natgillin/translations-raw huggingface dataset:
If you are taking calcium, phosphate and/or Vitamin D, your doctor will carefully consider if you need to temporarily stop taking these substances before you start treatment with Xofigo.
Če jemljete kalcij, fosfate in/ali vitamin D, bo zdravnik skrbno preučil, ali morate pred začetkom zdravljenja z zdravilom Xofigo začasno prekiniti jemanje teh snovi.
Xofigo is a clear and colourless solution for injection.
Zdravilo Xofigo je bistra, brezbarvna raztopina za injiciranje.
CI = confidence interval a The Phase 3 study ALSYMPCA was stopped for efficacy after the interim analysis.
IZ = interval zaupanja a Študija ALSYMPCA III. faze je bila zaradi učinkovitosti po vmesni analizi ustavljena.
Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician.
Zdravilo Xofigo lahko dajejo le osebe, pooblaščene za uporabo radiofarmakov v določenih kliničnih ustanovah (glejte poglavje 6.6) tistim bolnikom, za katere je mnenje podal za to usposobljen zdravnik.
In the event of an inadvertent overdose, general supportive measures, including monitoring for potential haematological and gastrointestinal toxicity should be undertaken.
V primeru nenamernega prevelikega odmerjanja so potrebni splošni podporni ukrepi, vključno s spremljanjem možnih toksičnih učinkov na kri in prebavila.
Data on a safe period after which Xofigo can be administered following treatment with abiraterone acetate in combination with prednisone/prednisolone and vice versa is limited.
Podatki o varnem obdobju, po katerem se lahko zdravilo Xofigo daje po zdravljenju z abirateronacetatom v kombinaciji s prednizonom/prednizolonom in obratno, so omejeni.
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.
Če imate simptome, kot so bolečina, otekanje ali odrevenelost čeljusti, »občutek težke čeljusti« ali majavost zob, se posvetujte z zdravnikom.
The most serious adverse reactions were thrombocytopenia and neutropenia (see section 4.4 and ‘Description of selected adverse reactions' below).
Najbolj resna neželena učinka sta bila trombocitopenija in nevtropenija (glejte poglavji 4.4 in »Opis izbranih neželenih učinkov« v nadaljevanju).
Interim analysis
Vmesna analiza
Embryotoxicity / Reproduction toxicity
Embriotoksičnost/toksičnost za razmnoževanje
Safety and effectiveness of Xofigo have not been studied in children and adolescents below 18 years of age.
Varnosti in učinkovitosti zdravila Xofigo pri otrocih in mladostnikih, mlajših od 18 let, niso preučevali.
The risk for patients to develop osteosarcomas with exposure to radium-223 is unknown at present.
Trenutno tveganje za razvoj osteosarkomov pri bolnikih, izpostavljenih [223Ra]radiju, ni znano.
Osteosarcomas, a known effect of bone-seeking radionuclides, were observed at clinically relevant doses in rats 7 - 12 months after start of treatment.
Osteosarkom, znan učinek radionuklidov, ki se nalagajo v kosteh, so pri podganah opazili 7-12 mesecev po začetku zdravljenja s klinično pomembnimi odmerki.
Due to the presence of osteolysis of trabecular bone in other bone locations of treated animals in varying degree, a spontaneous fracture in the context of osteolysis cannot be excluded.
Zaradi različnih stopenj osteolize trabekularne kosti na drugih mestih v kosteh zdravljenih živali, spontanih zlomov v povezavi z osteolizo ni mogoče izključiti.
Xofigo increases the incidence of diarrhoea, nausea, and vomiting (see section 4.8) which may result in dehydration.
Zdravilo Xofigo poveča pogostnost driske, navzee in bruhanja (glejte poglavje 4.8), kar lahko povzroči dehidracijo.
Health Related Quality of Life (HRQOL) was assessed in the phase III ALSYMPCA study using specific questionnaires: the EQ-5D (generic instrument) and the FACT-P (prostate cancer specific instrument).
Z zdravjem povezano kakovost življenja (HRQOL, Health Related Quality of Life), so ovrednotili v študiji ALSYMPCA III. faze s specifičnimi vprašalniki: EQ-5D (splošni vprašalnik) in FACT-P (specifični vprašalnik za raka prostate).
Calculations of absorbed doses were performed using OLINDA/EXM (Organ Level INternal Dose Assessment/EXponential Modeling), a software based on the Medical Internal Radiation Dose (MIRD) algorithm, which is widely used for established beta and gamma emitting radionuclides.
Izračun absorbiranih doz so opravili s pomočjo programske opreme OLINDA/EXM (Organ Level INternal Dose Assessment/EXponential Modeling), ki temelji na algoritmu Medical Internal Radiation Dose (MIRD) in se na splošno uporablja za uveljavljene radionuklide, ki oddajajo delce beta in žarke gama.
Castration-resistant prostate cancer is a cancer of the prostate (a gland of the male reproductive system) that does not respond to treatment that reduces male hormones.
Na kastracijo odporni rak prostate je rak prostate (moška spolna žleza), ki se ne odziva na zdravljenje, ki znižuje raven moških spolnih hormonov.
Xofigo increases the risk of bone fractures (see section 5.1).
Zdravilo Xofigo poveča tveganje za zlome kosti (glejte poglavje 5.1).
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.
Farmakokinetične podatke, podatke o biološki porazdelitvi in dozimetriji so pridobili pri 6 bolnikih z aktivnostmi 110 kBq/kg, danih dvakrat v časovnem razmaku 6 tednov in pri 10 bolnikih z aktivnostmi 55, 110 ali 221 kBq/kg.
Care should be used when handling materials, such as bed linen, that come into contact with such body fluids.
Previdnost je potrebna pri rokovanju z materiali (npr. posteljnina), ki pridejo v stik s telesnimi tekočinami.
There are no data on the use of Xofigo at the same time as chemotherapy (other medicines used to kill cancer cells).
Na voljo ni podatkov o uporabi zdravila Xofigo sočasno s kemoterapijo (drugimi zdravili, ki se uporabljajo za uničevanje rakavih celic).
The fraction emitted as beta-particles is 3.6% (average energies are 0.445 MeV and 0.492 MeV), and the fraction emitted as gamma-radiation is 1.1% (energy range of 0.01 - 1.27 MeV).
Delež energije, ki jo oddajajo v obliki delcev beta, je 3,6 % (povprečne energije so 0,445 MeV in 0,492 MeV), delež, ki jo oddajajo v obliki žarkov gama, pa je 1,1 % (razpon energije 0,011,27 MeV).
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.
Po intravenskem injiciranju se [223Ra]radij hitro očisti iz krvi in se primarno vključi v kosti in metastaze v kosteh ali izloči v črevesje.
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.
Zdravilo Xofigo se uporablja za zdravljenje odraslih z napredovalim na kastracijo odpornim rakom prostate v stanju napredovanja po najmanj dveh zdravljenjih raka poleg zdravljenj za ohranjanje znižanih ravni moškega hormona (hormonska terapija), ali bolnikov, ki ne sprejemajo nobenega drugega zdravljenja raka.
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.
Vse te primere so opazili le pri bolnikih, ki so jemali difosfonate pred ali med zdravljenjem z zdravilom Xofigo in kemoterapijo pred zdravljenjem z zdravilom Xofigo.
The vial contains 6 mL of solution.
Viala vsebuje 6 ml raztopine.
Studies on the mutagenic and carcinogenic potential of Xofigo have not been performed.
Študij mutagenega in kancerogenega potenciala zdravila Xofigo niso izvedli.
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]
1100 kBq/ml ob 12. uri (CET) na referenčni dan: [DD/MM/LLLL] 6,6 MBq/vialo ob 12. uri (CET) na referenčni dan: [DD/MM/LLLL]
Figure 1: Radium-223 decay chain with physical half-lives and mode of decay:
Slika 1: Veriga razpada [223Ra]radija s fizikalnimi razpolovnimi časi in načinom razpadanja:
The alpha particle range from radium-223 is less than 100 µm (less than 10 cell diameters) which minimises damage to the surrounding normal tissue.
Doseg delcev alfa iz [223Ra]radija je manjši od 100 mikrometrov (manjši od 10-kratnika premera celice), kar zmanjša poškodbe na normalnem okolnem tkivu na najmanjšo možno mero.
Therefore, if you suffer from these conditions your doctor will carefully consider if you can be treated with Xofigo.
Če imate te bolezni, bo zdravnik skrbno premislil, ali se smete zdraviti z zdravilom Xofigo.
In patients with a high baseline risk of fracture, the benefit of treatment should be carefully assessed to outweigh the risk.
Pri bolnikih z visokim izhodiščnim tveganjem za zlome kosti je treba skrbno oceniti korist zdravljenja, da se ugotovi prevlada koristi nad tveganjem.
As interactions with calcium and phosphate cannot be excluded, pausing supplementation with these substances and/or Vitamin D should be considered some days before starting with Xofigo treatment.
Ker ni možno izključiti medsebojnega delovanja s kalcijem in fosfatom, je treba razmisliti o prekinitvi uporabe prehranskih dopolnil s temi snovmi in/ali vitamina D nekaj dni pred uvedbo zdravljenja z zdravilom
Combination with abiraterone and prednisone/prednisolone or with systemic cancer therapies other than LHRH analogues
Kombinacija z abirateronom in prednizonom/prednizolonom ali s sistemskimi zdravljenji raka, razen z analogi LHRH
- 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.
- Če se vam je tumor obsežno razširil v kosti, je lahko tudi bolj verjetno, da se je zmanjšalo število krvnih celic in krvnih ploščic, zato bo zdravnik pri vas uporabljal zdravilo Xofigo previdno.
Pharmacokinetic data were obtained in 25 patients at activities ranging from 51 to 276 kBq/kg.
Farmakokinetične podatke so pridobili pri 25 bolnikih z aktivnostmi v razponu od 51 do 276 kBq/kg.
Osteosarcomas were not observed in dog studies.
V študijah na psih niso opazili osteosarkomov.
Duration of the procedure - Xofigo is given once every 4 weeks for a total of 6 injections.
- Zdravilo Xofigo se uporablja enkrat na vsake 4 tedne; skupno 6 injekcij.
Patients with a low level of osteoblastic bone metastases
Bolniki z nizko stopnjo osteoblastnih metastaz v kosteh
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.
V klinični študiji III. faze niso opazili pomembnih razlik v varnosti ali učinkovitosti med bolniki z blago okvaro ledvic (očistek kreatinina [CLCR]: 50 do 80 ml/min) in bolniki z normalnim delovanjem ledvic.
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.
Zdravilo Xofigo se verjetno kopiči na mestih z veliko kostno premeno, npr. na mestih degenerativne kostne bolezni (osteoporoza) ali nedavnega (mikro-)zloma, kar povečuje tveganje za zlome kosti.
Other possible side effects are listed below by how likely they are:
Drugi možni neželeni učinki so našteti spodaj po pogostnosti:
- 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.
- Omejeni podatki ne kažejo velikih razlik v nastajanju krvnih celic pri bolnikih, ki prejemajo kemoterapijo po zdravljenju z zdravilom Xofigo v primerjavi z bolniki, ki se niso zdravili z zdravilom
The gamma radiation associated with the decay of radium-223 and its daughters allows for the radioactivity measurement of Xofigo and the detection of contaminations with standard instruments.
Sevanje gama, povezano z razpadom [223Ra]radija in njegovih hčerinskih izotopov, omogoča merjenje radioaktivnosti zdravila Xofigo in odkrivanje kontaminacij s standardnimi napravami.
No overall differences in safety or efficacy were observed between elderly (aged ≥ 65 years) and younger patients (aged < 65 years) in the phase III study.
V klinični študiji III. faze niso opazili razlik v varnosti ali učinkovitosti med starejšimi (starimi ≥ 65 let) in mlajšimi bolniki (starimi < 65 let).
Patients with visceral metastases and malignant lymphadenopathy exceeding 3 cm were excluded.
Bolniki z metastazami v notranjih organih in maligno limfadenopatijo (z bezgavkami večjimi od 3 cm), so bili izključeni.
1As there was no uptake of radium-223 in most of the soft tissues observed, the alpha contribution to the total organ dose was set to zero for these organs.
1Ker privzema [223Ra]radija v večini preučevanih mehkih tkiv niso opazili, je bil prispevek oddajanja delcev alfa k skupni dozi sevanja za organe označen z nič.
At 4 hours post injection, the mean percentage of the radioactive dose present in bone and intestine was approximately 61% and 49%, respectively.
4 ure po injiciranju je bilo v kosteh in črevesju v povprečju 61 % oziroma 49 % radioaktivnega odmerka.
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.
Kadar se ga injicira bolniku, preide [223Ra]radij v kosti, do mesta kamor se je rak razširil, in oddaja sevanje kratkega dosega (delce alfa), ki uničuje okolne tumorske celice.
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).
Omejeni podatki kažejo, da so imeli bolniki, ki so prejemali kemoterapijo po uporabi zdravila Xofigo, podoben hematološki profil kot bolniki, ki so prejemali kemoterapijo po uporabi placeba (glejte tudi poglavje 5.1).
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).
Pri odraslih bolnikih z na kastracijo odpornim rakom prostate in blago simptomatskimi metastazami v kosteh je treba skrbno oceniti korist zdravljenja, da se ugotovi prevlada koristi nad tveganji, pri čemer je treba upoštevati, da bo za korist zdravljenja verjetno potrebna visoka osteoblastna aktivnost (glejte poglavje 5.1).
What Xofigo is and what it is used for
Kaj je zdravilo Xofigo in za kaj ga uporabljamo
The MAH shall conduct and submit the results of a non-interventional post-authorisation safety study (PASS) based on the data from the Prostate Cancer Data Base Sweden (PCBaSe) and other relevant Scandinavian cancer registers or other suitable data sources, in order to further characterise the safety of radium-223 in the authorized indication.
Imetnik dovoljenja za promet z zdravilom mora izvesti neintervencijsko študijo o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS) in predložiti rezultate študije, na osnovi podatkov iz raziskave Prostate Cancer Data Base Sweden (PCBaSe) in drugih ustreznih skandinavskih registrov raka ali drugih primernih virov podatkov, da se nadalje opredeli varnost [223Ra]radija za dovoljene indikacije.
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).
Za [223Ra]radij, ki oddaja predvsem delce alfa, so za črevesje, rdeči kostni mozeg in kostne/osteogene celice uporabili dodatne predpostavke z namenom zagotoviti najboljši možni izračun absorbirane doze zdravila Xofigo ob upoštevanju opažene biološke porazdelitve in določenih značilnosti (glejte preglednico 4).
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.
Šeststopenjski razpad [223Ra]radija v [207Pb]svinec poteka preko kratkoživih hčerinskih izotopov, spremljajo pa ga številne emisije delcev alfa in beta in žarkov gama z različnimi energijami in verjetnostmi emisij.
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.
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.
Xofigo should be handled in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Zdravilo Xofigo mora uporabnik pripraviti v skladu z varnostjo pred sevanjem in zahtevami za kakovost farmacevtskega izdelka.
Clear, colourless isotonic solution with pH between 6.0 and 8.0.
raztopina za injiciranje bistra, brezbarvna izotonična raztopina s pH med 6,0 in 8,0
Xofigo and chemotherapy used together may further decrease the number of your blood cells and blood platelets.
Sočasna uporaba zdravila Xofigo in kemoterapije lahko dodatno zmanjša število krvnih celic in krvnih ploščic.
No significant uptake was seen in other organs such as heart, liver, kidneys, urinary bladder and spleen at 4 hours post injection.
Pomembnega privzema v druge organe, kot so srce, jetra, ledvice, sečni mehur in vranica, 4 ure po injiciranju niso opazili.
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).
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..
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.
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.
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.
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.
Radium-223 is an isotope which decays and is not metabolised.
Biotransformacija [223Ra]radij je izotop, ki razpade in se ne presnavlja.
Administration of Xofigo and conduct of the procedure Xofigo will be injected slowly via a needle into one of your veins (intravenously).
Zdravilo Xofigo bo injicirano počasi z injekcijsko iglo v eno od vaših ven (intravensko).
Cardiac electrophysiology / QT prolongation
Elektrofiziološka preiskava srca / podaljšanje intervala QT
40% of patients had more than 20 bone metastases or superscan.
40 % bolnikov je imelo več kot 20 metastaz v kosteh ali napredovalo difuzno kopičenje v kosteh
Xofigo increases the risk of bone fractures.
Zdravilo Xofigo poveča tveganje za zlome kosti.
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.
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.
If you are already taking one of those medicines, please tell your doctor.
Če že jemljete katero izmed teh zdravil, se posvetujte z zdravnikom.
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.
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.
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.
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.
Xofigo is not indicated in women.
Zdravilo Xofigo ni indicirano za uporabo pri ženskah.
Your doctor will test your bone health before deciding whether you can be given Xofigo.
Zdravnik vam bo preveril stanje kosti, preden se bo odločil, ali lahko prejmete zdravilo Xofigo.
Storage of radiopharmaceuticals will be in accordance with national regulations on radioactive materials.
Shranjevanje radiofarmakov bo v skladu z nacionalnimi predpisi za radioaktivne snovi.
Table 1: Adverse reactions reported in clinical trials in patients treated with Xofigo System Organ Class
Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih pri bolnikih, zdravljenih z zdravilom Xofigo
There are no human data on the effect of Xofigo on fertility.
Ni podatkov o vplivu zdravila Xofigo na plodnost pri ljudeh.
Xofigo is a ready-to-use solution and should not be diluted or mixed with any other solutions.
Zdravilo Xofigo je raztopina, pripravljena za uporabo, ki se je ne sme redčiti ali mešati s katerimi koli drugimi raztopinami.
External beam radiation for pain relief
Zunanje obsevanje za lajšanje bolečine
Red marrow Osteogenic cells Skin
Rdeč kostni mozeg Osteogene celice
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).
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).
Male patients should seek advice on conservation of sperm prior to treatment.
Bolniki se morajo pred zdravljenjem posvetovati o možnostih shranjevanja sperme.
Subsequent treatment with cytotoxic substances
Nadaljnje zdravljenje s citotoksičnimi snovmi
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.
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.
In dogs, haematological changes were observed starting at the lowest activity of 55 kBq/kg, the clinically recommended dose.
Pri psih so hematološke spremembe najprej opazili pri najmanjši aktivnosti 55 kBq na kg, kar je klinično priporočeni odmerek.
The dose regimen of Xofigo is an activity of 55 kBq per kg body weight, given at 4 week intervals for 6 injections.
Režim odmerjanja zdravila Xofigo je aktivnost 55 kBq na kg telesne mase, in sicer kot 6 injekcij v 4tedenskih intervalih.