FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that Aerivio Spiromax be approved for use in the EU.
Estonian: Komitee soovitas Aerivio Spiromaxi kasutamise Euroopa Liidus heaks kiita.
English: This means that Aerivio Spiromax is similar to a ‘reference medicine' called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active substances.
Estonian: See tähendab, et Aerivio Spiromax on sarnane võrdlusravimiga Seretide Diskus (sama mis Seretide Accuhaler), mis sisaldab samu toimeaineid.
English: Since Aerivio Spiromax is only available in one high strength (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower strength become appropriate, patients should be switched to an alternative combination of salmeterol and fluticasone propionate containing a lower
Estonian: Et Aerivio Spiromaxi turustatakse ainult ühe suureannuselise ravimvormina (sisaldab 50 µg salmeterooli ja 500 µg flutikasoonpropionaati), siis juhul, kui väiksem annus sobib, tuleb patsient üle viia flutikasoonpropionaadi väiksemat annust sisaldavale teisele salmeterooli ja flutikasoonpropionaadi
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aerivio Spiromax have been included in the summary of product characteristics and the package leaflet.
Estonian: Aerivio Spiromaxi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: In asthma, Aerivio Spiromax can be used in patients whose disease is not adequately controlled despite treatment with a combination of a beta-2 agonist and a lower dose of inhaled corticosteroid, or those whose asthma is already controlled with a long-acting beta-2 agonist and a high-dose of inhaled
Estonian: Astma ravis tohib Aerivio Spiromaxi kasutada patsientidel, kelle haigus ei ole piisavalt ohjatud vaatamata ravile beeta-2-agonisti ja väiksemas annuses inhaleeritava kortikosteroidi kombinatsiooniga või kelle astma on juba ohjatud pikatoimelise beeta-2-agonisti ja suures annuses inhaleeritava kortikosteroidi kombinatsiooniga.
English: Other information about Aerivio Spiromax
Estonian: Muu teave Aerivio Spiromaxi kohta
English: This is a summary of the European public assessment report (EPAR) for Aerivio Spiromax.
Estonian: See on ravimi Aerivio Spiromax Euroopa avaliku hindamisaruande kokkuvõte.
English: Because Aerivio Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Aerivio Spiromax on hübriidravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: The two active substances in Aerivio Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Estonian: Aerivio Spiromaxi mõlemad toimeained on hästi tuntud ning need sisalduvad mitmes ravimis, mida kasutatakse kas eraldi või kombinatsioonis muude ravimitega astma ja kroonilise obstruktiivse
English: What is Aerivio Spiromax and what is it used for?
Estonian: Mis on Aerivio Spiromax ja milleks seda kasutatakse?
English: It is not intended to provide practical advice on how to use Aerivio Spiromax.
Estonian: Hindamisaruandes ei anta ravimi Aerivio Spiromax kasutamise praktilisi nõuandeid.
English: However, Aerivio Spiromax is available only as a single high strength, whereas the reference medicine is available in three strengths, the same high strength and two lower strengths.
Estonian: Aerivio Spiromaxi turustatakse ainult ühe, suureannuselise ravimvormina, samas kui võrdlusravimit turustatakse kolme tugevusega (sama suureannuselise ja kahe väikseannuselise) ravimvormina.
English: Aerivio Spiromax is a ‘hybrid medicine'.
Estonian: Aerivio Spiromax on hübriidravim.
English: Aerivio Spiromax is available as an inhalation powder in a portable inhaler device.
Estonian: Aerivio Spiromaxi turustatakse inhalatsioonipulbrina kaasaskantavas inhalaatoris.
English: Aerivio Spiromax is a medicine used for the regular treatment of adults with severe asthma and for the relief of symptoms of chronic obstructive pulmonary disease (COPD, a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing).
Estonian: Aerivio Spiromax on ravim, mida kasutatakse raske astmaga täiskasvanud patsientidel püsiraviks ja kroonilise obstruktiivse kopsuhaiguse (krooniline haigus, mille korral bronhid ja kopsualveoolid on kahjustunud või ummistunud ja see põhjustab hingamisraskusi) sümptomite leevendamiseks.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Aerivio Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Estonian: Inimravimite komitee otsustas, et on tõendatud Aerivio Spiromaxi võrdväärne kvaliteet ja bioekvivalentsus ravimiga Seretide Diskus.
English: Studies in people have been limited to tests to determine that Aerivio Spiromax is bioequivalent to the reference medicine, Seretide Diskus.
Estonian: Patsiendiuuringud piirdusid uuringutega, milles näidati Aerivio Spiromaxi bioekvivalentsust võrdlusravimiga Seretide Diskus.
English: For more information about treatment with Aerivio Spiromax, read the package leaflet (also part of the EPAR) or contact your
Estonian: Kui vajate ravimiga Aerivio Spiromax toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In COPD, Aerivio Spiromax is used in adults who have had exacerbations (flare-ups) of the disease in the past and have significant symptoms despite regular treatment.
Estonian: Kroonilise obstruktiivse kopsuhaiguse ravis kasutatakse Aerivio Spiromaxi täiskasvanud patsientidel, kellel regulaarsele ravile vaatamata esineb haiguse ägenemisi ja olulisi sümptomeid.
English: How has Aerivio Spiromax been studied?
Estonian: Kuidas Aerivio Spiromaxi uuriti?
English: For practical information about using Aerivio Spiromax, patients should read the package leaflet or
Estonian: Kui vajate ravimi Aerivio Spiromax kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Aerivio Spiromax can only be obtained with a prescription.
Estonian: Aerivio Spiromax on retseptiravim.
English: How is Aerivio Spiromax used?
Estonian: Kuidas Aerivio Spiromaxi kasutatakse?
English: As Aerivio Spiromax is only available in one high strength, its use in asthma has been restricted to
Estonian: Et Aerivio Spiromaxi turustatakse ainult ühe suureannuselise ravimvormina, tohib seda ravimit astmapatsientidel kasutada ainult raskekujulise haiguse korral.
English: What are the benefits and risks of Aerivio Spiromax?
Estonian: Milles seisneb Aerivio Spiromaxi kasulikkus ja mis riskid ravimiga
English: The agreement rate was 83%.
Estonian: Kokkulangevus oli 83%.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Scintimun on 11 January 2010.
Estonian: Euroopa Komisjon andis Scintimuni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 11. jaanuaril 2010.
English: The amount of besilesomab injected varies between 0.25 to 1 mg, depending on how much radioactivity is required.
Estonian: Süstitav besilesomaabi kogus on 0,25-1 mg sõltuvalt sellest, kui suurt radioaktiivsust on vaja.
English: The full EPAR for Scintimun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Scintimuni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Scintimun?
Estonian: Mis meetmed võetakse, et tagada Scintimuni ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Scintimun is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Scintimuni võimalikult ohutu kasutamine.
English: Patients limbs were then scanned and the images obtained using both techniques were compared.
Estonian: Seejärel skaneeriti patsientide jäsemed ja võrreldi kummagi tehnika alusel saadud pilte.
English: This is a summary of the European public assessment report (EPAR) for Scintimun.
Estonian: See on ravimi Scintimun Euroopa avaliku hindamisaruande kokkuvõte.
English: Scintimun is for diagnostic use only.
Estonian: Scintimun on ette nähtud ainult diagnostiliseks kasutamiseks.
English: The Committee recommended that Scintimun be given marketing authorisation.
Estonian: Komitee soovitas anda Scintimuni müügiloa.
English: Scintimun besilesomab
Estonian: Scintimun besilesomaab
English: Scintimun is not used on its own, but must be radiolabelled before use.
Estonian: Scintimuni ei kasutata eraldi, kuid see tuleb enne manustamist radiomärgistada.
English: Other information about Scintimun
Estonian: Muu teave Scintimuni kohta
English: The CHMP decided that Scintimun's benefits are greater than its risks.
Estonian: Inimravimite komitee otsustas, et Scintimuni kasulikkus ületab kaasnevaid riske.
English: As for all radioactive substances used in medicine, patients should be exposed to the lowest possible dose of Scintimun.
Estonian: Nagu kõiki meditsiinilisi radioaktiivseid aineid, tuleb ka Scintimuni patsientidele manustada väikseimas võimalikus annuses.
English: The most common side effect with Scintimun (seen in more than 1 patient in 10) is the production of anti-mouse antibodies.
Estonian: Scintimuni kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on hiireantikehade vastaste antikehade teke.
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 Scintimun.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: For more information about treatment with Scintimun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Scintimuniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scintimun, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Scintimuni ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Radiolabelling is a technique where a substance is labelled with a radioactive compound.
Estonian: Radiomärgistamine on meetod, mille korral aine märgistatakse radioaktiivse isotoobiga.
English: Three to six hours after the injection, the doctor takes a scan of the limbs to locate the areas in the bones affected by osteomyelitis.
Estonian: 3-6 tundi pärast süstimist skaneerib arst jäsemed, et teha kindlaks luupiirkonnad, kus esineb osteomüeliit.
English: As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate in areas affected by osteomyelitis, where it can be detected by scans.
Estonian: Et infektsioonikohta koguneb suur arv granulotsüüte, akumuleerub radioaktiivne aine osteomüeliidi piirkonda, mida saab skaneerimisega tuvastada.
English: In one main study in 130 patients who had or were suspected to have osteomyelitis in their limbs, radiolabelled Scintimun was compared with a standard diagnostic technique using the patients' own white blood cells that were radiolabelled before being injected back into the patient.
Estonian: Ühes põhiuuringus, milles osales 130 patsienti, kellel oli diagnoositud jäsemete osteomüeliit või selle kahtlus, võrreldi radiomärgistatud Scintimuni standardse diagnoositehnikaga, mille korral süstiti patsiendile tema enese eelnevalt radiomärgistatud leukotsüüte.
English: Scintimun should not be used to diagnose diabetic foot infection (infection that occurs in the feet of patients with diabetes).
Estonian: Scintimuni ei tohi kasutada diabeetilise jalainfektsiooni (diabeediga patsientide teatud jalainfektsioon) diagnoosimiseks.
English: Scintimun should only be used in hospitals with a nuclear medicine department and should only be handled by authorised staff.
Estonian: Scintimuni tohib kasutada üksnes haiglas, kus on olemas radiomärgistatud aineid haldav radioloogiaosakond, ning seda tohib käsitseda üksnes selleks volitatud personal.
English: In addition the company that makes Scintimun will make sure that all doctors who are expected to use it are provided with a letter explaining the risks associated with the medicine.
Estonian: Scintimuni tootja peab tagama, et seda ravimit eeldatavalt kasutavatele arstidele selgitataks ravimi kasutamisega seotud riske.
English: Why has Scintimun been approved?
Estonian: Miks Scintimun heaks kiideti?
English: What is Scintimun?
Estonian: Mis on Scintimun?
English: For the full list of all side effects reported with Scintimun, see the package leaflet.
Estonian: Scintimuni kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes.
Estonian: Radioaktiivselt märgistatud ravimi süstimisel patsiendile kannab monoklonaalne antikeha radioaktiivse aine granulotsüütidel oleva sihtantigeenini.
English: What is the risk associated with Scintimun?
Estonian: Mis riskid Scintimuniga kaasnevad?
English: Besilesomab has been designed to attach to an antigen called NCA-95, which is found on the surface of granulocytes, a type of white blood cell involved in inflammation and fighting infection.
Estonian: Besilesomaab on välja töötatud seonduma antigeeniga NCA-95, mis esineb granulotsüütide pinnal (teatud valgelibled, mis osalevad põletikureaktsioonis ja infektsioonide vastu võitlemisel).
English: The solution is given to the patient as one injection into a vein.
Estonian: Lahus manustatakse patsiendile ühekordse süstina veeni.
English: Scintimun must not be used in people who are hypersensitive (allergic) to besilesomab, to other mouse antibodies or to any of the other ingredients.
Estonian: Scintimuni ei tohi kasutada patsiendid, kes võivad olla besilesomaabi, teiste hiireantikehade või ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: The images will show where besilesomab has accumulated, which the doctor will use to locate the areas of infection or inflammation.
Estonian: Piltidel on näha, kuhu on besilesomaab akumuleerunud, ja arst teeb selle alusel kindlaks infektsiooni- või põletikukolded.
English: A radioactive Scintimun solution is made by mixing the powder and solvent provided in the kit and then radiolabelling it with technetium (99mTc).
Estonian: Scintimuni radioaktiivse lahuse valmistamiseks segatakse kõigepealt komplektis olev pulber ja lahusti ning seejärel märgistatakse lahus radioaktiivse tehneetsiumiga (99mTc).
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Estonian: Scintimuni toimeaine besilesomaab on monoklonaalne antikeha (valgu liik), mis tunneb ära teatud antigeeni (organismis leiduva spetsiifilise aine) ning seondub sellega.
English: Scintimun is a kit for the preparation of a radioactive solution for injection.
Estonian: Scintimun on radioaktiivse süstelahuse valmistamise komplekt.
English: Scintimun must not be used in patients who have tested positive for human anti-mouse antibody (HAMA) and must not be used in pregnant women.
Estonian: Scintimuni ei tohi kasutada rasedad ega patsiendid, kellel on leitud inimese hiireantikehade vastased antikehad (HAMA).
English: The main measure of effectiveness for Scintimun was based on how much the assessment of the images obtained with Scintimun agreed with that obtained with the radiolabelled white blood cells.
Estonian: Efektiivsuse põhinäitaja oli Scintimuni ja radioaktiivselt märgistatud leukotsüütide abil saadud piltide kokkulangevus.
English: It contains the active substance besilesomab.
Estonian: Ravimi toimeaine on besilesomaab.
English: What is Scintimun used for?
Estonian: Milleks Scintimuni kasutatakse?
English: It is used to locate areas of infection or inflammation in adults with suspected osteomyelitis (bone infection) in the limbs, in combination with other appropriate imaging methods.
Estonian: Seda kasutatakse täiskasvanutel koos teiste asjakohaste pildindusmeetoditega, et tuvastada infektsiooni- või põletikukoldeid, kui patsiendil kahtlustatakse jäsemete osteomüeliiti (luupõletikku).
English: How is Scintimun used?
Estonian: Kuidas Scintimuni kasutatakse?
English: Scintimun is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
Estonian: Scintimuni radiomärgistamiseks segatakse see radioaktiivse tehneetsiumi (99mTc) lahusega.
English: When Scintimun is radiolabelled, the radioactive compound technetium (99mTc) becomes attached to besilesomab.
Estonian: Scintimuni radiomärgistamisel seondub radioaktiivne tehneetsium (99mTc) besilesomaabiga.
English: What benefit has Scintimun shown during the studies?
Estonian: Milles seisneb uuringute põhjal Scintimuni kasulikkus?
English: How does Scintimun work?
Estonian: Kuidas Scintimun toimib?
English: How has Scintimun been studied?
Estonian: Kuidas Scintimuni uuriti?
English: Scintimun produced comparable results to the radiolabelled white blood cells when used to diagnose and locate osteomyelitis in limbs.
Estonian: Scintimuniga saadud osteomüeliidi diagnoosimise ja jäsemetes asukoha määramise tulemused olid sarnased radioaktiivselt märgistatud leukotsüütidega saadud tulemustega.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 April 2017
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21.
English: The company plans to include these data in a new marketing authorisation application in the EU.
Estonian: Ettevõte kavatseb need andmed lisada uuele Euroopa Liidu müügiloa taotlusele.
English: EMA/249992/2017 EMEA/H/C/004179
Estonian: aprill 2017 EMA/249992/2017 EMEA/H/C/004179
English: It works by blocking the production of bacterial proteins, thus preventing the growth of the bacteria.
Estonian: See blokeerib bakterite valgusünteesi, takistades seega bakterite arengut.
English: No studies in patients with inhaled anthrax or inhaled tularaemia have been carried out and the company presented data from laboratory studies.
Estonian: Kopsupõrnatõvega või kopsutulareemiaga patsientide uuringuid ei ole toimunud ning ettevõte esitas laboriuuringute andmed.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that its decision to withdraw is based on a request from the US FDA to provide additional safety data to support approval in the US.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et otsus taotlus tagasi võtta oli seotud sellega, et USA Toidu- ja Ravimiamet (FDA) taotles ravimi USAs heakskiitmiseks täiendavat ohutusteavet.
English: The company presented data from three studies in a total of 1,855 patients with community-acquired pneumonia, in which Solithromycin Triskel EU Services was compared with other antibiotics (levofloxacin and moxifloxacin).
Estonian: Ettevõte esitas andmed kolmest uuringust, milles osales kokku 1855 keskkonnatekkese pneumooniaga patsienti ja milles ravimit Solithromycin Triskel EU Services võrreldi muude antibiootikumidega (levofloksatsiin ja moksifloksatsiin).
English: There were also concerns that solithromycin could be harmful to the liver.
Estonian: Ühtlasi väljendati ettevaatlikkust, et solitromütsiin võib kahjustada maksa.
English: • community-acquired pneumonia (an infection of the lungs caught outside of hospital);
Estonian: • keskkonnatekkene pneumoonia (kopsuinfektsioon, mis tekib patsiendil väljaspool haiglat);
English: In addition, it had concerns about the manufacturing process of the active substance, which did not exclude the presence of impurities, and the test for ensuring sterility of the product for infusion was not considered valid.
Estonian: Samuti väljendas komitee ettevaatlikkust selle suhtes, et toimeaine tootmisprotsessis ei olnud välistatud lisandite olemasolu ning infusiooniravimi steriilsuse tagamise katset ei peetud valiidseks.
English: Solithromycin Triskel EU Services was expected to be used to treat the following bacterial infections:
Estonian: Ravimit Solithromycin Triskel EU Services kavatseti kasutada järgmiste bakterinfektsioonide raviks:
English: Solithromycin Triskel EU Services is a medicine that contains the active substance solithromycin.
Estonian: Solithromycin Triskel EU Services on ravim, mis sisaldab toimeainena solitromütsiini.
English: On 27 March 2017, Triskel EU Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solithromycin Triskel EU Services, intended for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Estonian: Triskel EU Services Ltd teatas 27. märtsil 2017 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Solithromycin Triskel EU Services müügiloa taotlus.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Solithromycin Triskel EU Services did not outweigh its risks.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ravimi Solithromycin Triskel EU Services kasulikkus ei ole suurem kui sellega kaasnevad riskid.
English: The active substance in Solithromycin Triskel EU Services, solithromycin, is a type of antibiotic similar to a group of antibiotics known as ‘macrolides'.
Estonian: Ravimi Solithromycin Triskel EU Services toimeaine solitromütsiin kuulub antibiootikumide rühma, mis sarnaneb antibiootikumide rühma makroliididega.
English: It was to be available as capsules to be taken by mouth and as a powder to be made into a solution for infusion (drip) into a vein.
Estonian: Seda kavatseti turustada suukaudsete kapslitena ja infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: What is Solithromycin Triskel EU Services?
Estonian: Mis on Solithromycin Triskel EU Services?
English: • inhaled tularaemia (another serious disease caught by inhaling bacteria).
Estonian: • kopsutulareemia (samuti bakterite sissehingamisel ülekanduv raske haigus).
English: Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that Solithromycin Triskel EU Services could not have been approved for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Estonian: Tuginedes esitatud andmete analüüsile, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Solithromycin Triskel EU Services kasutamist keskkonnatekkese pneumoonia, kopsupõrnatõve ja kopsutulareemia raviks ei ole võimalik heaks kiita.
English: How does Solithromycin Triskel EU Services work?
Estonian: Kuidas Solithromycin Triskel EU Services toimib?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Solithromycin Triskel EU Services.
Estonian: Taotluse tagasivõtmine ei mõjuta praegu ravimi Solithromycin Triskel EU Services kliinilistes uuringutes osalevaid patsiente.