natgillin/translations-raw huggingface dataset:
Therapy with Competact should not be initiated in patients with increased baseline liver enzyme levels (ALT &gt; 2.5 x upper limit of normal) or with any other evidence of liver disease.
Terapija lijekom Competact ne smije se započeti u bolesnika s povišenim razinama jetrenih enzima (ALT povišena više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Therapy with Glubrava should not be initiated in patients with increased baseline liver enzyme levels (ALT &gt; 2.5 X upper limit of normal) or with any other evidence of liver disease.
Terapija lijekom Glubrava ne smije se započeti u bolesnika s povišenim razinama jetrenih enzima (ALT povišena &gt; 2,5 x iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Therapy with Incresync should not be initiated in patients with increased baseline liver enzyme levels (ALT &gt; 2.5 x upper limit of normal) or with any other evidence of liver disease.
Terapija Incresyncom se ne smije započeti u bolesnika s povišenim početnim razinama jetrenih enzima (ALT &gt; 2,5 puta iznad gornje granice normale) ili bilo kojim drugim dokazom bolesti jetre.
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT &gt; 2.5 times the upper limit of normal) or with any other evidence of liver disease.
Terapija pioglitazonom ne smije se započeti u bolesnika s povišenim početnim razinama jetrenih enzima (ALT &gt; 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT &gt; 2.5 X upper limit of normal) or with any other evidence of liver disease.
Terapija pioglitazonom ne smije se započeti u bolesnika s povišenim početnim razinama jetrenih enzima (ALT &gt; 2,5 x iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT &gt; 2.5 X upper limit of normal) or with any other evidence of liver disease.
Terapija pioglitazonom ne smije se započeti u bolesnika s povišenim početnim razinama jetrenih enzima (ALT više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
Therapy with Tandemact should not be initiated in patients with increased baseline liver enzyme levels (ALT &gt; 2.5 x upper limit of normal) or with any other evidence of liver disease.
Terapija lijekom Tandemact se ne smije započeti u bolesnika s povišenim razinama jetrenih enzima (ALT povišena više od 2,5 puta iznad gornje granice normale) ili nekim drugim dokazom bolesti jetre.
There are insufficient data available to recommend dose modifications of Abraxane in patients with severe renal impairment or end stage renal disease (estimated creatinine clearance &lt; 30 ml/min) (see section 5.2).
Nema dovoljno podataka za preporuku prilagodbe doze lijeka Abraxane u bolesnika s teškim oštećenjem bubrežne funkcije ili s krajnjim stadijem bubrežne bolesti (procijenjeni klirens kreatinina &lt; 30 ml/min) (vidjeti dio 5.2).
There are insufficient data to draw conclusions regarding exposure in patients &gt; 70 years old.
Nema dovoljno podataka da bi se donijeli zaključci o izloženosti u bolesnika starijih od 70 godina.
There are limited available data in patients &gt; 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
There are limited data available in patients &gt; 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
There are limited data available in patients with creatinine clearance values &lt; 50 mL/min.
Dostupni podaci o primjeni u bolesnika s klirensom kreatinina &lt; 50 ml/min su ograničeni.
There are limited data in individuals aged 56-65 and there are no data in individuals aged &gt; 65 years.
Podaci za osobe u dobi od 56 do 65 godina su ograničeni, a za osobe starije od 65 godina nema podataka.
There are limited data on patients co-infected with HIV who have low CD4 cell counts ( &lt; 200 cells/mm3).
Postoje samo ograničeni podaci o bolesnicima istodobno inficiranima HIV-om koji imaju nizak broj CD4 stanica ( &lt; 200 stanica/mm3).
There are limited data on patients with body weight &lt; 60 kg in RCC.
Ograničeni su podaci o bolesnicima s karcinomom bubrežnih stanica i tjelesnom težinom &lt; 60 kg.
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in adult patients with moderate and severe renal impairment (creatinine clearance &lt; 50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/min).
Postoje ograničeni podaci o sigurnosti i djelotvornosti tenofovirdizoproksilfumarata u odraslih pacijenata s umjerenim i teškim oštećenjem funkcije bubrega (klirens kreatinina &lt; 50 ml/min), a podaci o sigurnosti dugoročne primjene kod blagog oštećenja funkcije bubrega (klirens kreatinina 50-80 ml/min) još nisu procijenjeni.
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in HBV infected patients with decompensated liver disease and who have a Child-Pugh-Turcotte (CPT) score &gt; 9.
Postoje ograničeni podaci o sigurnosti i djelotvornosti tenofovirdizoproksilfumarata u pacijenata s infekcijom HBV-om i dekompenziranom bolešću jetre te koji imaju Child-Pugh-Turcotte (CPT) rezultat veći od 9.
There are limited pharmacokinetic data in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min).
Postoje ograničeni farmakokinetički podaci za bolesnike s teškim oštećenjem bubrega (klirens kreatinina &lt; 30 ml/min).
There are limited safety data from open-label studies in children from 1 month to &lt; 16 years of age.
Postoje ograničeni podaci iz otvorenih ispitivanja o sigurnosti primjene u djece u dobi od 1 mjeseca do
There are no data available for patients with severe hepatic impairment (total bilirubin &gt; 3 x ULN and any AST).
Nema dostupnih podataka o primjeni u bolesnika s teškim oštećenjem jetrene funkcije (ukupni bilirubin &gt; 3 x GGN i bilo koja vrijednost AST-a).
There are no data in obese (BMI &gt; 30 kg/m2) or underweight (BMI &lt; 18 kg/m2) patients.
Nema podataka o primjeni kod bolesnica prekomjerne tjelesne težine (ITM &gt; 30 kg/m2) niti kod bolesnica premale tjelesne težine (ITM &lt; 18 kg/m2).
There are no data in patients with creatinine clearance &lt; 15 ml/min.
Nema podataka za bolesnike s klirensom kreatinina &lt; 15 ml/min.
There are no data in patients with severe impairment (creatinine clearance &lt; 30 ml/min).
Nema podataka o primjeni kod bolesnica s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 30 ml/min).
There are no data regarding olaratumab administration in patients with severe renal impairment (calculated creatinine clearance &lt; 30 mL/min) (see section 5.2).
Nema podataka o primjeni olaratumaba u bolesnika s teškim oštećenjem funkcije bubrega (izračunati klirens kreatinina &lt; 30 ml/min) (vidjeti dio 5.2).
There are no pharmacokinetic data available in patients with liver impairment or in the elderly ( &gt; 70 years).
Nema dostupnih farmakokinetičkih podataka za bolesnike s teškim poremećajem funkcije bubrega ili za starije bolesnike ( &gt; 70 godina).
There are no pharmacokinetic data on tenofovir alafenamide in patients with estimated CrCl &lt; 15 mL/min.
Nema farmakokinetičkih podataka o tenofoviralafenamidu u bolesnika s procijenjenim CrCl &lt; 15 ml/min.
There are no Phase III trial experiences with End Stage Renal Disease (ESRD) (CLcr &lt; 30 ml/min, requiring dialysis).
Nema iskustava iz ispitivanja faze III s bolesnicima u terminalnom stadiju bubrežne bolesti (Clcr &lt; 30 mL/min, potrebna je dijaliza).
There are no safety and efficacy data to support the use of adefovir dipivoxil in patients with a creatinine clearance &lt; 30 ml/min or on dialysis.
Ne postoje podaci o sigurnosti i djelotvornosti koji bi podržali primjenu adefovirdipivoksila u pacijenata s klirensom kreatinina &lt; 30 ml/min ili onih na dijalizi.
There have also been rare ( &lt; 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease.
Također su rijetko ( &lt; 0,1%) prijavljeni slučajevi novog nastupa kongestivnog zatajenja srca, uključujući kongestivno zatajenje srca u bolesnika sa poznatom postojećom kardiovaskularnom bolešću.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR &lt; 30ml/min/1.73 m²) and/or acute kidney injury.
Postoje izvješća o pojavi nefrogene sistemske fibroze (NSF) povezane s primjenom Optimarka i nekih gadolinijskih kontrastnih sredstava kod bolesnika s akutnim ili kroničnim teškim oštećenjem bubrežne funkcije (GFR &lt; 30ml/min/1,73m²) i/ili akutnom ozljedom bubrega.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR &lt; 30ml/min/1.73m2) and/or acute kidney injury.
Postoje izvješća o pojavi nefrogene sistemske fibroze (NSF) povezane s primjenom Optimarka i nekih gadolinijskih kontrastnih sredstava kod bolesnika s akutnim ili kroničnim teškim oštećenjem bubrežne funkcije (GFR &lt; 30ml/min/1,73m²) i/ili akutnom ozljedom bubrega.
There is a risk for premature delivery ( &lt; 37 week) (incidence of 66 of 123 births, i.e.
Postoji rizik od preuranjenog poroda ( &lt; 37 tjedana) (incidencija je 66 na 123 novorođenih, tj.
There is a risk for premature delivery ( &lt; 37 week) (incidence of 66 of 123 births, i.e.
Postoji rizik od prijevremenog poroda ( &lt; 37 tjedana) (incidencija 66 od 123 rođenja, tj.
There is insufficient clinical experience to make alternative posology recommendations for patients with a creatinine clearance &lt; 20 ml/min, as well as to make posology recommendations for patients on haemodialysis.
Nema dovoljno kliničkog iskustva za odgovarajuću preporuku o alternativnom doziranju u bolesnika u kojih je klirens kreatinina &lt; 20 ml/min kao niti za preporuku o doziranju u bolesnika na hemodijalizi.
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance &lt; 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Nedovoljno je iskustva s primjenom topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥10 mg/dl).
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance &lt; 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Nedovoljno je podataka o primjeni topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu 10 mg/dl ili više).
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance &lt; 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Nedovoljno je podataka o primjeni topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥ 10 mg/dl).
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance &lt; 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Nedovoljno je podataka o primjeni topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina &lt; 20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥10 mg/dl).
There is insufficient information to recommend dosage adjustments in adolescents aged from 12 to &lt; 18 years with bodyweight &lt; 33 kg and in children aged from 2 to 12 years with ESRD.
Nema dovoljno podataka za preporuku prilagodbe doziranja u adolescenata u dobi od navršenih 12 do &lt; 18 godina čija je tjelesna težina &lt; 33 kg te u djece u dobi od navršene 2 do 12 godina koji imaju završnu fazu bubrežne bolesti.
There is limited data on the safety of VFEND in patients with abnormal liver function tests (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], or total bilirubin &gt; 5 times the upper limit of normal).
Podaci o sigurnosti VFEND-a u bolesnika s abnormalnim testovima funkcije jetre (aspartat transaminaza [AST], alanin transaminaza [ALT], alkalna fosfataza [AP] ili ukupan bilirubin &gt; 5 puta od gornje granice normalne vrijednosti) su ograničeni.
There is limited data on the safety of voriconazole in patients with abnormal liver function tests (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), or total bilirubin &gt; 5 times the upper limit of normal).
Podaci o sigurnosti vorikonazola u bolesnika s abnormalnim testovima funkcije jetre (aspartat transaminaza [AST], alanin transaminaza [ALT], alkalna fosfataza [ALP] ili ukupan bilirubin &gt; 5 puta od gornje granice normalne vrijednosti) su ograničeni.
There is limited data on the safety of voriconazole in patients with abnormal liver function tests (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], or total bilirubin &gt; 5 times the upper limit of normal).
Podaci o sigurnosti vorikonazola u bolesnika s abnormalnim testovima funkcije jetre (aspartat transaminaza [AST], alanin transaminaza [ALT], alkalna fosfataza [AP] ili ukupan bilirubin &gt; 5 puta od gornje granice normalne vrijednosti) su ograničeni.
There is limited experience in clinical studies in patients with bacteraemia, peripheral vascular disease or neutropenia, in immunocompromised patients, in patients aged &gt; 65 years and in infections due to S. pyogenes.
Postoji ograničeno iskustvo u kliničkim ispitivanjima u bolesnika s bakterijemijom, perifernom vaskularnom bolesti ili neutropenijom, u imunokompromitiranih bolesnika, u bolesnika u dobi &gt; 65 godina i kod infekcija izazvanih bakterijom S. pyogenes.
There is limited experience in patients &gt; 65 years of age (see section 5.2), therefore CELSENTRI should be used with caution in this population.
Iskustva s primjenom lijeka u bolesnika starijih od 65 godina su ograničena (vidjeti dio 5.2), stoga se CELSENTRI treba oprezno primjenjivati u ovoj populaciji bolesnika.
There is limited information regarding the use of EDURANT in patients &gt; 65 years of age.
O primjeni EDURANTA u bolesnika u dobi &gt; 65 godina postoje ograničeni podaci.
There is limited information regarding the use of INTELENCE in patients &gt; 65 years of age (see section 5.2), therefore caution should be used in this population.
Za primjenu INTELENCEa kod populacije bolesnika starijih od 65 godina potreban je oprez s obzirom na to da su dostupni ograničeni podaci (vidjeti dio 5.2).
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm3 and &lt; 100,000/mm3.
Postoje ograničene informacije o preporučenoj početnoj dozi za bolesnike s brojem trombocita između 50 000/mm3 i &lt; 100 000/mm3.
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score &gt; 9).
Nema kliničkog iskustva u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh rezultat &gt; 9).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score &gt; 9).
Nema kliničkog iskustva u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh rezultat &gt; 9).
There is no clinical experience with riociguat in patients with elevated liver aminotransferases ( &gt; 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin ( &gt; 2 x ULN) prior to initiation of treatment; riociguat is not recommended in these patients.
Nema kliničkog iskustva s riocigvatom u bolesnika s povišenim vrijednostima jetrenih aminotransferaza ( &gt; 3 x gornje granice normale (GGN)) ili povećanim direktnim bilirubinom ( &gt; 2 x GGN) prije početka liječenja; riocigvat se ne preporučuje u ovih bolesnika.
There is no experience in patients &gt; 65 years.
Nema iskustva u bolesnika &gt; 65 godina.
There is no experience in the subgroup of patients with both high body weight ( &gt; 100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/min).
Ne postoje iskustva primjene u podskupini bolesnika s tjelesnom težinom &gt; 100 kg i umjerenim oštećenjem bubrežne funkcije (klirens kreatinina 30 - 50 ml/min).
There is no experience in the subgroup of patients with both high body weight ( &gt; 100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/min).
Nema iskustva u podskupini bolesnika koji imaju i veliku tjelesnu težinu ( &gt; 100 kg) i umjereno oštećenje bubrega (klirens kreatinina 30 - 50 ml/min).
There is no need for dose adaptation in patients with a creatinine clearance &gt; 30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula).
U bolesnika čiji je klirens kreatinina veći od 30 ml/min (utvrđen iz serumskog kreatinina pomoću Cockroftove i Gaultove formule) nije potrebna prilagodba doze.
There is no need to alter the dose in patients with mild or moderate kidney problems (patients with a creatinine clearance &gt; 30 ml/min).
Nema potrebe za izmjenom doze u bolesnika s blagim ili umjerenim problemima s bubrezima (bolesnici s klirensom kreatinina &gt; 30 ml/min).
There is no pharmacokinetic information in patients &gt; 75 years.
Nema farmakokinetičkih ipodataka u bolesnika &gt; 75 godina.
There is no pharmacokinetic information in patients &gt; 75 years.
Nema farmakokinetičkih podataka u bolesnika &gt; 75 godina.
There is no relevant use of BRINAVESS in children and adolescents &lt; 18 years of age in the current indication and therefore BRINAVESS should not be used in this population.
Nema relevantne primjene lijeka BRINAVESS u djece i adolescenata mlađih od 18 godina u trenutačnoj indikaciji te se stoga BRINAVESS ne smije primjenjivati u ovoj populaciji.
There is no relevant use of Humira in children aged &lt; 4 years for this indication.
Nema relevantne primjene lijeka Humira u djece mlađe od 4 godine u ovoj indikaciji.
There is no relevant use of Humira in patients aged &lt; 2 years for this indication.
Nema relevantne primjene lijeka Humira u bolesnika mlađih od 2 godine u ovoj indikaciji.
There is no relevant use of Pravafenix in the paediatric population ( &lt; 18 years old) for the indication of mixed dyslipidaemia (see section 4.3).
Nema relevantne primjene Pravafenixa u pedijatrijskoj populaciji ( &lt; 18 godina) za indikaciju miješane dislipidemije (vidjeti dio 4.3).
There is only limited information in elderly (n=12, &gt; 65 year old) and very elderly (n= 2, 75-84 year old) patients.
Postoje samo ograničeni podaci u starih (n=12, u dobi od &gt; 65 godina) i vrlo starih (n= 2, u dobi od 75 do 84 godina) bolesnika.
There is very limited clinical experience in patients with a body weight &lt; 50 kg or &gt; 110 kg at the recommended posology.
Kliničko iskustvo u bolesnika s tjelesnom težinom &lt; 50 kg ili &gt; 110 kg pri preporučenom načinu doziranja je vrlo ograničeno.
There was a higher rate of intolerance (grade 3 or 4 adverse events, serious adverse events, discontinuation) in patients with age &gt; 75 years, ISS stage III, ECOG PS≤2 or CLcr &lt; 60 mL/min when lenalidomide is given in combination.
Viša stopa nepodnošenja (nuspojave 3. ili 4. stupnja, ozbiljne nuspojave, obustava liječenja) opažena je u bolesnika u dobi &gt; 75 godina, ISS stupanj III, ECOG PS ≤ 2 ili CLcr &lt; 60 mL/min kada se lenalidomid davao u kombinaciji.
There was a low, similar overall incidence of virologic failure (viral load &gt; 50 copies/ml) in both the once and twice daily treatment groups (10% and 8% respectively).
Zabilježena je mala ukupna incidencija izostanka virološkog odgovora (virusno opterećenje &gt; 50 kopija/ml), slična u obje skupine (10% u skupini liječenoj jedanput na dan i 8% u skupini liječenoj dvaput na dan).
There was a significant difference (p &lt; 0.0001) between the two treatment groups in the time to relapse in favour of TREVICTA.
Postojala je značajna razlika (p &lt; 0,0001) u vremenu do relapsa između dvije skupine liječenja u korist lijeka TREVICTA.
There was a significant improvement in the primary endpoint of time to progression (TTP) for patients treated with combination therapy of Caelyx plus bortezomib compared to patients treated with bortezomib monotherapy as indicated by a risk reduction (RR) of 35% (95% CI: 21-47%), p &lt; 0.0001, based on 407 TTP events.
U bolesnika liječenih kombiniranom terapijom Caelyxa i bortezomiba nastupilo je značajno poboljšanje vremena do napredovanja bolesti (TTP) kao primarnog ishoda ispitivanja u usporedbi s bolesnicima liječenima monoterapijom bortezomibom, kao što je pokazalo smanjenje rizika (RR) za 35% (95% CI: 21-47%), p &lt; 0,0001, na temelju 407 TTP događaja.
There was a significantly (p &lt; 0.05) greater incidence of cardiovascular/thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis and pulmonary embolism) detected in the parecoxib/valdecoxib treatment group compared to the placebo/placebo treatment group for the IV dosing period (2.2% and 0.0% respectively) and over the entire study period (4.8% and 1.3% respectively).
Postojala je značajno veća incidencija (p &lt; 0,05) kardiovaskularnih/tromboembolijskih događaja (infarkt miokarda, ishemija, cerebrovaskularni incident, duboka venska tromboza i plućna embolija) u skupini liječenoj parekoksibom/valdekoksibom nego u skupini koja je primala placebo/placebo u razdoblju intravenskog doziranja (2,2% odnosno 0,0%) i tijekom cijelog razdoblja ispitivanja (4,8% i 1,3%).
There was a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight ( &gt; 80 kg), but no effect on clinical outcome was observed.
U žena s većom tjelesnom težinom ( &gt; 80 kg) opažena je tendencija prema povećanoj incidenciji porasta LH-a i progesterona, ali nije opažen učinak na klinički ishod.
There was also a significant difference over placebo in all domains for the responses from the partners (p &lt; 0.0001).
Značajna razlika u odnosu na placebo javila se u svim domenama i za odgovore od partnera (p &lt; 0,0001).
There was an expected moderate ( &lt; 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
Zabilježeno je očekivano umjereno ( &lt; 2 puta) povišenje u serumskoj koncentraciji nakon što se doseglo stanje dinamičke ravnoteže, ali nije bilo neočekivana nakupljanja nakon ponovne primjene.
There was an imbalance in age distribution with more elderly ( &gt; 65 years) patients in the palifermin group.
Skupine su bile dobno neuravnotežene, s više starijih ispitanika ( &gt; 65 godina) u skupini koja je primala palifermin.
There was an increased incidence of tumours (hepatocellular adenomas) in mice exposed for 2 years to high doses ( &gt; 75 times human exposure), but this was considered secondary to prasugrel-induced enzyme-induction.
Incidencija tumora (hepatocelularnih adenoma) bila je povećana u miševa koji su dvije godine bili izloženi visokim dozama ( &gt; 75 puta veća izloženost nego u ljudi), ali se to smatralo posljedicom enzimske indukcije izazvane prasugrelom.
There was an overall increased frequency of adverse events in the older population compared to patients &lt; 65 years which was comparable across all treatment groups, including placebo.
Došlo je do sveukupnog porasta u učestalosti štetnih događaja u starijoj populaciji u usporedbi s bolesnicima u dobi od &lt; 65 godina, što je bilo usporedivo u svim liječenim skupinama, uključujući i skupinu s placebom.