FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not intended to provide practical advice on how to use Avastin.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Avastin.
English: The first two studies included patients whose cancer came back 6 months or more after previous treatment (‘platinum-sensitive disease'), while the third study was in patients with more aggressive cancer that had come back within 6 months of previous treatment (‘platinum-resistant disease').
Croatian: Prva dva ispitivanja obuhvatila su bolesnike čiji se rak vratio 6 mjeseci ili više nakon prethodnog liječenja („bolest osjetljiva na platinu”), a treće je ispitivanje provedeno među bolesnicima s agresivnijim vrstama raka koji se vratio unutar 6 mjeseci od prethodnog liječenja („bolest otporna na platinu”).
English: Avastin 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: Avastin se ne smije koristiti u osoba koje su preosjetljive (alergične) na bevacizumab ili bilo koju drugu pomoćnu tvar, na proizvode pripravljene od jajnih stanica kineskog hrčka ili druga rekombinantna protutijela.
English: Avastin is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Croatian: Lijek Avastin dostupan je kao koncentrat za otopinu za infuziju (drip) u venu.
English: • metastatic breast cancer, in combination with paclitaxel or capecitabine;
Croatian: • metastatskim rakom dojke, u kombinaciji s paklitakselom ili kapecitabinom;
English: For more information about treatment with Avastin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Avastin pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Avastin is given in combination with paclitaxel and either the platinum-based medicine cisplatin or, if this cannot be used, another chemotherapy medicine, topotecan.
Croatian: Avastin se primjenjuje u kombinaciji s paklitakselom te cisplatinom, lijekom na bazi platine ili, ako se on ne može primijeniti, drugim kemoterapijskim lijekom, tj. topotekanom.
English: The most common side effects with Avastin are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Croatian: Najčešće nuspojave povezane s lijekom Avastin su hipertenzija (visoki krvni tlak), umor ili astenija (slabost), proljev i abdominalna bol (bol u trbuhu).
English: Avastin is a cancer medicine used to treat adults with the following types of cancer, in combination with other cancer medicines:
Croatian: Avastin je citostatik koji se primjenjuje u liječenju odraslih osoba sa sljedećim vrstama raka, u kombinaciji s drugim citostaticima:
English: What is the risk associated with Avastin?
Croatian: Koji su rizici povezani s lijekom Avastin?
English: The active substance in Avastin, 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 Avastin, 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: Avastin contains the active substance bevacizumab.
Croatian: Avastin sadrži djelatnu tvar bevacizumab.
English: • advanced non-small cell lung cancer in patients whose cancer cells are not mainly of the squamous type, where it is given with platinum-based chemotherapy;
Croatian: • uznapredovalim rakom nemalih stanica pluća u bolesnika čije stanice raka uglavnom nisu skvamozne, te se primjenjuje s kemoterapijom na bazi platine;
English: Why has Avastin been approved?
Croatian: Zašto je lijek Avastin odobren?
English: What benefits of Avastin have been shown in studies?
Croatian: Koje su koristi lijeka Avastin dokazane u ispitivanjima?
English: • Recurrent disease: three studies with Avastin in recurrent ovarian, fallopian tube and peritoneal cancers were performed in a total of 1,518 patients.
Croatian: • Rekurentna bolest: provedena su tri ispitivanja lijeka Avastin u slučaju rekurentnog raka jajnika, jajovoda i peritoneuma na ukupno 1 518 bolesnika.
English: Cancer of the colon or rectum
Croatian: Rak debelog crijeva ili rektuma
English: Avastin can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer treatments.
Croatian: Avastin se izdaje samo na liječnički recept, a liječenje mora nadzirati liječnik koji ima iskustva u primjeni citostatika.
English: When the type of chemotherapy was taken into account, there was a tendency for patients given cisplatin-based treatment to live on average about 2 months longer than those given topotecan-based treatment, independently of giving Avastin as part of the treatment regimens.
Croatian: Ako se uzme u obzir vrsta kemoterapije, bolesnici koji su primili terapiju na bazi cisplatina živjeli su u prosjeku oko dva mjeseca duže od onih koji su primili terapiju na bazi topotekana, neovisno o tome je li lijek Avastin dodavan terapiji.
English: In the second study, overall survival in patients given Avastin in combination with carboplatin and paclitaxel was 42.6 months, compared with 37.3 months in patients treated with carboplatin and paclitaxel only.
Croatian: U drugom ispitivanju ukupna stopa preživljenja u bolesnika koji su primali lijek Avastin u kombinaciji s karboplatinom i paklitakselom iznosila je 42,6 mjeseci, u usporedbi s 37,3 mjeseca u bolesnika liječenih samo karboplatinom i paklitakselom.
English: For practical information about using Avastin, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Avastin bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: The study compared the effect of adding Avastin to chemotherapy using paclitaxel plus cisplatin or topotecan to results in patients given chemotherapy alone.
Croatian: Ispitivanjem je uspoređen učinak dodavanja lijeka Avastin kemoterapiji paklitakselom i cisplatinom ili topotekanom s rezultatima u bolesnica koje su primale samo kemoterapiju.
English: • advanced non-small cell lung cancer in patients whose cancer cells have a certain change (‘activating mutations') in the gene for a protein called EGFR, where it is given in combination with erlotinib;
Croatian: • uznapredovalim rakom nemalih stanica pluća u bolesnika čije su stanice raka promijenjene („aktivirajuće mutacije”) u genu bjelančevine naziva EGFR, te se primjenjuje u kombinaciji s erlotinibom;
English: For the full list of all side effects reported with Avastin, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Avastin potražite u uputi o lijeku.
English: Results showed that the average overall survival was 16.8 months with chemotherapy including Avastin compared with 12.9 months on chemotherapy alone.
Croatian: Rezultati su pokazali da je prosječna ukupna stopa preživljenja iznosila 16,8 mjeseci u liječenju kemoterapijom s lijekom Avastin, u usporedbi s 12,9 mjeseci u liječenju samo kemoterapijom.
English: Ovarian, fallopian tube and peritoneal cancer
Croatian: Rak jajnika, jajovoda i peritoneuma
English: In the second study (1,237 patients), when Avastin was added to capecitabine, the average progression-free survival was 8.6 months, compared with 5.7 months in those receiving capecitabine with placebo.
Croatian: U drugom ispitivanju (1 237 bolesnika) u slučaju kada je lijek Avastin dodan kapecitabinu, prosječna stopa preživljenja bez progresije iznosila je 8,6 mjeseci, u usporedbi s 5,7 mjeseci u osoba koje su primale kapecitabin s placebom.
English: Cervical cancer
Croatian: Rak cerviksa
English: In the third study in patients with more aggressive cancer, progression-free survival was 6.7 months when Avastin was added to paclitaxel, topotecan, or pegylated liposomal doxorubicin, compared with 3.4 months when these chemotherapies were used on their own.
Croatian: U trećem ispitivanju u bolesnika s agresivnijim rakom, preživljenje bez progresije iznosilo je 6,7 mjeseci u slučaju kada je lijek Avastin dodan paklitakselu, topotekanu ili pegiliranom liposomalnom doksorubicinu, u usporedbi s 3,4 mjeseca u slučaju kada su te kemoterapije primijenjene samostalno.
English: In the first study, average progression-free survival was 12.4 months when Avastin was added to carboplatin and gemcitabine, compared with 8.4 months when placebo was added.
Croatian: U prvom ispitivanju prosječna je stopa preživljenja bez progresije iznosila 12,4 mjeseca u slučaju kad je lijek Avastin dodan karboplatinu i gemcitabinu, u usporedbi s 8,4 mjeseca u slučaju kad je dodan placebo.
English: Overall survival was 12.9 months in patients adding Avastin and 10.8 months in those receiving chemotherapy alone.
Croatian: Ukupna stopa preživljenja iznosila je 12,9 mjeseci u bolesnika kojima je u terapiju dodan lijek Avastin i 10,8 mjeseci u bolesnika koji su primali samo kemoterapiju.
English: How is Avastin used?
Croatian: Kako se Avastin koristi?
English: The first two studies involved patients whose metastatic disease was being treated for the first time (‘first-line' treatment): in the first study (923 patients),the average overall survival was 20.3 months in patients adding Avastin and 15.6 months in those receiving chemotherapy alone; in the second study in 1,401 patients, progression-free survival was 9.4 months in patients adding Avastin and 8.0 months in those receiving chemotherapy alone.
Croatian: Prvim dvama ispitivanjima bili su obuhvaćeni bolesnici čija je metastatska bolest liječena po prvi put (terapija „prve linije”): u prvom ispitivanju (923 bolesnika) prosječna ukupna stopa preživljenja iznosila je 20,3 mjeseci u bolesnika kojima je u terapiju dodan lijek Avastin te 15,6 mjeseci u bolesnika koji su primali samo kemoterapiju; u drugom ispitivanju na 1 401 bolesniku, preživljenje bez progresije iznosilo je 9,4 mjeseca u bolesnika kojima je u terapiju dodan lijek Avastin te 8,0 mjeseci u bolesnika koji su primali samo kemoterapiju.
English: • epithelial cancer of the ovary, cancer of the fallopian tube (that connect the ovaries to the womb) or the peritoneum (the membrane lining the abdomen).
Croatian: • epitelnim rakom jajnika, rakom jajovoda (koji jajnike spaja s maternicom) ili peritoneuma (membranske ovojnice koja obavija abdomen).
English: In advanced or metastatic kidney cancer, Avastin plus interferon alfa-2a has been shown to increase progression-free survival in one study in 649 patients: the average progression-free survival was 10.2 months in the patients receiving Avastin plus interferon alfa-2a and 5.4 months in those receiving interferon alfa-2a.
Croatian: U slučaju uznapredovalog ili metastatskog raka bubrega, u jednom je ispitivanju na 649 bolesnika dokazano da Avastin uz interferon alfa-2a produljuje preživljenje bez progresije: prosječna stopa preživljenja bez progresije iznosila je 10,2 mjeseca u bolesnika koji su uz interferon alfa-2a primali lijek Avastin te 5,4 mjeseca u bolesnika koji su primali samo interferon alfa-2a.
English: • In advanced, metastatic or recurrent lung cancer, Avastin plus platinum-based chemotherapy has been shown to increase overall survival in one study in 878 patients: the average overall survival was 12.3 months in the patients taking Avastin with platinum-based chemotherapy, and 10.3 months for those taking chemotherapy alone.
Croatian: • U slučaju uznapredovalog, metastatskog ili rekurentnog raka pluća, u jednom ispitivanju na 878 bolesnika dokazano je da Avastin uz kemoterapiju na bazi platine produljuje ukupnu stopu preživljenja: prosječna ukupna stopa preživljenja iznosila je 12,3 mjeseca u bolesnika koji su uzimali lijek Avastin uz kemoterapiju na bazi platine, te 10,3 mjeseci u bolesnika koji su primali samo kemoterapiju.
English: • Newly diagnosed disease (including advanced disease, first-line treatment): in newly diagnosed ovarian, fallopian tube and peritoneal cancer, Avastin, in combination with carboplatin and paclitaxel, has been shown to increase progression-free survival in two main studies involving 3,401 patients: the average progression-free survival was 19.3 months in patients adding Avastin versus 16.9 months with carboplatin and paclitaxel alone in one study, and 14.7 months versus 10.6 months in the second study.
Croatian: • Novodijagnosticirana bolest (uključujući uznapredovalu bolest, terapiju „prve linije”): u slučaju novodijagnosticiranog raka jajnika, jajovoda i peritoneuma u dvama je glavnim ispitivanjima na 3 401 bolesniku dokazano da Avastin u kombinaciji s karboplatinom i paklitakselom produljuje preživljenje bez progresije: prosječna stopa preživljenja bez progresije u jednom je ispitivanju iznosila 19,3 mjeseca u bolesnika kojima je u terapiju dodan lijek Avastin naspram 16,9 mjeseci u bolesnika koji su primali samo karboplatin i paklitaksel, a u drugom ispitivanju 14,7 mjeseci naspram 10,6 mjeseci.
English: Avastin is used in combination with certain chemotherapy medicines in newly diagnosed patients when the cancer is advanced, or in previously treated patients whose cancer has come back (recurrent).
Croatian: Avastin se primjenjuje u novodijagnosticiranih bolesnika u slučajevima uznapredovalog raka ili u prethodno liječenih bolesnika u kojih se rak ponovno vratio (rekurentan) u kombinaciji s određenim kemoterapijskim lijekovima.
English: In metastatic breast cancer, Avastin has been shown to increase progression-free survival in two main studies.
Croatian: U slučaju metastatskog raka dojke, u dvama je ispitivanjima dokazano da Avastin produljuje razdoblje preživljenja bez progresije.
English: In metastatic cancer of the colon or rectum, Avastin used with chemotherapy including a fluoropyrimidine has been shown to increase overall and progression-free survival in three main studies.
Croatian: U slučaju metastatskog raka debelog crijeva ili rektuma, u trima glavnim ispitivanjima dokazano je da Avastin u kombinaciji s kemoterapijom koja uključuje fluoropirimidin produljuje ukupnu stopu preživljenja i preživljenje bez progresije.
English: How does Avastin work?
Croatian: Kako djeluje Avastin?
English: In the first study (722 patients), progression-free survival was 11.4 months in patients receiving Avastin with paclitaxel, compared with 5.8 months in those receiving paclitaxel alone.
Croatian: U prvom ispitivanju (722 bolesnika) razdoblje preživljenja bez progresije iznosilo je 11,4 mjeseca u bolesnika koji su uz paklitaksel primali lijek Avastin, u usporedbi s 5,8
English: • In patients with a certain subtype of non-small cell lung cancer with activating mutations in the EGFR gene, Avastin plus erlotinib has been shown to increase progression-free survival in one study in 152 patients: patients on Avastin plus erlotinib had progression-free survival of 16.0 months on average compared with 9.7 months in patients given erlotinib alone.
Croatian: • U bolesnika s određenom podvrstom raka nemalih stanica pluća s aktivirajućim mutacijama u EGFR genu, u jednom ispitivanju na 152 bolesnika dokazano je da Avastin uz terapiju erlotinibom produljuje preživljenje bez progresije: u bolesnika koji su uz erlotinib primali lijek Avastin prosječna stopa preživljenja bez progresije iznosila je 16,0 mjeseci, u usporedbi s 9,7 mjeseci u bolesnika koji su primali samo erlotinib.
English: • cancer of the colon (large intestine) or rectum that is metastatic (has spread to other parts of the body), in combination with chemotherapy medicines that include a ‘fluoropyrimidine';
Croatian: • metastatskim (koji se proširio na druge dijelove tijela) rakom debelog crijeva ili rektuma, u kombinaciji s kemoterapijom na bazi „fluoropirimidina”;
English: In cancer of the cervix, Avastin has been shown to increase overall survival in one main study involving 452 patients with advanced persistent, recurrent or metastatic cancer of the cervix.
Croatian: U slučaju raka cerviksa, u jednom glavnom ispitivanju kojim su obuhvaćene 452 bolesnice s uznapredovalim perzistentnim, rekurentnim ili metastatskim rakom cerviksa, dokazano je da Avastin produljuje ukupnu stopu preživljenja.
English: • cancer of the cervix (the neck of the womb) that is persistent, recurrent or metastatic.
Croatian: • perzistentnim, rekurentnim ili metastatskim rakom cerviksa (vrata maternice).
English: The recommended dose is two tablets (40 mg) once a day.
Croatian: Preporučena je doza dvije tablete (40 mg) jedanput na dan.
English: The full EPAR for Talmanco can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Talmanco nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 05-2017.
Croatian: Ovaj sažetak je posljednji put ažuriran: 05. 2017.
English: Talmanco is a ‘generic medicine'.
Croatian: Talmanco je „generički lijek”.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tadalafil Generics on 9 January 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet lijeka Tadalafil Generics koje vrijedi na prostoru Europske unije dana 9. siječnja 2017.
English: Previously known as Tadalafil Generics.
Croatian: Prethodno poznat pod nazivom Tadalafil Generics.
English: As for every medicine, the company provided studies on the quality of Talmanco.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Talmanco.
English: Talmanco is not recommended for patients with severe kidney or liver problems.
Croatian: Talmanco se ne preporučuje bolesnicima koji imaju ozbiljnih problema s bubrezima ili jetrom.
English: This leads to high blood pressure in the vessels taking blood from the heart to the lungs and reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Croatian: To uzrokuje visok krvni tlak u žilama koje krv dovode iz srca u pluća i smanjuje količinu kisika koji može doprijeti u krv u plućima, što otežava tjelesnu aktivnost.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Talmanco has been shown to have comparable quality and to be bioequivalent to Adcirca.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Talmanco posjeduje usporedivu razinu kvalitete i da je bioekvivalentan lijeku Adcirca.
English: What measures are being taken to ensure the safe and effective use of Talmanco?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Talmanco?
English: Other information about Talmanco
Croatian: Ostale informacije o lijeku Talmanco
English: The name of the medicine was changed to Talmanco on 1 March
Croatian: Naziv lijeka izmijenjen je u Talmanco 1. ožujka 2017.
English: Talmanco is available as 20 mg tablets.
Croatian: Lijek Talmanco dostupan je u obliku tableta od 20 mg.
English: This is a summary of the European public assessment report (EPAR) for Talmanco.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Talmanco.
English: The active substance in Talmanco, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Croatian: Djelatna tvar lijeka Talmanco, tadalafil, ubraja se u skupinu lijekova naziva „inhibitori fosfodijesteraze tipa 5 (PDE5)”, što znači da inhibira djelovanje enzima PDE5.
English: Talmanco is a medicine used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Croatian: Talmanco je lijek koji se koristi u liječenju odraslih osoba oboljelih od pulmonalne arterijske hipertenzije (PAH) radi poboljšanja kapaciteta vježbanja (sposobnosti izvođenja tjelesne aktivnosti).
English: Talmanco can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.
Croatian: Talmanco se izdaje samo na recept, a terapiju mora započeti i pratiti liječnik koji ima iskustva u liječenju PAH-a.
English: What is Talmanco and what is it used for?
Croatian: Što je Talmanco i za što se koristi?
English: Patients with mild or moderate kidney or liver problems should be started on a lower dose.
Croatian: Bolesnici s blagim ili umjerenim oštećenjem bubrega ili jetre trebaju započeti terapiju s manjim dozama.
English: Because Talmanco is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Talmanco generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: What are the benefits and risks of Talmanco?
Croatian: Koje su koristi i rizici lijeka Talmanco?
English: This means that Talmanco contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Adcirca.
Croatian: To znači da sadrži iste djelatne tvari i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Adcirca.
English: Why is Talmanco approved?
Croatian: Zašto je Talmanco odobren?
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Adcirca, and do not need to be repeated for Talmanco.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari pri odobrenoj primjeni već su provedena za referentni lijek Adcirca te ih ne treba ponavljati za lijek Talmanco.
English: When the enzyme is blocked, a substance called ‘cyclic guanosine monophosphate' (cGMP) cannot be broken down and remains in the vessels where it causes widening of the blood vessels.
Croatian: Kada se inhibira djelovanje enzima, tvar „ciklički gvanozin monofosfat” (cGMP) ne može se razgraditi te zbog toga ostaje u krvnim žilama i uzrokuje njihovo širenje.
English: Talmanco contains the active substance tadalafil.
Croatian: Talmanco sadrži djelatnu tvar tadalafil.
English: The Committee recommended that Talmanco be approved for use in the EU.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Talmanco u promet u EU-u.
English: It is not intended to provide practical advice on how to use Talmanco.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Talmanco.
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Croatian: PAH predstavlja abnormalno visok krvni tlak u plućnim arterijama.
English: Talmanco tadalafil
Croatian: tadalafil
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Talmanco 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 Talmanco nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Croatian: PAH je onesposobljavajuća bolest kod koje postoji ozbiljno suženje krvnih žila u plućima.
English: This enzyme is found in the blood vessels of the lungs.
Croatian: Taj se enzim nalazi u krvnim žilama pluća.
English: In patients with PAH, this lowers the blood pressure in the lungs and improves symptoms.
Croatian: U bolesnika s PAH-om to dovodi do sniženja krvnog tlaka u plućima i ublažava simptome.