natgillin/translations-raw huggingface dataset:
At 12 weeks (primary endpoint), Seebri Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
12 tednih je zdravilo Seebri Breezhaler pri bolnikih z najnižjo stopnjo reverzibilnosti ob izhodišču (<5 %) povečalo najnižjo vrednost FEV1 (kar je bil primarni cilj opazovanja) za 72 ml, pri bolnikih z višjo stopnjo reverzibilnosti ob izhodišču (≥5 %) pa za 113 ml v primerjavi s placebom (za obe primerjavi je vrednost p<0,05).
At 12 weeks (primary endpoint), Tovanor Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
12 tednih je zdravilo Tovanor Breezhaler pri bolnikih z najnižjo stopnjo reverzibilnosti ob izhodišču (<5 %) povečalo najnižjo vrednost FEV1 (kar je bil primarni cilj opazovanja) za 72 ml, pri bolnikih z višjo stopnjo reverzibilnosti ob izhodišču (≥5 %) pa za 113 ml v primerjavi s placebom (za obe primerjavi je vrednost p<0,05).
At 12, 24 and 36 months, graft and patient survival were similar for both groups.
Po 12, 24 in 36 mesecih je bilo preživetje presadkov in preživetje bolnikov v obeh skupinah podobno.
At 14 days after initiation of treatment, 16.7 - 25.0% morbidity and 0.3 - 3.9% mortality were observed in the treated group in comparison to 50.0 - 53.3% morbidity and 0.3 - 4.5% mortality in an untreated group.
14 dni po začetku zdravljenja so v skupini, ki je bila zdravljena , zabeležili 16,7–25,0 % obolevnost in 0,3–3,9 % smrtnost v primerjavi s 50,0–53,3 % obolevnostjo in 0,3–4,5 % smrtnostjo v skupini, ki ni bila zdravljena .
At 14 days after initiation of treatment, 16.7 - 25.0% morbidity and 0.3 - 3.9% mortality were observed in the treated group in comparison to 50.0 - 53.3% morbidity and 0.3 - 4.5% mortality in an untreated group.
14 dni po začetku zdravljenja so v skupini, ki je bila zdravljena zabeležili 16,7–25,0 % obolevnost in 0,3– 3,9 % smrtnost v primerjavi s 50,0–53,3 % obolevnostjo in 0,3–4,5 % smrtnostjo v skupini, ki ni bila zdravljena .
At 144 weeks of treatment, the average change from baseline remained similar in both treatment groups (-3.07 and
V 144. tednu zdravljenja je ostala srednja vrednost spremembe od začetne vrednosti podobna v obeh zdravljenih skupinah (-3,07 log10 kopij/ml in
At 144 weeks, the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml was 71% and 68% respectively in the tenofovir disoproxil 245 mg (as fumarate) arm, compared to 64% and 63% in the stavudine arm.
V 144. tednu je bil delež bolnikov s HIV-1 RNA pod 400 kopij/ml 71% in bolnikov z manj kot 50 kopij/ml 68% v skupini z 245 mg dizoproksiltenofoviratom (v obliki dizoproksiltenofovirijevega fumarata) v primerjavi s 64% in 63% v stavudinski skupini.
At 18 months (week 76), 84% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 19% of patients re-randomised to placebo (treatment withdrawal).
18. mesecih (76. teden) je imelo 84% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za vzdrževalno zdravljenje, odziv PASI 75, v primerjavi z 19% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za prejemanje placeba (prenehanje zdravljenja).
At 182 weeks
po 182 tednih
At 2 years, the cumulative incidence of NRM was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI, 31.1-55.7%).
Po 2 letih je bila kumulativna pojavnost NRM 11,3 % (95-odstotni IZ 5,5–19,3 %), stopnja ponovitve ali napredovanja po alo-HCT pa 43,8 % (95-odstotni IZ 31,1–55,7 %).
At 2 years, the rate of non-melanoma skin malignancies was significantly lower in the Rapamune conversion group as compared to the calcineurin inhibitors continuation group (1.8% and 6.9%).
Po 2 letih je bila pogostnost ne-melanomskih kožnih malignih bolezni signifikantno manjša v skupini, ki je prešla na zdravilo Rapamune, kot v skupini, ki je nadaljevala z zaviralci kalcinevrina (1,8 % oziroma 6,9 %).
At 2 years1
pri 2 letih1
At 20 mg/kg bodyweight one of eight animals showed transient generalized body tremors with inability to stand after the first administration and the animal showed transient unsteadiness on its feet after the third administration.
V skupini, ki je dobivala po 20 mg/kg telesne teže, se je pri eni živali od osmih po prvem odmerku pokazal prehoden generaliziran tremor in ni mogla stati, po tretjem odmerku pa so pri njej opazili prehodno nestabilnost.
At 20 minutes post-injection, 75% of the radioactivity in plasma was present as polar metabolites.
20 minut po injiciranju ostane v krvi manj kot 75 % injicirane radioaktivnosti v obliki polarnih presnovkov.
At 208 weeks
po 208 tednih
At 24 months
po 24 mesecih
At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in post- menopausal women in the HORIZON-PFT study.
Po 24 mesecih so pri bolnikih, ki so prejemali zoledronsko kislino, opažali pomembno 3,6-odstotno povečanje mineralne gostote kosti celotnega kolka, kar je podobno učinkom, ki so jih opažali pri postmenopavzalnih ženskah v študiji HORIZON-PFT.
At 24 months a similar significant increase of 3.6% in total hip BMD was observed for patients treated with zoledronic acid as compared to the effects observed in post-menopausal women in the HORIZON-PFT study.
Po 24 mesecih so pri bolnikih, ki so prejemali zoledronsko kislino, opažali pomembno 3,6-odstotno povečanje mineralne gostote kosti celotnega kolka, kar je podobno učinkom, ki so jih opažali pri postmenopavzalnih ženskah v študiji HORIZON-PFT.
At 24 months post-operation, InductOs was demonstrated to be statistically non-inferior to autogenous bone graft with a success rate for radiologically determined fusion of 94.4% for InductOs versus 88.9% for autogenous bone graft (95% two-sided CI of the difference: -1.53, 12.46).
24 mesecev po operaciji je bilo zdravilo InductOs dokazano statistično neinferiorno avtogenemu kostnemu presadku z uspešnostjo radiološko ocenjene fuzije zdravila InductOs 94,4 % in za avtogeni kostni presadek 88,9 % (95 % dvosmerni IZ za razliko: –1,53, 12,46).
At 24 months, estimates for overall survival were 68.2 % in the R-CHOP arm compared to 57.4 % in the CHOP arm.
Pri 24 mesecih je bila ocena celokupnega preživetja v skupini R-CHOP 68,2 %, v skupini CHOP pa 57,4 %.
At 24 weeks, 16 of 23 (70%) adolescents (12 to less than 18 years of age) treated with Tivicay once daily (35 mg n=4, 50 mg n=19) plus OBR achieved viral load <50 copies/mL.
Po 24 tednih je 16 od 23 (70%) mladostnikov (starih od 12 do manj kot 18 let), zdravljenih z zdravilom Tivicay enkrat na dan (35 mg n=4, 50 mg n=19) plus OBR, doseglo virusno obremenitev < 50 kopij/ml.
At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo- treated patients.
V 24. tednu je 56 % bolnikov doseglo PASI 75 v skupini, zdravljeni z etanerceptom, v skupini s placebom pa 5 % bolnikov.
At 24 weeks, reductions in serum uric acid concentrations ranged from –48.3 to –18.3 micromoles/l (–0.87 to –0.33 mg/dl).
Po 24 tednih je znižanje koncentracije sečne kisline v serumu segalo od -48,3 do -18,3 mikromolov/l (-0,87 do -0,33 mg/dl).
At 24 weeks, the percentage of patients whose plasma HIV RNA levels had decreased to below the limit of detection of the assay (< 400 copies/ml) were 81 % and 8 % for the groups treated with nelfinavir 750 mg TID plus zidovudine and lamivudine or zidovudine and lamivudine, respectively.
(< 400 kopij/ml), 81 % za skupine, zdravljene s 750 mg nelfinavirja trikrat na dan v kombinaciji z zidovudinom in lamivudinom, ter 8 % za skupine, zdravljene le z zidovudinom in lamivudinom.
At 250 mg/kg/day, fetal malformations included limb anomalies (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia); moderate dilation of the lateral ventricle in the brain; abnormal placement of the right subclavian artery; absent intermediate lobe in the lungs; low- set kidney; altered liver morphology; incompletely or not ossified pelvis; an increased average for supernumerary thoracic ribs and a reduced average for ossified tarsals.
Pri odmerku 250 mg/kg/dan so deformacije zarodka vključevale anomalije udov (zviti in/ali obrnjeni sprednji in/ali zadnji udi, nepritrjeni ali odsotni prsti) in povezane deformacije okostja (neokostenela dlančnica, neporavnani prstnica in dlančnica, odsotni prsti, neokostenela prstnica in kratka, neokostenela ali zvita golenica); zmerna razširitev lateralnega možganskega ventrikla; nenormalen položaj desne subklavijske arterije; odsoten vmesni pljučni lobus; nizka lega ledvic; spremenjena oblika jeter; nepopolna ali neokostenela medenica; zvišano povprečje odvečnih torakalnih reber in zmanjšano povprečje okostenelih nartov.
At 26 weeks
pri 26 tednih
At 26-weeks
pri 26 tednih
At 3 years, LEMTRADA reduced the risk of 6-month SAD by 76% (hazard ratio 0.24 [95% CI: 0.110, 0.545], p<0.0006) and reduced the ARR by 67% (rate ratio 0.33 [95% CI: 0.196, 0.552], p<0.0001) as compared to subcutaneous IFNB-1a.
Po 3 letih je zdravilo LEMTRADA zmanjšalo tveganje 6-mesečnega SAD za 76 % (razmerje ogroženosti 0,24 [95-odstotni IZ: 0,110; 0,545], p<0,0006) in zmanjšalo stopnjo ARR za 67 % (razmerje stopenj 0,33 [95-odstotni IZ: 0,196; 0,552], p<0,0001) v primerjavi s subkutanim IFNB-1a.
At 3-years, the EFS and overall survival (OS) for the Oncaspar treatment arm were 85.1% [95% CI 72-92%] and 92.4% [95% CI 81-97%], respectively.
Po 3 letih sta bila EFS in celokupno preživetje v skupini, ki je prejemala zdravilo Oncaspar, 85,1 % [95-odstotni IZ 72-92 %] in 92,4 % [95-odstotni IZ 81-97 %], v tem zaporedju.
At 36 month follow-up, the GMT in girls (2 doses, n=86) remained non-inferior to the GMT in women (3doses, n=86) for all 4 HPV types.
Pri spremljanju v 36. mesecu je GMT pri deklicah (2 odmerka, n = 86) ostal neinferioren od GMT pri ženskah (3 odmerki, n = 86) za vse 4 tipe HPV.
At 36 months
po 36 mesecih
At 4 hours post first dose, there was a significant difference in the mean percentage change from baseline plasma uric acid concentration (p <0.0001) in the Fasturtec group (- 86.0%) compared to that for the allopurinol group (-12.1%).
4 ure po prvem odmerku je obstajala statistično značilna razlika v spremembi srednje vrednosti izhodiščne koncentracije sečne kisline v plazmi (p < 0,0001) med skupinama bolnikov, ki so prejemali zdravilo Fasturtec (-86,0 %) in alopurinol (-12,1 %).
At 48 months
po 48 mesecih
At 48 months, there was a statistically significant difference in graft survival in favour of the Rapamune following ciclosporin elimination group compared to the Rapamune with ciclosporin therapy group (including and excluding loss to follow-up).
Po 48 mesecih je bila statistično signifikantna razlika v preživetju presadka v korist skupine z zdravilom Rapamune po ukinitvi ciklosporina v primerjavi s skupino, ki se je zdravila z zdravilom Rapamune in ciklosporinom (ne glede na to, ali so bili bolniki, izgubljeni za spremljanje, vključeni ali izključeni).
At 48 weeks in Phase III study GS-US-264-0106 of virologically suppressed patients switching to Eviplera from a regimen containing a ritonavir-boosted protease inhibitor, the mean change from baseline in total cholesterol (fasted) was -24 mg/dL, in HDL cholesterol (fasted)
V 48. tednu je bila v študiji faze III GS-US-264-0106 pri bolnikih z virološko supresijo, ki so prešli na zdravljenje z zdravilom Eviplera z režima, ki je vseboval zaviralec proteaze, okrepljen z ritonavirjem, povprečna sprememba od začetne vrednosti za skupni holesterol (na tešče)
At 48 weeks non-inferiority in virologic response to the PREZISTA/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 400 and < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both ITT and OP populations.
Po 48 tednih zdravljenja z zdraviloma PREZISTA/ritonavir so inferiornost virološkega odziva, ki je določena kot odstotek bolnikov s koncentracijo HIV-1 RNK v plazmi < 400 kopij/ml in < 50 kopij, dokazali (pri predhodno določeni 12% meji primerljivosti) tako za ITT, kot tudi za OP populacijo bolnikov.
At 48 weeks of treatment the emtricitabine-containing regimen demonstrated an equivalent proportion of patients with HIV RNA < 400 copies/ml (94% emtricitabine versus 92%) and a greater proportion of patients with HIV RNA < 50 copies/ml (95% emtricitabine versus 87%) compared with the patients continuing with their PI-HAART regimen.
V času 48-tedenskega režima zdravljenja, ki je vsebovalo emtricitabin, se je izkazal ekvivalentni delež bolnikov s HIV RNA < 400 virionov/ml (94 % z emtricitabinom proti 92 %) in večji delež bolnikov s HIV RNA < 50 virionov/ml (95 % emtricitabina proti 87 %) v primerjavi z bolniki, ki so nadaljevali s svojim PI-HAART režimom.
At 48 weeks these rates were 25.2% of patients in the tipranavir with ritonavir arm and 15.6% in the comparator arm.
Po 48 tednih so bile te stopnje 25,2% bolnikov v skupini, ki je prejemala tipranavir ob ritonavirju, in 15,6% v primerjalni skupini.
At 48 weeks, approximately 75 % of the patients treated with nelfinavir 750 mg TID plus zidovudine and lamivudine remained below the level of detection of the assay (< 400 copies/ml); mean increase in CD4 cell counts was 198 cells/mm3 at 48 weeks in this group.
Po 48 tednih je približno 75 % bolnikov, zdravljenih s 750 mg nelfinavirja trikrat na dan v kombinaciji z zidovudinom in lamivudinom, ostalo pod mejo zaznave ( 400 kopij/ml); srednje število celic CD4 se je v tej skupini po 48 tednih povečalo za več kot 198 celic/mm3.
At 48 weeks, the difference for dapagliflozin as add-on to sitagliptin (with or without metformin) compared with placebo was -2.22 kg.
Po 48 tednih je bila razlika z dapagliflozinom kot dodatkom sitagliptinu (z ali brez metformina) v primerjavi s placebom -2,22 kg.
At 48 weeks, the difference for dapagliflozin as add-on to sitagliptin (with or without metformin) compared with placebo was -2.22 kg.
Po 48 tednih je bila razlika z dapagliflozinom kot dodatkom sitagliptinu (z ali brez metformina) v primerjavi s placebom –2,22 kg.
At 48-weeks in Phase III trials, rash of various types was observed in 15.5% males and 20.5% females receiving Aptivus co- administered with low dose ritonavir.
Po 48 tednih so v raziskavah III. faze zasledili različne oblike izpuščaja pri 15,5% moških in 20,5% žensk, ki so prejemali zdravilo Aptivus sočasno z majhnimi odmerki ritonavirja.
At 48-weeks, a higher proportion of patients receiving tipranavir with ritonavir achieved a treatment response in comparison to the comparator protease inhibitor/ritonavir for nearly all of the possible combinations of genotypic resistance mutations (see table below).
Po 48 tednih se je na zdravljenje pri skoraj vseh možnih kombinacijah mutacij pri genotipski odpornosti odzivalo več bolnikov, ki so prejemali tipranavir ob ritonavirju, kot tistih, ki so prejemali primerjalni zaviralec proteaze in ritonavir.
At 5 times the recommended dose, decreased bodyweight may be observed.
Pri 5-kratniku priporočenega odmerka se lahko zmanjša telesna masa.
At 5 years following initiation of a 0, 1, 6 month schedule of Twinrix Paediatric in children aged 1-11 years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 97% had anti-HBs antibody ≥10 mIU/ml.
Pet let po začetku cepljenja otrok, starih od 1 do 11 let, s cepivom Twinrix za otroke po shemi 0., 1., 6. mesec so se protitelesa anti-HAV vsem spremljanim preiskovancem ohranila na ≥ 15 mIE/ml in 97 % jih je imelo protitelesa anti-HBs ≥ 10 mi.e./ml.
At 5 years, LEMTRADA reduced the risk of SAD by 69% (hazard ratio 0.31 [95% CI: 0.161, 0.598], p=0.0005) and reduced the ARR by 66% (rate ratio 0.34 [95% CI: 0.202, 0.569], p<0.0001) as compared to subcutaneous IFNB-1a.
Po 5 letih je zdravilo LEMTRADA zmanjšalo tveganje SAD za 69 % (razmerje ogroženosti 0,31 [95- odstotni IZ: 0,161; 0,598], p=0,0005) in zmanjšalo stopnjo ARR za 66 % (razmerje stopenj 0,34 [95-odstotni IZ: 0,202; 0,569], p<0,0001) v primerjavi s subkutanim IFNB-1a.
At 500 mg twice daily, subjects lacking CYP2D6 activity (poor metabolisers, PM) had 62% higher AUC than subjects with CYP2D6 metabolising capacity (extensive metabolisers, EM).
Pri odmerku 500 mg dvakrat na dan je bila pri osebah, pri katerih ni aktivnosti encima CYP2D6 (slabi presnavljavci, SP), vrednost AUC za 62 % večja kot pri osebah s presnovno aktivnostjo encima CYP2D6 (dobri presnavljavci, DP).
At 52 weeks, treatment with Eperzan resulted in statistically significant reductions from baseline in HbA1c compared to placebo.
Po 52 tednih je zdravljenje z zdravilom Eperzan v primerjavi s placebom statistično značilno znižalo HbA1c v primerjavi z izhodiščem.
At 6 months
v 6. mesecu
At 6 months after the last dose, the median reductions in B cell counts were >99% for ofatumumab in combination with chlorambucil and 94% for chlorambucil alone.
Šest mesecev po zadnjem odmerku je bilo mediano zmanjšanje števila celic B pri kombinaciji ofatumumaba in klorambucila > 99 % in pri samem klorambucilu 94 %.
At 6 months, in the active-controlled, randomised, double-blind, multicenter, non-inferiority trial, in the MabThera group, 27%, 58% and 51% of patients with normal immunoglobulin levels at baseline, had low IgA, IgG and IgM levels, respectively compared to 25%, 50% and 46% in the cyclophosphamide group.
V randomiziranem, dvojno slepem, z zdravilno učinkovino kontroliranem multicentričnem preskušanju neinferiornosti so po 6 mesecih pri bolnikih, ki so imeli izhodiščno normalne ravni imunoglobulinov, med prejemniki zdravila MabThera zabeležili nizke IgA, IgG in IgM pri 27 %, 58 % in 51 % (v tem zaporedju), med prejemniki ciklofosfamida pa pri 25 %, 50 % in 46 %.
At 6 months, patients treated with Soliris with no history of RBC transfusion had significantly (p<0.001) reduced LDH levels (median LDH of 305 U/L; Table 4).
Po šestih mesecih so imeli bolniki, zdravljeni z zdravilom Soliris, brez anamneze transfuzije eritrocitov pomembno (p<0,001) znižane ravni LDH (mediana LDH 305 E/l; preglednica 4).
At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60 %) compared with the procarbazine arm (44 %) (chi-square p=0.019).
Po 6 mesecih je bil delež preživelih bolnikov statistično značilno večji v skupini, ki je prejemala TMZ (60 %), kot v tisti, ki je prejemala prokarbazin (44 %) (hi-kvadrat, p = 0,019).
At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60%) compared with the procarbazine arm (44%) (chi-square p = 0.019).
Po šestih mesecih je bila frakcija preživelih bolnikov znatno večja v kraku s TMZ (60 %) kot v kraku s prokarbazinom (44 %) (vrednost p testa hi-kvadrat = 0,019).
At 60 months
po 60 mesecih
At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (AST), C-reactive protein (CRP) and myoglobin levels.
Pri 600 mg je pri eni osebi prišlo do otekanja rok in stopal ter zvišanja koncentracij kreatin-kinaze (CK), aspartat- aminotransferaze (AST), C-reaktivnega proteina (CRP) in mioglobina.
At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), AST, C-reactive protein (CRP) and myoglobin levels.
Pri 600 mg je pri eni osebi prišlo do otekanja rok in stopal ter zvišanja koncentracij kreatin-kinaze (CK), aspartat- aminotransferaze (AST), C-reaktivnega proteina (CRP) in mioglobina.
At 72 months
po 72 mesecih
At 8 years, 81 of 207 patients originally treated with 40 mg Humira every other week were evaluated radiographically.
81 od 207 bolnikov, ki so bili zdravljeni s 40 mg z zdravilom Humira vsak drugi teden, so rentgenografsko ocenili po 8 letih.
At 8 years, 81 of 207 patients originally treated with 40 mg Humira every other week were evaluated radiographically.
81 od 207 bolnikov, ki so bili zdravljeni s 40 mg zdravila Humira vsak drugi teden, so rentgenografsko ocenili po 8 letih.
At 8 years, the survival rate was estimated to be 86.9% in the ACPH arm and 79.4% in the ACP arm, an absolute benefit of 7.4% (95% CI 4.9%, 10.0%).
Po 8 letih je bil delež celokupnega preživetja ocenjen na 86,9 % v skupini AC → PH in 79,4 % v skupini AC → P, z absolutno koristjo 7,4 % (95-% IZ 4,9 %, 10 %).
At 96 weeks, virologic suppression in the dolutegravir group (80%) was superior to the DRV/r group (68%), (adjusted treatment difference [DTG-(DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.2]).
Po 96 tednih je bila virološka supresija v skupini z dolutegravirjem (80 %) superiorna tisti v skupini z DRV/r (68 %) (korigirana razlika med zdravljenjema [DTG-(DRV+RTV)]: 12,4 %, 95 % IZ: [4,7; 20,2].
At a concentration of 0.4 mg/kg/day oxybutynin administered subcutaneously, the occurrence of organ anomalies is significantly increased, but is observed only in the presence of maternal toxicity.
Pri koncentraciji 0,4 mg/kg/dan subkutano danega oksibutinina se je pojavilo pomembno zvišanje organskih anomalij, vendar samo v prisotnosti toksičnosti za mater.
At a dose higher than the recommended dose for adult patients, a case of fatal cardiac failure occurred in the setting of life-threatening cytokine release syndrome (CRS) and tumour lysis syndrome (TLS), see section 4.4.
Med uporabo odmerka, večjega od priporočenega odmerka za odrasle, so zabeležili smrten primer srčnega popuščanja v okviru smrtno nevarnega sindroma sproščanja citokinov in sindroma lize tumorja, glejte poglavje 4.4.
At a dose of 1.0 mg/kg/wk subcutaneous efalizumab, lymphocyte levels returned to within 10% of baseline by 8 weeks post last dose.
Pri odmerku efalizumaba 1,0 mg/kg/teden subkutano, se je raven limfocitov povrnila na 10 % izhodiščne vrednosti v 8 tednih po zadnjem odmerku.
At a dose of 10 mg/kg, mean Vss averaged between 133 (SD 24) ml/kg after multiple dosing, corresponding to a value of approximately 10 l for a 75 kg person.
Pri odmerku 10 mg/kg je bila povprečna vrednost Vss 133 (SD 24) ml/kg po več odmerkih, kar ustreza vrednosti približno 10 l za osebo, ki tehta 75 kg.
At a dose of 100 mg/day, 71% of patients developed an ISR compared to 28% of the placebo treated patients.
Pri odmerku 100 mg/dan so se ISR razvile pri 71 % bolnikov z RA v primerjavi z 28 % bolnikov, ki so dobivali placebo.
At a dose of 100 mg/day, 71% of RA patients developed an ISR compared to 28% of the placebo treated patients.
Pri odmerku 100 mg/dan so se ISR razvile pri 71 % bolnikov z RA v primerjavi z 28 % bolnikov, ki so dobivali placebo.
At a dose of 1–2 mg/kg body weight, robenacoxib tablets produced a marked inhibition of COX-2 activity in cats and had no effect on COX-1 activity.
Pri mačkah so tablete robenakoksiba v odmerkih 1 - 2 mg/kg telesne mase povzročile vidno inhibicijo COX-2 aktivnosti, medtem ko na COX-1 aktivnost niso vplivale.
At a dose of 200 mg/kg, representing 11-fold a human exposure at 10 mg/kg based on AUC, limited changes in immune function (a 9-fold increase in the mean T-cell-dependent antibody response in female pups and inflammation of the thyroid of 1 female pup out of 10 male and 10 female pups evaluated at this dose) were observed.
Pri odmerku 200 mg/kg, kar je na osnovi AUC 11-krat večja izpostavljenost od izpostavljenosti človeka pri odmerku 10 mg/kg, so opazili omejene spremembe imunske funkcije (9-kratno povečanje srednjega T-celičnega protitelesnega odziva pri mladičih ženskega spola in vnetje ščitnice pri mladiču ženskega spola od 10 mladičev moškega in 10 mladičev ženskega spola, pri katerih je bil ta odmerek ovrednoten).
At a dose of 2200 mg/m2 given on days 1, 3 and 5 every 21 days, 2 patients developed a significant grade 3 ascending sensory neuropathy.
Pri uporabi odmerka 2.200 mg/m2 na 1., 3. in 5. dan vsakih 21 dni se je pri 2 bolnikih pojavila pomembna ascendentna senzorična nevropatija stopnje 3.