natgillin/translations-raw huggingface dataset:
&lt; 1/1,000); very rare ( &lt; 1/10,000).
&lt; 1/10); manje često (≥1/1000 i &lt; 1/100); rijetko (≥1/10 000 i &lt; 1/1000); vrlo rijetko ( &lt; 1/10 000).
&lt; 1/1,000); very rare ( &lt; 1/10,000).
&lt; 1/1000), vrlo rijetko ( &lt; 1/10 000).
&lt; 1/1,000); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
&lt; 1/10); manje često (≥1/1000 i &lt; 1/100); rijetko (≥1/10 000 i &lt; 1/1000); vrlo rijetko ( &lt; 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podatka).
&lt; 1/1,000; very rare: &lt; 1/10,000).
&lt; 1/1000, vrlo rijetko &lt; 1/10 000).
&lt; 1/1,000; very rare: &lt; 1/10,000, not known (cannot be estimated from the available data).
&lt; 1/1000; vrlo rijetko: &lt; 1/10 000, nepoznato (ne može se procijeniti iz dostupnih podataka).
&lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), and not known (cannot be estimated from the available data).
&lt; 1/10), manje često (≥1/1000 i &lt; 1/100), rijetko (≥1/10 000 i &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
&lt; 1/10), uncommon (1/1000 to &lt; 1/100), rare (1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
&lt; 1/100), rijetko (1/10 000 do &lt; 1/1000), vrlo rijetko ( &lt; 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
&lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
&lt; 1/100); rijetke (≥1/10 000, &lt; 1/1000); vrlo rijetke ( &lt; 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
&lt; 1/100) and neutropenia have been reported; therefore regular monitoring of patients taking Mycophenolate mofetil Teva is advised (see section 4.4).
Prijavljene su agranulocitoza (manje često) i neutropenija, stoga se preporučuje redovito praćenje bolesnika koji uzimaju Mikofenolat mofetil Teva (vidjeti dio 4.4).
&lt; 1/100), and not known: cannot be estimated from the available data.
&lt; 1/100) i nepoznato: ne može se procijeniti iz dostupnih podataka.
&lt; 1/100), rare (≥1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
&lt; 1/100), rijetko (≥1/10.000 do &lt; 1/1000), vrlo rijetko ( &lt; 1/10.000), nepoznato (ne može se utvrditi iz dostupnih podataka).
&lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000) or very rare ( &lt; 1/10,000) cannot be estimated from the available data.
&lt; 1/1000) ili vrlo rijetko ( &lt; 1/10 000) ne mogu se procijeniti iz dostupnih podataka.
&lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).
&lt; 1/1000); vrlo rijetko ( &lt; 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
&lt; 1/100); rare (1/10,000 to &lt; 1/1,000); very rare (1/10,000), not known (cannot be estimated from the available data).Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
&lt; 1/100; rare: ≥1/10,000 to &lt; 1/1,000; very rare: &lt; 1/10,000 and not known (cannot be estimated from the available data).
&lt; 1/100, rijetko ≥1/10 000 i &lt; 1/1000, vrlo rijetko &lt; 1/10 000 i nepoznato (ne može se procijeniti iz dostupnih podataka).
&lt; 10% decrease
&lt; 10% sniženje
&lt; 100 mmHg (see section 4.4).
&lt; 100 mmHg (vidjeti dio 4.4).
&lt; 100 nmol/ml after Strimvelisd n
venskoj krvi &lt; 100 nmol/ml nakon
&lt; 100,000 copies/ml
&lt; 100 000 kopija/ml
&lt; 100-80 g/L (grade 2)
&lt; 100-80 g/l (2. stupanj)
&lt; 100G/l)
&lt; 100 G/l)
&lt; 12 months
&lt; 12 mjeseci
&lt; 12 years (n=15)
&lt; 12 godina (N = 15)
&lt; 150 cells/L
&lt; 150 stanica/l
&lt; 16 years) with chronic iron overload due to blood transfusions.
&lt; 16 godina) bolesnika s kroničnim preopterećenjem željezom zbog transfuzija krvi.
&lt; 17 y
&lt; 17 god
&lt; 18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
&lt; 18 godina (119) koji su primili vorikonazol kao profilaksu (183) ili terapiju (105) u kliničkim ispitivanjima.
&lt; 18 years (see section 5.1), which did not indicate a difference in the safety profile of lipegfilgrastim in children compared to that in adults.
21 pedijatrijskog bolesnika u dobi od 2 do &lt; 18 godina (vidjeti dio 5.1), koje nije pokazalo razliku sigurnosnog profila lipegfilgrastima u djece u usporedbi s onim u odraslih.
&lt; 18 years of age with SEGA and concomitant hepatic impairment (Child-Pugh A, B and C) (see sections 4.2 and 5.2).
mlađih od 18 godina sa SEGA-om i istodobnim oštećenjem jetre (Child-Pugh A, B i C) (vidjeti dijelove 4.2 i 5.2).
&lt; 2 G/L), eosinophilia Very rare: agranulocytosis
Vrlo rijetko: agranulocitoza
&lt; 2 units/month for an adult)
&lt; 2 jedinice/mjesec za odraslu osobu)
&lt; 2 y
&lt; 2 god
&lt; 2 years (n=5)
&lt; 2 godine (N = 5)
&lt; 2.0 from the average of Day 112 and Day 183 compared to baseline
&lt; 2,0 od prosjeka na 112. i 183. dan u odnosu na početnu vrijednost
&lt; 2.8 g/dL (see section 4.3).
&lt; 2,8 g/dL (vidjeti dio 4.3).
&lt; 20 (n=17)
&lt; 20 (n=17)
&lt; 25 x 109/l
&lt; 25 x 109/l
&lt; 28 &gt; &lt; 28 x 1 &gt; &lt; 30 &gt; &lt; 30 x 1 &gt; &lt; 35 &gt; &lt; 35 x 1 &gt; &lt; 50 &gt; &lt; 50 x 1 &gt; &lt; 56 &gt; &lt; 56 x 1 &gt; &lt; 70 &gt; &lt; 70 x 1 &gt; &lt; 98 &gt; &lt; 98 x 1 &gt; film-coated tablets
&lt; 28 &gt; &lt; 28 x 1 &gt; &lt; 30 &gt; &lt; 30 x 1 &gt; &lt; 35 &gt; &lt; 35 x 1 &gt; &lt; 50 &gt; &lt; 50 x 1 &gt; &lt; 56 &gt; &lt; 56 x 1 &gt; &lt; 70 &gt; &lt; 70 x 1 &gt; &lt; 98 &gt; &lt; 98 x 1 &gt; filmom obloženih tableta
&lt; 28 &gt; &lt; 28 x 1 &gt; &lt; 30 &gt; &lt; 30 x 1 &gt; &lt; 35 &gt; &lt; 35 x 1 &gt; &lt; 56 &gt; &lt; 56 x 1 &gt; &lt; 60 &gt; &lt; 70 &gt; &lt; 70 x 1 &gt; &lt; 98 &gt; &lt; 98 x 1 &gt; film- coated tablets
&lt; 28 &gt; &lt; 28 x 1 &gt; &lt; 30 &gt; &lt; 30 x 1 &gt; &lt; 35 &gt; &lt; 35 x 1 &gt; &lt; 56 &gt; &lt; 56 x 1 &gt; &lt; 60 &gt; &lt; 70 &gt; &lt; 70 x 1 &gt; &lt; 98 &gt; &lt; 98 x 1 &gt; filmom obloženih tableta
&lt; 28 &gt; &lt; 30 &gt; &lt; 35 &gt; &lt; 50 &gt; &lt; 56 &gt; &lt; 70 &gt; &lt; 98 &gt; film-coated tablets
&lt; 28 &gt; &lt; 30 &gt; &lt; 35 &gt; &lt; 50 &gt; &lt; 56 &gt; &lt; 70 &gt; &lt; 98 &gt; filmom obloženih tableta
&lt; 28 &gt; &lt; 30 &gt; &lt; 35 &gt; &lt; 50 &gt; &lt; 56 &gt; &lt; 70 &gt; &lt; 98 &gt; orodispersible tablets
&lt; 28 &gt; &lt; 30 &gt; &lt; 35 &gt; &lt; 50 &gt; &lt; 56 &gt; &lt; 70 &gt; &lt; 98 &gt; raspadljivih tableta za usta
&lt; 28 &gt; &lt; 30 &gt; &lt; 35 &gt; &lt; 56 &gt; &lt; 70 &gt; &lt; 98 &gt; film-coated tablets
&lt; 28 &gt; &lt; 30 &gt; &lt; 35 &gt; &lt; 56 &gt; &lt; 70 &gt; &lt; 98 &gt; filmom obloženih tableta
&lt; 28 &gt; &lt; 30 &gt; &lt; 35 &gt; &lt; 56 &gt; &lt; 70 &gt; &lt; 98 &gt; orodispersible tablets
&lt; 28 &gt; &lt; 30 &gt; &lt; 35 &gt; &lt; 56 &gt; &lt; 70 &gt; &lt; 98 &gt; raspadljivih tableta za usta
&lt; 2D barcode carrying the unique identifier included. &gt;
&lt; Sadrži 2D barkod s jedinstvenim identifikatorom. &gt;
&lt; 2D barcode carrying the unique identifier included. &gt;
&lt; Sadrži 2D barkod s jedinstvenim identifikatorom &gt;
&lt; 2D barcode carrying the unique identifier included. &gt;
Sadrži 2D barkod s jedinstvenim identifikatorom.
&lt; 2D barcode carrying the unique identifier included. &gt; ]
Sadrži 2D barkod s jedinstvenim identifikatorom.
&lt; 2D barcode carrying the unique identifier included &gt;
Sadrži 2D barkod s jedinstvenim identifikatorom.
&lt; 3 mg Fe/g dw
&lt; 3 mg Fe/g težine suhog tkiva jetre
&lt; 3%); Skin disorder (G3/4: 0.6%); Nail disorders (G3/4: 0.4%)
&lt; 3%); kožna toksičnost (G3/4: 0,6%) poremećaji noktiju (G3/4: 0,4%)
&lt; 30 2 mg (2 ml of concentrate for solution for infusion)
&lt; 30 2 mg (2 ml koncentrata za otopinu za infuziju)
&lt; 30 As doses below 150 mg are needed the use of the oral solution is recommended
Budući da su potrebne doze manje od 150 mg, preporučuje se primjena oralne otopine
&lt; 30 ml/min) (see section 4.3).
&lt; 30 ml/min) (vidjeti dio 4.3).
&lt; 30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
&lt; 30 ml/min/1,73 m2) ili u završnom stadiju bolesti bubrega koje zahtijeva hemodijalizu.
&lt; 30 ml/mina
&lt; 30 ml/mina
&lt; 300 copies/ml was 44% for entecavir and 20% for adefovir at week 24 and 50% for entecavir and 17% for adefovir at week 48.
&lt; 300 kopija/ml bio je 44% bolesnika liječenih entekavirom i 20% liječenih adefovirom u 24. tjednu te 50% liječenih entekavirom i 17% liječenih adefovirom u 48. tjednu.
&lt; 35 years
&lt; 35 godina
&lt; 360 μmol/l.
360 μmol/l.
&lt; 4 watery stools/day for &lt; 2 days or soft stools
&lt; 4 vodene stolice dnevno &lt; 2 dana ili mekane stolice
&lt; 400 copies/ml
vrijednosti ili &lt; 400 kopija/ml
&lt; 400 copies/mL vRNA
&lt; 400 kopija/ml vRNA
&lt; 400 copies/ml vRNA
&lt; 400 kopija/ml vRNK
&lt; 5 years of age
&lt; 5 godina
&lt; 50 cells/mm3
&lt; 50 stanica/mm3
&lt; 50 copies/ml
&lt; 50 kopija/ml
&lt; 50 copies/mL at Week 48 were 77% (33/43) and 70% (30/43), respectively.
48. tjednu bio je 77% (33/43), odnosno 70% (30/43).
&lt; 50 copies/mle
&lt; 50 kopija/mle
&lt; 50 cp/mL All Patients
&lt; 50 cp/mL Svi bolesnici
&lt; 50% food intake ≥2 days
&lt; 50 % unosa hrane ≥ 2 dana
&lt; 6 months
&lt; 6 mjeseci
&lt; 60 kg (N=664)*
&lt; 60 kg (N = 664)
&lt; 60 ml/min/1.73 m²
&lt; 60 ml/min./1,73 m²
&lt; 65 g/L (Grade 4)
&lt; 65 g/l (4. stupanj)
&lt; 65 years (N=159)
&lt; 65 godina (N=159)
&lt; 7 mg Fe/g dw
&lt; 7 mg Fe/g težine
&lt; 7 ml/kg/month of PRBC (approx.
&lt; 7 ml/kg/mjesec KE-a (otprilike
&lt; 7% with baseline HbA1c ≥7%2
&lt; 7% s početnom vrijednošću HbA1c
&lt; 70 x 109/l (children and
&lt; 70 x 109/l
&lt; 75 years (N=11672)*
&lt; 75 godina (N=11 672)
&lt; 75 years (N=7180)**
&lt; 75 godina (N=7180)
&lt; 750/mm3
750/mm³
&lt; 80 c/ml
&lt; 80 kopija/ml
&lt; 80 c/ml: n/N (%)
&lt; 80 kopija/ml: n/N (%)
&lt; 80 mL/min/1.73 m2), moderate (eGFR ≥30 and &lt; 50 mL/min/1.73 m2), severe renal impairment (eGFR &lt; 30 mL/min/1.73 m2) and subjects with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
&lt; 80 ml/min/1,73m2), umjerenim (eGFR ≥ 30 i &lt; 50 ml/min/1,73m2), teškim oštećenjem bubrega (eGFR &lt; 30 ml/min/1,73 m2) i ispitanika s završnim stadijem bolesti bubrega koji su trebali hemodijalizu, nakon jedne doze od 400 mg sofosbuvira.
&lt; 80-65 g/L (grade 3)
&lt; 80-65 g/l (3. stupanj)
&lt; 90 ml/min), 22 patients with moderate renal impairment (CLcr 30 to &lt; 60 ml/min) and 183 patients with normal renal function (≥90 ml/min), ceritinib exposures were similar in patients with mild and moderate renal impairment and normal renal function, suggesting that no dose adjustment is necessary in patients with mild to moderate renal impairment.
183 bolesnika s normalnom bubrežnom funkcijom (≥90 ml/min), izloženosti ceritinibu bile su slične u bolesnika s blagim i umjerenim oštećenjem bubrega i normalnom bubrežnom funkcijom, što ukazuje na to da nije potrebno prilagođavanje doze u bolesnika s blagim do umjerenim oštećenjem bubrega.
&lt; =800,000 IU/mL
≤ 800 000 IU/ml
&lt; =800,000 IU/mL‡
≤ 800 000 IU/ml
&lt; [For HDPE bottle only:] &gt;
&lt; [Samo za HDPE bocu:] &gt;
&lt; Batch &gt; &lt; Lot &gt; {number}
&lt; Serija &gt; &lt; Lot &gt; {broj}
&lt; date &gt;
&lt; datum &gt;
&lt; DD month YYYY &gt;
&lt; DD mjesec GGGG &gt;
&lt; DD/MM/YY &gt;
&lt; DD/MM/GG &gt;
&lt; EXP {month/year} &gt;
&lt; EXP {mjesec/godina} &gt;
&lt; Justification for not including Braille accepted &gt;
&lt; Prihvaćeno obrazloženje za nenavoñenje Brailleovog pisma &gt;
&lt; Justification for not including Braille accepted &gt;
&lt; Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma. &gt;
&lt; Justification for not including Braille accepted &gt;
&lt; Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma &gt;
&lt; Justification for not including Braille accepted &gt;
Prihvaćeno obrazloženje za nenavoñenje Brailleovog pisma.
&lt; Justification for not including Braille accepted &gt; 56 x 1 tablet
&lt; Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma &gt; 56 x 1 tableta
&lt; MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND &gt; MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I &gt; NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
&lt; MON, TUE, WED, THU, FRI, SAT, SUN &gt;
&lt; PON, UTO, SRI, ČET, PET, SUB, NED &gt;
&lt; NN: &gt;
&lt; NN: &gt;
&lt; NN: &gt;
&lt; NN &gt; :
&lt; NN &gt; :
&lt; NN &gt; :
&lt; Not applicable. &gt;
&lt; Nije primjenjivo. &gt;
&lt; Not applicable. &gt; ]
&lt; Nije primjenjivo &gt;
&lt; Obligation to conduct post-authorisation measures &gt;
Obaveza provođenja mjera nakon davanja odobrenja
&lt; Open here &gt;
&lt; Ovdje otvoriti &gt;
&lt; Other sources of information &gt;
&lt; Drugi izvori informacija &gt;
&lt; Placeholder QR code &gt;
&lt; mjesto za QR oznaku &gt;
&lt; see side 1
&lt; vidjeti stranicu 1
&lt; This leaflet is available in all EU/EEA languages on the European Medicines Agency website. &gt;
&lt; Ova Uputa o lijeku je dostupna na svim EU/EEA jezicima na internetskoj stranici Europske agencije za lijekove. &gt;
&lt; www.xxx.xxx &gt;
&lt; www.xxx.xx &gt;
&lt; {DD month YYYY} &gt;
&lt; {DD mjesec GGGG} &gt;
&lt; {DD/MM/YYYY} &gt;
&lt; {DD/MM/GGGG} &gt;
&lt; {MM/YYYY} &gt;
&lt; {MM/GGGG} &gt;
&lt; {MM/YYYY} &gt;
{MM/GGGG}
&gt; 0.5 cm to 1.5 cm
&gt; 0,5 cm do 1,5 cm
&gt; 1 prior line of therapy
&gt; 1 linija prethodnog liječenja
&gt; 1 prior line of therapy
&gt; 1 linije prethodnog liječenja
&gt; 1 to 3 x ULN
&gt; 1 do 3 x GGN
&gt; 1 to 3 x ULN
&gt; 1 do 3x GGN
&gt; 1 to 3 x Upper Limit of Normal (ULN)
&gt; 1 do 3 x iznad gornje granice normale (GGN)
&gt; 1 to 3 x Upper Limit of Normal (ULN)
&gt; 1 do 3 × iznad gornje granice normale (GGN)
&gt; 1 year.
&gt; 1 godine.
&gt; 1,500 cells/mm3 and platelets recover to a level &gt; 100,000 cells/mm3.
&gt; 1500 stanica/mm3, a broj trombocita na &gt; 100.000 stanica/mm3.
&gt; 1,500 pg/mL (5,400 pmol/L) and more than 3 follicles of 14 mm or more in diameter.
&gt; 1500 pg/ml (5400 pmol/l) i više od 3 folikula od 14 mm ili više u promjeru.
&gt; 1.0 x 1.5 x ULN
&gt; 1,0 x - 1,5 x GGN
&gt; 1.0 x 109 /l for 3 consecutive days
&gt; 1,0 x 109 /l tijekom 3 uzastopna dana
&gt; 1.0 x 109/L for 3 consecutive days
&gt; 1,0 x 109/l tijekom 3 uzastopna dana
&gt; 1.0 x – 1.5 x ULN
&gt; 1,0 x – 1,5 x GGN
&gt; 1.0 x 1.5 x ULN
&gt; 1,0x1,5x GGN
&gt; 1.5 cm to 2.5 cm
&gt; 1,5 cm do 2,5 cm
&gt; 1.5 to ≤ 2.0 x ULN
&gt; 1,5 do ≤ 2,0 x GGN
&gt; 1.5 to ≤ 2.5 x ULN
&gt; 1,5 do ≤ 2,5 x GGN
&gt; 1.5 to ≤ 3.0 x ULN
&gt; 1,5 do ≤ 3,0 x GGN
&gt; 1.5 x 3 x ULN
&gt; 1,5 x - 3 x GGN
&gt; 1.5 x ULN) in the tenofovir disoproxil fumarate treatment group and 0% (0/32) of patients in the placebo group had HBV DNA &lt; 400 copies/ml.
&gt; 1,5 x GGN) u skupini liječenoj tenofovirdizoproksilfumaratom i 0% (0/32) pacijenata u skupini koja je primala placebo imalo je HBV DNK &lt; 400 kopija/ml.
&gt; 1.5 x – 3 x ULN
&gt; 1,5 x – 3 x GGN
&gt; 1.5 x 3 x ULN
&gt; 1,5x3x GGN
&gt; 10 to 30 (ml/min)
&gt; 10 do 30 (ml/min)
&gt; 10 to 12 g/dL
&gt; 10 i 12 g/dl
&gt; 10 x ULN*
&gt; 10 x GGN
&gt; 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
&gt; 10 000 puta jače na PDE5 nego na PDE3, enzim koji se nalazi u srcu i krvnim žilama.
&gt; 100,000 copies/mL
&gt; 100 000 kopija/ml
&gt; 100,000 copies/ml
HIV-RNK &gt; 100 000 kopija/ml
&gt; 100,000 copies/ml
≤ 100 000 kopija/ml
&gt; 100,000 copies/mL (n = 44)
&gt; 100 000 kopija/ml (n = 44)
&gt; 100,000/µl to ≤ 150,000/µl
&gt; 100 000/µl do  150 000/µl
&gt; 10x ULN
&gt; 10x GGN
&gt; 110 mm Hg on antihypertensive therapy)
&gt; 110 mm Hg uz terapiju antihipertenzivima)
&gt; 110 to ≤ 130
&gt; 110 do ≤ 130
&gt; 12 months (n=282)
&gt; 12 mjeseci (n=282)
&gt; 13 g/dl).
≤ 13 g/dl i &gt; 13 g/dl).
&gt; 15 kg to 23 kg
&gt; 15 kg do 23 kg
&gt; 150 for two consecutive weeks
&gt; 150 tijekom dva uzastopna tjedna
&gt; 150 mmHg or diastolic blood pressure &gt; 100 mmHg) was within the first month of the start of axitinib treatment and blood pressure increases have been observed as early as 4 days after starting axitinib.
&gt; 150 mmHg ili dijastolički krvni tlak &gt; 100 mmHg) bio je u prvih mjesec dana od početka terapije aksitinibom, a povišenje krvnog tlaka uočeno je već 4 dana nakon početka terapije.
&gt; 150,000/µl to  250,000/µl
&gt; 150 000/µl do  250 000/µl
&gt; 1500 pg/mL (5400 pmol/L) and more than 3 follicles of 14 mm or more in diameter.
&gt; 1500 pg/ml (5400 pmol/l) i više od 3 folikula od 14 mm ili više u promjeru.
&gt; 1st-line therapy
0,69 (0,581; 0,821)
&gt; 1st-line therapy
1. godini
&gt; 2 million copies/mL
&gt; 2 milijuna kopija/ml
&gt; 2 minutes.
&gt; 2 minute.
&gt; 2-6 months
&gt; 2-6 mjeseci
&gt; 2.0 to ≤ 5.0 x ULN
&gt; 2,0 do ≤ 5,0 x GGN
&gt; 2.5 cm to 5 cm
&gt; 2,5 cm do 5 cm
&gt; 2.5 to ≤ 5.0 x ULN
&gt; 2,5 do ≤ 5,0 x GGN
&gt; 2.50 to ≤ 5.00 x ULN
&gt; 2,50 do ≤ 5,00 x GGN
&gt; 200 cells/mm3
&gt; 200 stanica/mm3
&gt; 200 cells/mm3
&gt; 50 i ≤ 200 stanica/mm3
&gt; 200 cells/mm3
Broj CD4 stanica ≤ 50 stanica/mm3
&gt; 200 cells/mm3
Svi bolesnici
&gt; 200 cells/mm3 104 (80, 129)
&gt; 200 stanica/mm3 104 (80, 129)
&gt; 200 copies/ml at week 24 or thereafter.
≥ 5000 kopija/ml u 12. tjednu ili ≥ 200 kopija/ml u 24. tjednu ili kasnije.
&gt; 23 kg to 40 kg
&gt; 23 kg do 40 kg
&gt; 23 to 34
&gt; 23 do 34
&gt; 24 hours
&gt; 24 sata
&gt; 25 to 35
&gt; 25 do 35
&gt; 25% of the bone marrow infiltrated by lymphoma cells
bolesnicima kojima je &gt; 25 % koštane srži infiltrirano limfomskim stanicama
&gt; 250 mg/dL or &gt; 13.9 mmol/L) or associated with ketoacidosis Hyperthyroidism Grade ≥ 3
&gt; 250 mg/dl ili &gt; 13,9 mmol/l) ili povezana s ketoacidozom Hipertireoza ≥3. stupnja
&gt; 265 µmol/l or &gt; 3.0 mg/dl were excluded.
&gt; 3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa Zometom.
&gt; 3 and  5  ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
&gt; 3 i  5  GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđeno, donijeti odluku za svakog bolesnika ponaosob da li nastaviti liječenje STAYVEEROM, vjerojatno smanjenom dozom ili prekinuti primjenu STAYVEERA (vidjeti dio 4.2).
&gt; 3 and  5  ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue Tracleer, possibly at a reduced dose, or to stop Tracleer administration (see section 4.2).
&gt; 3 i  5  GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđen, donijeti odluku za svakog bolesnika ponaosob da li nastaviti liječenje Tracleerom, vjerojatno smanjenom dozom ili prekinuti primjenu Tracleera (vidjeti dio 4.2).
&gt; 3 hours to
&gt; 3 sata do
&gt; 3 to 5 x ULN
&gt; 3 do 5 x iznad GGN
&gt; 3 to 5 x ULN
&gt; 3 do 5 × GGN
&gt; 3 ULN
&gt; 3 GGN
&gt; 3 x the upper limit of normal, therapy should be discontinued.
&gt; 3 puta iznad gornje granice normale, terapiju treba prekinuti.
&gt; 3 x ULN
&gt; 3 x GGN
&gt; 3 x ULN
&gt; 3x GGN
&gt; 3 X ULN regardless of any level of ALT).
&gt; 3 x GGN neovisno o vrijednostima ALT-a).
&gt; 3 x ULN to 5x ULN
&gt; 3x do 5x GGN
&gt; 3 × ULN*
&gt; 3 x GGN
&gt; 3.0 to ≤ 5.0 x ULN
&gt; 3,0 do ≤ 5,0 x GGN
&gt; 30 to 60 (ml/min)
&gt; 30 do 60 (ml/min)
&gt; 30 to ≤ 50
&gt; 30 do ≤50 ≥12 godina do
&gt; 30 to60 (ml/min)
&gt; 30 do 60 (ml/min)
&gt; 35g/L
&gt; 35 g/L
&gt; 3ULN
&gt; 3 GGN
&gt; 3½ months up to 4 months
&gt; 3½ mjeseca do 4 mjeseca
&gt; 4 mg/dl (adults)
&gt; 4 mg/dl (odrasli)
&gt; 4 mg/dL (adults)
&gt; 4 mg/dl (odrasli)
&gt; 4 mg/dl (for &gt; 4 weeks)
&gt; 4 mg/dl (tijekom &gt; 4 tjedna)
&gt; 4 mg/dL (for &gt; 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
&gt; 4 mg/dl (tijekom &gt; 4 tjedna) (djeca i adolescenti liječeni peginterferonom alfa-2b)
&gt; 4 ml/min) (see section 5.2).
&gt; 4 ml/min) (vidjeti dio 5.2).
&gt; 4 seizures during 3 month baseline period
&gt; 4 napadaja tijekom početnog razdoblja od 3 mjeseca
&gt; 4 weeks and &lt; 5 weeks
&gt; 4 tjedna i &lt; 5 tjedana
&gt; 4 weeks and &lt; 6 weeks
&gt; 4 tjedna i &lt; 6 tjedana
&gt; 40 weeks
&gt; 40 tjedana
&gt; 400 copies/ml at week 48 (n = 6), week 72 (n = 5), week 96 (n = 4), week 144 (n = 2), and week 192 (n = 3).
HBV DNK &gt; 400 kopija/ml u 48. tjednu (n = 6), 72. tjednu (n = 5), 96. tjednu (n = 4), 144. tjednu (n = 2) i 192. tjednu (n = 3).
&gt; 45 min improvement in both nighttime and daytime sleep (%)(5)
&gt; 45-minutno poboljšanje u noćnom i dnevnom snu (%)(5)
&gt; 5 % of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed and 163 patients with mesothelioma randomised to receive single agent cisplatin.
168 bolesnika s mezoteliomom randomiziranih u skupinu koja je primala cisplatin i pemetreksed i 163 bolesnika s mezoteliomom randomiziranih u skupinu koja je primala samo cisplatin.
&gt; 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
265 bolesnika randomiziranih u skupinu koja je primala samo pemetreksed te nadomjestak folatne kiseline i vitamina B12 i 276 bolesnika randomiziranih u skupinu koja je primala samo docetaksel.
&gt; 5 and  8  ULN The result should be confirmed by a second liver test; if confirmed, treatment should be stopped and aminotransferase levels monitored at least every 2 weeks.
&gt; 5 i  8  GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđen, treba prekinuti liječenje i pratiti vrijednosti aminotransferaza najmanje svaka 2 tjedna.
&gt; 5 mg/dL
&gt; 5 mg/dl
&gt; 5 weeks
&gt; 5 tjedana
&gt; 5 x ULN
&gt; 5 x GGN
&gt; 5 x ULN
&gt; 5 x iznad GGN
&gt; 5 x ULN
&gt; 5 × GGN
&gt; 5.0 x ULN
&gt; 5,0 x GGN
&gt; 50 and
&gt; 50 i
&gt; 50 and ≤ 200 cells/mm3
&gt; 50 i ≤ 200 stanica/mm3
&gt; 50 and ≤ 200 cells/mm3
Broj CD4 stanica ≤ 50 stanica/mm3
&gt; 50 and ≤ 200 cells/mm3
Broj CD4 stanica ≤ 50 stanica/mm3 50 (41, 58)
&gt; 50 and ≤ 200 cells/mm3
≤ 100 000 kopija/ml
&gt; 50 kg Body Weight
&gt; 50 kg tjelesne težine
&gt; 50 to ≤ 70
&gt; 50 do ≤ 70
&gt; 500 ng/ml at baseline
&gt; 500 ng/ml
&gt; 500 ng/ml at Week 12
&gt; 500 ng/ml u 12. tjednu
&gt; 500 ng/ml at Week 52
&gt; 500 ng/ml u 52. tjednu
&gt; 54 weeks ( &lt; 0.001)
&gt; 54 tjedna ( &lt; 0,001)
&gt; 55 kg to ≤ 85 kg
&gt; 55 kg do ≤ 85 kg
&gt; 55 kg to ≤ 85 kg 390 mg
&gt; 55 kg do ≤ 85 kg 390 mg
&gt; 5x ULN
&gt; 5x GGN
&gt; 6 months
&gt; 6 mjeseci
&gt; 6 months to &lt; 1 year
&gt; 6 mjeseci do &lt; 1 godine
&gt; 6 to 7 kg
&gt; 6 do 7 kg
&gt; 6 weeks
&gt; 6 tjedana
&gt; 60 4.0 mg zoledronic acid
&gt; 60 4,0 mg zoledronatne kiseline
&gt; 60 years of age or
dob iznad 60 godina ili
&gt; 7 kg to 10 kg
&gt; 7 kg do 10 kg
&gt; 7 to 8 kg
&gt; 7 do 8 kg
&gt; 70 to ≤ 90
&gt; 70 do ≤ 90
&gt; 75 years (n=171).
&gt; 75 godina (n = 171).
&gt; 8 to 9 kg
&gt; 8 do 9 kg
&gt; 8 x ULN or any of the above with associated clinical symptoms of liver injury: Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
&gt; 8 x GGN ili bilo koja druga vrijednost iznad ove, uz kliničke simptome ozljede jetre: Liječenje se mora ukinuti i STAYVEER se ne smije ponovo uvesti.
&gt; 8 x ULN or any of the above with associated clinical symptoms of liver injury: Treatment must be stopped and re-introduction of Tracleer is not to be considered.
&gt; 8 x GGN ili bilo koja druga vrijednost iznad ove, uz kliničke simptome ozljede jetre: Liječenje se mora ukinuti i Tracleer se ne smije ponovo uvesti.
&gt; 8  ULN Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
&gt; 8  GGN Liječenje treba prekinuti bez razmatranja ponovnog liječenja STAYVEEROM.
&gt; 8  ULN Treatment must be stopped and re-introduction of Tracleer is not to be considered.
&gt; 8  GGN Liječenje treba prekinuti bez razmatranja ponovnog liječenja Tracleerom.
&gt; 8.5 to 10 g/dL
&gt; 8,5 i 10 g/dl
&gt; 9 months
&gt; 9 mjeseci
&gt; 9 to 10 kg
&gt; 9 do 10 kg