FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended daily dose is one tablet of Symkevi in the morning and one ivacaftor tablet (150 mg) in the evening, about 12 hours later.
Estonian: Soovitatav ööpäevane annus on üks Symkevi tablett hommikul ja üks ivakaftoori tablett (150 mg) õhtul, ligikaudu 12 tundi hiljem.
English: Further information on Symkevi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Symkevi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Symkevi (tezacaftor / ivacaftor)
Estonian: Symkevi (tesakaftoor/ivakaftoor)
English: The doses may also need to be adjusted in patients with reduced liver function.
Estonian: Annust võib olla vaja vähendada ka halvenenud maksafunktsiooniga patsientidel.
English: Side effects reported with Symkevi are carefully evaluated and any necessary action taken to protect patients.
Estonian: Symkevi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Each tablet contains 100 mg tezacaftor and 150 mg ivacaftor.
Estonian: Iga tablett sisaldab 100 mg tesakaftoori ja 150 mg ivakaftoori.
English: For more information about using Symkevi, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Symkevi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: In the latter group, there is a lack of authorised therapies.
Estonian: Teise patsiendirühma jaoks puuduvad heakskiidetud raviviisid.
English: Symkevi is available as tablets.
Estonian: Symkevit turustatakse tablettidena.
English: The most common side effects with Symkevi (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Estonian: Symkevi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu ja nasofarüngiit (nina-neelupõletik).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symkevi have been included in the summary of product characteristics and the package leaflet.
Estonian: Symkevi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What are the risks associated with Symkevi?
Estonian: Mis riskid Symkeviga kaasnevad?
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Estonian: Tsüstiline fibroos on pärilik haigus, mis kahjustab oluliselt kopse, seedesüsteemi ja teisi elundeid.
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Estonian: Tsüstilist fibroosi põhjustavad geeni CFTR mutatsioonid.
English: Symkevi should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.
Estonian: Symkevi-ravi tohib määrata üksnes tsüstilise fibroosi ravis kogenud arst ja üksnes patsientidele, kellel on kinnitatud eespool nimetatud mutatsioonid.
English: Patients who took Symkevi and ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took ivacaftor alone and a reduction of 0.3 percentage points in patients who took placebo.
Estonian: Symkevit ja ivakaftoori kasutanud patsientidel suurenes FEV1 keskmiselt 6,5 protsendipunkti võrra, ainult ivakaftoori kasutanud patsientidel suurenes 4,4 protsendipunkti võrra ja platseebot kasutanud patsientidel vähenes 0,3 protsendipunkti võrra.
English: After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Estonian: 24 ravinädala järel oli FEV1 ravimeid kasutanud patsientidel keskmiselt 3,4 protsendipunkti võrra suurem ning platseebot kasutanud patsientidel 0,6 protsendipunkti võrra väiksem.
English: Symkevi should be taken together with another medicine containing 150 mg ivacaftor alone.
Estonian: Symkevit tuleb võtta koos teise ravimiga, mis sisaldab ainult ivakaftoori (150 mg).
English: For the full list of side effects and restrictions with Symkevi, see the package leaflet.
Estonian: Symkevi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: How is Symkevi used?
Estonian: Kuidas Symkevit kasutatakse?
English: Symkevi is a medicine used to treat cystic fibrosis in patients aged 12 years and above.
Estonian: Symkevi on ravim, mida kasutatakse tsüstilise fibroosi raviks vähemalt 12-aastastel patsientidel.
English: Cystic fibrosis is rare, and Symkevi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 February 2017.
Estonian: Tsüstiline fibroos esineb harva ja Symkevi nimetati 27. veebruaril 2017 harvikravimiks.
English: FEV1 is the maximum amount of air a person can breathe out in one second and is a measure of how well the lungs work.
Estonian: Kopsufunktsiooni iseloomustav näitaja FEV1 on suurim õhumaht, mille inimene suudab ühe sekundi jooksul välja hingata.
English: Lung function was measured after 4 weeks and 8 weeks of treatment.
Estonian: Kopsufunktsiooni mõõdeti pärast 4 ja 8 ravinädalat.
English: One of the active substances in Symkevi, tezacaftor, increases the number of CFTR proteins on the cell surface and the other, ivacaftor, increases the activity of the defective CFTR protein.
Estonian: Symkevi toimeaine tesakaftoor suurendab valgu CFTR kogust raku pinnal ja ravimi teine toimeaine ivakaftoor suurendab defektse CFTR-valgu aktiivsust.
English: In the former group, Symkevi could especially be a treatment option for those who cannot take a combination of ivacaftor and lumacaftor (another cystic fibrosis medicine), due to side effects or interactions with other medicines they are taking.
Estonian: Esimeses patsiendirühmas võib Symkevi olla ravivalik eelkõige patsientidele, kes ei saa kõrvalnähtude või koostoimete tõttu muude võetavate ravimitega kasutada ivakaftoori ja lumakaftoori kombinatsiooni (samuti tsüstilise fibroosi ravim).
English: Symkevi contains the active substances tezacaftor and ivacaftor.
Estonian: Symkevi sisaldab toimeainetena tesakaftoori ja ivakaftoori.
English: What benefits of Symkevi have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Symkevi kasulikkus?
English: How does Symkevi work?
Estonian: Kuidas Symkevi toimib?
English: An overview of Symkevi and why it is authorised in the EU
Estonian: Ülevaade ravimist Symkevi ja ELis müügiloa väljastamise põhjendus
English: Symkevi is used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene.
Estonian: Symkevit kasutatakse patsientidel, kes on mutatsiooni F508del saanud mõlemalt vanemalt ja kellel on see mutatsioon seepärast CFTR-geeni mõlemas koopias.
English: These actions make mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease.
Estonian: See vedeldab lima ja seedemahlu, aidates leevendada haigussümptomeid.
English: The first study involved 510 patients with cystic fibrosis who have inherited the F508del mutation from both parents.
Estonian: Esimeses uuringus osales 510 tsüstilise fibroosiga patsienti, kes olid mutatsiooni F508del saanud mõlemalt vanemalt.
English: This gene makes the CFTR protein, which works on the surface of cells to regulate the production of mucus and digestive juices.
Estonian: See geen toodab valku CFTR, mis rakkude pinnal toimides reguleerib lima ja seedemahlade teket.
English: The doses of Symkevi and ivacaftor may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections.
Estonian: Kui patsient kasutab lisaks mõõdukat või tugevat CYP3A inhibiitorit (teatud tüüpi ravim), näiteks teatud antibiootikume või seeninfektsioonide ravimeid, võib olla vaja Symkevi ja ivakaftoori annuseid kohandada.
English: Symkevi is an effective treatment for patients with cystic fibrosis who have inherited the F508del mutation from both parents or patients who have the F508del mutation from one parent and certain other mutations.
Estonian: Symkevi on efektiivne ravim tsüstilise fibroosiga patsientidele, kes on mutatsiooni F508del saanud mõlemalt vanemalt, ning patsientidele, kes on mutatsiooni F508del saanud ühelt vanemalt ja kellel on teatud muud mutatsioonid.
English: The second study involved 248 patients with cystic fibrosis who have inherited the F508del mutation from one parent and who also have another CFTR mutation.
Estonian: Teises uuringus osales 248 tsüstilise fibroosiga patsienti, kes olid mutatsiooni F508del saanud ühelt vanemalt ja kellel oli lisaks geeni CFTR muu mutatsioon.
English: The mutations reduce the number of CFTR proteins on the cell surface or affect the way the protein works.
Estonian: Need mutatsioonid vähendavad valgu CFTR kogust raku pinnal või häirivad valgu toimimist.
English: Symkevi is used in patients who have a mutation (change) called F508del in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Estonian: Symkevit kasutatakse patsientidel, kellel on teatud valgu, tsüstilise fibroosi transmembraanse juhtivuse regulaatori (CFTR) geeni mutatsioon (muutus) F508del.
English: Symkevi, taken with ivacaftor, was compared with placebo (a dummy treatment).
Estonian: Uuringus võrreldi koos ivakaftooriga kasutatavat Symkevit platseeboga (näiv ravim).
English: Symkevi, taken with ivacaftor, was compared with ivacaftor taken alone and with placebo.
Estonian: Symkevi kasutamist koos ivakaftooriga võrreldi ainuravimina kasutatava ivakaftooriga ja platseeboga.
English: In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.
Estonian: Soolestikus aeglustab kõhunäärmejuhade ummistus seedimist ja põhjustab seetõttu kasvupeetust.
English: Symkevi taken together with ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above.
Estonian: Kahes põhiuuringus, milles osalesid vähemalt 12-aastased tsüstilise fibroosiga patsiendid, oli koos ivakaftooriga kasutatud Symkevi efektiivne kopsufunktsiooni leevendamisel.
English: Cystic fibrosis affects the cells that produce mucus and digestive juices.
Estonian: Tsüstiline fibroos kahjustab lima ja seedemahlu tekitavaid rakke, nii et need eritised muutuvad viskoosseks ja tekitavad ummistusi.
English: Why is Symkevi authorised in the EU?
Estonian: ELis Symkevile väljastatud müügiloa põhjendus
English: Further information on Sutent's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Sutenti kehtivate näidustuste kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: What is Sutent?
Estonian: Mis on Sutent?
English: In addition, the medicine has known side effects that affect patients' quality of life.
Estonian: Lisaks sellele on ravimil teadaolevad kõrvaltoimed, mis mõjutavad patsientide elukvaliteeti.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui osalete ravimi kliinilises uuringus ja vajate ravi kohta lisateavet, pöörduge palun arsti poole, kes teile ravi määras.
English: Sutent is a cancer medicine currently authorised for treating the following cancers:
Estonian: Sutent on vähiravim, mis on praegu heaks kiidetud järgmiste vähkkasvajate raviks:
English: Sutent has been authorised since July 2006 and contains the active substance sunitinib.
Estonian: Sutentil on müügiluba alates juulist 2006 ja selle toimeaine on sunitiniib.
English: Patients were treated for around a year and the study looked at how long it took for the cancer to come back (disease-free survival).
Estonian: Patsiente raviti ligikaudu aasta ja uuringus jälgiti, kui pikk aeg kulus vähi taastekkeni (haigusvaba elumus).
English: The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew the application.
Estonian: Ettevõte oli taotlenud negatiivse arvamuse taasläbivaatamist, mis ei olnud taotluse tagasivõtmise ajaks veel lõppenud.
English: The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Estonian: Sutenti toimeaine sunitiniib on proteiinkinaasiinhibiitor.
English: How does Sutent work?
Estonian: Kuidas Sutent toimib?
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas);
Estonian: • pankrease neuroendokriinsed tuumorid (pankrease hormoone tootvate rakkude kasvajad);
English: On 26 June 2018, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend use of Sutent to the treatment of patients at high risk of kidney cancer returning after surgery.
Estonian: 26. juunil 2018 teatas Pfizer Limited ametlikult inimravimite komiteele oma soovist võtta tagasi taotlus laiendada Sutenti kasutamist selliste patsientide raviks, kellel on pärast kirurgilist ravi suur neeruvähi taastekke risk.
English: This means that it blocks specific enzymes known as protein kinases that are involved in the growth and spread of cancer cells and the development of new blood vessels supplying them.
Estonian: See tähendab, et sunitiniib blokeerib teatud ensüümid, mida nimetatakse proteiinkinaasideks ja mis soodustavad vähirakkude kasvu ja levikut ning neid varustavate uute veresoonte teket.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing because the data provided do not allow the CHMP to conclude that the benefit outweighs the risks.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et võtab taotluse tagasi, sest esitatud andmete alusel ei olnud inimravimite komiteel võimalik järeldada, et ravimi kasulikkus on suurem kui sellega kaasnevad riskid.
English: There are no consequences for Sutent in its authorised uses.
Estonian: Tagasivõtmine ei avalda mõju Sutenti kasutamisele heakskiidetud näidustuste korral.
English: By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
Estonian: Neid ensüüme blokeerides vähendab Sutent vähi kasvu ja levikut ning peatab vähirakkude kasvu toetava verevarustuse.
English: The CHMP considered that the evidence that Sutent delays the return of the cancer was not convincing.
Estonian: Inimravimite komitee leidis, et tõendid selle kohta, et Sutent lükkab edasi vähi taasteket, ei olnud veenvad.
English: The company presented results of a main study comparing Sutent with placebo (a dummy treatment) in 615 patients at high risk of their kidney cancer coming back after surgery.
Estonian: Ettevõte esitas põhiuuringu tulemused, milles võrreldi Sutenti platseeboga (näiv ravim) 615 patsiendil, kel oli pärast kirurgilist ravi suur neeruvähi taastekke risk.
English: • gastrointestinal stromal tumour (a cancer of the stomach and bowel);
Estonian: • gastrointestinaalne stromaalne tuumor (üks mao- ja soole vähkkasvajatest);
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Sutent.
Estonian: Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmine ei mõjuta praegu Sutenti kliinilistes uuringutes osalevaid patsiente.
English: • metastatic renal cell carcinoma (kidney cancer that has spread to other parts of the body).
Estonian: • metastaatiline neerurakk-kartsinoom (neeruvähk, mis on levinud organismis ka mujale).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Sutent in the treatment of patients at high risk of kidney cancer returning after surgery did not outweigh its risks.
Estonian: Seepärast oli inimravimite komitee taotluse tagasivõtmise ajal arvamusel, et Sutenti kasulikkus nende neeruvähiga patsientide ravis, kellel on pärast kirurgilist ravi suur neeruvähi taastekke risk, ei ole suurem kui sellega kaasnevad riskid.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Sutent not be changed to add the treatment of patients at high risk of kidney cancer returning after surgery.
Estonian: Tuginedes esitatud andmete analüüsile oli inimravimite komitee andnud taotluse tagasivõtmise ajal negatiivse arvamuse ega soovitanud muuta Sutenti müügiluba ega lisada selliste patsientide ravi, kellel on pärast kirurgilist ravi suur neeruvähi taastekke risk.
English: Sutent was expected to be used to delay or prevent the return of kidney cancer in patients who have had surgery and are at high risk of their cancer coming back.
Estonian: Sutenti kavatseti kasutada neeruvähi taastekke edasilükkamiseks või tõkestamiseks patsientidel, kel on pärast kirurgilist ravi suur vähi taastekke risk.
English: What was Sutent expected to be used for?
Estonian: Milleks kavatseti Sutenti kasutada?
English: What is happening with Sutent for treatment in other uses?
Estonian: Kuidas mõjutab taotluse tagasivõtmine Sutenti kasutamist teistel näidustustel?
English: When data from patients at highest risk of cancer returning were looked at separately, the benefits of Sutent were still not convincing.
Estonian: Samuti ei olnud Sutenti kasulikkus veenev ka vähi taastekke suurima riskiga patsientide andmete eraldi analüüsimisel.
English: After first opening: 100 days
Estonian: Pärast esmakordset avamist: 100 päeva
English: The usual supportive measures should be employed.
Estonian: Tuleb rakendada tavalisi toetavaid meetmeid.
English: Never change the dose yourself.
Estonian: Ärge muutke kunagi ise ravimi annust.
English: Males may be at greater risk than females.
Estonian: Meestel võib olla suurem risk kui naistel.
English: • Wait until the tablet has broken down completely.
Estonian: • Oodake, kuni tabletid on täielikult lahustunud.
English: Adolescents and adults (>12 years old)
Estonian: Noorukid ja täiskasvanud (> 12-aastased)
English: This medicine should be used within 100 days after first opening.
Estonian: See ravim tuleb ära kasutada 100 päeva jooksul pärast esmast avamist.
English: Date of first authorisation: 20 September 2018
Estonian: Müügiloa esmase väljastamise kuupäev: 20. septembril 2018
English: The maximum recommended dose should not be exceeded.
Estonian: Maksimaalset soovitatavat annust ei tohi ületada.
English: Interaction studies have only been performed in adults.
Estonian: Koostoimete uuringuid on läbi viidud ainult täiskasvanutel.
English: Therefore, vigabatrin should only be used after careful benefit/ risk assessment compared with alternatives.
Estonian: Seetõttu tohib vigabatriini kasutada ainult pärast hoolikat kasu/riski hindamist võrreldes alternatiividega.
English: Nearly half of the cases involved multiple drug ingestions.
Estonian: Peaaegu pooled juhtudest hõlmasid mitme ravimi kasutamist.
English: Always give this medicine to your child exactly as the doctor has told you.
Estonian: Andke seda ravimit oma lapsele alati täpselt nii, nagu arst on teile selgitanud.
English: Time to reach maximum plasma concentrations (tmax) is approximately 1 hour.
Estonian: Aeg maksimaalse plasmakontsentratsiooni (tmax) saavutamiseni on ligikaudu 1 tund.
English: Ask your child's doctor to show you how to give this medicine.
Estonian: Paluge oma lapse arstilt, et ta näitaks teile, kuidas seda ravimit anda.
English: There is no direct correlation between plasma concentration and efficacy.
Estonian: Puudub otsene korrelatsioon plasmakontsentratsiooni ja efektiivsuse vahel.
English: How to give this medicine
Estonian: Kuidas seda ravimit manustada
English: Such patients may respond to a lower maintenance dose.
Estonian: Sellised patsiendid võivad reageerida väiksemale säilitusannusele.
English: Always check the label and the size of the tablets to make sure you are giving the right dose.
Estonian: Kontrollige alati tablettide märgistust ja suurust veendumaks, et annate õige annuse.
English: Suicidal ideation and behaviour
Estonian: Enesetapumõtted ja -käitumine
English: Neurologic and psychiatric conditions
Estonian: Neuroloogilised ja psühhiaatrilised seisundid
English: The exact nature of this interaction is presently not understood, however, in the majority of cases it is unlikely to be of therapeutic significance.
Estonian: Selle koostoime täpset olemust praegu ei mõisteta, kuid enamikul juhtudel ei ole sellel tõenäoliselt terapeutilist tähtsust.
English: White oval tablets.
Estonian: Valged ovaalsed tabletid.
English: It is important that you tell the doctor promptly if there is any change in your child's vision.
Estonian: On tähtis, et teataksite arstile kohe, kui teie lapse nägemises esineb mingeid muutusi.
English: Hence, this undesirable effect can only be reliably detected by systematic perimetry which is usually possible only in patients with a developmental age of more than 9 years.
Estonian: Seetõttu saab seda kõrvaltoimet usaldusväärselt avastada ainult süstemaatilise perimeetriaga, mida on tavaliselt võimalik teha ainult patsientidel, kelle arenguline vanus on üle 9 aasta.
English: The mechanism of this effect is not known and the available data do not exclude the possibility of an increased risk for vigabatrin.
Estonian: Selle mõju mehhanism ei ole teada ja olemasolevad andmed ei välista vigabatriini puhul suurenenud riski võimalust.
English: These responses are delayed and reduced beyond the normal limits.
Estonian: Need reaktsioonid on viivitunud ja normaalsest väiksemad.
English: Use only water to prepare solution.
Estonian: Kasutage lahuse valmistamiseks ainult vett.
English: The doctor will adjust the dose during treatment as necessary.
Estonian: Arst kohandab annust ravi jooksul vajaduse järgi.
English: Do not stop suddenly as this may cause your child's seizures to occur again.
Estonian: Ärge lõpetage ravi äkki, sest see võib põhjustada teie lapsel episoodide taasesinemist.
English: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne France
Estonian: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne Prantsusmaa
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja pudelil.
English: Pharmacotherapeutic group: Antiepileptics, fatty acid derivatives, ATC code: N03AG04
Estonian: Farmakoterapeutiline rühm: epilepsiavastased ained, rasvhappe derivaadid, ATC kood: N03AG04
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Estonian: Piiratud tingimustel väljastatav retseptiravim (vt I lisa: ravimi omaduste kokkuvõte, lõik 4.2).
English: For children aged 1 month to less than 7 years
Estonian: Lastele vanuses 1 kuu kuni 7 aastat
English: Children (from 8 to 12 years old)
Estonian: Lapsed (vanuses 8…12 aastat)
English: Common Uncommon Rare Very rare Not known
Estonian: Harv Väga harv Teadmata