natgillin/translations-raw huggingface dataset:
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).
No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance &gt; 30 ml/min).
Ne preporučuje se prilagođavanje doze kod bolesnika s blagim do umjerenim oštećenjem bubrega (klirens kreatinina &gt; 30 ml/min).
No dose adjustment is required in elderly patients (aged &gt; 65 years).
Nije potrebno prilagođavati dozu u starijih bolesnika (u dobi od &gt; 65 godina).
No dose adjustment of Copalia HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m2).
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR &gt; 30 ml/min/1,73 m2) dozu Copalia HCT-a nije potrebno prilagođavati.
No dose adjustment of Dafiro HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m2).
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR &gt; 30 ml/min/1,73 m2) dozu Dafiro HCT-a nije potrebno prilagođavati.
No dose adjustment of Empliciti is required for patients with mild (CrCl = 60 - 89 mL/min), moderate (CrCl = 30 - 59 mL/min), severe (CrCl &lt; 30 mL/min) renal impairment or end stage renal disease requiring dialysis (see section 5.2).
Nije potrebno prilagođavati dozu lijeka Empliciti u bolesnika s blagim (CrCl = 60 – 89 ml/min), umjerenim (CrCl = 30 – 59 ml/min) ili teškim (CrCl &lt; 30 ml/min) oštećenjem funkcije bubrega, kao ni u bolesnika u terminalnoj fazi bubrežne bolesti kojima je potrebna dijaliza (vidjeti dio 5.2).
No dosing recommendations can be made for the very young (children &lt; 2 years of age) and Telzir with ritonavir is not recommended for this patient population (see section 4.2).
Ne mogu se donijeti preporuke o doziranju za jako mladu djecu (djeca u dobi &lt; 2 godine starosti) te se Telzir s ritonavirom ne preporučuje za tu populaciju bolesnika (vidjeti dio 4.2).
No individual substitutions tested in genotypes 2a, 4a, or 5a conferred a &gt; 100-fold reduction in velpatasvir susceptibility.
Nikakve pojedinačne supstitucije ispitane u genotipovima 2a, 4a ili 5a nisu dovele do smanjenje osjetljivosti velpatasvira za &gt; 100 puta.
No information on the use of ZYPADHERA in patients &gt; 75 years is available.
Nisu dostupne informacije o primjeni lijeka ZYPADHERA u bolesnika starijih od 75 godina.
No initial dose adjustment is required in patients &gt; 65 years of age.
Nije potrebno prilagođavati početnu dozu u bolesnika starijih od 65 godina.
No metabolites were present at &gt; 10% relative to parent or total radioactivity in plasma.
Nije bilo prisutnih metabolita u postotku većem od &gt; 10% u odnosu na prekursor ili ukupnu radioaktivnost u plazmi.
No new safety concerns were identified from analyses of 48 week data from studies APV29005 or APV20002, in which 54 subjects 4 weeks to &lt; 2 years of age received twice daily fosamprenavir / ritonavir with background nucleoside reverse transcriptase inhibitor therapy and 5 subjects received only single doses of fosamprenavir with or without ritonavir.
Nisu identificirana nova sigurnosna pitanja u analizama podataka nakon 48 tjedana iz ispitivanja APV29005 ili APV20002, u kojima su 54 ispitanika u dobi od 4 tjedna do &lt; 2 godine primala fosamprenavir/ritonavir dvaput na dan uz osnovnu terapiju nukleozidnim inhibitorima reverzne transkriptaze, dok je 5 ispitanika primilo samo jednokratnu dozu fosamprenavira s ritonavirom ili bez njega.
No new safety concerns were identified from analyses of 48 week data from studies APV29005 or APV20002, in which 54 subjects 4 weeks to &lt; 2 years of age received twice daily fosamprenavir / ritonavir with background nucleoside reverse transcriptase inhibitor therapy and 5 subjects received only single doses of fosamprenavir with or without ritonavir.
Nisu identificirani novi sigurnosni signali u analizama podataka nakon 48 tjedana iz ispitivanja APV29005 ili APV20002, u kojima su 54 ispitanika u dobi od 4 tjedna do &lt; 2 godine primala fosamprenavir/ritonavir dvaput na dan uz osnovnu terapiju nukleozidnim inhibitorima reverzne transkriptaze, dok je njih 5 primilo samo jednokratnu dozu fosamprenavira s ritonavirom ili bez njega.
No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult ( &gt; 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Ukupne razlike u sigurnosti ili učinkovitosti nisu zabilježene u ispitanika starijih od 65 godina u usporedbi s mladim odraslim ispitanicima ( &gt; 18 godina starosti) koji su primali citotoksičnu kemoterapiju, a kliničko iskustvo nije utvrdilo razlike u odgovorima između starijih i mlađih odraslih bolesnika.
No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult ( &gt; 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Sveukupne razlike u sigurnosti i djelotvornosti nisu uočene između ispitanika starijih od 65 godina u odnosu na mlade odrasle ( &gt; 18 godina) ispitanike koji primaju citotoksičnu kemoterapije te kliničkim iskustvom nije identificirana razlika u odgovorima između starijih i mlađih odraslih bolesnika.
No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult ( &gt; 18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Sveukupne razlike u sigurnosti i djelotvornosti nisu uočene između ispitanika starijih od 65 godina u odnosu na mlađe odrasle ( &gt; 18 godina) ispitanike koji primaju citotoksičnu kemoterapije te kliničkim iskustvom nije identificirana razlika u odgovorima između starijih i mlađih odraslih bolesnika.
No overall differences in safety or effectiveness were observed between women aged &gt; 65 years and younger women, but greater sensitivity of some older individuals cannot be ruled out.
Ukupne razlike u sigurnosti i djelotvornosti nisu uočene u žena dobi &gt; 65 godina i mlađih žena, no ne može se isključiti veća osjetljivost nekih starijih bolesnica.
No overall differences in safety or efficacy have been observed in patients &lt; 65 and ≥ 65 years of age (see section 5.1).
Nisu primijećene razlike u sigurnosti i djelotvornosti u bolesnika &lt; 65 i ≥ 65 godina (vidjeti dio 5.1).
No overall differences in safety or efficacy were reported between elderly ( ≥65 years) and younger patients ( &lt; 65 years).
Sveukupno nisu prijavljene razlike u sigurnosti i djelotvornosti između starijih osoba ( ≥65 godina) i mlađih bolesnika ( &lt; 65 godina).
No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients ( &lt; 65 years).
Općenito nisu zabilježene razlike u djelotvornosti i sigurnosti primjene između starijih (≥ 65 godina) i mlađih bolesnika ( &lt; 65 godina).
No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients ( &lt; 65 years).
Sveukupno nisu prijavljene razlike u sigurnosti i djelotvornosti između starijih osoba (≥ 65 godina) i mlađih bolesnika ( &lt; 65 godina).
No overall differences in safety or efficacy were reported between elderly patients (≥ 65 years) and younger patients ( &lt; 65 years).
Sveukupno nisu prijavljene razlike u sigurnosti ili djelotvornosti između starijih bolesnika (≥65 godina) i mlađih bolesnika ( &lt; 65 godina).
No overall differences in safety were reported between elderly (≥ 65 years) and younger patients ( &lt; 65 years).
Sveukupno nisu prijavljene razlike u sigurnosti između starijih osoba (≥ 65 godina) i mlađih bolesnika ( &lt; 65 godina).
No overall differences were observed in the safety profile of elderly patients ≥ 65 years of age and younger adult patients &lt; 65 years of age in the clinical studies.
U kliničkim ispitivanjima nisu opažene sveukupne razlike u sigurnosnom profilu između starijih bolesnika u dobi ≥ 65 godina i mlađih odraslih bolesnika u dobi &lt; 65 godina.
No patient had a QTcF &gt; 480 msec.
Niti jedan bolesnik nije imao QTcF &gt; 480 msek.
No patient had an absolute QTcF &gt; 500 msec while on the study medicinal product.
Niti jedan bolesnik nije imao QTcF &gt; 500 msek tijekom primjene ispitivanog lijeka.
No patient in either group developed a ΔQTc &gt; 60 msec.
Ni u jednog bolesnika ni iz jedne skupine nije došlo do ΔQTc od &gt; 60 ms.
No patients had a QTc interval &gt; 500 msec.
Niti jedan bolesnik nije imao QTc-interval &gt; 500 msek.
No patients in the crizotinib arm of randomised Phase 3 Studies 1007 and 1014, and single arm Study 1005 were &gt; 85 years.
Niti jedan bolesnik u skupini krizotiniba u randomiziranim Ispitivanjima 1007 i 1014 faze 3 i u Ispitivanju 1005 s jednom skupinom bolesnika nije imao &gt; 85 godina.
No quantifiable levels ( &gt; 5 ng/ml) of drug were detected in serum after single or multiple topical doses.
Nakon jednokratno ili višekratno topikalno primijenjene doze nije zabilježena mjerljiva razina ( &gt; 5 ng/ml) u serumu.
No significant difference was observed in the pharmacokinetics of obinutuzumab among patients &lt; 65 years (n=375), patients between 65-75 years (n=265) and patients
Nije primijećena značajna razlika u farmakokinetici obinutuzumaba između bolesnika &lt; 65 godina (n = 375), bolesnika u dobi između 65 i 75 godina (n = 265) i bolesnika
No significant difference was observed in the PK of trastuzumab emtansine among patients &lt; 65 years (n = 577), patients between 65-75 years (n = 78) and patients &gt; 75 years (n = 16).
Nije primijećena značajna razlika u farmakokinetici trastuzumab emtanzina između bolesnika mlađih od 65 godina (n = 577), bolesnika u dobi između 65 i 75 godina (n = 78) i bolesnika starijih od 75 godina (n = 16).
No significant differences in safety and efficacy of Perjeta were observed between elderly patients aged 65 to 75 years and adult patients aged &lt; 65 years.
Nisu primijećene značajne razlike u sigurnosti i djelotvornosti lijeka Perjeta između starijih bolesnika u dobi od 65 do 75 godina i odraslih bolesnika mlađih od 65 godina.
No significant nausea (maximum VAS &lt; 25 mm on a scale of 0-100 mm)
Izostanak značajne mučnine ( &lt; 25 mm na vizualnoj analognoj ljestvici 0-100 mm)
No special dose adjustment is required in patients aged &gt; 65 years old.
Nije potrebno posebno prilagođavati dozu bolesnicima starijima od 65 godina.
No staining is observed or membrane staining is observed in &lt; 10 % of the tumour cells
Nema vidljive obojenosti ili se obojenost membrane primjećuje u &lt; 10 % tumorskih stanica.
No staining is observed or membrane staining is observed in &lt; 10 % of the tumour cells
Nema vidljive obojenosti ili se obojenost membrane primjećuje u &lt; 10% tumorskih stanica.
No starting dose adjustment is recommended for patients with mild (60≤ creatinine clearance [CLcr] &lt; 90 mL/min) or moderate (30≤ CLcr &lt; 60 mL/min) renal impairment, since the population pharmacokinetic analysis indicated no clinically meaningful changes in steady-state crizotinib exposure in these patients.
Nije potrebno prilagođavati početnu dozu lijeka u bolesnika s blagim (60≤ klirens kreatinina [CLcr] &lt; 90 ml/min) ili umjerenim (30≤ CLcr &lt; 60 ml/min) oštećenjem funkcije bubrega, budući da populacijska farmakokinetička analiza nije pokazala klinički značajne promjene u tih bolesnika kod izloženosti krizotinibu u stanju dinamičke ravnoteže.
No subject had a QTcF &gt; 450 msec.
Niti jedan ispitanik nije imao QTcF &gt; 450 msek.
No teratogenic effects were observed in rabbits at &gt; 1,000 times human exposure.
Nisu primijećeni teratogeni učinci u kunića pri dozama &gt; 1000 puta višima od izloženosti kod ljudi.
Non carrier added (n.c.a.) Lutetium (177Lu) chloride is produced by the irradiation of highly enriched ( &gt; 99 %) Ytterbium (176Yb) in neutron sources with a thermal neutron flux between 1013 and 1016 cm- 2s-1.
Lutecijev (177Lu) klorid kojem nije dodan nosač (engl. non carrier added, n.c.a.) dobiva se iradijacijom visoko obogaćenog ( &gt; 99 %) iterbija (176Yb) u neutronskim izvorima s termalnim neutronskim tokom između 1013 i 1016 cm-2s-1.
Non species related breakpoints: S ≤ 0.5 mg/L and R &gt; 1 mg/L (NB: Susceptibility of staphylococci to ertapenem is inferred from the methicillin susceptibility)
Granične vrijednosti nespecifične za vrstu: S ≤0,5 mg/l i R &gt; 1 mg/l (Napomena: Osjetljivost stafilokoka na ertapenem zaključena je na temelju osjetljivosti na meticilin.)
Non-inferiority for the proportion of subjects achieving an IgG concentration 0.35 μg/ml was demonstrated for all 13 serotypes (lower bound of the 97.5% confidence interval (CI) for the difference in percentage of responders at 0.35 µg/ml between groups was &gt; -10%).
Neinferiornost udjela ispitanika koji su postigli IgG koncentracije  0,35 μg/ml dokazana je za svih 13 serotipova (donja granica 97,5%-tnog intervala pouzdanosti (CI) za razliku u postotku bolesnika koji su odgovorili na cijepljenje pri 0,35 µg/ml između grupa iznosila je &gt; -10%).
Non-steroidal anti- inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid ( &gt; 3 g/day), and non- selective NSAIDs
Nesteroidni protuupalni lijekovi (NSAILi), uključujući selektivne inhibitore ciklooksigenaze-2 (COX-2 inhibitore), acetilsalicilatnu kiselinu ( &gt; 3 g/dan) i neselektivne NSAIL-e
Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid &gt; 3 g/day), and non-selective NSAIDs
Nesteroidni protuupalni lijekovi (NSAIL), uključujući selektivne COX-2 inhibitore, acetilsalicilatnu kiselinu ( &gt; 3 g na dan) i neselektivne NSAIL
Non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid &gt; 3 g/day), and non-selective NSAIDs
Nesteroidni protuupalni lijekovi (NSAIL), uključujući selektivne COX-2 inhibitore, acetilsalicilnu kiselinu ( &gt; 3 g na dan) i neselektivne NSAIL
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid ( &gt; 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Nesteroidni protuupalni lijekovi: kad se antagonisti angiotenzina II primjenjuju istodobno s nesteroidnim protuupalnim lijekovima (npr. selektivnim inhibitorima COX-2, acetilsalicilatnom kiselinom ( &gt; 3 g/dan) i neselektivnim nesteroidnim protuupalnim lijekovima), može doći do slabljenja antihipertenzivnog učinka.
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid ( &gt; 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Nesteroidni protuupalni lijekovi: kad se antagonisti angiotenzina II primjenjuju istodobno s nesteroidnim protuupalnim lijekovima (tj. selektivnim inhibitorima COX-2, acetilsalicilatnom kiselinom ( &gt; 3 g/dan) i neselektivnim NSAIL) moguć je oslabljeni antihipertenzivni učinak.
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid ( &gt; 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Nesteroidni protuupalni lijekovi: kad se antagonisti angiotenzina II primjenjuju istodobno s nesteroidnim protuupalnim lijekovima (tj. selektivnim inhibitorima COX2, acetilsalicilnom kiselinom ( &gt; 3 g/dan) i neselektivnim NSAIL) moguć je oslabljeni antihipertenzivni učinak.
Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid ( &gt; 3 g/day), and non-selective NSAIDs
Nesteroidni protuupalni lijekovi (NSAILi), uključujući selektivne COX-2 inhibitore, acetilsalicilatnu kiselinu ( &gt; 3 g/dan) i neselektivne NSAIL-e
Nonafact contains trace amounts ( &lt; 0.1 ng mouse IgG/IU of factor IX) of the murine monoclonal antibody used in its purification.
Nonafact sadrži u tragovima ( &lt; 0,1 ng mišjeg IgG/IU faktora IX) murino monoklonalno protutijelo koje se koristi za pročišćavanje.
None of the metabolites were present in &gt; 10% of the plasma concentrations of parent or total parent and metabolite related material.
Nijedan od metabolita nije bio prisutan u koncentraciji &gt; 10% plazmatske koncentracije ishodišnog spoja ili ukupnog materijala povezanog s ishodišnim spojem i metabolitima.
None of the patients had an increase of QTc to &gt; 500 msec.
Niti u jednog se bolesnika QTc interval nije produljio na &gt; 500 ms.
None of the patients had an increase of QTc to &gt; 500 msec.
Niti u jednog se bolesnika QTc-interval nije produljio na &gt; 500 ms.
Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound ( &gt; 97%) to serum proteins.
Norelgestromin i norgestrel (serumski metabolit norelgestromina) imaju visok afinitet vezanja ( &gt; 97%) na serumske proteine.
Normal ( &gt; 80) (n = 8)
Normalna ( &gt; 80) (n = 8)
Normal individuals and heterozygous subjects for cystinosis have white cell cystine levels of &lt; 0.2, and usually below 1 nmol hemicystine/mg protein, respectively.
Normalni pojedinci imaju razinu cistina u leukocitima &lt; 0,2, a heterozigotni ispitanici na cistinozu imaju razinu manju od 1 nmol hemicistina/mg proteina.
Normal weight: BMI 18.5-25 kg/m2, Pre-adipose: BMI 25-30 kg/m2, Adipose: BMI &gt; 30 kg/m2, SD = Standard deviation
Normalna težina: ITM 18,5 – 25 kg/m2, Prekomjerna tjelesna težina: ITM 25 – 30 kg/m2, Pretilost: ITM &gt; 30 kg/m2, SD = standardna devijacija
Not reached (Range: &gt; 0.0 to &gt; 16.8 months)
Nije postignut (Raspon: &gt; 0,0 do &gt; 16,8 mjeseci)
Note: An OR &gt; 1 indicates an advantage for bortezomib-containing induction therapy
Napomena: OR &gt; 1 ukazuje na prednost za uvodno liječenje koje sadrži bortezomib
Note: An OR &gt; 1 indicates an advantage for bortezomib-containing induction therapy.
Napomena: OR &gt; 1 ukazuje na prednost za uvodno liječenje koje sadrži bortezomib.
Note: An OR &gt; 1 indicates an advantage for Bz-containing induction therapy
Napomena: OR &gt; 1 ukazuje na prednost za uvodno liječenje koje sadrži Bz
Note: An OR &gt; 1 indicates an advantage for Bz-containing induction therapy.
Napomena: OR &gt; 1 ukazuje na prednost za uvodno liječenje koje sadrži Bz.
Note: An OR &gt; 1 indicates an advantage for Bzmb-containing induction therapy
Važno: OR &gt; 1 ukazuje na prednost za uvodno liječenje koje sadrži Bzmb
Note: An OR &gt; 1 indicates an advantage for Bzmb-containing induction therapy.
Važno: OR &gt; 1 ukazuje na prednost za uvodno liječenje koje sadrži Bzmb.
Note: An OR &gt; 1 indicates an advantage for Vc-containing induction therapy
Napomena: OR &gt; 1 ukazuje na prednost za uvodno liječenje koje sadrži Vc
Note: An OR &gt; 1 indicates an advantage for Vc-containing induction therapy.
Napomena: OR &gt; 1 ukazuje na prednost za uvodno liječenje koje sadrži Vc.
Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to &lt; 12 years and 26 immunocompromised adolescents aged 12 to &lt; 17 years.
Napomena: Na temelju populacijske farmakokinetičke analize u 112 imunokompromitiranih pedijatrijskih bolesnika u dobi od 2 do &lt; 12 godina te 26 imunokompromitiranih adolescenata u dobi od 12 do &lt; 17 godina.