FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study involving 150 patients with Waldenström's macroglobulinaemia, after 26 months, death or signs that the cancer was progressing occurred in 19% of patients who took Imbruvica together with rituximab compared with 56% of patients who took only rituximab.
Croatian: U ispitivanju koje je uključivalo 150 bolesnika s Waldenströmovom makroglobulinemijom, nakon 26 mjeseci u 19 % bolesnika koji su primali lijek Imbruvica u kombinaciji s rituksimabom došlo je do smrti ili napredovanja raka, u usporedbi s 56 % bolesnika koji su primali samo rituksimab.
English: How is Imbruvica used?
Croatian: Kako se Imbruvica primjenjuje?
English: In a study in 229 previously untreated patients, after 31 months, 79% of patients treated with Imbruvica and obinutuzumab were alive with their disease not having progressed compared with 36% of patients who took chlorambucil and obinutuzumab.
Croatian: U ispitivanju na 229 prethodno neliječenih bolesnika, nakon 31 mjeseca, 79 % bolesnika na terapiji lijekovima Imbruvica i obinutuzumab bilo je živo bez pogoršanja bolesti u usporedbi s 36 % bolesnika koji su primali klorambucil i obinutuzumab.
English: In one study in 391 patients whose disease did not respond to or had come back after previous treatment, 66% of patients receiving Imbruvica were still alive after one year with their disease not having progressed compared with around 6% of patients receiving another cancer medicine, ofatumumab.
Croatian: U jednom ispitivanju koje je obuhvatilo 391 bolesnika čija bolest nije reagirala na terapiju ili se vratila nakon prethodne terapije, 66 % bolesnika koji su primali lijek Imbruvica bilo je još uvijek živo nakon godinu dana, pri čemu nije došlo do napredovanja njihove bolesti, u usporedbi s otprilike 6 % bolesnika koji su primali ofatumumab.
English: • Waldenström's macroglobulinaemia (also known as lymphoplasmacytic lymphoma) Imbruvica can be taken alone but can also be taken with bendamustine and rituximab or with obinutuzumab in certain patients with CLL and with rituximab in patients with Waldenström's macroglobulinaemia.
Croatian: Imbruvica se može davati kao monoterapija ili zajedno s bendamustinom i rituksimabom, odnosno s obinutuzumabom u određenih bolesnika s KLL-om te s rituksimabom u bolesnika s Waldenströmovom makroglobulinemijom.
English: In a study involving 269 patients who had not been treated before, around 90% of patients receiving Imbruvica were still alive with their disease not having progressed after 1.5 years of treatment compared with around 52% of patients receiving a cancer medicine called chlorambucil.
Croatian: U ispitivanju koje je obuhvatilo 269 bolesnika koji prethodno nisu liječeni, otprilike 90 % bolesnika koji su primili lijek Imbruvica bilo je još uvijek živo, pri čemu nije došlo do napredovanja njihove bolesti nakon liječenja u trajanju od godinu i pol dana, u usporedbi s otprilike 52 % bolesnika koji su primali lijek protiv raka klorambucil.
English: For the full list of side effects of Imbruvica, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Imbruvica potražite u uputi o lijeku.
English: 3 ml (3.5mg/ml) 1 pre-filled pen
Croatian: 3 napunjene brizgalice
English: It must not be given to pregnant women.
Croatian: Ne smije se primjenjivati u trudnica.
English: The full EPAR for Mvasi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Mvasi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated and the other cancer medicines being used.
Croatian: Doza iznosi između 5 i 15 mg po kilogramu tjelesne težine svaka dva ili tri tjedna, ovisno o tipu raka koji se liječi i primjeni drugih lijekova za liječenje raka.
English: What is Mvasi and what is it used for?
Croatian: Što je Mvasi i za što se koristi?
English: The cancer responded to treatment in 39% of those given Mvasi (128 of 328 patients) and 42% of those given Avastin (131 of 314).
Croatian: Rak je reagirao na liječenje kod 39 % bolesnika koji su primali lijek Mvasi (128 od 328 bolesnika) te kod 42 % bolesnika koji su primali lijek Avastin (131 od 314).
English: This means that Mvasi is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: Drugim riječima, lijek Mvasi sličan je biološkom lijeku (poznatom kao „referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: The doctor may decide to interrupt or stop treatment if the patient develops certain side effects.
Croatian: Liječnik može prekinuti ili zaustaviti liječenje ako se kod bolesnika razviju određene nuspojave.
English: The treatment is continued until the patient no longer benefits from it.
Croatian: Terapija se provodi sve do trenutka kada prestane biti od koristi za bolesnika.
English: The first infusion of Mvasi should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well.
Croatian: Prva infuzija lijeka Mvasi treba trajati najmanje 90 minuta, no naknadne infuzije mogu se primijeniti tijekom kraćeg razdoblja ako je bolesnik dobro podnio prvu infuziju.
English: By attaching to VEGF, Mvasi stops it having an effect.
Croatian: Vezivanjem na VEGF Mvasi zaustavlja njegovo djelovanje.
English: Other information about Mvasi
Croatian: Ostale informacije o lijeku Mvasi
English: What measures are being taken to ensure the safe and effective use of Mvasi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mvasi?
English: As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Croatian: Kao rezultat toga, rak ne može razviti vlastitu opskrbu krvlju te su tumorskim stanicama uskraćeni kisik i hranjive tvari, što pomaže pri usporavanju rasta tumora.
English: This is a summary of the European public assessment report (EPAR) for Mvasi.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Mvasi.
English: What are the risks associated with Mvasi?
Croatian: Koji su rizici povezani s lijekom Mvasi?
English: In addition, a study involving 642 patients with advanced non-small cell lung cancer showed that Mvasi was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel.
Croatian: Nadalje, ispitivanje koje je uključivalo 642 bolesnika s uznapredovalim rakom nemalih stanica pluća pokazalo je da je lijek Mvasi jednako djelotvoran kao i Avastin kada se primjenjuje zajedno s lijekovima za liječenje raka karboplatinom i paklitakselom.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Mvasi has been shown to have a comparable quality, safety and effectiveness to Avastin.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Mvasi pokazao usporedivu kvalitetu, sigurnost i učinkovitost kao i Avastin.
English: Mvasi is a cancer medicine that is used to treat adults with the following cancers:
Croatian: Mvasi je lijek za liječenje raka koji se primjenjuje za liječenje odraslih osoba sa sljedećim vrstama raka:
English: Mvasi is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect its sensitivity to particular medicines.
Croatian: Lijek Mvasi primjenjuje se u kombinaciji s drugim lijekovima za liječenje raka, ovisno o prirodi prethodnih liječenja ili prisutnosti mutacija (genetske promjene) u tkivu raka koje utječu na osjetljivost na određene lijekove.
English: Because Mvasi is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Mvasi.
Croatian: Budući da je lijek Mvasi biosličan lijek, ispitivanja djelotvornosti i sigurnosti bevacizumaba provedena za lijek Avastin nije potrebno ponavljati za lijek Mvasi.
English: • cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb or the peritoneum, the membrane that lines the abdomen);
Croatian: • rakom jajnika ili povezanih struktura (jajovod kojim se jajašce prenosi od jajnika do maternice ili peritoneum, membrana koja oblaže abdomen);
English: The reference medicine for Mvasi is Avastin.
Croatian: Referentni lijek za lijek Mvasi je Avastin.
English: Why is Mvasi approved?
Croatian: Zašto je lijek Mvasi odobren?
English: The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Croatian: Najčešće nuspojave povezane s bevacizumabom (koje se mogu javiti u više od 1 na 10 osoba) su hipertenzija (visoki krvni tlak), umor ili astenija (slabost), proljev i abdominalna bol (bol u trbuhu).
English: It is not intended to provide practical advice on how to use Mvasi.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Mvasi.
English: How does Mvasi work?
Croatian: Kako djeluje Mvasi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mvasi have 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 Mvasi nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The Agency recommended that Mvasi be given marketing authorisation.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje lijeka Mvasi u promet.
English: For more information about treatment with Mvasi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Mvasi pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Mvasi must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies.
Croatian: Lijek Mvasi ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na bevacizumab ili bilo koju drugu pomoćnu tvar, na proizvode pripremljene od jajnih stanica kineskog hrčka ili druga rekombinantna protutijela.
English: Mvasi is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Croatian: Lijek Mvasi dostupan je kao koncentrat za otopinu za infuziju (drip) u venu.
English: Mvasi can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Croatian: Lijek Mvasi izdaje se samo na liječnički recept, a liječenje mora nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: Laboratory studies comparing Mvasi with Avastin have shown that the active substance in Mvasi is highly similar to that in Avastin in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Mvasi i Avastin pokazala su da je djelatna tvar u lijeku Mvasi vrlo slična djelatnoj tvari u lijeku Avastin u pogledu strukture, čistoće i biološke aktivnosti.
English: The active substance in Mvasi, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Croatian: Djelatna tvar lijeka Mvasi, bevacizumab, monoklonsko je protutijelo (vrsta bjelančevine) koje prepoznaje i vezuje se na krvožilni endotelni čimbenik rasta (VEGF), bjelančevinu koja cirkulira u krvi i potiče rast krvnih žila.
English: Therefore, the Agency's view was that, as for Avastin, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijek Avastin.
English: What benefits of Mvasi have been shown in studies?
Croatian: Koje su koristi lijeka Mvasi utvrđene u ispitivanjima?
English: Mvasi can be used in non-small cell lung cancer unless it orginates in cells of a particular type (called squamous cells);
Croatian: Lijek Mvasi može se primjenjivati za liječenje raka pluća nemalih stanica ako on ne potječe iz određene vrste stanica (naziva skvamozne stanice);
English: • a type of lung cancer called non-small cell lung cancer when it is advanced or has spread or come back, and cannot be treated with surgery, including cases where the cancer cells have a mutation
Croatian: • vrstom raka pluća naziva rak pluća nemalih stanica koji je uznapredovao, proširio se ili se ponovno javio, te se ne može liječiti kirurškim zahvatom, uključujući slučajeve kada stanice raka imaju mutaciju (promjenu) u genu bjelančevine naziva EGFR.
English: For practical information about using Mvasi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Mvasi bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Studies have also shown that giving Mvasi produces similar levels of the active substance in the body to giving Avastin.
Croatian: Ispitivanja su utvrdila i da se primjenom lijeka Mvasi stvaraju slične razine djelatne tvari u tijelu kao i primjenom lijeka Avastin.
English: • breast cancer that has spread to other parts of the body;
Croatian: • rakom dojke koji se proširio na ostale dijelove tijela;
English: • cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.
Croatian: • rakom cerviksa (grlić maternice) koji je perzistentan ili se ponovno javio nakon liječenja, ili se proširio na ostale dijelove tijela.
English: How is Mvasi used?
Croatian: Kako se Mvasi koristi?
English: Mvasi contains the active substance bevacizumab and is a ‘biosimilar medicine'.
Croatian: Lijek Mvasi sadržava djelatnu tvar bevacizumab te je „biosličan lijek”.
English: The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Croatian: Najčešće ozbiljne nuspojave su gastrointestinalna perforacija (rupa u stijenci crijeva), hemoragija
English: • cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
Croatian: • rakom bubrega (karcinom bubrežnih stanica) koji je uznapredovao ili se proširio drugdje po tijelu;
English: • cancer of the colon (large bowel) or the rectum, when it has spread to other parts of the body;
Croatian: • rakom debelog crijeva ili rektuma koji se proširio na ostale dijelove tijela;
English: For the full list of all side effects reported with Mvasi, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Mvasi potražite u uputi o lijeku.
English: The full EPAR and risk management plan summary for Tivicay can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Tivicay, kao i plan upravljanja rizikom, nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In addition, the dose of Tivicay may need to be adjusted if certain medicines are taken at the same time.
Croatian: Nadalje, doza lijeka Tivicay može se prilagoditi, ako se određeni lijekovi uzimaju istovremeno.
English: Tivicay is available as tablets (10, 25 and 50 mg).
Croatian: Lijek Tivicay dostupan je u obliku tableta (od 10, 25 i 50 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tivicay on 16 January 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Tivicay na snazi u Europskoj uniji od 16. siječnja 2014.
English: Tivicay was demonstrated to be effective against HIV-1 in four main studies in adults.
Croatian: Tivicay se pokazao djelotvornim protiv virusa HIV-1 u četiri glavna ispitivanja na odraslima.
English: What measures are being taken to ensure the safe and effective use of Tivicay?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tivicay?
English: This is a summary of the European public assessment report (EPAR) for Tivicay.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Tivicay.
English: This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Croatian: To je antivirusni lijek koji blokira enzim naziva integraza koji je potreban virusu HIV-a da stvori nove kopije samoga sebe u tijelu.
English: The main measure of effectiveness in all the studies was the response rate, which was the proportion of patients with a reduction of the levels of virus (viral load) in the blood to fewer than 50 copies of HIV-1 RNA per ml.
Croatian: Glavna mjera djelotvornosti u svim ispitivanjima bila je stopa odgovora, koja predstavlja udio bolesnika sa smanjenjem razina virusa (virusnim opterećenjem) u krvi manjim od 50 kopija HIV-1 RNK po ml.
English: Tivicay does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Tivicay ne liječi infekciju HIV-om ili SIDA-u, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih sa SIDA-om.
English: More serious adverse effects that have been reported include an uncommon but severe hypersensitivity (allergic) reaction with rash and possible effects on the liver.
Croatian: Ozbiljnije nuspojave koje su zabilježene uključuju neuobičajenu, no ozbiljnu preosjetljivu (alergijsku) reakciju praćenu osipom i mogućim posljedicama na jetri.
English: Although Tivicay can normally be taken with or without food, patients whose virus is resistant to this class of medicines should take Tivicay with food as it helps the medicine to get absorbed.
Croatian: Iako se Tivicay može normalno uzimati uz hranu ili bez nje, bolesnici čiji je virus otporan na ovu klasu lijekova trebaju uzimati Tivicay s hranom, budući da hrana pomaže pri apsorpciji lijeka.
English: The medicine was generally well tolerated, although the CHMP noted the possible risk of infrequent but severe hypersensitivity reactions.
Croatian: Lijek se općenito dobro podnosi, iako je CHMP uočio mogući rizik od neučestalih, no ozbiljnih preosjetljivih reakcija.
English: The dose for children 6 to 12 years old depends on the weight of the child; for those aged 12 and over it is usually one 50-mg tablet a day.
Croatian: Doza za djecu od 6 do 12 godina starosti ovisi o težini djeteta; za djecu u dobi od 12 godina i stariju djecu doza obično iznosi jedna tableta od 50 mg na dan.
English: Other information about Tivicay
Croatian: Ostale informacije o lijeku Tivicay
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tivicay'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 lijeka Tivicay nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tivicay 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 Tivicay također se nalaze u sažetku opisa svojstava i u uputu o lijeku.
English: What is Tivicay and what is it used for?
Croatian: Što je Tivicay i za što se koristi?
English: When it is given with other medicines, Tivicay helps to prevent the spread of HIV and keep the amount of the virus in the blood at a low level.
Croatian: Ako se primjenjuje s drugim lijekovima, Tivicay pomaže pri sprječavanju širenja HIV-a i održava količinu virusa u krvi na malim razinama.
English: The most common side effects with Tivicay (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, and headache.
Croatian: Najčešće nuspojave lijeka Tivicay (mogu se javiti u više od 1 na 10 osoba) su mučnina (osjećaj slabosti), proljev i glavobolja.
English: It is not intended to provide practical advice on how to use Tivicay.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Tivicay.
English: The results indicated that similar levels of the medicine were produced in children to those seen in adults and adolescents, which should result in similar effectiveness.
Croatian: Rezultati su upućivali na činjenicu da su se kod djece stvarale slične razine lijeka kakve su uočene kod odraslih osoba i adolescenata, što bi trebalo rezultirati sličnom razinom djelotvornosti.
English: • The first of these involved 715 patients whose previous treatment had not included an integrase inhibitor and whose infection was therefore not expected to be resistant to this class of medicines.
Croatian: • Prvo od ova dva ispitivanja uključilo je 715 bolesnika čije prethodno liječenje nije uključivalo inhibitor integraze, te se stoga za njihovu infekciju nije moglo očekivati da će biti otporna na ovu klasu lijekova.
English: The adult dose depends on whether the infection is known or suspected to be resistant to medicines of the class to which Tivicay belongs (integrase inhibitors).
Croatian: Doza za odrasle bolesnike ovisi o tome je li poznato ili se sumnja da je infekcija otporna na lijekove klase u koju se ubraja Tivicay (inhibitori integraze).
English: Tivicay must not be given together with dofetilide, a medicine for disturbances of heart rhythm, as it may cause serious side effects.
Croatian: Tivicay se ne smije primjenjivati zajedno s dofetilidom, lijekom za liječenje poremećaja srčanog ritma, jer može uzrokovati ozbiljne nuspojave.
English: What are the risks associated with Tivicay?
Croatian: Koji su rizici povezani s lijekom Tivicay?
English: The company subsequently presented available results in 23 children from 6 to less than 12 years of age, who were given doses of Tivicay based on their body weight.
Croatian: Tvrtka je naknadno predstavila dostupne rezultate iz ispitivanja na 23 djece koja su pripadala dobnoj skupini od 6 godina i starijoj te na djeci mlađoj od 12 godina, kojima su davane doze lijeka Tivicay ovisno o njihovoj tjelesnoj težini.
English: Two other studies looked at the effectiveness of Tivicay in patients whose previous HIV treatment had stopped working:
Croatian: Druga dva ispitivanja istražila su djelotvornost lijeka Tivicay u bolesnika čije je prethodno liječenje HIV-a prestalo biti djelotvorno:
English: The response rate at 48 weeks was 88% (364 of 414 patients) in those given Tivicay-based treatment compared with 81% (338 of 419 patients) in those given Atripla.
Croatian: Stopa odgovora u 48 tjednu bila je 88 % (364 od 414 bolesnika) u osoba koje su primile liječenje temeljeno na lijeku Tivicay u usporedbi s 81 % (338 od 419 bolesnika) u osoba koje su primile terapiju lijekom Atripla.
English: It is used together with other medicines to treat adults and children from 6 years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: U kombinaciji s ostalim lijekovima, Tivicay se koristi za liječenje odraslih osoba i djece u dobi od 6 godina i starijoj dobi koji su zaraženi virusom humane imunodeficijencije tipa 1 (HIV 1) koji uzrokuje sindrom stečene imunodeficijencije (AIDS).