natgillin/translations-raw huggingface dataset:
These additional reactions occurred at a frequency of &lt; 1% unless otherwise noted: meningism, myocarditis, pericardial effusion, cardiomyopathy, autoimmune hepatitis, erythema nodosum, autoimmune pancreatitis, hyperpituitarism, hypoparathyroidism, infectious peritonitis, episcleritis, scleritis, Raynaud’s phenomenon, palmar-plantar erythrodysaesthesia syndrome, cytokine release syndrome, sarcoidosis, decreased blood gonadotrophin, leukopenia, polycythaemia, lymphocytosis, ocular myositis, and neurosensory hypoacusis.
Te su se dodatne nuspojave javljale s učestalošću od &lt; 1%, osim ako nije drugačije navedeno: meningizam, miokarditis, perikardijalni izljev, kardiomiopatija, autoimuni hepatitis, nodozni eritem, autoimuni pankreatitis, hiperpituitarizam, hipoparatireoidizam, infektivni peritonitis, episkleritis, skleritis, Raynaudov fenomen, sindrom palmarno-plantarne eritrodizestezije, sindrom otpuštanja citokina, sarkoidoza, snižena razina gonadotropina u krvi, leukopenija, policitemija, limfocitoza, miozitis oka, i neurosenzorna hipoakuzija.
These adverse reactions are included based on clinical relevance and ranked in order of decreasing seriousness within each category using the following convention: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), not known (cannot be estimated from the available data).
Te nuspojave uključene su na temelju kliničke značajnosti i prikazane su u padajućem nizu prema ozbiljnosti u svakoj kategoriji koristeći sljedeće pojmove: vrlo često (≥1/10), često (≥1/100 i &lt; 1/10), manje često (≥1/1000 i &lt; 1/100), nepoznato (ne može se procijeniti iz dostupnih podataka).
These adverse reactions were common (≥ 1/100 to &lt; 1/10).
Ove nuspojave su bile česte (1/100 do  1/10).
These are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), including isolated reports.
Prikazane su prema učestalosti pomoću sljedeće konvencije: vrlo često (≥ 1/10); često (≥ 1/100 do &lt; 1/10); manje često (≥ 1/1000 do &lt; 1/100); rijetko (≥ 1/10 000 do &lt; 1/1000); vrlo rijetko ( &lt; 1/10 000), uključujući izolirane prijave.
These are ranked under heading of frequency, with the most frequent appearing first, using one decimal precision for percentages and the following convention: very common (≥1/10) or common (≥1/100 to &lt; 1/10).
Podijeljene su prema učestalosti, pri čemu su najčešće navedene prve, koristeći preciznost jedne decimale za postotke i sljedeće kategorije: vrlo često (≥1/10) ili često (≥1/100 i &lt; 1/10).
These are ranked under heading of frequency; with the most frequent appearing first, using one decimal precision for percentages and the following convention: very common (≥1/10) or common (≥1/100 to &lt; 1/10).
Podijeljene su prema učestalosti, pri čemu su najčešće navedene prve, koristeći preciznost jedne decimale za postotke i sljedeće kategorije: vrlo često (≥1/10) ili često (≥1/100 i &lt; 1/10).
These arrows show the direction to pull or turn the dose knob in the next step.
Ove pokazuju smjer u kojem treba povući ili okretati gumb za doziranje u sljedećem koraku.
These effects included bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells in rats at exaggerated exposure levels (150 mg/m2/day), and cell degeneration of the epididymis and degeneration of the seminiferous epithelium in dogs at clinically relevant exposure levels ( &gt; 7.5 mg/m2/day clofarabine).
Među njih se ubrajaju bilateralna degeneracija epitela sjemenovoda (150 mg/m2/dan) i atrofija intersticijskih stanica u štakora kod izloženosti prekomjernim dozama (150 mg/m2 na dan) te stanična degeneracija epididimisa i degeneracija epitela sjemenovoda u pasa pri klinički značajnim razinama izloženosti (doza klofarabina od ≥ 7,5 mg/m2 na dan).
These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; &gt; 25 units).
Ovi su se učinci vidjeli u bolesnika u svakom od tri razreda transfuzije crvenih krvnih stanica prije ispitivanja (4 – 14 jedinica; 15 – 25 jedinica; &gt; 25 jedinica).
These events occurred primarily with the starting dose whereas during maintenance therapy with the 80 mg dose, the incidence of these events pr 100 injections was: 3 for pain and &lt; 1 for erythema, swelling, nodule and induration.
Ove nuspojave javljale su se uglavnom pri primjeni početne doze, dok je tijekom terapije održavanja uz dozu od 80 mg incidencija tih događaja na 100 injekcija iznosila: 3 za bol a &lt; 1 za eritem, oticanje, nodule i otvrdnuće.
These events typically occurred early in the course of Kyprolis therapy ( &lt; 5 cycles).
Ovi su se događaji obično javljali rano u tijeku liječenja lijekom Kyprolis ( &lt; 5 ciklusa).
These findings collectively indicate that conversion of PAA to PAGN may be impaired in patients with severe hepatic impairment and that a plasma PAA to PAGN ratio &gt; 2.5 identifies patients at risk of elevated PAA levels.
Ti nalazi skupno upućuju na zaključak da pretvorba PAA u PAGN može biti ugrožena kod bolesnika s teškim oštećenjem jetre i da omjer PAA i PAGN u plazmi &gt; 2,5 identificira bolesnike s rizikom od povišenih razina PAA.
These patients experienced more serious adverse events and adverse events leading to death than those patients &lt; 75 years of age.
U tih su se bolesnika ozbiljnije nuspojave i nuspojave sa smrtnim ishodom javljale češće nego u bolesnika mlađih od 75 godina.
These patients had completed ≥ 52 weeks of telbivudine treatment, and had exhibited HBeAg loss for ≥ 24 weeks with HBV DNA &lt; 5 log10 copies/ml at the last on-treatment visit.
Navedeni bolesnici završili su liječenje telbuvidinom tijekom ≥52 tjedana, pri čemu je na dan posljednjeg dolaska radi primjene lijeka uočen gubitak HBeAg tijekom ≥24 tjedana s HBV DNA &lt; 5 log10 kopija/ml.
These patients had high disease activity as defined by elevated haemolysis (LDH ≥1.5x ULN) and the presence of related clinical symptom(s): fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), anaemia (haemoglobin &lt; 100 g/L), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Ovi su bolesnici imali visokoaktivnu bolest, tako definiranu prema pojačanoj hemolizi (LDH ≥1,5x GGN), i pridruženim kliničkim simptomima: umor, hemoglobinurija, abdominalni bol, nedostatak zraka (dispneja), anemija (hemoglobin &lt; 100 g/l), veliki štetni krvožilni događaj (uključujući trombozu), disfagija ili erektilna disfunkcija.
These proportions were highly significantly different (p &lt; 0.0001).
Udjeli bolesnika iz dviju skupina značajno su se razlikovali (p &lt; 0,0001).
These rates were significantly greater (p &lt; 0.0001) against a random effects meta-analysis of localisation rates from published literature for colloidal lymphatic mapping agents as used in European clinical practice.
Ove stope su značajno više (p &lt; 0,0001) u usporedbi s podacima iz meta analize lokaliziranih stopa metodom nasumičnih učinaka dostupnim u objavljenoj literaturi za koloidna sredstva za limfatičko označavanje koja se primjenjuju u europskoj kliničkoj praksi.
These reactions are listed in table 6 by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) or not known (cannot be estimated from the available data).
Te su nuspojave navedene u Tablici 6 prema organskim sustavima i učestalosti pojavljivanja (vrlo često (≥ 1/10), često (≥ 1/100 i &lt; 1/10), manje često (≥ 1/1000 i &lt; 1/100), rijetko (≥1/10 000 i &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
These reactions are listed in Table 7 by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) or not known (cannot be estimated from the available data).
Te su nuspojave navedene u Tablici 7 po organskim sustavima i učestalosti pojavljivanja (vrlo često (≥ 1/10), često (≥ 1/100 i &lt; 1/10), manje često (≥ 1/1000 i &lt; 1/100), rijetko (≥ 1/10 000 i &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
These reactions are reported as uncommon (≥ 1/1,000, &lt; 1/100).
Ove reakcije su prijavljene manje često (≥1/1000, &lt; 1/100).
These reactions occurred in &lt; 0.1% of injections and approximately 2% of patients.
Te su nuspojave zabilježene u &lt; 0,1% injekcija i približno 2% bolesnika.
These reactions were more common in patients with baseline eGFR ≥ 30 and &lt; 60 mL/min/1.73m2 (18.5% dapagliflozin 10 mg vs 9.3% placebo).
Te su reakcije bile češće u bolesnika čiji je početni eGFR iznosio ≥ 30 i &lt; 60 ml/min/1,73 m2 (18,5% bolesnika koji su primali dapagliflozin u dozi od 10 mg naspram 9,3% onih koji su primali placebo).
These results were confirmed in the analysis of data at 96 weeks of treatment in the TITAN trial, with 60.4% of patients in the PREZISTA/ritonavir arm having HIV-1 RNA &lt; 50 copies/ml at week 96 compared to 55.2% in the lopinavir/ritonavir arm [difference: 5.2%, 95% CI (-2.8; 13.1)].
Ti su rezultati potvrđeni analizom podataka u 96. tjednu liječenja u ispitivanju TITAN, sa 60,4% bolesnika u skupini liječenoj lijekom PREZISTA/ritonavir koji su imali HIV-1 RNK &lt; 50 kopija/ml u 96. tjednu u usporedbi s 55,2% u skupini liječenoj lopinavirom/ritonavirom [razlika: 5,2%, 95% CI (-2,8;13,1)].
These results were similar to the immune response rates induced by concomitant administration of a single dose of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc. at separate injection sites.
Ovi su rezultati bili slični stopama imunološkog odgovora izazvanog istodobnom primjenom jednokratne doze živog cjepiva protiv varičele (Oka/Merck) i cjepiva protiv morbila, parotitisa i rubele proizvođača Merck &amp; Co., Inc. primjenjenih na različita injekcijska mjesta.
These results were statistically significant (p &lt; 0.001) by comparison with the vehicle group, 3% (6/179) and 2% (3/179) respectively.
Ti su rezultati bili statistički značajni (p &lt; 0,001) u usporedbi sa skupinom liječenom drugim lijekom, 3% (6/179) odnosno 2% (3/179).
These studies indicate that excessive aliskiren exposure ( &gt; 400-fold higher in 8-day old rats compared with adult rats) and high acute toxicity in juvenile rats are caused by immature MDR1, which suggests that in paediatric patients with immature MDR1, there is a potential for aliskiren overexposure (see sections 4.2, 4.3 and 5.2).
Ova ispitivanja upućuju na to da su prekomjerna izloženost aliskirenu ( &gt; 400 puta viša u 8 dana starih štakora u usporedbi s odraslim štakorima) i visoka akutna toksičnost u mladih štakora uzrokovani nezrelim MDR1, što ukazuje na to da u pedijatrijskih bolesnika s nezrelim MDR1, postoji potencijal za prekomjernu izloženost aliskirenu (vidjeti dijelove 4.2, 4.3 i 5.2).
These substitutions conferred low level resistance (EC50 &lt; 1 nM) for genotype 1b, and higher levels of resistance for genotype 1a (EC50 up to 350 nM).
Te su supstitucije uzrokovale rezistenciju niskog stupnja (EC50 &lt; 1 nM) kod genotipa 1b te rezistenciju višeg stupnja kod genotipa 1a (EC50 do 350 nM).
They are classified according to the following convention: very common (≥1/10), common≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1000), very rare ( &lt; 1/10,000), or not known (cannot be estimated from the available data).
Razvrstane su prema učestalosti na sljedeći način: vrlo česte (≥1/10), česte (≥1/100 do &lt; 1/10), manje česte (≥1/1000 do &lt; 1/100), rijetke (≥1/10 000 do &lt; 1/1000), vrlo rijetke ( &lt; 1/10 000), ili nepoznato (ne može se procijeniti iz dostupnih podataka).
They are classified according to the subsequent convention: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) or not known (cannot be estimated from the available data).
Razvrstane su prema slijedećem dogovoru: vrlo često (≥1/10), često (≥1/100 i &lt; 1/10), manje često (≥1/1000 i &lt; 1/100), rijetko (≥1/10 000 i &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
They are present in plasma at levels that are &lt; 10% of erlotinib and display similar pharmacokinetics as erlotinib.
Oni su prisutni u plazmi u razinama koje su &lt; 10% razine erlotiniba i pokazuju sličnu farmakokinetiku kao erlotinib.
They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1000), very rare ( &lt; 1/10,000), or not known (cannot be estimated from the available data).
Razvrstane su prema organskim sustavima i klasificirane su prema slijedećem dogovoru: vrlo često (≥1/10), često (≥1/100 i &lt; 1/10), manje često (≥1/1000 i &lt; 1/100), rijetko (≥1/10 000 i &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1000), very rare ( &lt; 1/10,000), or not known (cannot be estimated from the available data).
Razvrstane su prema organskim sustavima i prema učestalosti na sljedeći način: vrlo često (≥1/10), često (≥1/100 do &lt; 1/10), manje često (≥1/1000 do &lt; 1/100), rijetko (≥1/10 000 do &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) i nepoznato (nije se moglo procijeniti na temelju dostupnih podataka).
They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1000), very rare ( &lt; 1/10,000), or not known (cannot be estimated from the available data).
Razvrstane su prema organskim sustavima i prema učestalosti na sljedeći način: vrlo često (≥1/10), često (≥1/100 do &lt; 1/10), manje često (≥1/1000 do &lt; 1/100), rijetko (≥1/10 000 do &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) ili nepoznato (nije se moglo procijeniti na temelju dostupnih podataka).
They are ranked under headings of SOC and frequency using the following convention: very common ( 1/10), common (1 /100 to &lt; 1 /10), uncommon ( 1/1,000 to &lt; 1 /100), rare (1 /10,000 to &lt; 1 /1,000), very rare ( &lt; 1 /10,000), not known (cannot be estimated from the available data).
Poredane su prema klasifikaciji organskih sustava i učestalosti, uz sljedeću konvenciju: vrlo često (≥ 1/10), često (≥ 1/100 do &lt; 1/10), manje često (≥ 1/1 000 do &lt; 1/100), rijetko (≥ 1/10 000 do &lt; 1/1 000), vrlo rijetko ( &lt; 1/10 000), nije poznato (ne može se utvrditi iz dostupnih podataka).
Thiomersal &lt; 120 μg.
Tiomersal ≤ 120 μg
Thirteen of these ONJ cases occurred in postmenopausal women with osteoporosis during the phase III clinical trial extension following treatment with Prolia for up to 10 years (0.3%; &lt; 0.1 events per 100 subject-years).
Trinaest od ovih slučajeva ONČ se pojavilo u postmenopauzalnih žena s osteoporozom tijekom produžetka kliničkog ispitavanja faze III nakon liječenja lijekom Prolia do 10 godina (0,3%; &lt; 0,1 događaja na 100 bolesnik-godina).
Thirteen percent (6/45) of the tenofovir disoproxil fumarate group, 13% (6/45) of the emtricitabine plus tenofovir disoproxil fumarate group, and 9% (2/22) of the entecavir group had a confirmed increase in serum creatinine ≥ 0.5 mg/dl or confirmed serum phosphate of &lt; 2 mg/dl.
Trinaest posto (6/45) pacijenata u skupini liječenoj tenofovirdizoproksilfumaratom, 13% (6/45) pacijenata u skupini liječenoj emtricitabinom i tenofovirdizoproksilfumaratom i 9% (2/22) pacijenata u skupini liječenoj entekavirom imalo je potvrđen porast kreatinina u serumu za ≥ 0,5 mg/dl ili potvrđeni fosfat u serumu &lt; 2 mg/dl.
Thirty two percent (30/94) of subjects demonstrated &gt; 15 percentile decrease in height-for-age percentile 5 years after completion of therapy (see sections 4.8 and 5.1).
Trideset i dva posto ispitanika (30/94) pokazalo je smanjenje od &gt; 15 percentila na percentilnoj krivulji rasta za određenu dob 5 godina nakon završetka terapije (vidjeti dijelove 4.8 i 5.1)
Thirty two percent (30/94) of subjects demonstrated &gt; 15 percentile decrease in height-for-age percentile 5 years after completion of therapy (see sections 4.8 and 5.1).
U 32% (30/94) ispitanika je 5 godina nakon završetka liječenja zabilježeno smanjenje od &gt; 15 percentila na percentilnoj krivulji visine za dob (vidjeti dijelove 4.8 i 5.1).
Thirty-six (36) months of Glivec treatment significantly prolonged RFS compared to 12 months of Glivec treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p &lt; 0.0001) (Table 8, Figure 1).
Trideset i šest (36) mjeseci liječenja Glivecom značajno je produljilo preživljenje bez recidiva bolesti u usporedbi s 12 mjeseci liječenja Glivecom (uz ukupan omjer rizika = 0,46 [0,32, 0,65], p &lt; 0,0001) (Tablica 8, Slika 1).
This 15% difference between treatment groups was confirmed at 24 months (53% Visudyne versus 38% placebo, p &lt; 0.001).
Ta se razlika od 15% između dviju ispitivanih skupina potvrdila i nakon 24 mjeseca (53% za Visudyne u odnosu na 38% za placebo, p &lt; 0,001).
This 18 month difference was statistically significant with a hazard ratio of reduction of risk of death in the MPT arm of 0.59, 97.5% confidence interval of 0.42-0.84 and p-value of &lt; 0.001 (see Figure 1).
Razlika od 18 mjeseci bila je statistički značajna uz smanjenje omjera rizika od smrti u skupini MPT od 0,59, 97,5%, intervala pouzdanosti od 0,42 do 0,84 i p-vrijednosti od &lt; 0,001 (vidjeti sliku 1).
This clearance was achieved in 69% (20/29) of the Fabrazyme treated patients, but in none of the placebo patients (p &lt; 0.001).
Takav je klirens postiglo 69% (20/29) bolesnika liječenih lijekom Fabrazyme, no niti jedan bolesnik koji je primao placebo (p &lt; 0,001).
This difference was statistically significant (p &lt; 0.001) for the pre-specified analysis at day 14 and day 28.
Za unaprijed određenu analizu 14. i 28. dana, ta je razlika bila statistički značajna (p &lt; 0,001).
This difference was statistically significant (p &lt; 0.001).
Ta je razlika bila statistički značajna (p &lt; 0,001).
This effect was seen in all patients, the severe (serum sodium: &lt; 130 mEq/l) and mild (serum sodium: 130 - &lt; 135 mEq/l) subsets and for all disease aetiology subsets (e.g.
To se primijetilo kod svih bolesnika, u teškoj (serumski natrij: &lt; 130 mEq/l) i blagoj (serumski natrij: 130 - &lt; 135 mEq/l) podskupini i za sve podskupine etiologije bolesti (npr. zatajenje srca, ciroza, SIADH/drugo).
This finding was further supported by a statistically significant decrease in GL-3 inclusions in kidney, heart and skin combined and in the individual organs in patients treated with agalsidase beta compared to placebo patients (p &lt; 0.001).
Ovaj nalaz dodatno podupire statistički značajno smanjenje inkluzija GL-3 u bubrezima, srcu i koži zajedno te u pojedinačnim organima u bolesnika liječenih agalzidazom beta u usporedbi s bolesnicima koji su primali placebo (p &lt; 0,001).
This includes any possible side effects not listed in this leaflet.
Ovo uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi &gt; .
This increased risk for toxicity based on CD4 count thresholds has not been detected in patients with undetectable (i.e. &lt; 50 copies/ml) plasma viral load.
Ovaj povećan rizik toksičnosti koji se temelji na broju CD4 nije uočen u bolesnika s nedetektabilnim (tj. &lt; 50 kopija/ml) virusnim opterećenjem u plazmi.
This interim analysis showed a TTP risk reduction of 45 % (95 % CI; 29-57 %, p &lt; 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Ova privremena analiza je pokazala redukciju TTP rizika za 45 % (95 % CI; 29-57 %, p &lt; 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom bortezomiba i pegiliranog liposomalnog doksorubicina.
This interim analysis showed a TTP risk reduction of 45% (95% CI: 29-57%), p &lt; 0.0001. The median TTP was
Ova privremena analiza pokazala je smanjenje rizika za TTP od 45% (95% CI: 29-57%), p &lt; 0,0001.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p &lt; 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Ova prijevremena analiza je pokazala redukciju TTP rizika za 45 % (95 % CI; 29 – 57 %, p &lt; 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom bortezomiba i pegiliranog liposomalnog doksorubicina.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p &lt; 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Ova prijevremena analiza je pokazala redukciju TTP rizika za 45 % (95 % CI; 29-57 %, p &lt; 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom bortezomiba i pegiliranog liposomalnog doksorubicina.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p &lt; 0.0001) for patients treated with combination therapy of VELCADE and pegylated liposomal doxorubicin.
Ova prijevremena analiza je pokazala redukciju TTP rizika za 45 % (95 % CI; 29-57 %, p &lt; 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom VELCADEa i pegiliranog liposomalnog doksorubicina.
This is a serious reaction which may occur uncommonly (≥ 1/1,000 to &lt; 1/100) (see section 4.4).
Hipoglikemija je ozbiljna reakcija koja može nastati manje često (≥ 1/1000 i &lt; 1/100) (vidjeti dio 4.4).
This is based upon clinical data in children &gt; 1 year of age and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza (see Section 5.2 for exposure simulation).
Preporuka se temelji na kliničkim podacima za djecu &gt; 1 godine starosti i odrasle, prema kojima je polovica dnevne terapijske doze klinički učinkovita za prevenciju gripe (vidjeti dio 5.2 za simulaciju izloženosti virusu):
This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight &lt; 60 kg when given a 10 mg once daily dose compared with patients ≥ 60 kg (see sections 4.4, 4.8 and 5.2).
Razlog tomu je povećana izloženost aktivnom metabolitu prasugrela i povećan rizik od krvarenja nakon primjene doze od 10 mg na dan u bolesnika tjelesne težine &lt; 60 kg u usporedbi s bolesnicima tjelesne težine ≥ 60 kg (vidjeti dijelove 4.4, 4,8 i 5.2).
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