FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Kadcyla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Kadcyla nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients may remain on treatment unless the disease gets worse or unless they no longer tolerate treatment.
Croatian: Bolesnici mogu ostati na terapiji osim ako dođe do pogoršanja bolesti ili ako više ne podnose terapiju.
English: Other information about Kadcyla
Croatian: Ostale informacije o lijeku Kadcyla
English: Kadcyla trastuzumab emtansine
Croatian: Kadcyla trastuzumab emtansin
English: This is a summary of the European public assessment report (EPAR) for Kadcyla.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Kadcyla.
English: It is not intended to provide practical advice on how to use Kadcyla.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Kadcyla.
English: • DM1, a toxic substance that kills cells when they attempt to divide and grow.
Croatian: • DM1, toksične tvari koja ubija stanice raka kad se pokušaju podijeliti i rasti.
English: What measures are being taken to ensure the safe and effective use of Kadcyla?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kadcyla?
English: What is Kadcyla and what is it used for?
Croatian: Što je Kadcyla i za što se koristi?
English: In one main study, which involved 991 such patients, those treated with Kadcyla lived on average for 9.6 months without their disease getting worse compared with 6.4 months for patients who were treated with two other anti-cancer medicines, capecitabine and lapatanib.
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo 991 takvih bolesnika, bolesnici liječeni lijekom Kadcyla živjeli su prosječno 9,6 mjeseci bez pogoršanja bolesti u usporedbi sa 6,4 mjeseci u bolesnika koji su liječeni s dva druga lijeka protiv raka, kapecitabinom i lapatanibom.
English: In patients who develop allergic reactions or side effects, the treating doctor may have to reduce the dose or stop treatment with Kadcyla.
Croatian: U bolesnika koji razviju alergijske reakcije ili nuspojave, liječnik koji provodi terapiju možda će morati smanjiti dozu ili obustaviti liječenje lijekom Kadcyla.
English: Patients treated with Kadcyla also survived for 31 months compared with 25 months for patients treated with capecitabine and lapatinib.
Croatian: Bolesnici liječeni lijekom Kadcyla također su preživjeli 31 mjesec u usporedbi s 25 mjeseci kod bolesnika liječenih kapecitabinom i lapatanibom.
English: Because of a potential risk of confusion between Kadcyla and Herceptin due to their similar sounding active substances (trastuzumab emtansine and trastuzumab) the company will provide educational material to all healthcare professionals expected to use Kadcyla or Herceptin to alert them not to use these medicines interchangeably and to inform them of measures they should take to avoid medication errors.
Croatian: Zbog mogućeg rizika od zabune između lijekova Kadcyla i Herceptin zbog njihovih djelatnih tvari koje slično zvuče (trastuzumab emtansin i trastuzumab), tvrtka će dostaviti edukacijske materijale svim stručnim zdravstvenim radnicima koji bi mogli koristiti lijekove Kadcyla i Herceptin s upozorenjem da te lijekove ne koriste kao zamjenu jednog za drugi te s informacijama o mjerama koje moraju poduzeti za izbjegavanje medicinske pogreške.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kadcyla on 15.11.2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Kadcyla na snazi u Europskoj uniji od 15. studenoga 2013.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kadcyla'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 Kadcyla nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: About a quarter of breast cancers overexpress HER2.
Croatian: Otprilike četvrtina karcinoma dojke pokazuje prekomjernu izraženost biljega HER2.
English: Patients should be observed during and after the infusion for any infusion-related reactions such as flushing, shivering fits and fever.
Croatian: Bolesnike treba nadzirati tijekom i nakon infuzije zbog mogućih reakcija na infuziju poput crvenila, napada drhtavice i vrućice.
English: The most common serious side effects are haemorrhage (bleeding), pyrexia (fever), dyspnoea (difficulty breathing), musculoskeletal pain (pain in muscles and bones), thrombocytopenia (low blood platelet counts), abdominal pain (stomach ache), and vomiting.
Croatian: Najčešće ozbiljne nuspojave su hemoragija (krvarenje), pireksija (vrućica), dispneja (teškoće pri disanju), muskuloskeletni bolovi (bolovi u mišićima i kostima), trombocitopenija (nizak broj trombocita), abdominalna bol (bol u trbuhu) i povraćanje.
English: • Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein HER2, which is found in large quantities on the surface of some cancer cells.
Croatian: • trastuzumaba, monoklonalnog protutijela (vrste bjelančevine) koje je osmišljeno da prepozna i veže se na HER2, koji se u velikim količinama nalazi na površini nekih stanica raka.
English: The most common side effects with Kadcyla (which may affect more than 25% of patients) are nausea (feeling sick), fatigue (tiredness) and headache.
Croatian: Najčešće nuspojave lijeka Kadcyla (koje se mogu javiti kod više od 25% bolesnika) su mučnina (osjećaj slabosti), umor (iscrpljenost) i glavobolja.
English: A risk management plan has been developed to ensure that Kadcyla is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Kadcyla.
English: What are the risks associated with Kadcyla?
Croatian: Koji su rizici povezani s lijekom Kadcyla?
English: Why is Kadcyla approved?
Croatian: Zašto je lijek Kadcyla odobren?
English: Kadcyla is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Kadcyla je dostupan kao prašak koji se koristi za pripremu otopine za infuziju (drip) u venu.
English: It is used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in adults who previously received trastuzumab and a taxane (type of cancer medicine).
Croatian: Koristi se za liječenje uznapredovalog metastatskog raka dojke (raka koji se proširio na druge dijelove tijela) u odraslih koji su prethodno primali trastuzumab i taksan (vrsta lijeka protiv raka).
English: The active substance in Kadcyla, trastuzumab emtansine, is made up of two active components which are linked together:
Croatian: Djelatna tvar u lijeku Kadcyla, trastuzumab emtansin, sastoji se od dvije aktivne i povezane komponente:
English: Regarding Kadcyla's safety, overall side effects were considered to be manageable and the overall safety profile was considered favorable compared with other currently available medicines.
Croatian: U pogledu sigurnost lijeka Kadcyla, smatralo se da se sveukupne nuspojave mogu kontrolirati te je cjelokupan sigurnosni profil procijenjen kao povoljan u usporedbi s drugim lijekovima trenutno na raspolaganju.
English: Kadcyla can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer cell produces on its surface large quantities of a protein which stimulates the growth of the cancer cell and is called HER2 (human epidermal growth factor).
Croatian: Kadcyla se može koristiti samo kada je utvrđeno da rak ima prekomjerno izražen HER2 biljeg: to znači da stanice raka na svojoj površini proizvode velike količine bjelančevine koja stimulira rast stanica raka naziva HER2 (human epidermal growth factor).
English: It attaches to a protein in cells called ‘tubulin', which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Croatian: Veže se na bjelančevinu u stanicama naziva „tubulin”, koja je važna za formiranje unutarnjeg „kostura” koji stanice trebaju oformiti prilikom podjele.
English: Trastuzumab also stops HER2 from stimulating the growth of the cancer cells.
Croatian: Trastuzumab također sprječava HER2 u stimulaciji rasta stanica raka.
English: DM1 becomes active once Kadcyla enters the cancer cell.
Croatian: DM1 se aktivira tek kad Kadcyla uđe u stanicu raka.
English: Kadcyla has been shown to significantly delay disease getting worse and to prolong survival in patients with advanced and metastatic breast cancer that expressed HER2 and who were previously treated with trastuzumab and a taxane.
Croatian: Pokazalo se da Kadcyla značajno odgađa pogoršanje bolesti te da produžava preživljenje bolesnika s uznapredovalim i metastatskim rakom dojke s izraženim biljegom HER2 koji su prethodno liječeni trastuzumabom i taksanom.
English: For more information about treatment with Kadcyla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Kadcyla pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the cancer cells.
Croatian: Vezivanjem na HER2, trastuzumab aktivira djelovanje stanica imunosnog sustava, koje zatim ubijaju stanice raka.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kadcyla, 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 Kadcyla nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine.
Croatian: Kadcyla je lijek protiv karcinoma koji sadrži djelatnu tvar trastuzumab emtansin.
English: By attaching to tubulin in cancer cells, DM1 stops the formation of this skeleton, preventing the division and growth of the cancer cells.
Croatian: Vezanjem za tubulin u stanicama raka, DM1 sprječava formiranje tog „kostura”, čime sprječava podjelu i rast stanica raka.
English: How does Kadcyla work?
Croatian: Kako djeluje Kadcyla?
English: The CHMP considered that in patients treated with Kadcyla, there was a significant improvement in survival compared with standard therapy.
Croatian: Stajalište je CHMP-a da je kod bolesnika liječenih lijekom Kadcyla došlo do znatnog produljenja preživljenja u usporedbi sa standardnom terapijom.
English: What benefits of Kadcyla have been shown in studies?
Croatian: Koje su koristi lijeka Kadcyla utvrđene u ispitivanjima?
English: For practical information about using Kadcyla, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Kadcyla pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Kadcyla used?
Croatian: Kako se Kadcyla koristi?
English: Kadcyla can only be obtained with a prescription and treatment should be prescribed by a doctor and given under the supervision of a healthcare professional who is experienced in the treatment of cancer patients.
Croatian: Terapiju se mora provoditi pod nadzorom stručnog zdravstvenog radnika s iskustvom u liječenju bolesnika od raka.
English: For the full list of all side effects reported with Kadcyla, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Kadcyla potražite u uputi o lijeku.
English: Further information on Viekirax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Viekirax možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is two tablets taken once a day with food for 8, 12 or 24 weeks.
Croatian: Preporučena je doza dvije tablete jedanput dnevno uz obrok tijekom 8, 12 ili 24 tjedana.
English: This slows the removal of paritaprevir from the body, allowing paritaprevir to act against the virus for longer.
Croatian: Time se usporava uklanjanje paritaprevira iz organizma, čime se paritapreviru omogućava dulje djelovanje protiv virusa.
English: It must also not be used together with medicines that can raise or lower the levels of Viekirax's active substances in the blood.
Croatian: Također se ne smije primjenjivati zajedno s lijekovima koji mogu povisiti ili sniziti razinu djelatnih tvari lijeka Viekirax u krvi.
English: What measures are being taken to ensure the safe and effective use of Viekirax?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Viekirax?
English: Viekirax is available as tablets containing 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.
Croatian: Viekirax je dostupan u obliku tableta koje sadrže 12,5 mg ombitasvira, 75 mg paritaprevira i 50 mg ritonavira.
English: Viekirax received a marketing authorisation valid throughout the EU on 15 January 2015.
Croatian: Lijek Viekirax dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 15. siječnja 2015.
English: What is Viekirax and what is it used for?
Croatian: Što je Viekirax i za što se primjenjuje?
English: The clearance rate was particularly high in patients infected with genotypes 1b and 4.
Croatian: Stopa čišćenja bila je osobito visoka u bolesnika zaraženih genotipovima 1b i 4.
English: Other information about Viekirax
Croatian: Ostale informacije o lijeku Viekirax
English: Side effects reported with Viekirax are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Viekirax pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Almost all the patients with these genotypes treated in studies had the virus cleared from their blood.
Croatian: U gotovo svih bolesnika s tim genotipovima virusa koji su liječeni u ispitivanju virus se iščistio iz krvi.
English: For more information about using Viekirax, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Viekirax pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: It contains 3 active substances: ombitasvir, paritaprevir and ritonavir.
Croatian: Sadrži tri djelatne tvari: ombitasvir, paritaprevir i ritonavir.
English: The third active substance, ritonavir, does not act directly against hepatitis C virus but it blocks the action of an enzyme called CYP3A that breaks down paritaprevir.
Croatian: Treća djelatna tvar, ritonavir, ne djeluje izravno protiv virusa hepatitisa C, ali blokira aktivnost enzima CYP3A koji razgrađuje paritaprevir.
English: What are the risks associated with Viekirax?
Croatian: Koji su rizici povezani s lijekom Viekirax?
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Croatian: To se ispitivanje provodi uzimajući u obzir podatke koji upućuju na to da bi liječenje tim lijekovima moglo izložiti osobe koje su imale rak jetre opasnosti od ranog povratka raka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Viekirax have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Viekirax nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Why is Viekirax authorised in the EU?
Croatian: Zašto je lijek Viekirax odobren u EU-u?
English: Between 96% and 100% of patients without liver scarring had their blood cleared of the virus after 12 weeks of treatment (with or without ribivarin).
Croatian: Kod 96 % do 100 % bolesnika bez ožiljaka na jetri očišćena je krv od virusa nakon 12 tjedana liječenja (s ribavirinom ili bez njega).
English: The Agency therefore decided that Viekirax's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Viekirax nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: When Viekirax was given with dasabuvir, the virus was cleared from the blood in 91% of the patients.
Croatian: Kad se Viekirax primijenio samo s dasabuvirom, virus se iščistio iz krvi 91 % bolesnika.
English: The most common side effects with Viekirax in combination with dasabuvir and ribavirin (which may affect more than 1 in 5 people) are tiredness and nausea (feeling sick).
Croatian: Najčešće nuspojave lijeka Viekirax u kombinaciji s dasabuvirom i ribavirinom (koje se mogu javiti u više od 1 na 5 osoba) jesu umor i mučnina (osjećaj slabosti).
English: Viekirax is always used in combination with other medicines for chronic hepatitis C, such as dasabuvir and ribavirin.
Croatian: Viekirax se uvijek primjenjuje u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa C, kao što su dasabuvir ili ribavirin.
English: By blocking these proteins, the medicine prevents the hepatitis C virus from multiplying and infecting new cells.
Croatian: Blokiranjem tih bjelančevina lijek zaustavlja umnožavanje virusa hepatitisa C i inficiranje novih stanica.
English: In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Viekirax in combination with dasabuvir was effective in clearing the virus from the blood.
Croatian: U šest početnih glavnih ispitivanja kojima je bilo obuhvaćeno oko 2 300 bolesnika zaraženih virusom hepatitisa C genotipa 1a ili 1b lijek Viekirax je u kombinaciji s dasabuvirom bio djelotvoran u čišćenju virusa iz krvi.
English: As for all medicines, data on the use of Viekirax are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Viekirax kontinuirano se prate.
English: In patients with liver scarring, Viekirax treatment in combination with dasabuvir and ribavirin resulted in a clearance rate of between 93% and 100% after 24 weeks of treatment.
Croatian: U bolesnika s ožiljcima jetre liječenje lijekom Viekirax u kombinaciji s dasabuvirom i ribavirinom rezultiralo je stopom čišćenja krvi od 93 % do 100 % nakon 24 tjedna liječenja.
English: The company that markets Viekirax will carry out a study in patients who have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Viekirax.
Croatian: Tvrtka koja lijek Viekirax stavlja u promet provest će ispitivanje na bolesnicima koji su prethodno imali rak jetre kako bi se procijenio rizik od povratka raka jetre nakon liječenja antivirusnim lijekom s izravnim djelovanjem kao što je Viekirax.
English: Viekirax must not be used in patients with moderate to severe liver impairment and in women taking ethinylestradiol, an oestrogen found in hormonal contraceptives.
Croatian: Viekirax se ne smije primjenjivati u bolesnika s umjerenim do teškim oštećenjem jetre i u žena koje uzimaju etinilestradiol, estrogen koji se nalazi u hormonskim kontracepcijskim sredstvima.
English: In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.
Croatian: U sedmom ispitivanju bolesnici s ožiljcima na jetri, ali stabilnom funkcijom jetre (kompenzirana ciroza) koji su bili zaraženi genotipom 1b liječeni su lijekovima Exvier i Viekirax bez ribavirina, a u 100 % bolesnika (60 od 60 bolesnika) virus se potpuno iščistio iz krvi.
English: An overview of Viekirax and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Viekirax i zašto je odobren u Europskoj uniji
English: Although there were some cases of raised liver enzymes in patients treated with Viekirax in combination with dasabuvir and ribavirin, side effects with this combination were generally well tolerated.
Croatian: Iako postoje slučajevi povišenih jetrenih enzima u bolesnika liječenih lijekom Viekirax u kombinaciji s dasabuvirom i ribavirinom, nuspojave uočene s ovom kombinacijom načelno se dobro podnosilo.
English: Viekirax is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Croatian: Viekirax je protuvirusni lijek koji se koristi u kombinaciji s drugim lijekovima za liječenje odraslih osoba oboljelih od kroničnog (dugotrajnog) hepatitisa C, infektivne bolesti jetre koju uzrokuje virus hepatitisa C.
English: The European Medicines Agency noted that Viekirax in combination with other medicines is effective in clearing the hepatitis C virus genotypes 1a, 1b and 4, including in patients with liver scarring.
Croatian: Europska agencija za lijekove primijetila je da je Viekirax u kombinaciji s drugim lijekovima djelotvoran u čišćenju genotipova 1a, 1b i 4 virusa hepatitisa C, uključujući u bolesnika koji su imali ožiljke na jetri.
English: Viekirax can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing patients with chronic hepatitis C.
Croatian: Viekirax se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik iskusan u liječenju osoba oboljelih od kroničnog hepatitisa C.
English: An additional study showed Viekirax to be effective against genotype 4: when given with ribavirin, Viekirax cleared this genotype from the blood of all the 91 patients infected with it after 12 weeks.
Croatian: Dodatno je ispitivanje pokazalo djelotvornost lijeka Viekirax protiv genotipa 4: kad se primijenio u kombinaciji s ribavirinom, lijek Viekirax iščistio je taj genotip iz krvi svakog od 91 zaraženog bolesnika nakon 12 tjedana.
English: The 3 active substances in Viekirax work in different ways: ombitasvir blocks the action of a protein in the hepatitis C virus called ‘NS5A' and paritaprevir blocks the action of another protein called ‘NS3/4A', both of which the virus needs to multiply.
Croatian: Tri djelatne tvari u lijeku Viekirax različito djeluju: ombitasvir blokira djelovanje bjelančevine u virusu hepatitisa C naziva „NS5A”, a paritaprevir blokira djelovanje druge bjelančevine naziva „NS3/4A”.
English: What benefits of Viekirax have been shown in studies?
Croatian: Koje su koristi od lijeka Viekirax utvrđene u ispitivanjima?
English: How does Viekirax work?
Croatian: Kako djeluje Viekirax?
English: For the full list of side effects and restrictions of Viekirax, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Viekirax potražite u uputi o lijeku.
English: The combination of medicines used and the duration of treatment will depend on the genotype of hepatitis C virus infecting the patient, the nature of the patient's liver problems, for example if they have liver cirrhosis (scarring) or their liver is not working properly, and whether they have received previous treatment.
Croatian: Postoji nekoliko vrsta (genotipova) virusa hepatitisa C, a Viekirax se preporučuje za primjenu u bolesnika zaraženih virusom genotipova 1a, 1b i 4. Kombinacija lijekova koji će se koristiti i trajanje liječenja ovise o genotipu virusa hepatitisa C kojim je bolesnik zaražen, prirodi problema koje ima s jetrom, kao što je ciroza jetre (nastajanje ožiljaka) ili nepravilna funkcija jetre, te o tome je li bolesnik prethodno liječen.