natgillin/translations-raw huggingface dataset:
bacterial or viral infections, bronchitis
bakterijske ali virusne okužbe, bronhitis,
Bacterial resistance mechanisms that could potentially affect ceftazidime/avibactam include mutant or acquired PBPs, decreased outer membrane permeability to either compound, active efflux of either compound, and β-lactamase enzymes refractory to inhibition by avibactam and able to hydrolyse ceftazidime.
Med mehanizmi bakterijske odpornosti, ki bi potencialno lahko vplivali na ceftazidim/avibaktam, so mutirani ali pridobljeni PBP, zmanjšanje permeabilnosti zunanje membrane za eno ali drugo učinkovino, aktivno izločanje ene ali druge učinkovine in betalaktamaze, ki so odporne proti zavrtju z avibaktamom in lahko hidrolizirajo ceftazidim.
Bacterial skin infection.
bakterijska okužba kože
bacterial skin infection.
bakterijska okužba kože,
Bacterial, fungal and viral infections of the digestive and urinary tract, cold sores and shingles
Bakterijske, glivične in virusne okužbe prebavnega in sečnega trakta, herpes febrilis, pasasti izpuščaj.
Bacterial, viral and fungal infections (including opportunistic infections)
bakterijske, virusne in glivične okužbe (vključno z oportunističnimi okužbami)
Bacteroides fragilis and species in the B. fragilis Group*
Bacteroides fragilis in vrste iz skupine B. fragilis
Bacteroides fragilis* Bacteroides caccae* Bacteroides ovatus Bacteroides uniformis* Bacteroides thetaiotaomicron* Bacteroides vulgatus* Bilophila wadsworthia Peptostreptococcus magnus Peptostreptococcus micros* Porphyromonas spp.
Bacteroides fragilis* Bacteroides caccae* Bacteroides ovatus Bacteroides uniformis* Bacteroides thetaiotaomicron* Bacteroides vulgatus* Bilophilora wadsworthia Peptostreptococcus magnus Peptostreptococcus micros* Porphyromonas spp.
bad breath
lab zadah
Bad breath (halitosis)
ustni zadah (halitoza)
bad breath, tooth decay, tooth or gum problems, bleeding gums, gum infections
lab zadah, zobna gniloba, težave z zobmi ali dlesnimi, krvavitev iz dlesni, okužbe dlesni
Bad effects are not expected if you accidentally inject more of this medicine than you should.
Ni verjetno, da bi prišlo do neželenih učinkov, če bi si pomotoma injicirali več zdravilaCetrotide, kot bi smeli.
bad taste in the mouth
lab okus v ustih
bad taste in the mouth
lab okus v ustih,
bad taste in your mouth
lab okus v ustih
BAG
VREČA
Bag
Vrečka
bag (plastic)
vreča (plastika)
Bag (plastic)
vreča (plastična)
bag (PP/PP)
vrečka (PP/PP)
BAG (without blue box)
VREČA (brez modrega okenca)
BAG LABEL
NALEPKA NA VREČKI
Bag must be inverted when the reconstituted Voriconazole is added
Vrečko je treba med dodajanjem rekonstituiranega vorikonazola obrniti s spodnjim koncem navzgor.
Bags of diluent
Vrečka z vehiklom
bait matrix
prevlečeni z
baits
CCID50/odmerek
Balance disorder
motnje ravnotežja;
balance disorder
ravnotežja
Balance disorder
razmišljanje(1)
Balance disorder Coordination abnormal Memory impairment
motnje ravnotežja težave s koordinacijo motnje spomina kognitivna motnja zaspanost
Balance disorder Gait abnormal
Neobičajna hoja
Balance disorder Memory impairment Dysphasia Dysarthria
motnja ravnotežja1, okvara spomina1, disfazija,
balance disorder,
fotofobija,
balance disorder, abnormal coordination, speech difficulties (dysarthria), movement dysfunction, pins and needles / tingling or numbness (paraesthesia), loss of feeling or function in the lower limbs (paraparesis), sedation
motnje ravnotežja, nenormalna koordinacija, težave z govorom (disartrija), motnje gibanja, zbadanje/mravljinčenje ali odrevenelost (parestezija), izguba občutka in nadzora spodnjih okončin (parapareza), sedacija
Balance disorder, Coordination abnormal, Dysarthria, Motor dysfunction, Paraesthesia, Paraparesis, Sedation
motnje ravnotežja, nenormalna koordinacija, disartrija, motorična disfunkcija, parestezija, parapareza, sedacija
Balance disorder, headache
motnje ravnotežja, glavobol
Balance disorders
motnje ravnotežja
Balance disorders
motnje ravnotežja,
Balance disorders Gait abnormal Seizures
omotica motnje ravnotežja neobičajna hoja epileptični napadi
balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
hemipareza, afazija, poslabšano ravnotežje, somnolenca, zmedenost, omotica, poslabšanje spomina, poslabšanje koncentracije, disfazija,
Balance problems
težave z ravnotežjem
Balance problems or feeling dizzy
težave z ravnotežjem ali občutek omotice
Balance problems or feeling dizzy
težave z ravnotežjem ali občutek omotice,
balance problems, lack of co-ordination, spinning sensation (vertigo), problems walking tremors
težave z ravnotežjem, zmanjšana koordinacija, občutek vrtenja (vrtoglavica), težave s hojo, tresenje.
balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess. dUrinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis. eVolume depletion includes, e.g. the predefined preferred terms: dehydration, hypovolaemia, hypotension. fPolyuria includes the preferred terms: pollakiuria, polyuria, urine output increased. gMean changes from baseline in haematocrit were 2.30% for dapagliflozin 10 mg versus –0.33% for placebo.
glivična okužba, okužba nožnice, balanitis, glivična okužba spolovil, vulvovaginalna kandidoza, vulvovaginitis, balanitis candida, genitalna kandidoza, okužba spolovil, okužba spolovil pri moškem, okužba spolnega uda, vulvitis, bakterijski vaginitis, absces vulve. dOkužbe sečil obsegajo naslednje prednostne izraze, naštete v zaporedju opisanih pogostnosti: okužba sečil, cistitis, okužba sečil z Escherichio, okužba genitourinarnega trakta, pielonefritis, trigonitis, uretritis, okužba ledvic in prostatitis. ePomanjkanje volumna vključuje npr. definirane prednostne izraze: dehidracija, hipovolemija, hipotenzija. fPoliurija vključuje prednostne izraze: polakisurija, poliurija, zmanjšano izločanje urina. gPovprečni odstotek spremembe hematokrita od izhodišča je bil 2,30 % z 10 mg dapagliflozina in -0,33 % s placebom.
Balanitis or balanoposthitis**, h
balanitis ali balanopostitis**,h
bald spots on the scalp, chills, headache lower immunity – because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection
plešasti predeli na lasišču, mrzlica, glavobol, zmanjšana imunost – zaradi manjše koncentracije protiteles, imenovanih imunoglobulini (IgG), v krvi; ta protitelesa pomagajo pri zaščiti proti okužbam.
bald spots on the scalp, chills, headache lower immunity – because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection.
plešasti predeli na lasišču, mrzlica, glavobol zmanjšana imunost – zaradi manjše koncentracije protiteles, imenovanih imunoglobulin (IgG), v krvi; ta protitelesa pomagajo pri zaščiti proti okužbam
baldness,
plešavost,
bAnalysis includes patients receiving BM transplant during this period
bAnaliza vključuje bolnike, ki so prejeli presadek kostnega mozga v tem časovnem obdobju
Banbury, Oxfordshire, OX16 4RS United Kingdom.
Oxfordshire, OX16 4RS United Kingdom
bandage or plaster.
ali obliž.
Baraclude 0.05 mg/ml oral solution
Baraclude 0,05 mg/ml peroralna raztopina
Baraclude 0.05 mg/ml oral solution
Baraclude 0,05 mg/ml peroralna raztopina entekavir
Baraclude 0.5 mg film-coated tablets
Baraclude 0,5 mg filmsko obložene tablete entekavir
Baraclude 0.5 mg film-coated tablets Tablet core:
Baraclude 0,5 mg filmsko obložene tablete Jedro tablete:
Baraclude 1 mg film-coated tablets
Baraclude 1 mg filmsko obložene tablete
Baraclude 1 mg film-coated tablets
Baraclude 1 mg filmsko obložene tablete entekavir
Baraclude 1 mg film-coated tablets Tablet core:
Baraclude 1 mg filmsko obložene tablete Jedro tablete:
Baraclude dosage
Odmerjanje zdravila Baraclude
Baraclude dosage*
Odmerjanje* zdravila Baraclude
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. decompensated liver disease (see section 4.4)
Zdravilo Baraclude je indicirano za zdravljenje kronične okužbe z virusom hepatitisa B (HBV) (glejte poglavje 5.1) pri odraslih: s kompenzirano boleznijo jeter in dokazano aktivno replikacijo virusa, persistentno povečanimi vrednostmi serumske alanin-aminotransferaze (ALT) in histološko dokazanim aktivnim vnetjem in/ali fibrozo. z dekompenzirano boleznijo jeter (glejte poglavje 4.4).
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. decompensated liver disease (see section 4.4).
Zdravilo Baraclude je indicirano za zdravljenje kronične okužbe z virusom hepatitisa B (HBV) (glejte poglavje 5.1) pri odraslih: s kompenzirano boleznijo jeter in dokazano aktivno replikacijo virusa, persistentno povečanimi vrednostmi serumske alanin-aminotransferaze (ALT) in histološko dokazanim aktivnim vnetjem in/ali fibrozo. z dekompenzirano boleznijo jeter (glejte poglavje 4.4).
Baraclude oral solution is an anti-viral medicine, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults.
Baraclude peroralna raztopina je protivirusno zdravilo, ki ga uporabljamo za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa B (HBV) pri odraslih.
Baraclude tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults.
Baraclude tablete so protivirusno zdravilo, ki ga uporabljamo za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa B (HBV) pri odraslih.
barbiturates (for difficult sleeping or epilepsy) phenytoin (for epilepsy)
barbiturate (proti nespečnosti ali epilepsiji)
Barbiturates (strong sleeping tablets)
barbiturati (močna uspavala),
barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine)
barbiturati (zdravila, ki se na splošno uporabljajo kot uspavala) dopaminergični agonisti (učinkovine kot L-dopa, bromokriptin)
barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine)
barbiturati (zdravila, ki se običajno uporabljajo kot uspavala), dopaminergični agonisti (učinkovine kot L-dopa, bromokriptin),
barbiturates (to treat nervousness and sleep problems)
barbiturati (za zdravljenje živčnost in težav s spanjem)
Barbiturates (used to treat epilepsy/seizures and some sleep disorders) or rifampicin (against tuberculosis) may decrease the effects of Samsca.
Barbiturati (uporabljajo se za zdravljenje epilepsije in nekaterih motenj spanja) ali rifampicin (proti tuberkulozi) lahko zmanjšajo učinke zdravila Samsca.
Barcode for data sheet for patient documentation Seal-Sticker
Črtna koda za podatkovni list za dokumentacijo bolnika Pečatna nalepka
Barcode labels and stickers
Etikete s črtno kodo in nalepko
Barcodes for 00-minute-value Barcodes for 30-minute-value
Črtne kode za 00-minutno vrednost Črtne kode za 30-minutno vrednost
Barnard Castle,
Barnard Castle
Basal cell carcinoma
Bazalnocelični karcinom
Basal cell carcinoma (BCC)
Bazalnocelični karcinom
Basal cell carcinoma (BCC) has been reported in patients receiving Gilenya (see section 4.8).
Pri bolnikih, ki so prejemali zdravilo Gilenya, so poročali o bazalnoceličnem karcinomu (glejte poglavje 4.8).
basal cell carcinoma and squamous cell
melanoma (vključno z bazalnoceličnim
Basal cell carcinoma develops when DNA in normal skin cells becomes damaged and the body cannot repair the damage.
Bazalnocelični karcinom nastane, ko se DNK v normalnih kožnih celicah okvari in telo ne more okvare popraviti.
Basal cell carcinoma of the skin Squamous cell carcinoma of the skin
bazalnocelični karcinom kože ploščatocelični karcinom kože
Basal cell carcinoma Squamous skin cancer^*
bazalnocelični karcinom, ploščatocelični karcinom kože^
Basal cell carcinoma, Cutaneous squamous cell carcinoma**, Keratoacanthoma**
bazalnocelični karcinom, ploščatocelični karcinom kože**, keratoakantom
Basal cell carcinoma, new primary melanoma(3)
bazalnocelični karcinom, novi primarni melanom(3)
Basal insulin (units)
bazalni insulin (enote)
Basal insulin and sulphonylurea/glinides were discontinued at randomisation.
Zdravljenje z bazalnim insulinom in sulfonilsečnino/glinidi so ukinili ob randomizaciji.
Basal insulin dose (IU/day) at week 78
Odmerek bazalnega insulina (i.e./dan) v 78. tednu
Basal insulin dosec (U/kg)
Odmerek bazalnega insulinac (E/kg)
Basal insulin is a long- acting background insulin.
Bazalni insulin je osnovni insulin z dolgotrajnim delovanjem.
BASDAIb 50
BASDAIb50
Base
modra ročica
Base
zapr oljenja
Base - once a week
Podnožje - enkrat na teden
Base Blisters
podnji del inhalatorja pretisni omot
Base of the ear administration:
Aplikacija na bazi ušesa:
Based
Skladno
Based on 1.5 years of surveillance following Synflorix introduction, with over 90% coverage in the vaccine-eligible age group, a decrease in vaccine serotype IPD incidence (largely due to changes in serotype 7F disease) was observed with no concomitant increase in non-vaccine serotype IPD incidence.
Po 1,5 letu nadzora po uvedbi cepiva Synflorix in ob več kot 90 % pokritosti starostne skupine, primerne za cepljenje, so opažali zmanjšanje incidence IPB s serotipi v cepivu (v veliki meri zaradi sprememb bolezni s serotipom 7F), brez sočasnega povečanja incidence IPB zaradi serotipov, ki jih ni v cepivu.
Based on 3 cumulative spontaneous post marketing reports of anaphylactic reaction (all serious), the MAH proposes to add anaphylactic reaction to section 4.8 (Undesirable effects) of the SmPC with a frequency of ‘not known’.
Na podlagi 3 kumulativnih spontanih poročil v obdobju trženja o anafilaktični reakciji (vsa resna) imetnik DzP predlaga dodatek anafilaktične reakcije v poglavje 4.8 (Neželeni učinki) SmPC s pogostnostjo ‘ni znana’.
based on a CHMP approved protocol.
v RMP, ki temelji na CHMP odobrenem protokolu.
based on a clinical
primerjava s preteklimi podatki
Based on a clinical pharmacokinetic study in patients at 80 mg, food does not alter osimertinib bioavailability to a clinically meaningful extent. (AUC increase by 6% (90% CI -5, 19) and Cmax decrease by 7% (90% CI -19, 6)).
Na podlagi klinične farmakokinetične študije pri bolnikih z odmerkom 80 mg hrana ne vpliva na biološko uporabnost osimertiniba v klinično pomembni meri. (Povečanje AUC za 6 % (90 % IZ: -5 do 19) in zmanjšanje Cmax za 7 % (90 % IZ: -19 do 6)).
Based on a comparison of the immune response of Synflorix with the vaccine used in the study, it is expected that Synflorix would provide similar protection against acute otitis media caused by S. pneumoniae.
Glede na primerjavo imunskega odziva na cepivo Synflorix in na cepivo, ki so ga uporabili v študiji, se pričakuje, da bi cepivo Synflorix zagotovilo podobno zaščito pred akutnim vnetjem srednjega ušesa, ki ga povzroči bakterija S. pneumoniae.
Based on a limited number of observations with Xeplion in subjects with mild renal impairment and pharmacokinetic simulations, a reduced dose is recommended (see section 4.2).
Zaradi majhnega števila podatkov o zdravilu Xeplion pri preiskovancih z blago ledvično okvaro in farmakokinetičnih simulacij je priporočeno zmanjšanje odmerka (glejte poglavje 4.2).
Based on a limited number of patients, inter- individual variability calculated as the coefficient of variation (CV %) was estimated to be approximately 30 % for the main pharmacokinetic parameters.
Na osnovi omejenega števila bolnikov, je bila variabilnost med posamezniki za glavne farmakokinetične parametre, izračunana kot koeficient variacije (CV- coefficient of variation %), ocenjena na približno 30 %.
based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
za uvajalni odmerek 8 mg trastuzumaba/kg telesne mase ali za nadaljnje tritedenske odmerke 6 mg trastuzumaba/kg telesne mase s pomočjo formule:
Based on a mass balance study in humans, oral absorption of enzalutamide is estimated to be at least 84.2%.
Na podlagi študije masnega ravnovesja pri človeku je ocenjena absorpcija enzalutamida po peroralni uporabi vsaj 84,2 %.
Based on a minimum of 12 months follow-up the most frequently reported adverse reactions in SPRYCEL-treated patients with newly diagnosed chronic phase CML were fluid retention (including pleural effusion) (19%), diarrhoea (17%), headache (12%), rash (11%), musculoskeletal pain (11%), nausea (8%), fatigue (8%), myalgia (6%), vomiting (5%), and muscle inflammation (4%).
Na osnovi najmanj 12-mesečnega obdobja spremljanja so bili neželeni učinki, o katerih so poročali najpogosteje pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju, ki so se zdravili z zdravilom SPRYCEL, naslednji: zastajanje tekočin (vključno s plevralnim izlivom) (19%), driska (17%), glavobol (12%), kožni izpuščaj (11%), mišično-skeletna bolečina (11%), navzea (8%), utrujenost (8%), mialgija (6%), bruhanje (5%) in vnetje mišic (4%).
Based on a multiple dose clinical trial in adults and adolescents, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
Na podlagi izsledkov kliničnega preskušanja z večkratnimi odmerki, v katerem so bolniki dobili do 45 mg desloratadina (devetkratni klinični odmerek), niso opazili klinično pomembnih učinkov.
Based on a multiple dose clinical trial, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed.
Na podlagi izsledkov kliničnega preskušanja z večkratnimi odmerki, v katerem so bili uporabljeni odmerki do 45 mg (to je devetkratni klinični odmerek), niso opažali klinično pomembnih učinkov zdravila.
Based on a non- compartmental analysis of data from adults (LAL-CL01/LAL-CL-04), the pharmacokinetics of sebelipase alfa appeared to be nonlinear with a greater than dose-proportional increase in exposure observed between the 1 and 3 mg/kg dosages.
Na podlagi nerazdelčne analize podatkov za odrasle (LAL-CL01/LAL-CL-04) je kazalo, da je farmakokinetika sebelipaze alfa nelinearna in da je povečanje, ki so ga opazili med odmerki 1 in 3 mg/kg večje kot z odmerkom sorazmerno povečanje v izpostavljenosti.
Based on a normal approximation of the difference in % response
Na osnovi normalne aproksimacije razlike v % odziva.
Based on a pharmacokinetic analysis of 44 patients with mild hepatic impairment and 330 patients with normal hepatic function osimertinib exposures were similar.
Na podlagi farmakokinetične analize 44 bolnikov z blago okvaro jeter in 330 bolnikov z normalnim delovanjem jeter je bila izpostavljenost osimertinibu podobna.
Based on a pharmacokinetic study with 16 subjects with haemophilia A, the following pharmacokinetic characteristics for FVIII:C were observed:
Na podlagi farmakokinetične študije z 16 preiskovanci s hemofilijo A so opazili naslednje farmakokinetične karakteristike za FVIII:C:
Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (calculated creatinine clearance [CLcr] 60-89 mL/min, n = 43), or moderate (CLcr 30-59 mL/min, n = 15) renal impairment compared to patients with normal renal function (CLcr ≥90 mL/min, n = 85).
Analiza PopPK ni pokazala klinično pomembnih razlik med bolniki z blago (izračunani očistek kreatinina (CLcr 60–89 ml/min, n = 43) ali zmerno (CLcr 30–59 ml/min, n = 15) okvaro ledvic in bolniki z normalnim delovanjem ledvic (CLcr ≥ 90 ml/min, n = 85).
Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (total bilirubin within upper limit of normal [ULN] and AST>ULN, or total bilirubin > 1.0-1.5 times ULN and any AST level, n = 16), or moderate (total bilirubin > 1.5-3.0 times ULN, n = 1) hepatic impairment compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN, n = 126).
Analiza PopPK ni pokazala klinično pomembnih razlik med bolniki z blago (skupni bilirubin pod zgornjo mejo normale [ULN] in AST > ULN ali skupni bilirubin > 1,0–1,5-krat ULN in katera koli raven AST, n = 16) ali zmerno (skupni bilirubin > 1,5–3,0-krat ULN, n = 1) okvaro jeter in bolniki z normalnim delovanjem jeter (skupni bilirubin in AST ≤ ULN, n = 126).
Based on a PopPK model, an increase in nintedanib exposure of approximately 20 - 25% was observed in patients ≥ 75 years compared with patients under 65 years.
Na podlagi modela PopPK so pri bolnikih, starih 75 let ali več, opazili povečano izpostavljenost nintedanibu za približno 20–25 % v primerjavi z bolniki, mlajšimi od 65 let.
Based on a population pharmacokinetic (PK) analysis no dosage adjustment is necessary for patients with renal impairment (see section 5.2).
Po podatkih populacijske farmakokinetične analize pri bolnikih z okvaro ledvic odmerkov ni treba prilagajati (glejte poglavje 5.2).
Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Na osnovi populacijske farmakokinetične analize pri bolnikih, starih od 19 do 78 let, je bilo ugotovljeno, da starost ne vpliva na očistekTMZ.
Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Na podlagi populacijske farmakokinetične analize pri bolnikih, starih med 19 in 78 let, starost ne vpliva na očistek TMZa.
Based on a population pharmacokinetic analysis increasing exposure (AUC) in patients with moderate and severe renal impairment at initiation of treatment during studies was observed (see sections 4.2 and 5.2).
Na podlagi populacijske farmakokinetične analize so med študijami pri bolnikih z zmerno in hudo okvaro ledvic na začetku zdravljenja opazili povečanje izpostavljenosti (AUC) (glejte poglavji 4.2 in 5.2).
Based on a population pharmacokinetic analysis of 330 patients with mild renal impairment (CLcr 60 to less than 90 mL/min), 149 patients with moderate renal impairment (CLcr 30 to <than 60 mL/min), 3 patients with severe renal impairment (CLcr 15 to <than 30 mL/min) and 295 patients with normal renal function (≥90 mL/min), osimertinib exposures were similar.
Na podlagi populacijske farmakokinetične analize 330 bolnikov z blago okvaro ledvic (očistek kreatinina od 60 do manj kot 90 ml/min), 149 bolnikov z zmerno okvaro ledvic (očistek kreatinina od 30 do manj kot 60 ml/min), 3 bolnikov s hudo okvaro ledvic (očistek kreatinina od 15 do manj kot 30 ml/min) ter 295 oseb z normalnim delovanjem ledvic (≥ 90 ml/min) so bile izpostavljenosti osimertinibu podobne.
Based on a population pharmacokinetic analysis of 351 patients who received oral doses of Odomzo in the dose range of 100 mg to 3000 mg, the apparent steady-state volume of distribution (Vss/F) was 9170 litres.
Po podatkih populacijske farmakokinetične analize pri 351 bolnikih, ki so prejemali peroralne odmerke zdravila Odomzo v višini od 100 mg do 3.000 mg, je navidezni volumen porazdelitve v stanju dinamičnega ravnovesja (Vss/F) znašal 9.170 litrov.
Based on a population pharmacokinetic analysis of 48 patients with mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >1.0 to 1.5 times ULN and any AST) and
Po podatkih populacijske farmakokinetične analize pri 48 bolnikih z blago okvaro jeter (z vrednostjo celokupnega bilirubina ≤ ZMN in vrednostjo aspartat-aminotransferaze (AST) > ZMN ali z vrednostjo celokupnega bilirubina >1,0 do 1,5-kratnika ZMN in kakršnokoli vrednostjo AST) in pri 254 bolnikih z normalnim delovanjem jeter (z vrednostjo celokupnega bilirubina ≤ ZMN in vrednostjo AST