natgillin/translations-raw huggingface dataset:
< 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000).
< 1/1000) i vrlo rijetko (< 1/10 000).
< 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
<1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000).
< 1/1000), very rare (< 1/10,000).
<1/100), rijetke (>1/10 000 do <1/1000), vrlo rijetke (<1/10 000).
< 10 g/dL
<10 g/dl
< 10 g/dl, and
<10 g/dl i
< 10 mg/litre) was observed in 97% of patients and appeared within 7 days of initiation of treatment.
<10 mg/litra) zabilježen je kod 97% bolesnika i pojavio se u roku od 7 dana od početka liječenja.
< 10 x 109/L) were observed in 3.6% and < 1% of patients, respectively.
<0,5 x 109/l) i trombocitopenija (broj trombocita <10 x 109/l) zapažene su u 3,6% odnosno <1% bolesnika.
< 10% absolute decrease from baseline
Apsolutno smanjenje za < 10% u odnosu na početnu vrijednost
< 10% points from baseline
< 10 postotnih bodova od početne vrijednosti
< 100,000 copies/ml
100.000 kopija/ml
< 12 g/dl
<12 g/dl
< 12 g/dl after 4 weeks of dose reduction
< 12 g/dl nakon 4 tjedna liječenja sniženom dozom
< 12 years
< 12 godina
< 170 g/L (10.6 mmol/L)
 170 g/L (10,6 mmol/L)
< 18 years
< 18 godina
< 18 years) with CF and documented initial/new onset P. aeruginosa infection/colonisation received Cayston 3 times a day for a single course of 28 days.
< 6 godina; 56 bolesnika u dobi od 6 do < 18 godina) s CF i dokumentiranom početnom/novonastalom infekcijom/kolonizacijom P. aeruginosa primalo je Cayston 3 puta na dan tijekom jedne kure od
< 2 mg/dl n (%)b
< 0,2 mg/dl n (%)b
< 2 months
< 2 mjeseca
< 2 months N=10 (%)
<2 mjeseca N = 10 (%)
< 2 years
< 2 godine
< 2 years old
u dobi < 2 godine
< 2 years, 2-8 years, ≥ 9 years.
< 2 godine, 2-8 godina,  9 godina.
< 2%.
< 2% bolesnika.
< 2,000/mm3
< 2.000/mm3
< 2,000/mm3 (1st time)
< .,000/mm3
< 2,000/mm3 (1st time)
< 2.000/mm3
< 2,000/mm3 (4th time)
< .,000/mm3 (4. put)
< 2,000/mm3 (4th time)
< 2.000/mm3 (4. put)
< 20 copies/mL
< 20 kopija/ml
< 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96 % CV (coefficient of variance)] compared to other renal groups [< 40 % CV].
<20 ml/min/1,73 m2), AUC posakonazola jako je varirao [>96% CV (koeficijent varijabilnosti)] u usporedbi s drugim kategorijama bubrežne funkcije [<40% CV].
< 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96 % CV (coefficient of variance)] compared to other renal groups [< 40 % CV].
CIcr<20 ml/min/1,73 m2), AUC posakonazola jako je varirao [>96% CV (koeficijent varijabilnosti)] u usporedbi s drugim kategorijama bubrežne funkcije [<40% CV].
< 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96 % CV (coefficient of variance)] compared to other renal groups [< 40 % CV].
Clcr <20 ml/min/1,73 m2), AUC posakonazola jako je varirao [>96% CV (koeficijent varijabilnosti)] u usporedbi s drugim kategorijama bubrežne funkcije [<40% CV].
< 200 cells/mm3
< 200 stanica/mm3
< 25 x 109/l (adults)
< 25 x 109/l (odrasli)
< 25,000/mm3
<25 000/mm3
< 250 cells/mm3 (or febrile neutropenia) discontinue treatment.
< 250 stanica/mm3 (ili febrilna neutropenija): obustaviti liječenje
< 250 cells/mm3 (or febrile neutropenia) discontinue treatment.
< 250 stanica/mm3 (ili febrilna neutropenija): obustaviti liječenje.
< 2g/24 hrs.
< 2 g/24 h.
< 3 log10 copies/ml
<3 log10 kopija/ml
< 3 years
< 3 godine
< 30 g/L. Azacitidine is contraindicated in patients with advanced malignant hepatic tumours (see section 4.3).
< 30 g/L. Azacitidin je kontraindiciran u bolesnika s uznapredovalim malignim tumorima jetre (vidjeti dio 4.3).
< 30 ml/min
<30 ml/min
< 30 ml/min) (see section 4.3).
30 ml/min) (vidjeti dio 4.3).
< 30 mL/min) in studies of tenofovir alafenamide.
< 30 ml/min) u ispitivanjima tenofoviralafenamida.
< 30 mL/min), according to the following tables, since enoxaparin sodium exposure is significantly increased in this patient population:
< 30 ml/min), prema sljedećim tablicama, budući da je izloženost enoksaparinnatriju značajno povišena u toj populaciji bolesnika:
< 30 ml/min/1.73 m2) is not recommended (see sections 4.4 and 5.2).
< 30 ml/min/1,73 m2) se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
< 30 ml/min/1.73 m2) or end stage renal disease, therefore Trulicity is not recommended in this population (see section 5.2).
< 30 ml/min/1,73 m2) ili bolesnika u terminalnoj fazi bubrežne bolesti vrlo je ograničeno pa se primjena lijeka Trulicity u toj populaciji ne preporučuje (vidjeti dio 5.2).
< 30 ml/min/1.73 m2).
<30 ml/min/1,73 m2).
< 300 copies/ml
<300 kopija/ml
< 30ml/min/1.73 m2) and/or acute kidney injury, in
<30ml/min/1,73m²) i/ili akutnom ozljedom bubrega, kod
< 4 seizures during 3 month
< 4 napadaja tijekom početnog razdoblja od 3 mjeseca
< 4 seizures during 3 month baseline period
< 4 napadaja tijekom početnog razdoblja od 3 mjeseca
< 4 years
< 4 godine
< 40% (or ≥ 10% absolute decrease from baseline)
< 40% (ili apsolutno smanjenje za ≥ 10% u odnosu na početnu vrijednost)
< 40% is
je LVEF < 40%,
< 400 copies/ml (95 % CI)
400 mg dvaput
< 400 copies/ml (< 69 IU/ml)
< 400 kopija/ml (< 69 IU/ml)
< 400 copies/mL (TLOVR)
< 400 kopija/mL (TLOVR)
< 400 copies/ml < 50 copies/ml (95 % C.I.b) (95 % C.I.b)
< 400 kopija/ml <50 kopija/ml (95% C.I.b) (95% C.I.b)
< 400 copies/ml < 50 copies/ml (95% C.I.b) (95% C.I.b)
(95% C.I.b) (95% C.I.b)
< 400 copies/ml n (%)
< 400 kopija/ml n (%)
< 400 HIV-1 RNA copies/ml was 63.4%.
< 400 HIV-1 RNK kopija/ml bio je 63,4%.
< 400 HIV-1 RNA copies/mla n (%)
< 400 HIV-1 RNK kopija/mla n (%)
< 5 years
< 5 godina
< 50 copies/mL
< 50 kopija/ml
< 50 copies/mL (TLOVR)
< 50 kopija/mL (TLOVR)
< 50 copies/mL (TLOVRa))b
< 50 kopija/ml (TLOVRa))b
< 50 copies/mL at week 48 in the elvitegravir and raltegravir treatment arms, respectively.
< 50 kopija/ml u 48. tjednu u skupini na elvitegraviru, odnosno u skupini na raltegraviru.
< 50 copies/mL by prior treatment regimen
< 50 kopija/ml prema prethodnom reţimu lijeĉenja
< 50 copies/mL by prior treatment regimen
HIV-1 RNK < 50 kopija/ml na prvotnom režimu liječenja
< 50 copies/mL by prior treatment regimend
< 50 kopija/ml na prvotnom režimu liječenjad
< 50 copies/mL by subgroup
HIV-1 RNK < 50 kopija/ml po podskupinama
< 50 copies/mL when compared to patients who stayed on a ritonavir-PI in combination with two NRTIs (94% (297/317) vs 90% 143/159), treatment difference [95% CI]: +3.8% [-1.6% to 9.1%]).
< 50 kopija/ml u usporedbi s bolesnicima koji su ostali na ritonaviru-PI u kombinaciji s dva NRTI-a (94% (297/317) nasuprot 90% 143/159), razlika u liječenju [95% CI]: +3,8% [-1,6% do 9,1%]).
< 50 copies/mL, 3% (8/317) were considered virologic failures (HIV RNA ≥ 50 copies/mL), and 8% (26/317) did not have data available in the Week 48 window.
≥ 50 kopija/ml), a 8% (26/317) nije imalo raspoložive podatke u okviru 48. tjedna.
< 50 copies/mL, n/N (%)
< 50 kopija/ml, n/N (%)
< 50 copies/mla
< 50 kopija/mla
< 50 copies/mlc
< 50 kopija/ml
< 50 copies/mLd
< 50 kopija/mld
< 50 copies/mLe
< 50 kopija/ mle
< 50 copies/mLe
< 50 kopija/mle
< 50 copies/mLf
< 50 kopija/mlf
< 50 HIV-1 RNA
< 50 HIV-1 RNK
< 50 ml/min then renal function should be re-evaluated within one week.
< 50 ml/min, da onda bubrežnu funkciju treba ponovno procijeniti u roku od jednog tjedna.
< 50 mL/min/1.73 m2), and 7,339 patients treated with placebo in the intention-to-treat population.
< 50 ml/min/1,73 m2) i 7339 bolesnika koji su primali placebo u populaciji bolesnika predviđenoj za liječenje.
< 50 mL/min/1.73 m2), and 7,339 patients treated with placebo in the intention-to-treat population.
< 50 ml/min/1,73 m2) i 7339 bolesnika koji su primali placebo u populaciji predviđenoj za liječenje.
< 50 x 109/l (adults)
< 50 x 109/l (odrasli)
< 50 x 109/l (children and adolescents)
< 50 x 109/l (djeca i adolescenti)
< 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
<50 x 109/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 260 mg/m2
< 50 years
< 50 godina
< 50 × 109/l, Grade 4 < 25 × 109/l); anaemia (haemoglobin Grade 3 ≥ 65 – < 80 g/l, Grade 4 < 65 g/l).
≥25–50 × 109/l, stupanj 4: <25 × 109/l); anemija (hemoglobin: stupanj 3 ≥65–<80 g/l, stupanj 4: < 65 g/l).
< 50,000/mm3
<50 000/mm3
< 50,000/µl following at least 2 weeks of therapy
< 50 000/µl nakon barem 2 tjedna liječenja
< 500 copies/ml
< 500 kopija/ml < 50 kopija /ml
< 500 copies/ml < 50 copies/ml
< 500 kopija/ml < 50 kopija/ml
< 500/mm3
<500/mm3
< 55 years
< 55 godina
< 6 years
< 6 god.
< 6 years
< 6 godina
< 60 mL/min; see section 4.4)
<60 ml/min; vidjeti dio 4.4)
< 65 years
< 65 godina
< 65 years compared to subjects between 65 and 75 years (see sections 4.2 and 4.4).
< 65 godina u usporedbi s bolesnicima u dobi između 65 i 75 godina (vidjeti dijelove 4.2 i 4.4).
< 7.0 % or ≤ 6.5 % at 26 weeks and < 7.0 % at 52 weeks than with insulin glargine.
< 7,0% ili ≤ 6,5% u 26. tjednu i < 7,0% u 52. tjednu uz Trulicity nego uz inzulin glargin.
< 70 x 109/l (children and adolescents)
< 70 x 109/l (djeca i adolescenti)
< 75 x 109/l it is recommended to delay treatment until ANC recovers to ≥ 1.0 x 109/l and platelet count to ≥ 75 x 109/l.
≥ 1,0 x 109/l, a broj trombocita do ≥ 75 x 109/l.
< 75 years of age and 46 patients 75 years of age to ≤ 80 years of age) with inadequate glycaemic control on current diabetes treatment (glucose-lowering medicinal products and/or diet and exercise) participated in a double-blind, placebo-controlled study over 26 weeks.
< 75 godina i 46 bolesnika starosti 75 godina do ≤ 80 godina) s neprikladnom regulacijom glikemije s dosadašnjom terapijom dijabetesa (lijekovi koji snižavaju glukozu i/ili dijeta i tjelovježba) sudjelovalo je u dvostruko slijepom, placebom-kontroliranom ispitivanju kroz 26 tjedana.
< 75 years of age and 46 patients 75 years of age to ≤ 80 years of age) with inadequate glycaemic control on current diabetes treatment (glucose-lowering medicinal products and/or diet and exercise) participated in a double-blind, placebo-controlled study over 26 weeks.
< 75 godina i 46 bolesnika starosti 75 godina do ≤ 80 godina) s neprikladnom regulacijom glikemije s trenutnim liječenjem dijabetesa (lijekovi koji snižavaju glukozu i/ili dijeta i vježba) sudjelovalo je u dvostruko slijepom, placebo-kontroliranom ispitivanju kroz 26 tjedana.
< 750 cells/μL on a Bortezomib Hospira dosing day (other than Day 1 of each cycle)
apsolutni broj neutrofila < 750 stanica/μl na dan primjene doze lijeka Bortezomiba Hospira (osim 1. dana svakog ciklusa)
< 8.4 mg/dl (2.1 mmol/l) and > 7.5 mg/dl (1.9 mmol/l) or persistent symptoms of hypocalcaemia despite attempts to increase serum calcium
< 8,4 mg/dl (2,1 mmol/l) I > 7,5 mg/dl (1,9 mmol/l), ili uporni simptomi hipokalcemije unatoč pokušajima da se povisi serumski kalcij
< 8.4 mg/dl (2.1 mmol/l) and >7.5 mg/dl (1.9 mmol/l), or in the presence of clinical symptoms of hypocalcaemia
< 8,4 mg/dl (2,1 mmol/l) I > 7,5 mg/dl (1,9 mmol/l), ili u prisutnosti kliničkih simptoma
< 8.4 mg/dl (2.1 mmol/l) and >7.5 mg/dl (1.9 mmol/l), or in the presence of clinical symptoms of hypocalcaemia
< 8,4 mg/dl (2,1 mmol/l) i > 7,5 mg/dl (1,9 mmol/l), ili u prisutnosti kliničkih simptoma hipokalcemije
< 8.5 g/dl
<8,5 g/dl
< 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
< 80 ml/min/1,73m2), umjerenim (eGFR ≥ 30 i < 50 ml/min/1,73m2), teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i pacijenata sa završnim stadijem bolesti bubrega koji su trebali hemodijalizu, nakon jedne doze od 400 mg sofosbuvira.
< 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
< 80 ml/min/1,73m2), umjerenim (eGFR ≥ 30 i < 50 ml/min/1,73m2), teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i pacijenata sa završnim stadijem bolesti bubrega koji su zahtijevali hemodijalizu, nakon jedne doze od 400 mg sofosbuvira.
< 90 mL/min unless, after review of the available treatment options, it is considered that Stribild is the preferred treatment for the individual patient.
< 90 ml/min, osim ako se nakon pregleda dostupnih mogućnosti liječenja ne smatra da je Stribild preferirano liječenje za pojedinog pacijenta.
< Grade 2 Recurrence at 15 mg:
Ponovna pojava uz 15 mg:
< Grade 2 Recurrence at 30 mg:
Ponovna pojava uz 30 mg:
< PC: {number} SN: {number} NN: {number} >
< PC: {broj} [oznaka lijeka] SN: {broj} [serijalizacijski broj]
< see side 1
< pogledajte 1. stranicu
< see side 1
< pogledajte stranicu 1
<0.0001 (1-sided and 2-sided)
<0,0001 (1-strano and 2-strano)
<0.001
placeba)
<0.001
udar/UCR)
<0.75 or APRI >1 to ≤2).
<0,75 ili APRI >1 do ≤2).
<0.8x109/L or <0.5x109/L. During treatment with Tecfidera in the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% from baseline at one year and then plateaued (see section 4.8).
Tijekom liječenja Tecfiderom u placebom kontroliranim ispitivanjima MS-a, srednja vrijednost broja limfocita smanjila se za otprilike 30% od početne vrijednosti tijekom prve godine nakon čega je uslijedio plato (vidjeti dio 4.8).
<1,000 cells/mm3) have not been investigated.
<1000 stanica/mm3) nisu ispitane.
<1,000 cells/mm3) or severely immunocompromised patients.
<1000 stanica/mm3) niti teško imunokompromitirane bolesnike.
<1.0x109/1 and/or platelets <50x109/1, repeat step1 and resume Imatinib Accordat reduced dose of 400 mg.
1,5 x 109/l i trombociti 75 x 109/l. nastaviti primjenu Imatinib Accorda u smanjenoj dozi od 400 mg.
<1.0x109/1 and/or platelets <50x109/1, repeat step1 and resume Imatinib Accordat reduced dose of 400 mg.
1,5 x 109/l i trombociti75 x 109/l. nastaviti primjenu Imatinib Accorda u smanjenoj dozi od400 mg.
<1.25 X upper normal limit
< 1,25 puta gornja normalna granica
<1/1,000) and very rare (<1/10,000).
<1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
<1/1,000), including isolated reports; not known (cannot be estimated from the available data)
<1/1000), uključujući izolirane slučajeve; nepoznato (ne može se procijeniti iz dostupnih podataka)
<1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data)
<1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka)
<1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).
< 1/1000); i vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
<1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
< 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nije poznato (ne može se procijeniti iz dostupnih podataka).
<1/1,000); very rare (<1/10,000).
<1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
<1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
<1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podatka).
<1/1,000; very rare: <1/10,000).
< 1/1000, vrlo rijetko < 1/10 000).
<1/1,000; very rare: <1/10,000, not known (cannot be estimated from the available data).
<1/1000; vrlo rijetko: <1/10 000, nepoznato (ne može se procijeniti iz dostupnih podataka).
<1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
<1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
<1/10), uncommon (1/1000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
<1/100), rijetko (1/10 000 do <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
<1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
<1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
<1/100) and neutropenia have been reported; therefore regular monitoring of patients taking Mycophenolate mofetil Teva is advised (see section 4.4).
Prijavljene su agranulocitoza (manje često) i neutropenija, stoga se preporučuje redovito praćenje bolesnika koji uzimaju Mikofenolat mofetil Teva (vidjeti dio 4.4).
<1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
<1/100), rijetko (≥1/10.000 do <1/1000), vrlo rijetko (<1/10.000), nepoznato (ne može se utvrditi iz dostupnih podataka).
<1/100); rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000) cannot be estimated from the available data.
<1/1000) ili vrlo rijetko (<1/10 000) ne mogu se procijeniti iz dostupnih podataka.
<1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
<1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
<1/100); rare (1/10,000 to <1/1,000); very rare (1/10,000), not known (cannot be estimated from the available data).Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
<1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000 and not known (cannot be estimated from the available data).
<1/100, rijetko ≥1/10 000 i <1/1000, vrlo rijetko <1/10 000 i nepoznato (ne može se procijeniti iz dostupnih podataka).
<10% decrease
<10% sniženje
<100 mmHg (see section 4.4).
<100 mmHg (vidjeti dio 4.4).
<100 nmol/ml after Strimvelisd n
venskoj krvi < 100 nmol/ml nakon
<100,000 copies/ml
<100 000 kopija/ml
<100-80 g/L (grade 2)
<100-80 g/l (2. stupanj)
<100G/l)
<100 G/l)
<12 months
<12 mjeseci
<12 years (n=15)
<12 godina (N = 15)
<150 cells/L
<150 stanica/l
<16 years) with chronic iron overload due to blood transfusions.
<16 godina) bolesnika s kroničnim preopterećenjem željezom zbog transfuzija krvi.
<17 y
<17 god
<18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
<18 godina (119) koji su primili vorikonazol kao profilaksu (183) ili terapiju (105) u kliničkim ispitivanjima.
<18 years (see section 5.1), which did not indicate a difference in the safety profile of lipegfilgrastim in children compared to that in adults.
21 pedijatrijskog bolesnika u dobi od 2 do < 18 godina (vidjeti dio 5.1), koje nije pokazalo razliku sigurnosnog profila lipegfilgrastima u djece u usporedbi s onim u odraslih.
<18 years of age with SEGA and concomitant hepatic impairment (Child-Pugh A, B and C) (see sections 4.2 and 5.2).
mlađih od 18 godina sa SEGA-om i istodobnim oštećenjem jetre (Child-Pugh A, B i C) (vidjeti dijelove 4.2 i 5.2).
<2 G/L), eosinophilia Very rare: agranulocytosis
Vrlo rijetko: agranulocitoza
<2 units/month for an adult)
<2 jedinice/mjesec za odraslu osobu)
<2 y
< 2 god
<2 years (n=5)
<2 godine (N = 5)
<2.8 g/dL (see section 4.3).
< 2,8 g/dL (vidjeti dio 4.3).
<20 (n=17)
< 20 (n=17)
<25 x 109/l
< 25 x 109/l
<28><28 x 1><30><30 x 1><35><35 x 1><50><50 x 1><56><56 x 1><70><70 x 1><98><98 x 1> film-coated tablets
<28><28 x 1><30><30 x 1><35><35 x 1><50><50 x 1><56><56 x 1><70><70 x 1><98><98 x 1> filmom obloženih tableta
<28><28 x 1><30><30 x 1><35><35 x 1><56><56 x 1><60><70><70 x 1><98><98 x 1> film- coated tablets
<28><28 x 1><30><30 x 1><35><35 x 1><56><56 x 1><60><70><70 x 1><98><98 x 1> filmom obloženih tableta
<28><30><35><50><56><70><98> film-coated tablets
<28><30><35><50><56><70><98> filmom obloženih tableta
<28><30><35><50><56><70><98> orodispersible tablets
<28><30><35><50><56><70><98> raspadljivih tableta za usta
<28><30><35><56><70><98> film-coated tablets
<28><30><35><56><70><98> filmom obloženih tableta
<28><30><35><56><70><98> orodispersible tablets
<28><30><35><56><70> <98>raspadljivih tableta za usta
<2D barcode carrying the unique identifier included.>
< Sadrži 2D barkod s jedinstvenim identifikatorom.>
<2D barcode carrying the unique identifier included.>
<Sadrži 2D barkod s jedinstvenim identifikatorom>
<2D barcode carrying the unique identifier included>
Sadrži 2D barkod s jedinstvenim identifikatorom.
<3 mg Fe/g dw
<3 mg Fe/g težine suhog tkiva jetre
<3%); Skin disorder (G3/4: 0.6%); Nail disorders (G3/4: 0.4%)
<3%); kožna toksičnost (G3/4: 0,6%) poremećaji noktiju (G3/4: 0,4%)
<30 2 mg (2 ml of concentrate for solution for infusion)
<30 2 mg (2 ml koncentrata za otopinu za infuziju)
<30 ml/min) (see section 4.3).
<30 ml/min) (vidjeti dio 4.3).
<30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
< 30 ml/min/1,73 m2) ili u završnom stadiju bolesti bubrega koje zahtijeva hemodijalizu.
<30 ml/mina
< 30 ml/mina
<300 copies/ml was 44% for entecavir and 20% for adefovir at week 24 and 50% for entecavir and 17% for adefovir at week 48.
<300 kopija/ml bio je 44% bolesnika liječenih entekavirom i 20% liječenih adefovirom u 24. tjednu te 50% liječenih entekavirom i 17% liječenih adefovirom u 48. tjednu.
<35 years
<35 godina
<360 μmol/l.
360 μmol/l.
<4 watery stools/day for < 2 days or soft stools
< 4 vodene stolice dnevno < 2 dana ili mekane stolice
<400 copies/ml
<400 kopija/ml
<400 copies/ml
vrijednosti ili < 400 kopija/ml
<400 copies/mL vRNA
<400 kopija/ml vRNA
<400 copies/ml vRNA
<400 kopija/ml vRNK
<50 cells/mm3
<50 stanica/mm3
<50 copies/ml
<50 kopija/ml
<50 copies/mL at Week 48 were 77% (33/43) and 70% (30/43), respectively.
48. tjednu bio je 77% (33/43), odnosno 70% (30/43).
<50 copies/mle
<50 kopija/mle
<50 cp/mL All Patients
<50 cp/mL Svi bolesnici
<50 years
<50 godina
<50% food intake ≥2 days
< 50 % unosa hrane ≥ 2 dana
<6 months
<6 mjeseci
<60 kg (N=664)*
< 60 kg (N = 664)
<60 ml/min/1.73 m²
<60 ml/min./1,73 m²
<65 g/L (Grade 4)
<65 g/l (4. stupanj)
<65 years (N=159)
<65 godina (N=159)
<7 mg Fe/g dw
<7 mg Fe/g težine
<7 ml/kg/month of PRBC (approx.
<7 ml/kg/mjesec KE-a (otprilike
<7% with baseline HbA1c ≥7%2
<7% s početnom vrijednošću HbA1c
<70 x 109/l (children and
< 70 x 109/l
<75 years (N=11672)*
< 75 godina (N=11 672)
<75 years (N=7180)**
< 75 godina (N=7180)
<750/mm3
750/mm³
<80 c/ml
<80 kopija/ml
<80 c/ml: n/N (%)
< 80 kopija/ml: n/N (%)
<80 mL/min/1.73 m2), moderate (eGFR ≥30 and <50 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2) and subjects with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
< 80 ml/min/1,73m2), umjerenim (eGFR ≥ 30 i < 50 ml/min/1,73m2), teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i ispitanika s završnim stadijem bolesti bubrega koji su trebali hemodijalizu, nakon jedne doze od 400 mg sofosbuvira.
<80-65 g/L (grade 3)
<80-65 g/l (3. stupanj)
<90 ml/min), 22 patients with moderate renal impairment (CLcr 30 to <60 ml/min) and 183 patients with normal renal function (≥90 ml/min), ceritinib exposures were similar in patients with mild and moderate renal impairment and normal renal function, suggesting that no dose adjustment is necessary in patients with mild to moderate renal impairment.
183 bolesnika s normalnom bubrežnom funkcijom (≥90 ml/min), izloženosti ceritinibu bile su slične u bolesnika s blagim i umjerenim oštećenjem bubrega i normalnom bubrežnom funkcijom, što ukazuje na to da nije potrebno prilagođavanje doze u bolesnika s blagim do umjerenim oštećenjem bubrega.
<=800,000 IU/mL
≤ 800 000 IU/ml
<=800,000 IU/mL‡
≤ 800 000 IU/ml
<[For HDPE bottle only:]>
<[Samo za HDPE bocu:]>
<date>
<datum>
<DD month YYYY>
<DD mjesec GGGG>
<DD/MM/YY>
<DD/MM/GG>
<Justification for not including Braille accepted>
<Prihvaćeno obrazloženje za nenavoñenje Brailleovog pisma>
<Justification for not including Braille accepted>
<Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.>
<Justification for not including Braille accepted>
Prihvaćeno obrazloženje za nenavoñenje Brailleovog pisma.
<Justification for not including Braille accepted> 56 x 1 tablet
<Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma> 56 x 1 tableta