natgillin/translations-raw huggingface dataset:
Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness 
Bolezni živčevja intrakranialna krvavitev (opisani so primeri s smrtnim izidom), glavobol, parestezije, omotica motnje okušanja, agevzija
In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR=23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR=7.3%; CI: -5.7 to 18.7 [p=0.258]). 
Pri analizi podskupin glede na vključitveni pogoj (miokardni infarkt, ishemična kap in periferna arterijska bolezen - PAD) je videti najmočnejšo korist (doseganje statistične značilnosti pri p=0,003) pri bolnikih, vključenih zaradi PAD (zlasti pri tistih, ki so doživeli tudi miokardni infarkt) (zmanjšanje RT=23,7 %; IZ: 8,9 do 36,2), in šibkejšo (ni bila pomembno različna od ASA) pri bolnikih s kapjo
Acute liver failure, hepatitis, abnormal liver function test 
žolčnika in žolčevodov akutna odpoved jeter, hepatitis, nenormalni testi jetrne funkcije
• Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. 
• odraslih bolnikih z miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo (od
Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding. 
Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje bolnišnične nujne zdravniške pomoči.
Calendar pack of aluminium-aluminium perforated blisters containing 28x1film coated tablets 
Koledarsko pakiranje: aluminij-aluminij perforirani pretisni omoti vsebuje 28x1 filmsko obloženo tableto.
Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters. 
Navodila o jemanju tablet iz pretisnega omota so na zunanji strani škatle s pretisnimi omoti z odstranljivo folijo.
Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia 
Bolezni mišično skeletnega sistema in vezivnega tkiva mišično-skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
− Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 
− Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca): zdravljenje moramo začeti z enkratnim udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favor of clopidogrel (95% CI: 24, 47%; p<0.001), mainly related to a reduction in occluded infarct-related arteries. 
Primarni opazovani dogodek je bil opažen pri 15,0 % bolnikov v skupini s klopidogrelom in 21,7 % bolnikov v skupini s placebom, kar predstavlja absolutno zmanjšanje za 6,7 % in 36 % zmanjšanje verjetnosti v prid klopidogrela (95 % IZ od 24 % do 47 %; p<0,001) v glavnem zaradi zmanjšanja zaradi infarkta zamašenih arterij.
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group. 
Število bolnikov s primarnim opazovanim dogodkom (srčno-žilna smrt, MI, kap ali neodzivna ishemija) je bilo 1.035 (16,5 %) v skupini zdravljeni s klopidogrelom in 1.187 (18,8 %) v skupini s placebom, to je 14 % zmanjšanje relativnega tveganja (95 % IZ od 6 %-21 %, p=0,0005) za skupino, zdravljeno s klopidogrelom.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below. 
Klinično pomembni neželeni odzivi, zabeleženi v študijah CAPRIE, CURE, CLARITY in
Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulfate). 
Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega sulfata.
• if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer). 
Na primer: o zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu).
o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, - anti-retroviral medicines (medicines to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer. 
- efavirenz, zdravilo za zdravljenje infekcij z virusom HIV (virus humane imunske pomanjkljivosti), - protiretrovirusna zdravila (zdravila za zdravljenje okužbe z virusom HIV), - karbamazepin, zdravilo za zdravljenje nekaterih oblik epilepsije, - moklobemid, zdravilo za zdravljenje depresije, - repaglinid, zdravilo za zdravljenje sladkorne bolezni, - paklitaksel, zdravilo za zdravljenje raka.
You have been prescribed Clopidogrel Teva to help prevent blood clots and reduce the risk of these severe events because: 
Zdravilo Klopidogrel Teva vam je bilo predpisano za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker: - imate stanje otrdelih arterij (znano tudi kot ateroskleroza), in
If you forget to take a dose of Clopidogrel Teva, but remember within 12 hours of usual time,take your tablet straightaway and then take your next tablet at the usual time. 
Če pozabite vzeti odmerek zdravila Klopidogrel Teva, vendar se spomnite v naslednjih 12 urah,
Clopidogrel Teva contains sodium 
Zdravilo Klopidogrel Teva vsebuje natrij
Light pink to pink, capsule-shaped film-coated tablets debossed with “93” on one side and “7314” on the other side. 
Ena stran tablete ima vtisnjeno številko »93«, druga stran tablete pa številko »7314«.
Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel. 
oksoklopidogrela povzroči nastanek aktivnega presnovka, ki je tiolski derivat klopidogrela.
While you are taking Clopidogrel Teva: 
Med jemanjem zdravila Klopidogrel Teva:
− Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172) and indigo carmine aluminium lake (E132). 
• Pomožne snovi so glejte poglavje 2: »Zdravilo Klopidogrel Teva vsebuje laktozo«: - Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, hidroksipropilceluloza (E463), krospovidon (vrsta A), hidrogenirano rastlinsko olje in natrijev lavril sulfat - Obloga tablete: laktoza monohidrat, hipromeloza (E464), titanov dioksid (E171), makrogol 4000, rdeč železov oksid (E172), rumen železov oksid (E172), indigo karmin barvilo (E132)
The expiry date refers to the last day of that month. 
plastenki ali pretisnem omotu za EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Clopidogrel Teva contains lactose 
Zdravilo Klopidogrel Teva vsebuje laktozo
Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a 
(vazospastična alergijska angina / alergijski miokardni infarkt) v okviru preobčutljivostne reakcije zaradi klopidogrela*
In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group. 
V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev v primerjavi s skupino s placebom in ASA.
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus 
(sindrom DIHS, Drug-Induced Hypersensitivity Syndrome), kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), eritematozen ali eksfoliativen izpuščaj,
− Calendar pack of perforated blisters of aluminium/aluminium containing 28x1 tablets 
- Koladarsko pakiranje: aluminij-aluminij perforirani pretisni omoti vsebuje 28x1 filmsko obloženo tableto.
There was no significant difference between groups in the primary composite endpoint of death, shunt thrombosis or cardiac-related intervention prior to 120 days of age following an event considered of thrombotic nature (89 [19.1%] for the clopidogrel group and 90 [20.5%] for the placebo group) (see section 4.2). 
Med skupinama ni bilo značilnih razlik v primarnem sestavljenem opazovanem dogodku, ki je obsegal smrt, trombozo spoja ali srčno intervencijo pred starostjo 120 dni po dogodku, za katerega je bilo ocenjeno, da je trombotične narave: v skupini s klopidogrelom je bilo takšnih 89
If you cut or injure yourself, it may take longer than usual for bleeding to stop. 
Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel Teva Če se urežete ali poškodujete, lahko traja malo dlje kot običajno, da se vam krvavitev ustavi.
After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day. 
Po večkratnih odmerkih 75 mg klopidogrela na dan, je bila pri osebah s hudo ledvično boleznijo (očistek kreatinina 5 do 15 ml/min) inhibicija z ADP sprožene agregacije trombocitov manjša (25 %)
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day). 
tedne v odmerkih do 77 mg/kg na dan (kar predstavlja najmanj 25-krat višjo izpostavljenost kot pri človeku ob prejemanju kliničnega odmerka 75 mg/dan).
EU/1/09/540/001 14x1 film-coated tablets EU/1/09/540/002 28x1 film-coated tablets EU/1/09/540/003 30x1 film-coated tablets EU/1/09/540/004 50x1 film-coated tablets EU/1/09/540/005 84x1 film-coated tablets EU/1/09/540/006 90x1 film-coated tablets EU/1/09/540/007 100x1 film-coated tablets 
EU/1/09/540/001 14x1 filmsko obložena tableta EU/1/09/540/002 28x1 filmsko obložena tableta EU/1/09/540/003 30x1 filmsko obložena tableta EU/1/09/540/004 50x1 filmsko obložena tableta EU/1/09/540/005 84x1 filmsko obložena tableta EU/1/09/540/006 90x1 filmsko obložena tableta EU/1/09/540/007 100x1 filmsko obložena tableta
EU/1/09/540/010 14x1 film-coated tablets EU/1/09/540/011 28x1 film-coated tablets EU/1/09/540/012 30x1 film-coated tablets EU/1/09/540/013 50x1 film-coated tablets EU/1/09/540/014 84x1 film-coated tablets EU/1/09/540/015 90x1 film-coated tablets EU/1/09/540/016 
EU/1/09/540/010 14x1 filmsko obložena tableta EU/1/09/540/011 28x1 filmsko obložena tableta EU/1/09/540/012 30x1 filmsko obložena tableta EU/1/09/540/013 50x1 filmsko obložena tableta EU/1/09/540/014 84x1 filmsko obložena tableta EU/1/09/540/015 90x1 filmsko obložena tableta EU/1/09/540/016 100x1 filmsko obložena tableta EU/1/09/540/017 28x1 filmsko obložena tableta
Carefully peel off the backing. 
Previdno odstranite zgornjo papirnato plast.
Thrombocytopenia, leucopenia, eosinophilia 
urtikarija, ekcem, lihen planus
Do not use this medicine if you notice any visible sign of deterioration Do not throw away any medicines of via wastewater or household waste. 
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Patients were treated for up to 5 years. 
bolnikov v starosti ≥65 let.
For the 28x1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel Teva by referring to the calendar printed on the blister 
Na koledarčku, ki je natisnjen na pretisnem omotu pri pakiranju 28x1 tableta, lahko preverite, kateri
- You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack). 
- ste doživeli hudo obliko bolečine v prsih, znano kot “nestabilna angina” ali “miokardni infarkt” (srčni napad).
Name and address of the manufacturers responsible for batch release 
IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serije
Your doctor should have prescribed Clopidogrel Teva and acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding. 
Zdravnik naj bi vam predpisal zdravilo Klopidogrel Teva skupaj z acetilsalicilno kislino, če ne morete prejemati
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING BOTTLE LABEL (30 or 100 film-coated tablets) 
Etiketa na plastenki (30 ali 100 filmsko obloženih tablet) 1.
The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia. 
spojnice (nestabilna angina ali miokardni infarkt brez Q zobca) do 24 ur po zadnji epizodi bolečine v prsih ali simptomih, konsistentnih z ishemijo.
Clopidogrel Teva 75 mg film-coated tablets 
Klopidogrel Teva 75 mg filmsko obložene tablete
• Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section 
• Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov.
Clopidogrel Teva 75 mg film-coated tablets clopidogrel oral use 
Klopidogrel Teva 75 mg filmsko obložene tablete klopidogrel peroralna uporaba
This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9% in the unchanged DAPT group (p<0.01). 
Ta statistično značilna razlika je bil predvsem posledica manjšega števila krvavitev, medtem ko razlik v ishemičnih opazovanih dogodkih ni bilo (p = 0,36); krvavitve
− Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA). 
− akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca), vključno z bolniki, katerim je bil vstavljen stent po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilno kislino (ASA), − akutni miokardni infarkt z elevacijo ST spojnice v kombinaciji z ASA pri bolnikih, ki se zdravijo z zdravili in so primerni za trombolitično zdravljenje; Preprečevanje aterotrombotičnih in trombemboličnih dogodkov pri atrijski fibrilaciji
Vascular disorders 
bulozen dermatitis
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDER BLISTER 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis 
kolitis (vključno z ulceroznim ali limfocitnim kolitisom), stomatitis
TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI. 
To randomizirano, odprto preskušanje je vključilo bolnike z AKS, ki so potrebovali PKI.
Clopidogrel Teva 75 mg film-coated tablets clopidogrel 
Klopidogrel Teva 75 mg filmsko obložene tablete klopidogrel
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Teva per day to be taken orally with or without food, and at the same time each day. 
(nepravilen srčni utrip), je ena 75 mg tableta zdravila Klopidogrel Teva na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
Eye bleeding (conjunctival, ocular, retinal) 
okularno, retinalno)
Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets. 
Perforirani pretisni omoti vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obloženo tableto.
C. 
AKS.
INSTRUCTIONS ON USE. 
− Navodilo shranite.
• Risk Management Plan (RMP) 
D. POGOJI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event. 
Pri analizi vključenih bolnikov so v skupini, ki je prejemala klopidogrel, opazili 939 dogodkov in v skupini, ki je prejemala ASA, 1.020 dogodkov (zmanjšanje relativnega tveganja (RT) 8,7 %, [95 % IZ: 0,2 do 16,4]; p=0,045),
Thur 
Tor
Acquired haemophilia has been reported following use of clopidogrel. 
Pridobljena hemofilija Po uporabi klopidogrela je bila opisana pridobljena hemofilija.
Secondary prevention of atherothrombotic events Clopidogrel is indicated in: 
Sekundarno preprečevanje aterotrombotičnih dogodkov
Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets. 
Perforirani enoodmerni pretisni omoti z odstranljivo folijo vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obloženo tableto.
Vertigo, enlarged breasts in males. 
Biotransformacija Klopidogrel se v jetrih izdatno presnovi.
- If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. 
− Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Bleeding time prolonged, neutrophil count decreased, platelet count decreased 
Preiskave podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov * Podatki se nanašajo na klopidogrel s pogostnostjo “neznani”.
Sodium 
ZDRAVILOM
Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8). 
tiklopidin in prasugrel), ker so poročali o navzkrižnih alergijah med tienopiridini (glejte poglavje 4.8).
43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01). 
Primarni izid, sestavljeni dogodek srčno-žilne smrti, možganske kapi, nujne revaskularizacije in krvavitve ≥ 2 po BARC (Bleeding Academic Research Consortium), se je 1 leto po AKS pojavil pri 43 bolnikih (13,4 %) v skupini z deeskaliranim DAPT in pri 85 bolnikih (26,3 %) v skupini z nespremenjenim DAPT (p < 0,01).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets) 
Pretisni omot (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta ) 1.
Haematoma 
OVOJNINAH
Package leaflet: Information for the user Clopidogrel Teva 75 mg film-coated tablets clopidogrel 
Navodilo za uporabo Klopidogrel Teva 75 mg filmsko obložene tablete klopidogrel
What Clopidogrel Teva is and what it is used for What you need to know before you take Clopidogrel Teva How to take Clopidogrel Teva Possible side effects 
Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel Teva 3.
The EMA will evaluate the results of this study as soon as they are available. 
Evropska agencija za zdravila bo rezultate študije ocenila takoj, ko bodo na voljo.
The review of Iclusig was initiated on 27 November 2013 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. 
Pregled zdravila Iclusig se je pričel 27. novembra 2013 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
• If you have any questions or concerns, you should consult your doctor or another healthcare professional. 
• Če imate kakršna koli vprašanja ali pomisleke, se posvetujte z zdravnikom ali drugim zdravstvenim delavcem.
Therefore, the recommended starting dose of Iclusig should remain 45 mg once a day. 
Priporočen začetni odmerek zdravila Iclusig tako ostaja 45 mg enkrat dnevno.
Iclusig was authorised as an orphan medicine (a medicine to treat rare diseases) in the EU in July 
Zdravilo Iclusig je bilo julija 2013 v EU odobreno kot zdravilo sirota (zdravilo za zdravljenje redkih bolezni).
• chronic myeloid leukaemia (CML); 
• kronično mieloično levkemijo (KML);
• Educational material will be provided to healthcare professionals, highlighting important risks for which monitoring and/or dose adjustments are recommended. 
• Zdravstvenim delavcem bo zagotovljeno izobraževalno gradivo, v katerem bodo izpostavljena pomembna tveganja, za katera se priporoča spremljanje in/ali prilagoditev odmerka.
• If a reduced dose of Iclusig is used, doctors should monitor patients for maintenance of therapeutic response. 
• Če se uporabi zmanjšan odmerek zdravila Iclusig, morajo zdravniki spremljati, ali se pri bolnikih ohrani terapevtski odziv.
Patients treated with Iclusig may be at increased risk of developing blood clots and blockages in the blood vessels, which can have serious consequences (such as heart attacks or strokes). 
Pri bolnikih, zdravljenih z zdravilom Iclusig, je lahko tveganje za nastanek krvnih strdkov in zapor v žilah večje, kar lahko ima resne posledice (kot so srčni napadi ali kapi).
This study has been imposed as a condition of the marketing authorisation for Iclusig. 
Ta študija je bila določena kot pogoj za izdajo dovoljenja za promet z zdravilom Iclusig.
It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib. 
Prav tako se uporablja pri bolnikih z genetsko mutacijo, imenovano mutacija T315I, zaradi katere so odporni na zdravljenje z imatinibom, dasatinibom ali nilotinibom.
The review of Iclusig was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC). 
Pregled zdravila Iclusig je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji.
Any assessment relating to dose reduction should take into account a number of factors, including the patient's cardiovascular risk, side effects of therapy, and time to cytogenetic response. 
Pri vsaki oceni v zvezi z zmanjšanjem odmerka je treba upoštevati vrsto dejavnikov, vključno s kardiovaskularnim tveganjem bolnika, neželenimi učinki zdravljenja in časom do citogenetskega odziva.
The CHMP opinion will be sent to the European Commission, which will issue a legally binding decision valid throughout the EU in due course. 
CHMP je svoje mnenje poslal Evropski komisiji, ki je 15. januarja 2015 izdala pravno zavezujoč sklep, veljaven po vsej EU.
• Before starting treatment, your doctor will assess your risk of heart and circulatory problems, and will continue to check your condition at regular intervals during your treatment with Iclusig. 
• Pred začetkom zdravljenja bo zdravnik ocenil vaše tveganje za težave s srcem in obtočili, vaše stanje pa bo med zdravljenjem z zdravilom Iclusig redno pregledoval.