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no case of osteosarcoma has been reported in clinical studies with xofigo.
v kliničnih študijah z zdravilom xofigo niso poročali o primerih osteosarkomov.
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in particular, the risk for osteosarcoma, myelodysplastic syndrome and leukaemias may be increased.
Še zlasti se lahko poveča tveganje za osteosarkom, mielodisplastični sindrom ter levkemijo.
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mepact treatment should be started and supervised by a specialised doctor who has experience in diagnosing and treating osteosarcoma.
zdravljenje z zdravilom mepact mora uvesti in nadzorovati specializiran zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem osteosarkoma.
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an osteosarcoma patient in a phase ii study who had high creatinine level at enrolment showed an increase in blood urea and blood creatinine which was associated with mifamurtide use.
v študiji ii. faze so pri bolniku z osteosarkomom, ki je imel ob vključitvi visoko vrednost kreatinina, poročali o zvišanih vrednostih sečnine v krvi in kreatinina v krvi, ki so bile povezane z uporabo mifamurtida.
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none of the patients treated in the osteosarcoma studies were 65 years or older and in the phase iii randomised study, only patients up to the age of 30 years were included.
nobeden od bolnikov, ki so se zdravili v okviru študij o osteosarkomu, ni bil star 65 let ali več, v randomizirano študijo iii. faze pa so bili vključeni le bolniki, mlajši od 30 let.
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studies in rats indicate an increased incidence of osteosarcoma with long-term administration of preotact (see section 5.3).
rezultati raziskav na podganah kažejo povečano pojavnost osteosarkoma pri dolgotrajnem zdravljenju z zdravilom preotact (glejte poglavje 5.3).
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rats treated with near-life time daily injections had dose-dependent exaggerated bone formation and increased incidence of osteosarcoma most probably due to an epigenetic mechanism.
podgane, ki so skoraj ves čas življenja prejemale dnevne injekcije, so imele od odmerka odvisno povečano tvorbo kosti in povečano incidenco osteosarkomov, najverjetneje zaradi epigenetskega mehanizma.
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mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection.
zdravilo mepact je indicirano za zdravljenje operabilnega nerazsejanega osteosarkoma visoke stopnje pri otrocih, mladostnikih in mladih odraslih po popolni makroskopski kirurški odstranitvi.
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mepact is used to treat osteosarcoma (bone cancer) in children, adolescents and young adults (between 2 and 30 years).
zdravilo mepact uporabljamo za zdravljenje osteosarkoma (kostnega raka) pri otrocih, mladostnikih in mladih odraslih (starih od 2 leti do 30 let).
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9 rats treated with near life-time daily injections had dose-dependent exaggerated bone formation and an increased incidence of bone tumours, including osteosarcoma, most probably due to an epigenetic mechanism.
9 kosti med podganami in človekom, je klinični pomen teh odkritij verjetno manjši.
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no osteosarcomas have been observed in clinical trials.
v kliničnih preskušanjih niso opazili osteosarkomov.
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