FrancophonIA/ELRC3.0 huggingface dataset:
English: Although a treatment effect was demonstrated in the overall study population, the data suggested that a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate dementia associated with Parkinson's disease.
Estonian: 2 Mugavuse pärast on esitatud keskmised andmed, kategoriaalne analüüs tehti Eltereni testiga ITT: ravikavatsuse alusel, RDO: Väljalangejad; LOCF: Viimane jälgimine Kuigi üldises uuringuvalimis oli ravi tõhusus tõestatud, viitasid andmed, et Parkinsoni tõvega seotud keskmise dementsusega patsientide alarühmas täheldati platseeboga võrreldes suuremat ravi mõju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Estonian: VÄLISPAKENDIL JA SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KLAASPUDELI PAPPKARP
English: e-mail: hapanicos@cytanet.com.cy
Estonian: Φαξ: 00357 25376400 e-mail: hapanicos@cytanet.com.cy
English: It is available as tablets (1, 3, 5 and 7 mg).
Estonian: Seda turustatakse tablettidena (1, 3, 5 ja 7 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inlyta on 3 September 2012.
Estonian: Euroopa Komisjon andis Inlyta müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 3. Septembril 2012.
English: Inlyta axitinib
Estonian: Inlyta aksitiniib
English: The full EPAR for Inlyta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Inlyta kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Inlyta is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Inlyta võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Inlyta?
Estonian: Mis meetmed võetakse, et tagada Inlyta ohutu ja efektiivne kasutamine?
English: The most common side effects with Inlyta (seen in more than 20% of patients) are diarrhoea, hypertension (high blood pressure), fatigue (tiredness), dysphonia (speech disturbance), nausea (feeling sick), vomiting, decreased appetite, weight loss, palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms of the hands and soles of the feet), haemorrhage (bleeding), hypothyroidism (an underactive thyroid gland), protein in urine, cough and constipation.
Estonian: Inlyta kõige sagedamad kõrvalnähud (esinenud enam kui 20%-l patsientidest) on kõhulahtisus, hüpertensioon (kõrge vererõhk), väsimus, düsfoonia (kõnehäired), iiveldus, oksendamine, isutus, kehakaalu vähenemine, palmaarplantaarne erütrodüsesteesia sündroom (löövet ja valu tekitav käe- ja jalalabade nahareaktsioon), hemorraagia (verejooks), hüpotüroidism (kilpnäärme alatalitlus), valgu sisaldumine uriinis, köha ja kõhukinnisus.
English: Regarding its safety, the side effects of the medicine are similar to other medicines in the same class and are considered to be acceptable and manageable.
Estonian: Seoses ravimi ohutusega leiti, et ravimi kõrvalnähud sarnanevad teiste sama klassi ravimite kõrvalnähtudega ning need on vastuvõetavad ja hallatavad.
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.
Estonian: Patsientidel, kes taluvad 5 mg annust hästi, kelle vererõhk on normaalne ja kes ei tarvita vererõhku langetavaid ravimeid, võib annust suurendada algul 7 mg-ni ning seejärel maksimumannuseni 10 mg kaks korda ööpäevas.
English: The dose can be adjusted according to the patient's response.
Estonian: Annust tuleb kohandada patsiendi ravivastuse järgi.
English: The recommended starting dose is 5 mg twice a day, taken approximately 12 hours apart.
Estonian: Soovitatav algannus on 5 mg kaks korda ööpäevas, mida võetakse ligikaudu 12-tunniste vahedega.
English: Effects were better for those patients who were previously treated with cytokines rather than sunitinib.
Estonian: Toime oli parem patsientidel, keda oli varem ravitud tsütokiinidega, mitte sunitiniibiga.
English: What is Inlyta?
Estonian: Mis on Inlyta?
English: The CHMP therefore decided that Inlyta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu otsustas inimravimite komitee, et Inlyta kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Other information about Inlyta
Estonian: Muu teave Inlyta kohta
English: It may be necessary to reduce the dose or interrupt treatment to manage certain side effects.
Estonian: Teatud kõrvaltoimete leevendamiseks võib olla vaja annust vähendada või ravi katkestada.
English: ‘Advanced' means that the cancer has started to spread.
Estonian: „Kaugelearenenud” tähendab, et vähk on hakanud levima organismis ka mujale.
English: For more information about treatment with Inlyta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Inlytaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects and restrictions with Inlyta, see the package leaflet.
Estonian: Inlyta kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: In patients taking certain other medicines, the doctor may need to adjust the dose of Inlyta.
Estonian: Teatud teisi ravimeid kasutavatel patsientidel võib arst Inlyta annust vajaduse korral kohandada.
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.
Estonian: Progresseerumiseta elulemus oli Inlytat kasutanud patsientidel keskmiselt 6,7 kuud ja sorafeniibi võtnud patsientidel 4,7 kuud.
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.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Inlyta ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Inlyta is a medicine that contains the active substance axitinib.
Estonian: Inlyta on ravim, mis sisaldab toimeainena aksitiniibi.
English: Inlyta is used when treatment with Sutent (sunitinib) or ‘cytokines' (other cancer medicines) has failed.
Estonian: Inlytat kasutatakse, kui ravi Sutenti (sunitiniib) või tsütokiinidega (teised vähiravimid) on ebaõnnestunud.
English: What benefit has Inlyta shown during the studies?
Estonian: Milles seisneb uuringute põhjal Inlyta kasulikkus?
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.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
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.
Estonian: Inlytat võrreldi sorafeniibiga (samuti vähiravim) ühes põhiuuringus, milles osales 723 kaugelearenenud neerurakk-kartsinoomiga patsienti, kellel eelnev ravi teiste vähiravimitega, nagu sunitiniib või tsütokiinid, oli ebaõnnestunud.
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.
Estonian: Neid retseptoreid blokeerides aitab Inlyta aeglustada vähi kasvu ja levikut ning peatada vähirakkude kasvu tagava verevarustuse.
English: Patients with moderately reduced liver function should receive a starting dose of 2 mg twice a day.
Estonian: Maksa mõõduka talitlushäirega patsientide algannus peab olema 2 mg kaks korda ööpäevas.
English: Why has Inlyta been approved?
Estonian: Miks Inlyta heaks kiideti?
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.
Estonian: Inlyta toimeaine aksitiniib blokeerib ensüüme türosiinkinaase, mis esinevad vaskulaarse endoteeli kasvuteguri (VEGF) retseptorites vähirakkude pinnal.
English: Treatment with Inlyta should be started by doctors who have experience in using cancer medicines.
Estonian: Ravi Inlytaga peab alustama vähiravimite kasutamises kogenud arst.
English: This is a summary of the European public assessment report (EPAR) for Inlyta.
Estonian: See on ravimi Inlyta Euroopa avaliku hindamisaruande kokkuvõte.
English: VEGF receptors are involved in the growth and spread of cancer cells and in the development of blood vessels that supply the tumours.
Estonian: VEGF-retseptorid osalevad vähirakkude kasvamises ja levikus ning kasvajat varustavate veresoonte arengus.
English: What is the risk associated with Inlyta?
Estonian: Mis riskid Inlytaga kaasnevad?
English: Inlyta should not be used in patients with severely reduced liver function.
Estonian: Inlytat ei tohi kasutada maksa raske talitlushäirega patsiendid.
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.
Estonian: Inimravimite komitee järeldas, et Inlyta efektiivsus on tõestatud nende kaugelearenenud neerurakkkartsinoomiga patsientide ravis, kelle ravi Sutenti või tsütokiinidega on ebaõnnestunud.
English: The main measure of effectiveness was how long the patients lived without their tumour getting worse.
Estonian: Efektiivsuse põhinäitaja oli progresseerumiseta elulemus (aeg haiguse süvenemiseni).
English: What is Inlyta used for?
Estonian: Milleks Inlytat kasutatakse?
English: Inlyta was more effective than sorafenib in treating advanced renal cell carcinoma.
Estonian: Inlyta oli kaugelearenenud neerurakk-kartsinoomi ravis sorafeniibist efektiivsem.
English: How is Inlyta used?
Estonian: Kuidas Inlytat kasutatakse?
English: How has Inlyta been studied?
Estonian: Kuidas Inlytat uuriti?
English: Inlyta is used to treat adults with advanced renal cell carcinoma, a type of kidney cancer.
Estonian: Inlytat kasutatakse täiskasvanute kaugelearenenud neerurakk-kartsinoomi (teatud neeruvähiliik) raviks.
English: What measures are being taken to ensure the safe and effective use of Votubia?
Estonian: Mis meetmed võetakse, et tagada Votubia ohutu ja efektiivne kasutamine?
English: Votubia (everolimus)
Estonian: Votubia (everoliimus)
English: Other information about Votubia
Estonian: Muu teave Votubia kohta
English: Renal angiomyolipoma
Estonian: Renaalne angiomüolipoom
English: Votubia received a conditional marketing authorisation valid throughout the EU on 2 September 2011.
Estonian: Votubia sai müügiloa tingimusliku heakskiidu alusel, mis kehtib kogu Euroopa Liidus, 2. septembril 2011.
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.
Estonian: Seda turustatakse tablettidena (2,5, 5 ja 10 mg) ja dispergeeruvate tablettidena (1, 2, 3 ja 5 mg), mida võetakse suu kaudu üks kord ööpäevas iga päev samal kellaajal, koos toiduga või ilma.
English: The Agency therefore concluded that the benefits of Votubia outweigh its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu järeldas amet, et Votubia kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: The side effects of the medicine were considered to be manageable and were generally mild or moderate.
Estonian: Ravimi kõrvalnähte peeti talutavateks ning üldiselt kergeks või mõõdukaks.
English: This was switched to a full marketing authorisation on 16 November 2015.
Estonian: Tingimuslik müügiluba muudeti tavaliseks müügiloaks 16. novembril 2015.
English: What is Votubia and what is it used for?
Estonian: Mis on Votubia ja milleks seda kasutatakse?
English: As for all medicines, data on the use of Votubia are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Votubia kasutamise kohta pidevat järelevalvet.
English: Side effects reported with Votubia are carefully evaluated and any necessary action taken to protect patients.
Estonian: Votubia kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Further information on Votubia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Lisateave Votubia kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Votubia was originally given ‘conditional authorisation' because there was more evidence to come about the medicine, in particular its long-term effects.
Estonian: Votubia müügiluba anti tingimusliku heakskiidu alusel, sest ravimi toetuseks, eelkõige selle pikaajalise toime kohta oodati täiendavaid andmeid.
English: Votubia contains the active substance everolimus.
Estonian: Votubia sisaldab toimeainena everoliimust.
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.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Votubia kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
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.
Estonian: Votubia ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: If patients experience severe side effects the doctor may need to reduce the dose or interrupt treatment temporarily.
Estonian: Raskete kõrvalnähtudega patsientidel tohib arst annust vähendada või ravi ajutiselt katkestada.
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.
Estonian: Votubia kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on akne, stomatiit (suu limaskesta põletik), ülemiste hingamisteede infektsioonid (külmetushaigused), nasofarüngiit (ninaneelupõletik), sinusiit (põskkoopapõletik), köha, kopsupõletik, kuseteede infektsioon (nakkus), vere kolesteroolisisalduse suurenemine, ebaregulaarne menstruatsioon, amenorröa (menstruatsiooni puudumine), peavalu, kõhulahtisus, oksendamine, lööve, väsimus, palavik ja isutus.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full authorisation.
Estonian: Et ettevõte esitas vajaliku lisateabe, muudeti tingimuslik müügiluba tavaliseks müügiloaks.
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).
Estonian: Votubiat kasutatakse partsiaalsete (aju teatud osas algavate) epilepsiaepisoodide korral, mis võivad levida ja mõjutada kogu aju (sekundaarne generalisatsioon).
English: What are the risks associated with Votubia?
Estonian: Mis riskid Votubiaga kaasnevad?
English: In renal angiomyolipoma caused by tuberous sclerosis, Votubia has been compared with placebo in one study involving 118 adults.
Estonian: Tuberoossest skleroosist põhjustatud renaalse angiomüolipoomi korral võrreldi Votubiat platseeboga uuringus, milles osales 118 täiskasvanut.
English: The second study involved 117 patients (including 20 children aged below 3 years) and compared Votubia with placebo (a dummy treatment).
Estonian: Teises uuringus osales 117 patsienti (sh 20 alla 3-aastast last) ja selles võrreldi Votubiat platseeboga (näiv ravim).
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%.
Estonian: Enne ravi esines patsientidel keskmiselt 16-17 epilepsiaepisoodi nädalas ja piisavaks ravivastuseks peeti epilepsiaepisoodide vähenemist vähemalt 50% võrra.
English: In patients with renal angiomyolipoma, the recommended dose is 10 mg once a day.
Estonian: Renaalse angiomüolipoomi korral on soovitatav annus 10 mg üks kord ööpäevas.
English: Tuberous sclerosis is rare, and Votubia was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 August 2010.
Estonian: Tuberoosne skleroos esineb harva ja Votubia nimetati 4. augustil 2010 harvikravimiks.
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.
Estonian: Tuberoossest skleroosist põhjustatud subependümaalse hiidrakulise astrotsütoomi korral uuriti Votubiat kahes põhiuuringus, milles esimeses osales 28 täiskasvanut ja vähemalt 3-aastast last.
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.
Estonian: Ravimi kasutamisel koos muude ravimitega, nt epilepsiaepisoodide lisaravimina, võivad annust mõjutada muud võetavad ravimid.
English: For more information about using Votubia, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Votubia kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Partial onset seizures
Estonian: Partsiaalsed epilepsiaepisoodid
English: How does Votubia work?
Estonian: Kuidas Votubia toimib?
English: How is Votubia used?
Estonian: Kuidas Votubiat kasutatakse?
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.
Estonian: Subependümaalse hiidrakulise astrotsütoomi korral ja epilepsiaepisoodide lisaravimina kasutamisel sõltub algannus patsiendi kehapindalast (arvutatakse patsiendi pikkuse ja kehamassi järgi) ja patsiendi vanusest, kuid arst kohandab annust vastavalt ravimi sisaldusele patsiendi veres ja patsiendi ravimitaluvusele.
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;
Estonian: • subependümaalne hiidrakuline astrotsütoom (teatud healoomuline ajukasvaja) täiskasvanutel ja lastel, kelle ajukasvajat ei saa kirurgiliselt eemaldada;
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.
Estonian: Votubiat ei tohi kasutada patsiendid, kes on everoliimuse, seonduvate ravimite (nt siroliimuse ja temsiroliimuse) või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
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.
Estonian: Efektiivsuse põhinäitaja oli patsiendi primaarse ajukasvaja vähenemine pärast 6-kuulist ravi: primaarne ajukasvaja vähenes poole võrra ligikaudu 30%-l patsientidest ja ligikaudu kolmandiku võrra ligikaudu 70%-l patsientidest.
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.
Estonian: Algannust võib vähendada või ravi vältida maksapuudulikkusega patsientidel sõltuvalt maksapuudulikkuse raskusest, patsiendi vanusest ja ravitavast seisundist.
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.
Estonian: Arvatavasti osaleb mTOR ka tuberoosse skleroosiga patsientide epilepsiaepisoodides, kuid ei ole täielikult teada, kuidas see ravim neid takistab.
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.
Estonian: See kompleks blokeerib valgu mTOR. Et mTOR osaleb rakkude jagunemise ja veresoonte kasvu reguleerimisel, takistab Votubia kasvajarakkude jagunemist ja vähendab nende verevarustust.
English: • renal angiomyolipoma, a benign tumour of the kidneys, where it is used in adults who are at risk of complications but who do not require immediate surgery.
Estonian: • renaalne angiomüolipoom (teatud healoomuline neerukasvaja) täiskasvanutel, kellel on tüsistuste risk, kuid kes ei vaja kohest operatsiooni.
English: Votubia treatment should be started by a doctor experienced in treating tuberous sclerosis and in monitoring levels of medicine in the blood.
Estonian: Ravi Votubiaga tohib alustada üksnes tuberoosse skleroosi ravis ja vere ravimisisalduse jälgimises kogenud arst.
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.
Estonian: Piisava ravivastusega patsiente oli väikse ravimisisalduse rühmas 28% (33 patsienti 117st), suure ravimisisalduse rühmas 40% (52 patsienti 130st) ja platseeborühmas 15% (18 patsienti 119st).
English: Votubia is a medicine used to treat the following benign (non-cancerous) tumours caused by the genetic disease tuberous sclerosis:
Estonian: Votubia on ravim, mida kasutatakse järgmiste healoomuliste kasvajate raviks, mille on põhjustanud geneetiline haigus tuberoosne skleroos:
English: For the full list of all side effects reported with Votubia, see the package leaflet.
Estonian: Votubia kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What benefits of Votubia have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Votubia kasulikkus?
English: For more information about treatment with Votubia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Votubiaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: An overview of Votubia and why it is authorised in the EU
Estonian: Ülevaade ravimist Votubia ja ELis müügiloa väljastamise põhjendus