natgillin/translations-raw huggingface dataset:
The full EPAR for Zejula can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zejula je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Patients had undergone treatment with two or more platinum-based therapies, with a lasting response (the cancer had not progressed for at least 6 months) before the last platinum-based therapy.
Bolnice so se pred zadnjim zdravljenjem na osnovi platine zdravile z enim ali dvema zdravljenjema na osnovi platine, pri čemer je bil odziv dolgotrajen (rak vsaj šest mesecev ni napredoval).
For practical information about using Zejula, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Zejula naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Zejula is used on its own for the ‘maintenance' treatment of patients who have relapsed disease (when the cancer comes back after previous treatment).
Zdravilo Zejula se uporablja samostojno za vzdrževalno zdravljenje bolnic z relapsom bolezni (ponovnim pojavom raka po predhodnem zdravljenju).
For the full list of all side effects reported with Zejula, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zejula, glejte navodilo za uporabo.
Zejula contains the active substance niraparib.
Zdravilo vsebuje zdravilno učinkovino niraparib.
How is Zejula used?
Kako se zdravilo Zejula uporablja?
How does Zejula work?
Kako zdravilo Zejula deluje?
Zejula has been shown to prolong the time before the disease gets worse again in patients who have responded to platinum-based therapies.
Dokazali so, da zdravilo Zejula pri bolnicah, ki so se odzvale na zdravljenje na osnovi platine, podaljša čas do poslabšanja bolezni.
Zejula has been shown to increase the time patients lived without their disease getting worse in one main study involving 553 patients.
V glavni študiji, ki je vključevala 553 bolnic, so dokazali, da zdravilo Zejula podaljša čas brez poslabšanja bolezni.
Treatment may be interrupted and the dose may be reduced in patients who experience side effects.
Pri bolnicah, ki imajo neželene učinke, se zdravljenje lahko prekine ali odmerek zmanjša.
Date of first authorisation: 19 July 2006 Date of latest renewal: 9 November 2016
Datum prve odobritve: 19. julij 2006 Datum zadnjega podaljšanja: 9. november 2016
You may require medical attention.
Morda boste potrebovali zdravniško oskrbo.
Long-term safety in MRCC
Dolgoročna varnost pri MRCC
e Median not achieved because the data were not yet mature.
e Mediana ni bila dosežena, ker podatki še niso bili popolni.
The median DR and OS had not yet been reached.
Mediani DR in OS še nista doseženi.
Patients were treated until disease progression or withdrawal from the study.
Bolnike so zdravili dokler bolezen ni napredovala ali do umika iz študije.
- If you are going to have surgery or if you had an operation recently.
- Če boste imeli kirurški poseg ali če ste pred kratkim imeli operacijo.
The primary active metabolite comprises 23% to 37% of the total exposure.
Primarni aktivni presnovek predstavlja od 23 % do 37 % celotne izpostavljenosti.
Most of these findings were reversible after 2 to 6 weeks without treatment.
Večina teh najdb je bila po 2 do 6 tednih brez zdravljenja reverzibilna.
Do not take Sutent:
Ne jemljite zdravila Sutent:
Invasive dental procedures are also an identified risk factor.
Invazivni zobozdravstveni posegi so prav tako znani dejavnik tveganja.
The study was closed at the time of planned interim analysis due to the lack of disease control.
Študijo so v času načrtovane vmesne analize zaključili zaradi pomanjkanja nadzora nad boleznijo.
What Sutent is and what it is used for
Kaj je zdravilo Sutent in za kaj ga uporabljamo
Daily dose should not exceed 75 mg nor be decreased below 25 mg.
Dnevni odmerek ne sme preseči 75 mg in ne sme biti manjši od 25 mg.
Fisher's Exact test
Fisherjev eksaktni test
OS (weeks)
OS (tedni)
• Abnormally decreased/increased sensitivity, particularly to touch.
• nenormalno zmanjšanje/povečanje občutljivosti, zlasti na dotik
Sutent with food and drink
Zdravilo Sutent skupaj s hrano in pijačo
No significant differences in safety or efficacy were observed between younger and older patients.
Med starejšimi in mlajšimi bolniki niso opazili pomembnih razlik v varnosti in učinkovitosti.
- If you have high blood pressure.
- Če imate visok krvni tlak.
• Pain in arms and legs.
• bolečine v rokah in nogah
• Decreased blood sugar level (see section 2)..
• znižana raven sladkorja v krvi (glejte poglavje 2)
Your doctor will determine the appropriate dose you need to take, as well as if and when you need to stop treatment with Sutent.
Zdravnik bo določil ustrezen odmerek, ki ga morate vzeti, pa tudi če in kdaj boste morali prekiniti zdravljenje z zdravilom Sutent.
• Changes in the electrical activity or abnormal rhythm of the heart.
• spremembe v električni aktivnosti ali nenormalen ritem srca
Approximately one-third of the patients in clinical studies who received sunitinib were 65 years of age or over.
Približno ena tretjina bolnikov v kliničnih študijah, ki so prejemali sunitinib, je bilo starih 65 let ali več.
In both the clinical study and the publications, the safety profile was consistent with the known safety profile in adults.
Tako v klinični študiji kot tudi objavah se je varnostni profil ujemal s poznanim varnostnim profilom pri odraslih.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Znotraj posamezne razvrstitve pogostnosti so neželeni učinki navedeni po padajoči resnosti.
The primary efficacy endpoint of this study was ORR.
Primarni opazovani dogodek učinkovitosti v tej študiji je bil ORR.
Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Pogostnosti so opredeljene na naslednji način: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Sutent is not recommended for people aged under 18.
Uporaba zdravila Sutent ni priporočljiva za osebe, mlajše od 18 let.
Your doctor will decide when to start Sutent again.
Zdravnik bo odločil, kdaj ponovno pričeti z jemanjem zdravila Sutent.
These data suggest that sunitinib increases the risk of cardiomyopathy.
Ti podatki nakazujejo, da sunitinib povečuje tveganje za kardiomiopatijo.
Some medicines can affect the levels of Sutent in your body.
Nekatera zdravila lahko vplivajo na raven zdravila Sutent v vašem telesu.
If the diagnosis of SJS or TEN is confirmed, treatment must not be restarted.
Če je diagnoza SJS ali TEN potrjena, se zdravljenja ne sme ponovno uvesti.
If you forget to take Sutent
Če ste pozabili vzeti zdravilo Sutent
Sutent can raise blood pressure.
Zdravilo Sutent lahko zviša krvni tlak.
Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.
Bisfosfonati so zdravila za preprečevanje kostnih zapletov, ki jih lahko prejemate za drugo bolezensko stanje.
• Abnormal sensations in extremities.
• nenormalni občutki v okončinah
Use of somatostatin analogues was allowed in the study.
V študiji je bila dovoljena uporaba analogov somatostatina.
Food has no effect on the bioavailability of sunitinib.
Hrana ne vpliva na biološko uporabnost sunitiniba.
Total oral clearance (CL/F) was 34-62 L/h.
Celotni peroralni očistek (CL/F) je bil 34-62 l/uro.
• Extreme tiredness, loss of strength.
• huda utrujenost, izguba moči
Paediatric population The safety and efficacy of Sutent in patients below 18 years of age have not been established.
Pediatrična populacija Varnost in učinkovitost zdravila Sutent pri bolnikih, mlajših od 18 let, nista bili dokazani.
These may be symptoms of heart problems that may include heart failure and heart muscle problems (cardiomyopathy).
To so lahko simptomi težav s srcem, ki lahko vključujejo srčno popuščanje in težave s srčno mišico (kardiomiopatija).
The PK were similar in all solid tumours populations tested and in healthy volunteers.
FK je bila pri vseh testiranih populacijah s čvrstimi tumorji in pri zdravih prostovoljcih podobna.
Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be treated.
Zdravnik vam bo predpisal odmerek, ki je za vas primeren, v odvisnosti od vrste rakavega obolenja, ki ga je treba zdraviti.
You must immediately contact your doctor if you experience any of those serious side effects (see also What you need to know before you take Sutent):
Nemudoma obvestite zdravnika, če opazite katerega od naslednjih resnih neželenih učinkov (glejte tudi poglavje Kaj morate vedeti, preden boste vzeli zdravilo Sutent):
The safety of continued sunitinib treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Varnosti nadaljnjega zdravljenja s sunitinibom pri bolnikih z zmerno do hudo proteinurijo niso sistematično ovrednotili.
The genotoxic potential of sunitinib was assessed in vitro and in vivo.
Genotoksični potencial sunitiniba so ocenili in vitro in in vivo.
• Swelling caused by fluid under the skin and around the eye, deep allergic rash.
• otekanje, ki ga povzroča tekočina pod kožo in okoli oči, globok alergijski izpuščaj
(not exceeding the total dose of 50 mg/day).
(odmerki niso presegli celokupnega odmerka 50 mg/dan).
It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.
Uporablja se za zdravljenje raka, deluje pa tako, da zavira aktivnost posebne skupine beljakovin, ki sodelujejo pri rasti in razširjanju rakavih celic.
These patients should be monitored closely and treated as clinically indicated, and prophylactic hydration should be considered.
Te bolnike je treba skrbno spremljati in obravnavati, kot je klinično indicirano, ter razmisliti o profilaktični hidraciji.
Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Opisali so primere proteinurije in redke primere nefrotskega sindroma.
The analyses of primary and secondary endpoints in the open-label phase of the study reaffirmed the results obtained at the time of the interim analysis, as shown in Table 2:
Analize primarnih in sekundarnih opazovanih dogodkov v fazi odprte študije so potrdile rezultate, pridobljene v času vmesne analize, kot je prikazano v spodnji Preglednici 2:
- If you are allergic to sunitinib or any of the other ingredients of Sutent (listed in section 6).
- če ste alergični na sunitinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Table 4 - pNET efficacy results from the Phase 3 study Efficacy parameter
Preglednica 4 - Rezultati učinkovitosti pri pNET v študiji 3. faze Parameter učinkovitosti
What you need to know before you take Sutent
Kaj morate vedeti, preden boste vzeli zdravilo Sutent
The primary efficacy endpoint of the study was TTP, defined as the time from randomisation to first documentation of objective tumour progression.
Primarni opazovani dogodek učinkovitosti v tej študiji je bil TTP, opredeljen kot čas od randomizacije do prvega dokumentiranega objektivnega napredovanja tumorja.
No patients had a QTc interval > 500 msec.
Noben bolnik ni imel vrednosti intervala QTc > 500 milisekund.
- Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
- Ne uporabljajte tega zdravila, če opazite, da je pakiranje poškodovano ali kaže znake, da ga je že kdo odpiral.
There were no Grade 5 adverse reactions in either group.
V nobeni skupini ni bilo neželenih učinkov 5. stopnje.
- If you have heart problems.
- Če imate težave s srcem.
• Loss of protein in the urine sometime resulting in swelling.
• izguba beljakovin z urinom, ki včasih povzroči otekanje
Median PFS was 2.3 months in the HGG group and 2.7 months in the ependymoma group.
Mediano PFS je bilo 2,3 meseca v skupini s HGG in 2,7 meseca v skupini z ependimomom.
Treatment with Sutent may lead to a higher risk of bleeding or lead to changes in the number of certain cells in the blood which may lead to anaemia or affect the ability of your blood to clot.
Zdravljenje z zdravilom Sutent lahko povzroči večje tveganje za krvavitve ali privede do sprememb v številu določenih celic v krvi, kar lahko privede do slabokrvnosti ali vpliva na sposobnost strjevanja vaše krvi.
Other side effects with Sutent may include:
Drugi neželeni učinki med zdravljenjem z zdravilom Sutent lahko vključujejo:
Other medicines and Sutent
Druga zdravila in zdravilo Sutent
Before initiating sunitinib, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred začetkom zdravljenja s sunitinibom je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot so hipertenzija ali anamneza anevrizme.
Your doctor should do blood tests to check your liver function before and during treatment with Sutent, and as clinically indicated.
Zdravnik mora narediti krvne teste, da preveri delovanje vaših jeter pred in med zdravljenjem z zdravilom Sutent in kot je klinično indicirano.
Available data indicate that females could have about 30% lower apparent clearance (CL/F) of sunitinib than males: this difference, however, does not necessitate starting dose adjustments.
Razpoložljivi podatki kažejo, da imajo ženske lahko za približno 30 % manjši navidezni očistek (CL/F) kot moški; ta razlika pa ne zahteva prilagajanja odmerka.
The overall PFS and OS, observed in the ITT population, as determined by the core radiology laboratory assessment, are summarised in Table 3.
Skupni podatki o PFS in OS pri populaciji ITT, ugotovljeni pri centralnem ocenjevanju radioloških izvidov, so povzeti v Preglednici 3:
The apparent volume of distribution (Vd) for sunitinib was large, 2230 L, indicating distribution into the tissues.
Navidezni volumen porazdelitve (Vd) za sunitinib je bil velik - 2.230 l - kar kaže, da se sunitinib porazdeli v tkiva.
Lung or breathing problems.
Težave s pljuči ali dihanjem.
If you are taking warfarin or acenocoumarole, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
Če jemljete varfarin ali acenokumarol, zdravila za redčenje krvi za preprečevanje nastajanja krvnih strdkov, lahko obstaja večje tveganje za krvavitev.
• Fluid retention including around the lungs.
• zastajanje tekočine, vključno okrog pljuč
These LVEF declines do not appear to have been progressive and often improved as treatment continued.
Zmanjšanja LVEF niso napredovala in so se med nadaljevanjem zdravljenja pogosto izboljšala.
Minor metabolites were identified in urine and faeces, but generally were not found in plasma.
V urinu in blatu so odkrili nekaj manj pomembnih presnovkov, ki pa jih na splošno ni bilo mogoče najti v plazmi.
If you have accidentally taken too many capsules, talk to your doctor straight away.
Če ste pomotoma vzeli preveč kapsul, se nemudoma posvetujte z zdravnikom.
Patients with pre-existing hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of sunitinib treatment.
Bolnike z obstoječim hipotiroidizmom ali hipertiroidizmom je treba zdraviti v skladu z običajno medicinsko prakso še pred začetkom zdravljenja s sunitinibom.
Overall, 7% of the MRCC population had either clinical or laboratory evidence of treatment-emergent hypothyroidism.
V celoti je imelo 7 % populacije z MRCC bodisi klinične bodisi laboratorijske znake hipotiroidizma zaradi zdravljenja.
Sutent has minor influence on the ability to drive and use machines.
Zdravilo Sutent ima blag vpliv na sposobnost vožnje in upravljanja strojev.
There is no specific antidote for overdose with Sutent and treatment of overdose should consist of general supportive measures.
Specifičnega antidota za preveliko odmerjanje zdravila Sutent ni. Zdravljenje prevelikega odmerjanja mora obsegati splošne podporne ukrepe.
The PK of sunitinib were evaluated in 135 healthy volunteers and 266 patients with solid tumours.
FK sunitiniba so ocenili pri 135 zdravih prostovoljcih in 266 bolnikih s čvrstimi tumorji.
Prior to treatment with Sutent, a dental examination and appropriate preventive dentistry should be considered.
Pred začetkom zdravljenja z zdravilom Sutent je treba razmisliti o pregledu zobovja in ustreznih preventivnih zobozdravstvenih posegih.
The maximum dose administered in the Phase 3 pNET study was 50 mg daily.
Največji odmerek, ki so ga uporabili v študiji 3. faze pri pNET, je znašal 50 mg na dan.
QT interval prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de pointes.
Podaljšanje intervala QT lahko zveča tveganje za ventrikularne aritmije, vključno s Torsade de pointes.
The use of vascular endothelial growth factor (VEGF) pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Uporaba zaviralcev poti žilnega endotelijskega rastnega faktorja (VEGF) pri bolnikih s hipertenzijo ali brez nje lahko spodbudi nastanek anevrizem in/ali disekcij arterij.
There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention.
Na voljo so le omejene klinične izkušnje glede časa ponovnega začetka zdravljenja po večjem kirurškem posegu.
Sutent is not approved for use in patients with lung cancer.
Zdravilo Sutent ni odobreno za uporabo pri bolnikih s pljučnim rakom.
These symptoms may diminish as treatment continues.
Ti simptomi se lahko izboljšajo ob nadaljevanju zdravljenja.
None of the subjects achieved complete response or partial response.
Noben preskušanec ni dosegel popolnega ali delnega odziva na zdravljenje.
28 x 1 hard capsules
28 x 1 trda kapsula
Routine assessment of bleeding events should include complete blood counts and physical examination.
Rutinsko ocenjevanje pojavov krvavitev mora obsegati celotno krvno sliko in klinični pregled.
The above reactions were not cumulative, were typically reversible, and generally did not result in treatment discontinuation.
Opisani učinki niso bili kumulativni, so bili praviloma reverzibilni in na splošno niso povzročili prekinitve zdravljenja.
Stable disease was observed in 6 patients (17%).
Nespremenjeno stanje bolezni so opazili pri 6 bolnikih (17 %).
• Depression.
• depresija
The primary objective was to compare PFS in patients receiving sunitinib versus patients receiving placebo.
Primarni cilj je bil primerjati PFS pri bolnikih, ki so prejemali sunitinib v primerjavi z bolniki, ki so prejemali placebo.
It is not known whether sunitinib or its primary active metabolite is excreted in human milk.
Ni znano, ali se sunitinib ali njegov primarni aktivni presnovek izloča v materino mleko.
Sutent should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus.
Zdravila Sutent se ne sme uporabljati med nosečnostjo in pri ženskah, ki ne uporabljajo učinkovite kontracepcije, razen če možna korist odtehta možno tveganje za plod.
Heart problems.
Težave s srcem.
- Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
- Metastatski karcinom ledvičnih celic (MRCC), vrsta raka ledvic, ki se je razširil na druge dele telesa.
Subsequent dose adjustments should be based on individual safety and tolerability (see section 5.2).
Nadaljnje prilagajanje odmerka mora temeljiti na varnosti in prenašanju pri posameznem bolniku (glejte poglavje 5.2).
These may be symptoms of a condition called pulmonary embolism that occurs when blood clots travel to your lungs.
To so lahko znaki stanja, imenovanega pljučna embolija, ki se pojavi, ko krvni strdki potujejo v pljuča.
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
• vnetje (otekanje in pordelost) žolčnika z ali brez povezanih žolčnih kamnov
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01XE04
Farmakoterapevtska skupina: antineoplastiki, zaviralci protein-kinaze, oznaka ATC: L01XE04
If you have any questions about how Sutent works or why this medicine has been prescribed for you, ask your doctor.
Če imate vprašanja o tem, kako zdravilo Sutent deluje ali zakaj ste ga dobili, se posvetujte z zdravnikom.
One patient with GIST was enrolled at the 15 mg/m dose level with no evidence of benefit.
En bolnik z GIST je bil v študijo vključen pri odmerku 15 mg/m2 brez znakov koristi.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and even those not prescribed.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
- If you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Sutent in particular when you are also receiving or have received intravenous bisphosphonates.
- Če ste naročeni na invazivno zobozdravstveno zdravljenje ali zobozdravstveni poseg, obvestite zobozdravnika, da se zdravite z zdravilom Sutent, še posebej v primeru, če sočasno prejemate ali ste prejeli intravenske bisfosfonate.
• Reduction in the number of platelets, red blood cells and/or white blood cells (e.g. neutrophils).
• zmanjšanje števila trombocitov, rdečih krvnih celic in/ali belih krvnih celic (npr. nevtrofilcev)
The pivotal study in pancreatic NET was terminated prematurely at the recommendation of an independent drug monitoring committee and the primary endpoint was based upon investigator assessment, both of which may have affected the estimates of the treatment effect.
Ključna študija pri nevroendokrinih tumorjih trebušne slinavke je bila predčasno zaključena na priporočilo neodvisnega Odbora za nadzor zdravil (drug monitoring committee), primarni opazovani dogodek pa je temeljil na oceni raziskovalca, obe pa sta lahko vplivali na ocene učinkovitosti zdravljenja.
Based on the modelling analyses, the younger age and lower body size did not appear to affect negatively the safety and efficacy responses to sunitinib plasma exposures.
Analize modelov so pokazale, da nižja starost in manjša velikost telesa nimata negativnega vpliva na odzive glede varnosti in učinkovitosti na izpostavljenosti sunitinibu v plazmi.
A sensitivity analysis of PFS was conducted where progression was based upon investigator-reported tumour measurements and where all subjects censored for reasons other than study termination were treated as PFS events.
Opravili so občutljivostno analizo PFS, pri čemer je napredovanje temeljilo na merjenjih tumorja, o katerih so poročali raziskovalci, in kjer so bile vse osebe, pri katerih je bilo zdravljenje prekinjeno iz vzrokov, ki niso predstavljali zaključka študije, obravnavane kot da je pri njih šlo za PFS dogodke.
(not to exceed the total dose of 50 mg/day) based on individual patient safety/tolerability.
(odmerki niso presegli celokupnega odmerka 50 mg/dan) glede na varnost in prenašanje pri posameznem bolniku.
After oral administration of sunitinib, Cmax are generally observed from 6 to 12 hours time to maximum concentration (tmax) postadministration.
Po peroralni uporabi sunitinib na splošno doseže Cmax od 6 do 12 ur do največje koncentracije (tmax) po aplikaciji.
If your thyroid gland is not producing enough thyroid hormone, you may be treated with thyroid hormone replacement.
Če vaša ščitnica ne proizvaja dovolj ščitničnega hormona, vas bodo morda zdravili z nadomestkom ščitničnega hormona.