natgillin/translations-raw huggingface dataset:
Fresh blood in stool or black tarry stool for &gt; 2 days or frank haemorrhage or blood clots in stool
Svježa krv u stolici ili crna katranasta stolica &gt; 2 dana ili očito krvarenje ili krvni ugrušci u stolici
From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS &gt; 1 point or &gt; 0.5 point for EDSS &gt; =6 in the previous two years) can help to identify patients with active disease.
Iz ovih retrospektivnih analiza podskupina vidljiv je dokaz koji ukazuje da relapsi, baš kao i izražena progresija na EDSS ljestvici (EDSS &gt; 1 boda ili &gt; 0,5 za EDSS &gt; =6 u prethodne dvije godine) mogu pomoći u identifikaciji bolesnika s aktivnom bolešću.
From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS &gt; 1 point or &gt; 0.5 point for EDSS ≥6 in the previous two years) can help to identify patients with active disease.
Iz ovih retrospektivnih analiza podskupina vidljiv je dokaz koji ukazuje da relapsi baš kao i izražena progresija na EDSS ljestvici (EDSS &gt; 1 bod ili &gt; 0,5 za EDSS ≥6 u prethodne dvije godine) mogu pomoći u identifikaciji bolesnika s aktivnom bolešću.
From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS &gt; 1 point or &gt; 0.5 point for EDSS ≥6 in the previous two years) can help to identify patients with active disease.
Iz ovih retrospektivnih analiza podskupina vidljiv je dokaz koji ukazuje da relapsi, baš kao i izražena progresija na EDSS ljestvici (EDSS &gt; 1 boda ili &gt; 0,5 za EDSS ≥6 u prethodne dvije godine) mogu pomoći u identifikaciji bolesnika s aktivnom bolešću.
FTC/TDF + rilpivirine hydrochloride was non-inferior in achieving HIV-1 RNA &lt; 50 copies/mL compared to FTC/TDF+efavirenz.
FTC/TDF + rilpivirinklorid bio je neinferioran u postizanju HIV-1 RNK &lt; 50 kopija/ml u usporedbi s FTC/TDF+efavirenz.
Further analysis of GUSTO mild bleeding revealed that a large proportion of mild bleeding events were ecchymosis, oozing and &lt; 5 cm haematoma.
Daljnja analiza blagog krvarenja prema GUSTO kriterijima pokazala je da su veliki udio događaja blagih krvarenja bili ekhimoza, eksudat i hematom &lt; 5 cm.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at &gt; 2.0 x 109/l.
Možda u bolesnika bude potrebna daljnja prilagodba doze, što se određuje prema apsolutnom broju neutrofila, da bi se broj neutrofila održao na &gt; 2,0 x 109/l.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at &gt; 2.0 x 109/L.
Može biti potrebna daljnja prilagodba doze, što se određuje prema ABN bolesnika, za održavanje broja neutrofila na &gt; 2,0 x 109/l.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at &gt; 2.0 x 109/l.
Može biti potrebno daljnje prilagođavanje doze za održavanje broja neutrofila na razini &gt; 2,0 x 109/l, određeno na temelju apsolutnog broja bolesnikovih neutrofila.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at &gt; 2.0 x 109/L.
Može se pokazati da je za održavanje broja neutrofila na razini &gt; 2,0 x 109/l potrebno dalje prilagođavanje doze, što se određuje na temelju apsolutnog broja bolesnikovih neutrofila.
Further evaluations which did show statistical significance (p &lt; 0.05) in favour of Xolair included reductions in severe exacerbations (where patient’s lung function was reduced to below 60% of personal best and requiring systemic corticosteroids) and asthma-related emergency visits (comprised of hospitalisations, emergency room, and unscheduled doctor visits), and improvements in Physician’s overall assessment of treatment effectiveness, Asthma-related Quality of Life (AQL), asthma symptoms and lung function.
Ostala ispitivanja koja su pokazala statističku značajnost (p &lt; 0,05) u korist Xolaira uključivala su smanjenje teških egzacerbacija (kada je funkcija pluća bolesnika bila smanjena na ispod 60% osobne najbolje vrijednosti te je bilo potrebno uvesti sistemske kortikosteroide) te u hitnim prijemima vezanim uz astmu (objedinjuju hospitalizacije, odjel hitne pomoći i neplanirane posjete liječniku), kao i poboljšanje u Ukupnoj liječničkoj procjeni učinkovitosti liječenja, kvaliteti života u odnosu na astmu (Asthma-related Quality of Life, AQL), simptomima astme i funkciji pluća.
Furthermore, Bonviva 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p &lt; 0.001.
Nadalje, Bonviva 150 mg jedanput mjesečno dokazano je bolja od ibandronatne kiseline 2,5 mg jedanput dnevno u povećavanju BMD lumbalne kralježnice u prospektivno planiranoj analizi nakon jedne godine, p=0,002, i nakon dvije godine, p &lt; 0,001.
Furthermore, ibandronic acid 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p &lt; 0.001.
Nadalje, ibandronatna kiselina 150 mg jedanput mjesečno dokazano je bolja od ibandronatne kiseline 2,5 mg jedanput dnevno u povećavanju BMD lumbalne kralježnice u prospektivno planiranoj analizi nakon jedne godine, p=0,002, i nakon dvije godine, p &lt; 0,001.
Furthermore, ibandronic acid 3 mg injection every 3 months was proven superior to oral ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p &lt; 0.001, and at two years, p &lt; 0.001.
Nadalje, injekcija ibandronatne kiseline od 3mg svaka tri mjeseca dokazano je učinkovitija od peroralno primijenjene ibandronatne kiseline od 2,5mg jedanput dnevno u povećanju BMD lumbalne kralježnice u prospektivno planiranoj analizi nakon jedne godine (p &lt; 0,001) i nakon dvije godine (p &lt; 0,001).
G-CSF (5 μg/kg, SC): days 4-13 or until ANC &gt; 1500 post nadir
G-CSF (5 μg/kg, s.c.): dani 4-13 ili do porasta ABN &gt; 1500 nakon najniže izmjerene vrijednosti
G-CSF (5 μg/kg, SC): days 4-13 or until ANC &gt; 1500 post nadir
G-CSF (5 μg/kg, s.c.): dani 4-13 ili do porasta ANC &gt; 1500 nakon najniže izmjerene vrijednosti
G-CSF (5 μg/kg, SC): days 5-14 or until ANC &gt; 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ABN &gt; 1500 nakon najniže izmjerene vrijednosti
G-CSF (5 μg/kg, SC): days 5-14 or until ANC &gt; 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ANC &gt; 1500 nakon najniže izmjerene vrijednosti
G3/4 ALT increased
G3/4 AST povišen ( &lt; 1%),
G3/4 ALT increased ( &lt; 1%)
G3/4 ALT povišen ( &lt; 1%)
G3/4 ALT increased ( &lt; 2%)
G3/4 povećanje ALT ( &lt; 2%)
G3/4 ALT increased ( &lt; 1%)
G3/4 ALT povišen
G3/4 AST increased ( &lt; 1%);
G3/4 AST povišen ( &lt; 1%)
G3/4 AST increased ( &lt; 1%);
G3/4 AST povišen ( &lt; 1%),
G3/4 AST increased ( &lt; 3%);
G3/4 povećanje AST ( &lt; 3%);
G3/4 AST increased ( &lt; 3%); G3/4 ALT increased ( &lt; 2%)
G3/4 povećanje ALT ( &lt; 2%)
G3/4 Blood alkaline
G3/4 povećanje alkalne fosfataze u krvi ( &lt; 2,5%)
G3/4 Blood alkaline phosphatase increased ( &lt; 4%);
G3/4 povećanje alkalne fosfataze u krvi ( &lt; 4%);
G3/4 Blood bilirubin
G3/4 povećanje bilirubina u krvi ( &lt; 2%)
G3/4 Blood bilirubin
G3/4 povećanje bilirubina u krvi ( &lt; 2,5%),
G3/4 Blood bilirubin increased ( &lt; 2%)
G3/4 povećanje bilirubina u krvi ( &lt; 2%)
G3/4 Blood bilirubin increased ( &lt; 5%);
G3/4 povećanje bilirubina u krvi ( &lt; 5%);
G3/4 Blood bilirubin increased ( &lt; 5%); G3/4 Blood alkaline phosphatase increased ( &lt; 4%);
G3/4 povećanje bilirubina u krvi ( &lt; 5%); G3/4 povećanje alkalne fosfataze u krvi ( &lt; 4%);
G3/4 Blood bilirubin increased ( &lt; 5%); G3/4 Blood alkaline phosphatase increased ( &lt; 4%);G3/4 AST
G3/4 povećanje bilirubina u krvi ( &lt; 5%), G3/4 povećanje alkalne fosfataze u krvi ( &lt; 4%), G3/4 povećanje AST ( &lt; 3%),
G3/4 Blood bilirubin increased ( &lt; 2.5%); G3/4 Blood alkaline phosphatase increased ( &lt; 2.5%)
G3/4 povećanje bilirubina u krvi
G3/4 Blood bilirubin increased ( &lt; 5%); G3/4
G3/4 povećanje bilirubina u krvi ( &lt; 5%);
Gadoversetamide plasma levels increase linearly with decreasing renal function; in patients with severe renal impairment (CrCl &lt; 30 ml/min) this even leads to a six-fold decreased gadoversetamide clearance and a corresponding six-fold increased extent of exposure AUC and t½.
Koncentracija gadoversetamida u plazmi raste linearno u odnosu na slabljenje renalne funkcije; kod bolesnika s teškim bubrežnim oštećenjem (CrCl &lt; 30 ml/min) to može dovesti do šesterostrukog pada klirensa gadoversetamida i odgovarajućeg šesterostrukog povećanja AUC i t½.
Galvus is not recommended for use in children and adolescents ( &lt; 18 years).
Galvus se ne preporučuje za primjenu u djece i adolescenata ( &lt; 18 godina).
Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Galvus se ne smije primjenjivati u bolesnika s oštećenjem jetre, uključujući bolesnike u kojih su vrijednosti alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) prije početka liječenja bile &gt; 3x vrijednosti gornje granice normale (GGN) (vidjeti također dijelove 4.4 i 5.2).
Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST &gt; 3x ULN (see also sections 4.2 and 5.2).
Galvus se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre, uključujući bolesnike u kojih su ALT ili AST prije početka liječenja bili &gt; 3x vrijednosti GGN (vidjeti također dijelove 4.2 i 5.2).
Gamithromycin administered subcutaneously into the neck of cattle at a single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 30 to 60 min with a long plasma half-life ( &gt; 2 days).
Subkutana primjena gamitromicina u područje vrata goveda u jednokratnoj dozi od 6 mg/kg tjelesne mase, rezultira brzom apsorpcijom s vršnom koncentracijom u plazmi nakon 30 do 60 min uz dugi poluvijek u plazmi ( &gt; 2 dana).
Gamithromycin levels in lung reached a maximum in less than 24 hr, with lung-to-plasma ratio of &gt; 264 indicating that gamithromycin was absorbed rapidly into the target tissue for BRD.
Razina gamitromicina u plućima dosegla je maksimum za manje od 24 sata, s omjerom pluća - plazma &gt; 264 što pokazuje da se gamitromicin brzo apsorbirao u ciljno tkivo za BRD.
Gastrointestinal and CNS haemorrhage were reported in 1% and &lt; 1% of patients, respectively.
Krvarenje u probavnom sustavu prijavljeno je u 1% bolesnika, a u središnjem živčanom sustavu u &lt; 1% bolesnika.
Gastrointestinal disorders (Common, ≥1/100 to &lt; 1/10)
Poremećaji probavnog sustava (Često, ≥1/100 do &lt; 1/10)
Gastrointestinal disorders: Obese patients [Body mass index (BMI) &gt; 30 kg/m2] treated with Benlysta reported higher rates of nausea, vomiting and diarrhoea relative to placebo, and compared with normal- weight patients (BMI ≥18.5 to ≤30 kg/m2).
Poremećaji probavnog sustava: Pretili bolesnici [indeks tjelesne mase (ITM) &gt; 30 kg/m2 liječeni lijekom Benlysta prijavili su veće stope mučnine, povraćanja i proljeva u odnosu na placebo, i u usporedbi s bolesnicima normalne težine (ITM ≥18,5 do ≤30 kg/m2).
Gastrointestinal perforationl ( &lt; 1%)
gastrointestinalna perforacijal ( &lt; 1%)
Gemcitabine (N=430)
&lt; 0,0001
Gender/age: there was no apparent difference in the safety profile of entecavir with respect to gender ( 25% women in the clinical trials) or age ( 5% of patients &gt; 65 years of age).
Spol/dob: Nije bilo vidljive razlike u profilu sigurnosti entekavira s obzirom na spol ( 25% žena u kliničkim ispitivanjima) ili dob ( 5% bolesnika u dobi od &gt; 65 godina).
gene therapy who met the definition of adequate metabolic detoxification, therefore baseline value is not applicable. e At baseline 9 of 11 (82%) patients had dAXP &lt; 100 nmol/ml.
gensku terapiju koji su zadovoljili definiciju odgovarajuće metaboličke detoksikacije i stoga početna vrijednost nije primjenjiva. e Na početku ispitivanja, 9 od 11 (82%) bolesnika imalo je dAXP &lt; 100 nmol/ml.
General disorders and Uncommon: chest pain administration site conditions:
Opći poremećaji i reakcije Manje često: bol u prsima na mjestu primjene
General disorders and Uncommon: chest pain administration site conditions:
Opći poremećaji i reakcije na Manje često: bol u prsima mjestu primjene
General disorders and Uncommon: chest pain administration site conditions:
Opći poremećaji i reakcije na Manje često: bol u prsištu mjestu primjene:
Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI &gt; 30 kg/m2) and systemic lupus erythematosus (SLE).
Općenito priznati rizici za pojavu VTE-a uključuju uznapredovalu životnu dob, pozitivnu obiteljsku anamnezu, tešku pretilost (BMI &gt; 30 kg/m2) i sistemski eritemski lupus (SLE).
Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (BMI &gt; 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Opće poznati faktori rizika za VTE uključuju uzimanje estrogena, stariju dob, veću operaciju, dugotrajnu nepokretnost, pretilost (ITM &gt; 30 kg/m2), trudnoću/poslijeporođajno razdoblje, sistemski eritemski lupus (SEL) i rak.
Generally, the most common adverse events reported in ≥ 65 years old were similar to &lt; 65 years old.
Načelno su najčešće prijavljeni štetni događaji kod ispitanika u dobi od ≥ 65 godina bili slični onima prijavljenima kod bolesnika u dobi &lt; 65 godina.
Genotype 1 &gt; 600,000
Genotip 1 &gt; 600 000
Genotype 1 &gt; 600,000 IU/ml
&gt; 600 000 IU/ml
Genotype Non-1: The decision to extend therapy to one year in patients with negative HCV- RNA after six months of treatment should be based on other prognostic factors (e.g., age &gt; 40 years, male gender, bridging fibrosis).
Osim genotipa 1: odluku o produžetku liječenja na godinu dana u bolesnika s negativnim HCV- RNK nakon šest mjeseci liječenja potrebno je donijeti na osnovi drugih prognostičkih faktora (npr. dob &gt; 40 godina, muškarci, premošćujuća fibroza).
Genotypes Non-1: The decision to extend therapy to one year in patients with negative HCV- RNA after six months of treatment should be based on other prognostic factors (e.g., age &gt; 40 years, male gender, bridging fibrosis).
Ostali genotipovi koji nisu genotip 1: Odluku o produljenju liječenja na godinu dana u bolesnika s negativnim nalazom HCV-RNK nakon šest mjeseci liječenja se mora donijeti na temelju drugih prognostičkih faktora (npr. dob &gt; 40 godina, muški spol, premoštavajuća fibroza).
Genotypes Non-1: The decision to extend therapy to one year in patients with negative HCVRNA after six months of treatment should be based on other prognostic factors (e.g., age &gt; 40 years, male gender, bridging fibrosis).
Ostali genotipovi koji nisu genotip 1: Odluku o produljenju liječenja na godinu dana u bolesnika s negativnim nalazom HCV-RNK nakon šest mjeseci liječenja se mora donijeti na temelju drugih prognostičkih faktora (npr. dob &gt; 40 godina, muški spol, premoštavajuća fibroza).
Genotypic data from paired baseline and on treatment HBV isolates were available for 6/8 patients with HBV DNA &gt; 400 copies/ml at week 48.
Podaci o genotipu iz sparenih početnih rezultata te HBV izolata tijekom liječenja bili su dostupni za 6/8 pacijenata s HBV DNK &gt; 400 kopija/ml u 48. tjednu.
Genotypic evaluations performed on all patients with HBV DNA &gt; 400 copies/ml at week 48 (n = 16), 96 (n = 5), 144 (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) and 384 (n = 2) of tenofovir disoproxil fumarate monotherapy showed that no mutations associated with tenofovir disoproxil fumarate resistance have developed.
Procjene genotipa provedene u svih pacijenata s vrijednostima HBV DNK &gt; 400 kopija/ml u 48. (n = 16), 96. (n = 5), 144. (n = 1), 192. (n = 2), 240. (n = 1), 288. (n = 1) i 384. tjednu (n = 2) na monoterapiji tenofovirdizoproksilfumaratom pokazale su da se nisu razvile mutacije povezane s rezistencijom na tenofovirdizoproksilfumarat.
Genotypic evaluations were performed on all patients within this group with HBV DNA &gt; 400 copies/ml at week 96 (n = 17), week 144 (n = 7), and week 192 (n = 8).
Unutar ove skupine provedena je genotipizacija u svih pacijenata s HBV DNK &gt; 400 kopija/ml u 96. tjednu (n = 17), 144. tjednu (n = 7) i 192. tjednu (n = 8).
Genotypic Susceptibility Score* &lt; 2
Rezultat za genotipsku osjetljivost* &lt; 2
Genvoya met the non-inferiority criteria in achieving HIV-1 RNA &lt; 50 copies/mL when compared to E/C/F/TDF.
U usporedbi sa skupinom E/C/F/TDF, lijek Genvoya je ispunio kriterije neinferiornosti u postizanju vrijednosti HIV-1 RNK &lt; 50 kopija/ml.
Genvoya should not be initiated in patients with estimated CrCl &lt; 30 mL/min as there are limited data available regarding the use of Genvoya in this population (see sections 5.1 and 5.2).
Primjena lijeka Genvoya se ne smije započeti u bolesnika s procijenjenim CrCl &lt; 30 ml/min budući da su podaci o primjeni lijeka Genvoya u ovoj populaciji ograničeni (vidjeti dijelove 5.1 i 5.2).
Geometric mean steady-state plasma Viramune prolonged-release pre-dose trough concentrations were 3,880 ng/ml, 3,310 ng/ml and 5,350 ng/ml in age groups 3 to &lt; 6 years, 6 to &lt; 12 years, and 12 to &lt; 18 years of age, respectively.
Geometrijski prosjek doze na kraju dozirnog intervala Viramunea s produljenim oslobađanjem u plazmi pri stanju dinamičke ravnoteže bio je 3880 ng/ml, 3 310 ng/ml odnosno 5350 ng/ml u dobnim skupinama 3 do &lt; 6 godina, 6 do &lt; 12 godina, i 12 do &lt; 18 godina starosti.
Geometric mean steady-state plasma Viramune prolonged-release pre-dose trough concentrations were 3,880 ng/ml, 3,310 ng/ml and 5,350 ng/ml in age groups 3 to &lt; 6 years, 6 to &lt; 12 years, and 12 to &lt; 18 years of age, respectively.
Geometrijski prosjek doze na kraju dozirnog intervala Viramunea s produljenim oslobađanjem u plazmi pri stanju dinamičke ravnoteže bio je 3880 ng/ml, 3310 ng/ml odnosno 5350 ng/ml u dobnim skupinama 3 do &lt; 6 godina, 6 do &lt; 12 godina, i 12 do &lt; 18 godina starosti.
GH &lt; 2.5 μg/l
GH &lt; 2,5 μg/l
GH &lt; 2.5 μg/l and IGF-1 ≤ULN
GH &lt; 2,5 μg/l i IGF-1 ≤GGN
GH &lt; 2.5 μg/l and normalised IGF-1*
GH &lt; 2,5 μg/l i normalizirani IGF-1
Gingival hyperplasia (≥ 1/100 to &lt; 1/10), colitis including cytomegalovirus colitis, (≥ 1/100 to &lt; 1/10), pancreatitis (≥ 1/100 to &lt; 1/10) and intestinal villous atrophy.
Hiperplazija gingive (≥ 1/100 do &lt; 1/10), kolitis, uključujući citomegalovirusni kolitis (≥ 1/100 do &lt; 1/10), pankreatitis (≥ 1/100 do &lt; 1/10) i atrofija crijevnih resica.
Gingival hyperplasia (≥ 1/100 to &lt; 1/10), colitis including cytomegalovirus colitis, (≥ 1/100 to &lt; 1/10), pancreatitis, (≥ 1/100 to &lt; 1/10) and intestinal villous atrophy.
Hiperplazija gingive (≥ 1/100 do &lt; 1/10), kolitis, uključujući citomegalovirusni kolitis (≥ 1/100 do &lt; 1/10), pankreatitis (≥ 1/100 do &lt; 1/10) i atrofija crijevnih resica.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis (≥1/100 to &lt; 1/10), pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Hiperplazija gingive (≥1/100 do &lt; 1/10), kolitis, uključujući citomegalovirusni kolitis (često), pankreatitis (često) i atrofija crijevnih resica.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis, (≥1/100 to &lt; 1/10), pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Hiperplazija gingive (≥1/100 i &lt; 1/10), kolitis, uključujući citomegalovirusni kolitis (≥1/100 i &lt; 1/10), pankreatitis (≥1/100 i &lt; 1/10) i atrofija crijevnih resica.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegalovirus colitis, (≥1/100 to &lt; 1/10), pancreatitis, (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Hiperplazija gingive (≥1/100 i &lt; 1/10), kolitis, uključujući citomegalovirusni kolitis (≥1/100 i &lt; 1/10), pankreatitis (≥1/100 i &lt; 1/10) i atrofija crijevnih resica.
Gingival hyperplasia (≥1/100 to &lt; 1/10), colitis including cytomegaloviruscolitis, (≥1/100 to &lt; 1/10), pancreatitis (≥1/100 to &lt; 1/10) and intestinal villous atrophy.
Hiperplazija gingive (≥1/100 i &lt; 1/10), kolitis, uključujući citomegalovirusni kolitis (≥1/100 i &lt; 1/10), pankreatitis (≥1/100 i &lt; 1/10) i atrofija crijevnih resica.
GIOTRIF has not been studied in patients with eGFR &lt; 15 mL/min/1.73m² or on dialysis.
GIOTRIF nije ispitan u bolesnika s eGFR &lt; 15 ml/min/1,73 m2 ili na dijalizi.
GIOTRIF treatment in patients with eGFR &lt; 15 mL/min/1.73m² or on dialysis is not recommended.
Terapija lijekom GIOTRIF ne preporučuje se kod bolesnika s eGFR &lt; 15 ml/min/1,73 m2 ili na dijalizi.
Given the available clinical and kinetic data, no dose adjustment is necessary (see section 5.2), but close clinical surveillance is recommended in patients with a body weight &lt; 50 kg (see section 4.4).
S obzirom na dostupne kliničke i kinetičke podatke, nije potrebna prilagodba doze (vidjeti dio 5.2), ali preporučuje se poman klinički nadzor nad bolesnicima s tjelesnom težinom &lt; 50 kg (vidjeti dio 4.4).
Glimepiride has a very low distribution volume (approximately 8.8 litres) which is roughly equal to the albumin distribution space, high protein binding ( &gt; 99%), and a low clearance (approximately 48 ml/min).
Glimepirid ima vrlo mali volumen distribucije (približno 8,8 litara), koji otprilike odgovara prostoru distribucije albumina, u visokom se postotku veže za proteine ( &gt; 99%) i ima niski klirens (približno 48 ml/min).
Grade 2 ( &lt; 75, ≥50x109/l)
Stupanj 2 ( &lt; 75, ≥50x109/l)
Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) &gt; 3 to 5 times ULN or total bilirubin &gt; 1.5 to 3 times ULN
2. stupanj s vrijednostima aspartat aminotransferaze (AST) ili alanin aminotransferaze (ALT) &gt; 3 do 5 puta iznad GGN-a ili ako je ukupni bilirubin &gt; 1,5 do 3 puta iznad GGN-a
Grade 2, 3 or 4 with renal impairment (serum Cr &gt; ULN)
Stupanj 2, 3 ili 4 uz oštećenje bubrega (serumski Cr &gt; GGN)
Grade 3 &amp; 4 ( &lt; 50x109/l)
Stupanj 3 &amp; 4 ( &lt; 50x109/l)
Grade 3 &amp; 4 ( &lt; 50x109/l)
Stupanj 3 i 4 ( &lt; 50x109/l)
Grade 3 &amp; 4 n (%)
3. i 4. stupanj n (%)
Grade 3 ( &lt; 1, ≥0.5x109/l)
Stupanj 3 ( &lt; 1, ≥0,5x109/l)
Grade 3 and 4 cases were reported in 0.8% (14/1728) and &lt; 0.1% (1/1728) of patients respectively.
Slučajevi 3. stupnja prijavljeni su u 0,8% (14/1728) bolesnika, a slučajevi 4. stupnja u &lt; 0,1% (1/1728) bolesnika.
Grade 3 or 4 asymptomatic elevation of lipase/amylase ( &gt; 2.0 x IULN*) only
Samo asimptomatsko povišenje lipaze/amilaze 3. ili 4. stupnja ( &gt; 2,0 x IGGN*)
Grade 3 or 4 elevations in creatinine were reported in &lt; 1% of patients with chronic phase CML and were reported with an increased frequency of 1 to 4% of patients with advanced phase CML.
Povišenje kreatinina 3. ili 4. stupnja bilo je prijavljeno u &lt; 1% bolesnika s KML u kroničnoj fazi te uz povećanu učestalost od 1 do 4% u bolesnika u uznapredovaloj fazi KML.
Grade 3 or higher and serious treatment emergent adverse reactions were more frequent in patients &lt; 65 years (84.1% and 50.8%) compared to patients ≥ 65 years (68.5 % and 44.4%).
Nuspojave stupnja 3 ili višeg te ozbiljne nuspojave nastale tijekom liječenja bile su učestalije u bolesnika &lt; 65 godina (84,1% i 50,8%) u usporedbi s bolesnicima ≥ 65 godina (68,5 % i 44,4%).
Grade 3 or higher pneumonia occurred more frequently among elderly patients treated with IMBRUVICA (13% of patients age ≥ 65 versus 7% of patients &lt; 65 years of age).
Pneumonija stupnja 3 ili višeg, češće se javila u starijih bolesnika liječenih lijekom IMBRUVICA (13% bolesnika starijih ≥ 65 godina u odnosu na 7% bolesnika &lt; 65 godina starosti).