FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Pregled je uslijedio nakon prethodne ocjene podataka kliničkog ispitivanja koji ukazuju da su slučajevi krvnih ugrušaka i okluzija u arterijama ili venama nastupili u većem broju nego što je to uočeno u trenutku prvotnog odobrenja za stavljanje u promet lijeka.
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.
Croatian: • Terapija lijekom Iclusig obično se prekida ako unutar tri mjeseca nema dovoljno povoljnog odgovora ili ako se tijekom liječenja razviju srčani problemi ili problemi s cirkulacijom.
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.
Croatian: Koristi se također za liječenje bolesnika koji imaju genetsku mutaciju naziva „mutacija T315I” što ih čini otpornima na terapiju imatinibom, dasatinibom ili nilotinibom.
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.
Croatian: Nadalje, zdravstveni djelatnici trebaju prekinuti terapiju lijekom Iclusig ako nije nastupio potpuni odgovor unutar tri mjeseca terapije, te trebaju pratiti bolesnike kako bi uočili visoki krvni tlak ili znakove srčanih problema.
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.
Croatian: Pregled je proveo Odbor za ocjenu rizika na području farmakovigilancije (PRAC), odbor odgovoran za ocjenu sigurnosnih pitanja vezana za lijekove za humanu uporabu, koje je donio niz preporuka.
English: The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Croatian: Preporuke PRAC-a dostavljene su Odboru za lijekove za humanu uporabu (CHMP), odgovornom za pitanja vezana za lijekove za humanu uporabu, koji je usvojio konačno mišljenje Agencije.
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.
Croatian: Europska agencija za lijekove (EMA) zaključila je svoj pregled koristi i rizika lijeka Iclusig (ponatinib), lijeka koji se koristi za liječenje leukemije (raka bijelih krvnih stanica), te je preporučila navođenje strožih upozorenja u informacijama o lijeku u cilju smanjenja rizika od ugrušaka krvi i okluzija u arterijama.
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.
Croatian: Iclusig se koristi u bolesnika koji ne podnose ili ne odgovaraju na terapiju dasatinibom ili nilotinibom (ili drugim lijekovima za liječenje leukemije) te za koje se naredna terapija imatinibom ne smatra primjerenom.
English: This study has been imposed as a condition of the marketing authorisation for Iclusig.
Croatian: to je ispitivanje postavljeno kao uvjet za izdavanje odobrenja za stavljanje u promet lijeka Iclusig.
English: Iclusig is a medicine used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Croatian: Iclusig je lijek koji se koristi za liječenje odraslih osoba sa sljedećim tipovima leukemije (rakom bijelih krvnih stanica):
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').
Croatian: Iclusig je odobren za primjenu u bolesnika s kroničnom mijeloidnom leukemijom (KML) i akutnom limfoblastičnom leukemijom (ALL) koji ne mogu uzimati ili ne podnose nekoliko drugih lijekova iste kategorije (poznati pod nazivom „inhibitori tirozin-kinaze”).
English: The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine-kinase inhibitors'.
Croatian: Djelatna tvar lijeka Iclusig, ponatinib, ubraja se u grupu lijekova naziva „inhibitori tirozin-kinaze”.
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.
Croatian: Ponatinib djeluje blokirajući tirozin kinazu (enzim) naziva Bcr-Abl, koji je prisutan u određenim receptorima na površini stanica raka gdje je uključen u poticanje stanica na nekontroliranu diobu.
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).
Croatian: Bolesnici liječeni lijekom Iclusig mogu biti izloženi povećanom riziku od nastanka krvnih ugrušaka i okluzija u krvnim žilama, što može imati ozbiljne posljedice (poput infarkta miokarda ili moždanog udara).
English: • acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive' (Ph+).
Croatian: • akutnom limfoblastičnom leukemijom (ALL) u bolesnika s „pozitivnim philadelphia kromosomom”
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.
Croatian: Tijekom tog pregleda PRAC je ocijenio dostupne podatke o prirodi, učestalosti i ozbiljnosti krvnih ugrušaka ili okluzija arterija ili vena, te je razmotrio potencijalan mehanizam tih nuspojava.
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.
Croatian: Svaka ocjena povezana sa smanjenjem doze treba uzeti u obzir niz čimbenika, uključujući kardiovaskularni rizik bolesnika, nuspojave terapije kao i vrijeme citogenetskog odgovora.
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.
Croatian: Dostupni dokazi pokazuju kako je izgledna povezanost rizika od okluzije krvnih žila s dozom lijeka Iclusig, no podaci nisu dostatni da bi se mogla službeno preporučiti primjena manjih doza lijeka Iclusig, te postoji rizik da manje doze možda neće biti djelotvorne u svih bolesnika i dugoročnoj terapiji.
English: • Iclusig is a medicine used for the treatment of leukaemia, a type of cancer that affects white blood cells.
Croatian: • Iclusig je lijek koji se koristi za liječenje leukemije, tipa raka koji zahvaća bijele krvne stanice.
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.
Croatian: • Izgledno je da je rizik od vaskularnih okluzivnih događaja pri primjeni lijeka Iclusig povezan s dozom, no trenutno dostupni podaci o odnosu djelotvornosti doze i toksičnosti doze nisu dostani da bi se donijela službena preporuka o smanjenju doze, te postoji rizik da manje doze mogu imati smanjenu djelotvornost.
English: Dose modifications or treatment interruption (temporary or permanent) should be considered to manage treatment toxicity.
Croatian: Za potrebe upravljanja toksičnošću terapije treba razmotriti modifikacije doze ili prekid terapije (privremeni ili trajni).
English: A study on the safety and benefits of Iclusig is also planned, to help clarify if lower doses of the medicine would carry a lower risk of blood clots or blockages of the blood vessels while still having a beneficial effect in patients with chronic phase CML.
Croatian: Planirano je i ispitivanje o sigurnosti i koristima lijeka Iclusig kako bi se razjasnilo imaju li manje doze lijeka manji rizik od krvnih ugrušaka ili okluzija krvnih žila, a da pritom još uvijek imaju korisno djelovanje za bolesnike s KML-om u kroničnoj fazi.
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.
Croatian: Tvrtka koja stavlja u promet lijek Iclusig dostavit će zdravstvenim djelatnicima edukacijske materijale u kojima se naglašavaju važni rizici kod kojih se preporuča praćenje i/ili prilagođavanje doze, te koji obuhvaćaju dostupne podatke o vezi između doze lijeka Iclusig i rizika okluzije krvnih žila.
English: The product information will be updated with strengthened warnings about the risks with Iclusig, and to also provide healthcare professionals with the latest evidence in case they wish to consider reducing the dose of Iclusig in patients with ‘chronic phase' CML who are responding well to treatment, and who might be at particular risk of blood vessel blockage.
Croatian: Informacije o lijeku ažurirane su strožim upozorenjima o rizicima lijeka Iclusig, te također pružaju zdravstvenim djelatnicima najnovije dokaze ako žele razmisliti o smanjivanju doze lijeka Iclusig u bolesnika s KMLom u „kroničnoj fazi” koji dobro odgovaraju na terapiju, te koji bi mogli biti posebice izloženi riziku od okluzije krvnih žila.
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.
Croatian: • Podaci o sigurnoj primjeni i djelotvornosti vezani uz smanjenje doze nakon značajnog citogenog odgovora u bolesnika s KML-om u kroničnoj fazi uključeni su u sažetak opisa svojstava lijeka kako bi se propisivačima pružile informacije i omogućila im se individualna ocjena omjera koristi i rizika lijeka Iclusig vezano uz smanjenje doze.
English: The cardiovascular status of the patient should be assessed before starting therapy with Iclusig, and regularly monitored during treatment.
Croatian: Prije početka terapije lijekom Iclusig treba ocijeniti kardiovaskularni status bolesnika, te je potrebno redovito pratiti liječenje.
English: A dose-ranging study will be conducted in patients with chronic phase CML in order to determine the optimal starting dose of Iclusig and characterise the safety and efficacy of Iclusig following dose reduction after achieving major cytogenetic response.
Croatian: Ispitivanje raspona doze provest će se u bolesnika s KML-om u kroničnoj fazi kako bi se utvrdila optimalna početna doza lijeka Iclusig i opisala sigurna primjena i djelotvornost lijeka Iclusig nakon smanjenja doze poslije postizanja značajnog citogenetskog odgovora.
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.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj komisiji koja je donijela pravno obvezujuću odluku primjenjivu na razini EU-a 15. siječnja 2015.
English: The material will also provide the available evidence regarding the safety and efficacy of ponatinib when dose is reduced in patients with chronic phase CML who have achieved major cytogenetic response.
Croatian: U materijalima će se navesti i dostupni podaci vezani uz sigurnu primjenu i djelotvornost ponatiniba pri smanjivanju doze u bolesnika s KML-om u kroničnoj fazi kod kojih je postignut značajan citogenetski odgovor.
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.
Croatian: Prije donošenja konačnih preporuka PRAC je također potražio savjet grupe stručnjaka s područja onkologije.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final decision in due course.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj komisiji, koja je donijela pravno obvezujuću odluku na razini EU-a 15. siječnja 2015.
English: Patients should not eat for at least two hours before and one hour after their dose of Cometriq.
Croatian: Bolesnici ne smiju jesti najmanje dva sata prije i jedan sat nakon što uzmu svoju dozu lijeka Cometriq.
English: Cometriq is available as capsules (20 and 80 mg).
Croatian: Cometriq je dostupan kao kapsule (20 i 80 mg).
English: Cometriq cabozantinib
Croatian: Cometriq kabozantinib
English: The side effects were considered manageable and were acceptable, compared with the limited other treatment options available.
Croatian: Nuspojave se smatraju upravljivima i prihvatljivima, u usporedbi s dostupnim ograničenim drugim opcijama za liječenje.
English: The recommended dose is 140 mg once a day, taken as one 80-mg and three 20-mg capsules.
Croatian: Preporučena doza iznosi 140 mg jednom na dan, a uzima se kao jedna kapsula od 80 mg i tri kapsule od 20 mg.
English: However, the Committee noted that many patients required reductions in their dose and recommended that the company should study whether starting at lower doses would still be effective but would have fewer side effects.
Croatian: Odbor je napomenuo da je u velikog broja bolesnika potrebno smanjivanje doze, te je preporučio da tvrtka ispita bi li započinjanje terapije s manjim dozama bilo djelotvorno, te bi li imalo manji broj nuspojava.
English: By blocking the activity of these receptors in cancer cells, the medicine reduces the growth and spread of the cancer.
Croatian: Inhibirajući djelovanje tih receptora u stanicama raka, lijek smanjuje rast i širenje raka.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom due to side effects, especially during the first eight weeks of therapy.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom terapije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cometriq on 21 March 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Cometriq na snazi u Europskoj uniji od 21. ožujka 2014.
English: The main measure of effectiveness was progression-free survival (how long the patients lived before their disease got worse): in patients given Cometriq this was 11.2 months, compared with 4.0 months in those given placebo.
Croatian: Glavna mjera djelotvornosti bilo je razdoblje koje su bolesnici preživjeli bez pogoršanja bolesti: u bolesnika koji su uzimali lijek Cometriq to je razdoblje iznosilo 11,2 mjeseca, u usporedbi s 4,0 mjeseci kod osoba koje su uzimale placebo.
English: Cometriq has been given ‘conditional approval'.
Croatian: Za lijek Cometriq izdano je „uvjetno odobrenje”.
English: This is a summary of the European public assessment report (EPAR) for Cometriq.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Cometriq.
English: What measures are being taken to ensure the safe and effective use of Cometriq?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cometriq?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cometriq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Cometriq nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Since Cometriq has been granted a conditional approval, the company that markets Cometriq will provide information from a study comparing the safety and effectiveness of different doses of Cometriq, and its benefit in patients lacking the RET gene mutation or whose cancer has changes in another family of genes called RAS.
Croatian: Budući da je lijek Cometriq dobio uvjetno odobrenje, tvrtka koja lijek Cometriq stavlja na tržište mora dostaviti informacije iz ispitivanja kojima se uspoređuju sigurnost i djelotvornost različitih doza lijeka Cometriq i njegove koristi u bolesnika kojima nedostaje mutacija gena RTE ili čiji rak ima promjene u drugoj obitelji gena naziva RAS.
English: Cometriq was given once a day in an initial dose of 140 mg (reduced if necessary due to side effects) and compared with placebo (a dummy treatment).
Croatian: Cometriq se uzimao jednom na dan u početnoj dozi od 140 mg (doza se smanjivala zbog nuspojava) i usporedio se s placebom (prividnim liječenjem).
English: These enzymes can be found in certain receptors (such as VEGF, MET and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer.
Croatian: Ti se enzimi nalaze u određenim receptorima (poput receptora VEGF, FGFR i RET) u stanicama raka, gdje aktiviraju nekoliko procesa, uključujući diobu stanica i rast novih krvnih žila za opskrbu raka.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Cometriq dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Cometriq and what is it used for?
Croatian: Što je Cometriq i za što se koristi?
English: Because the number of patients with medullary thyroid cancer is low, the disease is considered ‘rare', and Cometriq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 February
Croatian: Budući da je broj bolesnika s medularnim karcinomom štitnjače nizak, ta se bolest smatra „rijetkom” te se Cometriq označava kao lijek za liječenje rijetkih bolesti od 6. veljače 2009.
English: A risk management plan has been developed to ensure that Cometriq is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Cometriq.
English: This means that it blocks the activity of enzymes known as tyrosine kinases.
Croatian: To znači da inhibira određene enzime poznate pod nazivom tirozinske kinaze.
English: Other information about Cometriq
Croatian: Ostale informacije o lijeku Cometriq
English: It is not intended to provide practical advice on how to use Cometriq.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Cometriq.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cometriq, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Cometriq nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The full EPAR and risk management plan summary for Cometriq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Cometriq kao i sažetak plana upravljanja rizikom za lijek Cometriq nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Cometriq should be used with care in patients taking certain other medicines that affect the way it is broken down in the body.
Croatian: Cometriq treba pažljivo primjenjivati u bolesnika koji uzimaju određene druge lijekove koji imaju učinak na njegovu razgradnju u tijelu.
English: It is used to treat adults with medullary thyroid cancer, a type of cancer originating in the cells in the thyroid gland that produce the hormone calcitonin.
Croatian: Koristi se za liječenje odraslih osoba oboljelih od medularnog karcinoma štitnjače, tipa raka koji potječe iz stanica štitnjače koje proizvode hormon kalcitonin.
English: The benefits of Cometriq may be smaller for patients whose cancer does not have a mutation in a gene called the ‘re-arranged during transfection' (RET) gene, and this should be taken into account when deciding whether to start treatment.
Croatian: Koristi od lijeka Cometriq mogu biti manje u bolesnika čiji rak nema mutaciju u genu naziva gen „presložen tijekom transfekcije” (RET), te se isto mora uzeti u obzir pri donošenju pojedinačne odluke o liječenju.
English: The active substance in Cometriq, cabozantinib, is a tyrosine kinase inhibitor.
Croatian: Djelatna tvar lijeka Cometriq, kabozantinib, inhibitor je tirozinske kinaze.
English: What are the risks associated with Cometriq?
Croatian: Koji su rizici povezani s lijekom Cometriq?
English: The dose may need to be reduced or stopped temporarily
Croatian: Dozu će možda biti potrebno smanjiti ili će terapiju biti potrebno privremeno prekinuti zbog nuspojava, posebice tijekom prvih osam tjedana
English: Cometriq is used when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body.
Croatian: Cometriq se primjenjuje u slučajevima kada se rak ne može ukloniti kirurškim zahvatom, te ukoliko je uznapredovao ili se proširio u druge dijelove tijela.
English: For more information about treatment with Cometriq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Cometriq pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: Why is Cometriq approved?
Croatian: Zašto je lijek Cometriq odobren?
English: Cometriq is a cancer medicine that contains the active substance cabozantinib.
Croatian: Cometriq je lijek protiv raka koji sadrži djelatnu tvar kabozantinib.
English: Treatment is continued until the patient no longer benefits from it or side effects become unacceptable.
Croatian: Liječenje mora trajati sve dok bolesnik ima kliničku korist od terapije ili do pojave neprihvatljivih nuspojava.
English: Cometriq has been shown to be effective in one main study involving 330 adults with medullary thyroid cancer that could not be treated with surgery and was extensive or had spread to other parts of the body.
Croatian: Djelotvornost lijeka Cometriq dokazana je u jednom glavnom ispitivanju koje je obuhvatilo 330 odraslih osoba s medularnim karcinomom štitnjače koji se nije mogao izliječiti kirurškim zahvatom i koji je bio opsežan ili se proširio na druge dijelove tijela.