FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Na hitrost izločanja [223Ra]radijevega klorida iz prebavil vplivajo velike razlike v hitrosti prehoda skozi črevesje v populaciji z normalno pogostnostjo iztrebljanja enkrat dnevno do enkrat tedensko.
English: Xofigo should be handled in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Zdravilo Xofigo mora uporabnik pripraviti v skladu z varnostjo pred sevanjem in zahtevami za kakovost farmacevtskega izdelka.
English: Clear, colourless isotonic solution with pH between 6.0 and 8.0.
Slovenian: raztopina za injiciranje bistra, brezbarvna izotonična raztopina s pH med 6,0 in 8,0
English: Xofigo and chemotherapy used together may further decrease the number of your blood cells and blood platelets.
Slovenian: Sočasna uporaba zdravila Xofigo in kemoterapije lahko dodatno zmanjša število krvnih celic in krvnih ploščic.
English: No significant uptake was seen in other organs such as heart, liver, kidneys, urinary bladder and spleen at 4 hours post injection.
Slovenian: Pomembnega privzema v druge organe, kot so srce, jetra, ledvice, sečni mehur in vranica, 4 ure po injiciranju niso opazili.
English: No significant QTc prolonging effects were observed after intravenous injection of Xofigo in comparison with placebo in a subgroup of 29 patients in the phase III study (ALSYMPCA).
Slovenian: Po intravenskem injiciranju zdravila Xofigo niso opazili pomembnega podaljšanja intervala QTc v primerjavi s podskupino 29 bolnikov v študiji III. faze (ALSYMPCA), ki je prejemala placebo..
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.
Slovenian: Varnost in učinkovitost uporabe zdravila Xofigo v kombinaciji s sistemskimi zdravljenji raka, razen z analogi LHRH, še nista bili dokazani; možno je povečano tveganje za smrt in zlome kosti.
English: The clinical safety and efficacy of Xofigo have been evaluated in a double-blind, randomised, multiple dose, phase III, multicentre study (ALSYMPCA; EudraCT 2007-006195-1)) in castration-resistant prostate cancer patients with symptomatic bone metastases.
Slovenian: Klinično varnost in učinkovitost zdravila Xofigo so ovrednotili v dvojno slepi, randomizirani, multicentrični študiji III. faze večkratnega odmerjanja (ALSYMPCA; EudraCT 2007-006195-1) pri bolnikih z za kastracijo odpornim rakom prostate s simptomatskimi metastazami v kosteh.
English: Radium-223 is an isotope which decays and is not metabolised.
Slovenian: Biotransformacija [223Ra]radij je izotop, ki razpade in se ne presnavlja.
English: Administration of Xofigo and conduct of the procedure Xofigo will be injected slowly via a needle into one of your veins (intravenously).
Slovenian: Zdravilo Xofigo bo injicirano počasi z injekcijsko iglo v eno od vaših ven (intravensko).
English: Cardiac electrophysiology / QT prolongation
Slovenian: Elektrofiziološka preiskava srca / podaljšanje intervala QT
English: 40% of patients had more than 20 bone metastases or superscan.
Slovenian: 40 % bolnikov je imelo več kot 20 metastaz v kosteh ali napredovalo difuzno kopičenje v kosteh
English: Xofigo increases the risk of bone fractures.
Slovenian: Zdravilo Xofigo poveča tveganje za zlome kosti.
English: Colourless Type I glass vial closed with a grey bromobutyl rubber stopper either with or without foil-clad made of Ethylene tetrafluoroethylene (ETFE), both capped with aluminium seal, containing 6 mL of solution for injection.
Slovenian: Brezbarvna viala iz stekla tipa I, zaprta s sivim zamaškom iz bromobutilne gume, z ali brez folije iz etilentetrafluoroetilena (ETFE), oba pokrita z aluminijastim tesnilom, ki vsebuje 6 ml raztopine za injiciranje.
English: If you are already taking one of those medicines, please tell your doctor.
Slovenian: Če že jemljete katero izmed teh zdravil, se posvetujte z zdravnikom.
English: (12.9 - NE) 10.8 (7.9 - NE)
Slovenian: (12,9 - NE)
English: The following information is intended for healthcare professionals only The complete SmPC of Xofigo is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Slovenian: Povzetek glavnih značilnosti zdravila Xofigo je v celoti podan kot ločen dokument na koncu priloženega navodila za uporabo zdravila, in sicer z namenom, da zdravstvene delavce obvesti o drugih znanstvenih in uporabnih informacijah, povezanih z uporabo tega radiofarmaka.
English: If you are engaged in sexual activity with a woman who could become pregnant you are advised to use effective birth control methods during and up to 6 months after treatment with Xofigo.
Slovenian: Če imate spolne odnose z žensko, ki bi lahko zanosila, se priporoča uporaba učinkovite metode za preprečevanje nosečnosti med in še 6 mesecev po končanem zdravljenju z zdravilom Xofigo.
English: Xofigo is not indicated in women.
Slovenian: Zdravilo Xofigo ni indicirano za uporabo pri ženskah.
English: Your doctor will test your bone health before deciding whether you can be given Xofigo.
Slovenian: Zdravnik vam bo preveril stanje kosti, preden se bo odločil, ali lahko prejmete zdravilo Xofigo.
English: Storage of radiopharmaceuticals will be in accordance with national regulations on radioactive materials.
Slovenian: Shranjevanje radiofarmakov bo v skladu z nacionalnimi predpisi za radioaktivne snovi.
English: Table 1: Adverse reactions reported in clinical trials in patients treated with Xofigo System Organ Class
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih pri bolnikih, zdravljenih z zdravilom Xofigo
English: There are no human data on the effect of Xofigo on fertility.
Slovenian: Ni podatkov o vplivu zdravila Xofigo na plodnost pri ljudeh.
English: Xofigo is a ready-to-use solution and should not be diluted or mixed with any other solutions.
Slovenian: Zdravilo Xofigo je raztopina, pripravljena za uporabo, ki se je ne sme redčiti ali mešati s katerimi koli drugimi raztopinami.
English: External beam radiation for pain relief
Slovenian: Zunanje obsevanje za lajšanje bolečine
English: Red marrow Osteogenic cells Skin
Slovenian: Rdeč kostni mozeg Osteogene celice
English: These findings were related to radiation-induced impairment of haematopoiesis and a reduction of osteogenesis and started at the lowest activity of 22 kBq per kg body weight (0.4 times the clinically recommended dose).
Slovenian: Ti izsledki so bili povezani z motnjami hematopoeze zaradi sevanja in zmanjšanjem osteogeneze in so se začeli pri najmanjši aktivnosti 22 kBq na kg telesne mase (0,4-kratnik klinično priporočenega odmerka).
English: Male patients should seek advice on conservation of sperm prior to treatment.
Slovenian: Bolniki se morajo pred zdravljenjem posvetovati o možnostih shranjevanja sperme.
English: Subsequent treatment with cytotoxic substances
Slovenian: Nadaljnje zdravljenje s citotoksičnimi snovmi
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.
Slovenian: Odvisno od uporabljenega volumna raztopine lahko zdravilo vsebuje do 2,35 mmol (54 mg) natrija na odmerek , kar je enako 2,7 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: In dogs, haematological changes were observed starting at the lowest activity of 55 kBq/kg, the clinically recommended dose.
Slovenian: Pri psih so hematološke spremembe najprej opazili pri najmanjši aktivnosti 55 kBq na kg, kar je klinično priporočeni odmerek.
English: The dose regimen of Xofigo is an activity of 55 kBq per kg body weight, given at 4 week intervals for 6 injections.
Slovenian: Režim odmerjanja zdravila Xofigo je aktivnost 55 kBq na kg telesne mase, in sicer kot 6 injekcij v 4tedenskih intervalih.
English: There is no relevant use of Xofigo in the paediatric population in the indication of prostate cancer.
Slovenian: Uporaba zdravila Xofigo pri pediatrični populaciji za indikacijo raka prostate ni primerna.
English: At an interim analysis, an increased incidence of fractures (28.6% vs 11.4%) and reduced median overall survival (30.7 months versus 33.3 months, HR 1.195, 95% CI [0.950 - 1.505], p=0.13) was observed among patients receiving Xofigo in combination with abiraterone acetate and prednisone/prednisolone compared to patients receiving placebo in combination with abiraterone acetate and prednisone/prednisolone.
Slovenian: V vmesnih analizah so opazili povečano incidenco zlomov kosti (28,6 % v primerjavi z 11,4 %) in zmanjšano mediano celokupnega preživetja (30,7 meseca v primerjavi s 33,3 meseca, razmerje ogroženosti 1,195, 95-% IZ [0,950-1,505], p = 0,13) med bolniki, ki so prejemali zdravilo Xofigo v kombinaciji z abirateronacetatom in prednizonom/prednizolonom v primerjavi z bolniki, ki so prejemali placebo v kombinaciji z abirateronacetatom in prednizonom/prednizolonom.
English: The vial is stored in a lead pot.
Slovenian: Viala je shranjena v svinčenem vsebniku.
English: What Xofigo looks like and contents of the pack
Slovenian: Izgled zdravila Xofigo in vsebina pakiranja
English: Number (%) of deaths Median overall survival (months) (95% CI) Hazard ratiob (95% CI)
Slovenian: Mediana celokupnega preživetja (meseci) (95-% IZ)
English: - Xofigo can lead to a decrease in the number of your blood cells and blood platelets.
Slovenian: - Zdravilo Xofigo lahko povzroči zmanjšanje števila krvnih celic in krvnih ploščic.
English: Other factors such as concomitant use of steroids may further increase the risk of fracture.
Slovenian: Tveganje za zlome kosti lahko še dodatno povečajo tudi drugi dejavniki, kot je sočasna uporaba steroidov.
English: The most frequently observed adverse reactions (≥ 10%) in patients receiving Xofigo were diarrhoea, nausea, vomiting, thrombocytopenia and bone fracture.
Slovenian: Najpogosteje opaženi neželeni učinki (≥ 10 %) pri bolnikih, ki so prejemali zdravilo Xofigo, so bili driska, navzea, bruhanje, trombocitopenija in zlom kosti.
English: - If you experience a bone fracture, your doctor will first stabilise the fractured bone before starting or continuing treatment with Xofigo.
Slovenian: - Če imate zlom kosti, bo zdravnik najprej stabiliziral zlomljeno kost, preden bo začel ali nadaljeval zdravljenje z zdravilom Xofigo.
English: Therefore, haematological evaluation of patients must be performed at baseline and prior to every dose of Xofigo.
Slovenian: Zato je treba pri bolnikih ovrednotiti izvide hematoloških preiskav na začetku zdravljenja in pred vsakim odmerkom zdravila Xofigo.
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.
Slovenian: Glede na razpolovni čas izločanja zdravila Xofigo in abiraterona je priporočljivo, da z naknadnim zdravljenjem z zdravilom Xofigo ne začnete še vsaj 5 dni po zadnjem dajanju abirateronacetata v kombinaciji s prednizonom/prednizolonom.
English: Its active moiety radium-223 (as radium-223 dichloride) mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite.
Slovenian: Njegova učinkovina [223Ra]radij (v obliki [223Ra]radijevega klorida) posnema delovanje kalcija in selektivno deluje na kosti, predvsem na področja metastaz v kosteh, tako da tvori komplekse s kostnim mineralom hidroksiapatitom.
English: Table 3: Secondary efficacy endpoints from the phase III ALSYMPCA study (interim analysis)
Slovenian: Preglednica 3: Sekundarni opazovani dogodki učinkovitosti iz študije ALSYMPCA III. faze (vmesna analiza)
English: Grade 1 and 2 injection site reactions, such as erythema, pain and swelling, were reported in 1.2% of patients treated with Xofigo and in 0% of patients receiving placebo.
Slovenian: O reakcijah na mestu injiciranja stopnje 1 in 2, kot so eritem, bolečina in oteklina, so poročali pri 1,2 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 0 % bolnikov, ki so prejemali placebo.
English: In patients treated with bisphosphonates and Xofigo, an increased risk of development of osteonecrosis of the jaw (ONJ) cannot be excluded.
Slovenian: Pri bolnikih, zdravljenih z difosfonati in zdravilom Xofigo, ni mogoče izključiti povečanega tveganja za razvoj osteonekroze čeljusti.
English: 4Absorbed dose data to the lung are based on model-derived calculation using pooled blood time-activity data from all subjects
Slovenian: 2Podatki o absorbirani dozi sevanja za pljuča temeljijo na izračunu na podlagi modela z uporabo združenih podatkov čas aktivnost v krvi pri vseh bolnikih.
English: Xofigo is not for use in women and must not be given to women who are, or may be, pregnant or who are breast-feeding.
Slovenian: Zdravilo Xofigo se ne uporablja pri ženskah in se ga ne sme dajati nosečnicam, ženskam, ki menijo, da bi lahko bile noseče ali ženskam, ki dojijo.
English: - There are no data on the use of Xofigo in patients with Crohn's disease (a long-term inflammatory disease of the intestines) and with ulcerative colitis (a long-term inflammation of the colon).
Slovenian: - Podatkov o uporabi zdravila Xofigo pri bolnikih s Crohnovo boleznijo (dolgotrajna vnetna črevesna bolezen) in z ulceroznim kolitisom (dolgotrajno vnetje debelega črevesa) ni.
English: The intravenous access line or cannula must be flushed with isotonic sodium chloride 9 mg/mL (0.9%) solution for injection before and after injection of Xofigo.
Slovenian: Intravenski dostop ali kanilo je treba pred in po injiciranju zdravila Xofigo izprati z izotonično raztopino za injiciranje, ki vsebuje 9 mg/ml natrijevega klorida (0,9 % raztopina).
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).
Slovenian: V primeru nenamernega prevelikega odmerjanja bo zdravnik začel z ustreznim podpornim zdravljenjem in preveril morebitne spremembe števila krvnih celic in ali imate prebavne težave (npr. driska, navzea [občutek siljenja na bruhanje], bruhanje).
English: Xofigo must not be used after the expiry date which is stated on the vial and the lead pot.
Slovenian: Zdravila Xofigo ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in svinčenem vsebniku.
English: You might be at a higher risk of bone fractures.
Slovenian: Morda pri vas obstaja večje tveganje za zlome kosti.
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.
Slovenian: Enkratne odmerke zdravila Xofigo z aktivnostjo do 276 kBq na kg telesne mase so ovrednotili v kliničnih preskušanjih I. faze, vendar toksičnih učinkov, zaradi katerih bi bilo treba omejiti velikost odmerka, niso opazili.
English: Safety and efficacy of Xofigo in patients with Crohn's disease and with ulcerative colitis have not been studied.
Slovenian: Varnosti in učinkovitosti zdravila Xofigo pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom niso preučevali.
English: The results of both the interim and updated analysis revealed that overall survival was significantly longer in patients treated with Xofigo plus best standard of care compared to patients treated with placebo plus best standard of care (see Table 2 and Figure 2).
Slovenian: Izsledki obeh, vmesne in posodobljene analize, so razkrili, da je bilo celokupno preživetje pomembno daljše pri bolnikih, zdravljenih z zdravilom Xofigo, in najboljšo standardno nego, v primerjavi z bolniki, ki so prejemali placebo in najboljšo standardno nego (glejte preglednico 2 in sliko 2).
English: SSE composite endpoint a
Slovenian: Sestavljeni opazovani dogodek SSE a
English: The MAH shall conduct and submit the results of a phase IV randomised double-blind multicentre study according to an agreed protocol in order to further characterise the efficacy and safety, in particular the risk of fractures, the risk of formation of visceral and nodal metastases of radium-223 in the authorized indication.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora izvesti randomizirano, dvojno slepo multicentrično študijo faze IV v skladu z dogovorjenim protokolom in predložiti rezultate študije, da se nadalje opredeli učinkovitost in varnost, zlasti tveganje za zlome, tveganje za nastanek metastaz v notranjih organih in bezgavkah za [223Ra]radij pri odobrenih indikacijah.
English: In a phase I study, neutrophil and platelet count nadirs occurred at 2 to 3 weeks after intravenous administration of a single dose of Xofigo.
Slovenian: V študiji I. faze je bilo število nevtrofilcev in trombocitov najmanjše 2 do 3 tedne po intravenski uporabi enega odmerka zdravila Xofigo.
English: Time to event data on ALP progression were supported by statistically significant advantage with respect to ALP normalisation and ALP responses at week 12.
Slovenian: Podatki o času do povečanja vrednosti alkalne fosfataze so bili podprti s statistično značilno prednostjo, kar zadeva normalizacijo vrednosti alkalne fosfataze in odzive alkalne fosfataze v 12. tednu.
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.
Slovenian: Izsledki študije ALSYPMCA III. faze glede časa do zunanjega obsevanja (EBRT) za lajšanje bolečine in manjše število bolnikov, zdravljenih z zdravilom Xofigo, ki so poročali o bolečinah v kosteh kot o neželenem učinku, kažejo na ugoden učinek zdravila na bolečine v kosteh.
English: You may wish to seek advice on conservation of sperm before treatment starts.
Slovenian: Pred začetkom zdravljenja se boste morda želeli posvetovati tudi o možnostih shranjevanja sperme.
English: The pharmacokinetics of radium-223 dichloride were linear in the activity range investigated (51 to 276 kBq/kg).
Slovenian: Farmakokinetika [223Ra]radijevega klorida je bila v preučevanem razponu aktivnosti (51 do 276 kBq/kg) linearna.
English: The most serious side effects in patients receiving Xofigo are - decrease in the number of blood platelets (thrombocytopenia), - decrease in the number of neutrophils, a type of white blood cells (neutropenia, which may lead to an increased risk of infection).
Slovenian: Najbolj resna neželena učinka pri bolnikih, ki so prejemali zdravilo Xofigo, sta bila - zmanjšanje števila krvnih ploščic (trombocitopenija), - zmanjšanje števila nevtrofilcev, določene vrste belih krvnih celic (nevtropenija, ki lahko poveča tveganje za okužbe).
English: The combination of radium-223 with other systemic cancer therapies other than LHRH analogues is therefore not recommended.
Slovenian: Kombinacija [223Ra]radija z drugimi sistemskimi zdravljenji raka, razen z analogi LHRH, zato ni priporočljiva.
English: The healthcare professional will flush the intravenous access line or cannula before and after injection with a saline solution.
Slovenian: Zdravstveni delavec bo pred in po injiciranju izpral intravenski dostop ali kanilo s fiziološko raztopino.
English: INSTRUCTION FOR PREPARATION OF RADIOPHARMACEUTICALS This medicinal product should be visually inspected before use.
Slovenian: Pred uporabo je treba zdravilo vizualno pregledati.
English: After repeated administration of the clinically recommended activity of 55 kBq per kg body weight once every 4 weeks for 6 months, two dogs developed non-displaced pelvic fractures.
Slovenian: Po večkratni uporabi klinično priporočene aktivnosti 55 kBq na kg telesne mase, enkrat vsake 4 tedne v obdobju 6 mesecev, se je pri dveh psih pojavil stabilni zlom medenice.
English: 6 mL 6.6 MBq/vial at 12 h (CET) ref. date: [DD/MM/YYYY]
Slovenian: 6,6 MBq/vialo ob 12. uri (CET) na referenčni dan: [DD/MM/LLLL]
English: Main secondary endpoints included time to symptomatic skeletal events (SSE), time to progression of total alkaline phosphatase (ALP), time to progression of prostate specific antigen (PSA), response of total ALP and normalisation of total ALP.
Slovenian: Glavni sekundarni opazovani dogodki pa so bili čas do pojava simptomatskih dogodkov na kosteh (SSE - symptomatic skeletal events), čas do povečanja celokupne vrednosti alkalne fosfataze, čas do povečanja vrednosti za prostato specifičnega antigena (PSA),
English: Best standard of care included e.g. local external beam radiotherapy, bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine or ketoconazole.
Slovenian: Najboljša standardna nega je npr. vključevala zunanje obsevanje, difosfonate, kortikosteroide, antiandrogene,
English: - If you suffer from decreased blood cell production in the bone marrow, e.g. if you have received prior chemotherapy (other medicines used to kill cancer cells) and/or radiation therapy, you may be at higher risk and your doctor will give you Xofigo with caution.
Slovenian: - Če je pri vas nastajanje krvnih celic v kostnem mozgu zmanjšano, npr. če ste predhodno prejeli kemoterapijo (druga zdravila, ki se uporabljajo za uničevanje rakavih celic) in/ali ste bili obsevani, je tveganje lahko večje in bo zdravnik pri vas uporabljal zdravilo Xofigo previdno.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose
Slovenian: da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: Although radium-223 is predominantly an alpha emitter, gamma and beta radiation is associated with the decay of radium-223 and its radioactive daughter isotopes.
Slovenian: Čeprav [223Ra]radij oddaja predvsem delce alfa, je z razpadom [223Ra]radija in njegovih radioaktivnih hčerinskih izotopov povezano tudi sevanje gama in beta.
English: b Hazard ratio (Xofigo over placebo) < 1 favours Xofigo.
Slovenian: b razmerje ogroženosti (zdravilo Xofigo v primerjavi s placebom) < 1 je v korist zdravila Xofigo
English: A higher rate of non-prostate cancer related deaths was observed in the placebo group (26/541, 4.8% in the Xofigo arm compared to 23/268, 8.6% in the placebo arm).
Slovenian: Večjo stopnjo smrti, ki niso bile povezane z rakom prostate, so opazili v skupini bolnikov, ki je prejemala placebo (26/541; 4,8 % v skupini, ki je prejemala zdravilo Xofigo, v primerjavi s 23/268; 8,6 % v skupini, ki je prejemala placebo).
English: Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, 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 (see section 4.4).
Slovenian: Zdravilo Xofigo kot monoterapija ali v kombinaciji z analogom lutropin sproščajočega hormona (LHRH, luteinising hormone releasing hormone) je indicirano za zdravljenje odraslih bolnikov z metastatskim na kastracijo odpornim rakom prostate (mCRPC, metastatic castration-resistant prostate cancer) in simptomatskimi metastazami v kosteh ter brez znanih metastaz v notranjih organih, pri napredovali bolezni po najmanj dveh predhodnih linijah sistemskega zdravljenja mCRPC (razen z analogi LHRH) ali bolnikov, ki niso primerni za nobeno od sistemskih zdravljenj mCRPC, ki so na voljo (glejte poglavje 4.4).
English: Xofigo is for intravenous use.
Slovenian: Način uporabe Zdravilo Xofigo je za intravensko uporabo.