FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of aclidinium bromide on the occurrence of major adverse cardiovascular events (MACE) was assessed in a randomised, double-blind, placebo-controlled, parallel-group study in 3630 adult patients between 40 and 91 years of age with moderate to very severe COPD, treated for up to 36 months.
Slovenian: Dolgoročno preskušanje varnosti in učinkovitosti do 3 leta Vpliv aklidinijevega bromida na pojavljanje pomembnih neželenih srčno-žilnih učinkov (MACE - Major Adverse Cardiovascular Event) so ocenili v randomizirani, dvojno slepi, s placebom nadzorovani študiji vzporednih skupin pri 3630 odraslih bolnikih, starih od 40 do 91 let, z zmerno do zelo hudo KOPB, zdravljenih do 36 mesecev.
English: Additionally, no clinically relevant adverse reactions were observed following 7-day twice daily dosing of up to 800 µg aclidinium bromide in healthy subjects.
Slovenian: Poleg tega v naslednjih 7 dneh pri zdravih osebah, ki so dvakrat na dan prejele odmerek do 800 µg aklidinijevega bromida, niso opazili nobenih klinično pomembnih neželenih učinkov.
English: In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide are not substrates or inhibitors of P-glycoprotein.
Slovenian: V študijah in vitro so dokazali, da aklidinijev bromid ali presnovki aklidinijevega bromida niso substrati ali zaviralci glikoproteina P.
English: Posology The recommended dose is one inhalation of 322 micrograms aclidinium twice daily.
Slovenian: Odmerjanje Priporočen odmerek je en vdih 322 mikrogramov aklidinija dvakrat na dan.
English: The median time on-study in the Bretaris Genuair and placebo groups was approximately 1.4 and 1.3 years, respectively.
Slovenian: Mediani čas v študiji je bil v skupini z zdravilom Bretaris Genuair približno 1,4 leta in v skupini s placebom približno 1,3 leta.
English: Therefore, no dose adjustment is required for elderly COPD patients.
Slovenian: Zaradi tega prilagajanje odmerka pri starejših bolnikih s KOPB ni potrebno.
English: Other medicines and Bretaris Genuair
Slovenian: Druga zdravila in zdravilo Bretaris Genuair
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala ter vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: If you forget a dose of Bretaris Genuair, inhale the dose as soon as you remember.
Slovenian: Če ste pozabili uporabiti zdravilo Bretaris Genuair Če pozabite uporabiti odmerek zdravila Bretaris Genuair, ga morate uporabiti takoj, ko se spomnite.
English: Bretaris Genuair contains lactose
Slovenian: Zdravilo Bretaris Genuair vsebuje laktozo
English: Each delivered dose (the dose leaving the mouthpiece) contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium.
Slovenian: En dostavljen odmerek (odmerek, ki pride iz ustnika) vsebuje 375 µg aklidinijevega bromida (kar ustreza 322 µg aklidinija).
English: Method of administration For inhalation use.
Slovenian: Način uporabe za inhaliranje
English: Elderly No dose adjustments are required for elderly patients (see section 5.2).
Slovenian: Starejši Za starejše bolnike ni potrebno prilagajanje odmerka (glejte poglavje 5.2).
English: In a 3-week crossover, randomised, placebo-controlled clinical study Bretaris Genuair was associated with a statistically significant improvement in exercise endurance time in comparison to placebo of 58 seconds (95% CI=9-108; p=0.021; pre-treatment value: 486 seconds).
Slovenian: V tritedenski navzkrižni, randomizirani, s placebom nadzorovani klinični študiji je zdravilo Bretaris Genuair v primerjavi s placebom izkazalo občutno statistično podaljšanje časa vzdržljivosti med telesno vadbo, in sicer za 58 sekund (95 % IZ = 9-108; p = 0,021; vrednost pred zdravljenjem: 486 sekund).
English: The effects of Bretaris Genuair last for 12 hours; therefore, you should try to use your Bretaris Genuair inhaler at the same time every morning and evening.
Slovenian: Zaradi tega morate poskusiti uporabljati zdravilo Bretaris Genuair vsako jutro in vsak večer ob istem času.
English: The medicine is for inhalation use.
Slovenian: Pot uporabe To zdravilo je za inhaliranje.
English: The Genuair inhaler device is white coloured with an integral dose indicator and a green dosage button.
Slovenian: Inhalator Genuair je bele barve in ima vgrajen indikator odmerka ter zeleni gumb za odmerjanje.
English: No significant pharmacokinetic differences were observed between subjects with normal renal function and subjects with renal impairment.
Slovenian: Med osebami z normalno delujočimi ledvicami in osebami z ledvično okvaro niso opazili znatnih farmakokinetičnih razlik.
English: Keep breathing in as long as possible after you hear the ‘click'.
Slovenian: Ko zaslišite ‘klik', nadaljujte z vdihovanjem kolikor dolgo je mogoče.
English: What to do if the control window is still green after inhalation (Figure L).
Slovenian: Kaj storiti, če je kontrolno okence po inhaliranju še vedno obarvano zeleno?
English: Talk to your doctor, pharmacist or nurse before using Bretaris Genuair: - if you have had heart problems recently.
Slovenian: Pred začetkom uporabe zdravila Bretaris Genuair se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če ste imeli nedavno težave s srcem, - če vidite kolobarje okoli luči ali obarvanih slik (glavkom),
English: The median time on-treatment in the Bretaris Genuair and placebo groups was 1.1 and 1 year, respectively.
Slovenian: Mediani čas uporabe zdravila je bil v skupini z zdravilom Bretaris Genuair 1,1 leta in v skupini s placebom 1 leto.
English: It is white-coloured with an integral dose indicator and a green dosage button.
Slovenian: Je bele barve z vgrajenim indikatorjem odmerka ter zelenim gumbom za odmerjanje.
English: Exercise tolerance
Slovenian: Toleranca na telesno vadbo
English: Bretaris Genuair 322 micrograms inhalation powder
Slovenian: Bretaris Genuair 322 mikrogramov/odmerek prašek za inhaliranje
English: Bretaris Genuair did not increase the MACE risk in patients with COPD compared to placebo when added to current background therapy (hazard ratio (HR) 0.89; 95% CI: 0.64, 1.23).
Slovenian: Zdravilo Bretaris Genuair pri bolnikih s KOPB dodano trenutnemu osnovnemu zdravljenju v primerjavi s placebom ni povečalo tveganja za MACE (razmerje ogroženosti (HR-hazard ratio) 0,89; 95 % IZ: 0,64; 1,23).
English: Each delivered dose contains 375 micrograms aclidinium bromide equivalent to 322 micrograms of aclidinium.
Slovenian: En dostavljen odmerek vsebuje 375 mikrogramov aklidinijevega bromida, kar ustreza 322 mikrogramov aklidinija.
English: Patients treated with Bretaris Genuair showed a statistically significant reduction of 22% compared to placebo (rate ratio [RR] 0.78; 95% CI 0.68 to 0.89; p<0.001).
Slovenian: Bolniki, zdravljeni z zdravilom Bretaris Genuair, so imeli v primerjavi s placebom statistično značilno zmanjšanje za 22 % (razmerje deležev [RR-rate ratio] 0,78, 95 % IZ od 0,68 do 0,89, p < 0,001).
English: 1.6 Make sure the control window is now green (Figure G).
Slovenian: Preden nadaljujete, preverite: 1.6 Prepričajte se, da je kontrolno okence sedaj obarvano zeleno (Slika G).
English: No effects on QT interval (corrected using either the Fridericia or Bazett method or individuallycorrected) were observed when aclidinium bromide (200 µg or 800 µg) was administered once daily for 3 days to healthy subjects in a thorough QT study.
Slovenian: Pri dajanju aklidinijevega bromida (200 µg ali 800 µg) enkrat na dan 3 dni zdravim osebam niso opazili nobenih učinkov na interval QT (korigirano po metodi Fridericia ali Bazett ali korigirano individualno) v trajanju celotne študije QT.
English: Getting Started
Slovenian: Začetek
English: In addition, Bretaris Genuair showed a statistically significant reduction of 35% in the rate of hospitalisations due to COPD exacerbations while on-treatment during the first year compared with placebo (RR 0.65; 95% CI 0.48 to 0.89; p=0.006).
Slovenian: Poleg tega je zdravilo Bretaris Genuair v prvem letu v primerjavi s placebom doseglo statistično značilno 35-odstotno zmanjšanje deleža sprejemov v bolnišnico zaradi poslabšanj KOPB med zdravljenjem (RR 0,65, 95 % IZ od 0,48 do 0,89, p = 0,006).
English: Read the package leaflet before use Inhalation use
Slovenian: Pred uporabo preberite priloženo navodilo!
English: EU/1/12/781/001 30 doses
Slovenian: EU/1/12/781/001 30 odmerkov
English: EU/1/12/781/002 60 doses
Slovenian: EU/1/12/781/002 60 odmerkov
English: Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide has been used concomitantly with other COPD medicinal products including sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Slovenian: Čeprav formalnih raziskav o medsebojnem delovanju in vivo niso izvedli, so pri sočasni uporabi aklidinijevega bromida in drugih zdravil za KOPB, vključno s simpatomimetičnimi bronhodilatatorji,
English: What Bretaris Genuair is used for
Slovenian: Za kaj se zdravilo Bretaris Genuair uporablja
English: How to use Bretaris Genuair
Slovenian: Kako uporabljati zdravilo Bretaris Genuair
English: Carton containing 1 inhaler with 30 doses.
Slovenian: Škatla, ki vsebuje 1 inhalator s 30 odmerki.
English: Experience in patients with cardiovascular comorbidities in clinical trials is limited (see section 5.1).
Slovenian: Iz kliničnih preskušanj je malo izkušenj pri bolnikih s sočasnimi srčno-žilnimi boleznimi (glejte poglavje 5.1).
English: Refer to the Instructions for Use for instructions on how to use the Genuair inhaler.
Slovenian: Za navodila o uporabi inhalatorja Genuair glejte Navodila za uporabo.
English: Hepatically-impaired patients
Slovenian: Bolniki z jetrno okvaro
English: Preferred term Frequency
Slovenian: Izbrani izraz
English: What Bretaris Genuair contains - The active substance is aclidinium bromide.
Slovenian: Kaj vsebuje zdravilo Bretaris Genuair - Učinkovina je aklidinij (v obliki aklidinijevega bromida).
English: 2.7 Make sure the control window is now red (Figure K).
Slovenian: Preden nadaljujete, preverite: 2.7 Preverite, da je kontrolno okence sedaj obarvano rdeče (Slika K).
English: You should discard your inhaler if you lose the cap.
Slovenian: Če pokrovček izgubite, morate inhalator zavreči.
English: Carton containing 1 inhaler with 60 doses.
Slovenian: Škatla, ki vsebuje 1 inhalator s 60 odmerki.
English: Anaphylactic reaction Not known
Slovenian: Bolezni imunskega sistema preobčutljivost redki angioedem neznana anafilaktična reakcija neznana
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj pogosti disfonija občasni
English: Please contact your doctor if the control window is still green after repeated attempts.
Slovenian: Če je kontrolno okence po več poskusih še vedno obarvano zeleno, se posvetujte z zdravnikom.
English: Bretaris Genuair 322 micrograms inhalation powder Aclidinium (aclidinium bromide)
Slovenian: Bretaris Genuair 322 mikrogramov/odmerek prašek za inhaliranje aklidinij (aklidinijev bromid)
English: Hepatic impairment No dose adjustments are required for patients with hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Za bolnike z okvaro jeter ni potrebno prilagajanje odmerka (glejte poglavje 5.2).
English: If you have any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for assistance.
Slovenian: Če imate dodatna vprašanja o uporabi inhalatorja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Carton containing 3 inhalers each with 60 doses.
Slovenian: Škatla, ki vsebuje 3 inhalatorje s po 60 odmerki.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj občasni pruritus občasni
English: Renal impairment No dose adjustments are required for patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Za bolnike z okvaro ledvic ni potrebno prilagajanje odmerka (glejte poglavje 5.2).
English: No dose adjustment is required for hepatically-impaired COPD patients.
Slovenian: Zaradi tega za bolnike s KOPB in ledvično okvaro ni potrebno prilagajanje odmerka.
English: Laboratori Guidotti S.p.A. Tel: +39- 050 971011
Slovenian: Tel: +39- 050 971011
English: Bretaris Genuair 322 micrograms inhalation powder aclidinium (aclidinium bromide)
Slovenian: Bretaris Genuair 322 mikrogramov/odmerek prašek za inhaliranje aklidinij (aklidinijev bromid) za inhaliranje
English: Renally-impaired patients
Slovenian: Bolniki z ledvično okvaro
English: (Figure N), or
Slovenian: (Slika L).
English: OUTER CARTON
Slovenian: Zunanja škatla
English: Pack sizes supplied:
Slovenian: Na voljo so naslednje velikosti pakiranja:
English: 1 inhaler containing 30 doses 1 inhaler containing 60 doses 3 inhalers each containing 60 doses
Slovenian: 3 inhalatorji, ki vsebujejo vsak po 60 odmerkov
English: What Bretaris Genuair is
Slovenian: Kaj je zdravilo Bretaris Genuair
English: How to store Bretaris Genuair
Slovenian: Shranjevanje zdravila Bretaris Genuair
English: Mean Change from baseline
Slovenian: Povprečna sprememba od izhodiščne vrednosti
English: Pruritus
Slovenian: Pogostnost
English: This medicine is for long-term use.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Mouthpiece
Slovenian: Ustnik
English: Keep the inhaler inside the pouch until the administration period starts.
Slovenian: Inhalator hranite do uporabe v vrečki.
English: Keep the Genuair inhaler inside the pouch until the administration period starts.
Slovenian: Inhalator Genuair hranite do uporabe v vrečki.
English: Bottle (HDPE)
Slovenian: Pretisni omot (HDPE)
English: Therefore the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 on 27 November 2013.
Slovenian: Evropska komisija je zato 27. novembra 2013 uvedla postopek v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: The Marketing Authorisation was granted by the European Commission on 1 July 2013 for the following indications in adult patients:
Slovenian: Evropska komisija je 1. julija 2013 izdala dovoljenje za promet z zdravilom za naslednje indikacije pri odraslih bolnikih:
English: • Updated information on adverse reactions.
Slovenian: • posodobljene informacije o neželenih učinkih.
English: It is therefore appropriate to reinforce existing recommendations for the cardiovascular status of the patient to be assessed before initiating treatment.
Slovenian: Zato je ustrezno, da se bolj poudarijo obstoječa priporočila za oceno bolnikovega kardiovaskularnega stanja pred začetkom zdravljenja.
English: • Discontinuation of treatment if haematologic response has not occurred by 3 months.
Slovenian: • prekinitev zdravljenja, če po treh mesecih ni prišlo do hematološkega odziva;
English: Nevertheless the Committee agreed that it is important to reflect these data in the product information.
Slovenian: Vendar se je strinjal, da je te podatke pomembno vključiti v informacije o zdravilu;
English: The incidence of arterial thrombotic events (per 100 patient years) remains relatively constant.
Slovenian: Incidenca arterijskih trombotičnih dogodkov (na 100 bolnikovih let) ostaja sorazmerno stanovitna.
English: The Product Information for Iclusig was revised to include the following:
Slovenian: Informacije o zdravilu Iclusig so bile spremenjene tako, da vključujejo:
English: A total of 81 (18%) patients on the phase 2 study (n=449) have experienced serious vascular occlusive events and overall, a total of 101 patients (23%) have experienced vascular occlusive events (serious and non-serious).
Slovenian: V študiji 2. faze (n = 449) je imelo skupno 81 (18 %) bolnikov resne dogodke žilne okluzije, skupno 101 bolnik (23 %) pa je imel dogodke žilne okluzije (resne in neresne).
English: However these data include a relatively small number of patients, most of which had been dose reduced due to adverse events, and follow-up time is limited.
Slovenian: Vendar ti podatki vključujejo sorazmerno malo bolnikov, pri večini katerih so odmerek zmanjšali zaradi neželenih dogodkov, čas sledenja pa je omejen.
English: • Updated recommendations to assess cardiovascular status and consider alternative treatments where appropriate.
Slovenian: • posodobljena priporočila za oceno kardiovaskularnega stanja in razmislek o nadomestnih oblikah zdravljenja, kadar je to primerno;
English: It is therefore unclear whether the maintenance of response observed in this particular group of patients can be generalised to the CP-CML population.
Slovenian: Zato torej ni jasno, ali je mogoče vzdrževanje odziva, ki so ga opazili v tej skupini bolnikov, posplošiti za celotno populacijo KML v kronični fazi.
English: Serious cardiac failure events have occurred in a total of 23 patients (5.1%).
Slovenian: Resni dogodki srčnega popuščanja so se pojavili pri skupno 23 bolnikih (5,1 %).
English: In October 2013, the EMA was informed that the rate of vascular occlusive events was higher than observed in the clinical trials that supported the initial marketing authorisation.
Slovenian: Oktobra 2013 so agencijo EMA obvestili, da je delež dogodkov žilne okluzije večji od deleža, opaženega v kliničnih preskušanjih, ki so podprla prvotno dovoljenje za promet z zdravilom.
English: This raises the question of whether similar outcomes in terms of efficacy could be achieved with lower (starting and/or maintenance) doses, which are expected to reduce the risk of vascular occlusive events.
Slovenian: Pri tem se pojavi vprašanje, ali bi bilo mogoče podobne izide glede učinkovitosti doseči z manjšimi (začetnimi in/ali vzdrževalnimi) odmerki, za katere je pričakovati, da bodo zmanjšali tveganje za dogodke žilne okluzije.
English: While these data can be useful for physicians considering dose reduction, it is currently considered insufficient to adopt a formal recommendation for dose reduction in patients who have not experienced an adverse event.
Slovenian: Medtem ko so lahko ti podatki koristni za zdravnike, ki razmišljajo o zmanjšanju odmerka, trenutno ne zadostujejo za sprejetje uradnega priporočila za zmanjšanje odmerka pri bolnikih brez neželenega dogodka.
English: A type II variation was submitted and additional risk minimisation measures such as updates to the product information were put in place.
Slovenian: Predložila se je vloga za spremembo tipa II in uvedli so se dodatni ukrepi za zmanjševanje tveganja, kot so posodobitve informacij o zdravilu.
English: Non-clinical issues
Slovenian: Neklinična vprašanja
English: Ponatinib is a tyrosine kinase inhibitor (TKI), designed with the purpose of inhibiting the kinase activity of native BCR-ABL, and all mutant variants, including ‘gatekeeper' T315I.
Slovenian: Ponatinib je zaviralec tirozin-kinaze, zasnovan za zaviranje kinazne dejavnosti nativnega produkta BCR-ABL in vseh mutiranih različic, vključno s T315I.
English: In view of the high risk for vascular occlusive events, the PRAC considered that it should be made clear in the product information that ponatinib should be discontinued in patients who do not respond to treatment (no haematologic response by 3 months).
Slovenian: Odbor PRAC je zaradi velikega tveganja za dogodke žilne okluzije menil, da je treba v informacijah o zdravilu jasno navesti, da je treba uporabo ponatiniba prekiniti pri bolnikih, ki se ne odzivajo na zdravljenje (brez hematološkega odziva po treh mesecih).
English: • The PRAC considered Iclusig (ponatinib) in the procedure under Article 20 of Regulation (EC) No
Slovenian: • odbor PRAC je proučil zdravilo Iclusig (ponatinib) v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004, ki ga je uvedla Evropska komisija;
English: The PRAC considered whether a recommendation for dose reduction (in the absence of an adverse event) in patients with chronic phase CML who have achieved major cytogenetic response was appropriate.
Slovenian: Odbor PRAC je pretehtal, ali je priporočilo za zmanjšanje odmerka (ob odsotnosti neželenega dogodka) pri bolnikih s KML v kronični fazi, ki so dosegli velik citogenetski odziv, ustrezno.
English: However, there were a number of outstanding issues which could not be resolved within the expedited variation procedure and which required a further review of the benefit-risk balance of Iclusig.
Slovenian: Vendar so bile prisotne številne izrazite težave, ki jih ni bilo mogoče odpraviti s hitrim postopkom za spremembo in so zahtevale dodatno presojo razmerja med tveganji in koristmi zdravila Iclusig.
English: • Additional warnings about hypertension, cardiac failure and risk of bleeding with anti-clotting agents.
Slovenian: • dodatna opozorila glede hipertenzije, srčnega popuščanja in tveganja za krvavitev v kombinaciji z učinkovinami proti strjevanju krvi;
English: A number of plausible molecular mechanism exists that may contribute to vascular occlusive events.
Slovenian: Obstajajo številni verjetni molekularni mehanizmi, ki bi lahko prispevali k dogodkom žilne okluzije.
English: As part of the assessment of potential causes that may lead to an increased occurrence of vascular occlusive events in ponatinib treated patients, molecular mechanisms based on on-target and offtarget effects were discussed.
Slovenian: V okviru ocene morebitnih vzrokov, ki lahko pripeljejo do povečane pojavnosti dogodkov žilne okluzije pri bolnikih, zdravljenih s ponatinibom, so razpravljali o molekularnih mehanizmih, ki temeljijo na predvidenih in nepredvidenih učinkih.
English: The possible role of anti-platelet, anti-coagulant or lipid lowering drugs in reducing the risk of vascular occlusive events remains uncertain.
Slovenian: Morebitna vloga antitrombotikov, antikoagulantov ali zdravil za zniževanje ravni lipidov pri zmanjševanju tveganja za dogodke žilne okluzije ostaja neznana.
English: There is also an association between vascular occlusive events and a risk of cardiac failure as a secondary event.
Slovenian: Obstaja tudi povezava med dogodki žilne okluzije in tveganjem za srčno popuščanje kot sekundarnim dogodkom.
English: The majority of cases of cardiac failure occurred in patients at known risk from underlying disease, cardiovascular risk factors and prior treatment with cardiotoxic medications including other TKIs.
Slovenian: Večina primerov srčnega popuščanja se je pojavila pri bolnikih z znanim tveganjem zaradi osnovne bolezni, kardiovaskularnih dejavnikov tveganja in predhodnega zdravljenja s kardiotoksičnimi zdravili, vključno z drugimi zaviralci tirozin-kinaze.
English: • The PRAC took note of the serious risk of vascular occlusive events associated with Iclusig, which is likely to be dose-related.
Slovenian: • odbor PRAC se je seznanil z resnim tveganjem za dogodke žilne okluzije, povezanim z zdravilom Iclusig, ki je verjetno odvisno od odmerka;
English: • The PRAC reviewed all data presented by the MAH on the safety and efficacy of Iclusig, as well as the views expressed by the oncology scientific advisory group.
Slovenian: • odbor PRAC je pregledal vse podatke o varnosti ter učinkovitosti zdravila Iclusig, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, in mnenja Znanstvene svetovalne skupine za onkologijo;
English: The risk of vascular occlusive events is likely to be dose related and therefore a dose reduction would be expected to reduce the risk of vascular occlusive events.
Slovenian: Tveganje za dogodke žilne okluzije je verjetno povezano z odmerkom, zato je pričakovati, da bo zmanjšanje odmerka zmanjšalo tveganje za dogodke žilne okluzije.
English: The CHMP, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and is of the opinion that the marketing authorisation for Iclusig should be varied.
Slovenian: Po proučitvi priporočila odbora PRAC se je odbor CHMP strinjal s splošnimi znanstvenimi zaključki odbora PRAC in menil, da je treba dovoljenje za promet z zdravilom Iclusig spremeniti.