FrancophonIA/ELRC3.0 huggingface dataset:
English: • Xofigo should only be used as monotherapy or in combination with an LHRH analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, who are in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.
Croatian: LHRH) za liječenje odraslih bolesnika s metastatskim rakom prostate otpornim na kastraciju (engl. metastatic castration-resistant prostate cancer, mCRPC), simptomatskim koštanim metastazama i bez poznatih visceralnih metastaza, u progresiji, nakon najmanje dvije prethodne linije sustavne terapije za mCRPC (osim analoga LHRH-a) ili bolesnika nepodobnih za sva dostupna sustavna liječenja mCRPC-a.
English: Information for healthcare professionals
Croatian: Razlozi za preporuku PRAC-a
English: • In mildly symptomatic patients, the benefit of treatment should be carefully assessed against its risks, considering that high osteoblastic activity is likely to be required for treatment benefit (see below for more information).
Croatian: PRAC je smatrao da u odraslih s CRPC-om i blago simptomatskim koštanim metastazama treba pažljivo procijeniti korist od liječenja kako bi se nadmašili rizici, s obzirom da će za korist od liječenja vjerojatno biti potrebna velika osteoblastična aktivnost.
English: However, the reasons for a possible earlier death seen in this study are not fully understood.
Croatian: Međutim, veličina tog rizika nije potpuno jasna jer su u svim dostupnim ispitivanjima, što je i znanstvena savjetodavna skupina
English: The review of Xofigo was initiated on 1 December 2017 at the request of the European Commission, Article 20 of Regulation (EC) No 726/2004.
Croatian: Dana 30. studenog 2018., na temelju članka 20.
English: In addition, 29% of patients who received the Xofigo combination had fractures, compared with 11% of patients given the placebo combination.
Croatian: Nadalje, približno tri puta više bolesnika imalo je prijelome u skupini koja je primala radij-223 u usporedbi sa skupinom koja je primala placebo.
English: In addition, the combination used in this study is now contraindicated.
Croatian: Te su osobine u skladu s odobrenom indikacijom.
English: • Before starting and during treatment with Xofigo, an assessment of patients' bone status (e.g. by scintigraphy, bone mineral density measurement) and risk of fractures (e.g. osteoporosis, fewer than 6 bone metastases, medication increasing fracture risk, low body mass index) should be performed.
Croatian: Na temelju prethodno iznesenih opažanja, PRAC je smatrao da je prije početka liječenja radijem 223 potrebno procijeniti stanje kostiju upotrebom, na primjer, scintigrafije i mjerenja mineralne gustoće kostiju kao i početni rizik od prijeloma u bolesnika na temelju poznatih čimbenika rizika i onih prepoznatih u tom postupku (na primjer, osteoporoza, manje od šest koštanih metastaza, lijekovi koji povećavaju rizik od prijeloma i nizak indeks tjelesne mase).
English: EMA restricts use of prostate cancer medicine Xofigo
Croatian: CHMP stoga preporučuje izmjene uvjeta za izdavanje odobrenja za stavljanje u promet lijeka Xofigo (radij Ra223 diklorid).
English: The above recommendations are based on the assessment of data from a randomised, double blind, placebo controlled phase III trial (ERA-223), which showed that there was an increased incidence of fractures (28.6% vs 11.4%), a possible reduction in median overall survival (30.7 months vs 33.3 months, HR 1.195, 95% confidence interval (CI) 0.950 - 1.505, p=0.13) and an increased risk of radiological non-bone progression (HR 1.376 [95% CIs 0.972, 1.948], p=0.07) among patients receiving Xofigo in combination with abiraterone acetate plus prednisone/prednisolone (n=401) compared to patients receiving placebo in combination with abiraterone acetate plus prednisone/prednisolone (n=405).
Croatian: Budući da se skup podataka razvio tijekom tog postupka, naznačeno je da statistički značajna neravnoteža mortaliteta opažena u privremenoj analizi ispitivanja ERA 223 u vrijeme privremenih mjera (HR 1,347; 95 % CI [1,047; 1,732] p=0,02) više nije bila statistički značajna u analizi nakon zaključavanja baze podataka 8. lipnja 2018. (HR 1,195; 95 % CI [0,950; 1,505] p=0,128).
English: In the study, patients given the combination with Xofigo died on average 2.6 months earlier than those given the combination with placebo.
Croatian: U ispitivanju ALSYMPCA incidencija prijeloma u bolesnika s manje od šest koštanih metastaza bila je približno dvostruka u usporedbi sa skupinom koja je primala placebo.
English: An increased fracture risk was found particularly in patients with a medical history of osteoporosis and in patients with fewer than 6 bone metastases.
Croatian: U multivarijantnoj analizi rizik od prijeloma imao je tendenciju povećanja u bolesnika s manje od šest koštanih metastaza u usporedbi s bolesnicima sa šest ili više koštanih metastaza u skupini radija 223.
English: Also, having Xofigo together with the cancer medicine Zytiga and a corticosteroid medicine (prednisone or prednisolone) for prostate cancer could possibly increase the risk of death.
Croatian: Slično tomu, budući da je poznato da kemoterapija, koja je odobrena za liječenje mCPRC-a u kombinaciji s prednizonom/prednizolonom, štetno utječe na kosti, ne može se isključiti dodatno povećanje rizika.
English: On 26 July 2018, the European Medicines Agency concluded its review of the cancer medicine Xofigo (radium-223 dichloride), and recommended restricting its use to patients who have had two previous treatments for metastatic prostate cancer (prostate cancer that has spread to the bone) or who cannot receive other treatments.
Croatian: Ispitivanje ERA 223 isključivo je provedeno u bolesnika koji prethodno nisu bili liječeni kamoterapijom, što dodaje dodatne zabrinutosti u pogledu liječenja radijem 223 bolesnike s metastatskim rakom prostate koji prethodno nisu bili liječeni kamoterapijom.
English: The medicine should also not be used in patients who have no symptoms, in line with the current indication; in addition, the use of Xofigo is not recommended in patients with a low number of bone metastases called osteoblastic bone metastases.
Croatian: Stoga je navedeno da ograničena indikacija ne isključuje jasno liječenje bolesnika s niskom razine osteoblastičnih koštanih metastaza.
English: • Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone.
Croatian: PRAC je, nadalje, smatrao da radij-223 treba biti kontraindiciran u kombinaciji s abirateronacetatom i prednizonom/prednizolonom.
English: Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo.
Croatian: U nedostatku kliničkih podataka, PRAC je smatrao da zdravstvenim radnicima treba savjetovati da omoguće razdoblje bez liječenja na temelju poluvijeka eliminacije u trajanju od najmanje pet dana nakon abiraterona, a prije početka liječenja radijem-223 te u trajanju od najmanje 30 dana nakon posljednje doze radija-223 prije primjene naknadnog sustavnog liječenja raka.
English: Xofigo should not be used with other systemic cancer therapies, except for treatments to maintain reduced levels of male hormones (hormone therapy).
Croatian: PRAC je općenito smatrao se lijek Xofigo treba upotrebljavati samo kao monoterapija ili u kombinaciji s analogom hormona oslobađanja luteinizirajućeg hormona (engl. luteinising hormone releasing hormone,
English: In March 2018, the PRAC recommended contraindicating the use of Xofigo with Zytiga and prednisone/prednisolone, as an interim measure, while the review was ongoing.
Croatian: PRAC je općenito smatrao da se kontraindikacije uvedene u vrijeme privremenih mjera za upotrebu radija 223 u kombinaciji s abirateronom i prednizonom/prednizolonom trebaju zadržati.
English: Medicine to be used only after two previous treatments or when other treatments cannot be taken
Croatian: Neke od njih mogu ostati neotkrivene prije početka liječenja.
English: A possible increased risk of death was also observed in a clinical trial investigating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer.
Croatian: Uz to, nekoliko objavljenih ispitivanja upućuje na križnu rezistenciju na abirateron i enzalutamid ili docetaksel u nakon liječenja abirateronom.
English: • The prostate cancer medicine Xofigo can increase the risk of having fractures.
Croatian: Ostali čimbenici kao što je istodobna primjena steroida mogu još povećati rizik od prijeloma.
English: The review of Xofigo was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) after data from a clinical study suggested that patients given Xofigo in combination with Zytiga and prednisone/prednisolone could be at risk of dying earlier and had more fractures than patients given placebo (a dummy treatment) with Zytiga and prednisone/prednisolone.
Croatian: Analize neobrađenih preliminarnih podataka kliničkog ispitivanja u kojem je ocijenjen lijek Xofigo (radij Ra223 diklorid) u bolesnika s karcinomom prostate bez simptoma ili s blagim simptomima (ERA-223 [1]), pokazale su povećanu incidenciju smrtnih slučajeva i prijeloma u skupini koja je primala lijek (radij-223 diklorid u kombinaciji s abirateronaceatatom i prednizonom/prednizolonom) u usporedbi s kontrolnom skupinom (placebo u kombinaciji s abirateronaceatatom i prednizonom/prednizolonom).
English: The PRAC's recommendations were endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).
Croatian: Nakon što je pregledao preporuku PRAC-a, CHMP je suglasan s općim znanstvenim zaključcima i razlozima za preporuku PRAC-a.
English: Xofigo is currently used to treat adult men with cancer of the prostate (a gland of the male reproductive system).
Croatian: Xofigo (radij Ra223 diklorid) centralno je odobren lijek indiciran za liječenje odraslih s rakom prostate otpornim na kastraciju, sa simptomatskim koštanim metastazama i bez poznatih visceralnih metastaza.
English: Based on threshold of 10
Croatian: Temeljeno na pragu od 10
English: • then once every 4 weeks after that as long as your condition does not worsen.
Croatian: • i nakon toga jedanput svaka 4 tjedna toliko dugo dok se Vaše stanje ne pogorša.
English: If you miss an appointment, make another one as soon as possible.
Croatian: Ako propustite dogovoreni termin, dogovorite novi što je prije moguće.
English: * No Grade 4
Croatian: * Nije bilo 4. stupnja
English: Dilute under appropriate aseptic conditions.
Croatian: Razrjeđivanje provedite u odgovarajućim aseptičnim uvjetima.
English: Regardless of response per IMWG
Croatian: Bez obzira na IMWG odgovor
English: Initial rate (first hour)
Croatian: Početna brzina (prvi sat)
English: Otherwise, use a dilution volume of 1,000 mL.
Croatian: Inače, koristite volumen razrijeđene otopine od 1000 ml.
English: • high level of sugar in the blood
Croatian: • visoke razine šećera u krvi
English: Tell your doctor if you have ever had or might now have a hepatitis B infection.
Croatian: Obavijestite liječnika ako ste ikada imali ili bi mogli imati infekciju virusom hepatitisa B.
English: If you need a blood transfusion, you will have a blood test first to match your blood type.
Croatian: Ako Vam je potrebna transfuzija krvi, najprije će se provesti krvna pretraga za određivanje Vaše krvne grupe.
English: The procedure above should be repeated in the event of recurrence of Grade 3 symptoms.
Croatian: Prethodno opisan postupak treba ponoviti u slučaju ponovnog nastupa simptoma 3. stupnja.
English: This includes medicines you can get without a prescription, and herbal medicines.
Croatian: To uključuje i lijekove koje možete nabaviti bez recepta te biljne lijekove.
English: Unopened vials 24 months
Croatian: Neotvorene bočice 24 mjeseca
English: It is given as a drip into a vein (“intravenous infusion”) over several hours.
Croatian: Primjenjuje se ukapavanjem u venu („intravenskom infuzijom”) tijekom nekoliko sati.
English: There is a theoretical risk of haemolysis.
Croatian: Postoji teorijski rizik od hemolize.
English: It belongs to a group of medicines called “monoclonal antibodies”.
Croatian: On pripada skupini lijekova koji se zovu „monoklonska protutijela”.
English: • once a week for the first 8 weeks
Croatian: • jedanput na tjedan tijekom prvih 8 tjedana
English: • unusual feeling in the skin (such as a tingling or crawling feeling).
Croatian: • neuobičajen osjećaj na koži (poput trnaca ili žmaraca)
English: Monoclonal antibodies are proteins that have been designed to recognise and attach to specific targets in the body.
Croatian: Monoklonska protutijela su proteini koji su dizajnirani da prepoznaju i pričvrste se na specifične ciljeve u tijelu.
English: DARZALEX is indicated:
Croatian: DARZALEX je indiciran:
English: If you have had an infusion-related reaction once it is less likely to happen again.
Croatian: Ako jednom doživite reakciju na infuziju, manja je vjerojatnost da će se to ponovno dogoditi.
English: The consolidation phase of treatment began a minimum of 30 days post-ASCT, when the patient had recovered sufficiently, and engraftment was complete.
Croatian: Faza konsolidacijskog liječenja započela je najmanje 30 dana nakon ASCT-a, kada se bolesnik dovoljno oporavio, a usađivanje je bilo dovršeno.
English: • then once every 2 weeks for 16 weeks
Croatian: • zatim jedanput svaka 2 tjedna tijekom 16 tjedana
English: These reactions are most likely to happen with the first infusion.
Croatian: Nastup tih reakcija najvjerojatniji je tijekom prve infuzije.
English: This is because the medicine may pass into the mother's milk and it is not known how it will affect the baby.
Croatian: Naime, ovaj se lijek može izlučiti u majčino mlijeko, a nije poznato kako će utjecati na dijete.
English: Nervous system disorders Peripheral sensory neuropathy
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija
English: Therefore, the incidence of antibody development might not have been reliably determined.
Croatian: Stoga se incidencija razvoja protutijela ne može pouzdano odrediti.
English: Your healthcare professional will throw away any medicines that are no longer being used.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: The safety and efficacy of DARZALEX in children aged below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka DARZALEX u djece mlađe od 18 godina još nisu ustanovljene.
English: This is because it is not known how the medicine will affect them.
Croatian: Naime, nije poznato kako će ovaj lijek djelovati na njih.
English: Component of an initiation pack, cannot be sold separately.
Croatian: Sastavnica pakiranja za početak liječenja, ne može se prodavati odvojeno.
English: Do not give DARZALEX to children or young people below 18 years of age.
Croatian: DARZALEX se ne smije davati djeci ni osobama mlađima od 18 godina.
English: Otherwise, continue to use instructions indicated in the table for the Week 2 infusion rate.
Croatian: U suprotnom, nastavite pratiti upute naznačene u tablici za brzinu infuzije u 2. tjednu.
English: The solution is colourless to yellow.
Croatian: Otopina je bezbojna do žuta.
English: every two weeks (total of 4 doses) Stop for high dose chemotherapy and ASCT
Croatian: Svaka dva tjedna (ukupno 4 doze) Prekinuti liječenje radi primjene visokodozne kemoterapije i ASCT-a
English: • Antipyretics (oral paracetamol 650 to 1,000 mg)
Croatian: • Antipiretici (paracetamol 650 do 1000 mg peroralno)
English: You must not be given DARZALEX - if you are allergic to daratumumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primiti DARZALEX - ako ste alergični na daratumumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: 17.4 (17.4, NE)
Croatian: 17,4 (17,4; NP)
English: Terminal half-life increases with increasing dose and with repeated dosing.
Croatian: Terminalni poluvijek povećava se s povećanjem doze i primjenom ponovljenih doza.
English: Other medicines and DARZALEX
Croatian: Drugi lijekovi i DARZALEX
English: Store in a refrigerator (2 °C-8 °C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: Do not use DARZALEX if the above applies to you.
Croatian: Nemojte primiti DARZALEX ako se nešto od gore navedenoga odnosi na Vas.
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) and very rare (< 1/10,000).
Croatian: Učestalost je definirana kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
English: Therefore daratumumab should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh the potential risks to the fetus.
Croatian: Stoga se daratumumab ne smije primjenjivati u trudnoći, osim ako se ne smatra da korist liječenja za ženu nadmašuje mogući rizik za plod.
English: The significance of these in vitro effects in a clinical setting, and the implications on tumour growth, are not well-understood.
Croatian: Značaj tih učinaka in vitro u kliničkim uvjetima i njihove implikacije na rast tumora nisu dobro razjašnjene.
English: • medicines for an allergic reaction (anti-histamines)
Croatian: • lijekove za alergijsku reakciju (antihistaminike)
English: DARZALEX will be stored at the hospital or clinic.
Croatian: DARZALEX će se čuvati u bolnici ili klinici.
English: The dose of DARZALEX will depend on your body weight.
Croatian: Doza lijeka DARZALEX će ovisiti o Vašoj tjelesnoj težini.
English: 7.4 (5.5, NE)
Croatian: 7,4 (5,5; NP)
English: Only results from Part 1 are described henceforth.
Croatian: U nastavku su opisani samo rezultati iz prvog dijela ispitivanja.
English: The mean estimated terminal half-life associated with linear clearance in combination therapy was approximately 15-23 days.
Croatian: Srednja vrijednost procijenjenog terminalnog poluvijeka povezanog s linearnim klirensom u kombiniranoj terapiji bila je približno 15-23 dana.
English: • medicines for fever (such as paracetamol).
Croatian: • lijekove za vrućicu (poput paracetamola)
English: The estimated terminal half-life of daratumumab following the last 16 mg/kg dose increased, but there are insufficient data for a reliable estimation.
Croatian: Procijenjeni terminalni poluvijek daratumumaba nakon posljednje doze od 16 mg/kg se povećao, no nema dovoljno podataka za pouzdanu procjenu.
English: Therefore, body weight based dosing is an appropriate dosing strategy for the multiple myeloma patients.
Croatian: Stoga je doziranje na temelju tjelesne težine prikladna strategija doziranja za bolesnike s multiplim mijelomom.
English: Uncommon (may affect up to 1 in 100 people) • inflamed liver (hepatitis)
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): • upala jetre (hepatitis)
English: The efficacy results in this subgroup were consistent with the overall population.
Croatian: Rezultati djelotvornosti u ovoj podskupini bili su u skladu s onima u ukupnoj populaciji.
English: Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions.
Croatian: Postupno povećavanje brzine infuzije treba razmotriti samo ako nisu prisutne reakcije na infuziju.
English: DARZALEX may be given alone or together with other medicines used to treat multiple myeloma.
Croatian: DARZALEX se može primjenjivati sam ili zajedno s drugim lijekovima koji se koriste za liječenje multiplog mijeloma.
English: No chronic toxicity testing has been conducted.
Croatian: Nisu provedena ispitivanja kronične toksičnosti.
English: Median Time to Response [months (range)]
Croatian: Medijan vremena do odgovora [mjeseci (raspon)]
English: Date of first authorisation: 20 May 2016 Date of latest renewal: 24 April 2017
Croatian: Datum posljednje obnove odobrenja: 24. travnja 2018.
English: The incidence of infusion modifications due to reactions was 36%.
Croatian: Incidencija modifikacija infuzije zbog reakcija bila je 36%.
English: These reactions can happen during the infusion or in the 3 days after the infusion.
Croatian: Te se reakcije mogu javiti tijekom infuzije ili unutar 3 dana nakon nje.
English: People with breathing problems
Croatian: Osobe s dišnim tegobama
English: In the first week your doctor may give you the DARZALEX dose split over two consecutive days.
Croatian: U prvom tjednu liječnik Vam može primijeniti dozu lijeka DARZALEX podijeljenu kroz dva uzastopna dana.
English: When these reactions go away, or get better, the infusion can be started again.
Croatian: Nakon što se te reakcije povuku ili ublaže, infuzija se može ponovno započeti.
English: You and your doctor will decide if the benefit of breastfeeding is greater than the risk to your baby.
Croatian: Vi i Vaš liječnik odlučit ćete je li korist dojenja veća od rizika za Vaše dijete.
English: How the medicine is given
Croatian: Kako se lijek primjenjuje
English: From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta, ako metoda otvaranja/razrjeđivanja ne isključuje rizik od mikrobnog onečišćenja, lijek se mora primijeniti odmah.
English: Consider supportive care with transfusions or growth factors.
Croatian: Razmotrite primjenu potpornih mjera uz transfuzije ili faktore rasta.
English: There has been no experience of overdosage in clinical studies.
Croatian: Nema iskustva s predoziranjem u kliničkim ispitivanjima.
English: Alternatively, phenotyping or genotyping may also be considered (see section 4.4).
Croatian: S druge strane, mogu se također uzeti u obzir fenotipiziranje ili genotipiziranje (vidjeti dio 4.4).
English: In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment should be instituted immediately.
Croatian: U slučaju predoziranja, bolesnika treba nadzirati zbog moguće pojave znakova ili simptoma štetnih učinaka te odmah uvesti odgovarajuće simptomatsko liječenje.
English: If you are given more DARZALEX than you should This medicine will be given by your doctor or nurse.
Croatian: Ako primite više lijeka DARZALEX nego što ste trebali Ovaj će Vam lijek dati liječnik ili medicinska sestra.
English: Efficacy was evaluated by PFS based on IMWG criteria.
Croatian: Djelotvornost je bila procijenjena pomoću PFS-a temeljenog na IMWG kriterijima.
English: • infections of the airways - such as nose, sinuses or throat
Croatian: • infekcija dišnih putova - poput nosa, sinusa ili grla
English: Table 9: Efficacy results from Study MMY3006 D-VTd (n=543) VTd (n=542)
Croatian: Tablica 9: Rezultati za djelotvornost iz ispitivanja MMY3006 D-VTd (n=543) VTd (n=542)
English: Your doctor will work out your dose and schedule of DARZALEX.
Croatian: Vaš će liječnik odrediti dozu i raspored primjene lijeka DARZALEX.
English: Daratumumab has been designed to attach to specific cancer cells in your body, so that your immune system can destroy the cancer cells.
Croatian: Daratumumab je dizajniran da se pričvrsti za specifične stanice raka u Vašem tijelu kako bi imunosni sustav mogao uništiti te stanice raka.
English: Continuous monitoring for this safety signal will be performed in clinical studies and post-marketing safety data.
Croatian: Ovaj sigurnosni signal bit će kontinuirano praćen u kliničkim ispitivanjima i iz sigurnosnih podataka nakon stavljanja lijeka u promet.
English: Infusion-related reaction includes terms determined by investigators to be related to infusion, see below
Croatian: Reakcije na infuziju uključuju pojmove za koje je ispitivač utvrdio da su povezani s infuzijom, vidjeti u nastavku
English: • feeling short of breath or other breathing problems.
Croatian: • nedostatak zraka ili druge dišne tegobe.