FrancophonIA/ELRC3.0 huggingface dataset:
English: • chronic lymphocytic leukaemia (CLL) in both previously treated and untreated patients;
Estonian: • krooniline lümfotsüütleukeemia nii varem ravitud kui ka ravimata patsientidel;
English: In a study in 111 patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, 21% of patients taking Imbruvica had complete response (i.e. disappearance of all signs of cancer) and 47% had partial response (i.e. the patient improved but some signs of the disease remained).
Estonian: Uuringus, milles osales 111 mantelrakulise lümfoomiga patsienti, kellel haigus ei allunud varasemale ravile või tekkis pärast varasemat ravi uuesti, saavutas Imbruvicaga täieliku ravivastuse (pärast ravi puudusid kõik vähisümptomid) 21% patsientidest ja osalise ravivastuse (patsiendi seisund paranes, kuid säilis mõni haiguse sümptom) 47% patsientidest.
English: In a study involving 150 patients with Waldenström's macroglobulinaemia, after 26 months, death or signs that the cancer was progressing occurred in 19% of patients who took Imbruvica together with rituximab compared with 56% of patients who took only rituximab.
Estonian: Uuringus, milles osales 150 Waldenströmi makroglobulineemiaga patsienti, oli 26 kuu pärast surnud või vähi progresseerumise tunnustega patsiente Imbruvicat koos rituksimabiga kasutanute seas 19% ja ainult rituksimabi kasutanute seas 56%.
English: What benefits of Imbruvica have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Imbruvica kasulikkus?
English: Response to treatment was measured as a reduction in the blood levels of the protein IgM, which is present in high levels in patients with Waldenström's disease.
Estonian: Ravivastust mõõdeti vere IgM-i (teatud valk) sisalduse vähenemisega; selle valgu sisaldus on Waldenströmi tõvega patsientidel väga suur.
English: For the full list of side effects of Imbruvica, see the package leaflet.
Estonian: Imbruvica kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: • Waldenström's macroglobulinaemia (also known as lymphoplasmacytic lymphoma) Imbruvica can be taken alone but can also be taken with bendamustine and rituximab or with obinutuzumab in certain patients with CLL and with rituximab in patients with Waldenström's macroglobulinaemia.
Estonian: Imbruvicat võib kasutada ainuravimina, kuid ka koos bendamustiini ja rituksimabiga või koos obinutusumabiga teatud kroonilise lümfotsüütleukeemiaga patsientidel ning koos rituksimabiga Waldenströmi makroglobulineemiaga patsientidel.
English: An overview of Imbruvica and why it is authorised in the EU
Estonian: Ülevaade ravimist Imbruvica ja ELis müügiloa väljastamise põhjendus
English: Imbruvica contains the active substance ibrutinib.
Estonian: Imbruvica toimeaine on ibrutiniib.
English: The company that markets Imbruvica needs to provide further data on the benefits of Imbruvica in the treatment of chronic lymphocytic leukaemia from follow-up of previously treated patients.
Estonian: Imbruvica turustaja peab esitama lisaandmed Imbruvica kasulikkuse kohta kroonilise lümfotsüütleukeemia ravis.
English: In addition, Imbruvica was effective in patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, a group of patients with poor prognosis and few other treatment options.
Estonian: Imbruvica oli efektiivne ka halva prognoosi ja väheste muude ravivalikutega patsientidel, kellel mantelrakuline lümfoom ei allunud varasemale ravile või tekkis pärast varasemat ravi uuesti.
English: Imbruvica was shown to be effective at delaying progression of chronic lymphocytic leukaemia, both in untreated patients and in those who had received treatment previously.
Estonian: On tõendatud Imbruvica efektiivsus kroonilise lümfotsüütleukeemia progresseerumise edasilükkamisel varem ravitud ning ravimata patsientidel.
English: In a study in 229 previously untreated patients, after 31 months, 79% of patients treated with Imbruvica and obinutuzumab were alive with their disease not having progressed compared with 36% of patients who took chlorambucil and obinutuzumab.
Estonian: Uuringus, milles osales 229 varem ravimata patsienti, oli 79% Imbruvica ja obinutusumabiga ravitud patsientidest 31 kuu järel elus ja nende haigus ei olnud progresseerunud.
English: In one study in 391 patients whose disease did not respond to or had come back after previous treatment, 66% of patients receiving Imbruvica were still alive after one year with their disease not having progressed compared with around 6% of patients receiving another cancer medicine, ofatumumab.
Estonian: Põhiuuringus, milles osales 391 patsienti, kellel haigus ei allunud varasemale ravile või tekkis pärast varasemat ravi uuesti, oli 66% Imbruvicat kasutanud patsientidest ühe aasta järel elus ja nende haigus ei olnud progresseerunud.
English: Chronic lymphocytic leukaemia
Estonian: Krooniline lümfotsüütleukeemia
English: St. John's wort (a herbal remedy used for depression and anxiety) must not be used in patients treated with Imbruvica.
Estonian: Imbruvicaga ravitavad patsiendid ei tohi kasutada liht-naistepuna (taimne depressiooni- ja ärevusravim).
English: In a study involving 269 patients who had not been treated before, around 90% of patients receiving Imbruvica were still alive with their disease not having progressed after 1.5 years of treatment compared with around 52% of patients receiving a cancer medicine called chlorambucil.
Estonian: Uuringus, milles osales 269 varem ravimata patsienti, oli ligikaudu 90% Imbruvicat kasutanud patsientidest 1,5 raviaasta järel elus ja nende haigus ei olnud progresseerunud.
English: 27 February 2012
Estonian: 27. veebruar 2012
English: The European Commission issued a decision on 27 February 2012.
Estonian: Euroopa Komisjon tegi otsuse 27. veebruaril 2012.
English: Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 107 of Directive 2001/83/EC
Estonian: Määruse (EÜ) nr 726/2004 artikli 20 ja direktiivi 2001/83/EÜ artikli 107 kohaste menetluste tulemus
English: 1 Procedure numbers: EMEA/H/A-107/1287; EMEA/H/000607/A-20/0021; EMEA/H/C/000315/A-20/0040; and EMEA/H/C/000602/A-20/0008.
Estonian: 1 Hindamismenetluse numbrid: EMEA/H/A-107/1287, EMEA/H/000607/A-20/0021, EMEA/H/C/000315/A-20/0040 ja EMEA/H/C/000602/A-20/0008.
English: What is somatropin?
Estonian: Mis on somatropiin?
English: Why was somatropin reviewed?
Estonian: Miks somatropiini taotlus uuesti läbi vaadati?
English: • Patients or their carers who have any questions should speak to their doctor or pharmacist.
Estonian: • Küsimuste korral peavad patsiendid või nende hooldajad pöörduma oma arsti või apteekri poole.
English: • The maximum recommended daily dose should not be exceeded.
Estonian: • Ravimite maksimaalseid soovitatavaid annuseid ei tohi ületada.
English: In particular, an increased risk of mortality due to bone tumours and cardiovascular events (such as bleeding in the brain) was seen.
Estonian: Eelkõige täheldati suuremat suremuse riski luukasvajate või südameveresoonkonna juhtude (näiteks ajuverejooks) tõttu.
English: The nationally authorised medicines are Genotropin, Humatrope, Maxomat, Norditropin, Saizen and Zomacton.
Estonian: Riiklike müügilubadega ravimid on Genotropin, Humatrope, Maxomat, Norditropin, Saizen ja Zomacton.
English: They have been authorised in the EU since the 1980s through centralised or national procedures.2 The approved indications vary for the different somatropin-containing medicines: they may be used as hormone replacement therapy, and to correct short stature (height) in children with certain genetic diseases (Turner syndrome or Prader Willi syndrome), children who have long-standing kidney problems and children born small for their gestational age.
Estonian: Euroopa Liidus on nende ravimite müügiload antud tsentraliseeritud või riikliku menetluse korras alates 1980. aastatest.2 Erinevate somatropiini sisaldavate ravimite heakskiidetud näidustused on mitmesugused: neid kasutatakse hormoonasendusraviks ja väikese kehapikkuse (kasvu) korrigeerimiseks teatud geneetiliste haigustega lastel (Turneri sündroom või Praderi-Willi sündroom), aga ka pikaajaliste neeruprobleemidega lastel ning oma sünniaja kohta väikese pikkusega lastel.
English: The study, called ‘Santé Adulte GH Enfant' (SAGhE) study, was initiated in October 2007 and aimed at improving knowledge on the safety and appropriateness of somatropin
Estonian: Uuring „Santé Adulte GH Enfant“ (SAGhE) algas 2007. aasta oktoobris ning selle eesmärgiks oli täiendada teadmisi somatropiini ohutuse ja kasutamise korrektsuse kohta.
English: However, the Committee noted that the available data on the long-term effects of somatropin treatment are very limited.
Estonian: Samas märkis inimravimite komitee, et olemasolevad andmed somatropiiniravi pikaajaliste toimete kohta on väga piiratud.
English: It looked at data on 10,000 adults who started treatment between 1985 and 1996, using a mandatory national registry.
Estonian: Uuringus vaadeldi andmeid kohustuslikus riiklikus registris 10 000 täiskasvanu kohta, kelle ravi alustati ajavahemikus 1985-1996.
English: Somatropin is a copy of naturally occurring human growth hormone, produced by a method known as ‘recombinant DNA technology'.
Estonian: Somatropiin on loodusliku inimkasvuhormooni koopia, mida valmistatakse rekombinant-DNA-tehnika abil.
English: Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fats and carbohydrates.
Estonian: Kasvuhormoon soodustab kasvu lapse- ja noorukieas ning mõjutab ka valkude, rasvade ja süsivesikute ainevahetust organismis.
English: Consequently, in December 2010 the French agency asked the CHMP to issue an opinion on the impact of these data on the benefit-risk balance of somatropin-containing medicines, and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Estonian: Seetõttu palus Prantsusmaa ravimiamet 2010. aasta detsembris inimravimite komiteel esitada arvamus nende andmete mõju kohta somatropiini sisaldavate ravimite kasulikkuse ja riski suhtele ning kas Euroopa Liidus tuleks nende ravimite müügiload säilitada, muuta, peatada või tühistada.
English: In particular, the harmonised wording will emphasise that somatropin must not be used if there is any evidence of tumour activity, and that the maximum recommended daily dose should not be exceeded.
Estonian: Ühtlustatud sõnastusega tekst eelkõige rõhutab, et somatropiini ei tohi kasutada mis tahes kasvaja kahtluse korral ning ravimi maksimaalseid soovitatavaid annuseid ei tohi ületada.
English: • Patients and healthcare professionals are reminded that the benefits of somatropin continue to outweigh its risks in the approved indications.
Estonian: • Patsientidele ja arstidele kinnitatakse, et somatropiini kasulikkus heakskiidetud näidustustel on endiselt suurem kui sellega seotud riskid.
English: The CHMP concluded that the French SAGhE study had significant methodological limitations and that the results could not be considered robust.
Estonian: Inimravimite komitee järeldas, et Prantsusmaa SAGhE uuringul oli olulisi metodoloogilisi puudusi, mistõttu ei saa selle tulemusi pidada usaldusväärseteks.
English: In December 2010, the French medicines regulatory agency was made aware of preliminary results of a long-term population-based study in France of patients treated during childhood with somatropincontaining medicines.
Estonian: 2010. aasta detsembris teatati Prantsusmaa ravimiametile Prantsusmaal tehtud pikaajalise populatsiooniuuringu esialgsed tulemused nende patsientide kohta, keda oli lapseeas ravitud somatropiini sisaldavate ravimitega.
English: The CHMP reviewed the available data on the safety of somatropin-containing medicines, including data from clinical trials, registries, and observational studies, as well as reports of side effects from post-marketing surveillance.
Estonian: Inimravimite komitee vaatas läbi kõik olemasolevad andmed somatropiini sisaldavate ravimite ohutuse kohta, sealhulgas kliiniliste uuringute, registrite ja vaatluslike uuringute andmed, samuti turustamisjärgsel järelevalvel saadud kõrvalnähtude teated.
English: An analysis in approximately 7,000 of those patients who were treated for growth hormone deficiency and for gestational or idiopathic short stature showed a possible increased risk of mortality with somatropin compared with the general population.
Estonian: Kasvuhormooni puuduse või lühikese sünni- või idiopaatilise pikkuse tõttu ravitud ligikaudu 7000 patsiendi analüüs näitas somatropiiniga ravitud patsientide võimalikku suuremat suremuse riski võrreldes üldpopulatsiooniga.
English: Further mortality data from the European SAGhE study will be available by the end of 2012, and the CHMP considered an analysis of these results to be essential to address any concerns raised by the French study.
Estonian: Täiendavad suremuse andmed Euroopa SAGhE uuringust on kättesaadavad 2012. aasta lõpust, mistõttu inimravimite komitee peab nende andmete analüüsimist väga oluliseks, et kinnitada või ümber lükata uuringuga tõstatatud probleeme.
English: Medicines containing somatropin are given by injection.
Estonian: Somatropiini sisaldavaid ravimeid manustatakse süstimise teel.
English: The risk appeared to be highest when doses higher than the ones approved were used.
Estonian: Risk näis olevat suurem, kui oli kasutatud soovitatavatest annustest suuremaid somatropiini annuseid.
English: The European Medicines Agency has completed a review of the safety and effectiveness of somatropincontaining medicines, following the results of a French study which suggested an increased risk of mortality in patients treated with somatropin compared with the general population.
Estonian: Euroopa Ravimiamet lõpetas somatropiini sisaldavate ravimite ohutuse ja efektiivsuse läbivaatamise, mida põhjustas Prantsusmaal tehtud uuring, mis viitas, et somatropiiniga ravitud patsientidel võib olla üldpopulatsiooniga võrreldes suurem suremuse risk.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefit-risk balance of somatropin-containing medicines remains positive when used in the approved indications at the approved doses.
Estonian: Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, otsustas inimravimite komitee, et somatropiini sisaldavate ravimite kasulikkuse ja riski suhe on endiselt positiivne, kui ravimeid kasutatakse heakskiidetud näidustustel ja heakskiidetud annustes.
English: • Somatropin must not be used in patients with any evidence of tumour activity.
Estonian: • Somatropiini ei tohi kasutada mis tahes kasvaja kahtluse korral.
English: After assessing all other available safety data on somatropin, the CHMP concluded that the potential signal of an increased risk of mortality seen in the French study is not corroborated by any other data, and that the benefit-risk balance of somatropincontaining medicines has not changed.
Estonian: Pärast somatropiini ohutuse kõigi teiste olemasolevate andmete hindamist otsustas inimravimite komitee, et Prantsusmaa uuringus täheldatud võimalikku suuremat suremust muud andmed ei kinnita, mistõttu somatropiini sisaldavate ravimite kasulikkuse ja riski suhe ei ole muutunud.
English: 2 The centrally authorised somatropin-containing medicines are NutropinAq, Omnitrope and Valtropin.
Estonian: 2 Somatropiini sisaldavad ravimid, millel on tsentraalne müügiluba: NutropinAq, Omnitrope ja Valtropin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of somatropin continue to outweigh its risks, but recommended changes to the product information to ensure that somatropin-containing medicines are used appropriately.
Estonian: Euroopa Ravimiameti inimravimite komitee otsustas, et somatropiini kasulikkus on endiselt suurem kui ravimiga kaasnevad riskid, kuid soovitas muuta ravimiinfot, et tagada somatropiini sisaldavate ravimite õige kasutamine.
English: The CHMP also looked into additional data from the unpublished French SAGhE study.
Estonian: Inimravimite komitee tutvus ka avaldamata Prantsusmaa SAGhE uuringu lisaandmetega.
English: At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised somatropin-containing medicines.
Estonian: Euroopa Komisjon palus inimravimite komiteel ühtlasi hinnata ka somatropiini sisaldavaid tsentraliseeritud müügiloaga ravimeid.
English: However, to ensure that somatropin-containing medicines are used appropriately, the CHMP recommended that specific wording be included in the product information of all somatropin-containing medicines.
Estonian: Siiski soovitas inimravimite komitee lisada somatropiini sisaldavate ravimite õige kasutamise tagamiseks kõigi nende teabesse kindla sõnastusega teksti.
English: 10 ml (3.5mg/ml) 1 vial
Estonian: 10 ml (3,5 mg/ml) 1 viaal
English: 10 ml (3.5mg/ml) 5 vials
Estonian: 10 ml (3,5 mg/ml) 5 viaali
English: Pack size
Estonian: Pakendi suurus pen-süstel
English: Mvasi bevacizumab
Estonian: Mvasi bevatsisumaab
English: What measures are being taken to ensure the safe and effective use of Mvasi?
Estonian: Mis meetmed võetakse, et tagada Mvasi ohutu ja efektiivne kasutamine?
English: It must not be given to pregnant women.
Estonian: Ravimit ei tohi kasutada rasedatel.
English: The first infusion of Mvasi should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well.
Estonian: Mvasi esimene infusioon peab kestma 90 minutit ning järgmised infusioonid võivad olla kiiremad, kui patsient talub esimest infusiooni hästi.
English: The cancer responded to treatment in 39% of those given Mvasi (128 of 328 patients) and 42% of those given Avastin (131 of 314).
Estonian: Ravivastuse saavutas 39% Mvasit võtnud patsientidest (128 patsienti 328st) ning 42% Avastini võtnud patsientidest (131 patsienti 314st).
English: The full EPAR for Mvasi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Mvasi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Mvasi
Estonian: Muu teave Mvasi kohta
English: The treatment is continued until the patient no longer benefits from it.
Estonian: Ravi jätkatakse, kuni see on patsiendile kasulik.
English: The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated and the other cancer medicines being used.
Estonian: Annuse suurus on 5-15 mg kehakaalu kilogrammi kohta iga kahe või kolme nädala järel, olenevalt ravitava vähi liigist ja teistest kasutatavatest vähiravimitest.
English: What is Mvasi and what is it used for?
Estonian: Mis on Mvasi ja milleks seda kasutatakse?
English: Why is Mvasi approved?
Estonian: Miks Mvasi heaks kiideti?
English: This means that Mvasi is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Estonian: See tähendab, et Mvasi sarnaneb bioloogilise ravimiga (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba.
English: In addition, a study involving 642 patients with advanced non-small cell lung cancer showed that Mvasi was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel.
Estonian: Peale selle nähtus uuringust, milles osales 642 kaugelearenenud mitteväikerakk-kopsuvähiga patsienti, et Mvasi oli koos vähiravimite karboplatiini ja paklitakseeliga manustatuna sama efektiivne kui Avastin.
English: By attaching to VEGF, Mvasi stops it having an effect.
Estonian: VEGF-iga seondumisel blokeerib Mvasi selle toime.
English: What are the risks associated with Mvasi?
Estonian: Mis riskid Mvasiga kaasnevad?
English: Therefore, the Agency's view was that, as for Avastin, the benefit outweighs the identified risk.
Estonian: Seetõttu on EMA arvamusel, et nagu ka Avastini korral, ületab Mvasi kasulikkus sellega kaasnevad riskid.
English: This is a summary of the European public assessment report (EPAR) for Mvasi.
Estonian: See on ravimi Mvasi Euroopa avaliku hindamisaruande kokkuvõte.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Mvasi has been shown to have a comparable quality, safety and effectiveness to Avastin.
Estonian: Euroopa Ravimiamet otsustas, et vastavalt Euroopa Liidu nõuetele bioloogiliselt sarnaste ravimite kohta on tõendatud Mvasi võrreldav kvaliteedi-, ohutus- ja efektiivsusprofiil ravimi Avastin profiiliga.
English: It is not intended to provide practical advice on how to use Mvasi.
Estonian: Hindamisaruandes ei anta Mvasi kasutamise praktilisi nõuandeid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mvasi have been included in the summary of product characteristics and the package leaflet.
Estonian: Mvasi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: As a result, the cancer cannot develop its own blood supply and cancer cells are starved of oxygen and nutrients, helping to slow down the growth of tumours.
Estonian: Seetõttu ei teki vähirakkudel piisavat verevarustust ning nad jäävad hapniku ja toitaineteta, mis aitab aeglustada kasvajate kasvu.
English: Mvasi is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect its sensitivity to particular medicines.
Estonian: Mvasit kasutatakse koos teiste vähiravimitega, olenevalt võimaliku varasema ravi laadist või sellest, kas vähirakkudes on mutatsioonid (geneetilised muutused), mis mõjutavad vähirakkude tundlikkust konkreetsetele ravimitele.
English: Studies have also shown that giving Mvasi produces similar levels of the active substance in the body to giving Avastin.
Estonian: Uuringud on samuti näidanud, et Mvasi põhjustab organismis samasuguse toimeainesisalduse kui Avastin.
English: Because Mvasi is a biosimilar medicine, the studies on effectiveness and safety of bevacizumab carried out with Avastin do not all need to be repeated for Mvasi.
Estonian: Et Mvasi on bioloogiliselt sarnane ravim, ei pea Avastiniga tehtud bevatsisumaabi efektiivsus- ja ohutusuuringuid Mvasiga kordama.
English: Mvasi is a cancer medicine that is used to treat adults with the following cancers:
Estonian: Mvasi on vähiravim, mida kasutatakse järgmiste vähivormidega täiskasvanute raviks.
English: The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Estonian: Bevatsisumaabi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on hüpertensioon (kõrgvererõhk), väsimus või nõrkus, kõhulahtisus ja kõhuvalu.
English: For more information about treatment with Mvasi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Mvasiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Mvasi can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the use of cancer medicines.
Estonian: Mvasi on retseptiravim ja ravi peab jälgima vähiravimite kasutamises kogenud arst.
English: For practical information about using Mvasi, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Mvasi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The reference medicine for Mvasi is Avastin.
Estonian: Mvasi võrdlusravim on Avastin.