FrancophonIA/ELRC3.0 huggingface dataset:
English: During treatment and for 2 years after starting treatment with Xofigo, your doctor will continuously monitor your bone health.
Croatian: Tijekom liječenja te 2 godine nakon početka liječenja lijekom Xofigo, Vaš će liječnik stalno pratiti zdravlje Vaših kostiju.
English: During the treatment period, 83% of patients received luteinising hormone-releasing hormone (LHRH) agonists and 21% of patients received anti-androgens concomitantly.
Croatian: Tijekom razdoblja liječenja, 83% bolesnika primalo je agoniste hormona koji oslobađa luteinizirajući hormon (LHRH), a 21% bolesnika istovremeno je primalo antiandrogene.
English: Xofigo is believed to accumulate at sites of high bone turnover such as sites of degenerative bone disease (osteoporosis) or recent (micro-)fracture increasing the risk of fractures.
Croatian: Vjeruje se da se Xofigo nakuplja na mjestima intenzivne koštane pregradnje kao što su mjesta degenerativne bolesti kostiju (osteoporoze) ili nedavnih (mikro)fraktura te tako povećava rizik od prijeloma.
English: - If you plan to take other cancer therapy following treatment with Xofigo, you must wait at least 30 days before starting treatment.
Croatian: - Ako planirate uzimati drugu terapiju protiv raka nakon lijeka Xofigo, morate pričekati najmanje 30 dana prije početka liječenja.
English: There is limited evidence that the delay in loss of HRQOL extends beyond the treatment period.
Croatian: Postoje ograničeni dokazi da se odgoda gubitka kvalitete života povezane sa zdravljem (HRQOL) produljuje i nakon perioda liječenja.
English: What Xofigo is and what it is used for
Croatian: Što je Xofigo i za što se koristi
English: Xofigo increases the incidence of diarrhoea, nausea, and vomiting (see section 4.8) which may result in dehydration.
Croatian: Xofigo povećava incidenciju proljeva, mučnine i povraćanja (vidjeti dio 4.8), što može dovesti do dehidracije.
English: In case there is no recovery in these values within 6 weeks after the last administration of Xofigo despite receiving standard of care, further treatment with Xofigo should only be continued after a careful benefit/risk evaluation.
Croatian: U slučaju da se ove vrijednosti ne oporave unutar 6 tjedana nakon zadnje primjene lijeka Xofigo usprkos primanju standardne skrbi, daljnje liječenje lijekom Xofigo smije se nastaviti samo nakon pažljive procjene omjera koristi i rizika.
English: Table 2: Survival results from the phase III ALSYMPCA study
Croatian: Tablica 2: Rezultati preživljenja u ispitivanju faze III ALSYMPCA
English: There is a potential risk that radiation from Xofigo could affect your fertility.
Croatian: Postoji mogući rizik da zračenje od lijeka Xofigo može djelovati na Vašu plodnost.
English: Single Xofigo doses containing an activity of up to 276 kBq per kg body weight were evaluated in a phase I clinical trial and no dose-limiting toxicities were observed.
Croatian: Jednokratne doze lijeka Xofigo koje sadrže aktivnost do 276 kBq po kg tjelesne težine bile su procjenjivane u kliničkom ispitivanju faze I i nisu bile opažene toksičnosti koje ograničavaju dozu.
English: No histological changes were observed in organs involved in the excretion of radium-223 dichloride.
Croatian: Nisu bile opažene histološke promjene u organima koji sudjeluju u izlučivanju radijevog-223 diklorida.
English: After intravenous injection, radium-223 is rapidly cleared from the blood and is incorporated primarily into bone and bone metastases, or is excreted into the intestine.
Croatian: Nakon intravenske injekcije, radij-223 brzo se uklanja iz krvi i ugrađuje prvenstveno u kost i koštane metastaze ili se izlučuje u crijevo.
English: For radium-223, as primarily an alpha emitter, additional assumptions were made for the intestine, red marrow and bone/osteogenic cells, to provide the best possible absorbed dose calculations for Xofigo, considering its observed biodistribution and specific characteristics (see Table 4).
Croatian: Za radij-223, koji je prvenstveno alfa-emiter, napravljene su dodatne pretpostavke za crijevo, crvenu koštanu srž i kost/osteogene stanice da bi se omogućili najbolji mogući izračuni apsorbirane doze za Xofigo, uzimajući u obzir njegovu opaženu biodistribuciju i posebne značajke (vidjeti tablicu 4).
English: If you have any further questions on the use of Xofigo, please ask the doctor who supervises the procedure.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom lijeka Xofigo, obratite se liječniku koji nadzire postupak.
English: Patients with visceral metastases and malignant lymphadenopathy exceeding 3 cm were excluded.
Croatian: Bolesnici s metastazama u visceralnim organima i malignom limfadenopatijom koja prelazi 3 cm bili su isključeni.
English: The presence of neoplastic changes, other than osteosarcomas, was also reported in the longer term (12 to 15 months) rat toxicity studies (see section 4.8).
Croatian: Prisutnost drugih neoplastičkih promjena, osim osteosarkoma, također je bila zabilježena u dugotrajnijim (12 do 15 mjeseci) ispitivanjima toksičnosti na štakorima (vidjeti dio 4.8).
English: If you have symptoms of pain, swelling or numbness of the jaw, a “heavy jaw feeling” or loosening of a tooth, please contact your doctor.
Croatian: Ako imate simptome boli, oticanja ili utrnulosti čeljusti, „osjećaj teške čeljusti“ ili klimanja zuba, javite se Vašem liječniku.
English: Depending on the volume administered, this medicine can contain up to 54 mg sodium (main component of cooking/table salt) per dose.
Croatian: Ovisno o primijenjenom volumenu, ovaj lijek može sadržavati do 54 mg natrija (glavni sastojak kuhinjske soli) po dozi.
English: • 46% of patients had no pain or WHO scale 1 (asymptomatic or mildly symptomatic) and 54% had pain WHO scale 2-3.
Croatian: • 46% bolesnika nije osjećalo bol ili je osjećalo bol jačine 1 prema ljestvici Svjetske zdravstvene organizacije (SZO) (asimptomatski ili blago simptomatski), a 54% je osjećalo bol jačine 2-3 prema ljestvici SZO-a.
English: In particular, the risk for osteosarcoma, myelodysplastic syndrome and leukaemias may be increased.
Croatian: Posebice, rizik za osteosarkom, mijelodisplastični sindrom i leukemije može biti povećan.
English: The high linear energy transfer of alpha emitters (80 keV/µm) leads to a high frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a potent cytotoxic effect.
Croatian: Visok linearni prijenos energije alfa-emitera (80 keV/µm) dovodi do velike učestalosti prekida dvostruke uzvojnice DNK u okolnim tumorskim stanicama, s posljedičnim jakim citotoksičnim učinkom.
English: Depending on the volume administered, this medicinal product can contain up to 2.35 mmol (54 mg) sodium per dose, equivalent to 2.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovisno o primijenjenom volumenu, ovaj lijek može sadržavati do 2,35 mmol (54 mg) natrija po dozi, što odgovara 2,7% maksimalnog dnevnog unosa od 2g natrija prema preporukama SZO za odraslu osobu.
English: Safety and efficacy of Xofigo in combination with cancer therapies other than LHRH analogues have not been established; an increased risk of mortality and fractures is possible.
Croatian: Sigurnost i djelotvornost lijeka Xofigo u kombinaciji s terapijama protiv raka osim analoga LHRH nisu ustanovljene; moguć je povećan rizik od smrti i prijeloma.
English: Risk of dehydration: tell your doctor if you have any of the following symptoms: dizziness, increased thirst, decreased urination or dry skin as these can all be symptoms of dehydration.
Croatian: Rizik od manjka tekućine u tijelu: recite svom liječniku ako imate neki od sljedećih simptoma: omaglicu, povećanu žeđ, smanjeno mokrenje ili suhu kožu, budući da sve to mogu biti simptomi manjka tekućine u tijelu (dehidracija).
English: Combination with abiraterone and prednisone/prednisolone or with systemic cancer therapies other than LHRH analogues
Croatian: Kombinacija s abirateronom i prednizonom/prednizolonom ili sa sistemskom terapijom za rak osim analoga LHRH
English: What Xofigo contains
Croatian: Što Xofigo sadrži
English: - There are no data available on the safety and efficacy of treatment with more than 6 injections of
Croatian: - Nema dostupnih podataka o sigurnosti i djelotvornosti liječenja s više od 6 injekcija lijeka Xofigo.
English: A table of DK factors is provided with each vial as part of the booklet (preceding the package leaflet).
Croatian: Tablica s DK-faktorima priložena je uz svaku bočicu kao sastavni dio knjižice (prethodi uputi o lijeku).
English: 4Absorbed dose data to the lung are based on model-derived calculation using pooled blood time-activity data from all subjects
Croatian: 4 podaci o dozi apsorbiranoj u pluća temelje se na izračunu izvedenom iz modela koji objedinjuje podatke o vremenu-aktivnosti u krvi od svih ispitanika.
English: In dogs, haematological changes were observed starting at the lowest activity of 55 kBq/kg, the clinically recommended dose.
Croatian: U pasa je početak hematoloških promjena bio opažen kod najniže aktivnosti od 55 kBq/kg, što je klinički preporučena doza.
English: After administration of Xofigo - Care should be taken when handling materials, such as bed linen, that come into contact with body fluids (such as spill of urine, faeces, vomiting etc.).
Croatian: Nakon primjene lijeka Xofigo - Mora se primijeniti oprez pri rukovanju materijalima, poput posteljine, koji dolaze u kontakt s tjelesnim tekućinama (poput mokraće, stolice, povraćanog sadržaja itd).
English: Radiation protection precautions in accordance with national regulations must therefore be taken.
Croatian: Stoga se moraju poduzimati mjere zaštite od zračenja u skladu s nacionalnim propisima.
English: At 4 hours post injection, the mean percentage of the radioactive dose present in bone and intestine was approximately 61% and 49%, respectively.
Croatian: Četiri sata nakon injekcije, srednja postotna vrijednost radioaktivne doze prisutne u kostima bila je približno 61% te one prisutne u crijevima približno 49%.
English: d Defined as a ≥ 25% increase and an increase in absolute value of ≥ 2 ng/mL compared to baseline/nadir.
Croatian: d Definirano kao povišenje ≥ 25% i povišenje apsolutne vrijednosti za ≥ 2 ng/ml u usporedbi s početnom/najnižom vrijednošću.
English: There is no relevant use of Xofigo in the paediatric population in the indication of prostate cancer.
Croatian: Nema relevantne primjene lijeka Xofigo u pedijatrijskoj populaciji u indikaciji raka prostate.
English: The limited available data indicates that patients receiving chemotherapy after Xofigo had a similar haematological profile compared to patients receiving chemotherapy after placebo (see also section 5.1).
Croatian: Ograničeni dostupni podaci upućuju na to da su bolesnici koji su primali kemoterapiju nakon lijeka Xofigo imali sličan hematološki profil u usporedbi s bolesnicima koji su primali kemoterapiju nakon placeba (vidjeti također dio 5.1).
English: The results from the phase III ALSYPMCA study regarding time to external beam radiation therapy (EBRT) for pain relief and fewer patients reporting bone pain as an adverse event in the Xofigo group indicate a positive effect on bone pain.
Croatian: Rezultati ispitivanja faze III ALSYPMCA u pogledu vremena do radioterapije vanjskim snopom (EBRT) za ublažavanje boli i manji broj bolesnika koji su prijavili bol u kostima kao štetni događaj u skupini liječenoj lijekom Xofigo, ukazuju na pozitivan učinak na bol u kostima.
English: Xofigo is used to treat adults with advanced castration-resistant prostate cancer in progression after at least two other cancer treatments apart from treatments to maintain reduced levels of male hormone (hormone therapy), or who cannot take any other cancer treatment.
Croatian: Xofigo se primjenjuje za liječenje odraslih s uznapredovalim rakom prostate rezistentnim na kastraciju koji i dalje napreduje nakon primjene najmanje dva druga liječenja protiv raka osim liječenja koje održava sniženom razinu muških hormona (hormonsko liječenje) ili odraslih koji ne mogu uzimati druge lijekove za rak.
English: There are no data on the use of Xofigo at the same time as chemotherapy (other medicines used to kill cancer cells).
Croatian: Nema podataka o primjeni lijeka Xofigo istodobno s kemoterapijom (drugim lijekovima koji se primjenjuju za ubijanje stanice raka).
English: The haematological adverse reactions observed in the clinical studies with Xofigo are much lower in frequency and severity than what could be expected from the calculated absorbed doses to the red marrow.
Croatian: Hematološke nuspojave opažene u kliničkim ispitivanjima lijeka Xofigo imaju puno manju učestalost i težinu nego što bi se moglo očekivati s obzirom na izračunate apsorbirane doze za crvenu koštanu srž.
English: Therefore, efficacy may be diminished in patients with a low level of osteoblastic activity from their bone metastases.
Croatian: Zbog toga djelotvornost može biti smanjena u bolesnika s niskom razinom osteoblastičke aktivnosti koštanih metastaza.
English: The reference date is stated on the vial and lead pot label.
Croatian: Referentni datum je naveden na bočici i naljepnici olovne posude.
English: The healthcare professional will flush the intravenous access line or cannula before and after injection with a saline solution.
Croatian: Zdravstveni radnik će isprati intravensku liniju ili kanilu prije i nakon injekcije fiziološkom otopinom.
English: No dose adjustment is considered necessary in elderly patients.
Croatian: Smatra se da nije potrebna prilagodba doze u starijih bolesnika.
English: The risk for patients to develop osteosarcomas with exposure to radium-223 is unknown at present.
Croatian: Rizik za razvoj osteosarkoma kod izlaganja radiju-223 za sada nije poznat.
English: Symptomatic skeletal event (SSE)
Croatian: Simptomatski događaj povezan s kostima (SSE)
English: Since radium-223 is neither metabolised by the liver nor eliminated via the bile, hepatic impairment is not expected to affect the pharmacokinetics of radium-223 dichloride.
Croatian: Budući da se radij-223 ne metabolizira u jetri i ne eliminira putem žuči, ne očekuje se da će oštećenje funkcije jetre utjecati na farmakokinetiku radijevog-223 diklorida.
English: The pharmacokinetics of radium-223 dichloride were linear in the activity range investigated (51 to 276 kBq/kg).
Croatian: Farmakokinetika radijevog-223 diklorida bila je linearna u rasponu aktivnosti koji se ispitivao (51 do 276 kBq/kg).
English: Your doctor will test your bone health before deciding whether you can be given Xofigo.
Croatian: Vaš će liječnik provjeriti zdravlje Vaših kostiju prije nego odluči možete li primati Xofigo.
English: However, in the case of an accidental overdose, your doctor will start appropriate supportive treatment and will check you for changes in the number of blood cells, and for gastrointestinal symptoms (e.g. diarrhoea, nausea [feeling sick], vomiting).
Croatian: Međutim, u slučaju nehotičnog predoziranja, Vaš će liječnik početi s odgovarajućim potpornim liječenjem i provjerit će ima li promjena u broju krvnih stanica te jesu li prisutni probavni simptomi (npr. proljev, mučnina, povraćanje).
English: - The limited data available do not suggest any major differences in the blood cell production of patients receiving chemotherapy after treatment with Xofigo compared with those who did not receive Xofigo.
Croatian: - Ograničeni dostupni podaci ne upućuju na to da postoje bitne razlike u stvaranju krvnih stanica u bolesnika koji primaju kemoterapiju nakon liječenja lijekom Xofigo u usporedbi s bolesnicima koji nisu primili Xofigo.
English: All these cases were only seen in patients receiving bisphosphonates prior to or at the same time of treatment with Xofigo and chemotherapy prior to treatment with Xofigo.
Croatian: Svi ti slučajevi zabilježeni su samo u bolesnika koji su primali bisfosfonate prije ili u isto vrijeme kad i Xofigo i kemoterapiju prije liječenja lijekom Xofigo.
English: SSE composite endpoint a
Croatian: SSE-kompozitni ishod a
English: Xofigo is excreted mainly via the faeces.
Croatian: Xofigo se izlučuje uglavnom putem stolice.
English: Increased fracture risk has been found especially in patients with medical history of osteoporosis and in patients with less than 6 bone metastases.
Croatian: Povećan rizik od prijeloma zabilježen je osobito u bolesnika s osteoporozom u anamnezi i u bolesnika s manje od 6 koštanih metastaza.
English: 1100 kBq/mL at 12 h (CET) ref. date: [DD/MM/YYYY] 6.6 MBq/vial at 12 h (CET) ref. date: [DD/MM/YYYY]
Croatian: 1100 kBq/ml u 12 sati (SEV) na referentni datum: [DD/MM/GGGG] 6,6 MBq/bočici u 12 sati (SEV) na referentni datum: [DD/MM/GGGG]
English: When injected into the patient, radium-223 reaches the bone where the cancer has spread to and emits short-range radiation (alpha particles) which kills the surrounding tumour cells.
Croatian: Kada se ubrizga bolesniku, radij-223 dolazi u kost u koju se rak proširio i odašilje zračenje (alfa čestice) kratkog dometa koje ubija okolne tumorske stanice.
English: - If your tumour has spread to the bone extensively, you may also be more likely to have decreases in your blood cells and platelets, so your doctor will give you Xofigo with caution.
Croatian: - Ako se tumor proširio na kosti opsežno, kod Vas je vjerojatnija pojava smanjenja krvnih stanica i trombocita, pa će Vam liječnik dati Xofigo s oprezom.
English: Red marrow Osteogenic cells Skin
Croatian: Gušterača Crvena koštana srž Osteogene stanice Koža
English: In the phase III clinical study, no relevant differences in safety or efficacy were observed between patients with mild renal impairment (creatinine clearance [CLCR]: 50 to 80 mL/min) and normal renal function.
Croatian: U kliničkom ispitivanju faze III, nisu opažene važne razlike u sigurnosti i djelotvornosti između bolesnika s blagim oštećenjem funkcije bubrega (klirens kreatinina [CLCR]: 50 do 80 ml/min) i onih s normalnom funkcijom bubrega.
English: The adverse reactions observed with Xofigo are represented in the table below (see Table 1).
Croatian: Nuspojave opažene uz Xofigo prikazane su u tablici niže (vidjeti Tablicu 1).
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere:
English: Based on the elimination half-life of Xofigo and abiraterone, it is recommended that subsequent treatment with Xofigo is not initiated for at least 5 days after the last administration of abiraterone acetate in combination with prednisone/prednisolone.
Croatian: Temeljeno na poluvijeku eliminacije lijeka Xofigo i abiraterona, preporučuje se da se liječenje lijekom Xofigo ne započinje najmanje 5 dana nakon posljednje primjene abirateronacetata u kombinaciji s prednizonom/prednizolonom.
English: In single and repeated dose toxicity studies in rats, the main findings were reduced body weight gain, haematological changes, reduced serum alkaline phosphatase and microscopic findings in the bone marrow (depletion of haematopoietic cells, fibrosis), spleen (secondary extra-medullary haematopoiesis) and bone (depletion of osteocytes, osteoblasts, osteoclasts, fibro-osseous lesions, disruption/disorganisation of the physis/growth line).
Croatian: U ispitivanjima toksičnosti jednokratne i ponovljenih doza na štakorima, glavni su nalazi bili: smanjen dobitak na tjelesnoj težini, hematološke promjene, smanjena vrijednost alkalne fosfataze u serumu i mikroskopski nalazi u koštanoj srži (deplecija krvotvornih stanica, fibroza), slezeni (sekundarna ekstramedularna hematopoeza) i kosti (deplecija osteocita, osteoblasta, osteoklasta, fibrozno-koštane lezije, prekid/dezorganizacija linije fize/rasta).
English: Patients with evidence of compromised bone marrow reserve e.g. following prior cytotoxic chemotherapy and/or radiation treatment (EBRT) or prostate cancer patients with advanced diffuse infiltration of the bone (EOD4; “superscan”) should be treated with caution.
Croatian: Bolesnike s dokazano kompromitiranom rezervom koštane srži, npr. nakon prethodne citotoksične kemoterapije i/ili liječenja zračenjem (EBRT) ili bolesnike s rakom prostate s uznapredovalom difuznom infiltracijom kostiju (EOD4; „superscan“) potrebno je liječiti s oprezom.
English: Pharmacokinetic, biodistribution and dosimetry data were obtained in 6 patients at an activity of 110 kBq/kg given twice, 6 weeks apart, and in 10 patients at an activity of 55, 110 or 221 kBq/kg.
Croatian: Farmakokinetički, biodistribucijski i dozimetrijski podaci dobiveni su od 6 bolesnika za aktivnost od 110 kBq/kg primijenjenu dvaput u razmaku od 6 tjedana te od 10 bolesnika za aktivnost od 55, 110 ili 221 kBq/kg.
English: Administration of Xofigo and conduct of the procedure Xofigo will be injected slowly via a needle into one of your veins (intravenously).
Croatian: Xofigo će Vam polako ubrizgati putem igle u jednu od vena (intravenski).
English: The rate of elimination of radium-223 dichloride from the gastrointestinal tract is influenced by the high variability in intestinal transit rates across the population, with the normal range from once daily to once weekly bowel evacuation.
Croatian: Na brzinu eliminacije radijevog-223 diklorida iz probavnog trakta utječe velika varijabilnost brzine prolaska crijevnog sadržaja koja postoji u populaciji, uz normalni raspon pražnjenja crijeva od jedanput na dan do jedanput tjedno.
English: The vial contains 6 mL of solution.
Croatian: Bočica sadrži 6 ml otopine.
English: The volume to be administered to a given patient should be calculated using the: - Patient's body weight (kg) - Dosage level (55 kBq/kg body weight) - Radioactivity concentration of the product (1100 kBq/mL) at reference date.
Croatian: Volumen koji će se primijeniti određenom bolesniku treba izračunati pomoću: - tjelesne težine bolesnika (kg) - razine doze (55 kBq/kg tjelesne težine) - koncentracije radioaktivnosti lijeka (1100 kBq/ml) na referentni datum.
English: In adults with castrationresistant prostate cancer and mildly symptomatic bone metastases the benefit of treatment should be carefully assessed to outweigh the risks considering that high osteoblastic activity is likely to be required for treatment benefit (see section 5.1).
Croatian: U odraslih s rakom prostate rezistentnim na kastraciju i blago simptomatskim koštanim metastazama treba napraviti pažljivu procjenu kako bi se osiguralo da korist liječenja nadilazi moguće rizike, s obzirom da je za korist liječenja vjerojatno potrebna velika osteoblastička aktivnost (vidjeti dio 5.1).
English: In the course of the 2:1 randomised ALSYMPCA study, 93 (15.5%) patients in the Xofigo group and 54 (17.9%) patients in the placebo group received cytotoxic chemotherapy at varying times after the last treatment.
Croatian: Tijekom ispitivanja ALSYMPCA s randomizacijom 2:1, 93 (15,5%) bolesnika u skupini liječenoj lijekom Xofigo i 54 (17,9%) bolesnika u skupini koja je primala placebo primilo je citotoksičnu kemoterapiju u različito vrijeme nakon zadnjeg liječenja.
English: The six-stage-decay of radium-223 to lead-207 occurs via short-lived daughters, and is accompanied by a number of alpha, beta and gamma emissions with different energies and emission probabilities.
Croatian: Raspad radija-223 do olova-207 odvija se u šest stadija preko kćeri kratkog vijeka i praćen je brojnim alfa, beta i gama emisijama s različitim energijama i vjerojatnostima emisije.
English: However, all patients with ONJ were also exposed to prior or concomitant bisphosphonates (e.g. zoledronic acid) and prior chemotherapy (e.g. docetaxel).
Croatian: Ipak, svi bolesnici s osteonekrozom čeljusti bili su također prethodno ili istodobno izloženi bisfosfonatima (npr. zoledronatna kiselina) ili prethodnoj kemoterapiji (npr. docetaksel).
English: The recommended dose of Xofigo is 55 kBq (Becquerel, the unit used to express radioactivity) per kilogram body weight.
Croatian: Preporučena doza lijeka Xofigo je 55 kBq (Becquerel, jedinica za izražavanje radioaktivnosti) po kilogramu tjelesne težine.