natgillin/translations-raw huggingface dataset:
Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and &lt; 1%).
Vremenska povezanost liječenja olanzapinom i venske tromboembolije (VTE) prijavljivana je manje često ( &lt; 0,01% i &lt; 1%).
Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and &lt; 1%).
Vremenska povezanost liječenja olanzapinom i venske tromboembolije (VTE) zabilježena je manje često ( &lt; 0,01 % i &lt; 1 %).
Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and &lt; 1%).
Vremenska povezanost liječenja olanzapinom i venske tromboembolije (VTE) zabilježena je manje često ( &lt; 0,01% i &lt; 1%).
Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and &lt; 1%)..
Vremenska povezanost liječenja olanzapinom i venske tromboembolije (VTE) zabilježena je manje često ( &lt; 0,01% i &lt; 1%).
Temporal association of treatment with IM olanzapine with hypotension, bradycardia, respiratory depression and death has been very rarely ( &lt; 0.01 %) reported particularly in patients who have received benzodiazepines and/or other antipsychotics (see section 4.8).
Vremenska povezanost liječenja intramuskularnim olanzapinom s hipotenzijom, bradikardijom, respiratornom depresijom i smrću prijavljena je vrlo rijetko ( &lt; 0,01%), naročito u bolesnika koji su primali benzodiazepine i/ili druge antipsihotike (vidjeti dio 4.8).
Temporarily discontinue Fexeric if the serum phosphorus is &lt; 3 mg/dl and resume at a lower dose once the serum phosphorus has returned to the target range.
Ako je razina fosfora u serumu &lt; 3 mg/dl potrebno je privremeno prekinuti primjenu Fexerica i nastaviti s primjenom manje doze nakon što se vrijednost fosfora u serumu vrati unutar ciljnog raspona.
Temporarily suspend Caelyx treatment in patients when the ANC count is &lt; 1,000/mm3 and/or the platelet count is &lt; 50,000/mm3.
Privremeno prekinite liječenje bolesnika Caelyxom kad im je ANC &lt; 1.000/mm3 i/ili broj trombocita &lt; 50.000/mm3.
Tenofovir disoproxil fumarate was associated with significantly greater proportions of patients with undetectable HBV DNA ( &lt; 169 copies/ml [ &lt; 29 IU/ml]; the limit of quantification of the Roche Cobas Taqman HBV assay), when compared to adefovir dipivoxil (study GS-US-174-0102; 91%, 56% and study GS-US-174-0103; 69%, 9%), respectively.
Tenofovirdizoproksilfumarat bio je povezan sa značajno većim udjelom pacijenata u kojih se HBV DNK nije mogao detektirati ( &lt; 169 kopija/ml [ &lt; 29 I. J./ml]; granica mjerljivosti testa na HBV Roche Cobas Taqman) u usporedbi s adefovirdipivoksilom (ispitivanje GS-US-174-0102; 91% odnosno 56% i ispitivanje GS-US-174-0103; 69%, odnosno 9%).
Teriflunomide is extensively bound to plasma protein ( &gt; 99%), probably albumin and is mainly distributed in plasma.
Teriflunomid se u viskom stupnju veže za proteine u plazmi ( &gt; 99%), najvjerojatnije albumin, te se uglavnom raspodjeljuje u plazmi.
Terminal elimination half-life was &gt; 20 hours.
Poluvrijeme eliminacije je &gt; 20 sati.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in &gt; 2 % of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Pojmovi označeni zvjezdicom (*) odnose se na nuspojave koje su dodatno prijavljene u više od 2% dijabetičkih hipertenzivnih bolesnika s kroničnom insuficijencijom bubrega i manifestnom proteinurijom i to s većom učestalosti nego kod placeba.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in &gt; 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Pojmovi označeni zvjezdicom (*) odnose se na nuspojave koje su dodatno prijavljene u više od 2% bolesnika sa šećernom bolešću i hipertenzijom s kroničnom insuficijencijom bubrega i manifestnom proteinurijom i to češće nego kod placeba.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in &gt; 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Pojmovi označeni zvjezdicom (*) odnose se na nuspojave koje su dodatno prijavljene u više od 2% dijabetičkih hipertenzivnih bolesnika s kroničnom insuficijencijom bubrega i manifestnom proteinurijom i to s većom učestalosti nego kod placeba.
Terms marked with a star (*) refer to the adverse reactions that were additionally reported in &gt; 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Pojmovi označeni zvjezdicom (*) odnose se na nuspojave koje su dodatno prijavljene u više od 2% dijabetičkih hipertenzivnih bolesnika s kroničnom insuficijencijom bubrega i manifestnom proteinurijom i to češće nego kod placeba.
Tetanus toxoid, adsorbed &gt; /= 40 IU
Infanrix hexa
That Bronchitol has not been studied in patients with a history of significant haemoptysis ( &gt; 60 ml) in the previous three months.
Bronchitol nije ispitan u pacijenata s anamnezom znatne hemoptize ( &gt; 60 ml) u prethodna tri mjeseca.
That if creatinine clearance is confirmed as &lt; 50 mL/min or serum phosphate decreases to
Da ako se potvrdi da je klirens kreatinina &lt; 50 ml/min ili se fosfat u serumu smanji na
That if serum phosphate is &lt; 0.48 mmol/L (1.5 mg/dL) or creatinine clearance decreases during therapy to &lt; 70 mL/min then renal function should be re-evaluated within one week.
Da ako je fosfat u serumu &lt; 0,48 mmol/l (1,5 mg/dl) ili se klirens kreatinina smanji tijekom terapije na &lt; 70 ml/min, onda se bubrežnu funkciju mora ponovno procijeniti u roku od tjedan dana.
That if serum phosphate is &lt; 1.5 mg/dl or creatinine clearance decreases during therapy to
Ako je fosfat u serumu &lt; 1,5 mg/dl ili se klirens kreatinina smanji tijekom terapije na
That if serum phosphate is confirmed to be &lt; 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil fumarate, renal function should be re-evaluated within one week.
Ako se u bilo kojeg pedijatrijskog pacijenta koji uzima tenofovirdizoproksilfumarat potvrdi da je fosfat u serumu &lt; 3,0 mg/dl (0,96 mmol/l), bubrežnu funkciju treba ponovno procijeniti u roku od tjedan dana.
The 10 pneumococcal serotypes included in this vaccine represent the major disease-causing serotypes in Europe covering approximately 56% to 90% of invasive pneumococcal disease (IPD) in children &lt; 5 years of age.
Deset pneumokoknih serotipova, sadržanih u ovom cjepivu, predstavljaju glavne serotipove uzročnika bolesti u Europi, koji pokrivaju oko 56% do 90% invazivne pneumokokne bolesti (IPB) u djece mlađe od 5 godina.
The 12.5 mg dose in the LIR subgroup also demonstrated shorter time to first post-dose SBM as compared to placebo in Kodiac 4 (p=0.002) and Kodiac 5 (p &lt; 0.001).
Vrijeme do prvog spontanog pražnjenja crijeva nakon primjene doze u podskupini bolesnika s NOL-om bilo je kraće i u bolesnika liječenih dozom od 12,5 mg u odnosu na one koji su primali placebo u ispitivanjima Kodiac 4 (p=0,002) i Kodiac 5 (p &lt; 0,001).
The 16 viruses that displayed &gt; 20-fold change in susceptibility all contained mutations at positions 10, 54, 63 plus 82 and/or 84.
Svih 16 virusa koji su pokazali &gt; 20 puta promjenu u osjetljivosti sadržavalo je mutacije na položajima 10, 54, 63 plus 82 i/ili 84.
The 25 mg dose in the LIR subgroup improved rectal straining (Kodiac 4 p=0.043, Kodiac 5 p &lt; 0.001).
Primjena doze od 25 mg je u podskupini bolesnika s NOL-om ublažila rektalno napinjanje (Kodiac 4 p=0,043; Kodiac 5 p &lt; 0,001).
The 25 mg dose in the LIR subgroup increased mean days per week compared with placebo with at least 1 complete spontaneous bowel movement (CSBM) in both studies (Kodiac 4 p=0.002, Kodiac 5 p &lt; 0.001).
U podskupini bolesnika s NOL-om, primjena doze od 25 mg je u usporedbi s placebom srednju vrijednost broja dana na tjedan s najmanje 1 potpunim spontanim pražnjenjem crijeva u oba ispitivanja (Kodiac 4 p=0,002; Kodiac 5 p &lt; 0,001).
The 300 microgram dose resulted in a 170-180 ml increase compared to placebo (p &lt; 0.001) and a 100 ml increase compared to formoterol 12 microgram twice a day (p &lt; 0.001).
Doza od 300 mikrograma dovela je do povećanja od 170-180 ml u usporedbi s placebom (p &lt; 0,001) te do povećanja od 100 ml u usporedbi s formoterolom u dozi od 12 mikrograma dva puta na dan (p &lt; 0,001).
The &gt; 100 IU/l safety margin is the generally accepted level of effective prevention against HBV re-infection in liver transplant patients at risk.
Sigurnosna granica od &gt; 100 IU/l općenito je prihvaćena kao razina učinkovite prevencije protiv ponovne infekcije HBV-om u rizičnih bolesnika s transplantiranom jetrom.
The absolute bioavailability of asenapine when swallowed is low ( &lt; 2 % with an oral tablet formulation).
Apsolutna bioraspoloživost asenapina kad se proguta je mala ( &lt; 2% kod tablete za peroralnu primjenu).
The absolute difference in objective soft tissue response between enzalutamide and placebo arms was 53.9% (95% CI: 48.5%, 59.1%, p &lt; 0.0001).
Apsolutna razlika u objektivnom odgovoru mekog tkiva na liječenje između skupina liječenih enzalutamidom odnosno placebom iznosila je 53,9% (95% CI: 48,5%; 59,1%, p &lt; 0,0001).
The absolute oral bioavailability is &gt; 90%.
Apsolutna bioraspoloživost je nakon peroralne primjene &gt; 90%.
The accumulation ratios were 1.05 and 1.16 for AUC4weeks, and 1.43 and 2.22 for Cmin for 10 mg/kg (body weight &lt; 30 kg) and 8 mg/kg (body weight ≥ 30 kg) doses, respectively.
Omjer akumulacije za AUC4 tjedna odnosno Cmin iznosio je 1,05 odnosno 1,43 za dozu od 10 mg/kg (tjelesna težina &lt; 30 kg) te 1,16 odnosno 2,22 za dozu od 8 mg/kg (tjelesna težina ≥ 30 kg).
The Aclasta group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p &lt; 0.0001].
Skupina na Aclasti pokazala je otprilike 2,5 mm manji gubitak tjelesne visine, u usporedbi s placebom (95% CI: 1,6 mm, 3,5 mm) [p &lt; 0,0001].
The adjusted mean change in CD4+ T cell count from baseline were 267 cells versus 208 cells/mm3, respectively (p &lt; 0.001).
Prilagođena srednja vrijednost promjene broja CD4+ T-stanica u odnosu na početnu vrijednost iznosila je 267 stanica naspram 208 stanica/mm3 (p &lt; 0,001).
The adjusted mean change in the pain VAS after 12 weeks of tocilizumab treatment was a reduction of 41 points on a scale of 0 - 100 compared to a reduction of 1 for placebo patients (p &lt; 0.0001).
Prilagođena srednja promjena osjeta boli prema vizualnoj analognoj ljestvici (VAS) nakon 12 tjedana liječenja tocilizumabom bila je smanjenje za 41 bod na ljestvici od 0 do 100, u usporedbi sa smanjenjem od jednog boda kod bolesnika koji su primali placebo (p &lt; 0,0001).
The adjusted mean dietary phenylalanine tolerance in the Kuvan plus phenylalanine -restricted group was 80.6 mg/kg/day and was statistically significantly greater (p &lt; 0.001) than the adjusted mean dietary phenylalanine tolerance in dietary phenylalanine therapy alone group (50.1 mg/kg/day).
Prilagođena srednja vrijednost tolerancije na fenilalanin u prehrani u skupini koja je primala Kuvan uz prehranu siromašnu fenilalaninom iznosila je 80,6 mg/kg na dan i bila je statistički značajno veća (p &lt; 0,001) od prilagođene srednje vrijednosti tolerancije na fenilalanin u prehrani u skupini čija je terapija bila samo prehrana siromašna fenilalaninom (50,1 mg/kg na dan).
The adjusted mean difference was -6.5 points (CI95% -8.7; -4.4, p &lt; 0.0001).
Prilagođena srednja razlika bila je -6,5 bodova (CI95% -8,7; -4,4, p &lt; 0,0001).
The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in &lt; 6 year olds.
Primjena druge polovice doze ili cijele doze za odrasle nije pojačala reaktogenost, osim za stope općih simptoma koje su bile veće nakon druge doze, osobito stope vrućice u djece mlađe od 6 godina.
The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in &lt; 6 year olds.
Primjena druge polovice ili cijele doze za odrasle nije pojačala reaktogenost, osim za stope općih simptoma koje su bile veće nakon druge doze, osobito stope vrućice u djece mlađe od 6 godina.
The administration of sunitinib should be interrupted and/or the dose reduced in patients without clinical evidence of CHF but with an ejection fraction &lt; 50% and &gt; 20% below baseline.
Primjenu sunitiniba treba privremeno prekinuti i/ili smanjiti dozu u bolesnika u kojih nema kliničkih dokaza kongestivnog zatajivanja srca, ali im je istisna frakcija &lt; 50% i &gt; 20% manja od početne vrijednosti.
The ADRs in the pJIA and sJIA patients treated with tocilizumab are described below and are presented in the Table 2 by system organ class and frequency categories, defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10) or uncommon (≥ 1/1,000 to &lt; 1/100)
Nuspojave kod bolesnika s pJIA i sJIA liječenih tocilizumabom opisane su u nastavku i navedene u Tablici 2 prema klasifikaciji organskih sustava i učestalosti, koja se definirala sljedećim kategorijama: vrlo često (≥ 1/10); često (≥ 1/100 i &lt; 1/10) ili manje često (≥ 1/1000 i &lt; 1/100).
The adverse drug reactions (Table 1) are ranked under heading of frequency, the most frequent first, 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) and not known (cannot be estimated from the available data).
Nuspojave lijeka (Tablica 1) su poredane prema učestalosti, pri čemu su najčešće navedene prve, na sljedeći način: 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The adverse reaction profile reported in patients &gt; 75 years of age treated with thalidomide 100 mg once daily was similar to the adverse reaction profile observed in patients ≤75 years of age treated with thalidomide 200 mg once daily (see Table 3).
Profil nuspojava prijavljenih u bolesnika starijih od 75 godina liječenih talidomidom u dozi od 100 mg jedanput na dan bio je sličan profilu nuspojava opaženih u bolesnika u dobi ≤ 75 godina liječenih talidomidom u dozi od 200 mg jedanput na dan (vidjeti tablicu 3).
The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100).
Nuspojave su kategorizirane prema MedDRA klasifikaciji organskih sustava i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i &lt; 1/10), manje često (≥ 1/1000 i &lt; 1/100).
The adverse reactions are classified as: 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) and not known (cannot be estimated from the available data).
Učestalost nuspojava je klasificirana kao: 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); nepoznato (ne može se procijeniti iz dostupnih podataka).
The adverse reactions are classified by System Organ Class 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).
Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti, primjenom sljedećih kategorija: 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The adverse reactions are classified by System Organ Class 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) and were reported with Mirvaso in clinical studies (see Table 1).
Nuspojave su popisane prema MedDRA klasifikaciji organskih sustava i prema učestalosti uz sljedeće odrednice: 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); nepoznato (ne može se procijeniti iz dostupnih podataka), a zabilježene su kod gela Mirvaso u kliničkim ispitivanjima (vidjeti Tablicu 1.).
The adverse reactions are displayed by system organ class and frequency: 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) and very rare ( &lt; 1/10,000).
Nuspojave su navedene po organskim sustavima i učestalosti: 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) i vrlo rijetko ( &lt; 1/10 000).
The adverse reactions are listed by system organ class (SOC) 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).
Nuspojave su navedene prema klasifikaciji organskih sustava (SOC) i frekvenciji: 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).
The adverse reactions are listed by system organ class 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).
Nuspojave su podijeljene prema organskim sustavima i učestalosti koja se definira kao: 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), nepoznato (ne može se procijeniti iz dostupnih podataka).
The adverse reactions are listed 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), and not known (cannot be estimated from the available data).
prema organskim sustavima i učestalosti pojavljivanja: vrlo često (≥ 1/10), često (≥ 1/100 do &lt; 1/10), manje često (≥ 1/1000 do &lt; 1/100) i nepoznato (ne može se procijeniti iz dostupnih podataka)).
The adverse reactions are reported in this table with the following frequency 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).
Nuspojave su u ovoj tablici zabilježene prema sljedećoj konvenciji prikaza učestalosti: vrlo često (≥1/10), često (≥1/100 do &lt; 1/10), manje često (≥1/1000 i &lt; 1/100), rijetko (≥1/10 000 i &lt; 1/1000).
The adverse reactions listed in Table 3 are presented by system organ class and frequency categories, defined 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).
Nuspojave navedene u Tablici 3 prikazane su prema klasifikaciji organskih sustava i kategorijama učestalosti pojavljivanja, a definirane su na sljedeći način: 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), nepoznato (ne može se procijeniti iz dostupnih podataka) .
The adverse reactions listed in this section fall into the following frequency categories: 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).
Nuspojave navedene u ovom dijelu mogu se svrstati u sljedeće kategorije učestalosti: 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); nepoznato (ne može se procijeniti iz dostupnih podataka).
The adverse reactions reported below are classified according to frequency of occurrence as follows: 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).
Nuspojave navedene u daljnjem tekstu klasificirane su prema sljedećoj 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).
The adverse reactions with a reasonable possibility of causal relationship to the injection procedure or JETREA are listed by MedDRA system organ class 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) and not known (cannot be estimated from the available data).
Nuspojave s osnovanom mogućnošću da su uzrokovane postupkom injiciranja ili JETREom su navedene prema MedDRA klasifikaciji organskih sustava, a prema učestalosti su razvrstane 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) i nepoznato (procjena iz dostupnih podataka nije moguća).
The affinity of insulin degludec to serum albumin corresponds to a plasma protein binding of &gt; 99% in human plasma.
Afinitet degludek inzulina za albumine u serumu odgovara vezivanju na proteine plazme od &gt; 99% u humanoj plazmi.
The age range at randomisation was 4-58 years old (71% were &lt; 18 years old).
Raspon dobi pri randomizaciji bio je 4-58 godina (71% je bilo u dobi &lt; 18 godina).
The aim of the treatment is to maintain the plasma free copper (also known as non-ceruloplasmin plasma copper) below 250 microgram/l (normal: 100-150 microgram/l) and the urinary copper excretion below 125 microgram/24 h (normal: &lt; 50 microgram/24 h).
Cilj liječenja je održati slobodan bakar u plazmi (također poznat kao ne-ceruloplazminski bakar u plazmi) ispod 250 mikrograma/l (normalno: 100-150 mikrograma/l) te izlučivanje bakra mokraćom ispod 125 mikrograma/24 h (normalno: &lt; 50 mikrograma/24 h).
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p &lt; 0.001), PFS (hazard ratio 0.511;95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Analiza je pokazala poboljšani ORR (CR+PR) (omjer izgleda 3,769; 95% CI 2,045-6,947; p &lt; 0,001), PFS (omjer hazarda 0,511; 95% CI 0,309-0,845; p=0,008), TTP (omjer hazarda 0,385; 95% CI 0,212-0,698; p=0,001) za bortezomib u kombinaciji s deksametazonom nad monoterapijom bortezomibom.
The analysis included 68 patients with moderate (CLcr 30-59 ml/min), 147 patients with mild (CLcr 60-89 ml/min) renal impairment, and 135 patients with normal renal function (CLcr &gt; 90 ml/min).
Analiza je obuhvatila 68 bolesnika s umjerenim (CLcr 30-59 ml/min), 147 bolesnika s blagim (CLcr 60-89 ml/min) oštećenjem bubrega te 135 bolesnika s normalnom funkcijom bubrega (CLcr &gt; 90 ml/min).
The analysis of all recorded incremental recoveries in previously treated patients demonstrated a median rise of &gt; 2% ( &gt; 2 IU/dL) per IU/kg body weight for Iblias.
Analiza svih zabilježenih prirasta po jedinici doze u prethodno liječenih bolesnika pokazala je da prilikom korištenja lijeka Iblias dolazi do medijana porasta od &gt; 2% ( &gt; 2 IU/dl) po IU/kg tjelesne težine.