FrancophonIA/ELRC3.0 huggingface dataset:
English: Each mL of solution contains 0.194 mmol (equivalent to 4.5 mg) of sodium.
Slovenian: Pomožne snovi z znanim učinkom: 1 ml raztopine vsebuje 0,194 mmol (kar ustreza 4,5 mg) natrija.
English: Relative to placebo, the decline in quality of life was slower for Xofigo during the on-treatment period as measured by EQ-5D utility index score (-0.040 versus - 0.109; p=0.001), EQ-5D self-reported Visual Analogue health status scores (VAS) (-2.661 versus -5.860; p=0.018) and the FACT P total score (-3.880 versus -7.651, p=0.006) but did not reach published minimally important differences.
Slovenian: se je kakovost življenja poslabševala počasneje med zdravljenjem z zdravilom Xofigo, glede na rezultate izpolnjenega vprašalnika EQ-5D (-0,040 v primerjavi z -0,109; p = 0,001), vprašalnika za samooceno vizualno analognega zdravstvenega stanja EQ-5D VAS (-2,661 v primerjavi z -5,860; p = 0,018) ter skupnega rezultata vprašalnika FACT-P (-3,880 v primerjavi z -7,651; p = 0,006), vendar ni dosegla objavljenih najmanjših značilnih razlik.
English: Xofigo must not be given in combination with abiraterone and prednisone/prednisolone due to a possible increase in the risk of bone fracture or death.
Slovenian: Zdravila Xofigo se ne sme dajati v kombinaciji z abirateronom in prednizonom/prednizolonom zaradi morebitnega povečanja tveganja za zlome kosti ali smrt.
English: Bone fractures
Slovenian: Zlomi kosti
English: If you have been given more Xofigo than you should An overdose is unlikely.
Slovenian: Če ste prejeli večji odmerek zdravila Xofigo, kot bi smeli
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).
Slovenian: V dolgotrajnih študijah toksičnosti na podganah (12 do 15 mesecev) so poleg osteosarkomov poročali tudi o prisotnosti drugih neoplastičnih sprememb (glejte poglavje 4.8).
English: Xofigo is a clear, colourless solution and should not be used in case of discolouration, the occurrence of particulate matter or a defective container.
Slovenian: Zdravilo Xofigo je bistra, brezbarvna raztopina in se je ne sme uporabljati, če je obarvana, so v njej prisotni trdni delci ali je poškodovan vsebnik.
English: SSE components
Slovenian: Sestavni del SSE
English: Whole body
Slovenian: Maternica Celo telo
English: - If you take or have taken bisphosphonates or have received chemotherapy prior to treatment with Xofigo, please tell your doctor.
Slovenian: - Če jemljete ali ste jemali difosfonate ali ste pred zdravljenjem z zdravilom Xofigo prejeli kemoterapijo, obvestite zdravnika.
English: No significant effects were seen on vital organ systems, i.e. cardiovascular (dog), respiratory or central nervous systems (rat), after single dose administration of activities from 497 to 1100 kBq per kg body weight (9 [dog] to 20 [rat] times the clinically recommended activity).
Slovenian: Pomembnih učinkov na vitalne organske sisteme, tj. na kardiovaskularni sistem (pes), dihala ali osrednji živčni sistem (podgana) po enkratni uporabi odmerka z aktivnostjo od 497 do 1100 kBq na kg telesne mase (9-kratnik [psi] oziroma do 20-kratnik [podgane] klinično priporočene aktivnosti) niso opazili.
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.
Slovenian: Ker se [223Ra]radij ne presnavlja v jetrih in se ne izloča z žolčem, ni pričakovati, da bi okvara jeter vplivala na farmakokinetiko [223Ra]radijevega klorida.
English: It is supplied in a colourless glass vial closed with a grey rubber stopper and aluminium seal.
Slovenian: Zdravilo je na voljo v brezbarvnih steklenih vialah, zaprtih s sivim gumijastim zamaškomin z aluminijastim tesnilom.
English: Limited data are available for patients with moderate (CLCR: 30 to 50 mL/min) renal impairment.
Slovenian: Za bolnike z zmerno okvaro ledvic (očistek kreatinina [CLCR]: 30 do 50 ml/min) je na voljo malo podatkov.
English: Due to the faecal excretion of Xofigo, radiation may lead to aggravation of acute inflammatory bowel disease.
Slovenian: Ker se zdravilo Xofigo izloča z blatom, lahko sevanje poslabša akutno vnetno črevesno bolezen.
English: Therefore, efficacy may be diminished in patients with a low level of osteoblastic activity from their bone metastases.
Slovenian: Zato je pri bolnikih z nizko osteoblastno aktivnostjo kostnih metastaz učinkovitost lahko zmanjšana.
English: Concomitant chemotherapy with Xofigo may have additive effects on bone marrow suppression (see section 4.4).
Slovenian: Sočasna kemoterapija z zdravilom Xofigo lahko dodatno vpliva na supresijo kostnega mozga (glejte poglavje 4.4).
English: Pharmacotherapeutic group: Therapeutic radiopharmaceuticals, other therapeutic radiopharmaceuticals, various therapeutic radiopharmaceuticals, ATC code: V10XX03
Slovenian: Farmakoterapevtska skupina: radioterapevtiki, drugi radioterapevtiki, razni radioterapevtiki, oznaka ATC:
English: The use of Xofigo is therefore not recommended for treatment of adults with castration-resistant prostate cancer and only asymptomatic bone metastases.
Slovenian: Uporaba zdravila Xofigo zato ni priporočljiva za zdravljenje odraslih bolnikov z na kastracijo odpornim rakom prostate in samo asimptomatskimi metastazami v kosteh.
English: Uncommon (may affect up to 1 in 100 people) - decrease in the number of lymphocytes, a type of white blood cells (lymphopenia) - weakened bones (osteoporosis)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - zmanjšanje števila limfocitov, določene vrste belih krvnih celic (limfopenija) - oslabljene kosti (osteoporoza)
English: Subsequent systemic cancer treatment should not be initiated for at least 30 days after the last administration of Xofigo.
Slovenian: naknadnim sistemskim zdravljenjem raka ne smete začeti še najmanj30 dni po zadnjem dajanju zdravila
English: There are strict laws on the use, handling and disposal of medicines like Xofigo.
Slovenian: Uporabo zdravilu Xofigo podobnih zdravil, ravnanje z njimi in njihovo odstranjevanje določajo strogi zakoni.
English: Luxembourg / Luxemburg Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11
Slovenian: Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11
English: Xofigo is a therapeutic alpha particle-emitting pharmaceutical.
Slovenian: Zdravilo Xofigo je zdravilo, ki oddaja delce alfa.
English: The results of the interim analysis and the updated analysis also showed a significant improvement in all main secondary endpoints in the Xofigo arm compared to the placebo arm (see Table 3).
Slovenian: Izsledki vmesne analize in posodobljene analize so pokazali znatno izboljšanje v vseh glavnih sekundarnih opazovanih dogodkih v skupini, ki je prejemala zdravilo Xofigo, v primerjavi s skupino, ki je prejemala placebo (glejte preglednico 3).
English: Slovenská republika Bayer, spol.
Slovenian: Bayer, spol.
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.
Slovenian: Bolnike z znaki zmanjšane rezerve kostnega mozga, tj. po predhodni citotoksični kemoterapiji in/ali zunanjem obsevanju (EBRT, external beam radiation therapy) ali bolnike z rakom prostate z napredovalim difuznim kopičenjem v kosteh (EOD4; »superscan«), je treba zdraviti previdno.
English: Prior to starting radium-223 bone status (e.g. by scintigraphy, bone mineral density measurement) and baseline risk of fractures of patients (e.g. osteoporosis, less than 6 bone metastases, medication increasing fracture risk, low body mass index) should be carefully assessed, and closely monitored for at least 24 months.
Slovenian: merjenjem mineralne gostote kosti) in izhodiščno tveganje za zlome kosti pri bolnikih (npr. osteoporoza, manj kot 6 metastaz v kosteh, zdravila, ki povečujejo tveganje za zlome, nizek indeks telesne mase) in jih skrbno spremljati najmanj 24 mesecev.
English: Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects.
Slovenian: Dolgotrajna kumulativna izpostavljenost sevanju je lahko povezana z večjim tveganjem za raka in prirojene okvare.
English: In clinical studies, concurrent use of bisphosphonates or denosumab reduced the incidence of fractures in patients treated with radium-223 monotherapy.
Slovenian: V kliničnih študijah je sočasna uporaba difosfonatov ali denozumaba pri bolnikih, ki so se zdravili z [223Ra]radijem v monoterapiji, zmanjšala incidenco zlomov.
English: How Xofigo is used
Slovenian: Kako se uporablja zdravilo Xofigo
English: Additionally, there are uncertainties about the effects of Xofigo in combination with other medicines used to treat metastatic prostate cancer.
Slovenian: Poleg tega ni znan učinek zdravila Xofigo, če se uporablja v kombinaciji z drugimi zdravili, ki se uporabljajo za zdravljenje metastatskega raka prostate.
English: About 5% is excreted in the urine and there is no evidence of hepatobiliary excretion.
Slovenian: Približno 5 % se izloča s sečem, za izločanje skozi jetra ali z žolčem pa ni dokazov.
English: No dose adjustment is considered necessary in elderly patients.
Slovenian: Pri starejših bolnikih odmerkov ni treba prilagajati.
English: A pre-specified subgroup analysis also showed that overall survival was not significantly improved in patients with a total ALP < 220 U/L.
Slovenian: da se celokupno preživetje pri bolnikih s celokupno vrednostjo ALP < 220 enot/l ni bistveno izboljšalo.
English: No histological changes were observed in organs involved in the excretion of radium-223 dichloride.
Slovenian: Histoloških sprememb v organih, pomembnih za izločanje [223Ra]radijevega klorida, niso opazili.
English: The recommended dose of Xofigo is 55 kBq (Becquerel, the unit used to express radioactivity) per kilogram body weight.
Slovenian: Priporočeni odmerek je 55 kBq (Becquerel, enota za radioaktivnost) zdravila Xofigo na kilogram telesne mase.
English: A minimal number of abnormal spermatocytes were seen in a few seminiferous tubules in the testes of male rats after a single administration of ≥ 2270 kBq/kg body weight radium-223 dichloride (≥ 41 times the clinically recommended activity).
Slovenian: Najmanjše število nenormalnih spermatocitov so opazili v nekaj seminifernih tubulih v modih podganjih samcev po enkratni uporabi ≥ 2270 kBq/kg telesne mase [223Ra]radijevega klorida (≥ 41-kratnik klinično priporočene aktivnosti).
English: Treatment benefit of Xofigo in adults with castration-resistant prostate cancer and only asymptomatic bone metastases is not established.
Slovenian: Korist zdravljenja z zdravilom Xofigo pri odraslih bolnikih z na kastracijo odpornim rakom prostate in zgolj asimptomatskimi metastazami v kosteh ni bila dokazana.
English: Driving and using machines It is considered unlikely that Xofigo will affect your ability to drive or to use machines.
Slovenian: Ni verjetno, da bi zdravilo Xofigo vplivalo na vašo sposobnost vožnje ali upravljanja strojev.
English: The adverse reactions observed with Xofigo are represented in the table below (see Table 1).
Slovenian: Neželeni učinki, ki so jih opazili pri uporabi zdravila Xofigo, so navedeni v spodnji preglednici (glejte preglednico 1).
English: Neutropenia (all grades) was reported in 5% of patients treated with Xofigo and in 1% of patients receiving placebo.
Slovenian: O nevtropeniji (vseh stopenj) so poročali pri 5 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 1 % bolnikov, ki so prejemali placebo.
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.).
Slovenian: - Previdnost je potrebna pri rokovanju z materiali (npr. posteljnina), ki pridejo v stik s telesnimi tekočinami (npr. razlit seč, blato, bruhanje itd.).
English: Xofigo contributes to a patient's overall long-term cumulative radiation exposure.
Slovenian: Zdravilo Xofigo prispeva k splošni dolgotrajni kumulativni izpostavljenosti bolnika sevanju.
English: Safety and efficacy beyond 6 injections with Xofigo have not been studied.
Slovenian: Varnosti in učinkovitosti več kot 6 injekcij zdravila Xofigo niso preučevali.
English: The MAH shall conduct and submit the results of a phase IV biodistribution study according to an agreed protocol in order to further characterize correlation between the extent of the disease, the dose and the distribution of radium-223 in bone metastases versus sites of impaired bone health (e.g. osteoporosis) versus normal bone structure.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora izvesti študijo biorazgradljivosti faze IV in predložiti rezultate študije, da se nadalje opredeli povezava med obdegom bolezni, odmerkom in porazdelitvijo [223Ra]radija pri metastazah v kosteh v primerjavi z mesti okvar kosti (npr. osteoporozo) v primerjavi z normalno strukturo kosti.
English: Xofigo contains the radioactive substance radium-223 which mimics the calcium found in bones.
Slovenian: Zdravilo Xofigo vsebuje radioaktivni [223Ra]radij, ki posnema delovanje kalcija v kosteh.
English: An interim analysis from a clinical trial in chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer and progressive disease with bone metastases showed an increased risk of fractures and a trend for increased mortality 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 (see section 5.1).
Slovenian: Vmesna analiza klinične študije pri asimptomatskih ali blago simptomatskih bolnikih z na kastracijo odpornim rakom prostate in napredovalo boleznijo z metastazami v kosteh, ki predhodno niso bili zdravljeni s kemoterapijo, so pokazale povečano tveganje za zlome kosti in trend povečane smrtnosti pri bolnikih, 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 (glejte poglavje 5.1).
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.
Slovenian: - bolnikovo telesno maso (kg) - velikost odmerka (55 kBq/kg telesne mase) - koncentracijo radioaktivnosti zdravila (1100 kBq/ml) na referenčni dan.
English: - There are no data available on the safety and efficacy of treatment with more than 6 injections of
Slovenian: - Podatkov o varnosti in učinkovitosti zdravljenja z več kot 6 injekcijami zdravila Xofigo ni na voljo.
English: - If you suffer from untreated spinal cord compression or if it is thought likely that you are developing spinal cord compression (pressure on the spinal cord nerves which can be caused by a tumour or other lesion), your doctor will first treat this disease with standard treatment before starting or continuing treatment with Xofigo.
Slovenian: - Če imate nezdravljeno kompresijo hrbtenjače ali bo do nje zelo verjetno prišlo (pritisk tumorja ali druge lezije na hrbtenjačo), bo zdravnik najprej zdravil to bolezen s standardnim zdravljenjem, preden bo začel ali nadaljeval zdravljenje z zdravilom Xofigo.
English: Xofigo 1100 kBq/mL solution for injection
Slovenian: Xofigo 1100 kBq/ml raztopina za injiciranje
English: Overall, the frequency of grade 3 and 4 thrombocytopenia was lower in patients that did not previously receive docetaxel (2.8% in patients treated with Xofigo versus 0.8% in patients receiving placebo) compared to patients that previously received docetaxel (8.9% in patients treated with Xofigo versus 2.9% in patients receiving placebo).
Slovenian: Na splošno je bila pogostnost trombocitopenije stopnje 3 in 4 manjša pri bolnikih, ki predhodno niso prejeli docetaksela (2,8 % bolnikov, zdravljenih z zdravilom Xofigo, v primerjavi z 0,8 % bolnikov, ki so prejemali placebo), v primerjavi z bolniki, ki so predhodno prejeli docetaksel (8,9 % bolnikov, zdravljenih z zdravilom Xofigo, v primerjavi z 2,9 % bolnikov, ki so prejemali placebo).
English: Thrombocytopenia and neutropenia
Slovenian: Trombocitopenija in nevtropenija
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji,
English: Storage of Xofigo should be in accordance with national regulation on radioactive materials.
Slovenian: Zdravilo Xofigo shranjujte v skladu z nacionalnimi predpisi za radioaktivne snovi.
English: Overall, the frequency of grade 3 and 4 neutropenia was lower in patients that did not previously receive docetaxel (0.8% in patients treated with Xofigo versus 0.8% in patients receiving placebo) compared to patients that previously received docetaxel (3.2% in patients treated with Xofigo versus 0.6% in patients receiving placebo).
Slovenian: Na splošno je bila pogostnost nevtropenije stopnje 3 in 4 manjša pri bolnikih, ki predhodno niso prejeli docetaksela (0,8 % bolnikov, zdravljenih z zdravilom Xofigo, v primerjavi z 0,8 % bolnikov, ki so prejemali placebo), v primerjavi z bolniki, ki so predhodno prejeli docetaksel (3,2 % bolnikov, zdravljenih z zdravilom Xofigo, v primerjavi z 0,6 %
English: In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting or resuming treatment with Xofigo.
Slovenian: Pri bolnikih z nezdravljeno grozečo ali ugotovljeno kompresijo hrbtenjače je treba pred začetkom ali nadaljevanjem zdravljenja z zdravilom Xofigo dokončati s standardno nego, kot je klinično indicirano.
English: There is limited evidence that the delay in loss of HRQOL extends beyond the treatment period.
Slovenian: Dokazov o kasnejšem poslabšanju HRQOL po končanem zdravljenju je malo.
English: The clinical efficacy and safety of concurrent initiation of Xofigo, abiraterone acetate and prednisone/prednisolone treatment was assessed in a randomized, placebo-controlled multicenter phase III study (ERA-223 trial) in 806 chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer with bone metastases.
Slovenian: Kombinacija z abirateronom in prednizonom/prednizolonom Klinično učinkovitost in varnost pri sočasni uvedbi zdravljenja z zdravilom Xofigo, abirateronacetatom in prednizonom/prednizolonom so ocenili v randomizirani, s placebom nadzorovani multicentrični študiji III.faze (študija ERA-223) pri 806 bolnikih, z asimptomatskim ali blago simptomatskim na kastracijo odpornim rakom prostate z metastazami v kosteh, ki predhodno niso bili zdravljeni s kemoterapijo.
English: Long-term cumulative radiation exposure may increase your risk for developing cancer (in particular of bone cancer and leukaemia) and hereditary abnormalities.
Slovenian: Dolgotrajna kumulativna izpostavljenost sevanju lahko poveča tveganje za razvoj raka (predvsem kostnega raka in levkemije) in dednih nenormalnosti.
English: Grade 3 and 4 neutropenia was observed in 2.2% of patients treated with Xofigo and in 0.7% of patients receiving placebo.
Slovenian: Nevtropenijo stopnje 3 in 4 so opazili pri 2,2 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 0,7 % bolnikov, ki so prejemali placebo.
English: Table 2: Survival results from the phase III ALSYMPCA study
Slovenian: Preglednica 2: Preživetje v študiji ALSYMPCA III. faze zdravilo Xofigo placebo
English: This medicine contains the active substance radium Ra 223 dichloride (radium-223 dichloride).
Slovenian: To zdravilo vsebuje učinkovino [223Ra]radijev klorid (radium Ra 223 dichloride).
English: At the cut-off date of the pre-planned interim analysis (confirmatory analysis), a total of 809 patients were randomised 2:1 to receive Xofigo 55 kBq/kg intravenously every 4 weeks for 6 cycles (N=541) plus best standard of care, or matching placebo plus best standard of care (N=268).
Slovenian: Na presečni dan vnaprej načrtovane vmesne analize (potrditvena analiza) so skupno 809 bolnikov randomizirali 2:1 v skupino, ki je vsake 4 tedne 6 ciklov intravensko prejemala zdravilo Xofigo 55 kBq/kg
English: Xofigo is not to be used in women who are, or may be, pregnant or breast-feeding.
Slovenian: Zdravila Xofigo se ne sme uporabljati pri nosečnicah ali ženskah, ki bi lahko bile noseče ali dojijo.
English: There have been no reports of inadvertent overdosing of Xofigo during clinical studies.
Slovenian: V kliničnih študijah niso poročali o nenamernem prevelikem odmerjanju zdravila Xofigo.
English: What you need to know before Xofigo is used
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Xofigo Kako se uporablja zdravilo Xofigo
English: Xofigo should only be administered after a careful benefit-risk assessment in patients with acute inflammatory bowel disease.
Slovenian: Zdravilo Xofigo se lahko pri bolnikih z akutno vnetno črevesno boleznijo uporabi le po skrbni oceni tveganja in koristi.
English: Before subsequent administrations, the ANC should be ≥ 1.0 x 109/l and the platelet count ≥ 50 x 109/l.
Slovenian: ANC ≥ 1,0 x 109/l in število trombocitov ≥ 50 x 109/l.
English: Thrombocytopenia (all grades) occurred in 11.5% of patients treated with Xofigo and 5.6% of patients receiving placebo.
Slovenian: Trombocitopenija (vseh stopenj) se je pojavila pri 11,5 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 5,6 % bolnikov, ki so prejemali placebo.
English: Xofigo must not be used if discolouration, the occurrence of particulate matter or a defective container is noticed.
Slovenian: Zdravila Xofigo se ne sme uporabljati, če je obarvano, so v njem prisotni trdni delci ali je vsebnik poškodovan.
English: Each vial contains 6 mL of solution (6.6 MBq radium-223 dichloride at the reference date).
Slovenian: Ena viala vsebuje 6 ml raztopine (6,6 MBq [223Ra]radijevega klorida na referenčni dan).
English: Xofigo contains sodium
Slovenian: Zdravilo Xofigo vsebuje natrij
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).
Slovenian: Glavni izsledki v študijah toksičnosti po enkratnem in večkratnem odmerjanju pri podganah so bili manjše pridobivanje telesne mase, hematološke spremembe, znižane vrednosti serumske alkalne fosfataze in mikroskopske spremembe v kostnem mozgu (zmanjšanje števila krvotvornih celic, fibroza), vranici
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva zlom kosti osteoporoza
English: = Body weight (kg)  activity (55 kBq/kg body weight)
Slovenian: = telesna masa (kg) × aktivnost (55 kBq/kg telesne mase) koeficient razpada × 1100 kBq/ml
English: Xofigo has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Xofigo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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.
Slovenian: Xofigo in 54 (17,9 %) bolnikov v skupini, ki je prejemala placebo, prejelo citotoksično kemoterapijo v različnih obdobjih po zadnjem zdravljenju.