natgillin/translations-raw huggingface dataset:
Neutropenia (absolute neutrophil count &lt; 500) was generally reversible and was managed by temporarily withholding Jakavi (see sections 4.2 and 4.8).
Neutropenija (apsolutni broj neutrofila &lt; 500) općenito je bila reverzibilna i kontrolirana privremenim prekidom primjene Jakavija (vidjeti dijelove 4.2 i 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.
Neutropenija (apsolutni broj neutrofila [ABN] &lt; 1,5 x 109/l) i leukopenija su bile zabilježene kod primjene lijekova koji inhibiraju IL-1, što uključuje i Ilaris.
Neutropenia (ANC &lt; 1.5 x 109/l) was reported in 2.4% patients receiving Kineret compared with 0.4% of placebo patients.
Neutropenija (ABN &lt; 1,5 x 109/l) je bila prijavljena u 2,4% bolesnika koji su primali Kineret u usporedbi s 0,4% bolesnika koji su primali placebo.
Neutropenia (ANC &lt; 1000/mm3 ) or
Neutropenija (ABN &lt; 1000 /mm³) ili
Neutropenia &lt; 500/mm3 lasting for more than 5 days or associated with fever or infection
neutropenija &lt; 500/mm3 koja traje više od 5 dana ili je povezana s vrućicom ili infekcijom
Neutropenia &lt; 1.0-0.5x109/l (CTCAE Grade 3) was reported in 18 out of 3,430 (0.5%) patients on secukinumab, with no dose dependence and no temporal relationship to infections in 15 out of 18 cases.
Neutropenija &lt; 1,0-0,5x109/l (CTCAE stupanj 3) bila je prijavljena u 18 od 3430 (0,5%) bolesnika koji su uzimali sekukinumab, bez ovisnosti o dozi i bez vremenske povezanosti s infekcijama u 15 od 18 slučajeva.
Neutropenia Grade 4 (ANC  500/mm3) &gt; 7 days
Neutropenija 4. stupnja (ABN 500/mm³) &gt; 7 dana
Neutropenia resulted in discontinuation in &lt; 1% of patients receiving eribulin.
Neutropenija je bila razlog prekida primjene eribulina u &lt; 1% bolesnika.
Neutropenia was associated with dose reduction or permanent treatment discontinuation for 3% and &lt; 1% of patients, respectively.
Neutropenija je bila povezana sa smanjenjem doze ili trajnim prekidom liječenja kod 3%, odnosno &lt; 1% bolesnika.
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).
Neutropenija: teška neutropenija (broj neutrofila &lt; 0,5 x 109/1) tijekom prvog ciklusa zabilježena je u 55% bolesnika, od kojih je 20% bolesnika imalo neutropeniju u trajanju sedam dana ili dulje, a tijekom čitavog liječenja ukupno 77% bolesnika (39% ciklusa).
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).
Neutropenija: teška neutropenija (broj neutrofila &lt; 0,5 x 109/l) tijekom prvog ciklusa zabilježena je u 55% bolesnika, od kojih je 20% bolesnika imalo neutropeniju u trajanju sedam dana ili dulje, a tijekom čitavog liječenja u ukupno 77% bolesnika (39% ciklusa).
neutrophil counts &lt; 1,500/mm3 prior bone marrow transplant or stem cell support
bolesnicima s brojem neutrofila &lt; 1500/mm3 bolesnicima podvrgnutim prethodnom presađivanju koštane srži ili potpornom liječenju matičnim stanicama.
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.
U ispitivanju EMBRACE, broj neutrofila &lt; 0,5 x 109/l trajao je dulje od 7 dana u 13% bolesnika s rakom dojke liječenih eribulinom.
Neutrophils &lt; 1x109/l at baseline to &gt; 1.5x109/l
Neutrofili &lt; 1x109/l za početne vrijednosti do
Neutrophils &lt; 1x109/l at baseline to &gt; 1.5x109/l
Neutrofili &lt; 1x109/l za početne vrijednosti do &gt; 1,5x109 /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.
Ipak, najviše zabilježene koncentracije u plazmi su bile niske ( &lt; 10,5 ng/ml bez ketokonazola i &lt; 17 ng/ml s ketokonazolom).
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 smije primjenjivati na bolesnicima koji imaju AST ili ALT &gt; 5 x GGN prije početka liječenja sve dok se vrijednosti AST/ALT ne stabiliziraju na razini &lt; 5 x GGN (vidjeti dio 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 smije primjenjivati na bolesnicima koji imaju AST ili ALT &gt; 5 x GGN prije početka liječenja sve dok se vrijednosti AST/ALT ne stabiliziraju na razini &lt; 5 x GGN (vidjeti dio 4.3.).
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT - UK, United Kingdom or
Newcastle Upon Tyne, Tyne &amp; Wear NE3 3TT - UK, Velika Britanija ili
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 tableta za žvakanje za pse (2–4 kg) NexGard 28 mg tableta za žvakanje za pse ( &gt; 4–10 kg) NexGard 68 mg tableta za žvakanje za pse ( &gt; 10–25 kg) NexGard 136 mg tableta za žvakanje 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 tableta za žvakanje za pse 2–4 kg NexGard 28 mg tableta za žvakanje za pse &gt; 4–10kg NexGard 68 mg tableta za žvakanje za pse &gt; 10–25kg NexGard 136 mg tableta za žvakanje za pse &gt; 25–50kg
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 tablete za žvakanje za pse 2 – 4 kg NexGard 28 mg tablete za žvakanje za pse 4 – 10 kg NexGard 68 mg tablete za žvakanje za pse 10 – 25 kg NexGard 136 mg tablete za žvakanje za pse 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 tablete za žvakanje za pse od 2–4 kg NexGard 28 mg tablete za žvakanje za pse &gt; 4–10 kg NexGard 68 mg tablete za žvakanje za pse &gt; 10–25 kg NexGard 136 mg tablete za žvakanje za pse &gt; 25–50 kg
NexGard 11 mg dogs 2–4 kg NexGard 28 mg dogs &gt; 4–10 kg NexGard 68 mg dogs &gt; 10–25 kg NexGard 136 mg dogs &gt; 25–50 kg
NexGard 11 mg psi 2–4 kg NexGard 28 mg psi &gt; 4–10 kg NexGard 68 mg psi &gt; 10–25 kg NexGard 136 mg psi &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 tablete za žvakanje za pse 2–3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tablete za žvakanje za pse &gt; 3,5–7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tablete za žvakanje za pse &gt; 7,5–15 kg NEXGARD SPECTRA 75 mg/ 15 mg tablete za žvakanje za pse &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg tablete za žvakanje 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 tableta za žvakanje za pse 2–3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tableta za žvakanje za pse &gt; 3,5–7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tableta za žvakanje za pse &gt; 7,5–15 kg NEXGARD SPECTRA 75 mg/ 15 mg tableta za žvakanje za pse &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg tableta za žvakanje za pse &gt; 30–60 kg afoksolaner / milbemicin oksim
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 tableta za žvakanje za pse 2–3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg tableta za žvakanje za pse &gt; 3,5–7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg tableta za žvakanje za pse &gt; 7,5–15 kg NEXGARD SPECTRA 75 mg/ 15 mg tableta za žvakanje za pse &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg tableta za žvakanje 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 pse 2–3,5 kg NEXGARD SPECTRA 19 mg/ 4 mg pse &gt; 3,5–7,5 kg NEXGARD SPECTRA 38 mg/ 8 mg pse &gt; 7,5–15 kg NEXGARD SPECTRA 75 mg/ 15 mg pse &gt; 15–30 kg NEXGARD SPECTRA 150 mg/ 30 mg pse &gt; 30–60 kg
Nintedanib is predominantly eliminated via biliary/faecal excretion ( &gt; 90 %).
Nintedanib se pretežno izlučuje putem žuči/stolice ( &gt; 90%).
Nintedanib is predominantly eliminated via biliary/faecal excretion ( &gt; 90%).
Nintedanib se pretežno izlučuje putem žuči/stolice ( &gt; 90%).
Nitrate has been identified as the predominant nitric oxide metabolite excreted in the urine, accounting for &gt; 70 % of the nitric oxide dose inhaled.
Utvrđeno je da je nitrat predominantni metabolit dušikovog (II) oksida koji se izlučuje urinom i čini &gt; 70% udahnute doze dušikovog (II) oksida.
Nivolumab
p &lt; 0,0001
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.
Nivolumab BMS se mora primjenjivati uz oprez u bolesnika s umjerenim (ukupan bilirubin &gt; 1,5 × do 3 × gornja granica normale [GGN] i bilo koja vrijednost AST-a) ili teškim (ukupan bilirubin &gt; 3 × GGN i bilo koja vrijednost AST-a) oštećenjem jetrene funkcije.
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).
Nivolumab se nije ispitivao u bolesnika umjerenim (ukupni bilirubin &gt; 1,5 × do 3 × GGN i bilo koja vrijednost AST-a) ili teškim oštećenjem jetrene funkcije (ukupni bilirubin &gt; 3 × GGN i bilo koja vrijednost AST-a) (vidjeti dio 4.2).
Nivolumab+ipilimumab vs ipilimumab (primary analysis) - HR (99.5% CI): 0.42 (0.32, 0.56); p-value: &lt; 0.0001
Nivolumab + ipilimumab naspram ipilimumaba (primarna analiza) – HR (99,5% CI): 0,42 (0,32; 0,56); p-vrijednost: &lt; 0,0001
NN: &gt;
2019.
No adjustment of the initial dose is required in patients &gt; 65 years of age.
U bolesnika starijih od 65 godina nije potrebna prilagodba početne doze.
No adjustment of the standard dose is recommended in patients &gt; 70 years old (see section 4.8).
Ne preporučuje se prilagodba standardne doze u bolesnika ≥ 70 godina starosti (vidjeti dio 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).
Tijekom liječenja Spectrilom, od 12 dojenčadi mlađe od 1 godine ni u jednog nisu opažene alergijske reakcije (ispitivanje 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.
Nije zabilježeno povišenje ALT-a ≥ 3 x GGN u ispitivanju faze III u kojem se Humira primjenjivala u bolesnika s poliartikularnim juvenilnim idiopatskim artritisom u dobi od 2 do &lt; 4 godine.
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).
Ni u jednog dojenčeta od njih 12 mlađih od 1 godine nisu opažena protutijela protiv asparaginaze tijekom liječenja Spectrilom (ispitivanje MC-ASP.6/INF).
No cabozantinib-treated subjects had a QTcF &gt; 500 ms.
Nitko od bolesnika koji su primali kabozantinib nije imao 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).
Nijedan od ispitanika koji su primali kabozantinib u ovom ispitivanju nije imao QTcF &gt; 500 ms, kao i niti jedan od ispitanika koji su primali kabozantinib u ispitivanju RCC-a (pri dozi od 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.
Nisu bile uočene nikakve promjene u farmakokinetičkim parametrima na temelju klirensa ili volumena distribucije između starijih bolesnika i odraslih bolesnika u dobi od &lt; 65 godina.
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).
Nije potrebna promjena početne doze u bolesnika s teškim oštećenjem funkcije bubrega (procijenjena brzina glomerularne filtracije [eGFR] &lt; 30 ml/min/1,73 m2); titraciju doze u ovih bolesnika treba provoditi oprezno (vidjeti dio 4.4).
No clinical studies have been conducted in patients &gt; 75 years of age.
Nisu provedena klinička ispitivanja u bolesnika starijih od 75 godina.
No clinical studies have been conducted in patients &gt; 75 years of age.
Nisu provedena klinička ispitivanja u bolesnika u dobi &gt; 75 godina.
No clinical studies of prophylaxis in infants aged &lt; 1 have been performed.
Klinička ispitivanja profilakse u dojenčadi mlađoj &lt; 1 godine nisu provođena.
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).
Nisu provedena klinička ispitivanja SPRYCELA u bolesnika sa smanjenom funkcijom bubrega (ispitivanje u bolesnika s novodijagnosticiranom KML u kroničnoj fazi isključilo je bolesnike s koncentracijom kreatinina u serumu koja je bila &gt; 3 puta veća od gornje granice normalnog raspona, a ispitivanja u bolesnika s KML u kroničnoj fazi koji ne podnose ili su otporni na prethodnu terapiju imatinibom isključila su bolesnike s koncentracijom kreatinina u serumu koja je bila &gt; 1,5 puta veća od gornje granice normalnog raspona).
No clinical trials in subjects with a creatinine clearance &lt; 10 mL/min or in patients undergoing dialysis have been conducted.
Nisu provedena klinička ispitivanja na ispitanicima s klirensom kreatinina &lt; 10 ml/min ili na bolesnicima koji su na dijalizi.
No clinically important pharmacokinetic differences between subjects with severe renal impairment (CLcr &lt; 30 mL/min) and matching healthy subjects were observed.
Nisu primijećene klinički značajne farmakokinetičke razlike između ispitanika s teškim oštećenjem bubrežne funkcije (CLcr &lt; 30 ml/min) i odgovarajućih zdravih ispitanika.
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.
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira, kobicistata, tenofoviralafenamida ili tenofovira između zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl &gt; 15, ali &lt; 30 ml/min) u ispitivanjima elvitegravira pojačanog kobicistatom ili tenofoviralafenamida.
No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl &gt; 15 but
Nisu zapaţene klinički značajne razlike u farmakokinetici tenofoviralafenamida ili tenofovira izmeĎu zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl &gt; 15, ali
No clinically significant changes in the mean QTc interval (i.e., &gt; 20 ms) from baseline were detected in the study.
Nisu uočene kliničke promjene u prosječnom intervalu QTc (primjerice &gt; 20 ms) od početne vrijednosti.
No concurrent elevations of ALT ( &gt; 3 times the upper limit of normal [ULN]) and bilirubin ( &gt; 2 times the ULN) were observed.
Nisu opažena istodobna povišenja ALT-a ( &gt; 3 puta iznad gornje granice normale [GGN]) i bilirubina ( &gt; 2 puta iznad GGN).
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Trenutno nema dostupnih podataka na temelju kojih bi se mogla dati preporuka doze za nedonoščad ( &lt; 36 tjedana postkoncepcijske dobi).
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Trenutno nema podataka na temelju kojih bi se mogla dati preporuka doze za nedonoščad ( &lt; 36 tjedana postkoncepcijske starosti*).
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Trenutno nema podataka na temelju kojih bi se mogla dati preporuka doze za nedonoščad ( &lt; 37 tjedana postkoncepcijske starosti*).
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Trenutno nema podataka na temelju kojih bi se mogla dati preporuka doze za nedonoščad ( &lt; 37 tjedana postmenstrualne starosti*).
No data allowing a dose recommendation for premature children ( &lt; 36 weeks post-conceptual age) are currently available.
Trenutno nema dostupnih podataka na temelju kojih bi se mogla dati preporuka doze za nedonoščad ( &lt; 36 tjedana postkoncepcijske dobi ).
No data are available on administration of pomalidomide to paediatric or adolescent patients ( &lt; 18 years of age).
Nema dostupnih podataka o primjeni pomalidomida kod pedijatrijskih ispitanika i adolescenata (u dobi &lt; 18 godina).
No data are available on patients with severe (CLCR &lt; 30 mL/min) renal impairment or end-stage renal disease.
Nema dostupnih podataka za bolesnike s teškim (CLCR &lt; 30 ml/min) oštećenjem funkcije bubrega ili u završnom stadiju bolesti bubrega.
No data were available from patients with severe hepatic impairment (total bilirubin &gt; 3.0 times ULN and any AST level).
Nije bilo dostupnih podataka o primjeni u bolesnika s teškim oštećenjem funkcije jetre (ukupni bilirubin &gt; 3,0 puta iznad GGN-a i bilo koja vrijednost AST-a).
No decline (FVC change &gt; 0%)
Bez pada (promjena FVC &gt; 0%)
No decline (FVC change &gt; 0%)
Bez pada (promjena FVC za &gt; 0%)
No decline (FVC change &gt; 0%)
Bez pada (promjena FVC-a od &gt; 0%)
No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of &lt; 2 g/ml.
Tijekom programa kliničkog ispitivanja nije uočen razvoj rezistencije za vrijeme liječenja retapamulinom i svi su klinički izolati bili inhibirani koncentracijama retapamulina od &lt; 2 g/ml.
No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and &lt; 80 mL/min).
Bolesnicima s blagim oštećenjem bubrega (CLcr ≥50 i &lt; 80 ml/min) nije potrebna prilagodba doze.
No dosage adjustment is required for the elderly with creatinine clearance values &gt; 50 ml/min (see section 5.2).
Nije potrebna prilagodba doziranja u starijih bolesnika s vrijednostima klirensa kreatinina &gt; 50 ml/min (vidjeti dio 5.2).
No dosage adjustment is required in patients with mild, moderate or severe (CrCl &lt; 30 mL/min, not on dialysis) renal impairment.
Nije potrebno prilagođavati dozu u bolesnika s blagim, umjerenim ili teškim (CrCl &lt; 30 ml/min, bolesnik nije na dijalizi) oštećenjem bubrežne funkcije.
No dosage adjustment of amlodipine/valsartan is required for patients with mild to moderate renal impairment (GFR &gt; 30 ml/min/1.73 m2).
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR &gt; 30 ml/min/1,73 m2) doziranje amlodipina/valsartana nije potrebno prilagođavati.
No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR &gt; 30 ml/min/1.73 m2).
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR &gt; 30 ml/min/1,73 m2) doziranje Copalie nije potrebno prilagođavati.
No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR &gt; 30 ml/min/1.73 m2).
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR &gt; 30 ml/min/1,73 m2) doziranje Exforgea nije potrebno prilagođavati.
No dosage reduction is required for patients with creatinine clearance &gt; 20 ml/min.
U bolesnika s klirensom kreatinina &gt; 20 ml/min nije potrebno smanjenje doze.
No dosage reduction is required for patients with mild renal impairment (creatinine clearance &gt; 50 ml/min).
U bolesnika s blagim oštećenjem bubrega (klirens kreatinina &gt; 50 ml/min) nije potrebno smanjenje doze.
No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and &lt; 80 mL/min).
Prilagodba doze nije potrebna u bolesnika s blagim oštećenjem bubrega (CLcr ≥50 i &lt; 80 ml/min).
No dose adjustment is necessary in mildly and moderately renally impaired patients (CLCR
Kod bolesnika s blagim do umjerenim oštećenjem bubrega ne treba prilagođavati dozu (CLCR &gt;
No dose adjustment is necessary in patients with impaired renal function (creatinine clearance &gt; 4 ml/min) (see section 5.2).
Nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega (klirens kreatinina &gt; 4 ml/min) (vidjeti dio 5.2).
No dose adjustment is necessary in patients with mild to moderate renal impairment, see section 4.4 for patients with severe renal impairment (eGFR &lt; 30 mL/min/1.73 m2).
Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem bubrega, vidjeti dio 4.4 za bolesnike s teškim oštećenjem bubrega (eGFR &lt; 30 ml/min /1,73 m2).
No dose adjustment is necessary in TIH patients with serum creatinine &lt; 400 micromol/l or &lt; 4.5 mg/dl (see section 4.4).
Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu &lt; 400 mikromola/l ili &lt; 4,5 mg/dl (vidjeti dio 4.4).
No dose adjustment is necessary in TIH patients with serum creatinine &lt; 400 µmol/l or &lt; 4.5 mg/dl (see section 4.4).
Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu &lt; 400 μmol/l ili 4,5 mg/dl (vidjeti dio 4.4).
No dose adjustment is necessary in TIH patients with serum creatinine &lt; 400 µmol/l or &lt; 4.5 mg/dl (see section 4.4).
Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu &lt; 400 μmol/l ili &lt; 4,5 mg/dl (vidjeti dio 4.4).
No dose adjustment is necessary in TIH patients with serum creatinine &lt; 400 µmol/l or &lt; 4.5 mg/dl (see section 4.4).
Nije potrebna prilagodba doze u bolesnika s hiperkalcemijom izazvanom tumorom i vrijednostima kreatinina u serumu manjima od 400 μmol/l ili 4,5 mg/dl (vidjeti dio 4.4).