FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Rubraca are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Rubraca pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The most common side effects with Rubraca (which may affect more than 1 in 5 people) are tiredness or weakness, nausea (feeling sick), increased levels of creatinine (which may indicate kidney problems) and liver enzymes in the blood (which may indicate liver damage), vomiting, anaemia (low red blood cell counts), decreased appetite, dysgeusia (taste disturbances), diarrhoea, thrombocytopenia (low levels of platelets) and abdominal pain (belly ache).
Croatian: Najčešće nuspojave lijeka Rubraca (koje se mogu pojaviti u više od 1 na 5 osoba) jesu umor ili slabost, mučnina, povišene razine kreatinina (što može upućivati na tegobe s bubrezima), povišene razine jetrenih enzima u krvi (što može upućivati na oštećenje jetre), povraćanje, anemija (nizak broj crvenih krvnih stanica), smanjen apetit, disgeuzija (poremećaj okusa), proljev, trombocitopenija (niska razina trombocita) i bol u abdomenu (trbuhu).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rubraca 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 Rubraca nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Rubraca can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer.
Croatian: Lijek Rubraca izdaje se samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka.
English: In normal cells there is an alternative mechanism for repairing DNA but this alternative mechanism does not work properly in cancer cells with mutations in the BRCA genes.
Croatian: U normalnim stanicama postoji alternativni mehanizam za popravak DNK, no on ne funkcionira ispravno u stanicama raka s mutacijom gena BRCA.
English: Patients given Rubraca lived for 11 months without the disease coming back or getting worse compared with 5 months in patients given placebo (a dummy treatment).
Croatian: Bolesnice koje su uzimale lijek Rubraca živjele su 11 mjeseci bez povratka bolesti ili pogoršanja, u usporedbi s 5 mjeseci u bolesnica koje su primale placebo (prividno liječenje).
English: What are the risks associated with Rubraca?
Croatian: Koji su rizici povezani s lijekom Rubraca?
English: As for all medicines, data on the use of Rubraca are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Rubraca kontinuirano se prate.
English: The treatment should continue until the cancer progresses or the patient has unacceptable side effects.
Croatian: Liječenje treba nastaviti sve do napredovanja raka ili do neprihvatljivih nuspojava u bolesnica.
English: For such patients, tests for a genetic mutation (BRCA mutation) should be carried out first to see if Rubraca is likely to work for them.
Croatian: U takvih je bolesnica najprije potrebno provesti testove genetskih mutacija (mutacija u genima BRCA) kako bi se vidjelo hoće li u njih Rubraca djelovati.
English: Rubraca received a conditional marketing authorisation valid throughout the EU on 24 May 2018.
Croatian: Lijek Rubraca dobio je uvjetno odobrenje za stavljanje u promet koje je na snazi u EU-u od 24. svibnja
English: An overview of Rubraca and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Rubraca i zašto je odobren u EU-u
English: For more information about using Rubraca, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Rubraca pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Two other studies looked at 106 patients with ovarian cancer and BRCA mutation whose cancer had come back following at least 2 previous cancer treatments, including in many cases treatment with platinum-based medicines.
Croatian: U dva druga ispitivanja praćeno je 106 bolesnica s rakom jajnika i mutacijom gena BRCA u kojih se rak ponovno pojavio nakon najmanje 2 prethodne terapije protiv raka, što je u mnogo slučajeva uključivalo liječenje lijekovima na bazi platine.
English: proteins are blocked, the damaged DNA in these cancer cells cannot be repaired, and, as a result, the cancer cells die.
Croatian: Stoga, kada su PARP proteini blokirani, oštećeni se DNK u tim stanicama raka ne može popraviti, a posljedica je odumiranje stanica raka.
English: It can also be used if the patient's cancer has returned or is worsening after two treatments with platinum-based medicines and they can no longer have these medicines.
Croatian: Također se može primjenjivati u bolesnica u kojih se rak vratio ili pogoršao nakon dvije terapije lijekovima na bazi platine, i više se ne mogu liječiti tim lijekovima.
English: The active substance in Rubraca, rucaparib, blocks the activity of a family of proteins called poly(ADPribose) polymerases (PARPs) that help to repair damaged DNA in cells (both normal and cancer cells).
Croatian: Djelatna tvar u lijeku Rubraca, rukaparib, blokira djelovanje proteina iz obitelji poli(ADP-riboza) polimeraze (PARP), koji pomažu popraviti oštećeni DNK u stanicama (normalnim stanicama i stanicama raka).
English: Since Rubraca has been given conditional authorisation, the company that markets the medicine will provide the results from an ongoing study comparing Rubraca with chemotherapy (another cancer medicine) in patients with high-grade epithelial cancer of the ovary, of the fallopian tubes or of the peritoneum with BRCA mutation whose cancer has come back after chemotherapy treatments.
Croatian: Budući da je lijek Rubraca dobio uvjetno odobrenje, tvrtka koja stavlja lijek u promet mora dostaviti rezultate ispitivanja koje je u tijeku, a u kojem se lijek Rubraca uspoređuje s kemoterapijom (još jedan lijek protiv raka) u bolesnica s epitelnim rakom jajnika, jajovoda ili peritonealnim rakom visokog gradusa koje imaju mutaciju gena BRCA, u kojih se rak vratio nakon liječenja kemoterapijom.
English: Rubraca was also beneficial to patients whose cancer had come back after 2 previous cancer treatments, although these benefits have only been shown in patients with a BRCA mutation.
Croatian: Lijek Rubraca bio je također koristan u bolesnica u kojih se rak vratio nakon dvije prethodne terapije protiv raka, iako su se te koristi pokazale samo u bolesnica s mutacijom gena BRCA.
English: Treatment may be interrupted and doses may be reduced in patients who have certain side effects.
Croatian: U bolesnica s određenim nuspojavama liječenje se može prekinuti i doze se mogu smanjiti.
English: What information is still awaited for Rubraca?
Croatian: Koje se još informacije očekuju o lijeku Rubraca?
English: Rubraca has been shown to delay worsening or return of the disease in patients whose cancer had cleared partially or completely after treatment with platinum-based medicines.
Croatian: Pokazalo se da Rubraca odgađa pogoršanje ili povratak bolesti u bolesnica u kojih je rak djelomično ili potpuno nestao nakon terapije lijekovima na bazi platine.
English: Other information about Rubraca
Croatian: Ostale informacije o lijeku Rubraca
English: For maintenance treatment, Rubraca should be used no later than 8 weeks after the patient has finished their treatment with platinum-based medicine.
Croatian: Za terapiju održavanja bolesnice trebaju početi s primjenom lijeka Rubraca najkasnije osam tjedana nakon završetka terapije lijekom na bazi platine.
English: Rubraca is a cancer medicine for treating high-grade cancers of the ovary, fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).
Croatian: Rubraca je lijek protiv raka za liječenje raka jajnika, jajovoda (cjevaste strukture koje povezuju jajnike s maternicom) i peritoneuma (opna koja obavija abdomen) visokog gradusa.
English: What benefits of Rubraca have been shown in studies?
Croatian: Koje su koristi od lijeka Rubraca utvrđene u ispitivanjima?
English: This benefit was seen in patients with or without the BRCA mutation.
Croatian: Ova korist opažena je u bolesnica s mutacijom gena BRCA ili bez nje.
English: Rubraca as maintenance treatment was investigated in a study of 564 patients with ovarian cancer which had cleared (partially or completely) after treatment with platinum-based cancer medicines.
Croatian: Lijek Rubraca ispitan je kao terapija održavanja u ispitivanju koje je uključivalo 564 bolesnice s rakom jajnika koji je nestao (djelomično ili potpuno) nakon terapije lijekovima na bazi platine.
English: It can be used as maintenance treatment in patients whose recurring cancer has cleared (partially or completely) after treatment with platinum-based cancer medicines.
Croatian: Može se primjenjivati kao terapija održavanja u bolesnica u kojih se rak vratio, a zatim nestao (djelomično ili potpuno) nakon terapije lijekovima protiv raka na bazi platine.
English: In addition, fewer liver and blood-related problems occur with Rubraca than with other existing treatments for these patients.
Croatian: Osim toga, u usporedbi s drugim postojećim oblicima liječenja tih bolesnica, pri liječenju lijekom Rubraca dolazi do manje problema s jetrom i problema povezanih s krvi.
English: This benefit with Rubraca was seen in patients with or without the BRCA mutation.
Croatian: Korist od primjene lijeka Rubraca opažena je u bolesnica s mutacijom gena BRCA ili bez nje.
English: How does Rubraca work?
Croatian: Kako djeluje Rubraca?
English: How is Rubraca used?
Croatian: Kako se Rubraca primjenjuje?
English: For the full list of side effects of Rubraca, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Rubraca potražite u uputi o lijeku.
English: This summary was last updated in 10-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran u 10. 2014.
English: It is available as tablets (400 and 800 mg).
Croatian: Dostupan je u obliku tableta (400 i 800 mg).
English: The full EPAR for Renagel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za Renagel nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In the third, there was an average fall of 0.71 mmol/l over 44 weeks.
Croatian: U trećem, bilo je prisutno prosječno smanjenje od 0,71 mmol/l tijekom 44 tjedana.
English: In all of the studies, the main measure of effectiveness was the change in blood phosphate levels between the start and the end of treatment.
Croatian: U svim ispitivanjima, glavna mjera djelotvornosti bila je promjena u koncentraciji fosfata u krvi između početka i završetka ispitivanja.
English: This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart and bone disease.
Croatian: Ovo rezultira hiperfosfatemojom, što dugoročno gledano može uzrokovati komplikacije koje zahvaćaju srce i kosti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Renagel on 28 January 2000.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Renagel na snazi u Europskoj uniji od 28. siječnja 2000.
English: Patients with long-term kidney disease cannot eliminate phosphate from their bodies.
Croatian: Bolesnici s kroničnom bolesti bubrega ne mogu eliminirati fosfat iz svojeg tijela.
English: The most common side effects with Renagel (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Croatian: Najčešće nuspojave povezane s lijekom Renagel (uočene u više od 1 bolesnika na 10) su mučnina (osjećaj slabosti) i povraćanje.
English: This is a summary of the European public assessment report (EPAR) for Renagel.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Renagel.
English: Other information about Renagel
Croatian: Ostale informacije o lijeku Renagel
English: When taken with meals, it attaches to phosphate from food within the gut, preventing it from being absorbed into the body.
Croatian: Ako se uzima s obrocima, lijek se vezuje u crijevima na fosfat iz hrane, sprečavajući ga da se apsorbira u tijelu.
English: What measures are being taken to ensure the safe and effective use of Renagel?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Renagel?
English: The second, which did not compare Renagel with any other medicines, included 172 patients.
Croatian: Drugo ispitivanje, koje nije usporedilo lijek Renagel s bilo kojim drugim lijekom, obuhvatilo je 172 bolesnika.
English: For more information about treatment with Renagel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Renagel pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Renagel.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Renagel.
English: The longer study looked at the use of Renagel in 192 patients, the majority of whom had taken Renagel in previous studies.
Croatian: Dulje ispitivanje istražilo je primjenu lijeka Renagel u 192 bolesnika, od kojih je većina uzimala Renagel u prethodnim ispitivanjima.
English: Renagel sevelamer hydrochloride
Croatian: Renagel sevelamerhidroklorid
English: In haemodialysis, Renagel has been studied in two short-term studies lasting eight weeks and one longer study lasting 44 weeks.
Croatian: U slučaju hemodijalize, lijek Renagel ispitivan je u dva kratkoročna ispitivanja koja su trajala osam tjedana i jednom duljem ispitivanju koje je trajalo 44 tjedana.
English: The dose of Renagel should be adjusted to ensure that the blood phosphate level stays below 1.76 mmol/l.
Croatian: Dozu lijeka Renagel treba prilagoditi kako bi se osiguralo da koncentracija fosfata u krvi ostane ispod 1,76 mmol/l.
English: The recommended starting dose of Renagel depends on the level of phosphate in the blood and ranges from 800 to 1,600 mg three times a day.
Croatian: Preporučena početna doza za lijek Renagel ovisi o koncentraciji fosfata u krvi, te se kreće od 800 do 1 600 mg tri puta na dan.
English: A risk management plan has been developed to ensure that Renagel is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Renagel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Renagel, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Renagel nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Why has Renagel been approved?
Croatian: Zašto je Renagel odobren?
English: What is Renagel?
Croatian: Što je Renagel?
English: Renagel produced a significant decrease in serum phosphate in all of the studies.
Croatian: Renagel je proizveo značajno smanjenje u koncentraciji fosfata u serumu u svim ispitivanjima.
English: It can be used in patients undergoing haemodialysis (dialysis using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Croatian: Može se koristiti u bolesnika koji se podvrgavaju hemodijalizi (uz primjenu uređaja za filtraciju krvi) ili peritonealnoj dijalizi (u slučaju kada se tekućina pumpa u trbuh, a interna membrana tijela filtrira krv).
English: In the comparative study of patients undergoing haemodialysis, there was an average fall of 0.65 mmol/l over the eight weeks of Renagel treatment, compared with 0.68 mmol/l when the patients were taking calcium acetate.
Croatian: U komparativnom ispitivanju bolesnika koji se podvrgavaju hemodijalizi, bilo je prisutno prosječno smanjenje od 0,65 mmol/l tijekom razdoblja od osam tjedana terapije lijekom Renagel, u usporedbi s 0,68 mmol/ u bolesnika koji su uzimali kalcij acetat.
English: In peritoneal dialysis, there has been one study comparing Renagel with calcium acetate in 143 patients over 12 weeks.
Croatian: U slučaju perotonealne dijalize, provedeno je jedno ispitivanje koje je usporedilo Renagel s kalcij acetatom u 143 bolesnika tijekom 12 tjedana.
English: Patients should take Renagel tablets whole with meals and stick to their prescribed diets.
Croatian: Tablete Renagel moraju se uzimati s obrocima, a bolesnici se trebaju pridržavati svoje propisane prehrane.
English: The CHMP decided that Renagel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Renagel nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What is the risk associated with Renagel?
Croatian: Koji su rizici povezani s lijekom Renagel?
English: Patients taking Renagel had a similar fall in phosphate levels in the second study.
Croatian: Bolesnici koji su uzimali Renagel imali su slično smanjenje u koncetracijama fosfata u drugom ispitivanju.
English: The first study compared Renagel with calcium acetate (another phosphate-lowering medicine) in 84 patients.
Croatian: Prvo je ispitivanje usporedilo lijek Renagel s kalcij acetatom /drugim lijekom za snižavanje koncentracije fosfata) u 84 bolesnika.
English: Renagel must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Croatian: Renagel se ne smije koristi u osoba s hipofosfatemijom (niskim razinama fosfata u krvi) ili s opstrukcijom crijeva (blokadom u crijevima).
English: In the study of patients undergoing peritoneal dialysis, the patients receiving Renagel had similar falls in phosphate as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).
Croatian: U ispitivanju bolesnika koji su podvrgnuti peritonealnoj dijalizi, bolesnici koji su primali lijek Renagel imali su slično smanjenje u koncentraciji fosfata kao i bolesnici koji su primali kalcij acetat (0,52 odnosno 0,58 mmol/l).
English: Renagel is used to control hyperphosphataemia (high blood phosphate levels) in adults on dialysis (a blood clearance technique used in patients with kidney disease).
Croatian: Renagel se koristi za kontrolu hiperfosfatemije (visoke koncentracije fosfata u krvi) u odraslih bolesnika koji su na dijalizi (tehnika čišćenja krvi).
English: The active substance in Renagel, sevelamer hydrochloride, is a phosphate binder.
Croatian: Djelatna tvar u lijeku Renagel, sevelamerhidroklorid, je sredstvo za vezanje fosfata.
English: What benefit has Renagel shown during the studies?
Croatian: Koje su koristi lijeka Renagel dokazane u ispitivanjima?
English: Renagel is a medicine that contains the active substance sevelamer hydrochloride.
Croatian: Renagel je lijek koji sadrži sevelamerhidroklorid kao djelatnu tvar.
English: What is Renagel used for?
Croatian: Za što se Renagel koristi?
English: Renagel should be used with other treatments such as calcium or vitamin D supplements to control the development of bone disease.
Croatian: Renagel se smije koristiti s drugim terapijama poput dodataka kalcija i vitamina
English: For the full list of all side effects reported with Renagel, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Renagel potražite u uputi o lijeku.
English: How does Renagel work?
Croatian: Kako djeluje Renagel?
English: How is Renagel used?
Croatian: Kako se Renagel koristi?
English: How has Renagel been studied?
Croatian: Kako je Renagel ispitivan?
English: 50 ml (10 mg/ml) 1 vial
Croatian: 50 ml (10 mg/ml) 1 bočica
English: Strength Pharmaceutical Form
Croatian: EMA broj postupka (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Date of opening:____________
Croatian: Datum otvaranja:____________
English: Pregnancy and Postpartum During the second and third trimesters of pregnancy:
Croatian: Trudnoća i postpartalno razdoblje Tijekom drugog i trećeg tromjesečja trudnoće:
English: Your child's doctor will decide this.
Croatian: To će odlučiti liječnik
English: - Changes in the way your heart beats (heart rhythm change) may occasionally happen.
Croatian: - Promjenje u načinu na koje Vaše srce kuca (promjena srčanog ritma) mogu se povremeno dogoditi.
English: Severe rash may be developed in association with other symptoms which could be serious.
Croatian: Težak osip može se razviti u povezanosti s drugim simptomima koji mogu biti ozbiljni.
English: Week 48 Week 96 Week 48 Week 96 Week 48 Week 96
Croatian: 48. tjedan 96. tjedan 48. tjedan 96. tjedan 48. tjedan 96. tjedan
English: Therefore if the combination is unavoidable, the following recomendations are made according to the CYP2C19 status:
Croatian: Stoga se, ako je ova kombinacija neizbježna, donose sljedeće preporuke sukladno statusu CYP2C19:
English: b Cmin is concentration 24 hours post-dose
Croatian: b Cmin je koncentracija 24 sata nakon doze.
English: weeks for PIs, 281 weeks for NRTIs, and 85 weeks for NNRTIs.
Croatian: 281 tjedana za NRTI-jeve i 85 tjedana za NNRTI-jeve.
English: If you feel dizzy or lightheaded, do not drive or use machines and contact your doctor immediately.
Croatian: Ako osjetite omaglicu ili ošamućenost, nemojte voziti niti koristiti strojeve i odmah se obratite liječniku.
English: 90 (3 x 30) hard capsules
Croatian: 90 (3 x 30) tvrdih kapsula
English: During postpartum:
Croatian: Tijekom postpartalnog razdoblja:
English: If you have liver problems, including hepatitis B or C infection, you may experience a worsening of your liver problems.
Croatian: Ako imate problema s jetrom, uključujući infekciju hepatitisom B ili C, može doći do pogoršanja Vaših problema s jetrom.
English: Time-averaged difference ATV/RTV-LPV/RTV [97.5% CI d]
Croatian: Vremenski uprosječena razlika ATV/RTV-LPV/RTV [97,5% CI d]
English: Analyses of data through 96 weeks of treatment demonstrated durability of antiviral activity (Table 5).
Croatian: Analize podataka prikupljenih tijekom 96 tjedana liječenja pokazala je trajnost antivirusnog djelovanja
English: If you accidentally take more Atazanavir Krka capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Croatian: Ako slučajno uzmete više Atazanavir Krka kapsula nego što je preporučio Vaš liječnik, odmah se obratite liječniku ili potražite savjet u najbližoj bolnici.
English: It is recommended that the International Normalised Ratio (INR) be monitored carefully during treatment with atazanavir, especially when commencing therapy.
Croatian: Preporučuje se pažljivo pratiti međunarodni normalizirani omjer (INR) tijekom liječenja atazanvirom, osobito na početku terapije.
English: Shelf life after first opening is 2 months, stored below 25°C.
Croatian: Rok valjanosti nakon prvog otvaranja je 2 mjeseca, kada se čuva na temperaturi ispod 25°C.
English: The fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82%89%).
Croatian: Razine flutikazon propionata u plazmi značajno su se povisile, dok su se intrinzičke razine kortizola snizile za približno 86% (90%-tni raspon pouzdanosti: 82%-89%).
English: 15 to less than 35 At least 35
Croatian: 15 do manje od 35 Najmanje 35