natgillin/translations-raw huggingface dataset:
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.
Ni dovolj kliničnih izkušenj, da bi lahko predlagali alternativno odmerjanje pri bolnikih z vrednostjo kreatinina &lt; 20 ml/min, kakor tudi ne za alternativno odmerjanje pri bolnikih na hemodializi.
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.
Z uporabo topotekana za zdravljenje bolnikov s hudimi motnjami delovanja ledvic (očistek kreatinina &lt; 20 ml/min) ali s hudo okvaro jetrne funkcije, ki je posledica ciroze (serumski bilirubin ≥ 10 mg/dl), ni dovolj izkušenj.
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.
Z uporabo topotekana za zdravljenje bolnikov s hudimi motnjami delovanja ledvic (očistek kreatinina &lt; 20 ml/min) ali s hudo okvaro jetrne funkcije, ki je posledica ciroze (serumski bilirubin ≥ 10 mg/dl), nimamo dovolj izkušenj.
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.
Pri mladostnikih, starih od 12 do &lt; 18 let s telesno maso &lt; 33 kg, in otrocih, starih od 2 do 12 let, s končno odpovedjo ledvic (ESRD – end-stage renal disease) ni na voljo dovolj podatkov za priporočilo o prilagoditvi odmerka.
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).
Na voljo so omejeni podatki o varnosti zdravila VFEND pri bolnikih z nenormalnimi testi jetrne funkcije (aspartat-aminotransferaza [AST], alanin-aminotransferaza [ALT], alkalna fosfataza [ALP] ali celotni bilirubin &gt; 5-kratna zgornja meja normalne vrednosti).
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).
Na voljo so omejeni podatki o varnosti vorikonazola pri bolnikih z nenormalnimi testi jetrne funkcije (aspartat-aminotransferaza [AST], alanin-aminotransferaza [ALT], alkalna fosfataza [ALP] ali celotni bilirubin &gt; 5-kratna zgornja meja normalne vrednosti).
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).
Na voljo so omejeni podatki o varnosti zdravila Vorikonazol Accord pri bolnikih z nenormalnimi testi jetrne funkcije (aspartat-aminotransferaza [AST], alanin-aminotransferaza [ALT], alkalna fosfataza [ALP] ali celotni bilirubin &gt; 5-kratna zgornja meja normalne vrednosti).
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.
Izkušnje iz kliničnih študij z bolniki z bakteriemijo, periferno vaskularno boleznijo ali nevtropenijo so omejene pri bolnikih z oslabljenim imunskim sistemom, pri bolnikih, starejših od &gt; 65 let in pri okužbah s 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.
Izkušnje pri bolnikih, starejših od 65 let, so omejene (glejte poglavje 5.2), zato je treba pri tej populaciji zdravilo CELSENTRI uporabljati previdno.
There is limited experience with ambrisentan in individuals with severe renal impairment (creatinine clearance
Pri bolnikih s hudo okvaro ledvic (kreatininski očistek &lt; 30 ml/min) so izkušnje z uporabo ambrisentana omejene.
There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT &gt; 2.5X upper limit of normal).
Izkušnje pri bolnikih z zvišanimi jetrnimi encimi (ALT &gt; 2,5-krat zgornja normalna meja) so omejene.
There is limited information regarding the use of EDURANT in patients &gt; 65 years of age.
Pri bolnikih, starejših od 65 let, je o uporabi zdravila EDURANT na voljo malo podatkov.
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.
Podatki o uporabi zdravila INTELENCE pri bolnikih, starih &gt; 65 let, so omejeni (glejte poglavje 5.2), zato je pri uporabi v tej populaciji bolnikov potrebna previdnost.
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm3 and &lt; 100,000/mm3.
Priporočeni začetni odmerek za bolnike s številom trombocitov med 50.000/mm3 in &lt; 100.000/mm3 je težko opredeliti, ker je na voljo le malo podatkov.
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score &gt; 9).
Pri bolnikih s hudo jetrno okvaro (ocena po Child-Pugh-u &gt; 9) kliničnih izkušenj ni.
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.
Ker ni kliničnih izkušenj z riociguatom pri bolnikih s povečanimi vrednostmi jetrnih aminotransferaz ( &gt; 3-kratna zgornja meja normalne vrednosti (ULN - Upper Limit of Normal)) ali s povečanimi vrednostmi direktnega bilirubina ( &gt; 2 x ULN) pred začetkom zdravljenja, se uporaba riociguata pri teh bolnikih ne priporoča.
There is no experience in patients &gt; 65 years.
Izkušenj pri bolnikih, starejših od 65 let, ni.
There is no experience in patients with hepatic impairment (serum bilirubin &gt; 1.5 x ULN plus AST and ALT &gt; 5 x ULN) and the liver is a potential target organ for toxicity (see sections 4.3 and 4.4).
Ni izkušenj z uporabo pri bolnikih z okvarjenim delovanjem jeter (serumski bilirubin &gt; 1,5 x ULN plus AST in ALT &gt; 5 x ULN) in jetra so potencialna tarča za toksične učinke (glejte poglavji 4.3 in 4.4).
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).
S podskupino bolnikov, ki imajo tako preveliko telesno maso ( &gt; 100 kg) kot tudi zmerno okvaro ledvic (očistek kreatinina 30-50 ml/min), nimamo nobenih izkušenj.
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).
Pri bolnikih z očistkom kreatinina &gt; 30 ml/min (določenega po Cockroftovi in Gaultovi formuli glede na vrednosti kreatinina v serumu) prilagajanje odmerka ni potrebno.
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).
Pri bolnikih z blago ali zmerno okvaro ledvic (bolniki z očistkom kreatinina &gt; 30 ml/min) ni treba prilagajati odmerka.
There is no pharmacokinetic information in patients &gt; 75 years.
Farmakokinetičnih informacij za bolnike, starejše od 75 let, ni.
There is no pharmacokinetic information in patients &gt; 75 years.
Ni farmakokinetičnih podatkov o bolnikih &gt; 75 let.
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.
Za trenutno indikacijo zdravila BRINAVESS pri otrocih in mladostnikih, starih &lt; 18 let, ni primerne uporabe, zato se ga pri tej populaciji ne sme uporabljati.
There is no relevant use of Humira in children aged &lt; 4 years for this indication.
Uporaba zdravila Humira pri otrocih, starih manj kot 4 leta, za to indikacijo ni primerna.
There is no relevant use of Humira in patients aged &lt; 2 years for this indication.
Uporaba zdravila Humira pri bolnikih, starih manj kot 2 leti, za to indikacijo ni primerna.
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).
Zdravilo Pravafenix ni primerno za uporabo pri pediatrični populaciji z indikacijo mešane dislipidemije (glejte poglavje 4.3).
There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease and therefore, it is not recommended to use Lyxumia in these populations (see section 5.2).
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina &lt; 30 ml/min) ali s končno odpovedjo ledvic terapevtskih izkušenj ni, zato zdravila Lyxumia v teh populacijah ni priporočljivo uporabljati (glejte poglavje 5.2).
There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
Terapevtskih izkušenj pri bolnikih s hudo okvaro ledvic (očistek kreatinina &lt; 30 ml/min) ali s končno odpovedjo ledvic ni.
There is only limited information in elderly (n=12, &gt; 65 year old) and very elderly (n= 2, 75-84 year old) patients.
Informacije pri starejših (n = 12, &gt; 65 let starosti) in zelo starih bolnikih (n = 2, 75 do 84 let starosti) so omejene.
There is very limited clinical experience in patients with a body weight &lt; 50 kg or &gt; 110 kg at the recommended posology.
S priporočenim odmerjanjem je zelo malo kliničnih izkušenj pri bolnikih s telesno maso nižjo od 50 kg ali višjo od 110 kg.
There is very limited experience in patients with severe renal impairment (eGFR [by CKD-EPI]
Pri bolnikih s hujšo okvaro delovanja ledvic (eGFR [po CKD-EPI] &lt; 30 ml/min/1,73 m2 ) ali z ledvično boleznijo v zadnjem stadiju so izkušnje zelo omejene.
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).
Pri obeh režimih zdravljenja je bil virusni neodziv (obremenitev z virusom &gt; 50 kopij/ml) nizek: v skupini z režimom odmerjanja enkrat dnevno 10 % in v skupini z režimom odmerjanja dvakrat dnevno 8 %.
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).
Pri obeh režimih zdravljenja je bil virusni neodziv (virusna obremenitev &gt; 50 kopij/ml) podoben ter nizek: v skupini z režimom odmerjanja enkrat na dan 10 % in v skupini z režimom odmerjanja dvakrat na dan 8 %.
There was a significant difference (p &lt; 0.0001) between the two treatment groups in the time to relapse in favour of TREVICTA.
Med skupinama je bila tudi pomembna razlika (p &lt; 0,0001) v času do relapsa in sicer v prid zdravilu 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.
Opazno je bilo bistveno izboljšanje kar zadeva primarni končni rezultat, ki je bil čas do napredovanja bolezni (TTP) pri bolnikih, ki so bili zdravljeni s kombinirano terapijo z zdravilom Caelyx in bortezomibom, v primerjavi s tistimi, ki so prejemali bortezomib v monoterapiji; to so ugotovili na podlagi zmanjšanja tveganja (RR) za 35% (95% interval zaupanja IZ; od 21 do 47%), p &lt; 0,0001 na osnovi 407 TTP dogodkov.
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).
Znatno večjo pojavnost (p &lt; 0,05) kardiovaskularnih/trombemboličnih dogodkov (miokardni infarkt, ishemijo, cerebrovaskularni insult, globoko vensko trombozo in pljučno embolijo) so odkrili pri skupini, zdravljeni s parekoksibom/valdekoksibom, v primerjavi s skupino, ki je v obdobju i.v. odmerjanja prejemala placebo/placebo (2,2 % oz.
There was a statistically significant treatment difference in favour of Abilify Maintena 400 mg/300 mg compared to placebo at week 10 (+7.1, p &lt; 0.0001, 95 % CI: 4.1, 10.1 using an ANCOVA model (LOCF)).
Opazili so statistično pomembno razliko v zdravljenju z zdravilom Abilify Maintena 400 mg/300 mg v primerjavi s placebom v 10. tednu (+7,1, p &lt; 0,0001, 95-odstotni IZ: 4,1, 10,1 z modelom ANCOVA (LOCF)).
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.
Ženske z večjo telesno maso ( &gt; 80 kg) so bile nagnjene k večji pogostnosti zvišanja vrednosti LH in progesterona, vendar niso opažali nobenega učinka na klinični izid.
There was also a significant difference over placebo in all domains for the responses from the partners (p &lt; 0.0001).
Do pomembne razlike v primerjavi s placebom je prišlo na vseh področjih tudi pri odgovorih partnerk (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.
Ko se je bližalo stanje dinamičnega ravnovesja, je prišlo do pričakovanega zmernega ( &lt; 2-kratnega) povečanja koncentracije v serumu, ni pa bilo med ponavljajočo uporabo nobenega nepričakovanega kopičenja.
There was an imbalance in age distribution with more elderly ( &gt; 65 years) patients in the palifermin group.
Starostna porazdelitev v obeh skupinah ni bila enakomerna, ker je bilo v skupini, zdravljeni s paliferminom, več starejših ( &gt; 65 let) bolnikov.
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.
Povečana incidenca tumorjev (hepatocelularni adenomi) je bila opazna pri miših, ki so bile 2 leti izpostavljene visokim odmerkom ( &gt; 75 kratna izpostavljenost pri ljudeh), vendar so to ocenili kot sekundarno glede na indukcijo encima, povzročeno s 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.
Pri starejši populaciji so opazili splošno zvečanje pogostnosti neželenih učinkov v primerjavi z bolniki, mlajšimi od 65 let, kar je bilo primerljivo v vseh zdravljenih skupinah, vključno s prejemniki placeba.
There was insufficient data in patients with severe renal impairment (CLcr &lt; 30 ml/min) to assess its effect on pharmacokinetics (see sections 4.2 and 4.4).
Pri bolnikih s hudo ledvično okvaro (CLcr &lt; 30 ml/min) ni bilo dovolj podatkov, da bi lahko ocenili njen učinek na farmakokinetiko (glejte poglavji 4.2 in 4.4).
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease-related medications (p = 0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p &lt; 0,01), nemorfinskih analgetikov (p &lt; 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p &lt; 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m2 compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p &lt; 0,01), nemorfinskih analgetikov (p &lt; 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p &lt; 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p &lt; 0,01), nemorfinskih analgetikov (p &lt; 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p &lt; 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m², so rabili manj morfinskih analgetikov (p &lt; 0,01), nemorfinskih analgetikov (p &lt; 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p &lt; 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease related medications (p=0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, ki so se zdravili z docetakselom v odmerku 75 mg/m2, so potrebovali manj morfinskih analgetikov (p &lt; 0,01), nemorfinskih analgetikov (p &lt; 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in obsevanja (p &lt; 0,01) kot tisti, ki so bili deleţni najboljše podporne oskrbe.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease related medications (p=0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, ki so se zdravili z docetakselom v odmerku 75 mg/m2, so potrebovali manj morfinskih analgetikov (p &lt; 0,01), nemorfinskih analgetikov (p &lt; 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in obsevanja (p &lt; 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
There was less use of morphinic analgesic (p &lt; 0.01), non-morphinic analgesics (p &lt; 0.01), other disease-related medications (p=0.06) and radiotherapy (p &lt; 0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p &lt; 0,01), nemorfinskih analgetikov (p &lt; 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p &lt; 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
There was no apparent difference in efficacy for entecavir based on gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients &gt; 65 years of age).
Glede na spol (≈ 25% žensk v kliničnih preskušanjih) ali starost (≈ 5% bolnikov, starejših od 65 let) se učinkovitost entekavirja očitneje ne razlikuje.
There was no effect of mild (50 mL/min ≤ CLcr ≤80 mL/min) or moderate (30 mL/min ≤ CLcr &lt; 50 mL/min) renal insufficiency on the clearance of total MTP-PE, when compared with that observed in healthy adult subjects with normal renal function (CLcr &gt; 80 mL/min).
Vpliva blage (50 ml/min ≤CLcr ≤80 ml/min) ali zmerne (30 ml/min ≤CLcr &lt; 50 ml/min) ledvične insuficience na očistek skupnega MTP-PE v primerjavi z očistkom pri zdravih odraslih osebah z normalnim delovanjem ledvic (CLcr &gt; 80 ml/min) niso opazili.
There was no evidence of benefit (no reduction in the primary composite endpoint of CV death, MI and stroke, but an increase in major bleeding) when ticagrelor 60 mg twice daily was introduced in clinically stable patients &gt; 2 years from the MI, or more than one year after stopping previous ADP receptor inhibitor treatment (see also section 4.2).
Če so 60 mg ticagrelorja dvakrat na dan uvedli klinično stabilnim bolnikom več kot 2 leti po miokardnem infarktu ali več kot eno leto po prenehanju zdravljenja s predhodnim zaviralcem receptorjev ADP, niso ugotovili koristi (nobenega zmanjšanja primarnega sestavljenega opazovanega dogodka, ki je obsegal kardiovaskularno smrt, miokardni infarkt in možgansko kap, a porast hudih krvavitev) (glejte tudi poglavje 4.2).
There was no evidence of period, sequence/carry-over effects in the ASCEND-PD study (p-values all &gt; 0.10).
V študiji ASCEND-PD ni bilo dokazanih vplivov obdobja/prehoda (vse vrednosti p &gt; 0,10).
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in &lt; 6 years old children.
Po drugem odmerku ni bilo povečanja, ne glede na to, ali so otroci dobili polovični ali celotni odmerek za odrasle, razen nekaterih neželenih učinkov, ki so bili pogostejši po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri otrocih, mlajših od 6 let.
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in &lt; 6 years old children.
Razen nekaterih neželenih učinkov, ki so se bolj pojavili po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri otrocih, starih &lt; 6 let, povečanja po drugem odmerku ni bilo, ne glede na to, ali so otroci prejeli polovični odmerek za odrasle ali odmerek za odrasle.
There was no increased incidence of serious infections observed in patients with lymphocyte counts
Pri bolnikih s številom limfocitov &lt; 0,8 x 109/l ali &lt; 0,5 x 109/l niso opazili zvišanja incidence okužb in resnih okužb.
There was one ALK-positive patient &gt; 85 years old out of 154 patients in single-arm Study 1001 (see also section 4.2 and 5.2).
V enoskupinski Študiji 1001 je bil en bolnik z ALK-pozitivnim NSCLC od 154 bolnikov starejši od 85 let (glejte tudi poglavji 4.2 in 5.2).
There was the reduction of relative risk of recurrent myocardial infarction by 35% compared to treatment with unfractionated heparin (p &lt; 0.001).
Ob tem času je bilo relativno tveganje za ponovni miokardni infarkt za 35 % manjše kot pri nefrakcioniranem heparinu (p &lt; 0,001).
There were 10 new virologic failures between the Week 48 primary analysis and Week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load &gt; 100,000 copies/mL).
Med primarno analizo v 48. tednu in 96. tednom se je pojavilo 10 novih viroloških neuspehov (3 bolniki z začetno virusno obremenitvijo ≤ 100.000 kopij/ml in 7 bolnikov z začetno virusno obremenitvijo &gt; 100.000 kopij/ml).
There were 17 new virologic failures between the week 48 primary analysis and week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load &gt; 100,000 copies/mL).
Med primarno analizo v 48. tednu in 96. tednom se je pojavilo 17 novih viroloških neuspehov (6 bolnikov z začetno virusno obremenitvijo ≤ 100.000 kopij/ml in 11 bolnikov z začetno virusno obremenitvijo &gt; 100.000 kopij/ml).
There were 23 patients (4.4%) with a QTc increase from baseline &gt; 60 msec.
Pri 23 bolnikih (4,4 %) je prišlo do podaljšanja intervala QTc za &gt; 60 ms od izhodiščne vrednosti.