FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who tolerate the 5 mg dose well, who do not have high blood pressure and are not taking blood pressure medicines, the dose may be increased first to 7 mg then to a maximum of 10 mg twice a day.
Slovenian: Pri bolnikih, ki dobro prenašajo 5-miligramski odmerek, nimajo visokega krvnega tlaka in ne jemljejo zdravil za njegovo zdravljenje, se lahko odmerek poveča najprej na 7 mg, nato pa na največ 10 mg dvakrat dnevno.
English: Other information about Inlyta
Slovenian: Druge informacije o zdravilu Inlyta
English: For more information about treatment with Inlyta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Inlyta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Patients taking Inlyta lived for an average of 6.7 months without the disease getting worse, compared with 4.7 months in the patients taking sorafenib.
Slovenian: Bolniki, ki so jemali zdravilo Inlyta, so živeli povprečno 6,7 meseca brez poslabšanja bolezni, bolniki, ki so jemali sorafenib, pa 4,7 meseca.
English: A risk management plan has been developed to ensure that Inlyta is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Inlyta je bil pripravljen načrt obvladovanja tveganj.
English: Patients with moderately reduced liver function should receive a starting dose of 2 mg twice a day.
Slovenian: Bolniki z zmerno okvaro jeter morajo prejemati začetni odmerek 2 mg dvakrat dnevno.
English: What benefit has Inlyta shown during the studies?
Slovenian: Kakšne koristi je zdravilo Inlyta izkazalo med študijami?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Inlyta.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inlyta, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The CHMP therefore decided that Inlyta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor CHMP je zato zaključil, da so koristi zdravila Inlyta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: What is the risk associated with Inlyta?
Slovenian: Kakšna tveganja so povezana z zdravilom Inlyta?
English: Why has Inlyta been approved?
Slovenian: Zakaj je bilo zdravilo Inlyta odobreno?
English: Effects were better for those patients who were previously treated with cytokines rather than sunitinib.
Slovenian: Učinki so bili boljši pri bolnikih, ki so se predhodno zdravili s citokini, kot pri tistih, ki so se zdravili s sunitinibom.
English: Inlyta is a medicine that contains the active substance axitinib.
Slovenian: Inlyta je zdravilo, ki vsebuje zdravilno učinkovino aksitinib.
English: For the full list of all side effects and restrictions with Inlyta, see the package leaflet.
Slovenian: Za seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Inlyta glejte navodilo za uporabo.
English: Treatment with Inlyta should be started by doctors who have experience in using cancer medicines.
Slovenian: Zdravljenje z zdravilom Inlyta lahko uvede zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: Inlyta should not be used in patients with severely reduced liver function.
Slovenian: Zdravilo Inlyta se ne sme uporabljati pri bolnikih s hudo okvaro jeter.
English: VEGF receptors are involved in the growth and spread of cancer cells and in the development of blood vessels that supply the tumours.
Slovenian: Ti receptorji sodelujejo pri rasti in širjenju rakavih celic ter pri razvoju krvnih žil, ki oskrbujejo tumorje.
English: The active substance in Inlyta, axitinib, works by blocking some enzymes known as tyrosine kinases that are found in ‘vascular endothelial growth factor' (VEGF) receptors on the surface of cancer cells.
Slovenian: Aksitinib, zdravilna učinkovina v zdravilu Inlyta, deluje tako, da zavira nekatere encime, znane kot tirozinske kinaze, ki so prisotni v receptorjih žilnih endotelijskih rastnih faktorjev (vascular endothelial growth factors - VEGF) na površini rakavih celic.
English: It may be necessary to reduce the dose or interrupt treatment to manage certain side effects.
Slovenian: Za obvladovanje nekaterih neželenih učinkov bi morda bilo treba zmanjšati odmerek ali prekiniti zdravljenje.
English: Inlyta has been compared with sorafenib (another cancer medicine) in one main study involving 723 patients with advanced renal cell carcinoma whose previous treatment with other cancer medicines such as sunitinib or cytokines had failed.
Slovenian: Zdravilo Inlyta so primerjali s sorafenibom (drugim zdravilom za zdravljenje raka) v glavni študiji, v kateri je sodelovalo 723 bolnikov z napredovalim karcinomom ledvičnih celic, ki so se predhodno neuspešno zdravili z drugimi zdravili za zdravljenje rakavih bolezni, kot so sunitinib ali citokini.
English: Inlyta is used when treatment with Sutent (sunitinib) or ‘cytokines' (other cancer medicines) has failed.
Slovenian: Zdravilo Inlyta se uporablja, kadar zdravljenje z zdravilom Sutent (sunitinib) ali s citokini (drugimi zdravili za zdravljenje raka) ni bilo uspešno.
English: Inlyta was more effective than sorafenib in treating advanced renal cell carcinoma.
Slovenian: Zdravilo Inlyta je bilo učinkovitejše od sorafeniba pri zdravljenju napredovalega karcinoma ledvičnih celic.
English: The CHMP concluded that the effectiveness of Inlyta in treating patients with advanced renal cell carcinoma for whom treatment with Sutent or a cytokine failed has been demonstrated.
Slovenian: Odbor CHMP je ugotovil, da je bila dokazana učinkovitost zdravila Inlyta pri zdravljenju bolnikov z napredovalim karcinomom ledvičnih celic, pri katerih zdravljenje z zdravilom Sutent ali citokinom ni bilo uspešno.
English: Inlyta is used to treat adults with advanced renal cell carcinoma, a type of kidney cancer.
Slovenian: Zdravilo Inlyta se uporablja pri odraslih za zdravljenje napredovalega karcinoma ledvičnih celic, tj. vrste ledvičnega raka.
English: By blocking these receptors, Inlyta helps to reduce the growth and spread of the cancer and cut off the blood supply that keeps the cancer cells growing.
Slovenian: Zdravilo Inlyta z njihovim zaviranjem omogoča upočasnitev rasti in širjenja raka ter prekinitev oskrbe s krvjo, ki omogoča rast rakavih celic.
English: What is Inlyta used for?
Slovenian: Za kaj se zdravilo Inlyta uporablja?
English: What is Inlyta?
Slovenian: Kaj je zdravilo Inlyta?
English: How has Inlyta been studied?
Slovenian: Kako je bilo zdravilo Inlyta raziskano?
English: How is Inlyta used?
Slovenian: Kako se zdravilo Inlyta uporablja?
English: This overview was last updated in 04-2018.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2018.
English: It involved 366 adults and children 2 years of age and over.
Slovenian: Vključevala je 366 odraslih in otrok, starejših od dveh let.
English: This was switched to a full marketing authorisation on 16 November 2015.
Slovenian: To je bilo 16. novembra 2015 spremenjeno v običajno dovoljenje za promet.
English: What measures are being taken to ensure the safe and effective use of Votubia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Votubia?
English: Votubia was originally given ‘conditional authorisation' because there was more evidence to come about the medicine, in particular its long-term effects.
Slovenian: Zdravilo Votubia je prvotno pridobilo „pogojno dovoljenje za promet“, ker je bilo pričakovanih še več dokazov o zdravilu, zlasti o njegovih dolgoročnih učinkih.
English: It is available as tablets (2.5, 5 and 10 mg) and as dispersible tablets (1, 2, 3 and 5 mg) and is taken by mouth once a day at the same time every day, consistently either with or without food.
Slovenian: Na voljo je v obliki tablet (2,5 mg, 5 mg in 10 mg) in disperzibilnih tablet (1 mg, 2 mg, 3 mg in 5 mg) ter se jemlje peroralno enkrat na dan, vsak dan ob istem času, vedno s hrano ali vedno brez nje.
English: Other information about Votubia
Slovenian: Druge informacije o zdravilu Votubia
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full authorisation.
Slovenian: Ker je družba predložila dodatne zahtevane podatke, je bilo dovoljenje za promet spremenjeno iz pogojnega v običajno.
English: Renal angiomyolipoma
Slovenian: Ledvični angiomiolipom
English: Votubia received a conditional marketing authorisation valid throughout the EU on 2 September 2011.
Slovenian: Za zdravilo Votubia je bilo 2. septembra 2011 izdano dovoljenje za promet, veljavno po vsej EU.
English: An overview of Votubia and why it is authorised in the EU
Slovenian: Pregled zdravila Votubia in zakaj je odobreno v EU
English: If patients experience severe side effects the doctor may need to reduce the dose or interrupt treatment temporarily.
Slovenian: Če pri bolniku pride do hudih neželenih učinkov, bo zdravnik morda moral odmerek zmanjšati ali zdravljenje začasno prekiniti.
English: The Agency therefore concluded that the benefits of Votubia outweigh its risks and recommended that it be given marketing authorisation.
Slovenian: Agencija je zato zaključila, da koristi zdravila Votubia odtehtajo z njim povezana tveganja, in priporočila, da se zanj izda dovoljenje za promet.
English: What benefits of Votubia have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Votubia izkazalo v študijah?
English: What is Votubia and what is it used for?
Slovenian: Kaj je zdravilo Votubia in za kaj se uporablja?
English: As for all medicines, data on the use of Votubia are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Votubia stalno spremljajo.
English: Further information on Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Nadaljnje informacije za zdravilo Votubia so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Votubia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Since mTOR is involved in the control of cell division and the growth of blood vessels, Votubia prevents the division of tumour cells and reduces their blood supply.
Slovenian: Ker mTOR sodeluje pri nadzoru delitve celic in rasti krvnih žil, zdravilo Votubia preprečuje delitev tumorskih celic in zmanjšuje njihovo oskrbo s krvjo.
English: Why is Votubia authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Votubia odobreno v EU?
English: Side effects reported with Votubia are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Votubia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Two different dosage regimens of add-on treatment with Votubia (tailored to give lower or higher levels in the blood) were compared with placebo.
Slovenian: Dva različna režima odmerjanja zdravila Votubia kot dodatka k zdravljenju (prilagojena tako, da se dosežejo višje ali nižje ravni zdravila v krvi) so primerjali s placebom.
English: What are the risks associated with Votubia?
Slovenian: Kakšna tveganja so povezana z zdravilom Votubia?
English: Before treatment, patients had 16 to 17 seizures per week on average and response was considered to be shown by a reduction in seizures of at least 50%.
Slovenian: Pred zdravljenjem so bolniki imeli v povprečju 16-17 napadov na teden, kot odziv pa se je štelo zmanjšanje števila napadov za vsaj 50 %.
English: Partial onset seizures
Slovenian: Napadi parcialnega izvora
English: When used together with other medicines, e.g. as an add-on treatment for seizures, the dosage may also be affected by the other medicines being taken.
Slovenian: Ko se uporablja skupaj z drugimi zdravili, npr. kot dodatek k zdravljenju napadov, lahko na odmerek vplivajo tudi druga zdravila, ki so bila vzeta.
English: Votubia treatment should be started by a doctor experienced in treating tuberous sclerosis and in monitoring levels of medicine in the blood.
Slovenian: Zdravljenje z zdravilom Votubia mora uvesti zdravnik, ki ima izkušnje z zdravljenjem tuberozne skleroze in s spremljanjem ravni zdravila v krvi.
English: In renal angiomyolipoma caused by tuberous sclerosis, Votubia has been compared with placebo in one study involving 118 adults.
Slovenian: Pri ledvičnem angiomiolipomu, ki ga povzroča tuberozna skleroza, so zdravilo Votubia primerjali s placebom v študiji, ki je vključevala 118 odraslih.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Votubia have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Votubia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Tuberous sclerosis is rare, and Votubia was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 August 2010.
Slovenian: Tuberozna skleroza je redka bolezen, zato je bilo zdravilo Votubia 4. oktobra 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: In the body, everolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'.
Slovenian: Everolimus se v telesu najprej veže na beljakovino v celicah, imenovano FKBP12, in z njo tvori „skupek“.
English: The most common side effects with Votubia (seen in more than 1 in 10 patients) are acne, stomatitis (inflammation of the lining of the mouth), upper respiratory tract infections (colds), nasopharyngitis (inflammation of the nose and throat), sinusitis (inflammation of the sinuses), cough, pneumonia (infection of the lung), urinary tract infection, increased blood levels of cholesterol, irregular menstruation (periods), amenorrhoea (absence of periods), headache, diarrhoea, vomiting, rash, tiredness, fever and decreased appetite.
Slovenian: Najpogostejši neželeni učinki zdravila Votubia (opaženi pri več kot 1 bolniku od 10) so akne, stomatitis (vnetje ustne sluznice), okužbe zgornjih dihal (prehladi), nazofaringitis (okužbe nosu in žrela), sinuzitis (vnetje sinusov), kašelj, pljučnica (okužba pljuč), okužbe sečil, povečane ravni holesterola v krvi, neredne menstruacije, amenoreja (izostanek menstruacij), glavobol, driska, bruhanje, izpuščaj, utrujenost, povišana telesna temperatura in zmanjšan tek.
English: In patients with renal angiomyolipoma, the recommended dose is 10 mg once a day.
Slovenian: Pri bolnikih z ledvičnim angiomiolipomom je priporočeni odmerek 10 mg enkrat na dan.
English: Votubia must not be used in people who are hypersensitive (allergic) to everolimus, to related medicines such as sirolimus and temsirolimus or to any of the other ingredients.
Slovenian: Zdravila Votubia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) everolimus, katera koli druga podobna zdravila, kot sta sirolimus in temsirolimus, ali katero koli drugo sestavino zdravila.
English: It has also shown to be effective at reducing partial-onset seizures associated with tuberous sclerosis.
Slovenian: Prav tako se je izkazalo za učinkovito pri zmanjševanju števila napadov parcialnega izvora, povezanih s tuberozno sklerozo.
English: Votubia is used for partialonset seizures (seizures that start in one part of the brain), which may or may not spread to affect the whole brain (secondary generalisation).
Slovenian: Zdravilo Votubia se uporablja za napade parcialnega izvora (napade, ki se začnejo v enem delu možganov), ki se lahko razširijo na celotne možgane (sekundarna generalizacija) ali ne.
English: Votubia is a medicine used to treat the following benign (non-cancerous) tumours caused by the genetic disease tuberous sclerosis:
Slovenian: Votubia je zdravilo, ki se uporablja za zdravljenje naslednjih benignih (nerakavih) tumorjev, ki jih povzroča genetska bolezen, imenovana tuberozna skleroza:
English: For more information about treatment with Votubia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Votubia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: mTOR is also thought to play a role in the seizures that occur in patients with tuberous sclerosis but it is not fully understood how the medicine acts to prevent them.
Slovenian: Za mTOR se predvideva tudi, da sodeluje pri napadih, ki se pojavijo pri bolnikih s tuberozno sklerozo, vendar ni v celoti razumljeno, kako jih zdravilo prepreči.
English: The main measure of effectiveness was the proportion of patients who responded to treatment and whose brain tumour shrank by at least half after six months of treatment.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so se odzvali na zdravljenje in katerih možganski tumor se je po šestih mesecih zdravljenja zmanjšal vsaj za polovico.
English: Votubia contains the active substance everolimus.
Slovenian: Zdravilo Votubia vsebuje učinkovino everolimus.
English: This response was seen in 28% (33 of 117 patients) in the lower blood level group and 40% (52 of 130 patients) in the higher blood level group, compared with 15% (18 of 119) of patients taking placebo.
Slovenian: Ta odziv je bil opažen pri 28 % (33 od 117) bolnikov v skupini z nižjo ravnijo zdravila Votubia v krvi in pri 40 % (52 od 130) bolnikov v skupini z višjo ravnijo zdravila v Votubia v krvi, medtem kot je v skupini, ki je prejemala placebo bil odziv opažen pri 15 % (18 od 119) bolnikov.
English: The main measure of effectiveness was based on how much the patient's main brain tumour shrank after six months of treatment: the main brain tumour shrank by half in approximately 30% of patients and by about a third in around 70% of patients.
Slovenian: Glavno merilo učinkovitosti je temeljilo na zmanjšanju bolnikovega glavnega možganskega tumorja po šestih mesecih zdravljenja: glavni možganski tumor se je zmanjšal za polovico pri okoli 30 % bolnikov in za eno tretjino pri okoli 70 % bolnikov.
English: The European Medicines Agency noted that Votubia has been shown to reduce the size of the brain tumours in adults and children with tuberous sclerosis and that this is expected to reduce the signs and symptoms of SEGA such as seizures, hydrocephalus (accumulation of fluid in the brain), and increased pressure within the brain.
Slovenian: Evropska agencija za zdravila je menila, da je bilo dokazano, da zdravilo Votubia zmanjšuje velikost možganskih tumorjev pri odraslih in otrocih s tuberozno sklerozo, s čimer naj bi pripomoglo k zmanjšanju znakov in simptomov subependimskega gigantoceličnega astrocitoma, kot so epileptični napadi, hidrocefalus (nabiranje tekočine v možganih) in povišan tlak v možganih.
English: For more information about using Votubia, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Votubia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The second study involved 117 patients (including 20 children aged below 3 years) and compared Votubia with placebo (a dummy treatment).
Slovenian: V drugi študiji je sodelovalo 117 bolnikov (vključno z 20 otroki, mlajšimi od treh let), v njej pa so zdravilo Votubia primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: In SEGA caused by tuberous sclerosis, Votubia has been studied in two main studies: the first study involved 28 adults and children aged three years and above.
Slovenian: Zdravilo Votubia so pri bolnikih s subependimskim gigantoceličnim astrocitomom, ki ga povzroča tuberozna skleroza, proučevali v dveh glavnih študijah: v prvo je bilo vključenih 28 odraslih in otrok, starejših od treh let.
English: The side effects of the medicine were considered to be manageable and were generally mild or moderate.
Slovenian: Neželeni učinki tega zdravila, ki so na splošno blagi ali zmerni, so bili ocenjeni kot obvladljivi.
English: The benefits of Votubia as an add-on treatment of partial onset seizures related to tuberous sclerosis that have not been sufficiently controlled by other treatments have been shown in one main study.
Slovenian: Koristi zdravila Votubia kot dodatka k zdravljenju napadov parcialnega izvora, povezanih s tuberozno sklerozo, ki niso bili ustrezno uravnani z drugimi zdravljenji, so bile predstavljene v eni glavni študiji.
English: • subependymal giant cell astrocytoma (SEGA), a benign tumour of the brain, where it is used in adults and children whose brain tumour cannot be surgically removed;
Slovenian: • subependimskega gigantoceličnega astrocitoma (SEGA), tj. benignega možganskega tumorja, pri odraslih in otrocih, pri katerih tumorjev ni mogoče odstraniti s kirurškim posegom;
English: For SEGA, and for use as add-on treatment of seizures, the starting dose depends on the body surface area (calculated using the patient's height and weight) and the patient's age, but the doctor will adjust the dose based on the patient's blood levels of the medicine and how well the patient tolerates the medicine.
Slovenian: Začetni odmerek pri subependimskem gigantoceličnem astrocitomu in kadar se uporablja kot dodatek k zdravljenju je odvisen od bolnikove telesne površine (izračunane na podlagi njegove telesne višine in mase) in bolnikove starosti, vendar ga zdravnik lahko prilagodi glede na koncentracijo zdravila v krvi bolnika in glede na to, kako dobro ga ta prenaša.
English: The main measure of effectiveness was the proportion of patients who responded to treatment and whose kidney tumour shrank by at least half, which was seen in 42% of patients (33 out of 79) treated with Votubia, compared with none of the 39 patients who received placebo.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so se odzvali na zdravljenje in katerih ledvični tumor se je zmanjšal vsaj za polovico, kar je bilo opaženo pri 42 % (33 od 79) bolnikov, zdravljenih z zdravilom Votubia, medtem ko med 39 bolniki, ki so prejemali placebo, do tega ni prišlo pri nobenem bolniku.
English: Starting doses may need to be reduced, or treatment avoided, in patients with reduced liver function, depending on how severe this is and on the patient's age and the condition they are being treated for.
Slovenian: Pri bolnikih z okvaro delovanja jeter bo začetni odmerek morda treba zmanjšati ali se zdravljenju izogniti, odvisno od resnosti težave ter od starosti in stanja bolnika, zaradi katerega se zdravi.
English: This occurred in 35% of patients (27 out of 78 patients) treated with Votubia, compared with none of the 39 patients who received placebo.
Slovenian: Do tega je prišlo pri 35 % (27 od 78) bolnikov, zdravljenih z zdravilom Votubia, medtem ko med 39 bolniki, ki so prejemali placebo, do tega ni prišlo pri nobenem bolniku.