natgillin/translations-raw huggingface dataset:
140 mg once daily n = 304 All grades Grade 3/4
140 mg enkrat na dan n = 304 Vse stopnje Stopnja 3/4
14C-azacitidine, 85 and 50 % of the administered radioactivity was recovered in urine respectively, while &lt; 1 % was recovered in faeces.
intravenskem in subkutanem dajanju 14C-azacitidina so zaznali 85 % oziroma 50 % radioaktivnosti v urinu in le &lt; 1 % v blatu.
15 Changes in total fasting cholesterol levels from normal at baseline ( &lt; 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
15 Pogosto so opazovali spremembe v ravneh celokupnega holesterola na tešče z normalnih osnovnih vrednosti ( &lt; 4,39 mmol/l), ki so se povišale na visoke (≥ 5,17 mmol/l).
15 Changes in total fasting cholesterol levels from normal at baseline ( &lt; 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
15Pogosto so opazovali spremembe v ravneh celokupnega holesterola na tešče z normalnih osnovnih vrednosti ( &lt; 4,39 mmol/l), ki so se povišale na visoke (≥ 5,17 mmol/l).
15 Changes in total fasting cholesterol levels from normal at baseline ( &lt; 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
15Pogosto so opazovali spremembe vrednosti skupnega holesterola na tešče, ki so se z normalnih osnovnih vrednosti ( &lt; 4,39 mmol/l) zvišale na visoke (≥ 5,17 mmol/l).
150 children were followed-up for three years without booster, additional 150 children received a booster after 1 year (0.25 ml if aged &lt; 3 years at time of the booster, 0.5 ml if aged 3 years and above) and were followed-up for further two years.
150 otrok so spremljali 3 leta brez obnovitvenega odmerka, drugih 150 otrok je po enem letu prejelo obnovitveni odmerek (0,25 ml, če so bili v času prejema obnovitvenega odmerka stari manj kot 3 leta; 0,5 ml, če so bili stari 3 leta ali več) ter so jih spremljali še dve leti.
150 mg for patients with body weight &gt; 40 kg
150 mg za bolnike s telesno maso &gt; 40 kg
150 mg praziquantel &amp; 30 mg emodepside
prazikvantela &amp; 30 mg
150 to &lt; 300 cells/L
150 do &lt; 300 celic/l
15Changes in total fasting cholesterol levels from normal at baseline ( &lt; 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
15 Pogosto so opazovali spremembe v ravneh celokupnega holesterola na tešče z normalnih osnovnih vrednosti ( &lt; 4,39 mmol/l), ki so se povišale na visoke (≥ 5,17 mmol/l).
16 (24.6%), p &lt; 0.0001
16 (24,6 %), p &lt; 0,0001
16% had a Karnofsky Performance Status of 100; 42% had a KPS of 90; 35% had a KPS of 80; 7% had a KPS of 70; and &lt; 1% of patients had a KPS of below 70.
16 % jih je imelo oceno stanja zmogljivosti po Karnofskem (KPS) 100; 42 % jih je imelo KPS 90; 35 % jih je imelo KPS 80; 7 % jih je imelo KPS 70 in &lt; 1 % bolnikov pa je imelo KPS manjše od 70.
16% of patients had &lt; 6 bone metastases, 44% of patients had between 6 and 20 bone metastases, 40% of patients had more than 20 bone metastases or superscan.
16 % bolnikov je imelo &lt; 6 metastaz v kosteh, 44 % bolnikov je imelo med 6 in 20 metastaz v kosteh, 40 % bolnikov je imelo več kot 20 metastaz v kosteh ali intenzivno difuzno kopičenje po celotnem skeletu (t. i. superscan).
16.7% (Mayo regimen); p &lt; 0.0002. The median time to progression was 140 days (capecitabine) vs.
Mediana časa do napredovanja bolezni je bila 140 dni (kapecitabin) v primerjavi s 144 dnevi (shema Mayo).
168 (3 x 56) tablets (multipack)
Velikost ja) pakiranja
17 kg to &lt; 22 kg and 22 kg to &lt; 28 kg, respectively.
17 kg do &lt; 22 kg oziroma 22 kg do &lt; 28 kg.
17 kg to &lt; 22 kg and 28 kg to &lt; 35 kg, respectively.
17 kg do &lt; 22 kg oziroma 28 kg do &lt; 35 kg.
17 kg to &lt; 22 kg who are able to swallow film-coated tablets is one 123 mg tablet once daily taken orally with food.
17 kg do &lt; 22 kg, ki lahko pogoltnejo filmsko obložene tablete, je ena 123 mg tableta enkrat dnevno, peroralno, s hrano.
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score &gt; 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Pri 178 od 580 v študijo vključenih bolnikov (30,7 %) so ugotovili hudo obliko bolezni (ocena CDAI &gt; 300 in sočasna uporaba kortikosteroidov in /ali imunosupresivov), kar ustreza populaciji, opredeljeni v indikacijah (glejte poglavje 4.1).
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score &gt; 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Pri 178 od 580 v študijo vključenih bolnikov (30,7 %) so ugotovili hudo obliko bolezni (ocena CDAI &gt; 300 in sočasna uporaba kortikosteroidov in/ali imunosupresivov), kar ustreza populaciji, opredeljeni v indikacijah (glejte poglavje 4.1).
18 to 22 kg
18 do &lt; 22 kg
18.0% p &lt; 0.001 (12.0, 23.9)
18,0 % p &lt; 0,001 (12,0, 23,9)
19 % of patients had severe neutropenia for &gt; 7 days.
19 % bolnikov je imelo hudo nevtropenijo &gt; 7 dni.
19.3% p &lt; 0.001 (13.0, 25.6)
19,3 % p &lt; 0,001 (13,0, 25,6)
1Adverse events occurring with frequencies &lt; 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid (see section 4.8).
1 Neželene učinke s pogostnostjo &lt; 5 % so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenim varnostnim profilom zoledronske kisline (glejte poglavje 4.8).
1Adverse events occurring with frequencies &lt; 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid as indicated in sections 4.1 and 4.2 (see section 4.8)
1Neželene učinke s pogostnostjo &lt; 5% so ocenili z medicinskega vidika in pokazalo se je, da se ujemajo z že ugotovljenimi varnostnimi značilnostmi zoledronske kisline, uporabljene, kot je navedeno v poglavjih 4.1 in 4.2 (glejte poglavje 4.8).
1Children &lt; 2 years of age.
1Otroci, mlajši od 2 let.
1p &lt; 0.0001, tocilizumab vs. placebo
1p &lt; 0,0001, tocilizumab v primerjavi s placebom
2 HR 95% CI p-value (Z) vs (P) 0.83 (0.76, 0.90) &lt; .001
2 HR 95 % IZ p-vrednost (Z) vs (P) 0,83 (0,76, 0,90) &lt; 0,001
2 mg, 5 mg, 10 mg and 20 mg hard capsules: Apotek Produktion &amp; Laboratorier AB Prismavägen 2
2 mg, 5 mg, 10 mg in 20 mg trde kapsule: Apotek Produktion &amp; Laboratorier AB Primasvägen 2
2 months to &lt; 3 years
2 meseca do &lt; 3 leta
2 p &lt; 0.0001 compared to placebo.
2 p &lt; 0,0001 v primerjavi s placebom.
2 to &lt; 12 years (n = 23)
2 do &lt; 12 let (n = 23)
2 to &lt; 6 years
2 do &lt; 6 let
2 to &lt; 12 years (n=10)
2 do &lt; 12 let (n=10)
2 to &lt; 6 y
2 do &lt; 6 let
2 x baseline and &gt; 10 x ULN*
2 x začetna vrednost in &gt; 10 x ZMN
2% of patients experienced lymphocyte counts &lt; 0.5 x 109/L for at least six months.
Pri 2 % bolnikov je bilo število limfocitov vsaj 6 mesecev &lt; 0,5 x 109/l.
2-3 days before ( &gt; 48 hours)
2 do 3 dni pred ( &gt; 48 ur)
2.5 mg benazepril hydrochloride &amp; 20 mg spironolactone
2,5 mg benazeprilijev hidroklorid &amp; 20 mg spironolakton
20 ml &amp; 50 ml (EU/2/96/001/003, EU/2/96/001/004, EU/2/97/001/006 &amp; EU/2/96/001/007)
100 ml (EU/2/96/001/005 &amp; EU/2/96/001/008)
20 ml vial labels (EU/2/96/001/003 &amp; EU/2/96/001/006 only)
Nalepke na vialah po 20 ml (samo za EU/2/96/001/003 in EU/2/96/001/006)
20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - non- estimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p &lt; 0.0001).
20 meseci v skupini s placebom (95% IZ: [30 – neocenljivo] oziroma [14 – neocenljivo]); (razmerje tveganj = 0,398 [0,259-0,610], p &lt; 0,0001).
200 mg/kg/day for the fetuses (equal to the MRHD on a mg/m2 basis).
&lt; 200 mg/kg/dan za samice in 200 mg/kg/dan za plodove (je enako največjemu priporočenemu odmerku pri ljudeh glede na mg/m2.
200 to &lt; 350
od 200 do &lt; 350
21.7 % of patients had mild renal impairment (CrCL &gt; 50 - &lt; 80 mL/min) and 4.5% of patients had a moderate renal impairment (CrCL between 30 and 50 mL/min).
Blago ledvično okvaro (CrCl &gt; 50 do &lt; 80 ml/min) je imelo 21.7 % bolnikov, zmerno ledvično okvaro (CrCl med 30 in 50 ml/min) pa 4,5 % bolnikov.
22 kg to &lt; 28 kg and 28 kg to &lt; 35 kg, respectively.
22 kg do &lt; 28 kg oziroma 28 kg do &lt; 35 kg.
22 kg to &lt; 28 kg who are able to swallow film-coated tablets is one 163 mg tablet once daily taken orally with food.
22 do &lt; 28 kg, ki lahko pogoltnejo filmsko obložene tablete, je ena 163 mg tableta enkrat dnevno, peroralno, s hrano.
22.9 % and 22.5 % of the patients had a CrCL &gt; 50- &lt; 80 mL/min, and 4.1 % and 4.8 % had a CrCL between 30 and 50 mL/min in in the RE-MEDY and RE-SONATE studies.
CrCl &gt; 50 do &lt; 80 ml/min je imelo 22,9 % oziroma 22,5 % bolnikov, CrCl med 30 in 50 ml/min pa 4,1 % oziroma 4,8 % bolnikov.
245 mg film-coated tablet 12 to &lt; 18 years (n = 8)
245 mg filmsko obložene tablete 12 do &lt; 18 let (n = 8)
25 to &lt; 32.5
25 do &lt; 32.5
25% of the dose is excreted through expired air and a small fraction ( &lt; 3%) recovered in faeces where the amount of pitolisant or BP2.951 was negligible.
25 % odmerka se izloči z izdihanim zrakom, majhen delež ( &lt; 3 %) pa se izloči z blatom, v katerem je količina pitolizanta ali BP2.951 zanemarljiva.
250-499 cells/mm3: Week 1-2 - interrupt dosing until &gt; 750 cells/mm3 then resume dose with a 2 level adjustment; Week 3-48 - interrupt dosing until &gt; 750 cells/mm3 then resume dose with a 1 level adjustment.
250 – 499 celic/mm3: 1.-2. teden – prekinitev odmerjanja, dokler ni doseženo &gt; 750 celic/mm3, nato nadaljevanje z zmanjšanim odmerkom za 2 stopnji; 3.-48. teden – prekinitev odmerjanja dokler &gt; 750 celic/mm3, nato nadaljevanje z zmanjšanim odmerkom za 1 stopnjo.
28 kg to &lt; 35 kg who are able to swallow film-coated tablets is one 204 mg tablet once daily taken orally with food.
28 kg do &lt; 35 kg, ki lahko pogoltnejo filmsko obložene tablete, je ena 204 mg tableta enkrat dnevno, peroralno, s hrano.
28-Day Cycles 1 &amp; 2
1. in 2. cikel 28-dnevnega cikla
29.7% (docetaxel alone); p = 0.0058. Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p &lt; 0.0001).
Čas do napredovanja bolezni je bil v skupini, ki je jemala kapecitabin in docetaksel, daljši (p &lt; 0,0001).
29.7% (docetaxel alone); p = 0.0058. Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p &lt; 0.0001).
Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p &lt; 0,0001).
2D barcode carrying the unique identifier included.
&lt; Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako. &gt;
3 - &lt; 5 years
Otroci 3 - &lt; 5 let
3 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose &lt; 3.1 mmol/L or by the patient needing third party assistance.
3 Potrjena hipoglikemija je bila opredeljena kot potrjena koncentracija glukoze v plazmi &lt; 3,1 mmol/l ali potreba po pomoči druge osebe.
3 m &lt; 1 yr
3 mesece &lt; 1 leto
3 Observed for fasting normal levels at baseline ( &lt; 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
3 Opazovano pri osnovnih normalnih ravneh na tešče ( &lt; 5,17 mmol/l), ki so se povišale na visoke (≥ 6,2 mmol/l).
3 Observed for fasting normal levels at baseline ( &lt; 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
3Opazovano pri normalnih osnovnih vrednostih na tešče ( &lt; 5,17 mmol/l), ki so se zvišale na visoke (≥ 6,2 mmol/l).
3 Observed for fasting normal levels at baseline ( &lt; 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
3Opazovano pri osnovnih normalnih ravneh na tešče ( &lt; 5,17 mmol/l), ki so se povišale na visoke (≥ 6,2 mmol/l).
3 to &lt; 18 years
3 do &lt; 18 let
3% of patients exposed to Taltz had a shift from a normal baseline platelet value to &lt; 150,000 platelet cells/mm3 to ≥75,000 cells/mm3.
Pri 3 % bolnikov, izpostavljenih zdravilu Taltz, je prišlo do spremembe od normalne izhodiščne vrednosti trombocitov do &lt; 150.000 trombocitov/mm3 do ≥ 75.000 celic /mm3.
3.1-4.0 mmol/l (56-72 mg/dl)
&lt; 3,1 mmol/l ( &lt; 56 mg/dl)
3.7% (95% CI: 0.4% to 7.0%. p &lt; 0.017c)
3,7 % (95 % IZ: 0,4 % do 7,0 %. p &lt; 0,017c)
30 to &lt; 50
30 až &lt; 50
30 ≤ and &lt; 50
30 ≤ in &lt; 50
30- &lt; 50
30 až &lt; 50
300 to &lt; 500 cells/L
300 do &lt; 500 celic/l
309 patients had a count ≤ 25,000/μl during the study.
Izmed 309 bolnikov, ki so imeli začetno število trombocitov &gt; 75.000/μl, jih je samo 14 % imelo med preskušanjem število trombocitov ≤ 25.000/μl.
31% (19.9, 43.4) P &lt; 0.001b
31 % (19,9, 43,4) p &lt; 0,001b
32.5 to &lt; 40
32.5 do &lt; 40
35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged &lt; 6 months.
35 dojenčkov, starih manj kot 1 leto, s parcialnimi napadi, od katerih je bilo le 13 starih &lt; 6 mesecev, je bilo vključenih v placebo kontrolirane klinične študije.
35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged &lt; 6 months.
35 dojenčkov, starih manj kot 1 leto, s parcialnimi napadi, od katerih je bilo le 13 starih &lt; 6 mesecev, je bilo vključenih v s placebom kontrolirane klinične študije.
35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged &lt; 6 months.
35 dojenčkov, starih manj kot 1 leto, s parcialnimi napadi, od katerih je bilo le 13 starih &lt; 6 mesecev, je bilo vključenih v s placebom nadzorovane klinične študije.
35 infants aged less than 1 year with partial onset seizures have been exposed in placebo-control clinical studies of which only 13 were aged &lt; 6 months.
V s placebo nadzorovanih kliničnih študijah je bilo izpostavljenih 35 dojenčkov, mlajših od 1 leta, s parcialnimi napadi, od katerih je bilo le 14 mlajših od 6 mesecev.
35 kg &lt; calves ≤ 45 kg: 8 ml of HALOCUR once a day during 7 consecutive days
35 kg &lt; teleta ≤ 45 kg: 8 ml zdravila HALOCUR, 1-krat na dan, 7 zaporednih dni
35 kg &lt; calves ≤ 45 kg: 8 ml of HALOCUR once a day for 7 consecutive days
35 kg &lt; teleta ≤ 45 kg: 8 ml zdravila HALOCUR, 1-krat na dan, 7 zaporednih dni
38% (17-53), p &lt; 0.001
38 % (17 do 53), P &lt; 0,001
39% (27-49), p &lt; 0.001
39 % (27 do 49), P &lt; 0,001
39% (28.0, 51.2) P &lt; 0.001b
39 % (28,0, 51,2) p &lt; 0,001b
4 Final analysis includes patients who crossed over from the placebo group; median duration of exposure to everolimus of 204.1 weeks
4 Končna analiza je vključevala bolnike, ki so prešli iz placebo skupine; mediano trajanje izpostavljenosti everolimusu je bilo 204,1 tedna.
4 hours after at least 2 of the first 4 doses (52 %) than did placebo-treated patients (9 %); p &lt; 0.0001. Stool consistency was not meaningfully improved in patients who had soft stool at baseline.
Bolniki, zdravljeni z metilnaltreksonijevim bromidom, so tudi signifikantno pogosteje iztrebljali v 4 urah po vsaj 2 od prvih 4 odmerkov (52 %) kot bolniki, ki so prejemali placebo (9 %); p &lt; 0,0001.
4 Mean HbA1c change is the difference between the saxagliptin 5 mg + metformin and metformin alone groups (p &lt; 0.0001).
4 Povprečna sprememba HbA1c je razlika med skupinama s kombinacijo 5 mg saksagliptina in metforminom ter z metforminom samim (p &lt; 0,0001).
4 mg/kg for patients with body weight ≥ 7.5 kg and &lt; 15 kg
4 mg/kg za bolnike s telesno maso ≥ 7,5 kg in &lt; 15 kg
4 Observed for fasting normal levels at baseline ( &lt; 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
4 Opazovano pri osnovnih normalnih ravneh na tešče ( &lt; 5,56 mmol/l), ki so se povišale na visoke (≥ 7 mmol/l).
4 Observed for fasting normal levels at baseline ( &lt; 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
4Opazovano pri normalnih osnovnih vrednostih na tešče ( &lt; 5,56 mmol/l), ki so se zvišale na visoke (≥ 7 mmol/l).
4 Observed for fasting normal levels at baseline ( &lt; 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
4Opazovano pri osnovnih normalnih ravneh na tešče ( &lt; 5,56 mmol/l), ki so se povišale na visoke (≥ 7 mmol/l).
4 p=0.0059 compared to placebo.
4 p &lt; 0,0001v primerjavi s placebom. p=0,0059 v primerjavi s placebom.
4 Photosensitivity reactions (in 2.2 % of patients and &lt; 1 % of Visudyne courses) occurred in the form of sunburn following exposure to sunlight, usually within 24 hours from Visudyne treatment.
4 Fotosenzitivnostne reakcije (pri 2,2 % bolnikov in &lt; 1 % ciklusov zdravljenja z zdravilom Visudyne) so se pojavljale v obliki sončnih opeklin po izpostavljanju sončni svetlobi, običajno v 24 urah po zdravljenju z zdravilom Visudyne.
4,000 (number of doses per ampoule is presented on the colour coded clip attached to each cane containing the ampoule)
4.000 (Število odmerkov na ampulo je navedeno na oznaki vsakega niza ampul.)
4. p-value &lt; 0.0001.
Vrednost p &lt; 0,0001.
4.1% (95% CI: 1.6% to 6.7%, p &lt; 0.001c)
4,1 % (95 % IZ: 1,6 % do 6,7 %, p &lt; 0,001c)
40 mg BID &gt; 60 kg
40 mg 2-krat na dan &gt; 60 kg
41% (27-52), p &lt; 0.001
41 % (27 do 52), P &lt; 0,001
44 patients with schizophrenia &gt; 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.
44 patients with schizophrenia &gt; 65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Pri 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/dan ni bilo povezano s kakim razločevalnim profilom neželenih učinkov.
45 kg &lt; calves &lt; 60 kg: 12 ml of HALOCUR once a day during 7 consecutive days
45 kg &lt; teleta &lt; 60 kg: 12 ml zdravila HALOCUR, 1-krat na dan, 7 zaporednih dni
45 kg &lt; calves &lt; 60 kg: 12 ml of HALOCUR once a day for 7 consecutive days
45 kg &lt; teleta &lt; 60 kg: 12 ml zdravila HALOCUR, 1-krat na dan, 7 zaporednih dni
47.3%), p &lt; 0.001.
47,3 %), p &lt; 0,001.
478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score &gt; 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Pri 478 zajetih bolnikih (32%) je bila bolezen opredeljena kot huda (seštevek CDAI &gt; 300 ter sočasno zdravljenje s kortikosteroidom in//ali imunosupresivom), kar ustreza populaciji, opredeljeni pri indikacijah (glejte poglavje 4.1).
478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score &gt; 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Pri 478 zajetih bolnikih (32%) je bila bolezen opredeljena kot huda (seštevek CDAI &gt; 300 ter sočasno zdravljenje s kortikosteroidom in/ali imunosupresivom), kar ustreza populaciji, opredeljeni pri indikacijah (glejte poglavje 4.1).
48.7% of patients reached the HbA1c target of &lt; 7% without confirmed hypoglycaemic episodes, which was a significantly higher proportion than observed with insulin degludec (15.6%, odds ratio 5.57, p &lt; 0.0001).
Ciljno vrednost HbA1c &lt; 7 % je doseglo 48,7 % bolnikov brez potrjenih hipoglikemij, kar je pomembno večji delež od deleža pri uporabi insulina degludek (15,6 %, razmerje obetov 5,57, p &lt; 0,0001).
49% (26-64), p &lt; 0.001
49 % (26 do 64), P &lt; 0,001
4Children &lt; 5 years of age.
4Otroci, mlajši od 5 let.
5 mg benazepril hydrochloride &amp; 40 mg spironolactone
5 mg benazeprilijev hidroklorid &amp; 40 mg spironolakton
5 Observed for fasting normal levels at baseline ( &lt; 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
5 Opazovano pri osnovnih normalnih ravneh na tešče ( &lt; 1,69 mmol/l), ki so se povišale na visoke (≥ 2,26 mmol/l).
5 Observed for fasting normal levels at baseline ( &lt; 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
5Opazovano pri osnovnih normalnih ravneh na tešče ( &lt; 1,69 mmol/l), ki so se povišale na visoke (≥ 2,26 mmol/l).
5 Observed for fasting normal levels at baseline ( &lt; 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
5Učinek so opazili pri normalnih izhodiščnih vrednostih na tešče ( &lt; 1,69 mmol/l), ki so se povečale (≥ 2,26 mmol/).
5 years to &lt; 10 years
5 let do &lt; 10 let
5 yrs &lt; 10 yrs
5 let &lt; 10 let
50 &lt; CrCl 80 mL/min (mild renal impairment).
50 &lt; CrCl  80 ml/min (blaga okvara ledvic).
50 mg praziquantel &amp; 10 mg emodepside
prazikvantela &amp; 10 mg emodepsida
50 ml &amp; 100 ml vial labels (EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/007 &amp; EU/2/96/001/008 only)
Nalepke na vialah po 50 ml in 100 ml (samo za EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/0007 in EU/2/96/001/008)
50 to &lt; 100 cells/mm3
50 do &lt; 100 celic/mm3
50 to &lt; 200
od 50 do &lt; 200
50 ≤ and &lt; 80
50 ≤ in &lt; 80
50.6% (p &lt; 0.0001)
(p &lt; 0,0001)
500-749 cells/mm3: Week 1-2 - interrupt dosing until &gt; 750 cells/mm3 then resume dose with a 1 level adjustment, assess weekly for the next 3 weeks to verify ANC &gt; 750 cells/mm3; Week 3-48 - immediate 1 level adjustment.
500 – 749 celic/mm3: 1.-2. teden – prekinitev odmerjanja, dokler ni doseženo &gt; 750 celic/mm3, nato nadaljevanje z odmerkom, zmanjšanim za 1 stopnjo; naslednje 3 tedne preverjanje enkrat tedensko, ali je absolutno število nevtrofilcev (ANC) &gt; 750 celic/mm3; 3.-48. teden – takojšnja prilagoditev odmerka za 1 stopnjo.
5000 microgram (mcg/ml) for patients &gt; 2 years of age with a BSA of &gt; 1.3
5000 mikrogramov (μg/ml) za bolnike starosti &gt; 2 let s telesno površino &gt; 1,3
54.3% of patients treated with Xultophy reached the HbA1c target of &lt; 7% without confirmed hypoglycaemic episodes compared to 29.4% of patients treated with insulin glargine (odds ratio 3.24, p &lt; 0.001).
Pri zdravljenju z zdravilom Xultophy je ciljno vrednost HbA1c &lt; 7 % brez potrjenih hipoglikemij doseglo 54,3 % bolnikov v primerjavi z 29,4 % bolnikov, ki so se zdravili z insulinom glargin (razmerje obetov 3,24, p &lt; 0,001).
56 paediatric PKU patients &lt; 4 years of age were randomized 1:1 to receive either 10 mg/kg/day Kuvan plus a phenylalanine-restricted diet (n=27), or just a phenylalanine-restricted diet (n=29) over a 26-week Study Period.
56 pediatričnih bolnikov s PKU, starih &lt; 4 leta, je bilo randomiziranih v razmerju 1:1 za prejemanje bodisi 10 mg/kg/dan zdravila Kuvan in diete z omejitvijo fenilalanina (n = 27) ali le diete z omejitvijo fenilalanina (n = 29) v 26-tedenskem obdobju študije.
6 - &lt; 12 years (N=12)
6 - &lt; 12 let (N = 12)
6 months, with Plegridy 125 micrograms every 2 weeks demonstrating a 61% reduction (p &lt; 0.0001) in new or newly enlarging T2 lesions as compared with placebo.
125 mikrogramov vsaka 2 tedna pokazalo 61 % zmanjšanje (p &lt; 0,0001) novih ali na novo povečanih lezij T2 v primerjavi s placebom.
6 months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count &lt; 50 x 109/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
&lt; 50 x 109/l), potreba po klopidogrelu ali peroralnih antikoagulantih ali intoleranca za katero od obeh snovi.
6 to &lt; 12 months
6 do &lt; 12 mesecev
6 to &lt; 12 years
6 do &lt; 12 let
6 to &lt; 12 years ETR
6 do &lt; 12 let ETR N=41
6 to &lt; 17 years
6 do &lt; 17 let
6 to &lt; 18 years ETR
6 do &lt; 18 let ETR N=101
6 to &lt; 12 y
6 do &lt; 12 let
6 to &lt; 12 years (N=15)
6 do &lt; 12 let (N=15)
6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p &lt; 0.001).
12-mesečne) je bil po 26 tednih delež bolnikov, ki so dosegli izboljšanje ocene SGRQ za 4 točke ali več, statistično značilno večji med bolniki, ki so prejemali zdravilo Tovanor Breezhaler, v primerjavi s tistimi, ki so prejemali placebo (57,8 % v primerjavi s 47,6 %, p &lt; 0,001).
6- &lt; 12 years N=27
6- &lt; 12 let
6- &lt; 12 years N=27
6- &lt; 12 ára N=27
6.7%, p &lt; 0.001c)
1,6 % do 6,7 %, p &lt; 0,001c)