo BTVPUR na podlagi treh možnih serotipov z enim ali dvema izbranima serotipoma glede na potrebe.
In 22 CP patients evaluated for efficacy Tasigna induced a 32% MCyR rate and a 50% CHR rate.
Izmed 22 bolnikov v kronični fazi, pri katerih so ocenjevali učinkovitost, je zdravilo Tasigna povzročilo pomemben citogenetični odziv pri 32 % bolnikov, popolni hematološki odziv pa pri 50 % bolnikov.
In 24 healthy volunteers receiving Rapamune tablets with a high-fat meal, Cmax, tmax and AUC showed increases of 65%, 32%, and 23%, respectively.
Pri 24 zdravih prostovoljcih, ki so zaužili zdravilo Rapamune tablete skupaj z obrokom z visoko vsebnostjo maščob, se je Cmax povečala za 65 %, tmax za 32 % in AUC za 23 %.
In 258 dasatinib-treated patients and 258 imatinib-treated patients with a minimum of 60 months follow-up in the Phase III study in newly diagnosed chronic phase CML, 1 patient (< 1%) in each group had QTc prolongation reported as an adverse reaction.
V skupini 258 bolnikov, ki so prejemali dasatinib in v skupini 258 bolnikov, ki so prejemali imatinib v študiji III. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju, so po najmanj 60-mesečnem obdobju spremljanja o podaljšanju intervala QTc kot neželenem učinku poročali pri 1 bolniku (< 1%) iz vsake skupine.
In 27 reports of Fluenz administration to pregnant women from the US Vaccine Adverse Event Reporting System, no unusual patterns of pregnancy complications or foetal outcomes were observed.
V 27 poročilih izdelanih s strani ameriškega sistema poročanja o neželenih dogodkih v zvezi s cepivi ni bilo mogoče opaziti neobičajnih zapletov v nosečnosti ali izidov za plod pri uporabi cepiva Fluenz pri nosečnicah.
In 27 reports of T/LAIV administration to pregnant women from the US Vaccine Adverse Event Reporting System (VAERS), no unusual patterns of pregnancy complications or foetal outcomes were observed.
V 27 poročilih o uporabi T/LAIV pri nosečnicah na podlagi VAERS (US Vaccine Adverse Event Reporting System) niso ugotovili neobičajnih vzorcev zapletov med nosečnostjo ali izidov pri plodu.
In 3 additional cases where severe hyponatremia was associated with neurological symptoms such as brain oedema or major confusion and cerebral oedema, causality could also not be excluded.
Poleg tega vzorčne povezanosti niso mogli izključiti še v 3 primerih, pri katerih je bila huda hiponatriemija povezana z nevrološkimi simptomi, kot so možganski edem ali huda zmedenost in cerebralni edem.
In 3 controlled and 2 uncontrolled clinical studies, among adult chronic ITP patients receiving eltrombopag (n=446), 17 subjects experienced a total of 19 TEEs, which included (in descending order of occurrence) deep vein thrombosis (n=6), pulmonary embolism (n=6), acute myocardial infarction (n=2), cerebral infarction (n=2), embolism (n=1) (see section 4.4).
Pri odraslih bolnikih s kronično ITP, ki so se v 3 nadzorovanih in 2 nenadzorovanih kliničnih študijah zdravili z eltrombopagom (n = 446), se je pri 17 bolnikih pojavilo 19 trombemboličnih dogodkov, ki so vključevali (po padajoči pojavnosti) globoko vensko trombozo (n = 6), pljučno embolijo (n = 6), akutni miokardni infarkt (n = 2), možganski infarkt (n = 2) in embolijo (n = 1) (glejte poglavje 4.4).
In 3 month studies, evidence of liver toxicity, including elevated enzymes and morphologic alterations, was observed in both rats and monkeys at doses 4- to 6-fold higher than the anticipated clinical therapeutic exposure.
V 3-mesečnih študijah so pri podganah in opicah opažali znake toksičnih učinkov na jetra (vključno z zvišanjem encimov in morfološkimi spremembami) ob odmerkih, ki so bili od 4- do 6-krat večji od predvidene klinične terapevtske izpostavljenosti.
In 3 patients, the daily cysteamine dose exceeded the recommended maximum of 1.95 g/m(2)/day.
Pri treh bolnikih je dnevna doza cysteamina presegla priporočljivo največjo vrednost 1,95 g/m(2)/dan.
In 3.8% of the patients symptoms of SIRS were observed within 24 hours after catumaxomab infusion.
Pri 3,8 % bolnikov so v 24 urah po infundiranju katumaksomaba opazili simptome SIRS.
In 30-week placebo-controlled clinical trials with immediate-release exenatide, concomitant use of exenatide and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
V 30-tedenskih s placebom kontroliranih kliničnih preskušanjih sočasna uporaba eksenatida v obliki s takojšnim sproščanjem in zaviralcev HMG CoA reduktaze ni bila povezana s stalnimi spremembami lipidnega profila (glejte poglavje 5.1).
In 34 % of courses with severe neutropenia, the duration was > 7 days.
V 34 % ciklusov s hudo nevtropenijo je ta trajala > sedem dni.
In 34% of patients receiving 0.6 mg Signifor and 41% of patients receiving 0.9 mg Signifor, urine cortisol levels decreased by at least 50% within six months.
Pri 34 % bolnikov, ki so prejemali zdravilo Signifor v odmerku 0,6 mg, in 41 % bolnikov, ki so prejemali zdravilo Signifor v odmerku 0,9 mg, so se vrednosti kortizola v urinu v šestih mesecih zmanjšale za najmanj 50 %.
In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 µM (29%) mean ± S.D. (% C.V.), steady state Cmin was
35 bolnikih, ki so dobivali 600 mg efavirenza enkrat na dan, so bile v stanju dinamičnega ravnovesja Cmax 12,9 ± 3,7 M (29 %) [povprečje ± S.D. (% C.V.)] , Cmin 5,6 ± 3,2 M (57 %) in AUC
In 35 patients receiving efavirenz 600 mg once daily, steady-state peak concentration (Cmax) was 12.9 ± 3.7 µM (29%) [mean ± standard deviation (S.D.) (coefficient of variation (%CV))], steady-state Cmin was 5.6 ± 3.2 µM (57%), and AUC was 184 ± 73 µM•h (40%).
Pri 35 bolnikih, ki so prejemali 600 mg efavirenza enkrat na dan, so bile v stanju dinamičnega ravnovesja vrednosti Cmax 12,9 ± 3,7 M (29 %) [povprečje ± standardna deviacija (S.D.) (koeficient variabilnosti ( % C. V.))], Cmin 5,6 ± 3,2 M (57 %) in AUC 184 ± 73 M•h (40 %).
In 36 patients with MCL, including 4 poor metabolisers, the effect of CYP2D6 inhibition after administration of single doses of 175 mg and 75 mg temsirolimus was investigated.
Pri 36 bolnikih z MCL, vključno s 4 bolniki s slabo presnovo, so raziskali zaviranje CYP2D6 po enkratnem odmerku 175 mg in 75 mg temsirolimusa.
In 4 controlled and 2 uncontrolled clinical studies, 530 chronic adult ITP patients were treated with eltrombopag.
V 4 nadzorovanih in 2 nenadzorovanih kliničnih študijah so z eltrombopagom zdravili 530 odraslih bolnikov s kronično ITP.
In 4 of those 5 subjects, NRTI resistance was observed as well.
Pri 4 od 5 preiskovancev so opazili tudi odpornost na NRTI.
In 43 CAPS patients followed for up to 5 years the frequency of serious infections was 0.1/year, the most common being pneumonia and gastroenteritis.
Pri 43 bolnikih s CAPS, ki so jih spremljali do 5 let, je bila pogostnost resnih okužb 0,1/leto, najpogostejši pa sta bili pljučnica in gastroenteritis.
In 44 patients with schizophrenia > 65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
44 bolnikih s shizofrenijo, starejših od > 65 let, odmerjanje od 5 do 20 mg/dan ni bilo povezano s kakim razločevalnim profilom neželenih učinkov.
In 44 patients with schizophrenia >65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
44 bolnikih s shizofrenijo, starejših od > 65 let, odmerjanje od 5 do 20 mg/dan ni bilo povezano s kakim razločevalnim profilom neželenih učinkov.
In 44 patients with schizophrenia  65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/dan ni bilo povezano s kakim razločevalnim profilom neželenih učinkov.
In 46 % of courses with moderate to severe anaemia, the duration was > 7 days.
V 46 % ciklusov z zmerno do hudo anemijo je ta trajala > sedem dni.
In 5 cases pallor was associated with systemic events such as hypotension which is already an identified adverse drug reaction of Mirvaso.
V 5 primerih je bila bledica povezana s sistemskimi dogodki, kot je hipotenzija, ki je že znan neželeni učinek zdravila Mirvaso.
In 5 out of these 6 cases, ferumoxytol was administered via IV injection (either quick or slow IV push), for the remaining case the method of administration is unknown.
V 5 od teh 6 primerov so ferumoksitol dajali v obliki i.v. injekcije (bodisi hitrega ali počasnega i.v. bolusa), za preostali primer pa način uporabe ni znan.
In 5 patients with mucormycosis due to Rhizomucor spp., no favourable responses were observed.
Pri 5 bolnikih z zigomikozo zaradi Rhizomucor spp. ni bilo opaziti nobenega ugodnega odziva.
In 5 Phase II clinical studies in patients with resistance or intolerance to prior imatinib therapy, repeated baseline and on-treatment ECGs were obtained at pre-specified time points and read centrally for 865 patients receiving SPRYCEL 70 mg twice daily.
V 5 kliničnih študijah II. faze pri bolnikih, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali, so bili pri 865 bolnikih, ki so prejemali zdravilo SPRYCEL v odmerku 70 mg dvakrat na dan, v izhodišču in vnaprej določenih časovnih točkah med zdravljenjem pridobljeni elektrokardiogrami, ki so bili nato ovrednoteni centralno.
In 5 subjects (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Pri 5 osebah (12,5 %) so uporabo študijskega zdravila zaradi neželenih učinkov ukinili, prilagodili ali prekinili.
In 5,673 vaccinated infants (2,834 in the vaccine group) protective efficacy was measured as a reduction in the incidence of rotavirus (RV) gastroenteritis caused by vaccine G genotypes (G1- G4) that occurred at least 14 days after the third dose of vaccine through the first full rotavirus season after vaccination.
Pri 5.673 cepljenih otrocih (2.834 otrok v skupini, ki je prejemala cepivo) je bila učinkovitost zaščite merjena kot zmanjšanje pojavnosti rotavirusnega (RV) gastroenteritisa, ki so ga povzročili cepilni genotipi G (G1-G4) in ki se je pojavil vsaj 14 dni po prejemu tretjega odmerka cepiva med prvo celotno rotavirusno sezono po cepljenju.
In 6 additional patients reticulin was observed upon bone marrow biopsy (see section 4.4).
Pri 6 nadaljnih bolnikih so retikulin ugotovili z biopsijo kostnega mozga (glejte poglavje 4.4).
In 6 additional studies (two comparative vs. caspofungin and four non- comparative), 636 patients including 53 neutropenic patients and 131 patients with deep tissue infection were studied; the mean durations of intravenous treatment in neutropenics patients and patients with deep tissue infection in these studies were 10.0 (range, 1 to 42 days) and 14.0 (range, 1 to 42 days) days, respectively.
V šestih dodatnih študijah (dveh primerjalnih s kaspofunginom in štirih neprimerjalnih) so preučevali 636 bolnikov, vključno s 53 nevtropeničnimi bolniki in 131 bolniki z okužbo globokega tkiva; intravensko zdravljenje pri nevtropeničnih bolnikih je v povprečju trajalo 10,0 dni (razpon: od 1 do 42 dni), pri bolnikih z okužbo globokega tkiva pa 14,0 dni (razpon: od 1 do 42 dni).
In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Exviera in combination with Viekirax was effective in clearing the virus from the blood.
V šestih glavnih študijah, v katere je bilo vključenih približno 2 300 bolnikov, okuženih z genotipoma 1a ali 1b virusa hepatitisa C, je bilo zdravilo Exviera v kombinaciji z zdravilom Viekirax učinkovito pri odstranjevanju virusa iz krvi.
In 61 of these 117patients FIP1L1- PDGFRα fusion kinase was identified.
Pri 61 od teh 117 bolnikov so odkrili FIP1L1-PDGFRα fuzijsko kinazo.