natgillin/translations-raw huggingface dataset:
RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
RTC &lt; 15% blasta u KS i PK, &lt; 30% blasta+promijelocita u KS i PK, &lt; 20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri (samo za 0102 i 0109).
RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver.
RTC &lt; 15% blasta u KS i PK, &lt; 30% blasta+promijelocita u KS i PK, &lt; 20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri.
RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver.
RTCVraćanje na kroničnu fazu &lt; 15% blasta u KS i PK, &lt; 30% blasta+promijelocita u KS i PK, &lt; 20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri.
RTC: &lt; 15 % blasts BM and PB, &lt; 30 % blasts+promyelocytes in BM and PB, &lt; 20 % basophils in PB, no extramedullary disease other than spleen and liver.
RTC: &lt; 15 % blasta u KS i PK, &lt; 30 % blasta+promijelocita u KS i PK, &lt; 20 % bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri.
RTC &lt; 15% blasts BM and PB, &lt; 30% blasts+promyelocytes in BM and PB, &lt; 20% basophils in PB, no extramedullary disease other than spleen and liver.
VNK &lt; 15% blasta u KS i PK, &lt; 30% blasta+promijelocita u KS i PK, &lt; 20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri
Ruxolitinib is mainly metabolised by CYP3A4 ( &gt; 50%), with additional contribution from CYP2C9.
Ruksolitinib se uglavnom metabolizira putem CYP3A4 ( &gt; 50%), uz dodatni doprinos CYP2C9.
S  0.5 mg/L and R  0.5 mg/L
Staphylococcus spp., S 0,5 mg/l i R &gt; 0,5 mg/l
S. aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) &gt; 50 RED80 (In 80% of the animals).
S. aureus (CP8) soj SP 140 inaktiviran, koji izražava kompleks antigena pridružen sluzi (SAAC)
Safety and efficacy of INVEGA in patients &gt; 65 years of age with schizoaffective disorder have not been studied.
Nije istražena sigurnost i djelotvornost lijeka INVEGA kod bolesnika &gt; 65 godina koji boluju od shizoafektivnog poremećaja.
Safety in patients with left ventricular ejection fraction (LVEF) &lt; 50% or NYHA Class III or IV heart failure (in study 301) or NYHA Class II to IV heart failure (in study 302) was not established (see sections 4.8 and 5.1).
Nije bila ustanovljena sigurnost primjene u bolesnika s ejekcijskom frakcijom lijeve klijetke (LVEF) &lt; 50% niti u bolesnika sa zatajivanjem srca NYHA stupnja III ili IV (u ispitivanju 301), niti sa zatajivanjem srca NYHA stupnja II do IV (u ispitivanju 302), (vidjeti dijelove 4.8 i 5.1).
Safety was evaluated in an observational study that included 69,237 children vaccinated with ProQuad 12 months to 12 years old and 69,237 matched children in a historical comparison group who were vaccinated concomitantly with the measles, mumps, and rubella vaccine manufactured by Merck &amp; Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Sigurnost se procijenila u opažajnom ispitivanju koje je uključilo 69 237 djece cijepljene cjepivom ProQuad u dobi od 12 mjeseci do 12 godina i 69 237 djece odgovarajuće dobi i spola u povijesnoj usporednoj skupini koji su bili istodobno cijepljeni cjepivom protiv morbila, parotitisa i rubele proizvođača Merck &amp; Co., Inc. i živim cjepivom protiv varičele (Oka/Merck).
Safinamide undergoes almost complete metabolic transformation ( &lt; 10% of the administered dose was found unchanged in urine).
Safinamid prolazi gotovo potpunu metaboličku transformaciju ( &lt; 10% primijenjene doze pronađeno je nepromijenjeno u urinu).
Salmeterol and FP significantly reduced exacerbation rates compared with placebo by 15% (95% CI: 7% to 22%; p &lt; 0.001) and 18% (95% CI: 11% to 24%; p &lt; 0.001) respectively.
Salmeterol i FP značajno su smanjili stope egzacerbacija u usporedbi s placebom za 15% (95% CI: 7% do 22%; p &lt; 0,001) odnosno 18% (95% CI: 11% do 24%; p &lt; 0,001).
Same dose (see section 5.2) for elderly patients as for adults ( &lt; 50 years old) should be used.
Jednake doze (vidjeti dio 5.2) se trebaju primijeniti za starije bolesnike kao i za odrasle ( &lt; 50 godina starosti).
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SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥ 6.5 % and &lt; 12 % (12,959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
SAVOR je bilo ispitivanje kardiovaskularnih (KV) ishoda provedeno kod 16 492 bolesnika s vrijednostima HbA1c ≥ 6,5% i &lt; 12% (12 959 bolesnika s potvrđenom KV bolešću; 3533 bolesnika koji su samo imali višestruke faktore rizika), koji su bili randomizirani za primanje saksagliptina (n=8280) ili placeba (n=8212) kao dodatka standardnom liječenju kod povišene vrijednosti HbA1c i KV faktore rizika na određenom području.
SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥6.5% and &lt; 12% (12959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
3533 bolesnika koji su samo imali višestruke faktora rizika), koji su bili randomizirani na saksagliptin (N=8280) ili placebo (8212) kao dodatak regionalnom standardnom liječenju za HbA1c i kardiovaskularne faktore rizika.
Saxagliptin/dapagliflozin combination: Of the 1169 subjects treated in the pooled safety data from the 3 clinical trials, 1007 subjects (86.1 %) were aged &lt; 65 years, 162 subjects (13.9 %) were aged
Kombinacija saksagliptin/dapagliflozin: Od 1169 liječenih ispitanika čiji su podaci bili uključeni u objedinjene podatke o sigurnosti iz 3 klinička ispitivanja, 1007 ispitanika (86,1%) bilo je u dobi
Screening Viral Load &gt; 100,000 copies/mL
Količina virusa kod prvog pregleda  100 000 kopija/ml
SCS Boehringer Ingelheim Comm.V Boehringer Ingelheim RCV GmbH &amp; Co Tél/Tel: +32 2 773 33 11 Lietuvos filialas
SCS Boehringer Ingelheim Comm.V Boehringer Ingelheim RCV GmbH &amp; Co KG Tél/Tel: +32 2 773 33 11 Lietuvos filialas
SE = standard error, CI= confidence interval), * p &lt; 0.05, **p &lt; 0.0001
SE = standardna pogreška, CI= interval pouzdanosti, * p &lt; 0,05, **p &lt; 0,0001
SE = standard error, CI= confidence interval, * p &lt; 0.05
SE = standardna pogreška, CI= interval pouzdanosti, * p &lt; 0,05
SE = standard error, CI= confidence interval, * p &lt; 0.05, **p &lt; 0.0001
SE = standardna pogreška, CI= interval pouzdanosti, * p &lt; 0,05, **p &lt; 0,0001
SE = standard error, CI= confidence interval, *p &lt; 0.05, **p &lt; 0.0001
SE = standardna pogreška, CI= interval pouzdanosti, * p &lt; 0,05, **p &lt; 0,0001
Secondary endpoints included Progression Free Survival [PFS (defined as time from randomization to tumour progression, Prostatic Specific Antigen (PSA) progression, pain progression, or death due to any cause, whichever occurred first], Tumour Response Rate based on Response Evaluation Criteria in Solid Tumours (RECIST), PSA Progression (defined as a ≥25% increase or &gt; 50% in PSA
Sekundarni ishodi uključivali su preživljenje bez progresije bolesti [(engl. progression-free survival, PFS) definirano kao vrijeme od randomizacije do progresije tumora, progresije PSA, progresije boli ili smrti zbog bilo kojeg uzroka, štogod se dogodilo prvo], stopa tumorskog odgovora na temelju kriterija za ocjenu odgovora kod solidnih tumora (engl.
Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI &lt; 150) and clinical response over time.
Sekundarne mjere ishoda obuhvaćale su udio bolesnika u kliničkoj remisiji nakon 4 tjedna liječenja (CDAI &lt; 150) te održanost kliničkog odgovora tijekom vremena.
See also information under the heading “Do not take Sabervel’’.
Vidjeti također informacije pod naslovom “Nemojte &lt; uzimati &gt; &lt; primjenjivati &gt; Saberver”
See also information under the heading “Do not take Sabervel”.
Vidjeti također informacije pod naslovom “Nemojte &lt; uzimati &gt; &lt; primjenjivati &gt; Saberver”
See section 4. &gt;
Pogledajte dio 4.
See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to &lt; 3 years.
Za upute o pripremanju doze od 0,25 ml za djecu u dobi od 2 mjeseca do &lt; 3 godine vidjeti dio 6.6.
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts in adults, adolescents and children (6 to &lt; 12 years of age).
Pogledati Tablicu 1 za shemu konverzije te Tablice 2 i 3 za sheme određivanja doze u odraslih, adolescenata i djece (6 do &lt; 12 godina starosti).
Seen more frequently for glycopyrronium than placebo in elderly &gt; 75 years only.
Uočeno učestalije za glikopironij nego za placebo samo u starijih u dobi &gt; 75 godina
Seen more frequently for glycopyrronium than placebo in elderly &gt; 75 years only.
Uočeno učestalije za glikopironij nego za placebo samo u starijih u dobi &gt; 75 godina.
Select the applicator size (or combination of applicators, for cats &gt; 7.5 kg) adapted to the cat’s weight.
Odaberite veličinu aplikatora (ili kombinaciju aplikatora, za mačke &gt; 7,5 kg), prilagođenu težini mačke.
Sepsis (inc septic shock)*, Herpes zoster (inc disseminated &amp; ophthalmic), Herpes virus infection*,
Sepsa (uključujući septički šok)*, herpes zoster (uključujući diseminirani i oftalmički), infekcija virusom herpesa*, bakterijske infeckcije*, infekcija gornjih/donjih dišnih puteva*, gljivična infekcija*, herpes simpleks
Sepsis (inc septic shock)*, Herpes zoster (inc disseminated &amp; ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
Sepsa (uključujući septički šok)*, herpes zoster (uključujući diseminirani i oftalmički), infekcija virusom herpesa*, bakterijske infeckcije*, infekcija gornjih/donjih dišnih puteva*, gljivična infekcija*, herpes simpleks
Sepsis (inc septic shock)*, Herpes zoster (inc disseminated &amp; ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
sepsa (uključujući septički šok)*, herpes zoster (uključujući diseminirani i oftalmički), infekcija virusom herpesa*, bakterijske infekcije*, infekcija gornjih/donjih dišnih puteva*, gljivična infekcija*, herpes simpleks
Sepsis related to leukopaenia was observed infrequently ( &lt; 1%).
Sepsa povezana s leukopenijom nije bila česta ( &lt; 1%).
Sepsis related to leukopaenia was rarely ( &lt; 1%) observed.
Sepsa povezana s leukopenijom rijetko je bila primijećena ( &lt; 1%).
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 ro &lt; 1/1,000), and acute renal failure.
Teške nuspojave obuhvaćaju anafilaktičku reakciju i angioedem koji se mogu rijetko pojaviti (≥1/10 000 i &lt; 1/1000) i akutno zatajenje bubrega.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1000), and acute renal failure.
Teške nuspojave obuhvaćaju anafilaktičku reakciju i angioedem koji se mogu rijetko pojaviti (≥ 1/10 000 do &lt; 1/1000) i akutno zatajenje bubrega.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000) , and acute renal failure.
Teške nuspojave obuhvaćaju anafilaktičku reakciju i angioedem koji se mogu rijetko pojaviti (≥ 1/10 000 do &lt; 1/1000) i akutno zatajenje bubrega.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000), and acute renal failure.
Teške nuspojave obuhvaćaju anafilaktičku reakciju i angioedem koji se mogu rijetko pojaviti (≥ 1/10 000 do &lt; 1/1000) i akutno zatajenje bubrega.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000), and acute renal failure.
Teške nuspojave obuhvaćaju anafilaktičku reakciju i angioedem koji se mogu rijetko pojaviti (≥ 1/10000 do &lt; 1/1000) i akutno zatajenje bubrega.
Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to &lt; 1/1,000), and acute renal failure.
Teške nuspojave obuhvaćaju anafilaktičku reakciju i angioedem koji se mogu rijetko pojaviti (≥1/10 000 i &lt; 1/1000) i akutno zatajenje bubrega.
Serious angioedema may occur rarely (≥1/10,000 to &lt; 1/1,000).
Ozbiljni angioedem može se pojaviti rijetko (≥1/10 000 do &lt; 1/1000).
Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of &lt; 5 g/dL or a decrease of &gt; 4 g/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Na ozbiljnu hemolizu upućuju razine LDH u serumu veće od onih prije liječenja, uz bilo što od sljedećeg: apsolutno smanjenje broja PNH klonalnih stanica za više od 25% (kad nema razrjeđenja zbog transfuzije) u roku od jednog tjedna ili kraćem; razina hemoglobina od &lt; 5 g/dl ili smanjenje za &gt; 4 g/dl u roku od jednog tjedna ili kraćem; angina; promjene mentalnog statusa; povećanje razine kreatinina u serumu za 50%; ili tromboza.
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to A/H5N1/Indonesia/5/05 and A/H5N1/Vietnam/1194/2004 after the 2nd dose in adults (18-60 years) and elderly ( &gt; 60 years), measured by SRH and HI assays were as follows:
Stopa seroprotekcije*, stopa serokonverzije* i čimbenik serokonverzije** za anti-HA protutijela na viruse A/H5N1/Indonesia/5/05 i A/H5N1/Vietnam/1194/2004 nakon 2. doze u odraslih osoba (18-60 godina) i starijih osoba ( &gt; 60 godina), izmjereni SRH i HI analizama bili su sljedeći:
Serum albumin &lt; 2.8 g/dL (see section 4.4 regarding use in patients with serum albumin ≥2.8 g/dL)
Serumski albumin &lt; 2,8 g/dL (vidjeti dio 4.4 o primjeni u bolesnika sa serumskim albuminom ≥ 2,8 g/dL).
Serum creatinine elevations were mostly mild ( &gt; 1-1.5x ULN) to moderate ( &gt; 1.5-3x ULN) and observed to be reversible in nature (see table 4).
Povišenja vrijednosti kreatinina u serumu uglavnom su bila blage ( &gt; 1 – 1,5 x GGN) do umjerene ( &gt; 1,5 – 3 x GGN) težine i reverzibilne prirode (vidjeti
Seven percent of subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin had neutrophil counts of &lt; 0.5 x 109/L (Grade 4 neutropenia) compared to 4% of subjects receiving only peginterferon alfa-2b and ribavirin.
Sedam posto ispitanika koji su primali kombinaciju lijeka Victrelis s peginterferonom alfa-2b i ribavirinom imalo je &lt; 0,5 x 109/l neutrofila (neutropeniju stupnja 4), u usporedbi s 4% ispitanika koji su primali samo peginterferon alfa-2b i ribavirin.
Seventy-four percent of patients had cutaneous melanoma, and 11% had mucosal melanoma; 35% of patients had PD-L1 positive melanoma ( &gt; 5% tumour cell membrane expression).
Sedamdeset i četiri posto bolesnika imalo je kožni melanom, a 11% melanom sluznice; 35% bolesnika imalo je melanom pozitivan na PD-L1 (ekspresija na tumorskoj staničnoj membrani &gt; 5%).
Seventy-three percent of nucleoside-experienced and 69% of nucleoside-naïve patients achieved complete response to treatment; 90% of nucleoside-experienced and 88% of nucleoside-naïve patients achieved HBV DNA suppression &lt; 400 copies/ml.
U 73% pacijenata koji su primali nukleozide i 69% pacijenata koji prethodno nisu primali nukleozide postigao se potpuni odgovor na liječenje; u 90% pacijenata koji su primali nukleozide i 88% pacijenata koji nisu primali nukleozide postigla se supresija HBV DNK na razinu manju od 400 kopija/ml.
Severe ( &lt; 30) (n = 6)
Teško oštećena ( &lt; 30) (n = 6)
Severe (NCI-CTC grade 3) skin reactions were reported in 34% and life-threatening (NCI- CTC grade 4) skin reactions in &lt; 1% of patients who received Vectibix in combination with chemotherapy (n = 1536) (see section 4.8).
Teške kožne reakcije (NCI-CTC stupanj 3) bile su prijavljene u 34%, a životno opasne kožne reakcije (NCI-CTC stupanj 4) u &lt; 1% bolesnika koji su primali lijek Vectibix u kombinaciji s kemoterapijom (n = 1536) (vidjeti dio 4.8).
Severe (NCI-CTC grade 3) skin reactions were reported in 34% and life-threatening (NCI-CTC grade 4) skin reactions in &lt; 1% of patients who received Vectibix in combination with chemotherapy (n = 1,536).
Teške (NCI-CTC stupanj 3) kožne reakcije bile su zabilježene u 34%, a po život opasne (NCI-CTC stupanj 4) u &lt; 1% bolesnika koji su primali Vecibix u kombinaciji s kemoterapijom (n = 1536).
Severe cutaneous adverse drug reactions have been reported with INTELENCE; Stevens-Johnson Syndrome and erythema multiforme have been rarely ( &lt; 0.1%) reported.
Prijavljene su teške kožne nuspojave s INTELENCEom; Stevens-Johnsonov sindrom i multiformni eritem rijetko su prijavljeni ( &lt; 0,1%).
Severe elevation of transaminases ( &lt; 5%) or bilirubin ( &lt; 1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
U bolesnika s KML-om uočeno je veliko povišenje vrijednosti transaminaza ( &lt; 5%) ili bilirubina ( &lt; 1%) i obično je zbrinuto smanjenjem doze ili prekidom terapije (medijan trajanja tih epizoda bio je približno tjedan dana).
Severe elevation of transaminases ( &lt; 5%) or bilirubin ( &lt; 1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Veliko povišenje vrijednosti transaminaza ( &lt; 5%) ili bilirubina ( &lt; 1%) uočeno je u bolesnika s KML- om i obično je liječeno smanjenjem doze ili prekidom terapije (medijan trajanja tih epizoda bio je približno tjedan dana).
Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing &lt; 60 kg
u epizode značajnog krvarenja češće u bolesnika u dobi od ≥ 75 godina (uključujući i smrtonosna krvarenja) te onih tjelesne težine &lt; 60 kg.
Severe hepatic impairment (Child-Pugh classification C) or severe renal impairment (creatinine clearance &lt; 30 ml/min).
Teško oštećenje funkcije jetre (Child-Pugh stadij C) ili teško oštećenje bubrega (klirens kreatinina &lt; 30 ml/min).
Severe hepatic impairment (serum albumin &lt; 25 g/l or Child-Pugh score  10).
Teško oštećenje funkcije jetre (serumski albumin &lt; 25 g/l ili Child-Pugh rezultat  10).
Severe hepatic impairment (total bilirubin &gt; 3 x ULN).
Teško oštećenje jetrene funkcije (ukupan bilirubin &gt; 3 x GGN).
Severe hepatic impairment, if serum if bilirubin is &gt; 5 mg/dl (85.5 µmol/l) (see section 4.2).
teško oštećenje funkcije jetre ako je bilirubin u serumu &gt; 5 mg/dl (85,5 µmol/l) (vidjeti dio 4.2)
Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ &lt; 25% %; children between 12- 35 months: CD4+ &lt; 20%; children between 36-59 months: CD4+ &lt; 15% (see section 4.4).
Teška humoralna ili stanična (primarna ili stečena) imunodeficijencija, npr. teška kombinirana imunodeficijencija, agamaglobulinemija i AIDS ili simptomatska HIV-infekcija ili dobno specifični postotak CD4+ T limfocita u djece mlađe od 12 mjeseci: CD4+ &lt; 25%; u djece između 12 i 35 mjeseci: CD4+ &lt; 20%; u djece između 36 i 59 mjeseci: CD4+ &lt; 15% (vidjeti dio 4.4).
Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ &lt; 25% ; children between 12-35 months: CD4+ &lt; 20%; children between 36-59 months: CD4+ &lt; 15% (see section 4.4).
Teška humoralna ili stanična (primarna ili stečena) imunodeficijencija, npr. teška kombinirana imunodeficijencija, agamaglobulinemija i AIDS ili simptomatska HIV-infekcija ili dobno specifični postotak CD4+ T limfocita u djece mlađe od 12 mjeseci: CD4+ &lt; 25%; u djece između 12 i 35 mjeseci: CD4+ &lt; 20%; u djece između 36 i 59 mjeseci: CD4+ &lt; 15% (vidjeti dio 4.4).
Severe hypersensitivity reactions including anaphylaxis occur in &lt; 1 % of patients (see also section 4.8).
Jake reakcije preosjetljivosti, uključujući anafilaksiju, pojavljuju se u &lt; 1 % bolesnika (vidjeti dio 4.8).
Severe hypertension ( &gt; 200 mmHg systolic or 110 mmHg diastolic) occurred in 4.7% of patients with solid tumours.
Teška hipertenzija (sistolički krvni tlak &gt; 200 mmHg ili dijastolički krvni tlak 110 mmHg) se razvila u 4,7% bolesnika sa solidnim tumorima.
Severe hypertension occurred in 12% of treatment-naïve patients on sunitinib and &lt; 1% of patients on IFN-.
Teška hipertenzija se javila u 12% prethodno neliječenih bolesnika koji su primali sunitinib i u &lt; 1% bolesnika koji su primali INF-α.
Severe hypotension ( &lt; 90/50 mmHg)
Teška hipotenzija ( &lt; 90/50 mmHg)
Severe hypotension ( &lt; 90/50 mm Hg).
Teška hipotenzija ( &lt; 90/50 mmHg).
Severe rash: Extent of rash &gt; 50% of body surface area or associated with vesicles, bullae, ulcerations other than SJS
Teški osip: Osip zahvaća &gt; 50% površine tijela ili je povezan s vezikulama, bulama, i drugim ulceracijama, osim SJS.
Severe renal function disorders (creatinine clearance &lt; 30 ml/min)
teški poremećaji funkcije bubrega (klirens kreatinina &lt; 30 ml/min)
Severe renal impairment (CLcr &lt; 30 mL/min, not requiring dialysis)
Teško oštećenje funkcije bubrega (CLcr &lt; 30 mL/min, nije potrebna dijaliza)
Severe renal impairment (CrCl &lt; 30 ml/min)
Teško oštećenje funkcije bubrega (klirens kreatinina &lt; 30 ml/min)
Severe renal impairment (CrCl &lt; 30 ml/min) or end stage renal disease requiring dialysis (see sections 4.2 and 4.4).
Teško oštećenje funkcije bubrega (CrCl &lt; 30 ml/min ili terminalna faza bubrežne bolesti koja zahtijeva dijalizu (vidjeti dijelove 4.2 i 4.4).
Severe renal impairment (CrCl &lt; 30ml/min) and haemodialysis patients
Teško oštećenje funkcije bubrega (CrCl &lt; 30 ml/min) i bolesnici na hemodijalizi
Severe renal impairment (CrCl &lt; 30mL/min) and haemodialysis patients
Teško oštećenje funkcije bubrega (CrCl &lt; 30 mL/min) i pacijenti na hemodijalizi
Severe renal impairment (CrCl below 30 mL/min) or end stage renal disease
Teško oštećenje bubrega (CrCl &lt; 30 ml/min) ili terminalna faza bubrežne bolesti
Severe renal impairment (creatinine clearance &lt; 30 ml/min)
Teško oštećenje funkcije bubrega (klirens kreatinina &lt; 30 ml/min)
Severe renal impairment (creatinine clearance &lt; 30 ml/min) and haemodialysis patients
Teško oštećenje funkcije bubrega (klirens kreatinina &lt; 30 ml/min) i pacijenti na hemodijalizi
Severe renal impairment (creatinine clearance &lt; 30 ml/min).
Teško oštećenje bubrega (klirens kreatinina &lt; 30 ml/min).
Severe renal impairment (creatinine clearance &lt; 30 ml/min) (see section 4.4).
Teško oštećenje bubrežne funkcije (klirens kreatinina &lt; 30 ml/min) (vidjeti dio 4.4).
Severe renal impairment (creatinine clearance &lt; 30 ml/min).
Teško oštećenje bubrežne funkcije (klirens kreatinina &lt; 30 ml/min).
Severe renal impairment (eGFR &lt; 30 ml/min/1.73m2), including those with end-stage renal disease requiring dialysis.
Teško oštećenje funkcije bubrega (eGFR &lt; 30 ml/min/1,73m2), uključujući bolesnike s terminalnom bolesti bubrega koji trebaju dijalizu.
Severe renal impairment (GFR &lt; 30 ml/min/1.73 m2).
Teško oštećenje bubrežne funkcije (GFR &lt; 30 ml/min/1,73 m2).