FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Fareston, see the Package Leaflet.
Estonian: Farestoni kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Fareston is not recommended for patients with oestrogen-receptor-negative tumours (where the cancer cells do not have receptors for the hormone oestrogen on their surface).
Estonian: Farestoni ei soovitata kasutada östrogeenretseptornegatiivsete kasvajatega patsientidel (kui vähirakkude pinnal ei ole hormoon östrogeeni retseptoreid).
English: The effects of Fareston were compared with those of tamoxifen (another anti-oestrogen used to treat breast cancer).
Estonian: Farestoni toimet võrreldi tamoksifeeniga (samuti rinnavähi raviks kasutatav antiöstrogeen).
English: Fareston is used to treat hormone-dependent metastatic breast cancer in women who have been through the menopause.
Estonian: Farestoni kasutatakse hormoonsõltuva metastaatilise rinnavähi raviks menopausijärgses eas naistel.
English: It must not be used on a long-term basis in patients who have endometrial hyperplasia (thickening of the lining of the womb) or severe liver problems.
Estonian: Farestoni ei tohi pikaajaliselt kasutada patsiendid, kellel on endomeetriumi hüperplaasia (emakalimaskesta paksenemine) või raskekujulised maksahäired.
English: Therefore, the Committee decided that Fareston's benefits are greater than its risks for the first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Estonian: Komitee leidis seepärast, et Farestoni kasulikkus hormoonsõltuva metastaatilise rinnavähi esmavaliku hormoonravimina menopausijärgses eas patsientidel on suurem kui sellega kaasnevad riskid.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with oestrogen-receptor-positive tumours.
Estonian: Inimravimite komitee otsustas, et Farestoni kasulikkus ja riskid östrogeenretseptorpositiivsete kasvajatega naistel on võrreldavad tamoksifeeni kasulikkuse ja riskidega.
English: Fareston has been studied in 1,869 postmenopausal women with metastatic breast cancer in four main studies.
Estonian: Farestoni kasutamist uuriti neljas põhiuuringus 1869 menopausijärgses eas naisel, kellel oli metastaatiline rinnavähk.
English: What is the risk associated with Fareston?
Estonian: Mis riskid kaasnevad Farestoniga?
English: The full EPAR for Fareston can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Farestoni kohta leiate siit.
English: The effects of Fareston were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Farestoni toimet muude katsetega.
English: What benefit has Fareston shown during the studies?
Estonian: Milles seisneb uuringute põhjal Farestoni kasulikkus?
English: How does Fareston work?
Estonian: Kuidas Fareston toimib?
English: How is Fareston used?
Estonian: Kuidas Farestoni kasutatakse?
English: What is Fareston used for?
Estonian: Milleks Farestoni kasutatakse?
English: How has Fareston been studied?
Estonian: Kuidas Farestoni uuriti?
English: 12 July 2012
Estonian: 12. juuli 2012
English: What is Egrifta?
Estonian: Mis on Egrifta?
English: In addition, no long-term safety data were provided, although treatment with Egrifta was expected to be long term.
Estonian: Samuti ei esitatud pikaajalisi ohutusandmeid, kuigi ravi Egriftaga on eeldatavasti pikaajaline.
English: If you are in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui osalete ravimi eriloaga kasutamise programmis ja vajate oma ravi kohta lisateavet, pöörduge palun arsti poole, kes teile ravi määras.
English: Withdrawal of the marketing authorisation application for Egrifta (tesamorelin)
Estonian: Müügiloa taotluse tagasivõtmise teave Egrifta (tesamoreliin)
English: The company presented the results from two main studies involving 816 HIV patients with excessive accumulation of abdominal fat.
Estonian: Ettevõte esitas kahe põhiuuringu tulemused, milles osales 816 kõhupiirkonna liigse rasvkoega HIVpatsienti.
English: The relevance of the results was also questioned because the patients in the main studies were not representative of European HIV patients, who have a lower average body mass index (BMI) and smaller amounts of abdominal fats than the patients in the studies.
Estonian: Ka tulemuste asjakohasus oli küsitav, sest põhiuuringutes osalenud patsiendid ei esinda Euroopa HIV-patsiente, kellel on väiksem kehamassiindeks ja väiksem kõhupiirkonna rasvkoe suurus kui uuringus osalenutel.
English: Egrifta is a medicine that contains the active substance tesamorelin.
Estonian: Egrifta on ravim, mis sisaldab toimeainena tesamoreliini.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Egrifta did not outweigh its risks.
Estonian: Seepärast oli inimravimite komitee tagasivõtmise ajal arvamusel, et Egrifta kasulikkus ei ületa kaasnevaid riske.
English: In addition, although the main studies showed a reduction in abdominal fat with Egrifta, the reduction has not been shown to be clinically meaningful in terms of actual health benefits to patients.
Estonian: Kuigi põhiuuringud näitasid Egrifta kasutamisel kõhupiirkonna rasvkoe vähenemist, ei ole näidatud, et see vähenemine oleks patsientide tervisele kliiniliselt olulisel viisil reaalselt kasulik.
English: On 21 June 2012, Ferrer Internacional, S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egrifta, for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Estonian: 21. juunil 2012 teatas ettevõte Ferrer International, S.A. ametlikult inimravimite komiteele, et soovib tagasi võtta lipodüstroofiaga HIV-patsientidele kõhupiirkonna liigse rasvkoe vähendamiseks ette nähtud ravimi Egrifta müügiloa taotluse.
English: Growth hormone has been shown to play a role in regulating the formation and breakdown of fat tissue.
Estonian: Kasvuhormoon osaleb rasvkoe moodustamise ja lagunemise reguleerimisel.
English: The CHMP considered a suggestion by the company to restrict the medicine to patients with abdominal fat above a certain amount (defined as greater than 130 cm2), but the evidence supporting the cut-off point was not considered to be sufficient.
Estonian: Inimravimite komitee kaalus ettevõtte ettepanekut piirata ravimi kasutamist ainult patsientidega, kelle kõhupiirkonna rasvkoe suurus on üle teatud piirmäära (üle 130 cm2), kuid seda piirmäära toetavaid andmeid ei loetud piisavateks.
English: The studies compared Egrifta with placebo (a dummy treatment), and the main measure of effectiveness was the change in abdominal fat after 26 weeks of treatment.
Estonian: Uuringutes võrreldi Egriftat platseeboga (näiva ravimiga) ja efektiivsuse põhinäitaja oli kõhupiirkonna rasvkoe suuruse muutus pärast 26 ravinädalat.
English: The company informed the CHMP that there are no consequences for patients currently included in compassionate use programmes using Egrifta.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu Egrifta eriloaga kasutamise programmides osalevaid patsiente tagasivõtmine ei mõjuta.
English: In terms of safety, the CHMP noted that there was an increase in the level of a protein called insulinlike growth factor 1 (IGF-1) in a considerable number of patients treated with Egrifta.
Estonian: Ohutuse seisukohast märkis inimravimite komitee, et märkimisväärsel arvul Egriftaga ravitud patsientidest suurenes teatud proteiini - insuliinisarnase kasvuteguri 1 (IGF-1) - sisaldus.
English: The active substance in Egrifta, tesamorelin, is similar to ‘human growth hormone-releasing factor' (GRF), a hormone in the body that stimulates the release of growth hormone.
Estonian: Egrifta toimeaine tesamoreliin on sarnane inimese kasvuhormooni vabastava teguriga (GRF), mis on inimorganismis esinev kasvuhormooni vabanemist stimuleeriv hormoon.
English: The CHMP was concerned about how Egrifta would be used in clinical practice as it would be difficult to differentiate excess abdominal fat due to lipodystrophy from excess fat due to obesity.
Estonian: Inimravimite komitee pidas probleemiks Egrifta kasutamist kliinilises praktikas, sest raske on eristada kõhupiirkonna liigset rasvkude, mille on põhjustanud lipodüstroofia või rasvumine.
English: In its official letter, the company stated that it decided to withdraw the application because the CHMP considered that the data provided did not allow the Committee to conclude on a positive benefit-risk balance.
Estonian: Ettevõte märkis ametlikus kirjas, et otsus võtta taotlus tagasi põhines inimravimite komitee seisukohal, et esitatud andmete alusel ei saa komitee pidada ravimi kasulikkuse ja riski suhet positiivseks.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Egrifta could not have been approved for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et Egriftale ei või anda lipodüstroofiaga HIV-patsientidel kõhupiirkonna liigse rasvkoe vähendamiseks müügiluba.
English: How is Egrifta expected to work?
Estonian: Milline on Egrifta eeldatav toime?
English: Tesamorelin is expected to act in a similar way to GRF, causing the release of growth hormone, which is then expected to increase the breakdown of fat in HIV patients with lipodystrophy, thereby reducing excess fat in the abdomen.
Estonian: Tesamoreliini eeldatav toime sarnaneb GRF toimele, põhjustades kasvuhormooni vabanemist, mille tulemusel suureneb lipodüstroofiaga HIV-patsientidel rasvkoe lagunemine ja väheneb kõhupiirkonna liigne rasvkude.
English: Lipodystrophy is known to occur in some HIV-infected patients, where it leads to the loss of fat in certain areas of the body and sometimes to excessive accumulation of fat in the abdomen.
Estonian: Lipodüstroofiat võib esineda HIV-patsientidel, kellel võib see põhjustada rasva kadumist teatud kehapiirkondadest ja mõnikord kogunemist kõhupiirkonda.
English: High levels of IGF-1 may be associated with an increased risk of cancer and a potential worsening of diabetic eye disease, and the Committee considered this to be a major safety concern.
Estonian: IGF-1 suurenenud sisaldus võib olla seotud suurenenud kasvajariskiga ja diabeetilise silmahaiguse võimaliku süvenemisega.
English: What was Egrifta expected to be used for?
Estonian: Milleks kavatseti Egriftat kasutada?
English: It was to be available as a powder to be made up into a solution for injection.
Estonian: Seda pidi turustatama süstelahuse pulbrina.
English: Egrifta was expected to be used for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, a condition that leads to changes in the distribution of body fat.
Estonian: Egriftat kavatseti kasutada lipodüstroofiaga HIV-patsientidel kõhupiirkonna liigse rasvkoe vähendamiseks.
English: This summary was last updated in 06-2013.
Estonian: Kokkuvõtte viimane uuendus: 06-2013.
English: EMA/282918/2013
Estonian: EMA/414360/2013 EMEA/H/C/002522
English: What is MACI and what is it used for?
Estonian: Mis on MACI ja milleks seda kasutatakse?
English: A risk management plan has been developed to ensure that MACI is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada MACI võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of MACI?
Estonian: Mis meetmed võetakse, et tagada MACI ohutu ja efektiivne kasutamine?
English: The full EPAR for MACI can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst MACI kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: How does MACI work?
Estonian: Kuidas MACI toimib?
English: The study involved 144 adults with defects ranging between 3 and 20 cm2 in area.
Estonian: Uuringus osales 144 täiskasvanut, kelle kõhrekahjustuse pindala oli 3-20 cm2.
English: The other important risks are those related to the surgical procedure itself, including infection, inflammation, haemoarthrosis (blood in the joints), arthrofibrosis (scar tissue in the joints), and thromboembolic events (blood clots).
Estonian: Teised olulised riskid on seotud kirurgilise protseduuri endaga, sealhulgas infektsioon, põletik, hemartroos (verejooks liigesesse), artrofibroos (armkude liigestes) ja trombemboolia (trombid).
English: MACI must also not be used in patients whose growth plates in the thigh bone have not fully closed.
Estonian: Ravimit MACI ei tohi kasutada ka patsientidel, kelle reieluude kasvuplaadid ei ole täielikult luustunud.
English: What are the risks associated with MACI?
Estonian: Mis riskid MACI-ga kaasnevad?
English: Excess cartilage growth and detachment of the implant may occur in between 1 and 10 patients in 1,000 treated with MACI.
Estonian: Kõhrkoe vohamine ja implantaadi irdumine võivad esineda 1-10 MACI-ga ravitud patsiendil 1000st.
English: It is not intended to provide practical advice on how to use MACI.
Estonian: Hindamisaruandes ei anta MACI kasutamise praktilisi nõuandeid.
English: This is a summary of the European public assessment report (EPAR) for MACI.
Estonian: See on ravimi MACI Euroopa avaliku hindamisaruande kokkuvõte.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate
Estonian: Koetehnoloogiatoode sisaldab rakke või kudesid, mida on töödeldud nii, et neid saab kasutada koe parandamiseks, regenereerimiseks või
English: Around 6 weeks later, the surgeon shapes the membrane to fit the damaged area in the knee cartilage and then implants it using a surgical procedure.
Estonian: Ligikaudu 6 nädala pärast kohandab kirurg membraani kuju, et see sobiks põlveliigese kõhrkoe kahjustunud piirkonnaga, ja implanteerib selle siis kirurgilise protseduuri abil.
English: In addition, surgeons and healthcare professionals who will be involved in treating patients with MACI will receive educational materials providing detailed guidance on how to use MACI as well as information on its risks and the need to follow-up patients treated with MACI.
Estonian: Peale selle saavad kirurgid ja tervishoiutöötajad, kes hakkavad patsiente ravimiga MACI ravima, teabematerjali, milles on üksikasjalikult kirjeldatud MACI kasutamist ja kaasnevaid riske ning ravimiga MACI ravitud patsientide järelkontrolli vajadust.
English: MACI was evaluated to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the EMA in order to obtain an EU-wide marketing authorisation.
Estonian: Hinnangu kohaselt vastab MACI uudseid ravimeid käsitlevale Euroopa Liidu määrusele, mille kohaselt peab kõiki Euroopa Liidu liikmesriikide uudseid ravimeid kogu Euroopa Liitu hõlmava müügiloa saamiseks hindama Euroopa Ravimiamet.
English: The Committee noted that treatments such as MACI are already established in clinical practice and that the results from the main study were consistent with results in
Estonian: Komitee märkis, et MACI-sarnased raviviisid on juba kliinilises kasutuses ja põhiuuringu tulemused olid kooskõlas teaduskirjanduses avaldatud tulemustega.
English: Growth plates close (or harden) when a child has become skeletally mature and their bones have stopped growing.
Estonian: Kasvuplaadid luustuvad, kui lapse luustik on saavutanud küpsuse ja luude kasv peatub.
English: The cells are used to fill in the space where the cartilage has been damaged, thereby regenerating the damaged areas and helping to resolve the patient's symptoms such as pain and problems moving the knee.
Estonian: Rakke kasutatakse kõhrekahjustuse täitmiseks, regenereerides kahjustatud piirkondi ja aidates leevendada patsiendi sümptomeid, näiteks valu ja põlve liikuvuse probleeme.
English: MACI must not be used in patients with severe osteoarthritis (swelling and pain) of the knee, inflammatory joint disease, or uncorrected inborn blood clotting disorders.
Estonian: Ravimit MACI ei tohi kasutada põlveliigese raske osteoartriidi (turse ja valu), põletikulise liigesehaiguse või korrigeerimata kaasasündinud verehüübimishäiretega patsientidel.
English: In addition, patients treated with MACI had fewer side effects compared with microfracture
Estonian: Samuti esines ravimiga MACI ravitud patsientidel vähem kõrvalnähte kui mikrofraktuurravi saanud patsientidel.
English: It consists of the patient's own cartilage cells on 14.5 cm2 collagen membranes, which are used by a surgeon to fill in the spaces where cartilage is damaged.
Estonian: See koosneb patsiendi enda kõhrerakkudest 14,5 cm2 pindalaga kollageenmembraanidel, millega kirurg
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MACI, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele MACI ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavate ettevaatusmeetmete teave.
English: For more information about treatment with MACI, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga MACI toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: As MACI is an advanced therapy product, it was initially assessed by the Committee for Advanced Therapies (CAT).
Estonian: Et MACI on uudne ravim, hindas seda esialgu uudsete ravimite komitee.
English: The cells are then placed onto the collagen membrane.
Estonian: Seejärel asetatakse rakud kollageenmembraanile.
English: The CHMP therefore concluded that MACI's benefits are greater than its risks and recommended that it
Estonian: Inimravimite komitee otsustas seetõttu, et MACI kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: In the first stage of treatment, a sample of cartilage cells is taken from the patient's joint and grown in a laboratory.
Estonian: Ravi esimeses etapis võetakse patsiendi liigesest kõhrerakkude proov, mida kasvatatakse laboris.
English: A standard scale, known as the ‘knee injury and osteoarthritis outcome score' (KOOS), was used to measure pain and knee function, where 0 reflects extreme problems and 100 reflects an absence of problems.
Estonian: Valu ja põlveliigese talitluse mõõtmiseks kasutati standardskaalana kliinilise tulemuse mõõtmisvahendit KOOS (Knee Injury and Osteoarthritis Outcome Score), millel 0 tähendab äärmiselt raskeid probleeme ja 100 probleemide puudumist.
English: The CHMP's recommendation is based on an initial assessment by the CAT.
Estonian: Inimravimite komitee soovitus põhineb uudsete ravimite komitee esialgsel hinnangul.
English: MACI should only be used by a surgeon specifically trained and qualified to use it and the product can
Estonian: Ravimit MACI tohivad kasutada üksnes selle kasutamiseks eriväljaõppe saanud ja kvalifitseeritud kirurgid.
English: MACI is used to repair full-thickness defects with a surface area of between 3 to 20 cm2 in adults who are experiencing symptoms (such as pain and problems moving the knee).
Estonian: MACI-t kasutatakse kõhrkoe kogu paksuses, 3-20 cm2 pindalaga kahjustuste parandamiseks täiskasvanutel, kellel on põlveliigese kõhrkoe kahjustustele viitavad sümptomid (näiteks valu ja põlve
English: What benefits of MACI have been shown in studies?
Estonian: Milles seisneb uuringute põhjal MACI kasulikkus?
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Estonian: Euroopa Komisjon andis MACI-le müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 27. juunil
English: matrix applied characterised autologous cultured chondrocytes
Estonian: maatriksile kantud kirjeldatud omadustega autoloogsed kasvatatud
English: For both pain and function, improvements of around 45 points were seen in MACI patients compared with around 35 points in patients that
Estonian: Nii valu kui ka põlveliigese talitluse punktide arv suurenes MACI rühmas ligikaudu 45 võrra ja mikrofraktuurkirurgia rühmas ligikaudu 35 võrra.
English: The active substance in MACI consists of the patient's own cartilage cells, which are implanted into the cartilage defect in the knee.
Estonian: MACI toimeaine koosneb patsiendi enda kõhrerakkudest, mis implanteeritakse põlveliigese kõhrkoe kahjustatud piirkonda.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that the main study had shown that MACI was superior to microfracture surgery in treating patients with cartilage defects of the knee.
Estonian: Inimravimite komitee märkis, et põhiuuringu järgi on MACI põlveliigese kõhrekahjustustega patsientide ravis parem kui mikrofraktuurkirurgia.
English: For practical information about using MACI, patients should read the package leaflet or contact their
Estonian: Kui vajate MACI kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või
English: MACI was compared with microfracture surgery (a surgical procedure commonly used to treat cartilage defects) in a main study which looked at pain relief and improvements in knee function in patients with full thickness cartilage defects in the knee.
Estonian: Ravimit MACI võrreldi mikrofraktuurkirurgiaga (kõhrekahjustuste ravimise tavaline kirurgiline protseduur) põhiuuringus, milles vaadeldi põlvekõhre täispaksuses kahjustustega patsientidel valu vähenemist ja põlveliigese talitluse paranemist.
English: MACI is an implant used to repair cartilage defects at the ends of the bones of the knee joint.
Estonian: MACI on implantaat, millega parandatakse põlveliigese luude otstel oleva kõhrkoe kahjustusi.
English: The study showed that MACI is more effective than microfracture surgery at relieving pain and improving knee function: two years after surgery, patients treated with MACI had an average score of 82 for pain and 61 for knee function, compared with 71 and 49 respectively for patients treated with microfracture surgery.
Estonian: Kaks aastat pärast operatsiooni oli MACI-ga ravitud patsientidel keskmine punktide arv 82 (valu) ja 61 (põlveliigese talitlus) ning mikrofraktsioonkirurgiaga ravitud patsientidel vastavalt 71 ja 49.
English: For the full list of all side effects reported with MACI,
Estonian: MACI kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: MACI is an advanced therapy product called a ‘tissue engineered product'.
Estonian: MACI on koetehnoloogiatoodete hulka kuuluv uudne ravim.
English: A type of glue known as a fibrin sealant, which is made from blood clotting proteins, is used to hold the implant in place on the cartilage.
Estonian: Implantaat kinnitatakse kõhrkoele vere hüübimisvalkudest valmistatud fibriini sisaldavat koeliimi.
English: The full EPAR and risk management plan summary for Duloxetine Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Duloxetine Mylani 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 Duloxetine Mylan is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Duloxetine Mylani võimalikult ohutu kasutamine.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Estonian: Neurotransmitterid on keemilised ained, mis vahendavad närvirakkudevahelisi signaale.