FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are: water for injections, sodium citrate, sodium chloride and hydrochloric acid (see end of Section 2 for further information on sodium).
Slovenian: - Druge sestavine zdravila so: voda za injekcije, natrijev citrat, natrijev klorid in klorovodikova kislina (glejte zadnji odstavek poglavja 2 za več informacij glede natrija).
English: Crohn's disease and ulcerative colitis
Slovenian: Crohnova bolezen in ulcerozni kolitis
English: In particular, the risk for osteosarcoma, myelodysplastic syndrome and leukaemias may be increased.
Slovenian: Še zlasti se lahko poveča tveganje za osteosarkom, mielodisplastični sindrom ter levkemijo.
English: Because of potential effects on spermatogenesis associated with radiation, men should be advised to use effective contraceptive methods during and up to 6 months after treatment with Xofigo.
Slovenian: Zaradi možnih učinkov na spermatogenezo, povezanih s sevanjem, je treba moškim svetovati, da med zdravljenjem in do 6 mesecev po zdravljenju z zdravilom Xofigo uporabljajo učinkovite kontracepcijske metode.
English: Increased fracture risk has been found especially in patients with medical history of osteoporosis and in patients with less than 6 bone metastases.
Slovenian: Povečano tveganje za zlome so ugotovili zlasti pri bolnikih z anamnezo osteoporoze in pri bolnikih z manj kot 6 metastazami v kosteh.
English: Symptomatic skeletal event (SSE)
Slovenian: Simptomatski dogodki na kosteh (SSE)
English: The fraction of energy emitted from radium-223 and its daughters as alpha-particles is 95.3% (energy range of 5.0 - 7.5 MeV).
Slovenian: Delež energije, ki jo oddajajo [223Ra]radij in njegovi hčerinski izotopi v obliki delcev alfa, je 95,3 % (razpon energije 5,0 - 7,5 MeV).
English: The exact mechanism for induction of retinal detachment is unknown, but literature data suggests that radium is specifically taken up in the tapetum lucidum of the canine eye.
Slovenian: Natančen mehanizem odstopa mrežnice ni znan, vendar podatki iz literature kažejo na specifičen privzem radija v odbojno plast
English: - If you have any further questions, ask your doctor who will supervise the procedure.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, ki bo nadzoroval postopek uporabe zdravila.
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.
Slovenian: Hematološki neželeni učinki zdravila, ki so jih opazili v kliničnih študijah z zdravilom Xofigo, so manj pogosti in manj resni, kot jih je pričakovati iz izračunanih absorbiranih doz za rdeči kostni mozeg.
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.
Slovenian: Če se te vrednosti v 6 tednih po zadnji uporabi zdravila Xofigo kljub standardni negi ne izboljšajo, se lahko zdravljenje z zdravilom Xofigo nadaljuje le po skrbni oceni koristi in tveganj.
English: The specific activity of radium-223 is 1.9 MBq/ng.
Slovenian: Specifična aktivnost [223Ra]radija je 1,9 MBq/ng.
English: The overall safety profile of Xofigo is based on data from 600 patients treated with Xofigo in the phase III study.
Slovenian: Splošni varnostni profil zdravila Xofigo temelji na podatkih zbranih v študiji III. faze pri 600 bolnikih, zdravljenih z zdravilom Xofigo.
English: - Decay correction (DK) factor to correct for physical decay of radium-223.
Slovenian: - koeficient razpada (DK - decay correction) za popravek fizikalnega razpada [223Ra]radija.
English: - Xofigo is not recommended if cancer in your bones is not causing symptoms, such as pain.
Slovenian: - Zdravilo Xofigo ni priporočljivo, če vam rak v kosteh ne povzroča simptomov, kot je bolečina.
English: Based on studies in animals, there is a potential risk that radiation from Xofigo could cause adverse effects on fertility (see section 5.3).
Slovenian: Na podlagi študij na živalih obstaja tveganje, da bi sevanje zdravila Xofigo lahko povzročilo neželene učinke na plodnost (glejte poglavje 5.3).
English: Volume to be administered (mL)
Slovenian: volumen raztopine za aplikacijo (ml)
English: A table of DK factors is provided with each vial as part of the booklet (preceding the package leaflet).
Slovenian: Preglednica koeficientov razpada je priložena k vsaki viali kot del knjižice (pred navodilom za uporabo).
English: The doctor supervising the procedure will calculate the quantity of Xofigo to be used in your case.
Slovenian: Zdravnik, ki vas bo med postopkom nadzoroval, bo izračunal količino zdravila Xofigo, ki jo boste prejeli.
English: Your doctor will perform blood tests before starting treatment and before each injection to check your number of blood cells and platelets (see also section 2).
Slovenian: Pred začetkom zdravljenja in pred vsako injekcijo bo zdravnik pri vas opravil krvne preiskave in preveril število krvnih celic in krvnih ploščic (glejte tudi poglavje 2).
English: The reference date is stated on the vial and lead pot label.
Slovenian: Referenčni dan je naveden na viali in nalepki svinčenega vsebnika.
English: An updated descriptive analysis of safety and of overall survival was performed in 921 randomised patients prior to implementing crossover (i.e. offering patients in the placebo group to receive Xofigo treatment).
Slovenian: Posodobljena opisna analiza varnosti in celokupnega preživetja je bila opravljena pri 921 randomiziranih bolnikih pred prehodom (tj. preden so bolnikom, ki so prejemali placebo, ponudili zdravljenje z zdravilom Xofigo).
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.
Slovenian: Visok linearni prenos energije alfa sevalcev (80 keV/mikrometer) povzroči izredno pogoste prekinitve dvojne vijačnice DNA v sosednjih tumorskih celicah, kar povzroči močan citotoksični učinek.
English: No differences in haematological laboratory values were apparent between the two groups.
Slovenian: Med obema skupinama ni bilo očitnih razlik v izvidih hematoloških laboratorijskih preiskav.
English: 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.
Slovenian: 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.
English: Xofigo is a clear and colourless solution for injection.
Slovenian: Zdravilo Xofigo je bistra, brezbarvna raztopina za injiciranje.
English: CI = confidence interval a The Phase 3 study ALSYMPCA was stopped for efficacy after the interim analysis.
Slovenian: IZ = interval zaupanja a Študija ALSYMPCA III. faze je bila zaradi učinkovitosti po vmesni analizi ustavljena.
English: 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.
Slovenian: 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.
English: In the event of an inadvertent overdose, general supportive measures, including monitoring for potential haematological and gastrointestinal toxicity should be undertaken.
Slovenian: V primeru nenamernega prevelikega odmerjanja so potrebni splošni podporni ukrepi, vključno s spremljanjem možnih toksičnih učinkov na kri in prebavila.
English: 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.
Slovenian: Podatki o varnem obdobju, po katerem se lahko zdravilo Xofigo daje po zdravljenju z abirateronacetatom v kombinaciji s prednizonom/prednizolonom in obratno, so omejeni.
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.
Slovenian: Če imate simptome, kot so bolečina, otekanje ali odrevenelost čeljusti, »občutek težke čeljusti« ali majavost zob, se posvetujte z zdravnikom.
English: The most serious adverse reactions were thrombocytopenia and neutropenia (see section 4.4 and ‘Description of selected adverse reactions' below).
Slovenian: Najbolj resna neželena učinka sta bila trombocitopenija in nevtropenija (glejte poglavji 4.4 in »Opis izbranih neželenih učinkov« v nadaljevanju).
English: Interim analysis
Slovenian: Vmesna analiza
English: Embryotoxicity / Reproduction toxicity
Slovenian: Embriotoksičnost/toksičnost za razmnoževanje
English: Safety and effectiveness of Xofigo have not been studied in children and adolescents below 18 years of age.
Slovenian: Varnosti in učinkovitosti zdravila Xofigo pri otrocih in mladostnikih, mlajših od 18 let, niso preučevali.
English: The risk for patients to develop osteosarcomas with exposure to radium-223 is unknown at present.
Slovenian: Trenutno tveganje za razvoj osteosarkomov pri bolnikih, izpostavljenih [223Ra]radiju, ni znano.
English: Osteosarcomas, a known effect of bone-seeking radionuclides, were observed at clinically relevant doses in rats 7 - 12 months after start of treatment.
Slovenian: Osteosarkom, znan učinek radionuklidov, ki se nalagajo v kosteh, so pri podganah opazili 7-12 mesecev po začetku zdravljenja s klinično pomembnimi odmerki.
English: 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.
Slovenian: Zaradi različnih stopenj osteolize trabekularne kosti na drugih mestih v kosteh zdravljenih živali, spontanih zlomov v povezavi z osteolizo ni mogoče izključiti.
English: Xofigo increases the incidence of diarrhoea, nausea, and vomiting (see section 4.8) which may result in dehydration.
Slovenian: Zdravilo Xofigo poveča pogostnost driske, navzee in bruhanja (glejte poglavje 4.8), kar lahko povzroči dehidracijo.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Na kastracijo odporni rak prostate je rak prostate (moška spolna žleza), ki se ne odziva na zdravljenje, ki znižuje raven moških spolnih hormonov.
English: Xofigo increases the risk of bone fractures (see section 5.1).
Slovenian: Zdravilo Xofigo poveča tveganje za zlome kosti (glejte poglavje 5.1).
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.
Slovenian: 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.
English: Care should be used when handling materials, such as bed linen, that come into contact with such body fluids.
Slovenian: Previdnost je potrebna pri rokovanju z materiali (npr. posteljnina), ki pridejo v stik s telesnimi tekočinami.
English: There are no data on the use of Xofigo at the same time as chemotherapy (other medicines used to kill cancer cells).
Slovenian: Na voljo ni podatkov o uporabi zdravila Xofigo sočasno s kemoterapijo (drugimi zdravili, ki se uporabljajo za uničevanje rakavih celic).
English: 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).
Slovenian: 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).
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.
Slovenian: Po intravenskem injiciranju se [223Ra]radij hitro očisti iz krvi in se primarno vključi v kosti in metastaze v kosteh ali izloči v črevesje.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: The vial contains 6 mL of solution.
Slovenian: Viala vsebuje 6 ml raztopine.
English: Studies on the mutagenic and carcinogenic potential of Xofigo have not been performed.
Slovenian: Študij mutagenega in kancerogenega potenciala zdravila Xofigo niso izvedli.
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]
Slovenian: 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]
English: Figure 1: Radium-223 decay chain with physical half-lives and mode of decay:
Slovenian: Slika 1: Veriga razpada [223Ra]radija s fizikalnimi razpolovnimi časi in načinom razpadanja:
English: 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.
Slovenian: 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.
English: Therefore, if you suffer from these conditions your doctor will carefully consider if you can be treated with Xofigo.
Slovenian: Če imate te bolezni, bo zdravnik skrbno premislil, ali se smete zdraviti z zdravilom Xofigo.
English: In patients with a high baseline risk of fracture, the benefit of treatment should be carefully assessed to outweigh the risk.
Slovenian: Pri bolnikih z visokim izhodiščnim tveganjem za zlome kosti je treba skrbno oceniti korist zdravljenja, da se ugotovi prevlada koristi nad tveganjem.
English: 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.
Slovenian: 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
English: Combination with abiraterone and prednisone/prednisolone or with systemic cancer therapies other than LHRH analogues
Slovenian: Kombinacija z abirateronom in prednizonom/prednizolonom ali s sistemskimi zdravljenji raka, razen z analogi LHRH
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.
Slovenian: - 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.
English: Pharmacokinetic data were obtained in 25 patients at activities ranging from 51 to 276 kBq/kg.
Slovenian: Farmakokinetične podatke so pridobili pri 25 bolnikih z aktivnostmi v razponu od 51 do 276 kBq/kg.
English: Osteosarcomas were not observed in dog studies.
Slovenian: V študijah na psih niso opazili osteosarkomov.
English: Duration of the procedure - Xofigo is given once every 4 weeks for a total of 6 injections.
Slovenian: - Zdravilo Xofigo se uporablja enkrat na vsake 4 tedne; skupno 6 injekcij.
English: Patients with a low level of osteoblastic bone metastases
Slovenian: Bolniki z nizko stopnjo osteoblastnih metastaz v kosteh
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Other possible side effects are listed below by how likely they are:
Slovenian: Drugi možni neželeni učinki so našteti spodaj po pogostnosti:
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.
Slovenian: - 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
English: 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.
Slovenian: Sevanje gama, povezano z razpadom [223Ra]radija in njegovih hčerinskih izotopov, omogoča merjenje radioaktivnosti zdravila Xofigo in odkrivanje kontaminacij s standardnimi napravami.
English: 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.
Slovenian: V klinični študiji III. faze niso opazili razlik v varnosti ali učinkovitosti med starejšimi (starimi ≥ 65 let) in mlajšimi bolniki (starimi < 65 let).
English: Patients with visceral metastases and malignant lymphadenopathy exceeding 3 cm were excluded.
Slovenian: Bolniki z metastazami v notranjih organih in maligno limfadenopatijo (z bezgavkami večjimi od 3 cm), so bili izključeni.
English: 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.
Slovenian: 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.
English: At 4 hours post injection, the mean percentage of the radioactive dose present in bone and intestine was approximately 61% and 49%, respectively.
Slovenian: 4 ure po injiciranju je bilo v kosteh in črevesju v povprečju 61 % oziroma 49 % radioaktivnega odmerka.
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.
Slovenian: 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.
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).
Slovenian: 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).
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).
Slovenian: 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).
English: What Xofigo is and what it is used for
Slovenian: Kaj je zdravilo Xofigo in za kaj ga uporabljamo
English: 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.
Slovenian: 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.
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).
Slovenian: 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).
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.
Slovenian: 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.