natgillin/translations-raw huggingface dataset:
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( &lt; 10 %).
Tako levetiracetam kot njegov primarni presnovek se ne vežeta pomembno na beljakovine v plazmi ( 10 %).
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins ( &lt; 10%).
Tako levetiracetam kot njegov primarni presnovek se ne vežeta pomembno na beljakovine v plazmi ( 10 %).
Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins( &lt; 10 %).
Tako levetiracetam kot njegov primarni presnovek se ne vežeta pomembno na beljakovine v plazmi ( 10 %).
NELSame criteria as for CHR but ANC &gt; 1x109/l and platelets &gt; 20x109/l
NEL enaki kriteriji kot za CHR, a ANC  1 x 109/l in trombociti  20 x 109/l
NELSame criteria as for CHR but ANC &gt; 1x109/l and platelets &gt; 20x109/l
obolelosti zunaj kostnega mozga
Neocolipor contains inactivated strains of E. coli expressing the adhesins F4ab (K88ab), F4ac (K88ac), F4ad (_K88 ad) F5 (K99) F6 (987P) and F41.
Neocolipor vsebuje neaktiviran bakterijski sev E. coli, ki izraža adhezine F4ab (K88ab), F4ac (K88ac), F4ad (_K88 ad) F5 (K99) F6 (987P) in F41.
Nervous system disorders (Common, ≥1/100 to &lt; 1/10)
Bolezni živčevja (pogosti, ≥ 1/100 do &lt; 1/10)
Neutropenia ( &lt; 750 cells/mm3) was reported in 5%, thrombocytopenia (platelets &lt; 50,000/mm3) in 2%, and low haemoglobin ( &lt; 8 g/dl) in &lt; 1% of patients receiving Zerit.
O nevtropeniji ( &lt; 750 celic/mm3) so poročali pri 5%, trombocitopeniji (trombociti &lt; 50.000/mm3) pri 2% in o nizkem hemoglobinu ( &lt; 8 g/dl) pri &lt; 1% bolnikov, ki so dobivali zdravilo Zerit.
Neutropenia (absolute neutrophil count &lt; 500) was generally reversible and was managed by temporarily withholding Jakavi (see sections 4.2 and 4.8).
Nevtropenija (absolutno število nevtrofilcev &lt; 500) je bila večinoma reverzibilna in jo je bilo mogoče odpraviti z začasno prekinitvijo jemanja zdravila Jakavi (glejte poglavji 4.2 in 4.8).
Neutropenia (absolute neutrophil count [ANC] &lt; 1.5 x 109/l) and leukopenia have been observed with medicinal products that inhibit IL-1, including Ilaris.
Nevtropenijo (absolutno število nevtrofilcev &lt; 1,5 x 109/l) in levkopenijo so pogosto opažali pri uporabi zdravil, ki zavirajo IL-1, med katere sodi tudi zdravilo Ilaris.
Neutropenia (absolute neutrophil count [ANC] &lt; 1.5 x 109/l) has been observed commonly with another medicinal product that inhibits IL-1 used in a patient population (rheumatoid arthritis) other than CAPS.
Nevtropenijo (absolutna koncentracija nevtrofilcev [ANC] &lt; 1,5 x 109/l) so pogosto opazili pri drugih zdravilih, ki zavirajo IL-1 in se uporabljajo pri populaciji bolnikov z drugimi boleznimi (revmatoidni artritis), ne s CAPS.
Neutropenia (ANC &lt; 1.5 x 109/l) was reported in 2.4% patients receiving Kineret compared with 0.4% of placebo patients.
O nevtropeniji (ANC &lt; 1,5 x 109/l) so poročali pri 2,4 % bolnikov, ki so prejemali zdravilo Kineret, v primerjavi z 0,4 % pri bolnikih s placebom.
Neutropenia (ANC &lt; 1000/mm3 ) or
Nevtropenija (AŠN &lt; 1000 /mm3 )
Neutropenia &lt; 500/mm3 lasting for more than 5 days or associated with fever or infection
Nevtropenija &lt; 500/mm3, ki traja več kot 5 dni ali jo spremlja zvišana telesna temperatura ali okužba
Neutropenia Grade 4 (ANC  500/mm3) &gt; 7 days
Nevtropenija stopnja 4 (AŠN 500/mm3) &gt; 7 dni
Neutropenia resulted in discontinuation in &lt; 1% of patients receiving eribulin.
Pri &lt; 1 % bolnikov, ki so dobivali eribulin, je zaradi nevtropenije prišlo do prekinitve zdravljenja.
Neutropenia was associated with dose reduction or permanent treatment discontinuation for 3% and &lt; 1% of patients, respectively.
Nevtropenija je bila povezana z zmanjšanjem odmerka ali trajno prekinitvijo zdravljenja pri 3 % oziroma &lt; 1 % bolnikov.
Neutropenia: Severe (neutrophil count &lt; 0.5 x 109/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Nevtropenija: Med prvim ciklom zdravljenja je imelo 55 % bolnikov hudo obliko nevtropenije (število nevtrofilcev &lt; 0,5 x 109/l), ki je pri 20 % bolnikov trajala ≥ sedem dni, pri 77 % pa ves čas (39 % ciklov zdravljenja).
Neutropenia: Severe (neutrophil count &lt; 0.5 x 109/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Nevtropenija: Med prvim ciklom zdravljenja je imelo 55 % bolnikov hudo obliko nevtropenije (število nevtrofilcev &lt; 0,5 x 109/l), ki je pri 20 % bolnikov trajala  sedem dni, pri 77 % pa ves čas (39 % ciklov zdravljenja).
Neutropenia: Severe (neutrophil count &lt; 0.5 x 109/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Nevtropenija: Med prvim ciklom zdravljenja je imelo 55% bolnikov hudo obliko nevtropenije (število nevtrofilcev &lt; 0,5 x 109/l), ki je pri 20% bolnikov trajala ≥ sedem dni, pri 77% pa ves čas (39% ciklov zdravljenja).
Neutropenia: Severe (neutrophil count &lt; 0.5 x 109/l) during course 1 was seen in 55 % of the patients and with duration  seven days in 20 % and overall in 77 % of patients (39 % of courses).
Nevtropenija: Med prvim ciklom zdravljenja je imelo 55 % bolnikov hudo obliko nevtropenije (število nevtrofilcev &lt; 0,5 x 109/l), ki je pri 20 % bolnikov trajala  sedem dni, med celotnim obdobjem zdravljenja pa se je huda nevtropenija pojavila pri 77 % bolnikov (39 % ciklov zdravljenja).
Neutropenia: Severe neutropenia (Grade 4 - neutrophil count &lt; 0.5 x 109/l) occurred in 32 % of patients in 13 % of courses.
Nevtropenija: Huda nevtropenija (4. stopnje – število nevtrofilcev &lt; 0,5 x 109/l) se je pojavila pri 32 % bolnikov v 13 % ciklusov.
neutrophil counts &lt; 1,500/mm3 prior bone marrow transplant or stem cell support
število nevtrofilcev &lt; 1.500/mm3 predhodna presaditev kostnega mozga ali podpora matičnih celic
Neutrophil counts of &lt; 0.5 x 109/l that lasted for more than 7 days occurred in 13% of breast cancer patients treated with eribulin in the EMBRACE study.
Število nevtrofilcev &lt; 0,5 x 109/l s trajanjem več kot 7 dni se je pojavilo pri 13 % bolnikov z rakom dojke, zdravljenih z eribulinom v študiji EMBRACE.
Neutrophils &lt; 1x109/l at baseline to &gt; 1.5x109/l
Nevtrofilci &lt; 1 x 109/l izhodiščno do ≥ 1,5 x 109/l
Nevertheless, the highest plasma concentrations recorded were low ( &lt; 10.5 ng/ml in the absence of ketoconazole and &lt; 17 ng/ml in the presence of ketoconazole.
Kljub temu je bila največja zabeležena koncentracija v plazmi majhna (≤10,5 ng/ml v odsotnosti ketokonazola in ≤17 ng/ml v prisotnosti ketokonazola).
Nevirapine must not be administered to patients with pre- treatment ASAT or ALAT &gt; 5 ULN until baseline ASAT/ALAT are stabilised &lt; 5 ULN (see section 4.3).
Nevirapin ne smemo dajati bolnikom, ki imajo pred zdravljenjem raven ASAT ali ALAT &gt; 5-kratne zgornje laboratorijske mejne vrednosti, dokler se začetna raven ASAT/ALAT ne stabilizira na &lt; 5-kratno zgornjo mejno vrednost (glejte poglavje 4.3).
Nevirapine must not be administered to patients with pre- treatment ASAT or ALAT &gt; 5 ULN until baseline ASAT/ALAT are stabilised &lt; 5 ULN (see section 4.3).
Nevirapin se ne sme dajati bolnikom, ki imajo pred zdravljenjem raven AST ali ALT &gt; 5-kratne zgornje laboratorijske mejne vrednosti, dokler se začetna raven AST/ALT ne stabilizira na &lt; 5-kratno zgornjo mejno vrednost (glejte poglavje 4.3).
Nevirapine must not be administered to patients with pre- treatment ASAT or ALAT &gt; 5 ULN until baseline ASAT/ALAT are stabilised &lt; 5 ULN (see section 4.3).
Nevirapina ne smemo dajati bolnikom, ki imajo pred zdravljenjem raven ASAT ali ALAT &gt; 5-kratne zgornje laboratorijske mejne vrednosti, dokler se začetna raven ASAT/ALAT ne stabilizira na &lt; 5-kratno zgornjo mejno vrednost (glej poglavje 4.3).
Nevirapine must not be administered to patients with pre- treatment ASAT or ALAT &gt; 5 ULN until baseline ASAT/ALAT are stabilised &lt; 5 ULN (see section 4.3).
Nevirapina ne smemo dajati bolnikom, ki imajo pred zdravljenjem raven ASAT ali ALAT &gt; 5-kratne zgornje laboratorijske mejne vrednosti, dokler se začetna raven ASAT/ALAT ne stabilizira na &lt; 5-kratno zgornjo mejno vrednost (glejte poglavje 4.3).
New onset or worsening psoriasis including pustular psoriasis (primarily palm &amp; soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
pogosti: novo nastala in poslabšana psoriaza, vključno s pustulozno psoriazo (predvsem na dlaneh in podplatih), urtikarija, izpuščaj, pruritus, hiperhidroza, suha koža, glivični dermatitis, ekcem, alopecija
Newcastle Upon Tyne Tyne &amp; Wear NE3 3TT United Kingdom
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT Velika Britanija
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT - UK, United Kingdom and/or
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT – UK, Velika Britanija in/ali
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT - UK, United Kingdom or
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT – UK, Velika Britanija ali
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT - United Kingdom
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT - Velika Britanija
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT United Kingdom
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT Velika Britanija
NexGard 11 mg chewable tablets for dogs (2–4 kg) NexGard 28 mg chewable tablets for dogs ( &gt; 4–10 kg) NexGard 68 mg chewable tablets for dogs ( &gt; 10–25 kg) NexGard 136 mg chewable tablets for dogs ( &gt; 25–50 kg) Afoxolaner
NexGard 11 mg žvečljive tablete za pse 2–4 kg NexGard 28 mg žvečljive tablete za pse &gt; 4–10 kg NexGard 68 mg žvečljive tablete za pse &gt; 10–25 kg NexGard 136 mg žvečljive tablete za pse &gt; 25–50 kg
NexGard 11 mg chewable tablets for dogs 2–4 kg NexGard 28 mg chewable tablets for dogs &gt; 4–10 kg NexGard 68 mg chewable tablets for dogs &gt; 10–25 kg NexGard 136 mg chewable tablets for dogs &gt; 25–50 kg
NexGard 11 mg žvečljive tablete za pse 2 ̶ 4 kg NexGard 28 mg žvečljive tablete za pse &gt; 4 ̶ 10 kg NexGard 68 mg žvečljive tablete za pse &gt; 10 ̶ 25 kg NexGard 136 mg žvečljive tablete za pse &gt; 25 ̶ 50 kg
NexGard 11 mg chewable tablets for dogs 2–4 kg NexGard 28 mg chewable tablets for dogs &gt; 4–10 kg NexGard 68 mg chewable tablets for dogs &gt; 10–25 kg NexGard 136 mg chewable tablets for dogs &gt; 25–50 kg
NexGard 11 mg žvečljive tablete za pse 2–4 kg NexGard 28 mg žvečljive tablete za pse &gt; 4–10 kg NexGard 68 mg žvečljive tablete za pse &gt; 10–25 kg NexGard 136 mg žvečljive tablete za pse &gt; 25–50 kg
NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2–3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs &gt; 3.5–7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs &gt; 7.5–15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs &gt; 15–30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs &gt; 30–60 kg
NEXGARD SPECTRA 9 mg/ 2 mg žvečljive tablete za pse 2–3,5 kg NEXGARD SPECTRA 19mg/ 4 mg žvečljive tablete za pse &gt; 3,5–7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg žvečljive tablete za pse &gt; 7,5 –15 kg NEXGARD SPECTRA 75 mg/ 15 mg žvečljive tablete za pse &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg žvečljive tablete za pse &gt; 30–60 kg
NEXGARD SPECTRA 9 mg / 2 mg chewable tablets for dogs 2–3.5 kg NEXGARD SPECTRA 19 mg / 4 mg chewable tablets for dogs &gt; 3.5–7.5 kg NEXGARD SPECTRA 38 mg / 8 mg chewable tablets for dogs &gt; 7.5–15 kg NEXGARD SPECTRA 75 mg / 15 mg chewable tablets for dogs &gt; 15–30 kg NEXGARD SPECTRA 150 mg / 30 mg chewable tablets for dogs &gt; 30–60 kg
NEXGARD SPECTRA 9 mg/ 2 mg žvečljive tablete za pse 2–3,5 kg NEXGARD SPECTRA 19mg/ 4 mg žvečljive tablete za pse &gt; 3,5–7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg žvečljive tablete za pse &gt; 7,5–15 kg NEXGARD SPECTRA 75 mg/ 15 mg žvečljive tablete za pse &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg žvečljive tablete za pse &gt; 30–60 kg
NEXGARD SPECTRA 9 mg/ 2 mg chewable tablets for dogs 2–3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg chewable tablets for dogs &gt; 3.5–7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg chewable tablets for dogs &gt; 7.5–15 kg NEXGARD SPECTRA 75 mg/ 15 mg chewable tablets for dogs &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg chewable tablets for dogs &gt; 30–60 kg afoxolaner / milbemycin oxime
NEXGARD SPECTRA 9 mg/ 2 mg žvečljive tablete za pse 2–3,5 kg NEXGARD SPECTRA 19mg/ 4 mg žvečljive tablete za pse &gt; 3,5–7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg žvečljive tablete za pse &gt; 7,5 –15 kg NEXGARD SPECTRA 75 mg/ 15 mg žvečljive tablete za pse &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg žvečljive tablete za pse &gt; 30–60 kg afoxolaner/milbemycin oxime
NEXGARD SPECTRA 9 mg/ 2 mg dogs 2–3.5 kg NEXGARD SPECTRA 19 mg/ 4 mg dogs &gt; 3.5–7.5 kg NEXGARD SPECTRA 38 mg/ 8 mg dogs &gt; 7.5–15 kg NEXGARD SPECTRA 75 mg/ 15 mg dogs &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg dogs &gt; 30–60 kg
NEXGARD SPECTRA 9 mg/ 2 mg psi 2–3,5 kg NEXGARD SPECTRA 19mg/ 4 mg psi &gt; 3,5 –7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg psi &gt; 7,5 –15 kg NEXGARD SPECTRA 75 mg/ 15 mg psi &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg psi &gt; 30–60 kg
Ninety-five percent of nucleos(t)ide-naïve patients, 84% of nucleos(t)ide- experienced patients, and 83% of lamivudine-resistant patients achieved HBV DNA &lt; 400 copies/ml at week 72.
Petindevetdeset odstotkov bolnikov, ki se predhodno še niso zdravili z nukleoz(t)idi, 84% bolnikov, ki so se predhodno že zdravili z z nukleoz(t)idi in 83% bolnikov, rezistentnih na lamivudin, je doseglo koncentracijo HBV DNA &lt; 400 kopij/ml v 72. tednu.
Nintedanib is predominantly eliminated via biliary/faecal excretion ( &gt; 90 %).
Nintedanib se pretežno izloča z žolčem/blatom ( &gt; 90 %).
Nintedanib is predominantly eliminated via biliary/faecal excretion ( &gt; 90%).
Nintedanib se pretežno izloča z žolčem/blatom ( &gt; 90 %).
Nivolumab BMS must be administered with caution in patients with moderate (total bilirubin &gt; 1.5 × to 3 × the upper limit of normal [ULN] and any AST) or severe (total bilirubin &gt; 3 × ULN and any AST) hepatic impairment.
Pri bolnikih z zmerno (vrednost skupnega bilirubina &gt; 1,5 × do 3 × zgornja meja normalne vrednosti [ZMN] in katera koli
Nivolumab has not been studied in patients with moderate (total bilirubin &gt; 1.5 × to 3 × ULN and any AST) or severe hepatic impairment (total bilirubin &gt; 3 × ULN and any AST) (see section 4.2).
Pri bolnikih z zmerno (skupni bilirubin &gt; 1,5 × do 3 × ZMN in katera koli vrednost AST) ali s hudo okvaro jeter (skupni bilirubin &gt; 3 × ZMN in katera koli vrednost AST) uporabe nivolumaba niso raziskovali (glejte poglavje 4.2).
Nivolumab+ipilimumab vs nivolumab (descriptive analysis) - HR (95% CI): 0.76 (0.62, 0.95)
&lt; 0,0001 nivolumab+ipilimumab v primerjavi z nivolumabom (opisna analiza) - HR (95 % IZ): 0,76 (0,62; 0,95)
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
NN: {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila] &gt;
NN: &gt;
2019
No adjustment of the initial dose is required in patients &gt; 65 years of age.
Bolnikom, starejšim od 65 let, začetnega odmerka ni treba prilagoditi.
No adjustment of the standard dose is recommended in patients &gt; 70 years old (see section 4.8).
Pri bolnikih, ki so stari 70 let ali več, se ne priporočajo nobene spremembe standardnega odmerka (glejte poglavje 4.8).
No allergic reactions were observed in any of the 12 infants &lt; 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Med zdravljenjem z zdravilom Spectrila niso pri nobenem od 12 dojenčkov, mlajših od 1 leta, opazili alergijskih reakcij (študija MC-ASP.6/INF).
No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in patients with polyarticular juvenile idiopathic arthritis who were 2 to &lt; 4 years.
Zvišanja ALT ≥ 3 x ULN se niso pojavila v preskušanju faze 3 z zdravilom Humira pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 2 do &lt; 4 leta.
No anti-asparaginase antibodies were detected in any of the 12 infants &lt; 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Pri nobenem od 12 dojenčkov, mlajših od 1 leta, niso med zdravljenjem z zdravilom Spectrila zaznali antiasparaginaznih protiteles (študija MC-ASP.6/INF).
No cabozantinib-treated subjects had a QTcF &gt; 500 ms.
Osebe, ki niso bile zdravljene s kabozantinibom, so imele QTcF &gt; 500 ms.
No cabozantinib-treated subjects in this study had a confirmed QTcF &gt; 500 ms, nor did any cabozantinib-treated subjects in the RCC study (at a dose of 60 mg).
Nobena oseba, ki ni bila zdravljena s kabozantinibom v tej študiji, ni imela potrjenega QTcF &gt; 500 ms, niti ga ni imela nobena oseba, zdravljena s kabozantinibom v študiji KLC (pri odmerku 60 mg).
No change in pharmacokinetic parameters based on clearance or volume of distribution were observed between elderly patients and adult patients &lt; 65 years of age.
Med starejšimi bolniki in odraslimi bolniki, starimi manj kot 65 let, niso opažali razlik v farmakokinetičnih parametrih na osnovi opazovanja očistka in volumna porazdelitve.
No change in starting dose is required in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] &lt; 30 mL/min/1.73 m2); dose titration should be done with caution in these patients (see section 4.4).
Začetnega odmerka pri bolnikih s hudo okvaro ledvic ni treba spreminjati (ocenjena hitrost glomerularne filtracije [eGFR-estimated glomerular filtration rate] &lt; 30 ml/min/1,73 m2); pri teh bolnikih je potrebna previdnost pri titriranju odmerka (glejte poglavje 4.4).
No clinical studies have been conducted in patients &gt; 75 years of age.
Klinične študije pri bolnikih, starejših od 75 let, niso bile izvedene.
No clinical studies of prophylaxis in infants aged &lt; 1 have been performed.
Kliničnih študij glede preprečevanja gripe pri dojenčkih, mlajših od enega leta, niso izvedli.
No clinical studies were conducted with SPRYCEL in patients with decreased renal function (the study in patients with newly diagnosed chronic phase CML excluded patients with serum creatinine concentration &gt; 3 times the upper limit of the normal range, and studies in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy excluded patients with serum creatinine concentration &gt; 1.5 times the upper limit of the normal range).
Pri bolnikih z zmanjšanim delovanjem ledvic klinične študije z zdravilom SPRYCEL niso bile izvedene (študija, izvedena pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju, ni vključevala bolnikov, ki so imeli koncentracijo kreatinina v serumu &gt; 3-krat večjo od zgornje meje referenčne vrednosti, študije, izvedene pri bolnikih s KML v kroničnem obdobju, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali, pa niso vključevale bolnikov, ki so imeli koncentracijo kreatinina v serumu &gt; 1,5-krat večjo od zgornje meje referenčne vrednosti).
No clinical trials in subjects with a creatinine clearance &lt; 10 mL/min or in patients undergoing dialysis have been conducted.
Kliničnih preskušanj pri osebah z očistkom kreatinina &lt; 10 ml/min ali pri bolnikih na dializi niso izvedli.
No clinically important pharmacokinetic differences between subjects with severe renal impairment (CLcr &lt; 30 mL/min) and matching healthy subjects were observed.
Med preiskovanci s hudo okvaro ledvic (Clcr &lt; 30 ml/min) in zdravimi kontrolnimi osebami niso opazili klinično pomembnih razlik v farmakokinetiki.
No clinically relevant differences in elvitegravir, cobicistat, tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl &gt; 15 but &lt; 30 mL/min) in studies of cobicistat-boosted elvitegravir or of tenofovir alafenamide, respectively.
Klinično pomembnih razlik v farmakokinetičnih lastnostih elvitegravirja, kobicistata, alafenamidtenofovirata ali tenofovirja med zdravimi osebami in bolniki s hudo ledvično okvaro (ocenjeni CrCl &gt; 15, toda &lt; 30 ml/min) v študijah z elvitegravirjem, ojačanim s kobicistatom, oz. z alafenamidtenofoviratom, niso opazili.
No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and subjects with severe renal impairment (estimated CrCl from 15 to &lt; 30 mL/min) in studies of cobicistat-boosted elvitegravir or of tenofovir alafenamide, respectively.
Klinično pomembnih razlik v farmakokinetičnih lastnostih alafenamidtenofovirata ali tenofovirja med zdravimi osebami in bolniki s hudo ledvično okvaro (ocenjeni CrCl od 15 do &lt; 30 ml/min) v študijah s elvitegravirjem, ojačanim s kobicistatom, oz. z alafenamidtenofoviratom, niso opazili.
No concurrent elevations of ALT ( &gt; 3 times the upper limit of normal [ULN]) and bilirubin ( &gt; 2 times the ULN) were observed.
Sočasno prisotnih zvišanj ravni ALT ( &gt; 3-kratnik zgornje meje normalnih vrednosti [ZMN]) in bilirubina ( &gt; 2-kratnik ZMN) niso opažali.
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Podatki, ki bi omogočili pripravo priporočila za odmerjanje za nedonošene otroke ( &lt; 36 tednov postkoncepcijske starosti), trenutno niso na voljo.
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Podatki, ki bi omogočili pripravo priporočila za odmerjanje, za nedonošene otroke ( &lt; 36 tednov postkoncepcijske starosti) trenutno niso na voljo.
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Podatki, ki bi omogočili pripravo priporočila za odmerjanje, za nedonošene otroke ( &lt; 36 tednov postkoncepcijske starosti), trenutno niso na voljo.
No data are available on administration of pomalidomide to paediatric or adolescent patients ( &lt; 18 years of age).
Podatki o dajanju pomalidomida pediatričnim ali mladostniškim bolnikom ( &lt; 18 let starosti) niso na voljo.
No data are available on patients with severe (CLCR &lt; 30 mL/min) renal impairment or end-stage renal disease.
Za bolnike s hudo ledvično okvaro ali odpovedjo ledvic (očistek kreatinina &lt; 30 ml/min) ni podatkov.
No data were available from patients with severe hepatic impairment (total bilirubin &gt; 3.0 times ULN and any AST level).
Podatki o bolnikih s hudo okvaro jeter (skupni bilirubin &gt; 3,0-krat ULN in katera koli raven AST) niso bili na voljo.
No decline (FVC change &gt; 0%)
Ni zmanjšanja (sprememba forsirane vitalne kapacitete &gt; 0 %)
No dosage adjustment is necessary for patients with mild (estimated creatinine clearance &gt; 50 ml/min and  80 ml/min) to moderate (estimated creatinine clearance  30 ml/min and  50 ml/min) renal impairment.
Bolnikom z blago (ocenjeni očistek kreatinina &gt; 50 ml/min in  80 ml/min) do zmerno (ocenjeni očistek kreatinina  30 ml/min in  50 ml/min) okvaro ledvic odmerka ni treba prilagoditi.
No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and &lt; 80 mL/min).
Pri bolnikih z blago ledvično okvaro (CLcr ≥ 50 in &lt; 80 ml/min) prilagajanje odmerkov ni potrebno.
No dosage adjustment is required for the elderly with creatinine clearance values &gt; 50 ml/min (see section 5.2).
Starejšim z očistkom kreatinina &gt; 50 ml/min odmerka ni treba prilagoditi (glejte poglavje 5.2).
No dosage adjustment is required in patients with mild, moderate or severe (CrCl &lt; 30 mL/min, not on dialysis) renal impairment.
Pri bolnikih z blago, zmerno ali hudo okvaro ledvic (CrCl &lt; 30 ml/min, ki niso na dializi) prilagajanje odmerka ni potrebno.
No dosage adjustment of amlodipine/valsartan is required for patients with mild to moderate renal impairment (GFR &gt; 30 ml/min/1.73 m2).
Pri bolnikih z blago do zmerno okvaro ledvic (GFR &gt; 30 ml/min/1,73 m2) odmerka amlodipina/valsartana ni treba prilagajati.