FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore decided that Copalia HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: The Committeeand recommended that Copalia HCTit be given marketing authorisation.
English: This protein is often found on the surface of cells where it plays a role in regulating cell multiplication.
Croatian: Taj se protein često nalazi na površini stanica gdje ima ulogu u regulaciji umnažanja stanica.
English: These three-week cycles should be repeated until the disease gets worse or side effects become unacceptable.
Croatian: Te trotjedne cikluse treba ponavljati sve dok se bolest ne pogorša ili nuspojave ne postane nepodnošljive.
English: The recommended dose of Lartruvo is 15 mg per kilogram body weight, given twice over a period of three weeks, on days 1 and 8.
Croatian: Preporučena doza lijeka Lartruvo je 15 mg po kilogramu tjelesne težine, a daje se dva puta u razdoblju od tri tjedna, svakog 1. i 8. dana.
English: What measures are being taken to ensure the safe and effective use of Lartruvo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lartruvo?
English: The most serious side effects were neutropenia and musculoskeletal pain.
Croatian: Najozbiljnije nuspojave bile su neutropenija i mišićnokoštana bol.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila lijek kako bi preporučila njegovo odobrenje za stavljanje u promet u EU-u te uvjete za njegovu primjenu.
English: Doxorubicin is given on day 1 of each cycle, after the Lartruvo infusion.
Croatian: Doksorubicin se daje 1. dana svakog ciklusa, nakon infuzije lijeka Lartruvo.
English: What is Lartruvo and what is it used for?
Croatian: Što je Lartruvo i za što se koristi?
English: Lartruvo is available as a solution for infusion (drip) into a vein.
Croatian: Lartruvo je dostupan kao otopina za infuziju (drip) u venu.
English: This is a summary of the European public assessment report (EPAR) for Lartruvo.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Lartruvo.
English: During the infusion, patients should be monitored for signs and symptoms of infusion-related reactions and trained staff and equipment for emergency resuscitation should be available.
Croatian: Tijekom infuzije bolesnike treba nadzirati zbog moguće pojave znakova i simptoma reakcija na infuziju, a na raspolaganju moraju biti osoblje i oprema za postupak oživljavanja.
English: By attaching to PDGFRα on sarcoma cells, Lartruvo is expected to block its activity, thereby slowing down the growth of the cancer.
Croatian: Pričvršćivanjem za PDGFRα na stanicama sarkoma, očekuje se da će Lartruvo blokirati njegovu aktivnost i time usporiti rast stanica raka.
English: It is not intended to provide practical advice on how to use Lartruvo.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Lartruvo.
English: Lartruvo has been given ‘conditional approval'.
Croatian: Za lijek Lartruvo izdano je „uvjetno odobrenje”.
English: Why is Lartruvo approved?
Croatian: Zašto je Lartruvo odobren?
English: Since Lartruvo has been granted a conditional approval, the company that markets Lartruvo will provide additional data from an ongoing study in order to further confirm the efficacy and safety of the medicine.
Croatian: Budući da je lijek Lartruvo dobio uvjetno odobrenje, tvrtka koja stavlja na tržište lijek Lartruvo mora dostaviti dodatne podatke iz ispitivanja koja su u tijeku, kako bi se još više potvrdila djelotvornost i sigurnost ovoga lijeka.
English: Other information about Lartruvo
Croatian: Ostale informacije o lijeku Lartruvo
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Lartruvo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio da koristi od lijeka Lartruvo nadmašuju s njime povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Lartruvo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Lartruvo možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The most frequent side effects which lead to treatment termination were infusion-related reactions (allergic reactions which can be serious, with symptoms such as chills, fever and difficulty breathing) and mucositis.
Croatian: Najčešće nuspojave koje dovode do prestanka liječenja bile su reakcije na infuziju (alergijske reakcije koje mogu biti ozbiljne, sa simptomima kao što su zimica, vrućica i otežano disanje) i mukozitis.
English: However, because of the small number of patients included in the main study, further data will be needed from the company that markets the medicine.
Croatian: Međutim, kako je u glavno ispitivanje bio uključen mali broj ispitanika, potrebni su dodatni podaci tvrtke koja stavlja lijek na tržište.
English: In cancers such as soft tissue sarcoma, this protein is present in high levels or is overactive, causing cells to become cancerous.
Croatian: Kod vrste raka kao što je sarkom mekog tkiva, taj je protein prisutan u velikim količinama ili je pretjerano aktivan, zbog čega stanice postaju kancerogene.
English: What are the risks associated with Lartruvo?
Croatian: Koji su rizici povezani s lijekom Lartruvo?
English: The full EPAR for Lartruvo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Lartruvo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information about treatment with Lartruvo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Lartruvo pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lartruvo 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 Lartruvo nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Lartruvo can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the treatment of cancer.
Croatian: Lartruvo se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u primjeni terapija protiv raka.
English: The active substance in Lartruvo, olaratumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein called ‘platelet-derived growth factor receptor alpha' (PDGFRα).
Croatian: Djelatna tvar lijeka Lartruvo, olaratumab, monoklonsko je protutijelo (vrsta proteina) koje prepoznaje i veže se za protein pod nazivom „alfa receptor za faktor rasta koji potječe od trombocita” (PDGFRα).
English: With regards to the safety profile of the medicine, it was observed that patients treated with Lartruvo plus doxorubicin experienced an increase in the frequency of side effects; however, in view of the benefits of treatment, side effects were considered tolerable and manageable.
Croatian: S obzirom na sigurnosni profil lijeka, opaženo je da su bolesnici liječeni lijekom Lartruvo u kombinaciji s doksorubicinom imali veću učestalost nuspojava; ipak, u odnosu na koristi liječenja, nuspojave su se smatrale podnošljivima i moglo ih se kontrolirati.
English: Because the number of patients with soft tissue sarcoma is low, the disease is considered ‘rare', and Lartruvo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 12 February 2015.
Croatian: Budući da su bolesnici sa sarkomom mekog tkiva malobrojni, bolest se smatra „rijetkom” te je 12. veljače 2015.
English: In addition, patients treated with the combination Lartruvo plus doxorubicin lived overall almost twice as long as patients treated with doxorubicin (26.5 versus 14.7 months, respectively).
Croatian: Osim toga, bolesnici liječeni kombinacijom lijeka Lartruvo i doksorubicina, živjeli su sveukupno gotovo dvostruko dulje nego bolesnici liječeni doksorubicinom (26,5 naspram 14,7 mjeseci).
English: The most common side effects with Lartruvo (which may affect more than 1 in 10 people) include nausea (feeling sick), musculoskeletal pain (bone and muscle pain), neutropenia (low levels of neutrophils, a type of white blood cells that fights infection) and mucositis (inflammation of the body's moist surfaces, most commonly affecting the mouth and throat).
Croatian: Najčešće nuspojave lijeka Lartruvo (koje se mogu javiti u više od 1 na 10 osoba) uključuju mučninu, mišićno-koštanu bol (bol u kostima i mišićima), neutropeniju (niske razine neutrofila, vrste bijelih krvnih stanica koje suzbijaju infekciju) i mukozitis (upala vlažnih površina tijela, najčešće zahvaćaju usta i grlo).
English: Lartruvo has been investigated in one main study involving 133 adults with advanced soft tissue sarcoma who couldn't undergo surgery or radiotherapy and who had not been previously treated with anthracyclines (a group of cancer medicines that includes doxorubicin).
Croatian: Lartruvo je ispitivan u jednom glavnom ispitivanju koje je uključivalo 133 odrasla bolesnika s uznapredovalim sarkomom mekog tkiva koji nisu mogli biti podvrgnuti kirurškom zahvatu ili radioterapiji i koji prije nisu bili liječeni antraciklinima (skupina lijekova protiv raka koja uključuje doksorubicin).
English: What information is still awaited for Lartruvo?
Croatian: Koje se još informacije očekuju o lijeku Lartruvo?
English: Lartruvo is a cancer medicine used to treat adults with advanced soft tissue sarcoma, a type of cancer that affects the soft, supportive tissues of the body such as muscles, blood vessels and fat tissue.
Croatian: Lartruvo je lijek protiv raka za liječenje odraslih osoba s uznapredovalim sarkomom mekog tkiva, vrste raka koja zahvaća meka, potporna tkiva u tijelu kao što su mišići, krvne žile i masno tkivo.
English: Lartruvo is used together with doxorubicin (another cancer medicine) in patients who cannot undergo surgery or radiotherapy (treatment with radiation) and who have not been previously treated with doxorubicin.
Croatian: Lartruvo se primjenjuje u kombinaciji s doksorubicinom (još jedan lijek protiv raka) u bolesnika koji se ne mogu podvrgnuti kirurškom zahvatu ili radioterapiji (liječenje zračenjem) i koji prethodno nisu bili liječeni doksorubicinom.
English: Data from the main study show that Lartruvo in combination with doxorubicin improves progressionfree and overall survival of patients with advanced soft tissue sarcoma.
Croatian: Podaci glavnog ispitivanja pokazuju da Lartruvo u kombinaciji s doksorubicinom poboljšava preživljenje bez napredovanja bolesti te sveukupno preživljenje bolesnika s uznapredovalim sarkomom mekog tkiva.
English: How does Lartruvo work?
Croatian: Kako djeluje Lartruvo?
English: Patients treated with Lartruvo plus doxorubicin lived for an average of 6.6 months without their disease getting worse, compared with 4.1 months for patients treated with doxorubicin alone.
Croatian: Bolesnici liječeni lijekom Lartruvo u kombinaciji s doksorubicinom živjeli su bez pogoršanja bolesti u prosjeku 6,6 mjeseci, dok je za bolesnike liječene samo doksorubicinom to vrijeme iznosilo 4,1 mjesec.
English: The study showed that Lartruvo plus doxorubicin was more effective than doxorubicin alone at prolonging the time patients live without their disease getting worse (progression-free survival).
Croatian: Ispitivanje je pokazalo da je Lartruvo u kombinaciji s doksorubicinom učinkovitije od samog doksorubicina produljio vrijeme u kojem su bolesnici živjeli bez pogoršanja bolesti (preživljenje bez napredovanja bolesti).
English: For practical information about using Lartruvo, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Lartruvo bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Lartruvo is given in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo alone in patients whose disease has not got worse.
Croatian: Lartruvo se daje u kombinaciji s doksorubicinom do 8 ciklusa liječenja, a nakon toga, u bolesnika kojima se bolest nije pogoršala, primjenjuje se samo Lartruvo.
English: How is Lartruvo used?
Croatian: Kako se Lartruvo koristi?
English: For the full list of all side effects and restrictions with Lartruvo, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Lartruvo potražite u uputi o lijeku.
English: What benefits of Lartruvo have been shown in studies?
Croatian: Koje su koristi lijeka Lartruvo utvrđene u ispitivanjima?
English: Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Croatian: Bolesnici koji dobro podnesu prvu infuziju od 90 minuta mogu primiti naknadne infuzije u razdoblju od 30 minuta.
English: The full EPAR for Herzuma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Herzuma nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Herzuma can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Croatian: Herzuma može uzrokovati kardiotoksičnost (oštećenja srca), uključujući zatajenje srca (kada srce ne radi kako bi trebalo).
English: This means that Herzuma is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: To znači da je lijek Herzuma sličan drugom biološkom lijeku („referentni lijek”) koji je već odobren u Europskoj uniji (EU).
English: There were no relevant differences in the main measure of effectiveness (absence of invasive cancer cells in the breast or in linked tissues called lymph nodes) between the two products: this was seen in nearly 44% of those given Herzuma (118 of 271) and 47% of those given Herceptin (131 of 278).
Croatian: Nisu uočene bitne razlike u glavnom mjerilu učinkovitosti (nepostojanje stanica invazivnog raka u dojci ili u povezanom tkivu koje se naziva limfnim čvorovima) između dvaju proizvoda: navedeno je uočeno u gotovo 44 % bolesnika koji su primali lijek Herzuma (118 od 271) i 47 % onih koji su primali Herceptin (131 od 278).
English: The infusion may be associated with allergic reactions, so the patient should be monitored during and after the infusion.
Croatian: Moguće su alergijske reakcije povezane s infuzijom, stoga je potreban nadzor bolesnika tijekom i nakon infuzije.
English: • metastatic breast cancer (cancer that has spread to other parts of the body).
Croatian: • metastatski rak dojke (rak koji se proširio na ostale dijelove tijela).
English: What measures are being taken to ensure the safe and effective use of Herzuma?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Herzuma?
English: Herzuma is a cancer medicine used to treat the following conditions:
Croatian: Herzuma je lijek protiv raka koji se koristi za liječenje sljedećih bolesti:
English: What is Herzuma and what is it used for?
Croatian: Što je Herzuma i za što se koristi?
English: Herzuma must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Croatian: Herzuma se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na trastuzumab, mišje proteine ili bilo koji drugi sastojak lijeka.
English: The infusion is given over 90 minutes every week or every three weeks for breast cancer, and every three weeks for gastric cancer.
Croatian: Infuzija se daje tijekom 90 minuta jedanput tjedno ili svaka tri tjedna kod raka dojke, a svaka tri tjedna kod raka želuca.
English: Herzuma is a ‘biosimilar medicine'.
Croatian: Herzuma je „biosličan lijek”.
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
Croatian: Također se primjenjuje u kombinaciji s drugim lijekovima protiv raka: s paklitakselom ili docetakselom ili s drugim razredom lijekova pod nazivom inhibitori aromataze;
English: This is a summary of the European public assessment report (EPAR) for Herzuma.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Herzuma.
English: In addition, one main study involving 549 patients with early breast cancer that overexpressed HER2 showed that Herzuma was as effective as Herceptin.
Croatian: Nadalje, jedno glavno ispitivanje koje je obuhvaćalo 549 bolesnika s ranim rakom dojke s povećanom ekspresijom HER2 pokazalo je da je lijek Herzuma jednako djelotvoran kao i Herceptin.
English: The most common or serious side effects with Herzuma are heart problems, reactions related to the Herzuma infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Croatian: Najčešće ili ozbiljne nuspojave lijeka Herzuma su problemi sa srcem, reakcije na infuziju lijeka Herzuma, snižene razine krvnih stanica, posebno bijelih krvnih stanica, infekcije i problemi s plućima.
English: It is used on its own in patients in whom previous treatments have failed.
Croatian: Primjenjuje se kao monoterapija u bolesnika u kojih prethodno liječenje nije bilo uspješno.
English: Patients were given either Herzuma or Herceptin with other cancer medicines before surgery to remove the cancer, and then the same medicine on its own every three weeks for 1 year.
Croatian: Bolesnici su primali lijek Herzuma ili lijek Herceptin s drugim lijekovima protiv raka prije operacije uklanjanja raka, a potom isti lijek samostalno svaka tri tjedna tijekom 1 godine.
English: Because Herzuma is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Herzuma.
Croatian: Budući da je lijek Herzuma biosličan lijek, ispitivanja učinkovitosti i sigurnosti trastuzumaba provedena za lijek Herceptin nije potrebno ponavljati za lijek Herzuma.
English: Herzuma can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Croatian: Herzuma se izdaje samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u primjeni lijekova protiv raka.
English: For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.
Croatian: Liječenje ranog raka dojke traje godinu dana ili do povratka bolesti, a liječenje metastatskog raka dojke ili želuca nastavlja se sve dok je učinkovito.
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Croatian: • rani rak dojke (rak koji se proširio unutar dojke ili do žlijezda ispod pazuha, ali ne i na ostale dijelove tijela) nakon kirurškog zahvata, kemoterapije (lijekovi za liječenje raka) i radioterapije (liječenje zračenjem), ako su provedeni.
English: Other information about Herzuma
Croatian: Ostale informacije o lijeku Herzuma
English: It must not be used in patients who have serious breathing problems because of advanced cancer, even when resting, or who need oxygen therapy.
Croatian: Lijek se ne smije primjenjivati u bolesnika koji zbog uznapredovalog raka imaju ozbiljnih poteškoća s disanjem, čak i u mirovanju, ili im je potrebno liječenje kisikom.
English: Herzuma can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells.
Croatian: Primjena lijeka Herzuma moguća je samo ako tumor pokazuje „povećanu ekspresiju HER2”, što znači da rak proizvodi velike količine proteina pod nazivom HER2 na površini tumorskih stanica.
English: It is available as a powder used to make up a solution for adding to an infusion (drip) into a vein.
Croatian: Dostupan je kao prašak od kojeg se priprema otopina za intravensku infuziju (drip).
English: For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Herzuma is used before surgery in combination with chemotherapy and then again after surgery on its own;
Croatian: Kod tumora koji su lokalno uznapredovali (uključujući upalne tumore) ili širi od 2 cm, Herzuma se primjenjuje u kombinaciji s kemoterapijom prije kirurškog zahvata i potom nakon kirurškog zahvata kao monoterapija;
English: The recommended dose depends on the patient's body weight, on the condition being treated and on whether Herzuma is given weekly or three-weekly.
Croatian: Preporučena doza ovisi o tjelesnoj težini bolesnika i o bolesti koja se liječi te o tome primjenjuje li se lijek Herzuma jedanput tjedno ili svaka tri tjedna.
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).
Croatian: • metastatski rak želuca, u kombinaciji s cisplatinom i kapecitabinom ili fluorouracilom (drugi lijekovi protiv raka).
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Herzuma has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a za bioslične lijekove, za lijek Herzuma utvrđena usporediva kakvoća, sigurnost i učinkovitost kao za Herceptin.
English: What are the risks associated with Herzuma?
Croatian: Koji su rizici povezani s lijekom Herzuma?
English: The reference medicine for Herzuma is Herceptin.
Croatian: Referentni lijek za lijek Herzuma jest Herceptin.
English: It is not intended to provide practical advice on how to use Herzuma.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Herzuma.
English: For the full list of all side effects and restrictions with trastuzumab, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni trastuzumaba potražite u uputi o lijeku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Herzuma 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 Herzuma nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: For more information about treatment with Herzuma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Herzuma pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.