FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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 %)
English: 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).
Slovenian: 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).
English: 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
Slovenian: 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
English: 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
Slovenian: 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
English: Carefully peel off the backing.
Slovenian: Previdno odstranite zgornjo papirnato plast.
English: Thrombocytopenia, leucopenia, eosinophilia
Slovenian: urtikarija, ekcem, lihen planus
English: 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.
Slovenian: Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Patients were treated for up to 5 years.
Slovenian: bolnikov v starosti ≥65 let.
English: 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
Slovenian: Na koledarčku, ki je natisnjen na pretisnem omotu pri pakiranju 28x1 tableta, lahko preverite, kateri
English: - 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).
Slovenian: - ste doživeli hudo obliko bolečine v prsih, znano kot “nestabilna angina” ali “miokardni infarkt” (srčni napad).
English: Name and address of the manufacturers responsible for batch release
Slovenian: IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serije
English: 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.
Slovenian: Zdravnik naj bi vam predpisal zdravilo Klopidogrel Teva skupaj z acetilsalicilno kislino, če ne morete prejemati
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING BOTTLE LABEL (30 or 100 film-coated tablets)
Slovenian: Etiketa na plastenki (30 ali 100 filmsko obloženih tablet) 1.
English: 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.
Slovenian: spojnice (nestabilna angina ali miokardni infarkt brez Q zobca) do 24 ur po zadnji epizodi bolečine v prsih ali simptomih, konsistentnih z ishemijo.
English: Clopidogrel Teva 75 mg film-coated tablets
Slovenian: Klopidogrel Teva 75 mg filmsko obložene tablete
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section
Slovenian: • Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov.
English: Clopidogrel Teva 75 mg film-coated tablets clopidogrel oral use
Slovenian: Klopidogrel Teva 75 mg filmsko obložene tablete klopidogrel peroralna uporaba
English: 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).
Slovenian: Ta statistično značilna razlika je bil predvsem posledica manjšega števila krvavitev, medtem ko razlik v ishemičnih opazovanih dogodkih ni bilo (p = 0,36); krvavitve
English: − 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).
Slovenian: − 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
English: Vascular disorders
Slovenian: bulozen dermatitis
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDER BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Slovenian: kolitis (vključno z ulceroznim ali limfocitnim kolitisom), stomatitis
English: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
Slovenian: To randomizirano, odprto preskušanje je vključilo bolnike z AKS, ki so potrebovali PKI.
English: Clopidogrel Teva 75 mg film-coated tablets clopidogrel
Slovenian: Klopidogrel Teva 75 mg filmsko obložene tablete klopidogrel
English: 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.
Slovenian: (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.
English: Eye bleeding (conjunctival, ocular, retinal)
Slovenian: okularno, retinalno)
English: Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets.
Slovenian: Perforirani pretisni omoti vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obloženo tableto.
English: C.
Slovenian: AKS.
English: INSTRUCTIONS ON USE.
Slovenian: − Navodilo shranite.
English: • Risk Management Plan (RMP)
Slovenian: D. POGOJI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
English: 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.
Slovenian: 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),
English: Thur
Slovenian: Tor
English: Acquired haemophilia has been reported following use of clopidogrel.
Slovenian: Pridobljena hemofilija Po uporabi klopidogrela je bila opisana pridobljena hemofilija.
English: Secondary prevention of atherothrombotic events Clopidogrel is indicated in:
Slovenian: Sekundarno preprečevanje aterotrombotičnih dogodkov
English: Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets.
Slovenian: Perforirani enoodmerni pretisni omoti z odstranljivo folijo vsebujejo 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obloženo tableto.
English: Vertigo, enlarged breasts in males.
Slovenian: Biotransformacija Klopidogrel se v jetrih izdatno presnovi.
English: - If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist.
Slovenian: − Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Bleeding time prolonged, neutrophil count decreased, platelet count decreased
Slovenian: Preiskave podaljšan čas krvavitve, zmanjšano število nevtrofilcev, zmanjšano število trombocitov * Podatki se nanašajo na klopidogrel s pogostnostjo “neznani”.
English: Sodium
Slovenian: ZDRAVILOM
English: 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).
Slovenian: tiklopidin in prasugrel), ker so poročali o navzkrižnih alergijah med tienopiridini (glejte poglavje 4.8).
English: 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01).
Slovenian: 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).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets)
Slovenian: Pretisni omot (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 filmsko obložena tableta ) 1.
English: Haematoma
Slovenian: OVOJNINAH
English: Package leaflet: Information for the user Clopidogrel Teva 75 mg film-coated tablets clopidogrel
Slovenian: Navodilo za uporabo Klopidogrel Teva 75 mg filmsko obložene tablete klopidogrel
English: 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
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel Teva 3.
English: The EMA will evaluate the results of this study as soon as they are available.
Slovenian: Evropska agencija za zdravila bo rezultate študije ocenila takoj, ko bodo na voljo.
English: 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.
Slovenian: Pregled zdravila Iclusig se je pričel 27. novembra 2013 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: • If you have any questions or concerns, you should consult your doctor or another healthcare professional.
Slovenian: • Če imate kakršna koli vprašanja ali pomisleke, se posvetujte z zdravnikom ali drugim zdravstvenim delavcem.
English: Therefore, the recommended starting dose of Iclusig should remain 45 mg once a day.
Slovenian: Priporočen začetni odmerek zdravila Iclusig tako ostaja 45 mg enkrat dnevno.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 October 2014 EMA/641476/2014
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Iclusig was authorised as an orphan medicine (a medicine to treat rare diseases) in the EU in July
Slovenian: Zdravilo Iclusig je bilo julija 2013 v EU odobreno kot zdravilo sirota (zdravilo za zdravljenje redkih bolezni).
English: • chronic myeloid leukaemia (CML);
Slovenian: • kronično mieloično levkemijo (KML);
English: • Educational material will be provided to healthcare professionals, highlighting important risks for which monitoring and/or dose adjustments are recommended.
Slovenian: • Zdravstvenim delavcem bo zagotovljeno izobraževalno gradivo, v katerem bodo izpostavljena pomembna tveganja, za katera se priporoča spremljanje in/ali prilagoditev odmerka.
English: • If a reduced dose of Iclusig is used, doctors should monitor patients for maintenance of therapeutic response.
Slovenian: • Če se uporabi zmanjšan odmerek zdravila Iclusig, morajo zdravniki spremljati, ali se pri bolnikih ohrani terapevtski odziv.
English: 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).
Slovenian: 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).
English: This study has been imposed as a condition of the marketing authorisation for Iclusig.
Slovenian: Ta študija je bila določena kot pogoj za izdajo dovoljenja za promet z zdravilom Iclusig.
English: 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.
Slovenian: Prav tako se uporablja pri bolnikih z genetsko mutacijo, imenovano mutacija T315I, zaradi katere so odporni na zdravljenje z imatinibom, dasatinibom ali nilotinibom.
English: The review of Iclusig was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Pregled zdravila Iclusig je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji.
English: 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.
Slovenian: 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.
English: The CHMP opinion will be sent to the European Commission, which will issue a legally binding decision valid throughout the EU in due course.
Slovenian: CHMP je svoje mnenje poslal Evropski komisiji, ki je 15. januarja 2015 izdala pravno zavezujoč sklep, veljaven po vsej EU.
English: • 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.
Slovenian: • 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.
English: • Treatment with Iclusig should be stopped if a complete haematologic response has not occurred by three months.
Slovenian: • Zdravljenje z zdravilom Iclusig je treba prekiniti, v kolikor v treh mesecih ne pride do popolnega hematološkega odziva.
English: The review followed a previous assessment of clinical trial data which indicated that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the medicine's initial authorisation.
Slovenian: Pregled je sledil predhodni oceni podatkov iz kliničnih preizkušanj, ki so kazali, da je do primerov krvnih strdkov in zapor arterij ali ven prihajalo pogosteje, kot je bilo opaženo ob izdaji prvotnega dovoljenja za promet.
English: Additionally, healthcare professionals should stop Iclusig if a complete response has not occurred within three months of treatment, and should monitor patients for high blood pressure or signs of heart problems.
Slovenian: Poleg tega bi morali zdravstveni delavci zdravljenje z zdravilom Iclusig prekiniti, v kolikor po treh mesecih zdravljenja ne pride do popolnega odziva, ter spremljati, ali se pri bolnikih pojavijo visok krvni tlak ali znaki težav s srcem.
English: During its review, the PRAC assessed available data on the nature, frequency and severity of blood clots or blockage of the arteries or veins and considered the potential mechanism for these side effects.
Slovenian: V okviru pregleda je odbor PRAC ocenil razpoložljive podatke o značaju, pogostnosti in resnosti krvnih strdkov in zapor arterij ali ven ter obravnaval morebitne mehanizme za razvoj teh neželenih učinkov.
English: • Treatment with Iclusig will usually be stopped if there is insufficient beneficial response within three months, or if you develop heart or circulatory problems during treatment.
Slovenian: • Zdravljenje z zdravilom Iclusig se navadno prekine, če v treh mesecih ne pride do zadostnega koristnega odziva ali se med zdravljenjem pojavijo težave s srcem ali obtočili.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Slovenian: Opravil ga je Odbor za oceno tveganja na področju farmakovigilance (PRAC), pristojni odbor za ocenjevanje vprašanj glede varnosti zdravil za uporabo v humani medicini, ki je nato oblikoval niz priporočil.
English: • Iclusig is a medicine used for the treatment of leukaemia, a type of cancer that affects white blood cells.
Slovenian: • Zdravilo Iclusig se uporablja za zdravljenje levkemije, vrste raka, ki prizadene bele krvničke.
English: The PRAC also sought the advice of a group of experts in oncology before finalising its recommendations, which have now been endorsed by the Agency's Committee for Medicinal Products for Human Use (CHMP) in its final opinion.
Slovenian: Odbor PRAC se je pred dokončanjem svojih priporočil posvetoval s skupino izvedencev na področju onkologije, ta priporočila pa je nato v svojem končnem mnenju podprl Odbor za zdravila v humani medicini (CHMP) pri agenciji.
English: Iclusig is a medicine used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Slovenian: Zdravilo Iclusig se uporablja za zdravljenje odraslih z naslednjimi vrstami levkemije (raka belih krvničk):
English: Ponatinib works by blocking a tyrosine kinase (an enzyme) called Bcr-Abl, which is found in some receptors on the surface of the cancer cells where it is involved in stimulating the cells to divide uncontrollably.
Slovenian: Ponatinib deluje tako, da zavira tirozin-kinazo (encim), imenovano Bcr-Abl, ki se nahaja v nekaterih receptorjih na površini rakavih celic, kjer sodeluje pri spodbujanju njihovega nenadzorovanega razmnoževanja.
English: The available evidence shows that the risk of blood vessel blockage with Iclusig is likely to be doserelated, however the data are insufficient to formally recommend the use of lower doses of Iclusig, and there is a risk that lower doses might not be as effective in all patients and in long-term treatment.
Slovenian: Razpoložljivi dokazi kažejo, da je tveganje za zaporo žil ob uporabi zdravila Iclusig verjetno povezano z odmerkom, vendar podatki ne zadostujejo, da bi uradno priporočili uporabo nižjih odmerkov zdravila Iclusig, poleg tega pa obstaja tveganje, da nižji odmerki ne bi bili tako učinkoviti pri vseh bolnikih in pri dolgotrajnem zdravljenju.
English: Dose modifications or treatment interruption (temporary or permanent) should be considered to manage treatment toxicity.
Slovenian: Za obvladovanje toksičnosti zdravljenja je treba pretehtati prilagoditev odmerka ali prekinitev zdravljenja (začasno ali trajno).
English: • The risk of vascular occlusive events with Iclusig is likely to be dose-related; however, the currently available data on the dose-efficacy and dose-toxicity relationship are not sufficient to make a formal recommendation on dose reduction, and there is a risk that lower doses might have reduced efficacy.
Slovenian: • Tveganje dogodkov žilne okluzije pri uporabi zdravila Iclusig je verjetno povezano z odmerkom, vendar pa trenutno razpoložljivi podatki o razmerju med odmerkom in učinkovitostjo ter odmerkom in toksičnostjo ne zadostujejo za uradno priporočilo o zmanjšanju odmerkov; poleg tega obstaja pri manjših odmerkih tveganje zmanjšane učinkovitosti.
English: The European Medicines Agency (EMA) has concluded its review of the benefits and risks of Iclusig (ponatinib), a medicine used for the treatment of leukaemia (cancer of the white blood cells), and has recommended strengthened warnings in the product information aimed at minimising the risk of blood clots and blockages in the arteries.
Slovenian: Evropska agencija za zdravila je 23. oktobra 2014 zaključila pregled koristi in tveganj, povezanih z zdravilom Iclusig (ponatinib), ki se uporablja za zdravljenje levkemije (raka belih krvničk), in priporočila okrepitev opozoril v informacijah o zdravilu, namenjenih zmanjšanju tveganja za nastanek krvnih strdkov in zaporo arterij.
English: Iclusig is authorised for use in patients with chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL) who cannot take or tolerate several other medicines of the same class (known as ‘tyrosine-kinase inhibitors').
Slovenian: Zdravilo Iclusig je odobreno za uporabo pri bolnikih s kronično mieloično levkemijo (KML) in akutno limfoblastno levkemijo (ALL), ki ne morejo jemati več drugih zdravil istega razreda (znanih pod imenom „zaviralci tirozin-kinaze“) oziroma teh zdravil ne prenašajo.
English: Iclusig is used in patients who cannot tolerate or do not respond to dasatinib or nilotinib (other medicines for the treatment of leukaemia) and for whom subsequent treatment with imatinib is not considered appropriate.
Slovenian: Zdravilo Iclusig se uporablja pri bolnikih, ki ne prenašajo desatiniba ali nilotiniba (drugih zdravil za zdravljenje levkemije) oziroma se nanju ne odzivajo ali za katere nadaljnje zdravljenje z imatinibom ne velja za primerno.
English: The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine-kinase inhibitors'.
Slovenian: Zdravilna učinkovina zdravila Iclusig, ponatinib, spada v skupino zdravil, imenovanih zaviralci tirozinkinaze.
English: The company that markets Iclusig will provide healthcare professionals with educational material highlighting important risks for which monitoring and/or dose adjustments are recommended and including available data on the relationship between dose of Iclusig and risk of blood vessel blockage.
Slovenian: Družba, ki trži zdravilo Iclusig, bo zdravstvenim delavcem zagotovila izobraževalno gradivo, ki bo izpostavilo pomembna tveganja, za katera se priporoča spremljanje in/ali prilagoditev odmerka, ter vključevalo razpoložljive podatke o razmerju med odmerkom zdravila Iclusig in tveganjem za zaporo žil.
English: • Safety and efficacy data concerning dose reduction following major cytogenetic response in chronic phase CML patients have been included in the SmPC, to provide information to the prescriber and to facilitate an individual assessment of the benefit-risk balance of Iclusig with regards to dose reduction.
Slovenian: • V povzetek glavnih značilnosti zdravila so bili vključeni podatki o varnosti in učinkovitosti ob zmanjšanju odmerka pri bolnikih s KML v kronični fazi po velikem citogenetskem odzivu, da bi zagotovili informacije za zdravnike, ki predpisujejo zdravilo, ter olajšali individualno oceno razmerja med koristmi in tveganji zdravila Iclusig ob zmanjšanju odmerka.