natgillin/translations-raw huggingface dataset:
< 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
< 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
< 1/1000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
< 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000 ), ni znano (ocena ni možna iz danih podatkov).
< 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
< 1/1.000), zelo redki (< 1/10.000), neznani (ni mogoče oceniti iz razpoložljivih podatkov).
< 1/10; and uncommon  1/1000, < 1/100.
 1/1.000, < 1/100.
< 10 g/dl, and
< 8,5 g/dl
< 10 x 109/L) were observed in 3.6% and < 1% of patients, respectively.
3,6 % oziroma  1 % bolnikov.
< 10 x 109/L) were observed in 3.6% and < 1% of patients, respectively.
Stopnje ( 10 x 109/L) pri 3,6 % oziroma  1 % bolnikov.
< 10% points from baseline
< 10 % od izhodišča
< 10-10
nCR n (%)
< 10-fold, 10 to 40-fold, and > 40-fold reduced susceptibility to lopinavir at baseline, respectively.
< 10-krat, 10- do 40-krat oz. > 40-krat zmanjšano izhodiščno občutljivostjo za lopinavir.
< 12 g/dl
< 12 g/dl kljub
< 12 years of age.
< 12 let.
< 15 kg received darunavir/ritonavir 25/3 mg/kg twice daily, and patients weighing 15 kg to < 20 kg received darunavir/ritonavir 375/50 mg twice daily.
Bolniki s telesno maso 10 kg do < 15 kg so prejeli darunavir/ritonavir 25/3 mg/kg dvakrat na dan, bolniki s telesno maso 15 kg do < 20 kg pa darunavir/ritonavir 375/50 mg dvakrat na dan.
< 15 kg received darunavir/ritonavir 25/3 mg/kg twice daily, and patients weighing 15 kg to < 20 kg received darunavir/ritonavir 375/50 mg twice daily.
Bolniki s telesno maso 10 kg do < 15 kg so prejeli darunavir/ritonavir 25/3 mg/kg dvakrat na dan, bolniki s telesno maso15 kg do < 20 kg pa darunavir/ritonavir 375/50 mg dvakrat na dan.
< 15 ml/min (see sections 4.4 and 5.2).
15 ml/min (glejte poglavji 4.4 in 5.2).
< 15 ml/min (see sections 4.4 and 5.2).
< 15 ml/min (glejte poglavji 4.4 in 5.2).
< 18 years
< 18 let
< 2 months N=10 (%)
< 2 meseca n = 10 (%)
< 2 years old
Stari < 2 leti
< 2,000/mm3 (1st time)
< 2000/mm3 (prvič)
< 2,000/mm3 (2nd/3rd time)
< 2000/mm3 (drugič/tretjič)
< 2,000/mm3 (4th time)
< 2000/mm3 (četrtič)
< 20 copies/mL
< 20 kopij/ml
< 200 cells/mm3
< 200 celic/mm3
< 25 x 109/l
< 25 x 10 /l
< 25,000/mm3
< 25.000/mm3
< 250 cells/mm3 (or febrile neutropenia) discontinue treatment.
< 250 celic/mm3 (ali febrilna nevtropenija) – ukinitev zdravljenja.
< 2g/24 hrs.
< 2 g/24 ur.
< 3 log10 copies/ml
<3 log10 kopij/ml
< 30 g/L. Azacitidine is contraindicated in patients with advanced malignant hepatic tumours (see section 4.3).
Azacitidin je kontraindiciran pri bolnikih z napredovalo obliko malignih jetrnih tumorjev (glejte poglavje 4.3).
< 30 ml/min as severe impairment; < 15 ml/min as functionally anephric requiring haemodialysis).
< 30 ml/min kot resna oslabelost; < 15 ml/min kot funkcionalna anefričnost, ki zahteva hemodializo).
< 30 ml/min/1.73 m2) is not recommended.
< 30 ml/min/1,73 m2) ne priporočamo.
< 30 ml/min/1.73 m2) or end stage renal disease, therefore Trulicity is not recommended in this population (see section 5.2).
Pri tej populaciji bolnikov zato uporaba zdravila Trulicity ni priporočena (glejte poglavje 5.2).
< 30,000 copies/ml
< 30.000 kopij/ml
< 300 copies/ml
<300 kopij/ml
< 4 mutations from score
< 4 mutacije iz rezultata
< 4 seizures during 3 month
Kompleksni parcialni
< 4 seizures during 3 month
≤ 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem
< 4 seizures during 3 month baseline period
≤ 4 epileptični napadi med 3-mesečnim izhodiščnim obdobjem
< 4 years
< 4 leta
< 40% (or ≥ 10% absolute decrease from baseline)
< 40 % (ali ≥ 10 % absolutno zmanjšanje od izhodišča)
< 40% is
LVEF < 40 %,
< 40,000/µl
< 40.000/µl
< 400 copies/ml (95 % CI)
< 400 kopij/ml (95 % IZ)
< 400 copies/ml (< 69 IU/ml)
< 400 kopij/ ml (< 69 i.e./ml
< 400 copies/ml (< 69 IU/ml)
< 400 kopij/ ml (< 69 i.e./ml)
< 400 copies/ml (< 69 IU/ml)
< 400 kopij/ml (< 69 i.e./ml)
< 400 copies/mL (TLOVR)
< 400 kopij/ml (TLOVR)
< 400 copies/mL and 74 % had viral load < 50 copies/mL.
RNA < 400 kopij/ml, 74 % pa virusno breme < 50 kopij/ml.
< 400 copies/ml n (%)
< 400 kopij/ml n (%)
< 400 copies/ml, HIV RNA < 50 copies/ml and in terms of mean change from baseline CD4 cell count.
RNA < 400 kopij/ml, HIV RNA < 50 kopij/ml in glede na povprečno spremembo od izhodiščnega števila celic CD4.
< 400 HIV-1 RNA copies/mla n (%)
< 400 HIV-1 RNK kopij/mla n (%)
< 50 copies/mL (TLOVR)
< 50 kopij/ml (TLOVR)
< 50 copies/mL (TLOVRa))b
< 50 kopij/ml (TLOVRa))b
< 50 copies/mL at week 48 in the elvitegravir and raltegravir treatment arms, respectively.
< 50 kopij/ml v 48. tednu v kraku z elvitegravirjem oz. kraku z raltegravirjem.
< 50 copies/mL by prior treatment regimen
HIV-1 RNA < 50 kopij/ml po režimu predhodnega zdravljenja
< 50 copies/mL by prior treatment regimend
< 50 kopij/ml po režimu predhodnega zdravljenjad
< 50 copies/mL by subgroup
HIV-1 RNA < 50 kopij/ml po podskupini
< 50 copies/mL compared to staying on the baseline regimen (Table 4).
< 50 kopij/ml v primerjavi z bolniki, ki so ostali na začetnem režimu (preglednica 4).
< 50 copies/ml in 61.7 % of patients at Week 16, in 62.1 % at Week 48 and in 57.0 % at Week 96.
HIV RNA < 50 kopij/ml pri 61,7 % bolnikov po 16 tednih, pri 62,1 % po 48 tednih in pri 57,0 % po 96 tednih.
< 50 copies/ml in 82% of patients and < 400 copies/ml in 85% of patients (intention to treat analysis (ITT), missing=failure).
koncentracije HIV-1 RNA v plazmi pri 82 % bolnikov < 50 kopij/ml in pri 85 % bolnikov < 400 kopij/ml (analiza populacije, ki so jo nameravali zdraviti (analiza ITT), nepopoln = neuspešen).
< 50 copies/mL was 68.8 % and 88.7 %, respectively, at week 96.
RNA < 50 kopij/ml po 96. tednu 68,8 % bolnikov, v populaciji, ki se je zdravila, pa 88,7 % bolnikov.
< 50 copies/mL, n/N (%)
< 50 kopij/ml, n/N (%)
< 50 copies/mla
< 50 kopij/mla
< 50 copies/mLd
< 50 kopij/mld
< 50 copies/mLe
< 50 kopij/mle
< 50 copies/mLf
< 50 kopij/mlf
< 50 ml/min then renal function must be re-evaluated within one week.
< 50 ml/min, je treba ledvično delovanje ponovno oceniti v enem tednu.
< 50 x 109/l (children and adolescents)
< 50 x 109/l (otroci in mladostniki)
< 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
 50 x 109/l ponovi/ta, ponovite točko 1 in spet
< 50 x 109/L, repeat step 1 and resume imatinib at reduced dose of 300 mg.
 50 x 109/L ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z zdravilom Imatinib Actavis z zmanjšanim odmerkom 300 mg.
< 50 years
< 50 let
< 50 – 25 x 109/l
< 50 – 25 x 10 /l
< 50,000 copies/ml (mean 330.6 copies/ml), who were free of active AIDS-related illness and were previously vaccinated with 23-valent pneumococcal polysaccharide vaccine administered at least
≥ 200 celic/µl (povprečje 609,1 celic/µl) in virusnim bremenom < 50.000 kopij/ml (povprečje 330,6 kopij/ml), brez aktivne, z AIDS-om povezane bolezni in predhodno cepljenih s 23-valentnim pnevmokoknim polisaharidnim cepivom vsaj 6 mesecev pred vključitvijo v študijo.
< 50,000/mm3
< 50.000/mm3
< 50,000/µl following at least 2 weeks of therapy
< 50.000/µl po najmanj 2 tednih zdravljenja
< 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during Paxene therapy should have their dose reduced by 20 % (NSCLC and first-line treatment of ovarian cancer) or 25 % (MBC
< 500 celic/mm3 in traja teden dni ali več), ali huda periferna nevropatija, je potrebno pri naslednjih ciklih zdravljenja odmerke zmanjšati za 20 % (pri pljučnem karcinomu ne-majhnih celic in prvem zdravljenju raka jajčnika) ali 25 % (MBC in MOC).
< 500 copies/ml < 50 copies/ml
< 500 kopij/ml < 50 kopij/ml
< 6 years
< 6 let
< 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 4.3, 4.4 and 5.1).
Pri bolnikih s sladkorno boleznijo ali okvaro ledvic (GFR < 60 ml/min/1,73 m2) je sočasna uporaba aliskirena in zaviralcev angiotenzinskih receptorjev II ali zaviralcev ACE kontraindicirana, pri drugih bolnikih pa ni priporočena (glejte poglavja 4.3, 4.4 in 5.1).
< 7.0 % and ≤ 6.5 %.
≤ 6,5 %.
< 70 x 109/l (children
< 70 x 109/l (otroci in mladostniki)
< 70 x 109/l (children and adolescents)
< 70 x 109/l (otroci in mladostniki)
< 750 cells/μL on a Bortezomib Hospira dosing day (other than Day 1 of each cycle)
< 25.000 celic/μl ali ANC < 750 celic/μl.
< 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) in > 7,5 mg/dl (1,9 mmol/l) ali persistentni simptomi hipokalciemije kljub poskusom za zvišanje kalcija v serumu
< 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) in > 7,5 mg/dl (1,9 mmol/l) ali prisotnost kliničnih simptomov hipokalciemije
< 8.5 g/dl
< 10 g/dl in
< 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/1,73 m2), zmerno (eGFR ≥ 30 in < 50 ml/min/1,73m2) in hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ter pri bolnikih z ESRD, zaradi katere bolnik potrebuje hemodializo, po enkratnem 400-miligramskem odmerku sofosbuvirja.
< 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
< 800.000 i.e./ml (Amplicor) - njih so zdravili 24 tednov z nadaljnjim 6-mesečnim obdobjem spremljanja.
< 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Te so zdravili 24 tednov in jih spremljali še 6 mesecev.
< Grade 2 Recurrence at 15 mg:
< 2. stopnjo začnite z odmerkom 15 mg Ponovni pojavi pri 15 mg:
< Grade 2 Recurrence at 30 mg:
< 2. stopnjo začnite z odmerkom 30 mg Ponovni pojav pri 30 mg:
< PC: {number} SN: {number} NN: {number} >
< PC: {številka} [koda zdravila] SN: {številka} [serijska številka]
< see side 1
<glejte 1. stran
<0.0001 (1-sided and 2-sided)
< 0,0001 (enostranska in obojestranska)
<0.001
placebom)
<0.0011
(n=154)
<0.0011
(n=44)
<0.0011
ni podatka
<0.0012
(n=115)
<0.1% (1/1728) of patients, respectively.
< 0,1 % (1/1.728) bolnikov.
<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).
Med zdravljenjem z zdravilom Tecfidera v preskušanjih MS, nadzorovanih s placebom, se je povprečno število limfocitov zmanjšalo za približno 30 % od izhodišča v enem letu, nato pa je bilo stabilno (glejte poglavje 4.8).
<1%); Neuropathy peripheral
periferna nevropatija
<1,000 cells/mm3) have not been investigated.
< 1.000 celic/mm3) nista raziskani.
<1,000 cells/mm3) or severely immunocompromised patients.
< 1.000 celic/mm3) ali zelo oslabljenim imunskim sistemom.
<1.25 X upper normal limit
<1.25 X nad zgornjo referenčno mejo
<1.5 x ULN, total bilirubin <1 x ULN, AST and ALT <1.5 x ULN.
< 1-kratno ZNM ter AST in ALT < 1,5-kratno ZNM.
<1/1,000)
koša
<1/1,000)
ovarijske ciste
<1/1,000)
parozmija
<1/1,000) and very rare (<1/10,000).
<1/100), redki (≥1/10.000 do <1/1.000) in zelo redki (<1/10.000).
<1/1,000), including isolated reports; not known (cannot be estimated from the available data)
< 1/1.000), vključno s posameznimi primeri; neznana (ni mogoče oceniti iz razpoložljivih podatkov)
<1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
(< 1/10.000), neznana (iz razpoložljivih podatkov ni mogoče oceniti).
<1/1,000), Very rare (<1/10,000), Frequency not known (cannot be estimated from available data) Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
<1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).
<1/10), občasni (>1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (< 1/10.000), pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data).
< 1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
< 1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
<1/1.000); zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
<1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).
<1/1,000); in zelo redki (<1/10,000), ter neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
<1/1,000); very rare (<1/10,000).
<1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/1,000); very rare (<1/10,000).
<1/1.000); zelo redki (<1/10.000).
<1/1,000); very rare (<1/10,000); unknown (cannot be estimated from available data)).
<1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov):
<1/1,000; very rare: <1/10,000).
< 1/1.000; zelo redki < 1/10.000).
<1/1,000; very rare: <1/10,000, not known (cannot be estimated from the available data).
<1/1.000); zelo redki (<1/10.000), pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/10 of patients treated with CellCept in the controlled clinical trials of renal (2 g data) and hepatic transplant patients are listed in the following table.
< 1/10 bolnikov, zdravljenih z zdravilom CellCept v nadziranih kliničnih preskušanjih bolnikov z ledvičnim (podatki za 2 g) in jetrnim presadkom, so našteti v spodnji preglednici.
<1/10)
artralgija
<1/10)
očesna bolezen,
<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), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<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), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<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); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
< 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
<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).
<1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<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); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000)
< 1/100); redki (> 1/10.000, < 1/1.000); zelo redki (< 1/10.000).
<1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000).
< 1/100); redki (> 1/10.000, < 1/1.000); zelo redki (< 1/10.000).
<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).
<1/10); občasni (1/1.000 do <1/100); redki (1/10.000 do <1/1.000); zelo redki (<1/10.000); pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/100
do < 1/100
<1/100)
Bolezni sečil
<1/100)
nenormalen
<1/100), Rare (≥1/10,000 and <1/1000), Very rare (<1/10,000) and not known (cannot be estimated from available data-spontaneous reports).
< 1/100), redko (≥1/10.000 in < 1/1000), zelo redko (<1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov-spontanih poročil).
<1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) and not known (cannot be estimated from the available data).
 1/100), redki ( 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) and not known (cannot be estimated from the available data).
 1/100), redki ( 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
<1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).
<1/100); redki (>1/10.000, <1/1.000); zelo redki (<1/10.000).
<1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known.
≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost.
<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).
<1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
<1/100); rare (≥1/10,000 to <1/1,000).
<1/100); redki (≥1/10.000 do <1/1.000).
<1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
< 1/1.000), zelo redki (< 1/10.000), z neznano pogostnostjo (iz podatkov, ki so na voljo določitev ni mogoča).
<1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
≤1/1.000), zelo redki (≤ 1/10.000), z neznano pogostnostjo (iz podatkov, ki so na voljo določitev ni mogoča).
<1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known.
<1/1.000), zelo redki (<1/10.000), neznana.
<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.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
<1/1000
edem vek,
<1/1000)
Faringitis, suhi
<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).
≥ 1/1.000 do < 1/100, redki: ≥ 1/10.000 do < 1/1.000, zelo redki: < 1/10.000 in neznana pogostnost (pogostnostni iz razpoložljivih podatkov ni mogoče oceniti).
<100 x 109/L should not be treated with capecitabine.
< 100 x 109/l, ne zdravimo s kapecitabinom.
<100,000 c/ml
< 100.000 kopij/ml
<100,000 copies/mL
< 100.000 kopij/ml
<100,000 copies/ml
<100.000 kopij/ml
<100-80 g/L (grade 2)
< 100-80 g/l (2. stopnja)
<100G/l)
<100 g/l)
<12 months
< 12 mesecev
<12 years (n=15)
<12 let (n=15)
<140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
< 100 mg/dl [5,5 mmol/l] in postprandialnih ravni glukoze < 140 mg/dl [7,8 mmol/l].
<150 cells/L
< 150 celic/l
<18 years of age with SEGA and concomitant hepatic impairment (Child-Pugh A, B and C) (see sections 4.2 and 5.2).
ki so stari manj kot 18 let in imajo SEGA ter hkrati okvaro jeter (razredov A, B ali C po Child-Pughovi lestvici) (glejte poglavji 4.2 in 5.2).
<2 G/L), eosinophilia Very rare: agranulocytosis
Zelo redki: agranulocitoza
<2 units/month for an adult)
<2 enoti/mesec pri odraslem)
<2 y
<2 leti
<2 years (n=5)
<2 leti (n=5)
<2.8 g/dL (see section 4.3).
< 2.8 g/dl (glejte poglavje 4.3).
<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 filmsko obloženih tablet
<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 filmsko obloženih tablet
<28><30><35><50><56><70><98> film-coated tablets
28, 30, 35, 50, 56, 70, 98 filmsko obloženih tablet
<28><30><35><50><56><70><98> orodispersible tablets
28, 30, 35, 50, 56, 70, 98 orodisperzibilnih tablet
<28><30><35><56><70><98> film-coated tablets
28, 30, 35, 56, 70, 98 filmsko obloženih tablet
<28><30><35><56><70><98> orodispersible tablets
28, 30, 35, 56, 70, 98 orodisperzibilnih tablet
<2D barcode carrying the unique identifier included.>
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
<2D barcode carrying the unique identifier included>
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
<2log10 decline in HCV RNA Missing best previous response
< 2 log10 znižanje HCV RNA Brez podatka o prejšnjem
<2y
<2 leti
<3 mg Fe/g dw
<3 mg Fe/g suhe teže
<3%); Skin disorder (G3/4: 0.6%); Nail disorders (G3/4: 0.4%)
<3%), bolezni kože (S3/4: 0,6 %), spremembe nohtov (S3/4: 0,4 %)
<30 2 mg (2 ml of concentrate for solution for infusion)
< 30 2 mg (2 ml koncentrata za raztopino za infundiranje)
<30 ml/min) compared to subjects with normal renal function (see section 4.2).
17 % večja kot pri osebah z normalnim delovanjem ledvic (glejte poglavje 4.2).
<30 ml/min) were not included in the clinical studies of Zykadia (see section 4.2).
<30 ml/min) niso bili vključeni v klinične študije zdravila Zykadia (glejte poglavje 4.2).
<30 ml/min/1.73m2) and these patients may be at greatest risk of hypotension (see section 4.2).
<30 ml/min/1,73 m2), je zelo malo in pri teh bolnikih je tveganje za hipotenzijo lahko najbolj povečano (glejte poglavje 4.2).
<35 years
344
<35 years
< 35 let
<35 years
<35 let
<4 watery stools/day for < 2 days or soft stools
<4 tekoči iztrebki/dan za < 2 dni ali mehki iztrebki
<400 copies/ml
< 400 kopij/ml
<400 copies/ml
<400 kopij/ml
<400 copies/ml
RNA <400 kopij/ml
<400 copies/ml 72 % 79 %
< 400 kopij/ml 72 % 79
<400 copies/mL vRNA
< 400 kopij/ml vRNA
<5 years of age
Stari < 5 let
<5.0 mg/dL, or <4.0 mg/dL compared to the group that achieved an average post-baseline serum urate level ≥6.0 mg/dL during the last 32 weeks of the treatment period (Week 20-Week 24 to Week 49 - 52 intervals).
< 5,0 mg/dl ali < 4,0 mg/dl, v primerjavi s skupino, ki je dosegla povprečne vrednosti urata v serumu po izhodišču ≥ 6,0 mg/dl v obdobju zadnjih 32 tednov zdravljenja (v intervalih teden 20-24 do teden 49-52).
<50 cells/mm3
<50 celic/mm3
<50 copies/ml
<50 kopij/ml
<50 copies/ml
RNA <50 kopij/ml
<50 cp/mL All Patients
Vsi bolniki
<50 mL/min) or severe renal impairment (CLcr <30 mL/min) an adjustment in the dose is recommended (see section 4.2).
≥ 30 in < 50 ml/min) ali hudo ledvično okvaro (CLcr < 30 ml/min) se priporoča prilagajanje odmerkov (glejte poglavje 4.2).
<50 years
< 50 let
<50 years
<50 let
<50 years
≥35 let
<50% food intake ≥2 days
<50% zaužite hrane ≥2 dni
<500 µg/l
pri <500 µg/l
<6 months
< 6 mesecev
<6 years and received 50 mg/kg saquinavir bid (not to exceed 1000 mg bid) boosted with ritonavir at 3 mg/kg for patients with body weight ranging from 5 to <15 kg or 2.5 mg/kg for patients with body weight ranging from 15 to 40 kg (not to exceed 100 mg bid).
< 2 leti in 13 med 2 do <6 let, ki so prejemali 50 mg/kg sakvinavirja dvakrat na dan (niso presegli 1000 mg dvakrat na dan) s podporno terapijo z ritonavirjem 3 mg/kg pri bolnikih s telesno maso od 5 do <15 kg, ali 2,5 mg/kg pri bolniki s telesno maso od 15 do 40 kg (niso presegli 100 mg dvakrat na dan).
<65 g/L (Grade 4)
< 65 g/l (4. stopnja)
<65 years (N=159)
<65 let (N=159)
<7 mg Fe/g dw
<7 mg Fe/g suhe teže
<7 ml/kg/month of PRBC (approx.
<7 ml/kg/mesec koncentriranih eritrocitov (približno
<70 and <40, respectively, compared with 21.0% and 21.4% among placebo-treated patients, respectively.
37,7 % pri bolnikih s ppFEV1 <70 oziroma <40, v primerjavi z 21,0 % oziroma 21,4 % pri bolnikih, ki so prejemali placebo.
<70 x 109/l (children and
< 70 x 109/l (otroci in mladostniki)
<75 years (N=11672)*
< 75 let (N=11672)
<75 years (N=7180)**
< 75 let (N=7180)
<80 c/ml
< 80 kopij/ml
<80 c/ml: n/N (%)
< 80 kopij/ml: n/N (%)