natgillin/translations-raw huggingface dataset:
Following intravenous administration of umeclidinium to healthy volunteers, the mean volume of distribution was 86 litres. 
Povprečni volumen porazdelitve umeklidinija po intravenski uporabi je bil pri zdravih prostovoljcih 86 litrov.
There was no increase in tumour incidence in rats or mice at exposures 0.9- or 22-fold, respectively, the human clinical exposure of vilanterol at a daily dose of 22 micrograms based on AUC. 
Pri podganah in miših se pojavnost tumorjev ni povečala med izpostavljenostjo, ki je bila na podlagi AUC 0,9-kratnik (podgane) ali 22-kratnik (miši) klinične izpostavljenosti vilanterolu pri človeku med uporabo dnevnega odmerka 22 mikrogramov.
b) How to inhale the medicinal product 
b) Kako vdihniti zdravilo
Don't use Trelegy Ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na flutikazonfuroat, umeklidinij, vilanterol ali katero koli sestavino tega zdravila
One fatal case of pneumonia was reported in a patient who received Trelegy Ellipta. 
Med bolniki, ki so prejemali zdravilo Trelegy Ellipta, je bil zabeležen en primer pljučnice s smrtnim izidom.
In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation). 
V inhalacijskih študijah pri kuncih je vilanterol povzročil podobne učinke, kot se pojavljajo z drugimi agonisti adrenergičnih receptorjev beta2 (palatoshiza, odprte veke,
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter. 
Študije in vitro so pokazale, da se vilanterol presnavlja predvsem s citokromom P450 3A4 (CYP3A4) in da je substrat prenašalca P-gp.
In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter. 
Študije in vitro so pokazale, da se flutikazonfuroat presnavlja predvsem s citokromom P450 3A4 (CYP3A4) in da je substrat prenašalca P-gp.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/003 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1236/003
Clinically significant drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Klinično pomembna medsebojna delovanja z zdravili zaradi flutikazonfuroata/umeklidinja/vilanterola v kliničnih odmerkih niso verjetna, ker je koncentracija v plazmi po inhaliranju nizka.
How to use Trelegy Ellipta 
Kako uporabljati zdravilo Trelegy Ellipta
Trelegy Ellipta 
Zdravilo Trelegy Ellipta
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 
NALEPKA NA SKUPNEM PAKIRANJU (Z MODRIM OKENCEM - PAKIRANJE Z VEČ INHALATORJI)
Comparison 
Odmerjanje
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes. 
Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax flutikazonfuroata pojavila po 15 minutah.
The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with hepatic impairment. 
Učinkov kombinacije flutikazonfuroat/umeklidinij/vilanterol niso ocenili pri bolnikih z okvaro ledvic.
In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter. 
Študije in vitro so pokazale, da se umeklidinij presnavlja predvsem s citokromom P450 2D6 (CYP2D6) in da je substrat prenašalca P-gp.
What Trelegy Ellipta is and what it is used for 
Kaj je zdravilo Trelegy Ellipta in za kaj ga uporabljamo Kaj je zdravilo Trelegy Ellipta
It is packaged in a foil laminate tray with a peelable foil lid. 
Inhalator se nahaja v embalaži iz laminatne folije, zaprti s pokrovom iz folije.
1 inhaler of 30 doses 
1 inhalator s 14 odmerki 1 inhalator s 30 odmerki
A repeat dose study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and ketoconazole (400 milligrams, a strong CYP3A4 inhibitor). 
Pri zdravih preiskovancih so izvedli študijo s ponavljajočimi se odmerki kombinacije flutikazonfuroata/vilanterola (184/22 mikrogramov)
Lung Function 
Pljučna funkcija
Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively. 
Učinki na srce in ožilje Po uporabi antagonistov muskarinskih receptorjev in simpatikomimetikov, vključno z umeklidinijem in vilanterolom, se lahko pojavijo kardiovaskularni učinki, npr. motnje srčnega ritma, kot sta atrijska fibrilacija in tahikardija.
Rinsing your mouth out with water immediately after using Trelegy Ellipta may help prevent this side effect. 
Nastanek tega neželenega učinka lahko pomaga preprečiti izpiranje ust z vodo takoj po uporabi zdravila Trelegy
In FULFIL, bronchodilatory effects with Trelegy Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24). 
V študiji FULFIL so bili bronhodilatacijski učinki zdravila Trelegy Ellipta opazni že prvi dan zdravljenja in so se ohranili med 24-tedenskim obdobjem zdravljenja (povprečna sprememba FEV1 od izhodišča je bila 1.
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes. 
Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax vilanterola pojavila po 7 minutah.
What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol. 
Zdravilne učinkovine so flutikazonfuroat, umeklidinijev bromid in vilanterol.
Trough FEV1 (L) at Week 52, LS mean change from baseline (SE) a 
Najnižji FEV1 (L), povprečna sprememba (po mNK) od izhodišča (SN) po 52 tednih a
Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a 
Najnižji FEV1 (L), povprečna sprememba (po mNK) od izhodišča (SN) po 24 tednih a
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes. 
Po inhalacijski uporabi kombinacije flutikazonfuroat/umeklidinij/vilanterol pri zdravih preiskovancih se je Cmax umeklidinija pojavila po 5 minutah.
Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol 
Trelegy Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
Do not open the tray until you are ready to inhale a dose of your medicine. 
Ne odpirajte embalaže, dokler niste pripravljeni za vdihanje odmerka zdravila.
In IMPACT, Trelegy Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52. 
Nočna prebujanja V študiji IMPACT je zdravilo Trelegy Ellipta statistično značilno bolj zmanjšalo povprečno število nočnih prebujanj zaradi KOPB kot FF/VI (-0,05; 95 % IZ: -0,08, -0,01; p = 0,005) ali UMEC/VI (-0,10; 95 % IZ:
Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose of 55 micrograms umeclidinium, based on AUC respectively. 
Umeklidinij ni bil genotoksičen v standardni skupini študij in ni bil kancerogen v študijah vseživljenjskega vdihavanja pri miših ali podganah ob izpostavljenostih, ki so na podlagi AUC ≥ 20-kratnik (miši) ali
In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Trelegy Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43). 
V študiji IMPACT je bil delež bolnikov, ki so bili po 52. tednih opredeljeni kot odzivni glede na CAT značilno večji (p < 0,001) med prejemniki zdravila Trelegy Ellipta (42 %) kot med prejemniki FF/VI (37 %; RO 1,24; 95 % IZ: 1,14, 1,36) in UMEC/VI (36 %; RO 1,28; 95 % IZ: 1,15,
In FULFIL, based upon data up to 24 weeks, Trelegy Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR. 
tednov značilno zmanjšalo (p = 0,002) letni delež zmernih ali hudih poslabšanj za 35 % (95 % IZ: 14, 51) v primerjavi z BUD/FOR.
• infection of the upper airways 
• okužba zgornjih dihal,
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trelegy Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol 
IME ZDRAVILA IN POT(I) UPORABE Trelegy Ellipta 92 /55 /22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum za inhaliranje
• Don't shake the inhaler at any time. 
• Inhalatorja nikoli ne smete stresati.
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Trelegy Ellipta inhaler: 
Če se vam takoj po uporabi inhalatorja Trelegy Ellipta pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
Exacerbations 
Poslabšanja
Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs. 
Če se pojavi paradoksni bronhospazem, je treba zdravljenje z zdravilom Trelegy Ellipta nemudoma prenehati.
Tell your doctor as soon as possible if you develop any of these symptoms. 
Če se vam pojavi kateri od teh simptomov, o tem čim prej obvestite zdravnika.
Inhalation powder, pre-dispensed (inhalation powder). 
FARMACEVTSKA OBLIKA Prašek za inhaliranje, odmerjeni (prašek za inhaliranje).
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol 
Trelegy Ellipta 92/55/22 µg prašek za inhaliranje fluticasonum furoas/ umeclidinium/ vilanterolum
Write the “Discard by” date on the inhaler label and the carton in the space provided. 
V predvideni prostor na nalepki in škatli inhalatorja vpišite datum "Zavrzite do".
If you get any side effects, talk to your doctor, pharmacist or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, s farmacevtom ali medicinsko sestro.
The patient should be advised to not open the tray until they are ready to inhale a dose. 
a) Priprava odmerka Pokrovček naj bolnik odpre šele, ko je pripravljen, da uporabi odmerek.
A higher percentage of patients receiving Trelegy Ellipta responded with a clinically meaningful improvement in SGRQ total score in FULFIL at week 24 compared with BUD/FOR (50% and 41% respectively), odds ratios of response vs. non-response (OR) (1.41; 95% CI: 1.16, 1.70) and in IMPACT at week 52 compared with FF/VI and UMEC/VI (42%, 34% and 34% respectively), OR vs. FF/VI (1.41; 95% CI:1.29, 1.55) and OR vs. UMEC/VI (1.41; 95% CI: 1.26, 1.57); all treatment comparisons were statistically significant (p<0.001). 
V študiji IMPACT se je v 52. tednu celotna ocena po SGRQ klinično pomembno izboljšala pri višjem odstotku bolnikov, ki so prejemali zdravilo Trelegy Ellipta, v primerjavi s tistimi, ki so prejemali kombinaciji FF/VI in UMEC/VI (42 %, 34 % in 34 %), RO v primerjavi s kombinacijo FF/VI (1,41; 95 % IZ: 1,29, 1,55) in RO v primerjavi s kombinacijo UMEC/VI (1,41; 95 % IZ: 1,26, 1,57).
IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Trelegy Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI). 
Trelegy Ellipta (92/55/22 mikrogramov) s kombinacijo flutikazonfuroat/vilanterol 92/22 (FF/VI) in s kombinacijo umeklidinij/vilanterol 55/22 mikrogramov (UMEC/VI).
The first study included safety data from 911 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with an active comparator (study CTT116853, FULFIL). 
Prva študija je obsegala podatke o varnosti, zbrane pri 911 bolnikih s KOPB, ki so do 24 tednov prejemali kombinacijo flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan; 210 od teh bolnikov je kombinacijo flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan prejemalo do 52 tednov.
There was no effect of race on pharmacokinetic parametersof umeclidinium or vilanterol in subjects with COPD. 
Pri preiskovancih s KOPB rasa ni vplivala na farmakokinetične parametre umeklidinija ali vilanterola.
The third study included safety data from 4,151 patients with COPD who received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active comparators (study CTT116855, IMPACT). 
Tretja študija je obsegala podatke o varnosti, zbrane pri 4151 bolnikih s KOPB, ki so prejemali flutikazonfuroat/umeklidinij/vilanterol 92/55/22 mikrogramov enkrat na dan do 52 tednov.
Trelegy Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0). 
BUD/FOR (-2,2 enoti; 95 % IZ: -3,5, -1,0) kot tudi v študiji IMPACT (52. teden) v primerjavi s FF/VI (-1,8 enot; 95 % IZ: -2,4, -1,1) in UMEC/VI (-1,8 enot; 95 % IZ: -2,6, -1,0).
What Trelegy Ellipta looks like and contents of the pack The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter. 
Inhalator Ellipta sestavljajo svetlosivo plastično telo, pokrovček ustnika bež barve in števec odmerkov.
Package leaflet: Information for the patient Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol 
Navodilo za uporabo Trelegy Ellipta 92 mikrogramov/55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/umeklidinij/vilanterol
• increased mucus production, change in mucus colour 
• zvišano telesno temperaturo ali mrzlico, • obilnejše nastajanje sluzi, spremenjeno barvo sluzi,
No effect on umeclidinium AUC or Cmax was observed at a dose 8-fold higher than the therapeutic dose. 
Ob odmerku, ki je bil 8-krat večji od terapevtskega odmerka, niso opazili vpliva na AUC ali Cmax umeklidinija.
Umeclidinium was not teratogenic in rats or rabbits. 
Umeklidinij Umeklidinij pri podganah in kuncih ni bil teratogen.
No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed in fluticasone furoate, umeclidinium or vilanterol systemic exposure. 
Pri sistemski izpostavljenosti flutikazonfuroatu, umeklidiniju ali vilanterolu niso opazili nobenih klinično pomembnih razlik, ki bi zahtevale prilagoditev odmerka glede na raso, spol ali telesno maso.
No clinically relevant effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol at the recommended therapeutic dose. 
V kliničnih študijah kombinacije flutikazonfuroat/umeklidinij/vilanterol med uporabo priporočenih terapevtskih odmerkov niso opažali klinično pomembnih učinkov na glukozo v plazmi.
Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate). 
Vsak dostavljen odmerek vsebuje 92 mikrogramov flutikazonfuroata, 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida) in 22 mikrogramov vilanterola (kot trifenatata).
How to store Trelegy Ellipta 
Shranjevanje zdravila Trelegy Ellipta
Lactose monohydrate 
6.1 Seznam pomožnih snovi laktoza monohidrat magnezijev stearat
C. 
VI.
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate). 
Ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 92 mikrogramov flutikazonfuroata, 65 mikrogramov umeklidinijevega bromida (to ustreza 55 mikrogramom umeklidinija) in 22 mikrogramov vilanterola (kot trifenatata).
In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Trelegy Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75). 
(opredeljeno z zmanjšanjem izhodiščne vrednosti za ≥ 2 enoti) značilno večji (p < 0,001) med prejemniki zdravila Trelegy Ellipta kot med prejemniki BUD/FOR (53 % v primerjavi s 45 %; RO 1,44; 95 % IZ: 1,19, 1,75).
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija bolečine v hrbtu pogosti zlomi občasni
• Put the mouthpiece between your lips, and close your lips firmly around it. Don't block the air vent with your fingers. 
• Ustnik namestite čvrsto med ustnici.
Don't take a double dose to make up for a forgotten dose. 
Če ste pozabili uporabiti zdravilo Trelegy Ellipta Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Write the date that the inhaler should be discarded on the label and carton in the space provided. 
V predvideni prostor na nalepki in škatli inhalatorja vpišite datum, do katerega morate inhalator zavreči.
Viral respiratory tract infection 
NALEPKA NA INHALATORJU
B. 
KOPB.
Trelegy Ellipta significantly improved (p<0.001) lung function (as defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was maintained in the subset of patients who continued treatment to week 52. 
Zdravilo Trelegy Ellipta je značilno izboljšalo (p < 0,001) zdravstveno kakovost življenja (merjeno s celotno oceno po SGRQ (St. George's Respiratory Questionnaire) tako v študiji FULFIL (24. teden) v primerjavi z
Respiratory, thoracic & mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj orofaringealna bolečina pogosti disfonija občasni
TQT studies for FF/VI and umeclidinium/vilanterol (UMEC/VI) did not show clinically relevant effects on QT interval at clinical doses of FF, UMEC and VI. 
niso pokazale klinično pomembnih učinkov na interval QT med uporabo kliničnih odmerkov FF, UMEC in
A. 
sekunde).
In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Trelegy Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070). 
Trelegy Ellipta (n = 4151) 8 % (317 bolnikov), v skupini s kombinacijo flutikazonfuroat/vilanterol (n = 4134) 7 % (292 preiskovancev) in v skupini s kombinacijo umeklidinij/vilanterol (n = 2070) 5 % (97
• itchy, runny or blocked nose 
• srbenje nosu, izcedek iz nosu ali zamašen nos,
Vilanterol has a low association with red blood cells. 
Vezava vilanterola na eritrocite je majhna.
June 2019 
junij 2019
This is a long-term treatment. 
To je dolgoročno zdravljenje.
b Measured in peripheral blood. 
b Merjeno v periferni krvi.
An updated RMP shall be submitted by 24 November 2014. 
Posodobljen RMP je treba predložiti do 24. novembra 2014.
Your doctor will perform: 
Vaš zdravnik bo:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013 
Datum prve odobritve: 1. julij 2013
Other possible side effects that may occur with the following frequencies are: 
Drugi možni neželeni učinki, ki se lahko pojavijo z naslednjimi pogostnostmi, so:
Vascular occlusive events occurred in 44 of these 132 patients. 
Vaskularni okluzivni dogodki so se pojavili pri 44 od teh 132 bolnikov.
An alternative or additional method of contraception should be used. 
Uporabljati je treba alternativno ali dodatno metodo kontracepcije.
Your doctor may want to take additional precautions. 
Vaš zdravnik bo morda uvedel dodatne previdnostne ukrepe.
93055 Regensburg, Germany 
93055 Regensburg, Nemčija
The frequency of pancreatitis is greater in the first 2 months of use. 
Pogostnost pankreatitisa je večja prva 2 meseca uporabe.
Symptoms are severe pain in the stomach and back. 
Simptomi so huda bolečina v trebuhu in hrbtu.
The trial is ongoing. 
Preskušanje še poteka.
• inability to develop or maintain an erection 
• nezmožnost doseči ali ohraniti erekcijo
Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity. 
Zdravljenje je treba nadaljevati, dokler se pri bolniku ne pokažejo znaki napredovanja bolezni ali nesprejemljive toksičnosti.
Patients should be monitored for response according to standard clinical guidelines. 
Pri bolnikih je treba spremljati njihov odgovor v skladu s standardnimi kliničnimi smernicami.
The clinical relevance of this finding is unknown. 
Klinična pomembnost teh izsledkov ni znana.
• Importance of assessing the risks before starting treatment with ponatinib. 
• Pomen ocenitve tveganj pred začetkom zdravljenja s ponatinibom.
• Available data on the relationship between dose and risk of vascular occlusive events. 
• Razpoložljivi podatki o razmerju med odmerkom in tveganjem vaskularnih okluzivnih dogodkov.
Your doctor may evaluate your response to the treatment at regular intervals. 
Vaš zdravnik bo morda v rednih intervalih ocenjeval vaš odgovor na zdravljenje.
Afterwards it is performed monthly or as indicated by the doctor. 
Nato jo bodo opravljali mesečno ali po navodilih zdravnika.
Hypertension may contribute to risk of arterial thrombotic events. 
Hipertenzija lahko prispeva k tveganju arterijskih trombotičnih dogodkov.
Do not stop taking Iclusig without your doctor's permission. 
Ne prenehajte jemati zdravila Iclusig brez zdravnikovega dovoljenja.
Number of Patients 
Število bolnikov
Resistant or Intolerant 
Odporni ali ne prenašajo
Baseline demographic characteristics are described in Table 5 below. 
Izhodiščne demografske značilnosti so opisane spodaj v preglednici 5.
Key elements of the Healthcare Professional Brochure: 
Ključni elementi brošure za zdravstvene delavce:
Some patients experienced more than one type of event. 
Pri nekaterih bolnikih so se pojavili dogodki več kot ene vrste.
Bottles are packed within a cardboard box. 
Plastenke so pakirane v kartonski škatli.
Seek medical attention immediately if you experience any of the following serious side effects. 
Takoj poiščite zdravniško pomoč, če opazite katerega od naslednjih resnih neželenih učinkov.
Efficacy results are summarized in Table 6, Table 7, and Table 8. 
Rezultati učinkovitosti so povzeti v preglednici 6, 7 in 8.
Management of toxicities: 
Obravnava toksičnosti:
Patients with severe or very severe hypertriglyceridemia should be appropriately managed to reduce the risk of pancreatitis. 
Bolnike s hudo ali zelo hudo hipertrigliceridemijo je treba ustrezno obravnavati, da se zmanjša tveganje pankreatitisa.
In each Member State, the Marketing Authorisation Holder shall agree the format and content of the educational programme, including communication media, distribution modalities, and any other aspects of the programme with the National Competent Authority. 
V vsaki državi članici se bo imetnik dovoljenja za promet z zdravilom z nacionalno odgovornim organom dogovoril o obliki in vsebini izobraževalnega programa, vključno z mediji komunikacije, načinom razdeljevanja in drugimi vidiki programa.