natgillin/translations-raw huggingface dataset:
Note: For patients who weigh &lt; 47 kg, or are unable to swallow capsules, ribavirin oral solution is available and should be used if appropriate.
Napomena: za bolesnike težine &lt; 47 kg, ili one koji ne mogu progutati kapsulu, dostupna je ribavirin oralna otopina i potrebno ju je primjenjivati po potrebi.
Note: For patients who weigh &lt; 47 kg, or are unable to swallow capsules, ribavirin oral solution is available and should be used if appropriate.
Napomena: za pacijente tjelesne težine &lt; 47 kg ili one koji ne mogu (pro)gutati kapsule, dostupna je oralna otopina ribavirina koju se mora koristiti ako je to potrebno.
Note: For patients who weigh &lt; 47 kg, or are unable to swallow tablets, ribavirin oral solution is available and should be used if appropriate).
Napomena: za bolesnike težine &lt; 47 kg, ili one koji ne mogu progutati tabletu, dostupna je ribavirin oralna otopina i potrebno ju je primjenjivati po potrebi.
Note: For patients who weigh &lt; 47kg, or are unable to swallow capsules, ribavirin oral solution is available and should be used if appropriate).
Napomena: za bolesnike težine &lt; 47 kg, ili one koji ne mogu progutati tabletu, dostupna je ribavirin oralna otopina i potrebno ju je primjenjivati po potrebi.
Note: Temporary immobilisation including air travel &gt; 4 hours can also be a risk factor for VTE, particularly in women with other risk factors.
Napomena: privremena imobilizacija uključujući putovanje avionom &gt; 4 sata također može biti čimbenik rizika za VTE, osobito u žena s drugim čimbenicima rizika.
Novartis V &amp; D S.r.l. – Italy
Novartis V &amp; D S.r.l. - Italija
Now turn over &gt;
Sada okrenite &gt;
NSCLC patients with recent pulmonary bleeding ( &gt; 2.5 ml or bright red blood) as well as patients with evidence of baseline tumour cavitation, regardless of histology, or those with any evidence of tumour invasion or encasement of major blood vessels have been excluded from clinical trials (see section 4.3).
U klinička ispitivanja nisu bili uključeni bolesnici oboljeli od NSCLC-a s nedavnim plućnim krvarenjem ( &gt; 2,5 ml ili svjetlocrvena krv), bolesnici u kojih su na početku ispitivanja postojali dokazi kavitacije tumora, neovisno o histološkom tipu, kao ni bolesnici u kojih su na početku ispitivanja postojali bilo kakvi dokazi da je tumor prodro ili okružio velike krvne žile (vidjeti dio 4.3).
Nucleotide change
c.1102 G &gt; A
Nucleotide change
c.215 T &gt; G
Nucleotide change
c.911 G &gt; C
Null responders (as defined historically by a decrease in HCV-RNA viral load &lt; 2 log10 by Week 12 to prior therapy) were excluded.
Iz ispitivanja su isključeni bolesnici koji nisu odgovorili na prethodnu terapiju (što se uobičajeno definiralo kao smanjenje virusnog opterećenja HCV-RNK za &lt; 2 log10 do 12. tjedna prethodnog liječenja).
Number of cases Number of individuals*
Broj slučajeva Broj ispitanica
Number of cases Number of individuals*
Broj slučajeva Broj ispitanika
Number of patients &gt; 100 kg
Broj bolesnika &gt; 100 kg
number per
&lt; 0,001
O Taiwan 3/97, A22 Iraq and SAT2 Saudi Arabia
Shamir &amp; SAT2 Saudi Arabia
O Taiwan 3/97, Asia1 Shamir and SAT2 Saudi Arabia
O Taiwan 3/97, Asia 1 Shamir &amp; SAT2 Saudi Arabia
O1 BFS and SAT2 Saudi Arabia
O1 BFS &amp; SAT2
O1 BFS, A Turkey 14/98 and SAT2 Saudi Arabia
O1 BFS, A Turkey 14/98 &amp; SAT2 Saudi Arabia
O1 BFS, O Taiwan 3/97 and SAT2 Saudi Arabia
O1 BFS, O Taiwan 3/97 &amp; SAT2 Saudi Arabia
O1 Manisa, 01 BFS and SAT2 Saudi Arabia
O1 Manisa, 01 BFS &amp; SAT2 Saudi Arabia
O1 Manisa, Asia1 Shamir and SAT2 Saudi Arabia
O1 Manisa, Asia 1 Shamir &amp; SAT2 Saudi Arabia
Obese patients (defined as those with BMI &gt; 30 kg/m2) should receive telavancin at the reduced dose of 7.5 mg/kg once every 24 hours (see section 5.2).
Pretili bolesnici (defnirani kao oni s indeksom tjelesne mase &gt; 30 kg/m2) trebaju dobivati telavancin u smanjenoj dozi od 7,5 mg/kg svaka 24 sata (pogledajte dio 5.2).
Of 62 patients with FVIII:C &lt; 1%, 19 developed an inhibitor (31%).
Od 62 bolesnika s FVIII:C &lt; 1%, 19 ih je razvilo inhibitor (31%).
of itraconazole ( &gt; 200 mg/day) or
preporučuju se visoke doze itrakonazola
Of the 229 patients in the randomized study who received Abraxane monotherapy for breast cancer, 13% were at least 65 years of age and &lt; 2% were 75 years and older.
Od 229 ispitanika koji su u randomiziranom ispitivanju primali Abraxane kao monoterapiju za karcinom dojke, 13% ih je imalo najmanje 65 godina, a &lt; 2% bilo je u dobi od 75 i više godina.
Of the 23 patients who completed through Week 26, 19 (83%) had LDL-C reductions ≥25% with 8 (35%) having LDL-C &lt; 100 mg/dL and 1 having LDL-C &lt; 70 mg/dL at that time point.
Od 23 bolesnika koji su završili liječenje do 26. tjedna u 19 (83%) bolesnika smanjenje LDL kolesterola bilo je ≥ 25% s tim da je njih 8 (35%) imalo LDL kolesterol &lt; 100 mg/dl i 1 bolesnik LDL kolesterol &lt; 70 mg/dl u toj vremenskoj točki.
Of the 32 inhibitor cases of the full patient cohort (n=101), 16 (16%) were classified as high titre (≥ 5 BU/mL) and 16 (16%) as low titre ( &lt; 5 BU/mL).
Od 32 bolesnika koji su razvili inhibitore od ukupne kohorte bolesnika (n = 101), 16 (16%) ih je bilo klasificirano kao visoki titar (≥ 5 BU/ml), a 16 (16%) kao niski titar ( &lt; 5 BU/ml).
Of the 418 patients treated with Caelyx 50 mg/m2/cycle, and having a baseline measurement of left ventricular ejection fraction (LVEF) and at least one follow-up measurement assessed by MUGA scan, 88 patients had a cumulative anthracycline dose of &gt; 400 mg/m2, an exposure level associated with an increased risk of cardiovascular toxicity with conventional doxorubicin.
Od 418 bolesnika liječenih Caelyxom u dozi od 50 mg/m2 po ciklusu, kojima je na početku ispitivanja izmjerena ejekcijska frakcija lijeve klijetke (LVEF) i učinjeno najmanje jedno MUGA mjerenje tijekom praćenja, 88 bolesnika primilo je kumulativnu dozu antraciklina od &gt; 400 mg/m2, što predstavlja razinu izloženosti povezanu s povećanim rizikom od kardiovaskularne toksičnosti kod konvencionalnog doksorubicina.
Of the 611 patients treated with the ZALTRAP/FOLFIRI regimen in the pivotal study of MCRC patients, 172 (28.2%) were aged ≥65 and &lt; 75 and 33 (5.4%) were age ≥75.
Od 611 bolesnika liječenih protokolom ZALTRAP/FOLFIRI u pivotalnom ispitivanju u bolesnika s MKRK-om, njih 172 (28,2%) bila su u dobi ≥ 65 i &lt; 75 godina, a 33 bolesnika (5,4%) bila su u dobi od ≥ 75 godina.
Of the 97 patients treated with INOmax, 2(2 %) were withdrawn from study drug due to methaemoglobin levels &gt; 4 %.
Od 97 bolesnika koji su dobivali INOmax, 2 (2%) povučeno je iz ispitivanja zbog razina methemoglobina &gt; 4%.
Of the data collected, similar exposure was obtained compared with subjects &lt; 65 years.
U prikupljenim podacima, slično je bilo i u usporedbi s osobama &lt; 65 godina.
Of the most commonly reported, the following events occurred more often with Ranexa (placebo-corrected frequencies) in elderly ( 75 years of age) than younger patients ( &lt; 75 years of age): constipation (8% versus 5%), nausea (6% versus 3%), hypotension (5% versus 1%), and vomiting (4% versus 1%).
Među najčešće zabilježenim nuspojavama, slijedeće su se nuspojave pojavljivale češće kod primjene Ranexe (učestalosti su korigirane u odnosu na placebo) kod starijih ( 75 godina života) nego kod mlađih bolesnika ( &lt; 75 godina života): konstipacija (8% u odnosu na 5%), mučnina (6% u odnosu na 3%), hipotenzija (5% u odnosu na 1%), i povraćanje (4% u odnosu na 1%).
Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 45.0 % of these patients became RBC transfusion independent during the treatment period, compared with 11.4 % of the patients in the combined CCR groups (a statistically significant (p &lt; 0.0001) difference of 33.6 % (95 % CI: 22.4, 44.6).
Od bolesnika u skupini liječenoj azacitidinom koji su na početku bili ovisni o transfuziji eritrocita, tijekom liječenja ih je 45 % postalo neovisno o transfuziji eritrocita, u usporedbi s 11,4 % bolesnika u kombiniranim skupinama liječenih CCR-om, te je razlika i statistički značajna (p &lt; 0,0001) od 33,6 % (95 % CI: 22,4, 44,6).
Of the patients who experienced cuSCC, approximately 33% experienced &gt; 1 occurrence with median time between occurrences of 6 weeks.
Približno 33% bolesnika u kojih se razvio planocelularni karcinom kože imalo je &gt; 1 pojave, a medijan vremena između pojava bio je 6 tjedana.
Of these 25 patients, 20 had a decrease in inhibitor titres to &lt; 0.6 BU/mL, of whom initially 11 of 15 had high titres (≥ 5 BU/mL) and 9 of 10 had low titres.
Od tih 25 bolesnika, 20 ih je je imalo smanjenje titra inhibitora na &lt; 0,6 BU/ml, od njih je inicijalno 11 od 15 imalo visoki titar (≥5 BU/ml), a 9 od 10 niski titar.
Of those patients who were responders at week 96, 74% of patients receiving rilpivirine remained with undetectable viral load ( &lt; 50 HIV-1 RNA copies/ml) at week 240 compared to 81% of patients receiving efavirenz.
Od onih bolesnika koji su imali odgovor u 96. tjednu, 74% bolesnika koji su primili rilpivirin i dalje je imalo nemjerljivo virusno opterećenje ( &lt; 50 HIV-1 RNK kopija/ml) u 240. tjednu u usporedbi s 81% bolesnika koji su primili efavirenz.
OIC was confirmed through a two week run in period and defined as &lt; 3 spontaneous bowel movements (SBMs) per week on average with constipation symptoms associated with at least 25% of bowel movements.
Konstipacija uzrokovana primjenom opioida potvrđena je tijekom dvotjednog uvodnog razdoblja, a definirana je kao prosječno &lt; 3 spontana pražnjenja crijeva na tjedan, uz prisutnost simptoma konstipacije kod najmanje 25% pražnjenja crijeva.
Olaparib is not recommended for use in patients with hepatic impairment (serum bilirubin &gt; 1.5 time upper limit of normal).
Ne preporučuje se primjena olapariba kod bolesnica s oštećenjem jetrene funkcije (bilirubin u serumu &gt; 1,5 puta iznad gornje granice normale).
Older ( &gt; 60 years)
Starije osobe ( &gt; 60 godina)
Older children (6 &lt; 12 years)
Starija djeca (6 &lt; 12 godina)
Older children (6 &lt; 12 years)
Starija djeca (6 – &lt; 12 godina)
Older patients (≥ 75 years of age; n = 321) had a similar adverse reaction profile compared to younger patients ( &lt; 65 years of age; n = 1,016), but had a higher incidence of hypotension (2% versus &lt; 1%).
Stariji bolesnici (≥ 75 godina starosti; n = 321) imali su sličan profil nuspojava u usporedbi s mlađim bolesnicima ( &lt; 65 godina starosti; n = 1016), ali su imali veću incidenciju hipotenzije (2% odnosno &lt; 1%).
Older people 65 years)
Stariji osobei (≥ 65 godina)
Older people ( &gt; 65 years): Start with 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily.
Starije osobe (u dobi od &gt; 65 godina): Započeti s 1 mg jedanput na dan (vidjeti dio 5.2); po potrebi se doza može povisiti na 2 mg jedanput na dan.
Omalizumab at 300 mg reduced the weekly itch severity score by 8.55 to 9.77 (p &lt; 0.0001) compared to a reduction of 3.63 to 5.14 for placebo (see Table 7).
Omalizumab u dozi od 300 mg smanjio je tjedni rezultat za težinu svrbeža za 8,55,do 9,77 (p &lt; 0,0001) u usporedbi sa smanjenjem od 3,63, do 5,14, za placebo (vidjeti Tablicu 7).
on a 1 to 7 scale over the week prior to randomization. an average global symptom score &gt; 2.0 on a 0-4 scale (0 corresponds to no symptoms, 1 corresponds to mild symptoms, 2 corresponds to moderate symptoms, 3 corresponds to severe symptoms and 4 corresponds to very severe symptoms) over the week prior to randomization
≥5 na ljestvici od 1 do 7 tijekom tjedna prije randomizacije. prosječni bodovi globalnog simptoma &gt; 2,0 na ljestvici od 0 do 4 (0 odgovara stanju bez simptoma, 1 odgovara blagim simptomima, 2 odgovara umjerenim simptomima, 3 odgovara teškim simptomima, a 4 odgovara vrlo teškim simptomima) u tjednu prije randomizacije
On analyses of age subgroups, an increase in median overall survival was observed for all groups ( &lt; 65 years, ≥ 65 years and ≥ 75 years).
U analizi dobnih podskupina zabilježeno je povećanje medijana sveukupnog preživljenja kod svih skupina ( &lt; 65 godina, ≥ 65 godina i ≥ 75 godina).
On average, liver iron concentration decreased by 3.80 mg Fe/g dw in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 0.38 mg Fe/g dw in patients treated with placebo (p &lt; 0.001).
Koncentracija željeza u jetri snizila se u prosjeku za 3,80 mg Fe/g težine suhog tkiva jetre u bolesnika liječenih deferasiroks tabletama za oralnu suspenziju (početna doza 10 mg/kg/dan), dok se u bolesnika koji su primali placebo (p &lt; 0,001) povisila za 0,38 mg Fe/g težine suhog tkiva jetre.
On day 3 patients could receive a second dose of 1 g/ kg bw, for patients with a platelet count of &lt; 50×109 / l on day 3 this second dose was mandatory.
Treći dan bolesnici su mogli primiti drugu dozu od 1 g/kg TT, a za bolesnike s brojem trombocita od &lt; 50 x 109/1 treći dan je druga doza bila obavezna.
On the first day of treatment, inspiratory capacity under exercise was significantly improved (250 ml, p &lt; 0.001) compared to placebo.
Prvoga dana liječenja inspiratorni kapacitet pod naporom bio je značajno poboljšan (250 ml, p &lt; 0,001) u usporedbi s placebom.
On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥ 20% (13.1 % versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 30% (6,2% prema 1,1%).
On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥ 20% (13.1% versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 30% (6,2% prema 1,1%).
On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥20% (13.1% versus 6.1%), absolute LVEF decrease ≥30% (6.2% versus 1.1%).
S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 30% (6,2% prema 1,1%).
On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 30% (6,2% prema 1,1%).
On the other hand, AC arm showed a higher incidence of severe anemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) &gt; 30% (6,2% prema 1,1%).
On the primary efficacy endpoint, Weekly Rate of Cataplexy episodes (WRC), the results with pitolisant were significantly superior to those in the placebo group (p &lt; 0.0001), with a progressive 64% decrease from baseline to end of treatment (Figure 2).
Weekly Rate of Cataplexy, WRC) kao primarnog ishoda djelotvornosti, rezultati skupine koja je primala pitolizant bili su značajno superiorniji onima u skupini koja je primala placebo (p &lt; 0,0001), uz progresivno smanjenje od 64 % od početka do kraja liječenja (slika 2).
On-treatment response parameters at week 24 that predicted emergence of drug resistant virus by week 104 were HBV DNA &gt; 300 copies/ml and elevation of serum ALT.
Parametri odgovora za vrijeme liječenja u 24. tjednu koji su predviđali pojavu virusa rezistentnog na lijek do 104. tjedna bili su HBV DNK &gt; 300 kopija/ml i povišenje ALT-a u serumu.
Once absorbed, eprinomectin is highly bound to plasma proteins ( &gt; 99%), has low clearance from blood, and distributes well into tissues.
Nakon što se upije, eprinomektin se čvrsto veže za proteine plazme ( &gt; 99%), teško se eliminira iz krvi te izvrsno distribuira u tkivima.
Once the temperature in the distal subcutaneous tissue of the limb has reached &gt; 38°C, (but not exceeding 39°C), and pH of the perfusate is between 7.2 and 7.35, Beromun should be injected as a bolus into the arterial line of the circuit.
Kada temperatura u distalnom potkožnom tkivu uda dosegne &gt; 38°C (ali ne preko 39°C), a pH perfuzata je između 7,2 i 7,35, Beromun se injicira u obliku bolusa u arterijski dio kruga.
Once the urine protein level returns to &lt; 2 g/24 hours, treatment should be resumed at a reduced dose level.
Nakon što se razina proteina u mokraći vrati na &lt; 2 g/24 sata, liječenje treba nastaviti smanjenom dozom.
Once-daily treatment with dapagliflozin resulted in statistically significant (p &lt; 0.0001) reductions in HbA1c compared to placebo (Table 2).
Liječenje dapagliflozinom jedanput na dan rezultiralo je statistički značajnim (p &lt; 0,0001) sniženjem HbA1c u usporedbi s placebom (Tablica 2).
One further change was seen which was not statistically significant (p &gt; 0.05), but which did show a significant dose trend.
Primijećena je još jedna promjena koja nije bila statistički značajna (p  0,05), ali koja je pokazala značajnu ovisnost o dozi.
One patient ( &lt; 0.1%) discontinued pembrolizumab due to hypothyroidism.
Hipotireoza je dovela do prekida liječenja pembrolizumabom u jednog ( &lt; 0,1%) bolesnika.
One patient ( &lt; 1%) in each group experienced a QTcF &gt; 500 msec.
Po jedan bolesnik ( &lt; 1%) u svakoj skupini imao je QTcF &gt; 500 msek.
One patient in the 10 mg/kg &lt; 30kg group developed positive anti-tocilizumab antibodies without developing a hypersensitivity reaction and subsequently withdrew from the study.
Kod jednog bolesnika u skupini tjelesne težine &lt; 30 kg koji je primao dozu od 10 mg/kg razvila su se pozitivna protutijela na tocilizumab, ali se pritom nije pojavila reakcija preosjetljivosti; bolesnik se nakon toga povukao iz ispitivanja.
One patient met the pre-specified criteria for treatment success ( &gt; 75% reduction in SEGA volume) and was temporarily taken off trial therapy; however, SEGA re-growth was evident at the next assessment at 4.5 months and treatment was restarted.
Jedan je bolesnik udovoljio unaprijed specificiranim kriterijima prosudbe uspješnosti liječenja (smanjenje volumena SEGA-e za &gt; 75%) te je privremeno prekinuto liječenje u okviru ispitivanja; no kako je pri sljedećoj procjeni nakon 4,5 mjeseci ponovno uočen rast tumora, liječenje je nastavljeno.
One serious infusion reaction ( &lt; 1%) occurred in a patient on infliximab monotherapy.
Nastupila je jedna ozbiljna reakcija na infuziju ( &lt; 1%) u bolesnika koji je primao monoterapiju infliksimabom.
One subject ( &lt; 1 %) had a predicted Cav below 500 ng/mL and 19 % of the subjects had a predicted Cav above 2,500 ng/mL.
Jedan ispitanik ( &lt; 1%) imao je predviđeni Cav manji od 500 ng/ml, a 19% ispitanika imalo je predviđeni Cav veći od 2500 ng/ml.
One tenofovir disoproxil fumarate treated subject and no stavudine or zidovudine treated subjects experienced significant ( &gt; 4%) lumbar spine BMD loss at week 48.
Jedan ispitanik liječen tenofovirdizoproksilfumaratom imao je značajno ( &gt; 4%) smanjenje BMD-a lumbalne kralježnice u 48. tjednu, dok to nije opaženo niti u jednog ispitanika liječenog stavudinom ili zidovudinom.
One thousand and seventy-two (1072) patients were randomized: placebo (n=134), ADENURIC 80 mg QD (n=267), ADENURIC 120 mg QD (n=269), ADENURIC 240 mg QD (n=134) or allopurinol (300 mg QD [n=258] for patients with a baseline serum creatinine 1.5 mg/dL or 100 mg QD [n=10] for patients with a baseline serum creatinine &gt; 1.5 mg/dL and 2.0 mg/dL).
Tisuću i sedamdeset dva (1072) bolesnika su randomizirana te su primali: placebo (n = 134), ADENURIC 80 mg jednom dnevno (n = 267), ADENURIC 120 mg jednom dnevno (n = 269), ADENURIC 240 mg jednom dnevno (n = 134) ili alopurinol (300 mg jednom dnevno [n = 258] kod bolesnika s početnom razinom kreatinina u serumu 1,5 mg/dl ili 100 mg jednom dnevno [n = 10] kod bolesnika s početnom razinom kreatinina u serumu &gt; 1,5 mg/dl i 2,0 mg/dl).
ONIVYDE is not recommended for use in patients with severe renal impairment (CLcr &lt; 30 ml/min).
Ne preporučuje se primjena lijeka ONIVYDE u bolesnika s teškim oštećenjem bubrega (CLcr &lt; 30 ml/min).
Only a small fraction ( &lt; 5 %) of the radioactivity in urine (representing &lt; 3 % of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Samo mali dio ( &lt; 5%) radioaktivnosti u urinu (koji predstavlja &lt; 3% ukupne doze) otpada na neizmijenjeni lijek; stoga izlučivanje neizmijenjenog lijeka bubregom ima tek neznatnu ulogu u eliminaciji neizmijenjenog lijeka.
Only a small fraction ( &lt; 5 %) of the radioactivity in urine (representing &lt; 3% of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Samo mali dio ( &lt; 5%) radioaktivnosti u urinu (koji predstavlja &lt; 3% ukupne doze) otpada na neizmijenjeni lijek; stoga izlučivanje neizmijenjenog lijeka bubregom ima tek neznatnu ulogu u eliminaciji neizmijenjenog lijeka.
Only a small fraction ( &lt; 5%) of the radioactivity in urine (representing &lt; 3 % of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Samo mali dio ( &lt; 5%) radioaktivnosti u urinu (koji predstavlja &lt; 3% ukupne doze) otpada na neizmijenjeni lijek; stoga izlučivanje neizmijenjenog lijeka bubregom ima tek neznatnu ulogu u eliminaciji neizmijenjenog lijeka.
Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D &gt; 25).
Samo je malen udio bolesnika uključenih u pivotalna klinička ispitivanja imao tešku depresiju (HAM-D na početku liječenja &gt; 25).
Only a small proportion of patients included in pivotal clinical trials had severe depression (baseline HAM-D25).
Samo je malen udio bolesnika uključenih u pivotalna klinička ispitivanja imao tešku depresiju (HAM-D na početku liječenja &gt; 25).
Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance &lt; 30 ml/min).
Za bolesnike s teškom insuficijencijom bubrega dostupni su samo ograničeni farmakokinetički podaci (klirens kreatinina &lt; 30 ml/min).