natgillin/translations-raw huggingface dataset:
In advanced Parkinson’s disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
U uznapredovaloj Parkinsonovoj bolesti, dnevne doze više od 1,1 mg baze (1,5 mg soli) mogu biti korisne kod bolesnika kojima se namjerava sniziti terapija levodope.
In advanced renal cell carcinoma, Opdivo was compared with everolimus in one main study involving 821 patients whose disease advanced despite previous treatment.
Kod uznapredovalog karcinoma bubrežnih stanica, lijek Opdivo uspoređen je s everolimusom u glavnom ispitivanju koje je obuhvatilo 821 bolesnika čija je bolest uznapredovala unatoč prethodnom liječenju.
In advanced, metastatic or recurrent lung cancer, Avastin has been studied in 878 patients whose cancer cells are mainly non-squamous.
U slučaju uznapredovalog, metastatskog ili recidivirajućeg raka pluća, Avastin je ispitivan u 878 bolesnika čije stanice raka uglavnom nisu bile skvamozne.
In advanced, metastatic or recurrent lung cancer, the average overall survival was 12.3 months in the patients taking Avastin with platinum-based chemotherapy, and 10.3 months for those taking chemotherapy alone.
U slučaju uznapredovalog, metastatskog ili recidivirajućeg raka pluća, prosječna ukupna stopa preživljenja iznosila je 12,3 mjeseci u osoba koje su uzimale lijek Avastin uz kemoterapiju na bazi platine, te 10,3 mjeseci u osoba koje su primale samo kemoterapiju.
In agreement with these data, no clinically relevant drug interactions have been reported in clinical studies with SANCUSO.
U skladu s navedenim podacima, nisu zabilježene klinički značajne interakcije između lijekova u kliničkim ispitivanjima s lijekom SANCUSO.
In aHUS C10- 004, mean (±SD) platelet count increased from 119 ± 66 x109/L at baseline to 200 ± 84 x109/L by one week; this effect was maintained through 26 weeks (mean platelet count (±SD) at week 26: 252 ± 70 x109/L).
U ispitivanju aHUS-a C10-004, prosječna vrijednost broja trombocita povećala se od 119 ± 66 x109/l na početku, do 200 ± 84 x109/l za jedan tjedan; ovaj učinak održao se kroz 26 tjedana (prosječna vrijednost (±SD) broja trombocita u 26. tjednu: 252 ± 70 x109/l).
In aHUS patients, the safety profile in adolescents (patients aged 12 years to less than 18 years) is consistent with that observed in adults.
U bolesnika s aHUS-om, sigurnosni profil u adolescenata (bolesnici u dobi od 12 godina do manje od 18 godina) podudara se s profilom opaženim u odraslih.
In aHUS patients, uncontrolled terminal complement activation and the resulting complement- mediated thrombotic microangiopathy are blocked with Soliris treatment.
U bolesnika s aHUS-om, liječenje lijekom Soliris blokira nekontroliranu aktivaciju terminalnih komponenti komplementa i posljedičnu trombotičnu mikroangiopatiju posredovanu komplementom.
In aHUS Study C08-003A/B, the median duration of Soliris therapy was approximately 114 weeks (range: 26 to 129 weeks).
U ispitivanju aHUS-a C08-003A/B, medijan trajanja terapije lijekom Soliris iznosio je približno 114 tjedana (raspon: 26 do 129 tjedana).
In aHUS, chronic administration of Soliris resulted in a rapid and sustained reduction in complement- mediated thrombotic microangiopathy.
Kod aHUS-a, kronična primjena lijeka Soliris rezultirala je brzim i trajnim smanjenjem trombotične mikroangiopatije posredovane komplementom.
In aHUS, patients aged 18 and over receive an infusion of 900 mg over 25 to 45 minutes once a week for four weeks, followed by 1,200 mg in the fifth week.
U slučaju aHUS-a, bolesnici u dobi od 18 godina i stariji primaju infuziju od 900 mg tijekom 25 do 45 minuta jednom tjedno tijekom četiri tjedna, nakon čega slijedi 1 200 mg u petom tjednu.
In alignment with the effect on relapse rate, supportive analyses from Study 1 (CAMMS323) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (61% reduction, p=0.0056) and signficantly fewer relapses that led to steroid treatment (58% reduction, p<0.0001) compared to IFNB-1a.
U skladu s učinkom na stopu relapsa, suportivne analize iz Ispitivanja 1 (CAMMS323) pokazale su da je primjena lijeka LEMTRADA u dozi od 12 mg/dan značajno smanjila broj bolesnika liječenih lijekom LEMTRADA u kojih je došlo do teških relapsa (smanjenje za 61%, p=0,0056) kao i broj relapsa koji iziskuju liječenje steroidima (smanjenje za 58%, p<0,0001) u usporedbi s primjenom IFNB-1a.
In all age groups the most frequently reported local adverse reactions after vaccination were pain (24.1% to 41.3%), redness (15.5% to 35.6%), and swelling (11.3% to 19.9%).
U svim dobnim skupinama najčešće prijavljene lokalne nuspojave nakon cijepljenja bile su bol (24,1% do 41,3%), crvenilo (15,5% do 35,6%) i oticanje (11,3% do 19,9%).
In all aHUS patients, eculizumab serum concentrations of approximately 50 - 100 microgram/ml are sufficient for essentially complete inhibition of terminal complement activity.
U svih bolesnika s aHUS-om koncentracije ekulizumaba u serumu od približno 50 – 100 mikrograma/ml u biti su dovoljne za potpunu inhibiciju aktivnosti terminalnih komponenti komplementa.
In all cases of splenic enlargement in HIV patients, this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy.
U svim slučajevima povećanja slezene u bolesnika s HIV infekcijom , to je povećanje bilo blago do umjereno na fizikalnom pregledu i klinički je tijek bio dobroćudan; niti u jednog bolesnika nije dijagnosticiran hipersplenizam i niti u jednog nije napravljena splenektomija.
In all cases of splenic enlargement in HIV patients, this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy.
U svim slučajevima povećanja slezene u bolesnika s HIV infekcijom, to je povećanje bilo blago do umjereno na fizikalnom pregledu i klinički je tijek bio dobroćudan; niti u jednog bolesnika nije dijagnosticiran hipersplenizam i niti u jednog nije napravljena splenektomija.
In all cases the last dose is given at least two weeks before the expected date of farrowing.
U svim slučajevima posljednja se doza daje najmanje dva tjedna prije očekivanog datuma prasenja.
In all cases this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hyperplenism and no patients underwent splenectomy.
U svim slučajevima ona je bila blaga ili umjerena prilikom fizikalnog pregleda i klinički tijek je bio benigan; ni jednom bolesniku nije dijagnosticiran hipersplenizam i niti jedan bolesnik nije bio podvrgnut splenektomiji.
In all cases, dose should be adjusted according to therapeutic monitoring (see section 4.4.).
U svim slučajevima, dozu treba prilagoditi prema terapijskom praćenju (vidjeti dio 4.4.).
In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.
U svim slučajevima, potrebno je osigurati da je rizik od zračenja manji od same bolesti.
In all cases, the main measure of effectiveness was the disappearance of the markers of hepatitis virus infection from the blood after treatment and/or at ‘follow-up’ six months later.
U svim je slučajevima glavna mjera djelotvornosti bio izostanak markera infekcije virusom hepatitisa iz krvi nakon liječenja i/ili „praćenja” šest mjeseci kasnije.
In all cases, the risks of the radiation should be less than from the disease itself.
U svim slučajevima, rizici od zračenja trebaju biti manji od same bolesti.
In all clinical assessments parecoxib was administered at a fixed time interval whereas the opioids were administered on as needs basis.
U svim kliničkim ispitivanjima parekoksib se primjenjivao u uvijek istom vremenskom razmaku, dok su se opioidi primjenjivali po potrebi.
In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of age.
U svim kliničkom ispitivanjima 38-40 % bolesnika bilo je u dobi ≥60 godina, a 10-12% bolesnika bilo je u dobi ≥70 godina.
In all clinical studies 38–40% of patients were > 60 years of age and 10–12% of patients were >70 years of age.
U svim kliničkim ispitivanjima 38-40% bolesnika bilo je u dobi ≥60 godina, a 10-12% bolesnika bilo je u dobi ≥70 godina.
In all clinical studies, there was a significant increase in HbF from baseline after hydroxycarbamide use.
U svim kliničkim studijama nakon primjenehidroksikarbamida nastupilo je značajno povećanje razine HbF u odnosu na pročetnu vrijednost.
In all clinical trials individuals who had received immunoglobulin or blood products within 3 months prior to the first vaccine dose were excluded.
Osobe koje su u posljednja 3 mjeseca prije cijepljenja prvom dozom cjepiva primale imunoglobuline ili krvne derivate bile su isključene iz svih kliničkih ispitivanja.
In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded.
Osobe koje su u posljednja 3 mjeseca prije cijepljenja prvom dozom cjepiva primale imunoglobuline ili krvne derivate bile su isključene iz svih kliničkih ispitivanja.
In all controlled trials, the discontinuation rate due to adverse reactions was 2.0% for patients receiving Qutenza and 0.9% for patients receiving control.
U svim kontroliranim ispitivanjima, liječenje je zbog nuspojava prekinulo 2,0% bolesnika na kojima je primijenjen flaster Qutenza i 0,9% bolesnika koji su primali kontrolu.
In all evaluated patients, the estimated renal clearance of bexarotene was less than
U svih ispitanih bolesnika, procijenjeni klirens beksarotena bio je manji od
In all five studies, the main measure of effectiveness was based on changes in the patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
U svih pet ispitivanja, glavna mjera djelotvornosti temeljila se na promjenama u forsiranim ekspiracijskim volumenima bolesnika (FEV1, maksimalan volumen zraka kojeg osoba može izdahnuti u jednoj sekundi).
In all four studies, Bydureon was more effective than the comparator treatments at reducing the levels of HbA1c in the blood.
U sva četiri ispitivanja lijek Bydureon pokazao se učinkovitijim u smanjenju razina HbA1c u krvi od liječenja usporednom vrstom.
In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5).
U svim ispitivanjima u dojenčadi, Prevenar 13 primjenjivao se istovremeno s cjepivima koja se rutinski primjenjuju u pedijatrijske populacije (vidjeti dio 4.5).
In all multiple sclerosis studies Extavia was effective in reducing disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
U svim ispitivanjima multiple skleroze, Extavia je bila djelotvorna u smanjivanju aktivnosti bolesti (akutne upale u središnjem živčanom sustavu i trajne promjene tkiva), mjerene snimanjem magnetskom rezonancijom (MR).
In all of the studies, the main measure of effectiveness was based on the degree of itching and redness in the eye.
U svim ovim ispitivanjima, glavna mjera djelotvornosti temeljila se na stupnju svrbeži i crvenila očiju.
In all of the studies, the main measure of effectiveness was either overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
U svim tim ispitivanjima, glavna mjera djelotvornosti bila je ukupna stopa preživljenja ili preživljenje bez progresije (koliko su dugo bolesnici živjeli bez pogoršanja bolesti).
In all of the studies, the main measure of effectiveness was how long the patients lived without their cancer getting worse or how long they survived.
Glavna mjera djelotvornosti u svim ispitivanjima bila je koliko su bolesnici živjeli s rakom koji se nije pogoršao ili koliko su dugo preživjeli.
In all of the studies, the main measure of effectiveness was the change in pressure inside the eye, measured in units called ‘millimetres of mercury’ (mmHg).
U svim ispitivanjima, glavna mjera djelotvornosti bila je promjena u tlaku unutar oka, mjereno jedinicama naziva „milimetri žive” (mmHg).
In all of the studies, the main measure of effectiveness was the change in the levels of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
U svim ispitivanjima, glavna mjera djelotvornosti bila je promjena u razini tvari u krvi, naziva glikozilirani hemoglobin (HbA1c), koji ukazuje na to koliko se dobro kontrolira glukoza u krvi.
In all of the studies, the main measure of effectiveness was the change in the levels of ferritin in the blood.
Glavno mjerilo djelotvornosti u svim ispitivanjima bila je promjena razine feritina u krvi.
In all of the studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
U svim ispitivanjima, glavno mjerilo djelotvornosti bila je koncentracija glikoliziranog hemoglobina (HbA1c) u krvi, što ukazuje na to koliko se dobro kontrolira glukoza u krvi.
In all of the studies, the main measure of effectiveness was the number of patients who had undetectable levels of HIV 1 in their blood (viral loads) after 24 or 48 weeks of treatment.
U svim je ispitivanjima glavna mjera djelotvornosti bio broj bolesnika koji su imali razine HIV 1 u krvi (opterećenje virusom) koje nije moguće otkriti nakon 24 ili 48 tjedana liječenja.
In all of the studies, the main measure of effectiveness was the number of patients who had undetectable levels of HIV 1 in their blood (viral loads) after 24 or 48 weeks of treatment.
U svim je ispitivanjima glavna mjera djelotvornosti bio broj bolesnika s razinama HIV 1 u krvi (opterećenje virusom) koje nije moguće otkriti nakon 24 ili 48 tjedana liječenja.
In all of the studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
U svim ispitivanjima glavna mjera djelotvornosti bio je broj bolesnika čija je infekcija izliječena nakon završetka liječenja.
In all of the studies, Xolair was compared with placebo (a dummy treatment), when they were added to the patients’ existing treatment.
U svim ispitivanjima, Xolair je uspoređen s placebom (lažnim liječenjem), u slučaju kada su dodani postojećem liječenju bolesnika.
In all of the studies, Xolair was compared with placebo, when they were added to the patients’ existing treatment.
U svim ispitivanjima, Xolair je uspoređen s placebom u slučaju kada su dodani postojećem liječenju bolesnika.
In all of the studies, Ziagen caused a decrease in viral loads, particularly when taken with other antiviral medicines.
U svim ispitivanjima Ziagen je uzrokovao smanjenje virusnog opterećenja, posebice ako se uzimao s drugim antiviroticima.
In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen described in the Summary of Product Characteristics for PREZISTA 100 mg/ml oral suspension, 75 mg, 150 mg, 300 mg or 600 mg tablets.
U svih ostalih bolesnika prethodno liječenih ART-om ili u slučaju nemogućnosti genotipizacije HIV-1, preporučeni režim doziranja je opisan u Sažetku opisa svojstava lijeka za PREZISTA 100 mg/ml oralnu suspenziju, 75 mg, 150 mg, 300 mg ili 600 mg tablete.
In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen described in the Summary of Product Characteristics for PREZISTA 100 mg/ml oral suspension,75 mg, 150 mg, 300 mg or 600 mg tablets.
U svih ostalih bolesnika prethodno liječenih ART-om ili u slučaju nemogućnosti genotipizacije HIV-1, preporučeni režim doziranja je opisan u Sažetku opisa svojstava lijeka za PREZISTA 100 mg/ml oralnu suspenziju, 75 mg, 150 mg, 300 mg ili 600 mg tablete.
In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is 600 mg twice daily taken with ritonavir 100 mg twice daily taken with food.
U svih ostalih bolesnika prethodno liječenih ART-om ili u slučaju nemogućnosti genotipizacije HIV-1, preporučeni režim doziranja je 600 mg dva puta na dan uz 100 mg ritonavira dva puta na dan, uzeto s hranom.
In all packs the needles are attached to the pens ready to inject.
U svim pakiranja igle su pričvršćene na brizgalice i spremne su za ubrizgavanje.
In all packs the needles are attached to the syringes ready to inject.
U svim pakiranja igle su pričvršćene na štrcaljke i spremne su za ubrizgavanje.
In all paediatric patients, careful titration to a patient- specific daily dose is needed.
U svih pedijatrijskih bolesnika potrebna je pažljiva titracija doze na dnevnu dozu specifičnu za bolesnika.
In all patients with renal impairment, the dose titration should be performed with caution (see section 5.2).
Kod svih bolesnika s oštećenjem bubrega treba oprezno titrirati dozu (vidjeti dio 5.2).
In all patients, infusion-associated reactions occurred primarily during the first infusion.
U svih bolesnika reakcije povezane s infuzijom pojavile bi se tijekom prve infuzije.
In all patients, IVIg administration requires: adequate hydration prior to the initiation of the infusion of IVIg
U svih bolesnika, i.v. primjena Ig zahtijeva: odgovarajuću hidrataciju prije početka i.v. infuzije Ig
In all patients, IVIg administration requires: adequate hydration prior to the initiation of the infusion of IVIg
U svih pacijenata, primjena i.v.Ig terapije zahtijeva: odgovarajuću hidrataciju prije početka infuzije i.v.Ig-a
In all patients, kidney function should also be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected.
U svih bolesnika treba ocijeniti funkciju bubrega prije početka liječenja kako bi se isključili bolesnici s ozbiljno smanjenom funkcijom bubrega te, ako se sumnja na pogoršanje, potrebna je ponovna ocjena funkcije bubrega tijekom liječenja.
In all phases of treatment, serum asparagine concentrations decreased within 4 days of the first dose of asparaginase in the treatment phase and remained low for approximately 3 weeks for both Oncaspar and native E. coli L-asparaginase arms.
U svim fazama liječenja, koncentracije asparagina u serumu smanjile su se u roku od 4 dana od prve doze asparaginaze u fazi liječenja i ostale su niske otprilike 3 tjedna u obje skupine, one na Oncasparu i na nativnoj L-asparaginazi iz E. coli.
In all PNH and aHUS clinical studies the most serious adverse reaction was meningococcal septicaemia (see section 4.4).
U svim kliničkim ispitivanjima PNH-a i aHUS-a najozbiljnija nuspojava bila je meningokokna septikemija (vidjeti dio 4.4).
In all reported cases, intracranial hypertension-associated signs and symptoms resolved after reduction of the somatropin dose or termination of the therapy.
U svim prijavljenim slučajevima znakovi i simptomi povezani s intrakranijalnom hipertenzijom povukli su se nakon smanjenja doze somatropina ili prekida liječenja.
In all situations described below, the benefit/risk balance of Inflectra therapy should be very carefully considered.
U svim situacijama opisanima u daljnjem tekstu potrebno je vrlo pažljivo odvagnuti omjer rizika i koristi liječenja lijekom Inflectra.
In all situations described below, the benefit/risk balance of Remsima therapy should be very carefully considered.
U svim situacijama opisanima u daljnjem tekstu potrebno je vrlo pažljivo odvagnuti omjer rizika i koristi liječenja lijekom Remsima.
In all situations described below, the benefit/risk balance of Simponi therapy should be very carefully considered.
U svim situacijama opisanima u daljnjem tekstu, potrebno je pažljivo odvagnuti omjer rizika i koristi liječenja lijekom Simponi.
In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus ≥1).
U svim ispitivanjima sljedeći nezavisni čimbenici su bili statistički značajno povezani s povećanim rizikom razvoja sindroma šaka- stopalo: povećana početna doza kapecitabina (u gramima), smanjena kumulativna doza kapecitabina (0,1*kg), povećanje intenziteta relativne doze u prvih šest tjedana, produženje liječenja u ispitivanju (tjedni), starija životna dob (u intervalima od 10 godina), ženski spol i dobar ECOG status na početku liječenja (0 nasuprot ≥ 1).
In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus 1).
U svim ispitivanjima sljedeći nezavisni čimbenici su bili statistički značajno povezani s povećanim rizikom razvoja sindroma šaka- stopalo: povećana početna doza kapecitabina (u gramima), smanjena kumulativna doza kapecitabina (0,1*kg), povećanje intenziteta relativne doze u prvih šest tjedana, produženje liječenja u ispitivanju (tjedni), starija životna dob (u intervalima od 10 godina), ženski spol i dobar ECOG status na početku liječenja (0 nasuprot ≥ 1).
In all studies in rats and dogs darbepoetin alfa produced marked increases in haemoglobin, haematocrits, red blood cell counts and reticulocytes, which correspond to the expected pharmacological effects.
U svim studijima na štakorima i psima, darbepoetin alfa je pokazao znatno povećanje hemoglobina, hematokrita, broja crvenih krvnih stanica i retikulocita, što odgovara očekivanim farmakološkim učincima.
In all studies, Draxxin was at least as effective as the comparator medicines.
U svim ispitivanjima Draxxin je bio barem jednako učinkovit kao i usporedni lijekovi.
In all studies, dulaglutide produced clinically significant improvements in glycaemic control as measured by glycosylated haemoglobin A1c (HbA1c).
U svim je ispitivanjima dulaglutid doveo do klinički značajnih poboljšanja regulacije glikemije, koja su se mjerila razinom glikoziliranog hemoglobina A1c (HbA1c).
In all studies, patient response was better when treatment was started at an early age with good renal function.
U svim ispitivanjima odgovor bolesnika bio je bolji kada se liječenje započelo u ranoj dobi uz dobru funkciju bubrega.
In all studies, patients received a 10-minute infusion of 3.0 mg/kg BRINAVESS (or matching placebo) followed by a 15-minute observation period.
U svim su ispitivanjima bolesnici primili 10-minutnu infuziju lijeka BRINAVESS u dozi od 3,0 mg/kg (ili odgovarajući placebo), a zatim bi uslijedilo 15-minutno razdoblje promatranja.
In all studies, patients treated with silodosin had a greater decrease in both storage (irritative) and voiding (obstructive) symptoms of BPH as compared to placebo as assessed after 12 weeks of treatment.
U svim su ispitivanjima bolesnici liječeni silodozinom imali veće smanjenje simptoma BHP-a i kod zadržavanja mokraće (iritativnih) i mokrenja (opstruktivnih) u usporedbi s placebom na temelju procjene nakon 12 tjedana liječenja.
In all studies, patients treated with tocilizumab 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 2).
U svim su ispitivanjima bolesnici liječeni tocilizumabom u dozi od 8 mg/kg imali statistički značajno više stope odgovora prema kriterijima ACR 20, 50 i 70 nakon 6 mjeseci u usporedbi s kontrolnim ispitanicima (Tablica 2).