natgillin/translations-raw huggingface dataset:
1: adverse reactions noted with increased frequency when bexarotene was administered at a dose
1: nuspojave zabilježene povećanom učestalošću kad se beksaroten primjenjivao u dozi od &gt; 300 mg/m2 na dan.
1 &gt; &lt; 60 &gt; &lt; 70 &gt; &lt; 70 x 1 &gt; &lt; 98 &gt; &lt; 98 x 1 &gt; OLANZAPINE TEVA 10 mg FILM-COATED TABLETS
&gt; &lt; 98 &gt; &lt; 98 x 1 &gt; OLANZAPIN TEVA 10 mg FILMOM OBLOŽENIH TABLETA
1 &gt; &lt; 98 &gt; &lt; 98 x 1 &gt; film-coated tablets
&gt; &lt; 98 &gt; &lt; 98 x 1 &gt; filmom obloženih tableta
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 Štetni događaji koji nastaju s učestalošću &lt; 5% bili su medicinski procijenjeni i pokazalo se da su u skladu s dobro utvrđenim sigurnosnim profilom zoledronatne kiseline (vidjeti dio 4.8).
1Children &lt; 2 years of age.
1Djeca &lt; 2 godine.
1p &lt; 0.0001, tocilizumab vs. placebo
1p &lt; 0,0001, tocilizumab u odnosu na placebo
1st occurrence of QTc &gt; 500 ms during treatment and change from pre-treatment value remains &lt; 60 ms
Prvi nastup produljenja QTc na &gt; 500 ms tijekom liječenja, a promjena u odnosu na vrijednosti prije liječenja ostaje &lt; 60 ms
2 ( &lt; 0.1%) patients, respectively, receiving pembrolizumab.
2 ( &lt; 0,1%) bolesnika.
2 mg, 5 mg, 10 mg and 20 mg hard capsules: Apotek Produktion &amp; Laboratorier AB Prismavägen 2
2 mg, 5 mg, 10 mg i 20 mg tvrde kapsule: Apotek Produktion &amp; Laboratorier AB Prismavägen 2
2 months to &lt; 3 years
2 mjeseca do &lt; 3 godine
2 p &lt; 0.0001 compared to placebo.
2 p &lt; 0,0001 u usporedbi s placebom.
2 Phenotypic resistance to rilpivirine ( &gt; 3.7-fold change compared to control).
2 Fenotipska rezistencija na rilpivirin (promjena za više od &gt; 3,7 puta u usporedbi s kontrolom).
2 to &lt; 12 years (n = 23)
2 do &lt; 12 godina (n = 23)
2 to &lt; 6 years
2 do &lt; 6 godina
2 to &lt; 12 years (n=10)
od 2 do &lt; 12 godina (N = 10)
2 to &lt; 6 y
2 do &lt; 6 god
2- to 5-year-olds ( &lt; 14 kg)
od 2 do 5 godina ( &lt; 14 kg)
2- to 5-year-olds (≥14 kg to &lt; 25 kg)
od 2 do 5 godina (≥14 kg do &lt; 25 kg)
2-3 days before ( &gt; 48 hours)
2-3 dana prije ( &gt; 48 sati)
2.00 (1.56, 2.55) , P &lt; 0.0001
117/1026 (11,4%)
2.06f (1.41, 3.00)
&lt; 0,0001c
2.30 (1.83, 2.90) , P &lt; 0.0001
138/1009 (13,7%)
2.5 to &lt; 5
2,5 do &lt; 5
2.5 to &lt; 6
2,5 do &lt; 6
2.5 x ULN*
&gt; 10 x GGN
20 7%; P &lt; .0001
20 7%; P &lt; 0,0001
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)
20 ml i 50 ml (EU/2/96/001/003, EU/2/96/001/004, EU/2/97/001/006 &amp; EU/2/96/001/007)
20 ml vial labels (EU/2/96/001/003 &amp; EU/2/96/001/006 only)
20 ml bočice s etiketom(EU/2/96/001/003i EU/2/96/001/006 samo)
20 to 52 [ &lt; 0.0001]
20 do 52 [ &lt; 0,0001]
20 to &lt; 25
20 do &lt; 25
20 to &lt; 40
20 do &lt; 40
20 to &lt; 30 kg
20 do &lt; 30 kg
20 to &lt; 30 kg
od 20 do &lt; 30 kg
200 to &lt; 350
200 do &lt; 350
21 ART-experienced HIV-1 infected paediatric patients aged from 3 to &lt; 6 years and weighing 10 kg to &lt; 20 kg (16 participants from 15 kg to &lt; 20 kg) who received PREZISTA oral suspension with low dose ritonavir twice daily in combination with other antiretroviral agents.
21 pedijatrijski bolesnik u dobi od 3 do &lt; 6 godina i težine od 10 kg do &lt; 20 kg (16 ispitanika imalo je od 15 kg do &lt; 20 kg), prethodno liječeni ART-om, a inficirani su virusom HIV-1 te su primali PREZISTA oralnu suspenziju s niskom dozom ritonavira dva puta na dan u kombinaciji s drugim antiretrovirusnim lijekovima.
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).
21,7 % bolesnika imalo je blago oštećenje bubrega (CrCL &gt; 50 - &lt; 80 mL/min) i 4,5% bolesnika imalo je umjereno oštećenje bubrega (CrCL između 30 i 50 mL/min).
22 to &lt; 24
22 do &lt; 24
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.
22,9 % i 22,5 % bolesnika imalo je CrCL &gt; 50 - &lt; 80 mL/min, a 4,1 % i 4,8 % imalo je CrCL između 30 i 50 mL/min u ispitivanjima RE-MEDY i RE-SONATE.
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.
22,9 % i 22,5 % bolesnika imalo je CrCL &gt; 50- &lt; 80 mL/min, a 4,1 % i 4,8 % imalo je CrCL između 30 i 50 mL/min u ispitivanjima RE-MEDY i RE-SONATE.
24 to &lt; 27
24 do &lt; 27
24 to &lt; 36
24 do &lt; 36
245 mg film-coated tablet 12 to &lt; 18 years (n = 8)
245 mg filmom obložene tablete 12 do &lt; 18 godina (n = 8)
25 to 67 [ &lt; 0.0001]
25 do 67 [ &lt; 0,0001]
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.
Izdahnutim zrakom izlučuje se 25 % doze, a mala frakcija ( &lt; 3%) nađe se u stolici, gdje je količina pitolizanta ili BP2.951 bila zanemariva.
26.2L/min p &lt; 0.001 (18.0, 34.3)
26,2 l/min p &lt; 0,001 (18,0; 34,3)
27 (13)b
1 ( &lt; 1)
27 to &lt; 29
27 do &lt; 29
27 to &lt; 32
27 do &lt; 32
28-Day Cycles 1 &amp; 2
1. i 2.
28.2L/min p &lt; 0.001 (21.7, 34.8)
28,2 l/min p &lt; 0,001 (21,7; 34,8)
29 to &lt; 32
29 do &lt; 32
29.6 days or a 66% reduction, p &lt; 0.0001).
29,6 dana ili smanjenje za 66%, p &lt; 0,0001).
29.7% (docetaxel alone); p = 0.0058. Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p &lt; 0.0001).
Vrijeme do progresije bolesti bilo je duže u skupini koja je liječena kombinacijom kapecitabina i docetaksela (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).
Vrijeme do progresije bolesti je bilo dulje u skupini koja je primala kombinaciju docetaksel + kapecitabin (p &lt; 0,0001).
2D barcode carrying the unique identifier included.
&lt; Sadrži 2D barkod s jedinstvenim identifikatorom. &gt;
2D barcode carrying the unique identifier included.
Sadrži 2D barkod s jedinstvenim identifikatorom. &gt;
2nd occurrence of QTc &gt; 500 ms during treatment and change from pre-treatment value remains &lt; 60 ms
Drugi nastup produljenja QTc na &gt; 500 ms tijekom liječenja, a promjena u odnosu na vrijednosti prije liječenja ostaje &lt; 60 ms
3 ( &gt; 5-10 x ULN)
3 ( &gt; 5-10 x GGN)
3 - &lt; 5 years
3 - &lt; 5 godina
3 Abbott Genostics solution hybridisation assay (LLOD &lt; 1.6 pg/ml 4 Chiron Quantiplex assay (LLOD 0.7 Meq/ml)
Abbott Genostics hibridizacijski test u otopini (LLOD &lt; 1,6 pg/ml) 4 Chiron Quantiplex test (LLOD 0,7 Meq/ml)
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 Potvrđena hipoglikemija definirana je kao epizoda potvrđena razinom glukoze u plazmi &lt; 3,1 mmol/l ili time što je bolesniku potrebna pomoć druge osobe.
3 m &lt; 1 yr
3 mj &lt; 1 god
3 months to &lt; 1 year
od 3 mjeseca do &lt; 1 godine
3 Observed for fasting normal levels at baseline ( &lt; 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
3 Opažena kod normalnih vrijednosti natašte na početku ( &lt; 5,17 mmol/l) koje su porasle do visokih (≥ 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).
3 Uočeno za početne normalne razine natašte ( &lt; 5,17 mmol/l) koje su porasle na visoke razine (≥ 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).
&lt; 2,26 mmol/l) do visokih vrijednosti (≥ 2,26 mmol/l) bile su vrlo česte.
3 p &lt; 0.0001 compared to placebo.
3 p &lt; 0,0001 u usporedbi s placebom.
3 to &lt; 18 years
3 do &lt; 18 godina
3 Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial &lt; 100 mg/dl (5.5 mmol/l), post-prandial &lt; 140 mg/dl (7.8 mmol/l)
3 19. - 40. tjedan režima liječenja usmjerenog ka cilju (engl. treat-to-target) za prilagođavanje doze inzulina kako bi se postigle prethodno definirane ciljne razine glukoze u krvi ( &lt; 100 mg/dl (5,5 mmol/l) preprandijalno, &lt; 140 mg/dl (7,8 mmol/l) postprandijalno)
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.
U 3% bolesnika izloženih lijeku Taltz došlo je do promjene broja trombocita od početne normalne vrijednosti na &lt; 150 000 stanica/mm3 do ≥ 75 000 stanica/mm3.
3.46 (2.08, 5.77) p = &lt; 0.001*
3,46 (2,08; 5,77)p = &lt; 0,001
3.5 to &lt; 5
3,5 do &lt; 5
30 25%; P &lt; .0001
30 25%; P &lt; 0,0001
30 to &lt; 50
30 do &lt; 50
30 to &lt; 40 kg
30 do &lt; 40 kg
30 to &lt; 40 kg
od 30 do &lt; 40 kg
30 to &lt; 50
30 do 50
30 ≤ and &lt; 50
30 ≤ i &lt; 50
30.7L/min p &lt; 0.001 (22.5, 38.9)
30,7 l/min p &lt; 0,001 (22,5; 38,9)
300 to &lt; 500 cells/L
300 do &lt; 500 stanica/l
31% (19.9, 43.4) P &lt; 0.001b
31% (19,9; 43,4) P &lt; 0,001b
32 to &lt; 34
32 do &lt; 34
32%; P &lt; .0001
32%; P &lt; 0,0001
32.5 to &lt; 40
32,5 do &lt; 40
32.9L/min p &lt; 0.001 (24.8, 41.1)
32,9 l/min p &lt; 0,001 (24,8; 41,1)
33.3L/min p &lt; 0.001 (26.5, 40.0)
33,3 l/min p &lt; 0,001 (26,5; 40,0)
33.5L/min p &lt; 0.001 (22.3, 41.7)
33,5 l/min p &lt; 0,001 (22,3; 41,7)
34 to &lt; 35
34 do &lt; 35
34%, p &lt; .0055
34%, p &lt; 0,0055
34.6 (26.4, 43.6)
3,46 (1,90; 6,27); &lt; 0,001a
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 dojenčadi s parcijalnim napadajima u dobi od manje od 1 godine, od kojih je samo njih 13 bilo u dobi &lt; 6 mjeseci, bilo je uključeno u placebo kontroliranu kliničku studiju.
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.
Trideset i pet dojenčadi mlađe od godine dana s parcijalnim napadajima bili su izloženi lijeku u placebom kontroliranim kliničkim ispitivanjima od kojih su samo njih 13 bili mlađi od 6 mjeseci.
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.
U placebom kontroliranim kliničkim ispitivanjima lijeku je bilo izloženo 35 dojenčadi mlađe od 1 godine s parcijalnim napadajima, a samo je njih 13 bilo u dobi &lt; 6 mjeseci.
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.
U placebom kontroliranim kliničkim ispitivanjima lijeku je bilo izloženo 35 dojenčadi mlađe od 1 godine s parcijalnim napadajima, a samo je njih 13 bilo u dobi ˂ 6 mjeseci.
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.
U placebom kontroliranim kliničkim ispitivanjima lijeku je bilo izloženo35 dojenčadi mlađe od 1 godine s parcijalnim napadajima, a samo je njih 13 bilo u dobi ˂ 6 mjeseci.
36 to &lt; 75
36 do &lt; 75
3663
P &lt; 0
39 ml/min/1.73 m2, n=9), and Severe (CrCL &lt; 20 ml/min/1.73 m2, n=3).
&lt; 20 ml/min/1,73 m2, n=3).
39% (28.0, 51.2) P &lt; 0.001b
39% (28,0; 51,2) P &lt; 0,001b
3: adverse reactions noted with increased frequency when bexarotene was administered at a dose of &gt; 300 mg/m2/day (compared to administration to CTCL patients at 300 mg/m2/day) in non-CTCL cancer patients.
3: nuspojave zabilježene povećanom učestalošću kad se beksaroten primjenjivao u dozi od &gt; 300 mg/m2 na dan (u usporedbi s primjenom doze od 300 mg/m2 na dan bolesnicima s CTCL-om) u onkoloških bolesnika bez CTCL-a.
3rd occurrence of QTc &gt; 500 ms during treatment and change from pre-treatment value remains &lt; 60 ms
Treći nastup produljenja QTc na &gt; 500 ms tijekom liječenja, a promjena u odnosu na vrijednosti prije liječenja ostaje &lt; 60 ms
4 ( &lt; 6.5 g/dL)
4 ( &lt; 6,5 g/dl)
4 ( &gt; 10 x ULN)
4 ( &gt; 10 x GGN)
4 Final analysis includes patients who crossed over from the placebo group; median duration of exposure to everolimus of 204.1 weeks
4 Završna analiza uključuje bolesnike koji su prešli iz placebo skupine; medijan trajanja izloženosti everolimusu bio je 204,1 tjedan
4 Mean HbA1c change is the difference between the saxagliptin 5 mg + metformin and metformin alone groups (p &lt; 0.0001).
4 Srednja promjena vrijednosti HbA1c je razlika između skupine koja je primala saksagliptin 5 mg + metformin i skupine koja je primala samo metformin (p &lt; 0,0001).
4 mg/kg for patients with body weight ≥ 7.5 kg and &lt; 15 kg
4 mg/kg za bolesnike s tjelesnom težinom ≥7,5 kg i &lt; 15 kg
4 Observed for fasting normal levels at baseline ( &lt; 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
4 Uočena kod normalnih vrijednosti natašte na početku ( &lt; 5,56 mmol/l) koje su porasle 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).
4 Uočeno za početne normalne razine natašte ( &lt; 5,56 mmol/l) koje su porasle na visoke razine (≥ 7 mmol/l).
4 p=0.0059 compared to placebo.
4 p &lt; 0,0059 u usporedbi 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 Reakcije fotosenzibilnosti (u 2,2% bolesnika i &lt; 1% infuzija Visudyneom) javljale su se u obliku sunčanih opeklina nakon izlaganja sunčevoj svjetlosti, obično unutar 24 sata od liječenja Visudyneom.
4. p-value &lt; 0.0001.
4. p-vrijednost &lt; 0,0001.
4.02 (2.94, 5.50)
4,02 (2,94; 5,50) p &lt; 0,0001
4.04 p &lt; 0.0001
p &lt; 0,0001
4.5 log10 copies/mL (range: 1.3-7.0) and 23% had baseline viral loads &gt; 100,000 copies/mL.
4,5 log10 kopija/ml (raspon: 1,3-7,0), a 23% imalo je početno virusno opterećenje &gt; 100 000 kopija/ml.
40 20%; P &lt; .0001
40 20%; P &lt; 0,0001
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.
U 44 bolesnika sa shizofrenijom starijih od 65 godina doziranje od 5 do 20 mg/dan nije bilo povezano ni sa kakvim posebnim profilom nuspojava.
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.
U 44 bolesnika sa shizofrenijom, starijih od 65 godina doziranje od 5 do 20 mg/dan nije bilo povezano ni sa kakvim posebnim profilom nuspojava.
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).
48,7% bolesnika postiglo je ciljnu vrijednost HbA1c &lt; 7% bez potvrđenih epizoda hipoglikemije, što je bio značajno veći udio od onog zapaženog s degludek inzulinom (15,6%; omjer šansi: 5,57; p &lt; 0,0001).
4Children &lt; 5 years of age.
4 Djeca &lt; 5 godina.
5 Observed for fasting normal levels at baseline ( &lt; 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
5 Opažena kod normalnih vrijednosti natašte na početku ( &lt; 1,69 mmol/l) koje su porasle 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).
5 Uočeno za početne normalne razine natašte ( &lt; 1,69 mmol/l) koje su porasle na visoke razine (≥ 2,26 mmol/l).
5 p=0.0157 compared to placebo.
5 p &lt; 0,0157 u usporedbi s placebom.
5 to &lt; 10
5 do &lt; 10
5 to &lt; 15
5 do &lt; 15
5 to &lt; 7.5
5 do &lt; 7,5
5 to &lt; 10 kg
5 do &lt; 10 kg
5 to &lt; 10 kg
od 5 do &lt; 10 kg
5 to &lt; 7
5 do &lt; 7
5 years to &lt; 10 years
od 5 godina do &lt; 10 godina
5 yrs &lt; 10 yrs
5 god &lt; 10 god
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)
50 ml i 100 ml bočice s etiketom (EU/2/96/001/004 , EU/2/96/001/005, EU/2/97/001/007 &amp; EU/2/96/001/008 samo)
50 to &lt; 100 cells/mm3
50 do &lt; 100 stanica
50 to &lt; 200
50 do &lt; 200
50 ≤ and &lt; 80
50 ≤ i &lt; 80
50% (p &lt; 0.0001)
50 % (p &lt; 0,0001)
50%; P &lt; .0001
50%; P &lt; 0,0001
50.6% (p &lt; 0.0001)
(1,07; 2,15)
5000 microgram (mcg/ml) for patients &gt; 2 years of age with a BSA of &gt; 1.3
5000 mikrograma (μg/ml) za bolesnike &gt; 2 godine starosti s površinom tijela &gt; 1,3
54% (p &lt; 0.0001)
54 % (p &lt; 0,0001)
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).
Ciljnu vrijednost HbA1c od &lt; 7% bez potvrđenih epizoda hipoglikemije postiglo je 54,3% bolesnika liječenih lijekom Xultophy, u usporedbi s 29,4% bolesnika liječenih glargin inzulinom (omjer šansi: 3,24; p &lt; 0,001).
54.9 (p &lt; 0.0001)
54,9 (p &lt; 0,0001)
55%; P &lt; .0001
55%; P &lt; 0,0001
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 pedijatrijskih bolesnika s PKU u dobi &lt; 4 godine bilo je randomizirano u omjeru 1:1 u skupinu koja je primala Kuvan u dozi od 10 mg/kg na dan uz prehranu siromašnu fenilalaninom (n=27) ili skupinu koja je bila samo na prehrani siromašnoj fenilalaninom (n=29) tijekom 26 tjedana ispitivanja.
56.4 years; for women 53.5 years) treated with &gt; 7.5 mg/day oral prednisone (or equivalent).
833 muškaraca i žena u dobi od 18-85 godina (srednja dob za muškarce 56,4 godine; za žene 53,5 godine) liječenih s &gt; 7,5 mg/dan peroralnog prednizona (ili ekvivalenta).
59% (p &lt; 0.0001)
59 % (p &lt; 0,0001)
6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p &lt; 0.01 etanercept vs. placebo at all timepoints for both ACR 20 and ACR 50 responses).
3 odnosno 6 mjeseci; ACR 50: etanercept 41% i 40%, placebo 8% i 5% nakon 3, odnosno 6 mjeseci; p &lt; 0,01 etanercept u odnosu na placebo u svim vremenskim točkama za ACR 20 i ACR 50 odgovore).
6 to &lt; 12
6 do &lt; 12
6 to &lt; 12 months
6 do &lt; 12 mjeseci
6 to &lt; 12 years
6 do &lt; 12 godina
6 to &lt; 12 years ETR
6 do &lt; 12 godina ETR
6 to &lt; 17 years
6 do &lt; 17 godina
6 to &lt; 18 years ETR
6 do &lt; 18 godina ETR
6 to &lt; 12 y
6 do
6 to &lt; 12 years
od 6 do &lt; 12 godina
6 to &lt; 12 years (N=15)
6 do &lt; 12 godina (N=15)
6- to 11-year-olds (≥14 kg to &lt; 25 kg)
od 6 do 11 godina (≥ 14 kg do &lt; 25 kg)
6- to 11-year-olds (≥14 kg to &lt; 25 kg)
od 6 do 11 godina (≥14 kg do &lt; 25 kg)
6- &lt; 12 years N=27
6- &lt; 12 godina N=27
6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively.
&lt; 6,0 mg/dl na završnoj kontroli) u CONFIRMS ispitivanju, a kojima je početna razina urata u serumu bila ≥ 10 mg/dl bio je 27% (66/249) kod bolesnika liječenih febuksostatom od 40 mg jednom dnevno, 49% (125/254) kod liječenih febuksostatom od 80 mg jednom dnevno te 31% (72/230) kod bolesnika liječenih alopurinolom 300 mg/200 mg jednom dnevno.
6.7%, p &lt; 0.001c)
6,7%; p &lt; 0,001c)
60.4% of patients treated with Xultophy reached a target of HbA1c &lt; 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.
60,4% bolesnika liječenih lijekom Xultophy dostiglo je ciljnu vrijednost HbA1c &lt; 7% bez potvrđenih epizoda hipoglikemije nakon 26 tjedana liječenja.
62% of patients required no dose adjustment to maintain sUA &lt; 6 mg/dL and 38% of patients required a dose adjustment to achieve a final stable dose.
Kod 62% bolesnika nije bilo potrebno prilagođavanje doze kako bi se održala razina mokraćne kiseline u serumu ispod 6 mg/dl, a kod 38% bolesnika bilo je potrebno prilagođavanje doze kako bi se postigla krajnja stabilna doza.
65 ≤ and &lt; 75
65 ≤ i &lt; 75
65%; P &lt; .0001
65%; P &lt; 0,0001
66% of patients were receiving vitamin D sterols at study entry, and &gt; 90% were receiving phosphate binders.
Na početku studije 66 % bolesnika primalo je sterole vitamina D, a &gt; 90 % bolesnika primalo je tvari koje vežu fosfate.
66%; P &lt; .0001
66%; P &lt; 0,0001
67%; P &lt; .0001
67%; P &lt; 0,0001
6MWD Results in Patients with a Baseline 6MWD &lt; 350 meters.
Rezultati udaljenosti prijeđene u 6 minuta u bolesnika s početnom vrijednosti &lt; 350 metara.
6MWD Results in Patients with a Baseline 6MWD &lt; 350 meters.
Rezultati udaljenosti prijeđene u 6 minuta u bolesnika s početnom vrijednosti &lt; 350 metara
6− &lt; 12 years
6 − &lt; 12 godina
7 &amp; 10 TABLET PVC-PCTFE/ALU BLISTER (for white and clear blister)
PVC-PCTFE/AL BLISTER SA 7 i 10 TABLETA (za bijeli i prozirni blister)
7 &amp; 10 TABLET PVC-PTFE/ALU BLISTER (for white and clear blister)
PVC-PTFE/AL BLISTER SA 7 i 10 TABLETA (za bijeli i prozirni blister)
7 Mean HbA1c change is the difference between the saxagliptin+metformin and metformin alone groups (p &lt; 0.0001).
7 Prosječna promjena vrijednosti HbA1c odnosi se na razliku između skupine koja je primala saksagliptin+metformin i skupine koja je primala samo metformin (p &lt; 0,0001).
7 to &lt; 13
7 do &lt; 13
7.0 years, EDSS score 2.0. In addition, 16% of patients had an EDSS score &gt; 3.5, 28% had ≥2 relapses in the prior year and 42% had previously received other approved MS treatments.
Osim toga, 16% bolesnika imalo je EDSS bodova &gt; 3,5, 28% je imalo ≥ 2 relapsa u prethodnoj godini, a 42% je prethodno dobilo drugo odobreno liječenje za MS.
7.08 (4.34, 11.55) p &lt; 0.0001
7,08 (4,34; 11,55) p &lt; 0,0001
7.5 to &lt; 15
13 do &lt; 15
7.5 to &lt; 15
7,5 do &lt; 15
70%; P &lt; .0001
70%; P &lt; 0,0001
7000 microgram (mcg/ml) for patients &gt; 2 years of age with a BSA of ≤1.3
7000 mikrograma (μg/ml) za bolesnike &gt; 2 godine starosti s površinom tijela ≤1,3
71%; P &lt; .0001 73%; P &lt; .0001
71%; P &lt; 0,0001 73%; P &lt; 0,0001
73%, p &lt; .0021
73%, p &lt; 0,0021
73%; P &lt; .0001
73%; P &lt; 0,0001
75) at week 13
&lt; 75) u 13. tjednu
76%; P &lt; .0001 77%; P &lt; .0001
76%; P &lt; 0,0001 77%; P &lt; 0,0001
77%; P &lt; .0001
77%; P &lt; 0,0001
79%; P &lt; .0001
79%; P &lt; 0,0001
8 subjects with moderate renal impairment (CrCl 30 mL/min to &lt; 50 mL/min), and 8 subjects with severe renal impairment (CrCl &lt; 30 mL/min) as well as 8 subjects with ESRD on haemodialysis.
8 ispitanika s teškim oštećenjem bubrega (CrCl &lt; 30 mL/min), kao i 8 ispitanika u završnom stadiju bubrežne bolesti.
8.3 (8.05; 9.43) p-value* &lt; 0.0001
p-vrijednost* &lt; 0,0001 omjer hazarda
8.5 ml/m2/day (9.4 g/m2/day) in patients with a body surface area (BSA) &lt; 1.3 m2
8,5 ml/m2/dan (9,4 g/m2/dan) za bolesnike s površinom tijela &lt; 1,3 m2
800 mg pazopanib once daily is the recommended dose in patients with mild abnormalities in serum liver tests (defined as either normal bilirubin and any degree of alanine aminotransferase (ALT) elevation or as an elevation of bilirubin ( &gt; 35 % direct) up to 1.5 x upper limit of normal (ULN) regardless of the ALT value).
Preporučena doza pazopaniba je 800 mg jednom dnevno, u bolesnika s blagim poremećajima serumskih jetrenih testova (definirani kao ili normalni bilirubin i bilo koji stupanj povišenja alanin aminotransferaze (ALT) ili kao povišenje bilirubina ( &gt; 35 % direktnog) do 1,5 x od gornje granice normale (GGN) neovisno o vrijednostima ALT-a).
86 p &lt; 0.0001
86 p &lt; 0,0001