natgillin/translations-raw huggingface dataset:
A meta-analysis of patients with moderate to severe Alzheimer’s disease (MMSE total scores &lt; 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Metaanaliza bolesnika s umjerenom do teškom Alzheimerovom bolešću (ukupni MMSE &lt; 20) iz šest faza III placebom kontroliranih ispitivanja u trajanju od 6 mjeseci (uključujući monoterapijska ispitivanja i ispitivanja s bolesnicima na stabilnoj dozi inhibitora acetilkolinesteraze) pokazala je da postoji statistički značajan učinak u korist liječenja memantinom u kognitivnom, globalnom i funkcionalnom području.
A meta-analysis of patients with moderate to severe Alzheimer’s disease (MMSE total scores &lt; 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Metaanaliza bolesnika s umjerenom do teškom Alzheimerovom bolešću (ukupni MMSE &lt; 20) iz šest placebom kontroliranih ispitivanja faze III u trajanju od 6 mjeseci (uključujući monoterapijska ispitivanja i ispitivanja s bolesnicima na stabilnoj dozi inhibitora acetilkolinesteraze) pokazala je da postoji statistički značajan učinak u korist liječenja memantinom u kognitivnom, globalnom i funkcionalnom području.
A meta-analysis of patients with moderate to severe Alzheimer’s disease (MMSE total scores &lt; 20)from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Metaanaliza bolesnika s umjerenom do teškom Alzheimerovom bolešću (ukupni MMSE &lt; 20) iz šest faza III placebom kontroliranih ispitivanja u trajanju od 6 mjeseci (uključujući monoterapijska ispitivanja i ispitivanja s bolesnicima na stabilnoj dozi inhibitora acetilkolinesteraze) pokazala je da postoji statistički značajan učinak u korist liječenja memantinom u kognitivnom, globalnom i funkcionalnom području.
A meta-analysis of patients with moderate to severe Alzheimer’s disease (MMSE total scores &lt; 20)from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Metaanaliza bolesnika s umjerenom do teškom Alzheimerovom bolešću (ukupni MMSE &lt; 20) iz šest placebom kontroliranih ispitivanja faze III u trajanju od 6 mjeseci (uključujući monoterapijska ispitivanja i ispitivanja s bolesnicima na stabilnoj dozi inhibitora acetilkolinesteraze) pokazala je da postoji statistički značajan učinak u korist liječenja memantinom u kognitivnom, globalnom i funkcionalnom području.
A meta-analysis showed a statistically significant lower rate of both clinical heart failure (RR = 0.20, p=0.02) and clinical and subclinical heart failure combined (RR = 0.38, p &lt; 0.0001) in patients treated with Myocet versus conventional doxorubicin.
Metaanaliza je pokazala statistički značajno nižu stopu i kliničkog zatajenja srca (RR = 0,20, p = 0,02) i kombiniranog kliničkog i subkliničkog zatajenja srca (RR = 0,38, p &lt; 0,0001) u bolesnica liječenih Myocetom naspram onih liječenih standardnim doksorubicinom.
A moderate increase of piperaquine plasma concentrations ( &lt; 2-fold) was observed when co-administered with strong CYP3A4 inhibitors, resulting in a potential exacerbation of the effect on QTc prolongation (see section 4.5).
Umjereno povećanje koncentracija piperakina u plazmi ( &lt; 2 puta) opaženo je kada se primjenjivao istovremeno s jakim inhibitorima CYP3A4, što je rezultiralo mogućim pogoršanjem učinka na produljenje QTc intervala (vidjeti dio 4.5).
A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure &lt; 90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78 % of patients treated with amlodipine/valsartan 10 mg/160 mg, compared to 67 % of patients remaining on amlodipine 10 mg.
Multicentrično, randomizirano, dvostruko slijepo, aktivno kontrolirano ispitivanje paralelnih skupina je u bolesnika, koji nisu bili odgovarajuće kontrolirani amlodipinom 10 mg, pokazalo normalizaciju krvnog tlaka (donja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju &lt; 90 mmHg na kraju ispitivanja) u 78% bolesnika liječenih amlodipinom/valsartanom 10 mg/160 mg, u usporedbi s 67% bolesnika koji su ostali na amlodipinu 10 mg.
A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure &lt; 90 mmHg at the end of the trial) in patients not adequately controlled on amlodipine 10 mg in 78% of patients treated with amlodipine/valsartan 10 mg/160 mg, compared to 67% of patients remaining on amlodipine 10 mg.
Multicentrično, randomizirano, dvostruko slijepo, aktivno kontrolirano ispitivanje paralelnih skupina je u bolesnika, koji nisu bili odgovarajuće kontrolirani amlodipinom 10 mg, pokazalo normalizaciju krvnog tlaka (donja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju &lt; 90 mmHg na kraju ispitivanja) u 78% bolesnika liječenih amlodipinom/valsartanom 10 mg/160 mg, u usporedbi s 67% bolesnika koji su ostali na amlodipinu 10 mg.
A multicentre, randomised, double-blind, active-controlled, parallel-group trial showed normalisation of blood pressure (trough sitting diastolic blood pressure &lt; 90 mmHg at the end of the trial) in patients not adequately controlled on valsartan 160 mg in 75% of patients treated with amlodipine/valsartan 10 mg/160 mg and 62% of patients treated with amlodipine/valsartan 5 mg/160 mg, compared to 53% of patients remaining on valsartan 160 mg.
Multicentrično, randomizirano, dvostruko slijepo, aktivno kontrolirano ispitivanje paralelnih skupina je u bolesnika, koji nisu bili odgovarajuće kontrolirani valsartanom 160 mg, pokazalo normalizaciju krvnog tlaka (donja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju &lt; 90 mmHg na kraju ispitivanja) u 75% bolesnika liječenih amlodipinom/valsartanom 10 mg/160 mg i 62% bolesnika liječenih amlodipinom/valsartanom 5 mg/160 mg, u usporedbi s 53% bolesnika koji su ostali na valsartanu 160 mg.
A negligible amount of substance is excreted as MPA ( &lt; 1 % of dose) in the urine.
Zanemariva količina lijeka izlučuje se u urin u obliku MPA ( &lt; 1 % doze).
A negligible amount of substance is excreted as MPA ( &lt; 1 % of dose) in the urine.
Zanemariva količina lijeka izlučuje se u urin u obliku MPA ( &lt; 1% doze).
A negligible amount of substance is excreted as MPA ( &lt; 1% of dose) in the urine.
Zanemariva količina lijeka izlučuje se u urin u obliku MPA ( &lt; 1% doze).
A negligible amount of substance is excreted as MPA ( &lt; °1% of dose) in the urine.
Zanemariva količina lijeka izlučuje se u urin u obliku MPA ( &lt; 1% doze).
A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a &lt; 20% reduction).
Neutralizirajuće antitijelo CYP2C9 pokazalo je minimalni učinak na formaciju metabolita kabozantiniba (tj. smanjenje &lt; 20%).
A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a &lt; 20% reduction).
Neutralizirajuće protutijelo na CYP2C9 pokazalo je minimalni učinak na stvaranje metabolita kabozantiniba (tj. smanjenje &lt; 20 %).
A no observed effect level (NOEL) for pupil size was not established, but the NOEL for impaired gait occurred at exposures &gt; 8-fold those in CML patients receiving the 500 mg dose.
Razina kod koje se ne opaža učinak (engl. no observed effect level, NOEL) na veličinu zjenice nije ustanovljena, ali NOEL na poremećaj hoda pojavio se kod izloženosti &gt; 8 puta od one u bolesnika s KML-om koji su dobivali dozu od 500 mg.
a Number of patients b Mean percent change (least square mean  standard error) between baseline measured after 8 weeks on Pravastatin 40 mg and 12 additional weeks with Pravafenix 40 mg/160 mg or Pravastatin 40 mg c Pairwise p-value is significant if &lt; 0.05
a Broj bolesnika b Srednja vrijednost postotka promjene (metodom najmanjih kvadrata  standardna pogreška) između početnih vrijednosti izmjerenih nakon 8 tjedana na Pravastatinu 40 mg i 12 dodatnih tjedana primjene Pravafenixa 40 mg/160 mg ili Pravastatina 40 mg c p-vrijednost parnog testa je značajna ako je &lt; 0,05
a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml). b Ten patients had baseline phenotypic resistance to atazanavir + ritonavir (fold change [FC] &gt; 5.2).
a Broj bolesnika s uparenim genotipovima klasificiranih kao virološki neuspjeh (HIV RNK ≥ 400 kopija/ml). b Deset bolesnika imalo je na početku fenotipsku rezistenciju na atazanavir s ritonavirom (promjena ekspresije [FC] &gt; 5,2 puta).
A once daily dose regimen of PREZISTA taken with ritonavir taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA &lt; 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l.
Režim doziranja lijeka PREZISTA jedanput na dan s ritonavirom uzeto s hranom, može se primjeniti u bolesnika koji su prethodno bili izloženi antiretrovirusnim lijekovima, ali nemaju mutacije povezane s rezistencijom na darunavir (DRV-RAM)* i koji imaju plazmatsku HIV-1 RNK &lt; 100 000 kopija/ml i CD4+ broj stanica  100 stanica x 106/l.
A once daily dose regimen of PREZISTA taken with ritonavir taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA &lt; 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l.
Režim doziranja lijeka PREZISTA jedanput na dan s ritonavirom uzeto s hranom, može se primjeniti u bolesnika koji su prethodno bili izloženi antiretrovirusnim, ali nemaju mutacije povezane s rezistencijom na darunavir (DRV-RAM)* i koji imaju plazmatsku HIV-1 RNK &lt; 100 000 kopija/ml i CD4+ broj stanica  100 stanica x 106/l.
A once daily dose regimen of PREZISTA taken with ritonavir taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA &lt; 100,000 copies/ml and CD4+ cell count  100 cells x 106/l.
Režim doziranja lijeka PREZISTA jedanput na dan s ritonavirom uzeto s hranom, može se primjeniti u bolesnika koji su prethodno bili izloženi antiretrovirusnim lijekovima, ali nemaju mutacije povezane s rezistencijom na darunavir (DRV-RAM)* i koji imaju plazmatsku HIV-1 RNK &lt; 100 000 kopija/ml i CD4+ broj stanica  100 stanica x 106/l.
a p &lt; 0.001 b CDLQI: The CDLQI is a dermatology instrument to assess the effect of a skin problem on the health-related quality of life in the paediatric population.
a p &lt; 0,001 b CDLQI: CDLQI je dermatološki uređaj za procjenu utjecaja problema s kožom na kvalitetu života povezanu sa zdravljem u pedijstrijskoj populaciji.
a p &lt; 0.001 compared with placebo
a p &lt; 0,001 u usporedbi s placebom
a p &lt; 0.001 compared with placebo b Patients with Itch NRS &gt; = 4 at baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 80 mg Q2W N = 391
a p &lt; 0,001 u usporedbi s placebom b Bolesnici s početnim NRS rezultatom za svrbež od ≥ 4: placebo N = 374, Taltz 80 mg svaka 4 tjedna N = 379, Taltz 80 mg svaka 2 tjedna N = 391
a p &lt; 0.001 Humira vs. placebo b p &lt; 0.001 Humira vs. methotrexate c p &lt; 0.01 Humira vs. placebo d p &lt; 0.05 Humira vs. methotrexate
a p &lt; 0,001 Humira naspram placeba b p &lt; 0,001 Humira naspram metotreksata c p &lt; 0,01 Humira naspram placeba d p &lt; 0,05 Humira naspram metotreksata
a p &lt; 0.001, etanercept vs. placebo b p = 0.002, etanercept vs. placebo
a p &lt; 0,001, etanercept u odnosu na placebo b p = 0,002, etanercept u odnosu na placebo
a p &lt; 0.001, for each infliximab treatment group vs control
a p &lt; 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
a p &lt; 0.001, for each infliximab treatment group vs. control
a p &lt; 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu. b n = 292
a p &lt; 0.001, for each infliximab treatment group vs. control.
a p &lt; 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
a p &lt; 0.001, for each infliximab treatment group vs. placebo
a p &lt; 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s placebom.
a p &lt; 0.001, for each infliximab treatment group vs. placebo.
a p &lt; 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s placebom.
a p &lt; 0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
a p &lt; 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu b veće vrijednosti znače jače oštećenje zgloba
a p &lt; 0.001, for each infliximab treatment group vs control. b greater values indicate more joint damage.
a p &lt; 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu. b veće vrijednosti znače jače oštećenje zgloba.
a p &lt; 0.001, for each infliximab treatment group vs. control b n = 292 c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
a p &lt; 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu b n = 292 c Analiza je temeljena na bolesnicima s psorijazom noktiju na početku ispitivanja (81,8% bolesnika).
a p-value calculated using Pearson’s Chi-Squared test bStatistically significantly more patients achieved ≥ 5 x 106 cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=89; 59.3%) than with placebo and G-CSF (n=29; 19.6%), p &lt; 0.001; statistically significantly more patients achieved
a p-vrijednost izračunata je primjenom Pearsonovog hi-kvadrat testa bstatistički je značajno više bolesnika postiglo ≥ 5 x 106 stanica/kg u ≤ 4 dana afereze kod primjene lijeka Mozobil i G-CSF-a (n = 89; 59,3%) nego kod primjene placeba i G-CSF-a (n = 29; 19,6%), p &lt; 0,001; statistički je značajno više bolesnika postiglo
a p-value is from the pairwise comparison of methotrexate monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
ap-vrijednost dobivena sparenom usporedbom monoterapije metotreksatom i kombinirane terapije lijekom Humira i metotreksatom uz primjenu Mann-Whitney U testa bp-vrijednost dobivena sparenom usporedbom monoterapije lijekom Humira i kombinirane terapije lijekom Humira i metotreksatom uz primjenu Mann-Whitney U testa cp-vrijednost dobivena sparenom usporedbom monoterapije lijekom Humira i monoterapije metotreksatom uz primjenu Mann-Whitney U testa
a p &lt; 0.001 versus placebo
a p &lt; 0,001 u odnosu na placebo
A paediatric Phase 1 study examined the pharmacokinetics and pharmacodynamics of canagliflozin in children and adolescents ≥ 10 to &lt; 18 years of age with type 2 diabetes mellitus.
Pedijatrijsko ispitivanje faze 1, ispitalo je farmakokinetiku i farmakodinamiku kanagliflozina u djece i adolescenata s dijabetesom tipa 2 starosti ≥ 10 do &lt; 18 godina.
A PBAC &gt; 100 within the first 8 days of menses is considered to represent excessive menstrual blood loss.
Rezultat PBAC &gt; 100 unutar prvih osam dana menstruacije smatra se prekomjernim gubitkom krvi kod menstruacije.
A pharmacokinetic study in paediatric patients aged 2 months to &lt; 18 years demonstrated very low plasma exposure to travoprost free acid, with concentrations ranging from below the 10 pg/mL assay limt of quantitation (BLQ) to 54.5 pg/mL.
Ispitivanje farmakokinetike u pedijatrijskih bolesnika u dobi od 2 mjeseca do &lt; 18 godina pokazalo je vrlo nisku izloženost travoprost slobodnoj kiselini u plazmi, s koncentracijama u rasponu od ispod 10 pg/ml granice kvantifikacije testa (BLQ) do 54,5 pg/ml.
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL &lt; 20 ml/min/1.73 m2, n=3).
Provedeno je farmakokinetičko ispitivanje u bolesnika s različitim stupnjevima oštećenja bubrega koji su bili podijeljeni prema vrijednostima klirensa kreatinina (CrCL) u sljedeće skupine: normalno (CrCL ≥ 60 ml/min/1,73 m2, n = 12), blago (CrCL = 40-59 ml/min/1,73 m2, n = 10), umjereno (CrCL = 20-39 ml/min/1,73 m2, n = 9) i teško (CrCL &lt; 20 ml/min/1,73 m2, n = 3).
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL &lt; 20 ml/min/1.73 m2, n=3).
Provedeno je farmakokinetičko ispitivanje u bolesnika s različitim stupnjevima oštećenja bubrega koji su bili podijeljeni prema vrijednostima klirensa kreatinina (CrCL) u sljedeće skupine: normalno (CrCL ≥ 60 ml/min/1,73 m2, n=12), blago (CrCL=40-59 ml/min/1,73 m2, n=10), umjereno (CrCL=20-39 ml/min/1,73 m2, n=9) i teško (CrCL &lt; 20 ml/min/1,73 m2, n=3).
A phase I study in 18 obese patients with type 2 diabetes mellitus (BMI between 35 and 40 kg/m2) with insulin glulisine and insulin lispro [90% CI: 0.81, 0.95 (p= &lt; 0.01)] has shown that insulin glulisine effectively controls diurnal postprandial blood glucose excursions.
Ispitivanje faze I u 18 pretilih bolesnika sa šećernom bolešću tipa 2 (ITM između 35 i 40 kg/m2) s inzulinom glulizinom i inzulinom lispro [90% CI: 0,81, 0,95 (p = &lt; 0,01)] pokazala je da inzulin glulizin učinkovito kontrolira postprandijalne skokove glukoze tijekom dana.
A Phase IIb, placebo-controlled, double-blind, randomised trial (C208) evaluated the antibacterial activity, safety, and tolerability of SIRTURO in newly diagnosed patients with sputum smear-positive pulmonary MDRH &amp; R- and pre-XDR-TB.
Placebom kontrolirano, dvostruko slijepo, randomizirano ispitivanje (C208) Faze IIb, procijenilo je antibakterijsko djelovanje, sigurnosti i podnošljivosti lijeka SIRTURO u novodijagnosticiranih bolesnika s razmazom sputuma pozitivnim na MDRH &amp; R- i pre-XDR-TB.
a platelet count &gt; 1000 x 109/l or a history of thrombo-haemorrhagic events.
broj trombocita &gt; 1000 x 109/l ili trombohemoragijski događaji u anamnezi.
A population PK analysis was performed based on pre-existing renal function data in patients receiving daratumumab, including 71 with normal renal function (creatinine clearance [CRCL] ≥ 90 mL/min), 78 with mild renal impairment (CRCL &lt; 90 and ≥ 60 mL/min), 68 with moderate renal impairment (CRCL &lt; 60 and ≥ 30 mL/min), and 6 with severe renal impairment or end stage renal disease (CRCL &lt; 30 mL/min).
Provedena je populacijska farmakokinetička analiza na temelju otprije postojećih podataka o bubrežnoj funkciji u bolesnika liječenih daratumumabom, uključujući 71 bolesnika s normalnom bubrežnom funkcijom (klirens kreatinina [CrCl] ≥ 90 ml/min), 78 bolesnika s blagim oštećenjem bubrežne funkcije (CrCl &lt; 90 i ≥ 60 ml/min), 68 bolesnika s umjerenim oštećenjem bubrežne funkcije (CrCl &lt; 60 i ≥ 30 ml/min) i 6 bolesnika s teškim oštećenjem bubrežne funkcije ili u terminalnoj fazi bubrežne bolesti (CrCl &lt; 30 ml/min).
A pre-specified follow-up rPFS analysis based on the investigator assessment of radiographic progression demonstrated a statistically significant improvement between the treatment groups with a 69.3% reduction in risk of radiographic progression or death [HR = 0.307 (95% CI: 0.267, 0.353), p &lt; 0.0001].
Unaprijed planirana analiza praćenja rPFS- a temeljena na procjeni radiografske progresije od strane ispitivača pokazala je statistički značajno poboljšanje između ispitivanih skupina sa 69,3%-tnim smanjenjem rizika od radiografske progresije ili smrti [HR = 0,307 (95% CI: 0,267; 0,353), p &lt; 0,0001].
a Proportion significantly higher with OZURDEX compared to sham (p &lt; 0.001)
a Udio značajnije viši kod lijeka OZURDEX u usporedbi s placebo postupkom (p &lt; 0,001)
A Q &amp; A document, providing answers to potential questions on the following topics:
Dokumenta s pitanjima i odgovorima u kojiem se nude odgovori na moguća pitanja o sljedećim temama:
A QTcF interval of &gt; 500 ms (confirmed by repeat electrocardiogram).
QTcF interval od &gt; 500 ms (potvrđen ponovljenim elektrokardiogramom).
A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPD – aged &gt; 50 years) and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device (containing placebo).
Randomizirano, otvoreno ispitivanje s placebom provedeno je na djeci i adolescentima s astmom (u dobi od 6-17 godina), odraslima s astmom (u dobi od 18-45 godina), odraslima s kroničnom opstruktivnom plućnom bolesti (KOPB– u dobi &gt; 50 godina) i zdravim dobrovoljcima (u dobi od 18- 45 godina) za procjenu brzine vršnog inspiratornog protoka (eng. peak inspiratory flow rate, PIFR) i drugih povezanih inhalacijskih parametara nakon inhalacije iz inhalatora Spiromax (koji sadrži placebo) u usporedbi s inhalacijom iz već na tržištu dostupnog inhalatora s više doza suhog praška (koji sadrži placebo).
A randomised, open-label placebo study was performed in children and adolescents with asthma (aged 6-17 years), adults with asthma (aged 18-45 years), adults with chronic obstructive pulmonary disease (COPD – aged &gt; 50 years) and healthy volunteers (aged 18-45 years) to evaluate the peak inspiratory flow rate (PIFR) and other related inhalation parameters following inhalation from a Spiromax device (containing placebo) compared with inhalation from an already marketed multi-dose dry powder inhaler device(containing placebo).
Randomizirano, otvoreno ispitivanje s placebom provedeno je na djeci i adolescentima s astmom (u dobi od 6-17 godina), odraslima s astmom (u dobi od 18- 45 godina), odraslima s kroničnom opstruktivnom plućnom bolesti (KOPB – u dobi &gt; 50 godina) i zdravim dobrovoljcima (u dobi od 18- 45 godina) za procjenu brzine vršnog inspiratornog protoka (eng. peak inspiratory flow rate, PIFR) i drugih povezanih inhalacijskih parametara nakon inhalacije iz inhalatora Spiromax (koji sadrži placebo), u usporedbi s inhalacijom iz već na tržištu dostupnog inhalatora s više doza suhog praška (koji sadrži placebo).
A recommended dosage regimen for patients with creatinine clearance below 50 ml/min is shown in the dosage section (see section 4.2).
Preporuke za određivanje doze u bolesnika s klirensom kreatinina &lt; 50 ml/min dane su u odjeljku o doziranju (vidjeti dio 4.2).