FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefits of Samsca have been shown in studies?
Slovenian: Kakšne koristi zdravila Samsca so se pokazale v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Samsca have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Samsca upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: An overview of Samsca and why it is authorised in the EU
Slovenian: Pregled zdravila Samsca in zakaj je odobreno v EU
English: Treatment with Samsca should be started in hospital so that healthcare professionals can determine the most appropriate dose and monitor the patient's level of blood sodium and blood volume.
Slovenian: Zdravljenje z zdravilom Samsca je treba začeti v bolnišnici, tako da lahko zdravstveni delavci določijo najustreznejši odmerek ter spremljajo raven natrija v bolnikovi krvi in krvni volumen.
English: Why is Samsca authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Samsca odobreno v EU?
English: Side effects reported with Samsca are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Samsca, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Samsca must also not be used in women who are pregnant or breast-feeding.
Slovenian: Prav tako zdravila Samsca ne smejo uporabljati ženske, ki so noseče ali dojijo.
English: For more information about using Samsca, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Samsca glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Samsca?
Slovenian: Kakšna tveganja so povezana z zdravilom Samsca?
English: Samsca received a marketing authorisation valid throughout the European Union on 3 August
Slovenian: Za zdravilo Samsca je bilo 3. avgusta 2009 izdano dovoljenje za promet, veljavno po vsej EU.
English: The active substance in Samsca, tolvaptan, is a ‘vasopressin-2 receptor antagonist'.
Slovenian: Učinkovina v zdravilu Samsca, tolvaptan, je „antagonist receptorja za vazopresin tipa 2“.
English: The most common side effects with Samsca (which may affect more than 1 patient in 10) are thirst, nausea (feeling sick) and sodium levels rising too quickly.
Slovenian: Najpogostejši neželeni učinki zdravila Samsca (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so žeja, navzea (siljenje na bruhanje) in prehitro zvišanje ravni natrija.
English: What is Samsca and what is it used for?
Slovenian: Kaj je zdravilo Samsca in za kaj se uporablja?
English: Samsca is a medicine for treating abnormally low levels of sodium in the blood in adults with a condition called ‘syndrome of inappropriate antidiuretic hormone secretion' (SIADH).
Slovenian: Samsca je zdravilo, ki se uporablja za zdravljenje nenormalno nizkih ravni natrija v krvi pri odraslih z boleznijo, imenovano „sindrom neustreznega izločanja antidiuretičnega hormona“ (SIADH).
English: Samsca must not be used in patients with anuria (an inability to pass urine), very low blood volume, low blood sodium levels with low blood volume, hypernatremia (abnormally high levels of sodium in the blood) or in patients who cannot perceive thirst.
Slovenian: Zdravilo Samsca se ne sme uporabljati pri bolnikih z anurijo (nezmožnostjo odvajanja urina), zelo majhnim krvnim volumnom, nizko ravnijo natrija v krvi pri majhnem krvnem volumnu, hipernatriemijo (nenormalno visoko ravnijo natrija v krvi) in pri bolnikih, ki ne zaznavajo žeje.
English: Samsca has been shown to be effective at increasing sodium levels, particularly in patients with SIADH.
Slovenian: Zdravilo Samsca se je pokazalo kot učinkovito pri zviševanju ravni natrija, zlasti pri bolnikih s SIADH.
English: This increases urine production, decreasing the amount of water in the blood and increasing the blood sodium level.
Slovenian: To poveča tvorbo urina, zaradi česar se zmanjša količina vode v krvi in poveča raven natrija v krvi.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Samsca contains the active substance tolvaptan.
Slovenian: Zdravilo Samsca vsebuje učinkovino tolvaptan.
English: For the full list of side effects reported with Samsca, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Samsca, glejte navodilo za uporabo.
English: This medicine must therefore not be used in women who are pregnant or breastfeeding.
Slovenian: Nosečnice ali ženske, ki dojijo, tega zdravila torej ne smejo jemati.
English: People with SIADH have an excessive amount of vasopressin, leading to decreased urine production and dilution of the blood.
Slovenian: Bolniki s SIADH imajo čezmerno količino vazopresina, kar vodi v zmanjšano tvorbo urina in redčenje krvi.
English: How is Samsca used?
Slovenian: Kako se zdravilo Samsca uporablja?
English: How does Samsca work?
Slovenian: Kako zdravilo Samsca deluje?
English: 28 days.
Slovenian: 28 dni
English: Date of first authorisation: 13 November 2013 Date of latest renewal: 21 June 2018
Slovenian: Datum prve odobritve: 13. november 2013 Datum zadnjega podaljšanja: 21. junij 2018
English: Please ask your doctor how this may affect you, especially if you are planning to have children in the future.
Slovenian: Posvetujte se z zdravnikom, kako lahko to vpliva na vas, še zlasti, če v prihodnosti načrtujete imeti otroke.
English: It will only be used in special controlled areas.
Slovenian: Uporablja se lahko samo v posebnih nadzorovanih prostorih.
English: • the mean age of patients was 70 years (range 49 to 90 years).
Slovenian: • povprečna starost bolnikov je bila 70 let (razpon od 49 do 90 let),
English: Drammensveien 288 NO-0283 Oslo Norway
Slovenian: Drammensveien 288 NO-0283 Oslo Norveška
English: As the updated analysis is provided for descriptive purposes only, a p-value is not provided.
Slovenian: Ker je posodobljena analiza navedena samo zaradi opisa, vrednost p ni navedena.
English: 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.
Slovenian: Glede na izvide teh preiskav bo zdravnik odločil, če se lahko zdravljenje začne, nadaljuje ali pa ga je treba odložiti ali prekiniti.
English: It must be administered by slow injection (generally up to 1 minute).
Slovenian: Zdravilo se injicira počasi (običajno do 1 minute).
English: The volume of distribution was higher than the blood volume indicating distribution to peripheral compartments.
Slovenian: Volumen porazdelitve je bil večji kot volumen krvi, kar kaže na porazdelitev v periferne prostore.
English: For additional instructions on the use of the medicinal product, see sections 6.6 and 12.
Slovenian: Za dodatna navodila o uporabi zdravila glejte poglavji 6.6 in 12.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.
Slovenian: Sprejem, shranjevanje, uporabo, prenos in odstranjevanje radiofarmakov urejajo predpisi in/ali ustrezna dovoljenja pristojnih uradnih organov.
English: The dose you receive depends on your body weight.
Slovenian: Odmerek, ki ga boste prejeli, je odvisen od vaše telesne mase.
English: The study was unblinded early based on an Independent Data Monitoring Committee Recommendation.
Slovenian: Podatki študije so bili na priporočilo neodvisnega odbora za spremljanje podatkov (Independent Data Monitoring Committee Recommendation) razkriti predčasno.
English: Coefficient of variation
Slovenian: Koeficient variacije
English: The doctor will tell you if you need to take any special precautions after receiving this medicine.
Slovenian: Zdravnik vas bo obvestil, če bodo potrebni posebni previdnostni ukrepi po prejemu tega zdravila.
English: Both groups experience a loss of quality of life.
Slovenian: V obeh skupinah se je kakovost življenja poslabšala.
English: The following information is intended for the specialist only:
Slovenian: Naslednje informacije so namenjene samo zdravnikom specialistom:
English: Patients who display signs or symptoms of dehydration or hypovolemia should be promptly treated.
Slovenian: Bolnike, pri katerih se kažejo znaki ali simptomi dehidracije ali hipovolemije, je treba takoj zdraviti.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti so opredeljene kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100).
English: In general, radionuclides are considered to be genotoxic and carcinogenic.
Slovenian: Na splošno velja, da so radionuklidi genotoksični in kancerogeni.
English: Figure 2: Kaplan-Meier overall survival curves (updated analysis)
Slovenian: Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja (posodobljena analiza)
English: Children and adolescents This medicine is not for use in children and adolescents.
Slovenian: To zdravilo ni namenjeno za uporabo pri otrocih in mladostnikih.
English: Updated analysis
Slovenian: Posodobljena analiza
English: Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy.
Slovenian: Dodatni učinki na tumorsko mikrookolje, tudi na osteoblaste in osteoklaste, prav tako prispevajo k učinkovitosti in vivo.
English: The primary efficacy endpoint was overall survival.
Slovenian: Primarni opazovani dogodek je bilo celokupno preživetje.
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Slovenian: Te osebe bodo ustrezno poskrbele za varno uporabo tega zdravila in vas obveščale o postopkih.
English: This product will only be handled and given to you by people who are trained and qualified to use it safely.
Slovenian: S tem zdravilom smejo rokovati in ga uporabljati samo osebe, ki so poučene in usposobljene za njegovo varno uporabo.
English: It is important to avoid dehydration by drinking plenty of fluids.
Slovenian: Pomembno je, da v izogib dehidraciji pijete veliko tekočine.
English: At 4 hours, about 4% of the injected activity remained in the blood, decreasing to less than 1% at 24 hours after the injection.
Slovenian: Po 4 urah je ostalo v krvi približno 4 % injicirane aktivnosti, ki se je 24 ur po injiciranju zmanjšala na manj kot 1 %.
English: At 10 minutes post injection, activity was observed in the bone and in the intestine.
Slovenian: 10 minut po injiciranju so aktivnost opazili v kosteh in v črevesju.
English: • 42% of patients did not receive prior docetaxel because they were deemed ineligible or refused to receive docetaxel.
Slovenian: • 42 % bolnikov predhodno ni prejelo docetaksela, saj so bili obravnavani kot neprimerni ali pa so prejemanje docetaksela zavrnili,
English: Fractures have occurred for up to 24 months after the first dose of radium-223.
Slovenian: Zlomi kosti so se pojavili do 24 mesecev po prvem odmerku [223Ra]radija.
English: Subgroup survival analysis
Slovenian: Analiza preživetja v podskupini
English: 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.
Slovenian: Meritve po vsem telesu sedmi dan po injiciranju (po prilagoditvi razpada) kažejo, da se je v povprečju izločilo iz telesa 76 % uporabljene aktivnosti.
English: The protocol should foresee a stratified randomization of patients according to bone ALP levels.
Slovenian: Protokol mora predvideti stratificirano randomizacijo bolnikov glede na ravni ALP v kosteh.
English: 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).
Slovenian: 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).
English: Patients should be advised to seek medical advice if they experience severe or persistent diarrhoea, nausea, vomiting.
Slovenian: Bolnikom je treba svetovati, da poiščejo medicinsko pomoč, če se pojavijo huda ali trdovratna driska, navzea, bruhanje.
English: • 87% of patients enrolled had an ECOG performance status score of 0-1.
Slovenian: • 87 % vključenih bolnikov je imelo status zmogljivosti po ECOG 0 - 1,
English: No dose adjustment is necessary if you are 65 years of age or older or if you have reduced kidney or liver function.
Slovenian: Odmerka ni treba prilagajati, če ste stari 65 let ali več, ali če vam ledvice in jetra slabo delujejo.
English: • 41% received bisphosphonates.
Slovenian: • 41 % je prejemalo difosfonate,
English: Oral intake and fluid status of patients should be carefully monitored.
Slovenian: Peroralni vnos in tekočinsko stanje pri bolnikih je treba skrbno spremljati.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Before starting treatment and before each subsequent dose your doctor will perform blood tests.
Slovenian: Pred začetkom zdravljenja in pred vsakim naslednjim odmerkom bo zdravnik opravil krvne preiskave.
English: This booklet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano.
English: The amount of radioactivity in the dispensed volume shall be confirmed by measurement in a properly calibrated activimeter.
Slovenian: Radioaktivnost v uporabljenem volumnu raztopine je treba potrditi z meritvami v pravilno umerjenem merilcu aktivnosti.
English: Table 4: Calculated absorbed radiation doses to organs Target Organ
Slovenian: Preglednica 4: Izračunane absorbirane doze sevanja za organe
English: They are classified according to System Organ Class.
Slovenian: Razvrščeni so po organskih sistemih.
English: For details on the calculation of the volume to be administered see section 12.
Slovenian: Za podrobnosti o izračunu volumna, ki ga je treba uporabiti, glejte poglavje 12.
English: • 16% of patients had <6 bone metastases, 44% of patients had between 6 and 20 bone metastases,
Slovenian: • 16 % bolnikov je imelo < 6 metastaz v kosteh, 44 % bolnikov je imelo med 6 in 20 metastaz v kosteh,
English: This may be related to spatial distribution of alpha particle radiation resulting in non-uniform radiation dose to the red marrow.
Slovenian: To je morda povezano s prostorsko porazdelitvijo oddajanja delcev alfa, kar povzroči neenakomerne doze sevanja za rdeči kostni mozeg.
English: Distribution and organ uptake
Slovenian: Porazdelitev in privzem v organe
English: This medicine is stored under the responsibility of the specialist in appropriate premises.
Slovenian: Za shranjevanje tega zdravila so odgovorni strokovnjaki v ustrezni ustanovi.
English: The total volume to be administered to a patient is calculated as follows:
Slovenian: Skupni volumen raztopine za uporabo pri bolniku, se izračuna kot sledi:
English: The testes seemed to otherwise be functioning normally and the epididymides revealed a normal content of spermatocytes.
Slovenian: Delovanje mod je bilo sicer normalno in epididimis je imel normalno vsebnost spermatocitov.
English: 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.
Slovenian: 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.
English: Fifteen minutes post injection, about 20% of the injected activity remained in the blood.
Slovenian: Petnajst minut po injiciranju je ostalo v krvi 20 % injicirane aktivnosti.
English: Adverse reactions from clinical trials are classified according to their frequencies.
Slovenian: Neželeni učinki iz kliničnih preskušanj so razvrščeni po pogostnostih.
English: Secondary malignant neoplasms
Slovenian: Sekundarne maligne neoplazme
English: The absorbed radiation dose calculation was performed based on clinical biodistribution data.
Slovenian: Absorbirana doza sevanja je bila izračunana na podlagi kliničnih podatkov o biološki porazdelitvi.
English: Since humans do not have a tapetum lucidum, the clinical relevance of these findings for humans is uncertain.
Slovenian: Ker pri ljudeh ni odbojne plasti celic (tapetum lucidum), klinični pomen tega izsledka za ljudi ni znan.
English: Xofigo is administered as an intravenous injection and is thus 100% bioavailable.
Slovenian: Zdravilo Xofigo se uporablja v obliki intravenske injekcije in je zato biološka uporabnost 100 %.
English: During the treatment period, 83% of patients received luteinising hormone-releasing hormone (LHRH) agonists and 21% of patients received anti-androgens concomitantly.
Slovenian: V obdobju zdravljenja je 83 % bolnikov sočasno prejemalo agoniste luteinizirajoči hormon sproščajočega hormona (LHRH) in 21 % bolnikov antiandrogena zdravila.
English: Studies on reproductive and developmental toxicity have not been performed.
Slovenian: Študij toksičnosti za razmnoževanje in razvoj niso izvedli.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Slovenian: Splošna opozorila Radiofarmake lahko sprejmejo, uporabijo in dajejo le pooblaščene osebe v določenih kliničnih ustanovah.
English: If you have any further questions on the use of Xofigo, please ask the doctor who supervises the procedure.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila Xofigo, se prosimo posvetujte z zdravnikom, ki nadzoruje postopek uporabe.
English: Any unused product or waste materials should be disposed of in accordance with local regulations.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Any materials used in connection with the preparation or administration of Xofigo are to be treated as radioactive waste.
Slovenian: Material, uporabljen za pripravo ali uporabo zdravila Xofigo, obravnavajte kot radioaktivni odpadek.
English: In general, radionuclides induce reproductive and developmental effects.
Slovenian: Na splošno radionuklidi vplivajo na sposobnost razmnoževanja in razvoj.
English: • in combination with abiraterone and prednisone/prednisolone (which are used together to treat prostate cancer).
Slovenian: • v kombinaciji z abirateronom in prednizonom/prednizolonom (ki se uporabljajo skupaj za zdravljenje raka prostate).
English: 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.
Slovenian: 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.
English: • 46% of patients had no pain or WHO scale 1 (asymptomatic or mildly symptomatic) and 54% had pain WHO scale 2-3.
Slovenian: • 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,
English: Genotoxicity / Carcinogenicity
Slovenian: Genotoksičnost/kancerogenost
English: During treatment and for 2 years after starting treatment with Xofigo, your doctor will continuously monitor your bone health.
Slovenian: Med zdravljenjem in 2 leti po začetku zdravljenja z zdravilom Xofigo, bo zdravnik stalno spremljal stanje kosti.
English: Radium-223 is an alpha particle-emitter with a half-life of 11.4 days.
Slovenian: [223Ra]radij oddaja delce alfa z razpolovnim časom 11,4 dni.
English: Pharmacokinetic, biodistribution and dosimetry data have been obtained from 3 phase I studies.
Slovenian: Farmakokinetični podatki, podatki o biološki porazdelitvi in dozimetriji so bili pridobljeni iz treh študij I. faze.
English: Therefore in patients with a low level of osteoblastic bone metastases radium-223 is not recommended (see section 5.1).
Slovenian: Zato pri bolnikih z nizko stopnjo osteoblastnih metastaz v kosteh [223Ra]radij ni priporočljiv (glejte poglavje 5.1).
English: - If you plan to take other cancer therapy following treatment with Xofigo, you must wait at least 30 days before starting treatment.
Slovenian: - Če načrtujete vzeti drugo zdravilo za zdravljenje raka po zdravljenju z zdravilom Xofigo, morate pred začetkom zdravljenja počakati vsaj 30 dni.
English: Water for injections, sodium citrate, sodium chloride, hydrochloric acid.
Slovenian: Voda za injekcije, natrijev citrat, natrijev klorid, klorovodikova kislina.
English: No clinical interaction studies have been performed.
Slovenian: Kliničnih študij medsebojnega delovanja niso izvedli.
English: 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).
Slovenian: 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).