FrancophonIA/ELRC3.0 huggingface dataset:
English: Bavencio is a cancer medicine used to treat adults with Merkel cell carcinoma (MCC), a type of skin cancer, when the cancer has spread to other parts of the body.
Croatian: Bavencio je lijek protiv raka koji se primjenjuje za liječenje odraslih osoba s karcinomom Merkelovih stanica (MCC), vrstom raka kože, kada se rak proširio na ostale dijelove tijela.
English: What are the risks associated with Bavencio?
Croatian: Koji su rizici povezani s lijekom Bavencio?
English: Bavencio can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the treatment of cancer.
Croatian: Bavencio se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju raka.
English: For more information about using Bavencio, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Bavencio pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The company that markets Bavencio will issue educational materials for patients containing important information about possible side effects of Bavencio, particularly immune-related reactions, and how to manage them.
Croatian: Tvrtka koja lijek Bavencio stavlja u promet izdat će materijale za obuku bolesnika s važnim informacijama o mogućim nuspojavama lijeka Bavencio, osobito o reakcijama povezanima s imunosnim sustavom, te o načinima njihove kontrole.
English: An overview of Bavencio and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Bavencio i zašto je odobren u EU-u
English: In a main study involving 88 patients with metastatic MCC who had received previous treatment with chemotherapy (cancer medicines), around 33% of patients (29 out of 88) were considered to have had a reduction in tumour size or no sign of it after treatment with the medicine; in most of these patients, the response lasted for at least 6 months.
Croatian: U glavnom ispitivanju u kojemu je sudjelovalo 88 bolesnika s metastatskim MCC-om koji su prethodno liječeni kemoterapijom (lijekovima protiv raka), smatralo se da se kod otprilike 33 % bolesnika (29 od 88) tumor smanjio ili potpuno povukao nakon terapije ovim lijekom, a kod većine tih bolesnika reakcija je trajala barem šest mjeseci.
English: PD-L1 usually attaches to cells of the immune (defence) system called T cells, preventing the T cells from attacking the cancer cells.
Croatian: PD-L1 se obično veže na stanice imunosnog (obrambenog) sustava pod nazivom T-stanice te ih sprječava da napadanu stanica raka.
English: In a main study involving 886 patients with advanced RCC, who had not been previously treated, Bavencio infusion in combination with axitinib by mouth was compared with standard treatment using another cancer medicine, sunitinib.
Croatian: U jednom glavnom ispitivanju koje je uključivalo 886 bolesnika s uznapredovalim RCC-om koji prethodno nisu liječeni, infuzija lijeka Bavencio u kombinaciji s aksitinibom danim kroz usta uspoređena je sa standardnim liječenjem drugim lijekom protiv raka, sunitinibom.
English: Serious side effects include immune-related and infusion-related reactions, anaemia (low red blood cell counts), difficulty breathing and abdominal pain.
Croatian: Ozbiljne nuspojave uključuju reakcije povezane s imunosnim sustavom i infuzijom, anemiju (nizak broj crvenih krvnih stanica), otežano disanje i bol u abdomenu.
English: In addition, early data from an ongoing study indicate that the majority of patients who have not had previous chemotherapy also respond to treatment with Bavencio, with a similar duration of response.
Croatian: Uz to, rani podatci iz ispitivanja koje je u tijeku pokazuju da većina bolesnika koja nije prethodno liječena kemoterapijom također reagira na terapiju lijekom Bavencio sa sličnim trajanjem reakcije.
English: The average time patients lived without their disease getting worse was around 13 months in those given Bavencio and axitinib versus 8 months in those given sunitinib.
Croatian: Prosječno vrijeme koje su bolesnici proveli bez pogoršanja bolesti bilo je oko 13 mjeseci kod bolesnika koji su primali Bavencio i aksitinib u usporedbi s osam mjeseci kod bolesnika koji su primali sunitinib.
English: How does Bavencio work?
Croatian: Kako djeluje Bavencio?
English: Bavencio contains the active substance avelumab.
Croatian: Bavencio sadržava djelatnu tvar avelumab.
English: As for all medicines, data on the use of Bavencio are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Bavencio kontinuirano se prate.
English: Bavencio is also used in combination with another cancer medicine, axitinib, for the initial treatment of patients with advanced renal cell carcinoma (RCC, a cancer of the kidney).
Croatian: Bavencio se također koristi u kombinaciji s drugim lijekom protiv raka, aksitinibom, za početno liječenje bolesnika s uznapredovalim karcinomom bubrežnih stanica (RCC), rakom bubrega.
English: Since Bavencio has been granted a conditional approval for MCC, the company that markets the medicine will provide further data from the ongoing study of patients who did not receive chemotherapy before starting treatment with Bavencio.
Croatian: Budući da je lijek Bavencio dobio uvjetno odobrenje, tvrtka koja lijek Bavencio stavlja u promet mora dostaviti dodatne podatke iz ispitivanja koje je u tijeku o bolesnicima koji nisu prošli kemoterapiju prije početka terapije lijekom Bavencio.
English: Early results from an ongoing study looking at the effects of Bavencio in patients with metastatic MCC who had not received previous chemotherapy showed that the overall response rate at the time of analysis was 62% (18 out of 29 patients).
Croatian: Rani rezultati ispitivanja koje je u tijeku i bavi se učincima lijeka Bavencio u bolesnika s metastatskim MCC-om koji nisu prethodno liječeni kemoterapijom pokazali su da je ukupna stopa reakcije u vrijeme analize iznosila 62 % (18 od 29 bolesnika).
English: The safety of Bavencio for this use is considered acceptable and side effects manageable with the additional measures put in place.
Croatian: Sigurnost lijeka Bavencio u ovoj primjeni smatra se prihvatljivom, a nuspojave je moguće kontrolirati s dodatnim uvedenim mjerama.
English: By attaching to PD-L1, Bavencio prevents the cancer cells from switching off the T cells, thereby increasing the ability of the T cells to kill the cancer cells.
Croatian: Vezivanjem na PD-L1, lijek Bavencio sprječava da stanice raka ugase aktivnost T-stanica, čime se povećava njihova sposobnost ubijanja stanica raka.
English: In patients with advanced RCC, Bavencio plus axitinib has been shown to improve the length of time patients survive without their disease getting worse, when compared with sunitinib, though how long patients survive overall remains to be shown.
Croatian: Pokazalo se da u bolesnika s uznapredovalim RCC-om Bavencio u kombinaciji s aksitinibom produžuje vrijeme koje bolesnici provedu bez pogoršanja bolesti u usporedbi sa sunitinibom, iako još nije utvrđeno koje je ukupno vrijeme preživljenja bolesnika.
English: What information is still awaited for Bavencio?
Croatian: Koje se još informacije očekuju o lijeku Bavencio?
English: The active substance in Bavencio, avelumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand-1' (PD-L1), which is present on the surface of many cancer cells.
Croatian: Djelatna tvar u lijeku Bavencio, avelumab, monoklonsko je protutijelo, odnosno vrsta bjelančevine osmišljena za prepoznavanje bjelančevine naziva „ligand 1 programirane smrti stanice” (PD-L1) koja je prisutna na površini mnogih stanica raka, te za vezivanje na nju.
English: When Bavencio is used with axitinib the most common side effects of the combination, which may affect more than 1 in 5 people, are diarrhoea, high blood pressure, tiredness, nausea, dysphonia (hoarseness), decreased appetite, hypothyroidism (reduced thyroid function), cough, headache, breathing difficulties and arthralgia (joint pain).
Croatian: Kad se Bavencio koristi s aksitinibom, najčešće nuspojave u toj kombinaciji, koje se mogu javiti u više od 1 na 5 osoba su proljev, visoki krvni tlak, umor, mučnina, disfonija (promuklost), smanjeni apetit, hipotireoza (smanjena funkcija štitnjače), kašalj, glavobolja, teškoće pri disanju i artralgija (bol u zglobovima).
English: Bavencio has been shown to be of benefit in one main study that showed the cancer shrank in patients with MCC and one that showed patients with RCC could live longer without their disease getting worse.
Croatian: Korist od lijeka Bavencio utvrđena je u jednom glavnom ispitivanju u kojem se rak smanjio u bolesnika s MCC-om i u drugom gdje se pokazalo da bolesnici s RCC-om mogu duže živjeti bez pogoršanja bolesti.
English: Longer follow-up was needed to draw a reliable conclusion on how well patients given Bavencio and axitinib survive overall.
Croatian: Bilo je potrebno dugoročno praćenje da bi se moglo pouzdano zaključiti koje je opće preživljenje bolesnika koji su primili lijek Bavencio.
English: Before the first 4 infusions of Bavencio, the patient receives an antihistamine and paracetamol to help prevent infusion-related reactions, such as reddening of the skin, chills, fever, back or abdominal (belly) pain, allergic reactions and difficulty breathing.
Croatian: Bolesnici primaju antihistaminik i paracetamol prije prve četiri infuzije lijeka Bavencio kao pomoć u sprječavanju reakcija povezanih s infuzijom kao što su crvenilo kože, zimica, vrućica, bolovi u leđima ili abdomenu (trbuhu), alergijske reakcije i otežano disanje.
English: What benefits of Bavencio have been shown in studies?
Croatian: Koje su koristi od lijeka Bavencio utvrđene u ispitivanjima?
English: The most common side effects with Bavencio used alone (which may affect more than 1 in 10 people) include tiredness, nausea (feeling sick), diarrhoea, decreased appetite, constipation, infusion-related reactions, weight loss and vomiting.
Croatian: Najčešće nuspojave lijeka Bavencio kad se primjenjuje sam (koje se mogu javiti u više od 1 od 10 osoba) uključuju umor, mučninu (slabost), proljev, smanjeni apetit, zatvor, reakcije povezane s infuzijom, gubitak tjelesne težine i povraćanje.
English: For the full list of side effects and restrictions of Bavencio, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Bavencio potražite u uputi o lijeku.
English: Each cycle was 28 days.
Croatian: Svaki je ciklus trajao 28 dana.
English: Drink plenty of water
Croatian: Pijte puno vode
English: It also slows down the worsening of the disease.
Croatian: On ujedno usporava pogoršanje bolesti.
English: For the first 4 weeks you will get a new pack each week.
Croatian: Tijekom prva 4 tjedna svaki ćete tjedan dobivati novo pakiranje.
English: Some infections can be serious and may lead to death.
Croatian: Neke infekcije mogu biti ozbiljne i dovesti do smrti.
English: This may affect your ability to father a child.
Croatian: To može utjecati na Vašu sposobnost za začnete dijete.
English: 30 April 2015
Croatian: 30. travnja 2015.
English: eOverall survival data are not yet mature.
Croatian: ePodaci za ukupno preživljenje još nisu zreli.
English: Reversibility of this finding has not been demonstrated.
Croatian: Nije dokazana reverzibilnost tog učinka.
English: • you think you may have an infection or have had a long-lasting or repeated infection
Croatian: • ako mislite da biste mogli imati infekciju ili ako ste imali infekciju koja je dugo trajala ili se ponavljala
English: Overall Survivale
Croatian: Ukupno preživljenjee
English: Response assessments were performed at 8 weeks, 24 weeks, and every 12 weeks thereafter.
Croatian: Ocjene odgovora provedene su u 8. tjednu, 24. tjednu i svakih 12 tjedana nakon toga.
English: very rare (<1/10,000), not known (cannot be estimated from available data).
Croatian: < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Treatment should be continued until disease progression or no longer tolerated by the patient.
Croatian: Liječenje treba nastaviti do progresije bolesti ili dok ga bolesnik više ne bude mogao podnositi.
English: Take the tablets and this leaflet with you.
Croatian: Ponesite tablete i ovu uputu sa sobom.
English: The safety and efficacy of venetoclax in children aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost venetoklaksa u djece mlađe od 18 godina nisu ustanovljene.
English: Time to next anti-leukaemic therapy Number of events (%)
Croatian: Vrijeme do sljedeće terapije za leukemiju Broj događaja (%)
English: Venclyxto with food and drink
Croatian: Venclyxto s hranom i pićem
English: This is to see if you can continue to take this medicine safely.
Croatian: Svrha toga je utvrditi možete li nastaviti sigurno uzimati ovaj lijek.
English: IRC assessment (N=107)a
Croatian: Ocjena IRC-a (N=107)a
English: Low white blood cell count can increase your risk for infection.
Croatian: Nizak broj bijelih krvnih stanica može povećati rizik od infekcije.
English: Your doctor will advise what your dose should be.
Croatian: Liječnik će Vam reći koju dozu trebate uzimati.
English: 12-month estimate
Croatian: 12-mjesečna procjena
English: Hospitalisation should be considered for subsequent dose increases based on reassessment of risk.
Croatian: Hospitalizaciju treba razmotriti i kod sljedećih povećanja doze, na temelju ponovne ocjene rizika.
English: Your doctor will gradually increase the dose over the next 4 weeks to the full standard dose.
Croatian: Vaš će liječnik postupno povećavati dozu tijekom naredna 4 tjedna do pune standardne doze.
English: After completion of titration phase
Croatian: Nakon završetka faze titracije
English: A risk to the breast-feeding child cannot be excluded.
Croatian: Ne može se isključiti rizik za dijete.
English: The population estimate for the terminal phase elimination half-life of venetoclax was approximately 26 hours.
Croatian: Populacijska procjena za poluvijek eliminacije terminalne faze venetoklaksa iznosila je približno 26 sati.
English: Frequency (all grades)a
Croatian: Učestalost (svi stupnjevi)a
English: This protein helps cancer cells survive.
Croatian: Taj protein pomaže stanicama raka da prežive.
English: Alternative treatments should be considered.
Croatian: Treba razmotriti druge mogućnosti liječenja.
English: Take your dose in the morning with a meal and water.
Croatian: Uzmite dozu lijeka ujutro, uz obrok i s vodom.
English: When your Venclyxto dose has been increased to the full standard dose, check with your doctor if you can start taking these medicines again.
Croatian: Nakon što se doza lijeka Venclyxto poveća na punu standardnu dozu, provjerite sa svojim liječnikom možete li ponovno početi uzimati te lijekove.
English: The risk of TLS is a continuum based on multiple factors, including comorbidities.
Croatian: Rizik od TLS-a je kontinuirano stanje koje se temelji na većem broju faktora, uključujući komorbiditete.
English: Effects of age, sex, and weight
Croatian: Učinci dobi, spola i tjelesne težine
English: After approximately 3 months of daily dosing in dogs, venetoclax caused progressive white discoloration of the hair coat, due to loss of melanin pigment in the hair.
Croatian: Nakon približno 3 mjeseca svakodnevne primjene u pasa, venetoklaks je uzrokovao progresivnu promjenu boje dlake u bijelu, zbog gubitka melaninskog pigmenta u dlaci.
English: It is important to follow all of the instructions in the ‘how to take' section of the leaflet.
Croatian: Važno je da se pridržavate svih uputa u dijelu „Kako uzimati“
English: 28 film-coated tablets Component of a multipack, can't be sold separately.
Croatian: 28 filmom obloženih tableta Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: The tablets should be taken with a meal in order to avoid a risk for lack of efficacy (see section 5.2).
Croatian: Tablete treba uzimati uz obrok kako bi se izbjegao rizik od nedostatne djelotvornosti (vidjeti dio 5.2).
English: In CLL, the lymphocytes multiply too quickly and live for too long, so that there are too many of them in the blood.
Croatian: Kod KLL-a se limfociti prebrzo umnažaju i predugo žive, zbog čega ih u krvi ima previše.
English: The prophylaxis measures listed below should be followed.
Croatian: Treba provoditi profilaktičke mjere navedene u nastavku.
English: At the time of data cut-off (26 July 2017), 127 patients were enrolled and treated with venetoclax.
Croatian: U trenutku završetka prikupljanja podataka (26. srpnja 2017.), 127 bolesnika bilo je uključeno u ispitivanje i liječeno venetoklaksom.
English: The pharmacokinetics of venetoclax do not change over time.
Croatian: Farmakokinetika venetoklaksa ne mijenja se s vremenom.
English: 17p deletion status was determined based on central laboratory test results.
Croatian: Status delecije 17p određivao se na temelju nalaza testiranja provedenog u centralnom laboratoriju.
English: It is very important that you drink plenty of water when taking Venclyxto during the first 5 weeks of treatment.
Croatian: Vrlo je važno da pijete puno vode dok uzimate Venclyxto tijekom prvih 5 tjedana liječenja.
English: In the film-coating:
Croatian: U film ovojnici:
English: Your doctor, pharmacist or nurse will do blood tests to check for TLS.
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra provodit će krvne pretrage kako bi provjerili imate li TLS.
English: If you have problems taking this medicine, talk to your doctor.
Croatian: Ako imate poteškoća s uzimanjem ovog lijeka, obratite se svom liječniku.
English: EU/1/16/1138/001 (10 mg, 10 tablets) EU/1/16/1138/002 (10 mg, 14 tablets) EU/1/16/1138/003 (50 mg, 5 tablets) EU/1/16/1138/004 (50 mg, 7 tablets) EU/1/16/1138/005 (100 mg 7 tablets) EU/1/16/1138/006 (100 mg, 14 tablets) EU/1/16/1138/007 (100 mg, 112 (4 x 28) tablets)
Croatian: EU/1/16/1138/001 (10 mg, 10 tableta) EU/1/16/1138/002 (10 mg, 14 tableta) EU/1/16/1138/003 (50 mg, 5 tableta) EU/1/16/1138/004 (50 mg, 7 tableta) EU/1/16/1138/005 (100 mg 7 tableta) EU/1/16/1138/006 (100 mg, 14 tableta) EU/1/16/1138/007 (100 mg, 112 (4 x 28) tableta)
English: During the dose-titration phase, venetoclax should be taken in the morning to facilitate laboratory monitoring.
Croatian: Tijekom faze titracije doze, venetoklaks treba uzimati ujutro kako bi se olakšalo laboratorijsko praćenje.
English: Tell your doctor or pharmacist if you take any of the following medicines as they can increase or decrease the amount of venetoclax in your blood:
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova jer oni mogu povećati ili smanjiti količinu venetoklaksa u krvi:
English: • higher level of a body salt (electrolyte) called phosphate
Croatian: • povišene vrijednosti tjelesne soli (elektrolita) koja se zove fosfat
English: • Swallow the tablets whole with a glass of water
Croatian: • Tablete progutajte cijele, s čašom vode.
English: The tablets should not be chewed, crushed, or broken before swallowing.
Croatian: Tablete se ne smiju žvakati, drobiti ni lomiti prije gutanja.
English: • lower number of red blood cells
Croatian: • smanjen broj crvenih krvnih stanica
English: Blocking this protein helps to kill and lower the number of cancer cells.
Croatian: Blokiranje tog proteina pomaže uništiti stanice raka i smanjiti njihov broj.
English: For patients who require dose reductions to less than 100 mg for more than 2 weeks, discontinuation of venetoclax should be considered.
Croatian: U bolesnika kojima su potrebna smanjenja doze na manje od 100 mg tijekom više od 2 tjedna, treba razmotriti prekid liječenja venetoklaksom.
English: Patients should be instructed to swallow the tablets whole with water at approximately the same time each day.
Croatian: Bolesnike treba uputiti da tablete progutaju cijele, s vodom, približno u isto vrijeme svaki dan.
English: It belongs to a group of medicines called “BCL-2 inhibitors”.
Croatian: Pripada skupini lijekova koji se zovu 'inhibitori BCL-2'.
English: Venclyxto should not be used in children and adolescents.
Croatian: Venclyxto se ne smije primjenjivati u djece i adolescenata.
English: Drink 1.5-2 litres of water a day.
Croatian: Pijte 1,5 - 2 litre vode na dan.
English: The risk of TLS was reduced after revision of the dosing regimen and modification to prophylaxis and monitoring measures.
Croatian: Rizik od TLS-a smanjen je nakon revizije režima doziranja i promjena u mjerama profilakse i praćenja.
English: Some people may develop unusual levels of some body salts (such as potassium and uric acid) in the blood caused by the fast breakdown of cancer cells during treatment.
Croatian: U nekih se osoba mogu razviti neuobičajene razine nekih tjelesnih soli (npr. kalija i mokraćne kiseline) u krvi, što je posljedica brze razgradnje stanica raka tijekom liječenja.
English: - Venclyxto should not be used during pregnancy.
Croatian: - Venclyxto se ne smije primjenjivati tijekom trudnoće.
English: Supportive measures including antimicrobials for any signs of infection should be considered.
Croatian: Treba razmotriti potporne mjere, uključujući primjenu antimikrobnih lijekova kod pojave bilo kakvih znakova infekcije.
English: Tell your doctor if you notice any of the following side effects: Very common
Croatian: Obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava: Vrlo česte
English: Table 2: Dose modification for TLS and other toxicities
Croatian: Tablica 2: Prilagodba doze kod TLS-a i drugih toksičnosti
English: • a medicine for cancer known as everolimus
Croatian: • lijek za liječenje raka poznat pod nazivom everolimus
English: NE=not evaluable.
Croatian: NO = ne može se ocijeniti.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX52
Croatian: Farmakoterapijska skupina: ostali antineoplastici, ATK oznaka: L01XX52
English: This may lead to changes in kidney function, abnormal heartbeat, or seizures.
Croatian: To može dovesti do promjena u bubrežnoj funkciji, abnormalnih srčanih otkucaja ili napadaja.
English: Investigator-assessed efficacy results are presented for 158 patients with a later data cutoff date 10 June 2016.
Croatian: Rezultati za djelotvornost prema ocjeni ispitivača prikazani su za 158 bolesnika za koje su se podaci prikupljali do kasnijeg datuma 10. lipnja 2016.
English: • During the first 5 weeks of treatment, you should take the tablets in the morning to help you follow-up with blood tests, if needed.
Croatian: • Tijekom prvih 5 tjedana liječenja uzimajte tablete ujutro jer će to olakšati provođenje kontrolnih krvnih pretraga, ako one budu potrebne.
English: In vitro interaction studies
Croatian: Ispitivanja interakcija in vitro
English: Patients should be instructed to drink plenty of water daily starting 2 days before and throughout the dose-titration phase.
Croatian: Bolesnike treba uputiti da svakodnevno piju puno vode, počevši 2 dana prije i tijekom cijelog trajanja faze titracije doze.
English: No specific dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.1).
Croatian: Nije potrebna specifična prilagodba doze za starije bolesnike (u dobi od ≥ 65 godina) (vidjeti dio 5.1).
English: Additional efficacy results for the pre-specified primary analysis are shown in Table 5 and Figure 2 and Figure 3.
Croatian: Dodatni rezultati za djelotvornost za unaprijed specificiranu primarnu analizu prikazani su u Tablici 5 te na Slici 2 i Slici 3.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Croatian: Učestalosti su definirane kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i
English: Patients who experience overdose should be closely monitored and appropriate supportive treatment provided.
Croatian: Bolesnike u kojih dođe do predoziranja treba pažljivo nadzirati i treba uvesti odgovarajuće potporno liječenje.