natgillin/translations-raw huggingface dataset:
The recommended dose of Xofigo is 55 kBq (Becquerel, the unit used to express radioactivity) per kilogram body weight.
Priporočeni odmerek je 55 kBq (Becquerel, enota za radioaktivnost) zdravila Xofigo na kilogram telesne mase.
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).
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).
Treatment benefit of Xofigo in adults with castration-resistant prostate cancer and only asymptomatic bone metastases is not established.
Korist zdravljenja z zdravilom Xofigo pri odraslih bolnikih z na kastracijo odpornim rakom prostate in zgolj asimptomatskimi metastazami v kosteh ni bila dokazana.
Driving and using machines It is considered unlikely that Xofigo will affect your ability to drive or to use machines.
Ni verjetno, da bi zdravilo Xofigo vplivalo na vašo sposobnost vožnje ali upravljanja strojev.
The adverse reactions observed with Xofigo are represented in the table below (see Table 1).
Neželeni učinki, ki so jih opazili pri uporabi zdravila Xofigo, so navedeni v spodnji preglednici (glejte preglednico 1).
Neutropenia (all grades) was reported in 5% of patients treated with Xofigo and in 1% of patients receiving placebo.
O nevtropeniji (vseh stopenj) so poročali pri 5 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 1 % bolnikov, ki so prejemali placebo.
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.).
- Previdnost je potrebna pri rokovanju z materiali (npr. posteljnina), ki pridejo v stik s telesnimi tekočinami (npr. razlit seč, blato, bruhanje itd.).
Xofigo contributes to a patient's overall long-term cumulative radiation exposure.
Zdravilo Xofigo prispeva k splošni dolgotrajni kumulativni izpostavljenosti bolnika sevanju.
Safety and efficacy beyond 6 injections with Xofigo have not been studied.
Varnosti in učinkovitosti več kot 6 injekcij zdravila Xofigo niso preučevali.
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.
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.
Xofigo contains the radioactive substance radium-223 which mimics the calcium found in bones.
Zdravilo Xofigo vsebuje radioaktivni [223Ra]radij, ki posnema delovanje kalcija v kosteh.
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).
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).
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.
- bolnikovo telesno maso (kg) - velikost odmerka (55 kBq/kg telesne mase) - koncentracijo radioaktivnosti zdravila (1100 kBq/ml) na referenčni dan.
- There are no data available on the safety and efficacy of treatment with more than 6 injections of
- Podatkov o varnosti in učinkovitosti zdravljenja z več kot 6 injekcijami zdravila Xofigo ni na voljo.
- 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.
- 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.
Xofigo 1100 kBq/mL solution for injection
Xofigo 1100 kBq/ml raztopina za injiciranje
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).
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).
Thrombocytopenia and neutropenia
Trombocitopenija in nevtropenija
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.
• 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,
Storage of Xofigo should be in accordance with national regulation on radioactive materials.
Zdravilo Xofigo shranjujte v skladu z nacionalnimi predpisi za radioaktivne snovi.
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).
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 %
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.
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.
There is limited evidence that the delay in loss of HRQOL extends beyond the treatment period.
Dokazov o kasnejšem poslabšanju HRQOL po končanem zdravljenju je malo.
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.
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.
Long-term cumulative radiation exposure may increase your risk for developing cancer (in particular of bone cancer and leukaemia) and hereditary abnormalities.
Dolgotrajna kumulativna izpostavljenost sevanju lahko poveča tveganje za razvoj raka (predvsem kostnega raka in levkemije) in dednih nenormalnosti.
Grade 3 and 4 neutropenia was observed in 2.2% of patients treated with Xofigo and in 0.7% of patients receiving placebo.
Nevtropenijo stopnje 3 in 4 so opazili pri 2,2 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 0,7 % bolnikov, ki so prejemali placebo.
Table 2: Survival results from the phase III ALSYMPCA study
Preglednica 2: Preživetje v študiji ALSYMPCA III. faze zdravilo Xofigo placebo
This medicine contains the active substance radium Ra 223 dichloride (radium-223 dichloride).
To zdravilo vsebuje učinkovino [223Ra]radijev klorid (radium Ra 223 dichloride).
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).
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
Xofigo is not to be used in women who are, or may be, pregnant or breast-feeding.
Zdravila Xofigo se ne sme uporabljati pri nosečnicah ali ženskah, ki bi lahko bile noseče ali dojijo.
There have been no reports of inadvertent overdosing of Xofigo during clinical studies.
V kliničnih študijah niso poročali o nenamernem prevelikem odmerjanju zdravila Xofigo.
What you need to know before Xofigo is used
Kaj morate vedeti, preden boste prejeli zdravilo Xofigo Kako se uporablja zdravilo Xofigo
Xofigo should only be administered after a careful benefit-risk assessment in patients with acute inflammatory bowel disease.
Zdravilo Xofigo se lahko pri bolnikih z akutno vnetno črevesno boleznijo uporabi le po skrbni oceni tveganja in koristi.
Before subsequent administrations, the ANC should be ≥ 1.0 x 109/l and the platelet count ≥ 50 x 109/l.
ANC ≥ 1,0 x 109/l in število trombocitov ≥ 50 x 109/l.
Thrombocytopenia (all grades) occurred in 11.5% of patients treated with Xofigo and 5.6% of patients receiving placebo.
Trombocitopenija (vseh stopenj) se je pojavila pri 11,5 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 5,6 % bolnikov, ki so prejemali placebo.
Xofigo must not be used if discolouration, the occurrence of particulate matter or a defective container is noticed.
Zdravila Xofigo se ne sme uporabljati, če je obarvano, so v njem prisotni trdni delci ali je vsebnik poškodovan.
Each vial contains 6 mL of solution (6.6 MBq radium-223 dichloride at the reference date).
Ena viala vsebuje 6 ml raztopine (6,6 MBq [223Ra]radijevega klorida na referenčni dan).
Xofigo contains sodium
Zdravilo Xofigo vsebuje natrij
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).
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
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva zlom kosti osteoporoza
= Body weight (kg)  activity (55 kBq/kg body weight)
= telesna masa (kg) × aktivnost (55 kBq/kg telesne mase) koeficient razpada × 1100 kBq/ml
Xofigo has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Xofigo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
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.
Xofigo in 54 (17,9 %) bolnikov v skupini, ki je prejemala placebo, prejelo citotoksično kemoterapijo v različnih obdobjih po zadnjem zdravljenju.
However, since excretion in urine is minimal and the major route of elimination is via the faeces, renal impairment is not expected to affect the pharmacokinetics of radium-223 dichloride.
Ker se izloča v majhnih količinah s sečem in večinoma z blatom, ni pričakovati, da bi okvara ledvic vplivala na farmakokinetiko [223Ra]radijevega klorida.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Za opis določenega učinka, njegovih sinonimov in sorodnih stanj so uporabljeni najustreznejši izrazi po klasifikaciji MedDRA.
Alpha1 emission (Gy/MBq)
Emisija delcev alfa1 (Gy/MBq)
In a clinical study, the addition of Xofigo to abiraterone acetate and prednisone/prednisolone, increased the incidence of fractures approximately three-fold in the Xofigo arm (see sections 4.8 and 5.1).
V klinični študiji se je incidenca zlomov v skupini, ki je prejemala zdravilo Xofigo, po dodajanju zdravila Xofigo abirateronacetatu in prednizonu/prednizolonu približno trikrat povečala (glejte poglavji 4.8 in 5.1).
Each vial contains 6 mL of solution (6600 kBq radium-223 dichloride at the reference date).
Ena viala vsebuje 6 ml raztopine (6600 kBq [223Ra]radijevega klorida na referenčni dan).
As Xofigo is excreted in the faeces, it may make acute inflammation of your bowels worse.
Ker se zdravilo Xofigo izloča z blatom, lahko poslabša akutno vnetje črevesja.
Dose-limiting myelotoxicity was seen in dogs after single administration of 497 kBq radium-223 dichloride per kg body weight (9 times the clinically recommended activity).
Mielotoksičnost, ki omejuje velikost odmerka, so pri psih opazili po enkratni uporabi 497 kBq [223Ra]radijevega klorida na kg telesne mase (9-kratnik klinično priporočene aktivnosti).
The efficacy and safety of cytotoxic chemotherapy performed after treatment with Xofigo has not been established.
Varnost in učinkovitost citotoksične kemoterapije po zdravljenju z zdravilom Xofigo nista bili dokazani.
Additionally, there are uncertainties about the effects of Xofigo in combination with other systemic medicines used to treat metastatic prostate cancer.
Xofigo v kombinaciji z drugimi sistemskimi zdravili, ki se uporabljajo za zdravljenje metastatskega raka prostate.
Subgroup survival analysis showed a consistent survival benefit for treatment with Xofigo, independent of use of bisphosphonates at baseline and prior use of docetaxel.
Analiza preživetja po podskupinah je pokazala dosledno korist zdravljenja z zdravilom Xofigo za preživetje,
Contact your doctor immediately if you notice the following symptoms as they may be signs of thrombocytopenia or neutropenia (see above): - any unusual bruising, - more bleeding than usual after injury, - fever, - or if you seem to be catching a lot of infections.
Takoj se posvetujte z zdravnikom, če opazite naslednje simptome, saj so lahko znaki trombocitopenije ali nevtropenije (glejte zgoraj):
Xofigo 1100 kBq/mL solution for injection radium Ra 223 dichloride
Xofigo 1100 kBq/ml raztopina za injiciranje [223Ra]radijev klorid
Cases of osteonecrosis of the jaw (dead tissue in the jaw bone which is mainly seen in patients who have been treated with bisphosphonates) have occurred in patients treated with Xofigo.
Pri bolnikih, ki so prejemali zdravilo Xofigo, so se pojavili primeri osteonekroze čeljusti (mrtvo tkivo čeljustnice, ki se pojavlja predvsem pri bolnikih, zdravljenih z difosfonati).
Storage should be in accordance with national regulation on radioactive materials.
Shranjujte v skladu z nacionalnimi predpisi za radioaktivne snovi.
Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date.
1 ml raztopine vsebuje 1100 kBq [223Ra]radijevega klorida (radium Ra 223 dichloride), kar ustreza 0,58 ng [223Ra]radija na referenčni dan.
A statistically significant overall survival benefit of treatment could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.553 -1.466], p=0.674) or a baseline total alkaline phosphatase (ALP) < 220 U/L (HR 0.823; 95% CI [0.633 -1.068], p=0.142) in the phase III ALSYMPCA study.
[223Ra]radij v primerjavi s placebom 0,901; 95-% IZ [0,553-1,466], p = 0,674) ali z izhodiščno vrednostjo celokupne alkalne fosfataze (ALP) < 220 enot/l (razmerje ogroženosti 0,823; 95-% IZ [0,633-1,068], p = 0,142).
Grade 3 and 4 thrombocytopenia was observed in 5.9% of patients treated with Xofigo and in 6.7% of patients receiving placebo (see section 4.4).
Trombocitopenijo stopnje 3 in 4 so opazili pri 5,9 % bolnikov, zdravljenih z zdravilom Xofigo in pri 6,7 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, faeces, vomiting etc.
Pri uporabi radiofarmakov obstaja zaradi zunanjega sevanja ali kontaminacije z razlitim sečem, blatom,
Demographic and baseline disease characteristics (interim analysis population) were similar between the Xofigo and placebo groups and are shown below for Xofigo:
Demografske in izhodiščne značilnosti bolezni (vmesna analiza populacije) so bile podobne med skupino,
If you take or have taken bisphosphonates or other medicines to protect your bone health or steroids (e.g. prednisone/prednisolone) prior to treatment with Xofigo, please tell your doctor.
Obvestite svojega zdravnika, če jemljete ali ste jemali difosfonate ali druga zdravila za zaščito kosti ali steroide (npr. prednizon/prednizolon) pred zdravljenjem z zdravilom Xofigo.
- The active substance is: radium Ra 223 dichloride (radium-223 dichloride).
- Učinkovina je [223Ra]radijev klorid (radium Ra 223 dichloride).
Safety and efficacy of concomitant chemotherapy with Xofigo have not been established.
Varnost in učinkovitost sočasne kemoterapije z zdravilom Xofigo nista bili dokazani.
Compared with placebo, there was a significant difference in favour of Xofigo for all five serum biomarkers for bone turnover studied in a phase II randomised study (bone formation markers: bone alkaline phosphatase [ALP], total ALP and procollagen I N propeptide [PINP], bone resorption markers: C-terminal crosslinking telopeptide of type I collagen / serum C-terminal crosslinked telopeptide of type I collagen [S-CTX-I] and type I collagen crosslinked C-telopeptide [ICTP]).
kostna alkalna fosfataza [ALP], celokupna vrednost alkalne fosfataze in prokolagen I N propeptid [PINP], označevalci resorpcije kosti: C-terminalni prečno povezani telopeptid kolagena tipa I / serumski C-terminalni prečno povezani telopeptid kolagena tipa I [S-CTX-I] in prečno povezani C-telopeptid kolagena tipa I [ICTP]).
- If you experience any new or unusual pain or swelling in bone region prior, during or after your treatment with Xofigo, you should consult your doctor.
- Če se vam pred, med ali po zdravljenju z zdravilom Xofigo pojavi kakršna koli nova ali nenavadna bolečina ali oteklina v predelu kosti, se posvetujte z zdravnikom.
Adrenals Brain
Nadledvične žleze Možgani
In patients with bone fractures, orthopaedic stabilisation of fractures should be performed before starting or resuming treatment with Xofigo.
Pri bolnikih z zlomi kosti je treba zlome pred začetkom ali nadaljevanjem zdravljenja z zdravilom Xofigo ortopedsko oskrbeti.
Radiation protection precautions in accordance with national regulations must therefore be taken.
V skladu z nacionalnimi in lokalnimi predpisi je treba vnaprej poskrbeti za zaščito pred sevanjem.
Xofigo is excreted mainly via the faeces.
Zdravilo Xofigo se izloča predvsem z blatom.
Grade 3 and 4 thrombocytopenia was observed in 6.3% of patients treated with Xofigo and in 2% of patients receiving placebo (see section 4.4).
Trombocitopenijo stopnje 3 in 4 so opazili pri 6,3 % bolnikov, zdravljenih z zdravilom Xofigo, in pri 2 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
Beta emission (Gy/MBq)
Emisija delcev beta (Gy/MBq)
Pain relief
Lajšanje bolečine
- If you have osteoporosis or a known increased risk for fractures (e.g. recent bone fracture, fragility), or take or have been taking steroids (e.g. prednisone/prednisolone), please tell your doctor.
nedavni zlom kosti, krhkost), jemljete ali ste jemali steroide (npr. prednizon/prednizolon).
Contents of the pack and other information
Shranjevanje zdravila Xofigo Vsebina pakiranja in dodatne informacije
- Xofigo contributes to your overall long-term cumulative radiation exposure.
- Zdravilo Xofigo prispeva k splošni dolgotrajni kumulativni izpostavljenosti bolnika sevanju.
Depending on the volume administered, this medicine can contain up to 54 mg sodium (main component of cooking/table salt) per dose.
Odvisno od injiciranega volumna lahko to zdravilo vsebuje do 54 mg natrija (glavne sestavine kuhinjske soli) na odmerek, kar je enako 2,7 % priporočenega največjega dnevnega vnosa natrija za odrasle osebe.
The European Medicines Agency has waived the obligation to submit the results of studies with Xofigo in all subsets of the paediatric population in the treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) and in the treatment of multiple myeloma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Xofigo za vse podskupine pediatrične populacije za zdravljenje vseh stanj, ki sodijo v kategorijo malignih neoplazem
Each mL of solution contains 1100 kBq radium-223 dichloride, corresponding to 0.58 ng radium-223 at the reference date.
1 ml raztopine vsebuje 1100 kBq [223Ra]radijevega klorida, kar ustreza 0,58 ng [223Ra]radija na referenčni dan.
There is a potential risk that radiation from Xofigo could affect your fertility.
Zdravilo Xofigo ima lahko škodljiv vpliv na vašo plodnost.
No case of retinal detachment has been reported in clinical trials.
V kliničnih preskušanjih niso poročali o odstopu mrežnice.
Before the first administration, the absolute neutrophil count (ANC) should be ≥ 1.5 x 109/l, the platelet count ≥ 100 x 109/l and haemoglobin ≥ 10.0 g/dl.
Pred prvo uporabo mora biti absolutno število nevtrofilcev (ANC) ≥ 1,5 x 109/l,
Uterine polyps (endometrial stroma) were observed in female rats after single or repeated administration of ≥ 359 kBq/kg body weight radium-223 dichloride (≥ 6.5 times the clinically recommended activity).
Pri podganjih samicah so po enkratni ali večkratni uporabi ≥ 359 kBq/kg telesne mase [223Ra]radijevega klorida (≥ 6,5-kratnik klinično priporočene aktivnosti) opazili polipe v maternici (stroma endometrija).