natgillin/translations-raw huggingface dataset:
This increases urine production, decreasing the amount of water in the blood and increasing the blood sodium level.
To poveča tvorbo urina, zaradi česar se zmanjša količina vode v krvi in poveča raven natrija v krvi.
By day 30, sodium had increased by an average of 7.4 mmol/l in patients who took Samsca, compared with 1.5 mmol/l in patients receiving placebo.
Do 30. dne se je raven natrija pri bolnikih, ki so jemali zdravilo Samsca, zvišala za povprečno 7,4 mmol/l v primerjavi z zvišanjem za 1,5 mmol/l pri bolnikih, ki so prejemali placebo.
In patients with SIADH, sodium levels, which were around 129 mmol/l at the start of treatment, rose by an average of 4.8 mmol/l by day 4 in those who took Samsca, compared with 0.2 mmol/l in those who took placebo (dummy treatment).
Pri bolnikih s SIADH, ki so se zdravili z zdravilom Samsca, se je raven natrija, ki je bila na začetku zdravljenja približno 129 mmol/l, do četrtega dne zdravljenja zvišala za povprečno 4,8 mmol/l v primerjavi z 0,2 mmol/l pri tistih, ki so jemali placebo (zdravilo brez učinkovine).
Two studies involving 424 adults showed that Samsca is effective at increasing sodium levels in patients with low levels caused by SIADH and other conditions such as liver and heart problems.
Dve študiji, v kateri je bilo vključenih 424 odraslih, sta pokazali, da zdravilo Samsca učinkovito povečuje raven natrija pri bolnikih z nizko ravnijo natrija, ki jo povzroča SIADH, in drugimi boleznimi, kot so težave z jetri in srcem, vendar pa je bilo zdravilo Samsca učinkovitejše pri bolnikih s SIADH kot pri tistih, ki so imeli težave z jetri ali srcem.
In SIADH, an excessive amount of the hormone vasopressin makes the patient produce less urine and thereby retain more water in the body, which dilutes the concentration of sodium in the blood.
Pri SIADH čezmerna količina hormona vazopresina povzroči, da bolnik proizvaja manj urina in zato v telesu zadržuje več vode, kar redči koncentracijo natrija v krvi.
Samsca contains the active substance tolvaptan.
Zdravilo Samsca vsebuje učinkovino tolvaptan.
For the full list of side effects reported with Samsca, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Samsca, glejte navodilo za uporabo.
This medicine must therefore not be used in women who are pregnant or breastfeeding.
Nosečnice ali ženske, ki dojijo, tega zdravila torej ne smejo jemati.
People with SIADH have an excessive amount of vasopressin, leading to decreased urine production and dilution of the blood.
Bolniki s SIADH imajo čezmerno količino vazopresina, kar vodi v zmanjšano tvorbo urina in redčenje krvi.
How is Samsca used?
Kako se zdravilo Samsca uporablja?
How does Samsca work?
Kako zdravilo Samsca deluje?
28 days.
28 dni
Date of first authorisation: 13 November 2013 Date of latest renewal: 21 June 2018
Datum prve odobritve: 13. november 2013 Datum zadnjega podaljšanja: 21. junij 2018
Please ask your doctor how this may affect you, especially if you are planning to have children in the future.
Posvetujte se z zdravnikom, kako lahko to vpliva na vas, še zlasti, če v prihodnosti načrtujete imeti otroke.
It will only be used in special controlled areas.
Uporablja se lahko samo v posebnih nadzorovanih prostorih.
• the mean age of patients was 70 years (range 49 to 90 years).
• povprečna starost bolnikov je bila 70 let (razpon od 49 do 90 let),
As the updated analysis is provided for descriptive purposes only, a p-value is not provided.
Ker je posodobljena analiza navedena samo zaradi opisa, vrednost p ni navedena.
Depending on the results of these tests your doctor will decide if treatment can be started, can be continued, or needs to be postponed or discontinued.
Glede na izvide teh preiskav bo zdravnik odločil, če se lahko zdravljenje začne, nadaljuje ali pa ga je treba odložiti ali prekiniti.
It must be administered by slow injection (generally up to 1 minute).
Zdravilo se injicira počasi (običajno do 1 minute).
The volume of distribution was higher than the blood volume indicating distribution to peripheral compartments.
Volumen porazdelitve je bil večji kot volumen krvi, kar kaže na porazdelitev v periferne prostore.
For additional instructions on the use of the medicinal product, see sections 6.6 and 12.
Za dodatna navodila o uporabi zdravila glejte poglavji 6.6 in 12.
Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.
Sprejem, shranjevanje, uporabo, prenos in odstranjevanje radiofarmakov urejajo predpisi in/ali ustrezna dovoljenja pristojnih uradnih organov.
The dose you receive depends on your body weight.
Odmerek, ki ga boste prejeli, je odvisen od vaše telesne mase.
The study was unblinded early based on an Independent Data Monitoring Committee Recommendation.
Podatki študije so bili na priporočilo neodvisnega odbora za spremljanje podatkov (Independent Data Monitoring Committee Recommendation) razkriti predčasno.
The doctor will tell you if you need to take any special precautions after receiving this medicine.
Zdravnik vas bo obvestil, če bodo potrebni posebni previdnostni ukrepi po prejemu tega zdravila.
Both groups experience a loss of quality of life.
V obeh skupinah se je kakovost življenja poslabšala.
The following information is intended for the specialist only:
Naslednje informacije so namenjene samo zdravnikom specialistom:
Patients who display signs or symptoms of dehydration or hypovolemia should be promptly treated.
Bolnike, pri katerih se kažejo znaki ali simptomi dehidracije ali hipovolemije, je treba takoj zdraviti.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Pogostnosti so opredeljene kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100).
In general, radionuclides are considered to be genotoxic and carcinogenic.
Na splošno velja, da so radionuklidi genotoksični in kancerogeni.
Figure 2: Kaplan-Meier overall survival curves (updated analysis)
Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja (posodobljena analiza)
Children and adolescents This medicine is not for use in children and adolescents.
To zdravilo ni namenjeno za uporabo pri otrocih in mladostnikih.
Updated analysis
Posodobljena analiza
Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy.
Dodatni učinki na tumorsko mikrookolje, tudi na osteoblaste in osteoklaste, prav tako prispevajo k učinkovitosti in vivo.
The primary efficacy endpoint was overall survival.
Primarni opazovani dogodek je bilo celokupno preživetje.
These persons will take special care for the safe use of this product and will keep you informed of their actions.
Te osebe bodo ustrezno poskrbele za varno uporabo tega zdravila in vas obveščale o postopkih.
This product will only be handled and given to you by people who are trained and qualified to use it safely.
S tem zdravilom smejo rokovati in ga uporabljati samo osebe, ki so poučene in usposobljene za njegovo varno uporabo.
It is important to avoid dehydration by drinking plenty of fluids.
Pomembno je, da v izogib dehidraciji pijete veliko tekočine.
At 4 hours, about 4% of the injected activity remained in the blood, decreasing to less than 1% at 24 hours after the injection.
Po 4 urah je ostalo v krvi približno 4 % injicirane aktivnosti, ki se je 24 ur po injiciranju zmanjšala na manj kot 1 %.
At 10 minutes post injection, activity was observed in the bone and in the intestine.
10 minut po injiciranju so aktivnost opazili v kosteh in v črevesju.
• 42% of patients did not receive prior docetaxel because they were deemed ineligible or refused to receive docetaxel.
• 42 % bolnikov predhodno ni prejelo docetaksela, saj so bili obravnavani kot neprimerni ali pa so prejemanje docetaksela zavrnili,
Fractures have occurred for up to 24 months after the first dose of radium-223.
Zlomi kosti so se pojavili do 24 mesecev po prvem odmerku [223Ra]radija.
Subgroup survival analysis
Analiza preživetja v podskupini
The whole body measurements at 7 days after injection (after correcting for decay) indicate that a median of 76% of administered activity was excreted from the body.
Meritve po vsem telesu sedmi dan po injiciranju (po prilagoditvi razpada) kažejo, da se je v povprečju izločilo iz telesa 76 % uporabljene aktivnosti.
The protocol should foresee a stratified randomization of patients according to bone ALP levels.
Protokol mora predvideti stratificirano randomizacijo bolnikov glede na ravni ALP v kosteh.
Xofigo is only used when the disease has spread to the bone but is not known to have spread to other internal organs, and is causing symptoms (e.g. pain).
Zdravilo Xofigo se uporablja samo, kadar se je bolezen razširila v kosti, vendar ni znano, da bi se razširila v druge notranje organe, in povzroča simptome (npr. bolečino).
Patients should be advised to seek medical advice if they experience severe or persistent diarrhoea, nausea, vomiting.
Bolnikom je treba svetovati, da poiščejo medicinsko pomoč, če se pojavijo huda ali trdovratna driska, navzea, bruhanje.
• 87% of patients enrolled had an ECOG performance status score of 0-1.
• 87 % vključenih bolnikov je imelo status zmogljivosti po ECOG 0 - 1,
No dose adjustment is necessary if you are 65 years of age or older or if you have reduced kidney or liver function.
Odmerka ni treba prilagajati, če ste stari 65 let ali več, ali če vam ledvice in jetra slabo delujejo.
• 41% received bisphosphonates.
• 41 % je prejemalo difosfonate,
Oral intake and fluid status of patients should be carefully monitored.
Peroralni vnos in tekočinsko stanje pri bolnikih je treba skrbno spremljati.
The external radiation exposure associated with handling of patient doses is considerably lower in comparison to other radiopharmaceuticals for therapeutic purposes as the administered radioactivity will usually be below 8 MBq.
Izpostavljenost zunanjemu sevanju, povezana z rokovanjem z odmerki za bolnike, je znatno manjša kot pri drugih radiofarmakih za terapevtsko uporabo, saj je uporabljena radioaktivnost običajno pod 8 MBq.
However, in keeping with the ALARA (“As Low As Reasonably Achievable”) principle, for minimisation of radiation exposure, it is recommended to minimise the time spent in radiation areas, to maximise the distance to radiation sources, and to use adequate shielding.
Vendar pa se v skladu z načelom ALARA (»As Low As Reasonably Achievable« - »nizko, kolikor se razumno še lahko doseže«) za zmanjšanje izpostavljenosti sevanju, priporoča čim krajši čas zadrževanja v območju sevanja, čim večja razdalja od vira sevanja in uporaba ustrezne zaščite pred sevanjem.
Before starting treatment and before each subsequent dose your doctor will perform blood tests.
Pred začetkom zdravljenja in pred vsakim naslednjim odmerkom bo zdravnik opravil krvne preiskave.
This booklet was last revised in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano.
The amount of radioactivity in the dispensed volume shall be confirmed by measurement in a properly calibrated activimeter.
Radioaktivnost v uporabljenem volumnu raztopine je treba potrditi z meritvami v pravilno umerjenem merilcu aktivnosti.
Table 4: Calculated absorbed radiation doses to organs Target Organ
Preglednica 4: Izračunane absorbirane doze sevanja za organe
They are classified according to System Organ Class.
Razvrščeni so po organskih sistemih.
For details on the calculation of the volume to be administered see section 12.
Za podrobnosti o izračunu volumna, ki ga je treba uporabiti, glejte poglavje 12.
• 16% of patients had <6 bone metastases, 44% of patients had between 6 and 20 bone metastases,
• 16 % bolnikov je imelo < 6 metastaz v kosteh, 44 % bolnikov je imelo med 6 in 20 metastaz v kosteh,
This may be related to spatial distribution of alpha particle radiation resulting in non-uniform radiation dose to the red marrow.
To je morda povezano s prostorsko porazdelitvijo oddajanja delcev alfa, kar povzroči neenakomerne doze sevanja za rdeči kostni mozeg.
Distribution and organ uptake
Porazdelitev in privzem v organe
This medicine is stored under the responsibility of the specialist in appropriate premises.
Za shranjevanje tega zdravila so odgovorni strokovnjaki v ustrezni ustanovi.
The total volume to be administered to a patient is calculated as follows:
Skupni volumen raztopine za uporabo pri bolniku, se izračuna kot sledi:
The testes seemed to otherwise be functioning normally and the epididymides revealed a normal content of spermatocytes.
Delovanje mod je bilo sicer normalno in epididimis je imel normalno vsebnost spermatocitov.
Risk of dehydration: tell your doctor if you have any of the following symptoms: dizziness, increased thirst, decreased urination or dry skin as these can all be symptoms of dehydration.
Tveganje za dehidracijo: obvestite zdravnika, če imate katerega koli izmed naslednjih simptomov: omotica, povečan občutek žeje, zmanjšana količina izločenega seča, ali suha koža, ker so to vse lahko simptomi dehidracije.
Fifteen minutes post injection, about 20% of the injected activity remained in the blood.
Petnajst minut po injiciranju je ostalo v krvi 20 % injicirane aktivnosti.
Adverse reactions from clinical trials are classified according to their frequencies.
Neželeni učinki iz kliničnih preskušanj so razvrščeni po pogostnostih.
The absorbed radiation dose calculation was performed based on clinical biodistribution data.
Absorbirana doza sevanja je bila izračunana na podlagi kliničnih podatkov o biološki porazdelitvi.
Since humans do not have a tapetum lucidum, the clinical relevance of these findings for humans is uncertain.
Ker pri ljudeh ni odbojne plasti celic (tapetum lucidum), klinični pomen tega izsledka za ljudi ni znan.
Xofigo is administered as an intravenous injection and is thus 100% bioavailable.
Zdravilo Xofigo se uporablja v obliki intravenske injekcije in je zato biološka uporabnost 100 %.
During the treatment period, 83% of patients received luteinising hormone-releasing hormone (LHRH) agonists and 21% of patients received anti-androgens concomitantly.
V obdobju zdravljenja je 83 % bolnikov sočasno prejemalo agoniste luteinizirajoči hormon sproščajočega hormona (LHRH) in 21 % bolnikov antiandrogena zdravila.
Studies on reproductive and developmental toxicity have not been performed.
Študij toksičnosti za razmnoževanje in razvoj niso izvedli.
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Splošna opozorila Radiofarmake lahko sprejmejo, uporabijo in dajejo le pooblaščene osebe v določenih kliničnih ustanovah.
If you have any further questions on the use of Xofigo, please ask the doctor who supervises the procedure.
Če imate dodatna vprašanja o uporabi zdravila Xofigo, se prosimo posvetujte z zdravnikom, ki nadzoruje postopek uporabe.
Any unused product or waste materials should be disposed of in accordance with local regulations.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Any materials used in connection with the preparation or administration of Xofigo are to be treated as radioactive waste.
Material, uporabljen za pripravo ali uporabo zdravila Xofigo, obravnavajte kot radioaktivni odpadek.
In general, radionuclides induce reproductive and developmental effects.
Na splošno radionuklidi vplivajo na sposobnost razmnoževanja in razvoj.
• in combination with abiraterone and prednisone/prednisolone (which are used together to treat prostate cancer).
• v kombinaciji z abirateronom in prednizonom/prednizolonom (ki se uporabljajo skupaj za zdravljenje raka prostate).
In clinical studies, patients with fewer than 6 bone metastases had an increased risk of fractures and did not have a statistically significant survival benefit.
V kliničnih študijah so imeli bolniki z manj kot 6 metastazami v kosteh povečano tveganje za zlome kosti in niso imeli statistično značilnega izboljšanja preživetja.
• 46% of patients had no pain or WHO scale 1 (asymptomatic or mildly symptomatic) and 54% had pain WHO scale 2-3.
• 46 % bolnikov ni imelo bolečin ali je imelo bolečine stopnje 1 po lestvici SZO (asimptomatske ali blago simptomatske) in 54 % jih je imelo bolečine stopnje 2 - 3 po lestvici SZO,
Genotoxicity / Carcinogenicity
Genotoksičnost/kancerogenost
During treatment and for 2 years after starting treatment with Xofigo, your doctor will continuously monitor your bone health.
Med zdravljenjem in 2 leti po začetku zdravljenja z zdravilom Xofigo, bo zdravnik stalno spremljal stanje kosti.
Radium-223 is an alpha particle-emitter with a half-life of 11.4 days.
[223Ra]radij oddaja delce alfa z razpolovnim časom 11,4 dni.
Pharmacokinetic, biodistribution and dosimetry data have been obtained from 3 phase I studies.
Farmakokinetični podatki, podatki o biološki porazdelitvi in dozimetriji so bili pridobljeni iz treh študij I. faze.
Therefore in patients with a low level of osteoblastic bone metastases radium-223 is not recommended (see section 5.1).
Zato pri bolnikih z nizko stopnjo osteoblastnih metastaz v kosteh [223Ra]radij ni priporočljiv (glejte poglavje 5.1).
- If you plan to take other cancer therapy following treatment with Xofigo, you must wait at least 30 days before starting treatment.
- Če načrtujete vzeti drugo zdravilo za zdravljenje raka po zdravljenju z zdravilom Xofigo, morate pred začetkom zdravljenja počakati vsaj 30 dni.
Water for injections, sodium citrate, sodium chloride, hydrochloric acid.
Voda za injekcije, natrijev citrat, natrijev klorid, klorovodikova kislina.
No clinical interaction studies have been performed.
Kliničnih študij medsebojnega delovanja niso izvedli.
Since radium-223 distributes mainly to bone, the potential risk for adverse effects in the male gonads in cancer patients with castration-resistant prostate cancer is very low, but cannot be excluded (see section 4.6).
Ker se [223Ra]radij porazdeli predvsem po kosteh, je možno tveganje za neželene učinke v moških spolnih žlezah pri bolnikih z na kastracijo odpornim rakom prostate zelo majhno, vendar ga ni mogoče izključiti (glejte poglavje 4.6).
- The other ingredients are: water for injections, sodium citrate, sodium chloride and hydrochloric acid (see end of Section 2 for further information on sodium).
- Druge sestavine zdravila so: voda za injekcije, natrijev citrat, natrijev klorid in klorovodikova kislina (glejte zadnji odstavek poglavja 2 za več informacij glede natrija).
Crohn's disease and ulcerative colitis
Crohnova bolezen in ulcerozni kolitis
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.
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.
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.
Increased fracture risk has been found especially in patients with medical history of osteoporosis and in patients with less than 6 bone metastases.
Povečano tveganje za zlome so ugotovili zlasti pri bolnikih z anamnezo osteoporoze in pri bolnikih z manj kot 6 metastazami v kosteh.
Symptomatic skeletal event (SSE)
Simptomatski dogodki na kosteh (SSE)
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).
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).
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.
Natančen mehanizem odstopa mrežnice ni znan, vendar podatki iz literature kažejo na specifičen privzem radija v odbojno plast
- If you have any further questions, ask your doctor who will supervise the procedure.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, ki bo nadzoroval postopek uporabe zdravila.
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.
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.
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.
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.
The specific activity of radium-223 is 1.9 MBq/ng.
Specifična aktivnost [223Ra]radija je 1,9 MBq/ng.
The overall safety profile of Xofigo is based on data from 600 patients treated with Xofigo in the phase III study.
Splošni varnostni profil zdravila Xofigo temelji na podatkih zbranih v študiji III. faze pri 600 bolnikih, zdravljenih z zdravilom Xofigo.
- Decay correction (DK) factor to correct for physical decay of radium-223.
- koeficient razpada (DK - decay correction) za popravek fizikalnega razpada [223Ra]radija.
- Xofigo is not recommended if cancer in your bones is not causing symptoms, such as pain.
- Zdravilo Xofigo ni priporočljivo, če vam rak v kosteh ne povzroča simptomov, kot je bolečina.
Based on studies in animals, there is a potential risk that radiation from Xofigo could cause adverse effects on fertility (see section 5.3).
Na podlagi študij na živalih obstaja tveganje, da bi sevanje zdravila Xofigo lahko povzročilo neželene učinke na plodnost (glejte poglavje 5.3).
Volume to be administered (mL)
volumen raztopine za aplikacijo (ml)
A table of DK factors is provided with each vial as part of the booklet (preceding the package leaflet).
Preglednica koeficientov razpada je priložena k vsaki viali kot del knjižice (pred navodilom za uporabo).
The doctor supervising the procedure will calculate the quantity of Xofigo to be used in your case.
Zdravnik, ki vas bo med postopkom nadzoroval, bo izračunal količino zdravila Xofigo, ki jo boste prejeli.
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).
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).
The reference date is stated on the vial and lead pot label.
Referenčni dan je naveden na viali in nalepki svinčenega vsebnika.
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).
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).
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.
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.
No differences in haematological laboratory values were apparent between the two groups.
Med obema skupinama ni bilo očitnih razlik v izvidih hematoloških laboratorijskih preiskav.