natgillin/translations-raw huggingface dataset:
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. 
Buđenje noću U ispitivanju IMPACT, Trelegy Ellipta statistički je značajno smanjio srednju vrijednost broja buđenja noću zbog KOPB-a u odnosu na FF/VI (-0,05; 95% CI: -0,08; -0,01; p = 0,005) i UMEK/VI (-0,10; 95% CI: -0,14; -0,05; p < 0,001) između 49. i 52. tjedna.
Vilanterol had no adverse effect on preor post-natal development in rats. 
Vilanterol nije imao štetnih učinaka na prenatalni ni postnatalni razvoj štakora.
The step-by-step instructions for use of the inhaler provided below can be used for either the 30-dose (30 day supply) or the 14-dose (14 day supply) Ellipta inhaler. 
Upute za uporabu inhalatora korak po korak prikazane u nastavku odnose se i na inhalator s 30 doza (terapija za 30 dana) i na inhalator s 14 doza (terapija za 14 dana).
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed 
NAZIV LIJEKA Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani
Warnings and precautions 
(naveden u dijelu 6.) Upozorenja i mjere opreza
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). 
St. George's Respiratory Questionnaire, SGRQ]) i u ispitivanju FULFIL (24. tjedan) u usporedbi s kombinacijom BUD/FOR (-2,2 jedinice; 95% CI: -3,5; -1,0) i u ispitivanju IMPACT (52. tjedan) u usporedbi s kombinacijom FF/VI (-1,8 jedinica; 95% CI: -2,4; -1,1) i UMEK/VI (-1,8 jedinica; 95% CI: -2,6; -1,0).
Fluticasone furoate/umeclidinium/vilanterol is a combination of inhaled synthetic corticosteroid, long-acting muscarinic receptor antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA). 
Flutikazonfuroat/umeklidinij/vilanterol je kombinacija inhalacijskog sintetičkog kortikosteroida, dugodjelujućeg antagonista muskarinskih receptora (engl. long-acting muscarinic receptor antagonist,
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). 
U trećem su se ispitivanju podaci o sigurnosti prikupljali u 4151 bolesnika s KOPB-om koji je primao flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 52 tjedna; ispitivanje je uključivalo dva aktivna usporedna lijeka (ispitivanje CTT116855, IMPACT).
No clinically relevant effects on the QTc interval were observed on review of centrally read ECGs from 911 subjects with COPD exposed to fluticasone furoate/umeclidinium/vilanterol for up to 24 weeks, or in the subset of 210 subjects exposed for up to 52 weeks. 
911 ispitanika s KOPB-om izloženih flutikazonfuroatu/umeklidiniju/vilanterolu do 24 tjedna niti u podskupini od 210 ispitanika koji su toj kombinaciji bili izloženi do 52 tjedna.
No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed in fluticasone furoate, umeclidinium or vilanterol systemic exposure. 
Nisu opažene klinički važne razlike u sistemskoj izloženosti flutikazonfuroatu, umeklidiniju ili vilanterolu koje bi zahtijevale prilagodbu doze na temelju rase, spola ili tjelesne težine.
There is no relevant use of Trelegy Ellipta in the paediatric population (under 18 years of age) for the indication of COPD. 
Nema relevantne primjene lijeka Trelegy Ellipta u pedijatrijskoj populaciji (bolesnici mlađi od
In IMPACT, Trelegy Ellipta prolonged the time to first moderate/severe exacerbation and significantly decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1). 
U ispitivanju IMPACT, Trelegy Ellipta produljio je vrijeme do prve umjerene/teške egzacerbacije te je značajno smanjio (p < 0,001) rizik od umjerene/teške egzacerbacije, mjeren vremenom do prve egzacerbacije, i u odnosu na FF/VI (14,8%; 95% CI: 9,3; 19,9) i u odnosu na UMEK/VI (16,0%;
The tray contains a desiccant sachet, to reduce moisture in the packaging. 
Podložak sadrži vrećicu sa sredstvom za sušenje, koje služi za smanjivanje količine vlage u pakiranju.
The mouthpiece should be placed between the lips and the lips should then be closed firmly around it. 
Stavite nastavak za usta među usne i čvrsto ga obujmite usnama.
There was no effect of race on pharmacokinetic parametersof umeclidinium or vilanterol in subjects with COPD. 
Rasa ispitanika nije utjecala na farmakokinetičke parametre umeklidinija ili vilanterola u ispitanika s KOPB-om.
The dose counter will appear completely red if the cover is opened again. 
Ako se poklopac ponovno otvori, brojač doza će postati potpuno crven.
Wait to open the cover until you are ready to take your dose. 
Otvorite poklopac tek onda kada ste spremni uzeti dozu.
Multipack of 90 (3 packs of 30) dose inhalers. 
Višestruko pakiranje: inhalatori s 90 (3 pakiranja s 30) doza.
Symptom Relief 
Ublažavanje simptoma
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). 
- ako ste alergični na flutikazonfuroat, umeklidinij, vilanterol ili neki drugi sastojak ovoga lijeka
However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk. 
Međutim, u majčinu su mlijeku otkriveni drugi kortikosteroidi, muskarinski antagonisti i beta2-adrenergički agonisti.
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). 
U prvom su se ispitivanju podaci o sigurnosti prikupljali u 911 bolesnika s KOPB-om koji su primali flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 24 tjedna, od kojih je njih 210 primalo flutikazonfuroat/umeklidinij/vilanterol u dozi od 92/55/22 mikrograma jedanput na dan tijekom najviše 52 tjedna; ispitivanje je uključivalo aktivan usporedni lijek (ispitivanje CTT116853, FULFIL).
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1236/003 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1236/003
Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol 
Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
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). 
FEV1 u odnosu na početnu vrijednost iznosila je 90 - 222 ml prvog dana te 160 - 339 ml u 24. tjednu).
What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol. 
Djelatne tvari su flutikazonfuroat, umeklidinijev bromid i vilanterol.
Pharmacological and toxicological effects seen with fluticasone furoate, umeclidinium or vilanterol in nonclinical studies were those typically associated with glucocorticoids, muscarinic receptor antagonists, or beta2-adrenergic receptor agonists. 
Farmakološki i toksikološki učinci zabilježeni kod primjene flutikazonfuroata, umeklidinija ili vilanterola u nekliničkim ispitivanjima bili su oni koji se tipično povezuju s glukokortikoidima,
NAME OF THE MEDICINAL PRODUCT Trelegy Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol 
Trelegy Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, vilanterol Cmax occurred at 7 minutes. 
Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, vilanterol je dosegnuo Cmax nakon 7 minuta.
The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled. 
Vrećicu sa sredstvom za sušenje treba baciti; njezin se sadržaj ne smije otvoriti,
At weeks 49-52, the treatment difference was -0.28 (95% CI: -0.37, -0.19) when compared with FF/VI and -0.30 (95% CI: -0.41, -0.19) with UMEC/VI. 
Razlika između liječenja u razdoblju od 49. do 52. tjedna iznosila je -0,28 (95% CI: -0,37; -0,19) u odnosu na FF/VI te -0,30 (95% CI: -0,41; -0,19) u odnosu na UMEK/VI.
In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter. 
Ispitivanja in vitro pokazala su da se flutikazonfuroat prvenstveno metabolizira posredstvom izoenzima 3A4 citokroma P450 (CYP3A4) i da je supstrat prijenosnika P-gp-a.
Based on the magnitude of these changes, no clinically relevant drug interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients who are genetically deficient in CYP2D6 activity (poor metabolisers). 
CYP2D6 niti pri primjeni flutikazonfuroata/umeklidinija/vilanterola u bolesnika s genetski nedostatnom aktivnošću CYP2D6 (spori metabolizatori).
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter. 
Ispitivanja in vitro pokazala su da se vilanterol prvenstveno metabolizira posredstvom izoenzima 3A4 citokroma P450 (CYP3A4) i da je supstrat prijenosnika P-gp-a.
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. 
Nakon primjene antagonista muskarinskih receptora i simpatomimetika, uključujući umeklidinij i vilanterol, mogu nastupiti kardiovaskularni učinci poput srčanih aritmija, npr. fibrilacije atrija i tahikardije.
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, fluticasone furoate Cmax occurred at 15 minutes. 
Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, flutikazonfuroat je dosegnuo Cmax nakon 15 minuta.
Comparison Trelegy vs. UMEC/VI 
Trelegy u odnosu na UMEK/VI
Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium (equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate). 
Jedna isporučena doza sadrži 92 mikrograma flutikazonfuroata, 55 mikrograma umeklidinija (što odgovara količini od 65 mikrograma umeklidinijeva bromida) i 22 mikrograma vilanterola (u obliku trifenatata).
The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with hepatic impairment. 
Učinak flutikazonfuroata/umeklidinija/vilanterola nije se ocjenjivao u ispitanika s oštećenjem jetrene funkcije.
What Trelegy Ellipta is used for 
Za što se Trelegy Ellipta koristi
How to store Trelegy Ellipta 
Kako primjenjivati Trelegy Ellipta
In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Trelegy Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57). 
FF/VI (29%; OR 1,36; 95% CI: 1,19; 1,55) i UMEK/VI (30%; OR 1,33; 95% CI: 1,13; 1,57).
In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-gp transporter. 
Ispitivanja in vitro pokazala su da se umeklidinij prvenstveno metabolizira posredstvom izoenzima 2D6 citokroma P450 (CYP2D6) i da je supstrat prijenosnika P-gp-a.
Package leaflet: Information for the patient Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol 
Uputa o lijeku: Informacije za bolesnika Trelegy Ellipta 92 mikrograma/55 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/umeklidinij/vilanterol
Use of Rescue Medication 
NAČIN PRIMJENE LIJEKA
What Trelegy Ellipta is 
Što je Trelegy Ellipta
4) Close the inhaler and rinse your mouth 
4) Zatvorite inhalator i isperite usta • Povucite poklopac prema gore koliko ide kako biste prekrili nastavak za usta.
PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed. 
Prašak inhalata, dozirani.
c) Close the inhaler and rinse your mouth 
c) Zatvorite inhalator i isperite usta Povucite poklopac prema gore koliko ide kako biste prekrili nastavak za usta.
Dry mouth 
Sredstvo za sušenje
The “Discard by” date should be written on the inhaler label and carton in the space provided. 
Datum kada lijek treba baciti treba napisati na za to predviđeno mjesto na naljepnici inhalatora i kutiji.
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, umeclidinium Cmax occurred at 5 minutes. 
Nakon inhalacijske primjene flutikazonfuroata/umeklidinija/vilanterola u zdravih ispitanika, umeklidinij je dosegnuo Cmax nakon 5 minuta.
The tray contains a desiccant sachet, to reduce moisture. 
Podložak sadrži vrećicu sa sredstvom za sušenje radi smanjivanja vlage.
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 se nije pokazao genotoksičnim u standardnom skupu ispitivanja niti kancerogenim u ispitivanjima cjeloživotne inhalacije na miševima odnosno štakorima pri razinama izloženosti
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trelegy Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Trelegy Ellipta 92/55/22 µg prašak inhalata Fluticasone furoate/Umeclidinium/Vilanterol
In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, based on AUC). 
U prenatalnom i postnatalnom ispitivanju supkutana primjena umeklidinija u štakora smanjila je prirast majčine tjelesne težine i unos hrane te blago smanjila tjelesnu težinu mladunčadi prije prestanka sisanja u ženki koje su primale dozu od
• itchy, runny or blocked nose 
• svrbež nosa, curenje iz nosa ili začepljen nos
• inflammation of the sinuses 
• upala sinusa
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. 
0,9 odnosno 22 puta veće od kliničke izloženosti u ljudi nakon primjene dnevne doze vilanterola od 22 mikrograma, što je utvrđeno na temelju AUC-a.
The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption. 
Apsolutna bioraspoloživost inhaliranog vilanterola iznosila je 27%,
Once the tray is opened Trelegy Ellipta is ready to use. 
Trelegy Ellipta spreman je za uporabu odmah nakon otvaranja podloška.
Umeclidinium 
Umeklidinij
No clinically relevant effects of hypokalaemia were observed in clinical studies with Trelegy Ellipta at the recommended therapeutic dose. 
U kliničkim ispitivanjima nisu primijećeni klinički značajni učinci hipokalijemije kod primjene lijeka
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 sastoji se od svijetlosivog plastičnog tijela, bež poklopca nastavka za usta i brojača doza.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
Treatment difference 95% CI 
(95% CI) Trelegy u odnosu na FF/VI
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Trelegy Ellipta inhaler: 
Ako se neposredno nakon primjene lijeka Trelegy Ellipta jave stezanje u prsnom košu, kašalj, piskanje pri disanju ili nedostatak zraka:
Treatment with Trelegy Ellipta should be discontinued immediately if paradoxical bronchospasm occurs. 
U slučaju paradoksalnog bronhospazma potrebno je odmah prekinuti liječenje lijekom
After inhalation, patients should rinse their mouth with water without swallowing. 
Za inhalaciju morate usnama obujmiti nastavak za usta uz označeni rub.
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). 
Jedna pojedinačna inhalacija osigurava isporučenu dozu (doza koja izlazi iz nastavka za usta) od 92 mikrograma flutikazonfuroata, 65 mikrograma umeklidinijeva bromida, što odgovara količini od
No effect on umeclidinium AUC or Cmax was observed at a dose 8-fold higher than the therapeutic dose. 
Pri primjeni doze 8 puta veće od terapijske nije primijećen učinak na AUC niti Cmax umeklidinija.
Mouthpiece Air vent 
Nastavak za usta Otvor za zrak
FEV1= forced expiratory volume in 1 second; L= litres; LS=least squares; SE= standard error; N= number in the intentto-treat population; CI= confidence interval; a Statistically significant treatment differences for FF/UMEC/VI vs. FF/VI and FF/UMEC/VI vs. UMEC/VI were also observed at the other assessment timepoints (Weeks 4, 16, 28, and 40). 
aStatistički značajna razlika između liječenja za FF/UMEK/VI u odnosu na FF/VI i za FF/UMEK/VI u odnosu na UMEK/VI opažena je i u drugim vremenskim točkama u kojima se provodila ocjena ( 4., 16., 28. i 40. tjedan).
Keep this medicine out of the sight and reach of children. 
Kako čuvati Trelegy Ellipta Lijek čuvajte izvan pogleda i dohvata djece.
Cough Oropharyngeal pain 
Poklopac podloška
INSTRUCTIONS ON USE 
Ova uputa
Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Trelegy Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months. 
Ispitivanje 200812 bilo je 24-tjedno ispitivanje neinferiornosti (N = 1055) u kojem se Trelegy Ellipta (92/55/22 mikrograma) uspoređivao s flutikazonfuroatom/vilanterolom (92/22 mikrograma) +
Other long acting antimuscarinics and long acting beta2- adrenergic agonists 
LAMA) i dugodjelujućeg agonista beta2-adrenergičkih receptora (engl. long-acting beta2-adrenergic agonist, LABA) (IKS/LAMA/LABA).
In vitro plasma protein binding in human plasma was on average 94%. 
Stupanj vezivanja za proteine u ljudskoj plazmi in vitro u prosjeku je iznosio
In 113 East Asian subjects with COPD (Japanese and East Asian Heritage), who received FF/UMEC/VI from a single inhaler (27% subjects), fluticasone furoate AUC(ss) estimates were on average 30% higher compared with Caucasian subjects. 
Procijenjene vrijednosti AUC(ss) flutikazonfuroata u 113 ispitanika s KOPB-om iz istočne Azije
June 2019 
lipanj 2019.
Your doctor will perform: 
Vaš liječnik će obaviti:
The trial is ongoing. 
Ispitivanje je u tijeku.
b Measured in peripheral blood. 
b Mjereno u perifernoj krvi.
Resistant or Intolerant 
Rezistentan ili intolerantan
Iclusig blocks this signal, thereby stopping the production of these cells. 
Iclusig blokira taj signal i tako zaustavlja stvaranje tih stanica.
Take your next dose at your regular time. 
Svoju sljedeću dozu uzmite u redovno vrijeme.
Do not stop taking Iclusig without your doctor's permission. 
Nemojte prestati uzimati Iclusig bez dopuštenja svog liječnika.
Your doctor may want to take additional precautions. 
Vaš liječnik možda će željeti poduzeti dodatne mjere opreza.
Make sure you take Iclusig daily for as long as it is prescribed. 
Pobrinite se da uzimate Iclusig svakodnevno sve dok Vam je propisan.
Do not give this medicine to children under 18 years because no data are available in children. 
Ovaj lijek nemojte davati djeci mlađoj od 18 godina jer nema raspoloživih podataka za djecu.
Iclusig is available as: 
Iclusig je dostupan kao:
• inability to develop or maintain an erection 
• nesposobnost postizanja ili održavanja erekcije
What Iclusig is and what it is used for 
Što je Iclusig i za što se koristi
An updated RMP should be submitted: 
Dopunjeni RMP treba dostaviti:
• pain in one or both legs when walking or exercising, which disappears after some minutes of rest 
• bol u jednoj ili obje noge pri hodu ili vježbanju, koja nakon nekoliko minuta odmora nestaje
If you take more Iclusig than you should 
Ako uzmete više Iclusiga nego što ste trebali
An alternative or additional method of contraception should be used. 
Potrebno je koristiti alternativne ili dodatne metode kontracepcije.
Vascular occlusive events occurred in 44 of these 132 patients. 
Događaji vaskularne okluzije javili su se u 44 od tih 132 bolesnika.
Key elements of the Healthcare Professional Brochure: 
Ključni elementi Brošure za zdravstvene radnike:
Talk to your doctor immediately if this occurs. 
Odmah obavijestite svog liječnika ako se to dogodi.
Other possible side effects that may occur with the following frequencies are: 
Druge moguće nuspojave koje se mogu pojaviti sa sljedećom učestalosti su:
Swallow the tablets whole, with a glass of water. 
Tablete gutajte cijele, s čašom vode.
Symptoms are severe pain in the stomach and back. 
Simptomi su jaka bol u želucu i leđima.
• night sweats, increased sweating 
• noćno znojenje, pojačano znojenje
The safety and efficacy of Iclusig in patients less than 18 years of age have not been established. 
Sigurnost i djelotvornost u bolesnika mlađih od 18 godina još nije utvrđena.
The MAH shall complete, within the stated timeframe, the below measures: Description 
Nositelj odobrenja će, unutar navedenog vremenskog okvira, provesti niže navedene mjere: Opis
Seek medical attention immediately if you experience any of the following serious side effects. 
Odmah zatražite liječničku pomoć ako iskusite bilo koju od sljedećih ozbiljnih nuspojava.
Continue Iclusig at the same dose 
Nastavite s lijekom Iclusig pri istoj dozi
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 July 2013 
Datum prvog odobrenja: 1. srpnja 2013.
Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity. 
Liječenje treba nastaviti sve dok bolesnik ne pokazuje znakove napredovanja bolesti ili neprihvatljive toksičnosti.
What Iclusig is and what it is used for What you need to know before you take Iclusig How to take Iclusig 
Što je Iclusig i za što se koristi Što morate znati prije nego počnete uzimati Iclusig Kako uzimati Iclusig
Other medicines and Iclusig 
Drugi lijekovi i Iclusig
Efficacy results are summarized in Table 6, Table 7, and Table 8. 
Rezultati djelotvornosti sažeti su u Tablici 6, Tablici 7 i Tablici 8.
Your doctor may reduce your dose or tell you to temporarily stop taking Iclusig if: 
Vaš liječnik može smanjiti Vašu dozu ili Vam reći da privremeno prekinete uzimati Iclusig:
93055 Regensburg, Germany 
93055 Regensburg, Njemačka
Bottles are packed within a cardboard box. 
Boce su pakirane u kartonsku kutiju.
An updated RMP shall be submitted by 24 November 2014. 
Dopunjeni Plan upravljanja rizikom treba biti podnesen do 24. studenog 2014..
Maintained MMR 
Održani MMR