natgillin/translations-raw huggingface dataset:
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PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I> NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
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Obaveza provođenja mjera nakon davanja odobrenja
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= 0.56-0.88, p = 0.002).
= 0,56-0,88, p = 0,002).
= A ml of Busilvex to be diluted
= A ml Busilvexa koji je potrebno razrijediti
= A ml of Busilvex to be diluted
= A ml Busilvexa za razrjeđivanje
= A ml of Busulfan Fresenius Kabi to be diluted 6 (mg/ml)
= A ml lijeka Busulfan Fresenius Kabi potrebnog za razrjeđivanje 6 (mg/ml)
= Amount to inject in ml
= količina za injiciranje u ml
= body weight (kg) times 50 (U/kg)
= tjelesna težina (kg) x 50 (U/kg)
= complete haematologic response (CHR) + no evidence of leukaemia (NEL).
= potpun hematološki odgovor (CHR) + nema znakova leukemije (NEL engl. no evidence of leukaemia).
= serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8
= kalcij u serumu (mmol/l) - [0,02 x albumin (g/l)] + 0,8
> 0.5 cm to 1.5 cm
> 0,5 cm do 1,5 cm
> 1 prior line of therapy
> 1 linija prethodnog liječenja
> 1 prior line of therapy
> 1 linije prethodnog liječenja
> 1 to 3 x ULN
> 1 do 3 x GGN
> 1 to 3 x ULN
> 1 do 3x GGN
> 1 to 3 x Upper Limit of Normal (ULN)
> 1 do 3 × iznad gornje granice normale (GGN)
> 1 year.
> 1 godine.
> 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
> 1500 stanica/mm3, a broj trombocita na > 100.000 stanica/mm3.
> 1,500 pg/mL (5,400 pmol/L) and more than 3 follicles of 14 mm or more in diameter.
> 1500 pg/ml (5400 pmol/l) i više od 3 folikula od 14 mm ili više u promjeru.
> 1.0 x 1.5 x ULN
> 1,0 x - 1,5 x GGN
> 1.0 x 109 /l for 3 consecutive days
> 1,0 x 109 /l tijekom 3 uzastopna dana
> 1.0 x – 1.5 x ULN
> 1,0 x – 1,5 x GGN
> 1.0 x 1.5 x ULN
> 1,0x1,5x GGN
> 1.5 cm to 2.5 cm
> 1,5 cm do 2,5 cm
> 1.5 to ≤ 2.0 x ULN
> 1,5 do ≤ 2,0 x GGN
> 1.5 to ≤ 3.0 x ULN
> 1,5 do ≤ 3,0 x GGN
> 1.5 x 3 x ULN
> 1,5 x - 3 x GGN
> 1.5 x ULN) in the tenofovir disoproxil fumarate treatment group and 0% (0/32) of patients in the placebo group had HBV DNA < 400 copies/ml.
> 1,5 x GGN) u skupini liječenoj tenofovirdizoproksilfumaratom i 0% (0/32) pacijenata u skupini koja je primala placebo imalo je HBV DNK < 400 kopija/ml.
> 1.5 x – 3 x ULN
> 1,5 x – 3 x GGN
> 1.5 x 3 x ULN
> 1,5x3x GGN
> 10 to 12 g/dL
> 10 i 12 g/dl
> 10 x ULN*
> 10 x GGN
> 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
> 10 000 puta jače na PDE5 nego na PDE3, enzim koji se nalazi u srcu i krvnim žilama.
> 100,000 copies/mL
> 100 000 kopija/ml
> 100,000 copies/ml
HIV-RNK > 100 000 kopija/ml
> 100,000 copies/ml
≤ 100 000 kopija/ml
> 100,000 copies/mL (n = 44)
> 100 000 kopija/ml (n = 44)
> 100,000/µl to ≤ 150,000/µl
> 100 000/µl do  150 000/µl
> 10x ULN
>10x GGN
> 110 to ≤ 130
> 110 do ≤ 130
> 12 months (n=282)
> 12 mjeseci (n=282)
> 13 g/dl).
≤ 13 g/dl i > 13 g/dl).
> 150 for two consecutive weeks
> 150 tijekom dva uzastopna tjedna
> 150 mmHg or diastolic blood pressure > 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.
> 150 mmHg ili dijastolički krvni tlak > 100 mmHg) bio je u prvih mjesec dana od početka terapije aksitinibom, a povišenje krvnog tlaka uočeno je već 4 dana nakon početka terapije.
> 150,000/µl to  250,000/µl
> 150 000/µl do  250 000/µl
> 1500 pg/mL (5400 pmol/L) and more than 3 follicles of 14 mm or more in diameter.
> 1500 pg/ml (5400 pmol/l) i više od 3 folikula od 14 mm ili više u promjeru.
> 1st-line therapy
0,69 (0,581; 0,821)
> 1st-line therapy
1. godini
> 2 million copies/mL
> 2 milijuna kopija/ml
> 2 minutes.
> 2 minute.
> 2-6 months
> 2-6 mjeseci
> 2.0 to ≤ 5.0 x ULN
> 2,0 do ≤ 5,0 x GGN
> 2.5 cm to 5 cm
> 2,5 cm do 5 cm
> 200 cells/mm3
> 200 stanica/mm3
> 200 cells/mm3
> 50 i ≤ 200 stanica/mm3
> 200 cells/mm3
Broj CD4 stanica ≤ 50 stanica/mm3
> 200 cells/mm3
Svi bolesnici
> 200 cells/mm3 104 (80, 129)
> 200 stanica/mm3 104 (80, 129)
> 200 copies/ml at week 24 or thereafter.
≥ 5000 kopija/ml u 12. tjednu ili ≥ 200 kopija/ml u 24. tjednu ili kasnije.
> 23 to 34
> 23 do 34
> 25% of the bone marrow infiltrated by lymphoma cells
bolesnicima kojima je > 25 % koštane srži infiltrirano limfomskim stanicama
> 25,000/mm3
>25 000/mm3
> 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis Hyperthyroidism Grade ≥ 3
>250 mg/dl ili >13,9 mmol/l) ili povezana s ketoacidozom Hipertireoza ≥3. stupnja
> 265 µmol/l or > 3.0 mg/dl were excluded.
>3,0 mg/dl bili su isključeni iz kliničkih ispitivanja sa Zometom.
> 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).
> 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).
> 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).
> 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).
> 3 hours to
> 3 sata do
> 3 to 5 x ULN
> 3 do 5 x iznad GGN
> 3 to 5 x ULN
> 3 do 5 × GGN
> 3 x the upper limit of normal, therapy should be discontinued.
> 3 puta iznad gornje granice normale, terapiju treba prekinuti.
> 3 X ULN regardless of any level of ALT).
>3 x GGN neovisno o vrijednostima ALT-a).
> 3 x ULN to 5x ULN
> 3x do 5x GGN
> 3 × ULN*
> 3 x GGN
> 3.0 to ≤ 5.0 x ULN
> 3,0 do ≤ 5,0 x GGN
> 30 to ≤ 50
>30 do ≤50 ≥12 godina do
> 30 to60 (ml/min)
> 30 do 60 (ml/min)
> 35g/L
> 35 g/L
> 3ULN
> 3 GGN
> 4 mg/dl (adults)
> 4 mg/dl (odrasli)
> 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
> 4 mg/dl (tijekom > 4 tjedna) (djeca i adolescenti liječeni peginterferonom alfa-2b)
> 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
>4 mg/dl (tijekom >4 tjedna) (djeca i adolescenti liječeni peginterferonom alfa-2b)
> 4 ml/min) (see section 5.2).
> 4 ml/min) (vidjeti dio 5.2).
> 4 seizures during 3 month baseline period
> 4 napadaja tijekom početnog razdoblja od 3 mjeseca
> 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 > 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).
> 45 min improvement in both nighttime and daytime sleep (%)(5)
> 45-minutno poboljšanje u noćnom i dnevnom snu (%)(5)
> 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.
> 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.
> 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.
> 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.
> 5 mg/dL
>5 mg/dl
> 5 x ULN
> 5 x GGN
> 5 x ULN
> 5 x iznad GGN
> 50 and
> 50 i
> 50 and ≤ 200 cells/mm3
> 50 i ≤ 200 stanica/mm3
> 50 and ≤ 200 cells/mm3
Broj CD4 stanica ≤ 50 stanica/mm3
> 50 and ≤ 200 cells/mm3
Broj CD4 stanica ≤ 50 stanica/mm3 50 (41, 58)
> 50 and ≤ 200 cells/mm3
≤ 100 000 kopija/ml
> 50 to ≤ 70
> 50 do ≤ 70
> 500 ng/ml at baseline
> 500 ng/ml
> 500 ng/ml at Week 12
> 500 ng/ml u 12. tjednu
> 500 ng/ml at Week 52
> 500 ng/ml u 52. tjednu
> 54 weeks (< 0.001)
> 54 tjedna (< 0,001)
> 55 kg to ≤ 85 kg 390 mg
> 55 kg do ≤ 85 kg 390 mg
> 5x ULN
> 5x GGN
> 6 months
> 6 mjeseci
> 60 4.0 mg zoledronic acid
> 60 4,0 mg zoledronatne kiseline
> 60 years of age or
dob iznad 60 godina ili
> 70 to ≤ 90
> 70 do ≤ 90
> 75 years (n=171).
> 75 godina (n = 171).
> 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.
> 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.
> 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.
> 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.
> 8  ULN Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
> 8  GGN Liječenje treba prekinuti bez razmatranja ponovnog liječenja STAYVEEROM.
> 8  ULN Treatment must be stopped and re-introduction of Tracleer is not to be considered.
> 8  GGN Liječenje treba prekinuti bez razmatranja ponovnog liječenja Tracleerom.
> 8.5 to 10 g/dL
> 8,5 i 10 g/dl
> 9 years.
 9 godina.
> 90 to ≤ 110
> 90 do ≤ 110
> age appropriate ULN**
> GGN-a prikladnog za godine
>0.5 mg/l
> 0,5 mg/l
>1 log reduction in HIV RNA or
>1 log smanjenje HIV RNA ili
>1 to ≤ 2 years
>1 do ≤2 godine
>1 to ≤2 years
>1 do ≤2 godine
>1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
> 1500 stanica/mm3, a zatim smanjiti dozu kabazitaksela s 25 mg/m2 na 20 mg/m2.
>10 to ≤20 x ULN
> 10 do ≤ 20 x GGN
>10 ULN
>10 GGN
>10 × ULN (grade 4)
>10 × GGN (4. stupanj)
>10% to ≤15%
> 10% do ≤ 15
>10,000 – 100,000 copies/ml
>10 000 – 100 000 kopija/ml
>10,000 – 100,000 copies/ml
>10000 – 100 000 kopija/ml
>10.0 × ULN (Grade 4)
>10,0 × GGN (stupanj 4)
>100,000
Virološki neuspjeh
>100,000 copies/ml
>100 000 kopija/ml
>100,000 copies/ml, n (%)
>100 000 kopija/ml, n (%)
>100,000 copies/ml, n (%)
>100,000 kopija/ml, n (%)
>1000/ul
> 1000/ul
>12 to ≤18 years
>12 do ≤ 18 godina
>12 to ≤18 years
>12 do ≤18 godina
>14 ml/kg/month of PRBC (approx.
>14 ml/kg/mjesec KE-a (otprilike
>15% to ≤20%
> 15% do ≤ 20
>18 to ≤64 years
>18 do ≤ 64 godina
>1X – 3X upper normal limit
> jednostruka – trostruka gornja normalna granica
>2 for 7 patients.
>2 za 7 bolesnika.
>2 months N=5 (%)
>2 mjeseca N = 5 (%)
>2 to ≤5 years
>2 do ≤5 godina
>20 ULN
>20 GGN
>20 x ULN
> 20 x GGN
>20 × ULN (Grade 4)
>20 × GGN (4. stupanj)
>20% none
>20% nijedna
>20% to ≤25%
> 20% do ≤ 25
>200,000/mm3.
>200 000/mm3.
>21 mg/kg/day
>21 mg/kg/dan
>2xULN (N=139)
>2xGGN (N=139)
>3 and ≤ 5 x ULN: Confirm levels and if confirmed, reduce the daily dose or stop treatment and monitor liver function at least every 2 weeks.
>3 i  5 x GGN: Potvrditi vrijednosti i ukoliko je potvrđeno, smanjiti dnevnu dozu ili obustaviti liječenje i pratiti funkciju jetre barem svaka 2 tjedna.
>3 and  5 x ULN: Confirm levels and if confirmed, reduce the daily dose or stop treatment and monitor liver function at least every 2 weeks.
>3 i  5 x GGN: Potvrditi vrijednosti i ukoliko je potvrđeno, smanjiti dnevnu dozu ili obustaviti liječenje i pratiti funkciju jetre barem svaka 2 tjedna.
>3 times ULN (Grade 2 or higher) with concurrent bilirubin >2 times ULN
> 3 puta GGN (2. ili viši stupanj) uz bilirubin istodobno > 2 puta iznad GGN
>3 to ≤5 x ULN
> 3 do ≤ 5 x GGN
>3 ULN
>3 GGN
>3-10 × ULN (grade 3)
>3-10 × GGN (3. stupanj)
>30 mg/kg/day
>30 mg/kg/dan
>30 ml/min).
30 ml/min).
>30 ml/min).
> 30 ml/min).
>30 to 50 mL/min
>30 i 50 ml/min
>33% above pre- treatment average
> 33% iznad prosjeka prije liječenja
>33% above pre- treatment average
>33% iznad prosjeka prije liječenja
>35 years
≥35 godina
>3X upper normal limit
> trostruka gornja normalna granica
>4 units/month for an adult)
>4 jedinice/mjesec za odraslu osobu)
>45 minutes increase in average nighttime sleep duration
> 45- minutno skraćenje prosječnog trajanja dnevnog sna
>480 ms in 1 patient in the pasireotide intramuscular use 40 mg group.
>480 ms u 1 bolesnika u skupini koja je primala 40 mg pasireotida intramuskularno.
>5 and ≤ 8 x ULN: Confirm levels and if confirmed stop treatment and monitor liver function at least every 2 weeks.
>5 i  8 x GGN: Potvrditi vrijednosti i ukoliko je potvrđeno, obustaviti liječenje i pratiti funkciju jetre barem svaka 2 tjedna.
>5 and  8 x ULN: Confirm levels and if confirmed stop treatment and monitor liver function at least every 2 weeks.
>5 i  8 x GGN: Potvrditi vrijednosti i ukoliko je potvrđeno, obustaviti liječenje i pratiti funkciju jetre barem svaka 2 tjedna.
>5 cm
hematom > 5 cm
>5 times baseline)   * °
>5 puta početna vrijednost)   * °
>5 times ULN
> 5 puta GGN
>5 to ≤10 x ULN
> 5 do ≤ 10 x GGN
>5 to ≤12 years
>5 do ≤12 godina
>5 to ≤12years
>5 do ≤12 godina
>5 ULN
>5 GGN
>5% to ≤10%
> 5% do ≤ 10
>5-20 × ULN* (Grade 3)
>5-20 × GGN* (3. stupanj)
>5.0 × ULN (Grade 4)
>5,0 × GGN (stupanj 4)
>5.5 and <6.7 mmol/l (>100 and <120 mg/dl)
>5,5 i <6,7 mmol/l (>100 i <120 mg/dl)
>50 to ≤60
>50 do ≤60
>50 years
≥50 godina
>50,000 copies/mL
> 50 000 kopija/ml
>6 to 8 hours after first dose
>6 do 8 sati nakon prve doze
>60 to ≤70
>60 do ≤70
>60 years
>60 godina
>70 to ≤80
>70 do ≤80
>8 mg/l
> 8 mg/l
>80 to ≤90
>80 do ≤90
>90 to ≤100
>90 do ≤100
>99% of Xiapex-treated patients developed high titers of antibodies to both AUX-I and AUX-II.
>99% bolesnika liječenih Xiapexom razvilo je visok titar protutijela i na AUX-I i na AUX-II.
>R (Resistant)
> R (Rezistentni)
>R (Resistant)
>R (rezistentna)
>ULN (N=87)
>GGN (N=87)
[ (OR = 2.21)
OŠ = 2,34 (OŠ= 2,21)
[ 48.1, NE]
[48,1; NP]
[(S) -3- (aminomethyl) -5-methylhexanoic acid].
[(S)-3-(aminometil)-5-metilheksanoična kiselina].
[(S)-3(aminomethyl)-5-methylhexanoic acid].
[(S)-3-(aminometil)-5-metilheksanoična kiselina].
[(S)-3-(aminomethyl)-5-methylhexanoic acid].
[(S)-3-(aminometil)-5-metilheksanoična kiselina].
[-1.36, -0.51], p<0.0001. There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Također je postojalo i statistički značajno poboljšanje u razagilin 0,5 mg skupini u usporedbi s placebom, iako je razmjer poboljšanja bio manji.
[0.58 to 0.81]
[0,58 do 0,81]
[0.70 to 0.96]
[0,70 do 0,96]
[0.89, 1.14]
p=0,1041
[0.905, 1.150] c
[-8,2%; 46,0%]
[0.93, 1.18]
[0,905; 1,150] c
[100 and 250 ml vials]
{100 i 250 ml bočice}
[111In]-radiolabelled ibritumomab tiuxetan predicted acceptable radiation to normal human tissue with limited levels of skeleton and bone marrow radiation.
[90Y]-radioaktivno označenog ili [111In]-radioaktivno označenog ibritumomab tiuksetana na miševima predviđeno je prihvatljivo zračenje normalnog ljudskog tkiva s ograničenim razinama zračenja kostura i koštane srži.
[129,
148b [129, 192]
[140-age (years)] x weight (kg)
[140 – dob (godine)] x težina (kg)
[140-age( years)] x weight (kg)
[140 – dob (godine)] x težina (kg)
[14C]-ranolazine to healthy subjects, 73% of the radioactivity was recovered in urine and 25% in faeces.
[14C]-ranolazina kod zdravih ispitanika, 73% radioaktivnosti pronađeno je u urinu, a 25% u stolici.
[150 mg single dose (sustained release)/600 mg once daily]
[150 mg u jednokratnoj dozi (s odgođenim oslobađanjem)/600 mg jedanput na dan]
[150 mg single dose (sustained release)/600 mg q.d.]
[150 mg u jednoj dozi (s održanim oslobađanjem)/600 mg q.d.]
[2 spray bottle:]
[Bočica sa 2 potiska:]
[20 and 50 ml vials]
{20 i 50 ml bočice}
[27.6 ng/ml]) than in the Vitamin D3 2,800 group (64 nmol/l [25.5 ng/ml]).
[27,6 ng/ml]) nego u skupini Vitamin D3 2800 (64 nmol/l [25,5 ng/ml]).
[47.6 months]
[47,6 mjeseci]
[48.4 months]
[48,4 mjeseci]
[60.2 months]
[60,2 mjeseca]
[84, 107]
87b [84, 107]
[90Y]-radiolabelled ibritumomab tiuxetan binds specifically to CD20-expressing B-cells, including malignant cells.
Ibritumomab tiuksetan radioaktivno označen izotopom [90Y] veže se specifično za B-stanice koje izražavaju CD20, uključujući zloćudne stanice.
[90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma.
Zevalin radioaktivno označen izotopom [90Y] indiciran je kao konsolidacijska terapija nakon indukcije remisije u prethodno neliječenih bolesnika s folikularnim limfomom.
[90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).
Zevalin radioaktivno označen izotopom [90Y] indiciran je za liječenje odraslih bolesnika s recidivirajućim ili refraktornim CD20+ folikularnim B-staničnim ne-Hodgkinovim limfomom (NHL- om) liječenih rituksimabom.
[90Y]-radiolabelled Zevalin must only be received, handled and administered by qualified personnel and must be prepared in accordance with both radiation safety and pharmaceutical quality requirements (for more details see also sections 4.4, 6.6 and 12).
Zevalin radioaktivno označen izotopom [90Y] smije zaprimati, koristiti i primjenjivati samo kvalificirano osoblje, a mora se pripremati u skladu sa zahtjevima propisa o zaštiti od radioaktivnosti i farmaceutskoj kakvoći (za dodatne pojedinosti vidjeti dijelove 4.4, 6.6 i 12).
[90Y]-radiolabelled Zevalin solution must not be administered to patients who are likely to develop life-threatening haematological toxicity signs.
Otopina Zevalina radioaktivno označenog izotopom [90Y] ne smije se davati bolesnicima za koje postoji vjerojatnost razvoja životno opasnih znakova hematološke toksičnosti.
[90Y]-radiolabelled Zevalin solution must only be received, handled and administered by qualified personnel with the appropriate government authorization for the use and manipulation of radionuclides within a designated clinical setting.
Otopinu Zevalina radioaktivno označenog izotopom [90Y] smije zaprimati, koristiti i primjenjivati samo kvalificirano osoblje koje su nadležna tijela ovlastila za rukovanje radionuklidima u za to namijenjenom kliničkom okruženju.
[95% CI: 0.7; 13.5]
Razlika u liječenju: 7,1% [95% CI: 0,7; 13,5]
[95% CI]
1. godina
[95% CI]
N=7 [95% CI]
[97.5; 99.6]
Parotitis (titar
[98.1; 99.9]
Rubela (titar
[> 25 x 109/L] and/or renal impairment [CrCl <70 mL/min]) should receive prophylaxis.
[CrCl <70 ml/min]) potrebno je primijeniti profilaksu.
[ATS]/European Respiratory Society [ERS] 2000 workshop definition for refractory asthma) from Studies I and II was analysed post hoc.
European Respiratory Society – ERS] 2000. godine) u Ispitivanjima I i II bio je analiziran post hoc.
[CK elevation >2.5 x ULN - 5 x ULN]
[povišenje CPK > 2,5 x GGN - 5 x GGN]
[CK elevation >ULN - 2.5 x ULN]
[povišenje CPK > GGN – 2,5 x GGN]
[CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.3, 4.4, 4.8, 5.1 and 5.2).
[eGFR] < 60 ml/min/1,73 m2, vidjeti dijelove 4.3, 4.4, 4.8, 5.1 i 5.2).
[CYP2C9 and CYP3A4
[supstrati CYP3A4]
[CYP2C9 substrate and potent
[inhibitor CYP2C9, CYP2C19 I
[CYP2C9 substrate and potent
[supstrat CYP2C9 i snažan
[CYP2C9 substrate]
[supstrat CYP2C9]
[CYP2C9 substrates]
[supstrati CYP3A4]
[CYP2C9, CYP2C19 and CYP3A4
[supstrat CYP3A4, supstrat
[CYP3A4 inhibitor and substrate]
[inhibitor i supstrat CYP3A4]
[CYP3A4 inhibitor]
[inhibitor CYP3A4]
[CYP3A4 inhibitor]
Rijetko
[CYP3A4 substrate, P-gp
[supstrat CYP3A4, supstrat P-glikoproteina]
[CYP3A4 substrate]
[supstrat CYP3A4]
[CYP3A4 substrate]
Endokrini poremećaji
[CYP3A4 substrate]
krvarenje u retini
[CYP3A4 substrate]
U neovisnom objavljenom ispitivanju:
[CYP3A4 substrates and inhibitors]
[inhibitor CYP3A4]
[CYP3A4 substrates and inhibitors]
[supstrati i inhibitori CYP3A4]
[CYP3A4 substrates]
[supstrati i inhibitori CYP3A4]
[CYP3A4 substrates]
Interakcija
[CYP3A4 substrates]
plazmi.
[CYP3A4 substrates]
tih lijekova u plazmi.
[CYP450 inducer; CYP3A4
[induktor CYP450; inhibitor i
[Mechanism of interaction]
Nije poznat potencijalan rizik za ljude.
[Multi-dose bottle]
[Bočica s više doza]
[Multi-dose container:]
Bočica s više doza:
[muscular fatigue and muscular weakness]
[umor mišića i slabost mišića]
[n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; for genotype 1b: Y93H [n = 3], Y93H/C [n = 1]).
[n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; za genotip 1b: Y93H [n = 3], Y93H/C [n = 1]).
[no. (%) of patients]
[br. (%) bolesnika]
[NR]
[ND]
[Only Carton for bottle:] 2D barcode carrying the unique identifier included.
(Samo kutija za bocu:) Sadrži 2D barkod s jedinstvenim identifikatorom.
[Only Carton for bottle:] PC: {number}
(Samo kutija za bocu:) PC: {broj}
[OR=2.34]
66,8
[poly(ethylene-co-tetrafluoroethylene)-coated bromobutyl rubber] and a fixed injection needle (stainless steel, 29G [0.34 mm] or 27G [0.4 mm] x 0.5 inch [12.7 mm]).
[poli(etilen-ko-tetrafluoroetilen)-obložena brombutilna guma] i pričvršćenom iglom za injekciju (nehrđajuči čelik, 29G [0,34 mm] ili 27G [0,4 mm] x 0,5 inča [12,7 mm]).
[potent CYP450 inducer; CYP3A4
[snažan induktor CYP450]
[Single-dose container:]
Bočica s jednom dozom:
[Single-dose pipettes]
[pipete s pojedinačnom dozom]
[Tick boxes of 10, 20 or 40 tick boxes]
[Kvadratići za označavanje od 10, 20 ili 40 kvadratića]
[To be provided in the carton]
[Treba dostaviti unutar kartonske kutije]
[UDP-glucuronyl transferase substrate]
diseminirana intravaskularna koagulacija
[Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)]
[vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000)]
^ 400 mg was administered only on Day 3
^ doza od 400 mg primijenjena je samo 3. dana
^ Data cut-off date of 19 September 2014
^ Podaci prikupljeni do 19. rujna 2014.
^ Objective response rate and duration of response are based on IRF-assessed tumour assessments.
^ Stopa objektivnog odgovora i trajanje odgovora temelje se na ocjenama tumora prema procjeni neovisnog ocjenjivačkog tijela.
^ Table 1 shows pooled data from the overall treatment period in CLEOPATRA (data cutoff 11 February 2014; median number of cycles of Perjeta was 24); and from the neoadjuvant treatment period in NEOSPHERE (median number of cycles of Perjeta was 4, across all treatment arms) and TRYPHAENA (median number of cycles of Perjeta was 3 – 6 across treatment arms)
^ Tablica 1 prikazuje objedinjene podatke prikupljene tijekom cjelokupnog razdoblja liječenja u ispitivanju CLEOPATRA (završni datum prikupljanja podataka: 11. veljače 2014.; medijan broja ciklusa liječenja lijekom Perjeta bio je 24) i tijekom razdoblja neoadjuvantnog liječenja u ispitivanjima NEOSPHERE (medijan broja ciklusa liječenja lijekom Perjeta bio je 4 u svim liječenim skupinama) i TRYPHAENA (medijan broja ciklusa liječenja lijekom Perjeta bio je 3-6 u svim liječenim skupinama).
^Exploratory Endpoint
^Eksplorativni ishod
^See section 4.8 description of selected adverse reactions
^ Vidjeti dio 4.8 Opis odabranih nuspojava
^see section 4.8 description of selected adverse reactions
^Vidjeti dio 4.8 Opis odabranih nuspojava