FrancophonIA/ELRC3.0 huggingface dataset:
English: Xalkori is available as capsules (200 mg and 250 mg).The recommended dose is 250 mg twice per day.
Estonian: Xalkorit turustatakse kapslitena (200 mg ja 250 mg).Soovitatav annus on 250 mg kaks korda ööpäevas.
English: Other information about Xalkori
Estonian: Muu teave Xalkori kohta
English: If certain side effects develop the doctor may decide to interrupt or reduce the dose to 200 mg twice per day then to 250 mg once per day.
Estonian: Teatud kõrvalnähtude tekkimisel võib arst otsustada ravi lõpetada või vähendada annust 200 mg-ni kaks korda ööpäevas ja edasi 250 mg-ni üks kord ööpäevas.
English: Therefore the Agency decided that Xalkori's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu otsustas EMA, et Xalkori kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: What is Xalkori and what is it used for?
Estonian: Mis on Xalkori ja milleks seda kasutatakse?
English: It is not intended to provide practical advice on how to use Xalkori.
Estonian: Hindamisaruandes ei anta Xalkori kasutamise praktilisi nõuandeid.
English: This is a summary of the European public assessment report (EPAR) for Xalkori.
Estonian: See on ravimi Xalkori Euroopa avaliku hindamisaruande kokkuvõte.
English: Why is Xalkori approved?
Estonian: Miks Xalkori heaks kiideti?
English: The most common side effects with Xalkori (seen in more than 1 in 4 patients) are vision problems, nausea (feeling sick), diarrhoea, vomiting, oedema (swelling), increases in liver enzymes in the blood, decreased appetite, constipation, dizziness, neuropathy (pain due to nerve damage) and tiredness.
Estonian: Xalkori kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 4st) on nägemisprobleemid, iiveldus, kõhulahtisus, oksendamine, tursed, maksaensüümide sisalduse suurenemine veres, isutus, kõhukinnisus, peapööritus, neuropaatia (närvikahjustusest tingitud valu) ja väsimus.
English: Treatment with Xalkori should be started and supervised by a doctor who is experienced in using cancer medicines.
Estonian: Ravi Xalkoriga peab alustama ja jälgima vähiravimite kasutamises kogenud arst.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xalkori have also been included in the summary of product characteristics and the package leaflet.
Estonian: Xalkori ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: ALK and ROS1 belong to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells.
Estonian: ALK ja ROS1 kuuluvad retseptor-türosiinkinaasideks (RTK) nimetatavate valkude rühma, mis on seotud rakkude kasvamisega.
English: For patients with ROS1-positive NSCLC, for whom no specific treatments are currently available, the Agency noted the evidence of a high response rate, in particular for patients who had previously received other cancer treatments.
Estonian: ROS1-positiivse mitte-väikerakulise kopsuvähiga patsientidel, kellel praegu puuduvad muud spetsiifilised raviviisid, täheldas amet suurt ravivastuse määra, eelkõige varem teisi vähiravimeid saanud patsientidel.
English: This is considered a favourable response when compared with response rates of around 20 to 30% to previous treatments, in those patients who had been given them.
Estonian: Seda peetakse soodsaks ravivastuseks, sest varem ravitud patsientide ravivastuse määrad olid teiste ravimitega 20-30%.
English: The most serious side effects are liver damage, pneumonitis (lung inflammation), neutropenia (low blood levels of neutrophils, a type of white blood cell) and prolonged QT interval (a problem with the electrical activity of the heart).
Estonian: Kõige raskemad kõrvalnähud on maksakahjustused, pneumoniit (kopsukoe põletik), neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus) ja QT-intervalli pikenemine (südame elektrilise talitluse häire).
English: The active substance in Xalkori, crizotinib, is an RTK inhibitor.
Estonian: Xalkori toimeaine krisotiniib on RTK inhibiitor.
English: What is the risk associated with Xalkori?
Estonian: Mis riskid Xalkoriga kaasnevad?
English: Xalkori contains the active substance crizotinib.
Estonian: Xalkori sisaldab toimeainena krisotiniibi.
English: This means that the cancer cells contain changes affecting the gene responsible for the protein ROS1.
Estonian: et vähirakkudes on muutused, mis mõjutavad valku ROS1 tekitavat geeni.
English: A study in 53 ROS1-positive patients with advanced disease showed that around 70% of patients taking Xalkori (37 out of 53) responded completely or partially to treatment.
Estonian: 53 kaugelearenenud ROS1-positiivse patsiendi uuringus oli täieliku või osalise ravivastusega patsiente Xalkori uuringurühmas 70% (37 patsienti 53st).
English: The European Medicines Agency concluded that treatment with Xalkori increases the time patients with ALK-positive NSCLC live without the disease getting worse, irrespective of whether they are previously treated.
Estonian: Euroopa Ravimiamet (EMA) järeldas, et Xalkori-ravi suurendab ALK-positiivse mitte-väikerakulise kopsuvähiga patsientide progresseerumiseta elumust olenemata sellest, kas neid on varem ravitud.
English: The company that markets Xalkori will ensure that doctors who are expected to prescribe Xalkori receive a pack containing the medicine's summary of product characteristics and a patient alert card to be given to patients.
Estonian: Xalkori turustaja varustab kõik Xalkorit määravad arstid teabepakmega, milles on ravimi omaduste kokkuvõte ja patsiendi hoiatuskaart.
English: It works mainly by blocking the activity of ALK or ROS1, including when the genetic change is present, thereby reducing the growth and spread of the cancer in ALK-positive or in ROS1-positive NSCLC.
Estonian: Xalkori toimib peamiselt ALK või ROS1 blokeerimise teel, ka geneetilise muutuse esinemisel, vähendades seeläbi ALK-positiivse või ROS1-positiivse mitteväikerakulise kopsuvähi kasvu ja levikut.
English: In patients either ‘ALK-positive' or ‘ROS1-positive', the ALK or ROS1 protein is abnormally active and can promote the growth of cancer cells and the development of new blood vessels that supply them.
Estonian: ALK- või ROS1-positiivsetel patsientidel on ALK- või ROS1-valk ebanormaalselt aktiivne ning võib soodustada vähirakkude kasvamist ja nende verevarustuseks vajalike uute veresoonte arenemist.
English: For the previously untreated patients, 6 out of 7 responded to treatment.
Estonian: Varem ravimata patsientidest tekkis ravivastus 6 patsiendil 7st.
English: For the full list of all side effects reported with Xalkori, see the package leaflet.
Estonian: Xalkori kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: For practical information about using Xalkori, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Xalkori kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Doses may need to be adjusted in patients with severely reduced kidney function.
Estonian: Raske neerupuudulikkusega patsientidel võib olla vaja annust kohandada.
English: Xalkori is a cancer medicine used on its own to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC), when the disease is advanced:
Estonian: Xalkori on vähiravim, mida kasutatakse ainuravimina täiskasvanutel teatud tüüpi kopsuvähi, nimelt kaugelearenenud mitte-väikerakulise kopsuvähi (NSCLC) ravimiseks.
English: How does Xalkori work?
Estonian: Kuidas Xalkori toimib?
English: A study in 347 previously treated ALK-positive patients showed that those taking Xalkori lived on average for nearly 8 months without their disease getting worse compared with 3 months in patients who were treated with either pemetrexed or docetaxel.
Estonian: Varem ravitud 347 ALK-positiivse patsiendi uuringus oli progresseerumiseta elumus Xalkoriga ravitud patsientidel keskmiselt ligikaudu 8 kuud ja kas pemetrekseedi või dotsetakseeliga ravitud patsientidel 3 kuud.
English: What benefits of Xalkori have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Xalkori kasulikkus?
English: For more information about treatment with Xalkori, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Xalkoriga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: How is Xalkori used?
Estonian: Kuidas Xalkorit kasutatakse?
English: • It is used if the NSCLC is ‘ALK-positive', which means that the cancer cells contain certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Estonian: • Xalkorit kasutatakse siis, kui mitte-väikerakuline kopsuvähk on ALK-positiivne, mis tähendab, et vähirakkudes on muutused, mis mõjutavad teatud valku - anaplastilise lümfoomi kinaasi (ALK)
English: • It is also used when the NSCLC is ‘ROS1-positive'.
Estonian: • Ravimit kasutatakse ka siis, kui mitte-väikerakuline kopsuvähk on ROS1-positiivne.
English: In another study in 343 patients who had not received previous treatment for their NSCLC before, patients treated with Xalkori lived on average for nearly 11 months without their disease getting worse compared with 7 months in patients who were treated with pemetrexed-containing therapy.
Estonian: Varem ravimata 343 mitte-väikerakulise kopsuvähiga patsiendi uuringus oli progresseerumiseta elumus (kui kaua patsiendid elasid haiguse süvenemiseta) Xalkoriga ravitud patsientidel keskmiselt ligikaudu 11 kuud ja pemetrekseedi sisaldava ravimikombinatsiooniga ravitud patsientidel 7 kuud.
English: Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Estonian: Kui patsiendil tekivad teatud rasked kõrvalnähud, võib olla vaja annuste manustamist edasi lükata või ravi katkestada.
English: ROS1-positive NSCLC
Estonian: ROS1-positiivne mitte-väikerakuline kopsuvähk
English: The medicine can only be obtained with a prescription.
Estonian: Xalkori on retseptiravim.
English: The presence of the genetic changes affecting ALK (‘ALK-positive' status) or ROS1 (‘ROS1-positive' status) has to be confirmed before starting treatment with Xalkori.
Estonian: Enne ravi alustamist peab kontrollima ALK-positiivsust või ROS1-positiivsust põhjustava geenidefekti esinemist.
English: ALK-positive NSCLC
Estonian: ALK-positiivne mitte-väikerakuline kopsuvähk
English: What measures are being taken to ensure the safe and effective use of Vepacel?
Estonian: Mis meetmed võetakse, et tagada Vepaceli ohutu ja efektiivne kasutamine?
English: The vaccine is given according to official recommendations.
Estonian: Vaktsiini määratakse vastavalt ametlikele soovitustele.
English: Side effects are similar in children.
Estonian: Laste kõrvalnähud on sarnased.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vepacel on 17 February 2012.
Estonian: Euroopa Komisjon andis Vepaceli müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 17. veebruaril
English: The full EPAR for Vepacel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Vepaceli 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 Vepacel is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Vepaceli võimalikult ohutu kasutamine.
English: Other information about Vepacel
Estonian: Muu teave Vepaceli kohta
English: Vepacel contains a flu strain called A/Vietnam/1203/2004 (H5N1).
Estonian: Vepacel sisaldab gripiviiruse tüve A/Vietnam/1203/2004 (H5N1).
English: Vepacel must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine or to any of the substances found at trace (very low) levels in the vaccine such as formaldehyde, benzonase, sucrose, trypsin or vero cell protein.
Estonian: Vepaceli ei tohi anda inimestele, kellel on tekkinud anafülaktiline reaktsioon (raske allergiline reaktsioon) vaktsiini mis tahes komponendi või aine suhtes, mida vaktsiin sisaldab mikrokogustes, näiteks formaldehüüd, bensonaas, sahharoos, trüpsiin või Vero rakkude valk.
English: What is Vepacel?
Estonian: Mis on Vepacel?
English: What is the risk associated with Vepacel?
Estonian: Mis riskid Vepaceliga kaasnevad?
English: The first main study involved 561 healthy adults, while the second study involved around 3,600 adults including those at higher risk of flu (such as people with a long-term illness or a weakened immune system).
Estonian: Esimeses põhiuuringus osales 561 tervet täiskasvanut ja teises ligikaudu 3600 täiskasvanut, sh suure gripiriskiga inimesed (nt pikaajalise haigusega või nõrgenenud immuunsüsteemiga inimesed).
English: Both studies looked separately at people aged above and below 60 years old.
Estonian: Kummaski uuringus vaadeldi eraldi üle ja alla 60-aastaste rühma.
English: Vepacel is a ‘prepandemic' vaccine.
Estonian: Vepacel on prepandeemiline vaktsiin.
English: The CHMP decided that the benefits of Vepacel are greater than its risks and recommended that it be granted a marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Vepaceli kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda vaktsiini müügiloa.
English: The vaccine is given by injection into the shoulder or thigh in two single doses, at least three weeks apart.
Estonian: Vaktsiini manustatakse süstena õla- või reielihasesse kahe üksikannusena, mille vahele tuleb jätta vähemalt kolm nädalat.
English: This is a summary of the European public assessment report (EPAR) for Vepacel.
Estonian: See on vaktsiini Vepacel Euroopa avaliku hindamisaruande kokkuvõte.
English: Moreover, protective levels of antibodies were seen in 71.6% of patients with a weakened immune system and 77.5% of patients with a long-term illness.
Estonian: Kaitsev antikehade sisaldus oli tekkinud ka 71,6%-l nõrgenenud immuunsüsteemiga osalejatest ja 77,5%-l pikaajalise haigusega osalejatest.
English: The Committee noted that Vepacel produced a good antibody response in healthy adults and an acceptable response in healthy adults aged 60 and over and in patients with a weakened immune system or long-term illness.
Estonian: Komitee märkis, et Vepacel tekitas tervetel täiskasvanutel hea antikehavastuse ning rahuldava vastuse vähemalt 60-aastastel ja nõrgenenud immuunsüsteemiga või pikaajalise haigusega inimestel.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
Estonian: Inimravimite komitee kriteeriumide järgi võib prepandeemilist vaktsiini pidada sobivaks, kui see tekitab antikehade kaitsva sisalduse vähemalt 70%-l täiskasvanutest.
English: The use of Vepacel was later extended to children from 6 months of age since the vaccine was shown to produce a good antibody response also in this population, with a safety profile similar to that seen in adults.
Estonian: Vepaceli kasutamist laiendati hiljem vähemalt 6-kuustele lastele, sest tõestati, et vaktsiin tekitab selles rühmas hea antikehavastuse ja ohutusprofiil sarnaneb täiskasvanute omaga.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vepacel, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati Vepaceli omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Vaccination with Vepacel in adults produced an antibody response that met these criteria.
Estonian: Täiskasvanute vaktsineerimine Vepaceliga tekitas nendele kriteeriumidele vastava antikehade sisalduse.
English: Two main studies provided data on vaccination with Vepacel in adults.
Estonian: Vepaceliga vaktsineeritud täiskasvanutel tehti kaks põhiuuringut.
English: Vepacel is a vaccine.
Estonian: Vepacel on vaktsiin.
English: For more information about treatment with Vepacel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Vepaceli kasutamise kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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 Vepacel.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: The viruses used in Vepacel are grown in mammal cells (‘vero cells'), as opposed to hen's eggs.
Estonian: Vepacelis kasutatavaid viirusi kasvatatakse imetajarakkudes (Vero rakukultuuris), mitte kanamunades.
English: No major safety issues were seen during the studies and the side effects seen were generally mild and similar to those seen with other flu vaccines.
Estonian: Esinenud kõrvalnähud olid üldiselt kerged ja muude gripivaktsiinide kõrvalnähtudega sarnased.
English: The booster vaccination (one year after the 2-dose vaccination with Vepacel) also produced a strong antibody response against the strains used in the booster and in Vepacel.
Estonian: Ka kordusvaktsineerimne (üks aasta pärast vaktsineerimist Vepaceli 2 annusega) tekitas tugeva antikehareaktsiooni kordusvaktsiinis ja Vepacelis sisaldunud tüvede vastu.
English: The vaccine has been developed so that it can be used before or during a flu pandemic to provide protection against the H5N1 virus.
Estonian: Vaktsiin on välja töötatud nii, et seda saab kasutada enne gripipandeemiat ja selle ajal H5N1-viiruse eest kaitsmiseks.
English: The Committee also noted that Vepacel produced a reasonable antibody response against other H5N1 strains that could potentially cause a flu pandemic.
Estonian: Komitee märkis ka, et Vepacel tekitas mõistliku antikehavastuse muude H5N1-tüvede suhtes, mis võivad põhjustada gripipandeemia.
English: Vepacel is a vaccine for use in adults and children from 6 months of age to protect against flu caused by the H5N1 (“bird flu”) subtype of the influenza A virus.
Estonian: Vepacel on vaktsiin, mida kasutatakse täiskasvanutel ja vähemalt 6-kuustel lastel, et kaitsta neid Atüüpi gripiviiruse alatüübi H5N1 (nn linnugripiviiruse) põhjustatud gripi eest.
English: In both studies, participants were given two doses of Vepacel followed by a booster dose (given after six months, one year or two years) of a vaccine containing different strengths of the same H5N1 flu strain as in Vepacel or a different H5N1 flu strain.
Estonian: Mõlemas uuringus manustati osalejatele kaks annust Vepaceli ja seejärel (6 kuu, 1 aasta või 2 aasta pärast) revaktsineerimisannus, mis sisaldas mitmesuguse tugevusega sama H5N1-viiruse tüve kui Vepacel või muud H5N1-viiruse tüve.
English: This may help to provide protection in the event of a pandemic caused by a new strain of the H5N1 virus.
Estonian: See võib aidata kaitsta pandeemia korral, mille tekitab H5N1-viiruse uus tüvi.
English: The study in children showed that vaccination with Vepacel brought about similar levels of antibodies to those seen in adults: at 21 days after the second injection, 85.4% of children aged 9 to 17 years, 72.9% of children aged 3 to 8 years and 68.8% of children aged 6 to 35 months had levels of antibodies that would protect them against H5N1.
Estonian: Laste uuringus tekitas vaktsineerimine Vepaceliga sarnase antikehasisalduse kui täiskasvanutel: lapsi, kellel oli 21 päeva pärast teist süstet tekkinud H5N1-tüve eest kaitsev antikehasisaldus, oli 9-17aastaste vanuserühmas 85,4%, 3-8-aastaste vanuserühmas 72,9% ja 6-35-kuuste vanuserühmas 68,8%.
English: This vaccine contains a strain of the H5N1 virus.
Estonian: Vaktsiin sisaldab H5N1-viiruse üht tüve.
English: If vaccination is necessary, facilities to resuscitate patients need to be immediately available.
Estonian: Kui vaktsineerimist on vaja, peab olema võimalik kasutada erakorralist meditsiinilist abi.
English: What benefit has Vepacel shown during the studies?
Estonian: Milles seisneb uuringute põhjal Vepaceli kasulikkus?
English: In both studies, patients who received Vepacel and a booster with a different H5N1 flu strain produced antibodies that could react with several strains of H5N1 virus.
Estonian: Mõlemas uuringus tekkisid patsientidel, kes said Vepaceli ja H5N1-viiruse muud tüve sisaldanud revaktsineerimisannust, antikehad, mis võivad reageerida H5N1-viiruse mitme tüvega.
English: For the full list of all side effects reported with Vepacel, see the package leaflet.
Estonian: Vepaceli kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The most common side effects with Vepacel (seen in more than 1 person in 10) in adults are headache, fatigue (tiredness) and pain at the site of injection.
Estonian: Vepaceli kõige sagedamad kõrvalnähud täiskasvanutel (võivad esineda enam kui 1 patsiendil 10st) on peavalu, väsimus ja süstekoha valulikkus.
English: Vepacel has also been studied in a main study involving 657 healthy children aged 6 months to 17 years, who were given two doses of Vepacel, three weeks apart.
Estonian: Vepaceli uuriti ka põhiuuringus, milles osales 657 tervet 6-kuust kuni 17-aastast last, kes said Vepaceli kaks annust (teise annuse 3 nädalat pärast esimest).
English: How is Vepacel used?
Estonian: Kuidas Vepaceli kasutatakse?
English: What is Vepacel used for?
Estonian: Milleks Vepaceli kasutatakse?
English: In the second main study, 85.8% of healthy adults under 60 and 80.2% of healthy adults aged 60 and over had protective levels of antibodies.
Estonian: Teises põhiuuringus oli terveid täiskasvanuid, kellel tekkis kaitsev antikehade sisaldus, alla 60aastastest 85,8% ja vähemalt 60-aastastest 80,2%.
English: Health experts are concerned that a future flu pandemic could be caused by a strain of the H5N1 virus.
Estonian: Tervishoiuekspertide arvates võib järgmise gripipandeemia põhjustada H5N1-gripiviiruse mingi tüvi.
English: Why has Vepacel been approved?
Estonian: Miks Vepacel heaks kiideti?
English: All of the studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against H5N1.
Estonian: Kõigis uuringutes jälgiti, kuidas tekivad vaktsiini toimel H5N1-tüve vastased antikehad (immunogeensus).
English: Some children also received a booster dose of a vaccine containing a different H5N1 flu strain after one year.
Estonian: Osa lastest sai aasta pärast vaktsiini korduvannuse, mis sisaldas teist H5N1-gripitüve.
English: In the first main study, at 21 days after the second injection, 72.5% of adults under 60 and 74.1% of adults aged 60 and over had levels of antibodies that would protect them against H5N1.
Estonian: Esimeses põhiuuringus oli täiskasvanuid, kellel oli 21 päeva pärast teist süstet tekkinud H5N1-viiruse vastu kaitsev antikehade sisaldus, alla 60-aastastest 72,5% ja vähemalt 60-aastastest 74,1%.
English: Influenza vaccine (whole virion, inactivated)
Estonian: Kokkuvõte üldsusele inaktiveeritud tervikviriooni sisaldav gripivaktsiin
English: How does Vepacel work?
Estonian: Kuidas Vepacel toimib?
English: How has Vepacel been studied?
Estonian: Kuidas Vepaceli uuriti?
English: It was decided that a re-inspection would be done after one year to assess the progress in eliminating the major deficiencies.
Estonian: Otsustati, et ühe aasta pärast tehakse uus kontroll, et hinnata peamiste puuduste kõrvaldamist.
English: Therefore, at present the positive benefit-risk cannot be confirmed.
Estonian: Järelikult ei saa praegu kinnitada kasulikkuse ja riski positiivset tasakaalu.