FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the CHMP noted that the long-term benefit for the heart and circulatory system still needed to be confirmed.
Estonian: Samas märkis komitee, et pikaajaline kasulikkus südamele ja vereringele vajab veel kinnitust.
English: The patient's disease should be confirmed by genetic testing whenever possible.
Estonian: Võimaluse korral tuleb patsiendi haiguse kinnitamiseks teha geeniuuring.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lojuxta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Lojuxta kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The most common side effects are problems with the gut, which may affect as many as 9 out of 10 people: diarrhoea and nausea (feeling sick) were each seen in around 7 out of 10 people, dyspepsia (heartburn) and vomiting were each seen in more than 3 out of 10 people, while pain, discomfort and bloating of the abdomen (belly), constipation and flatulence were each seen in at least 2 out of 10 people.
Estonian: Kõige sagedamad kõrvalnähud on sooleprobleemid, mis võivad esineda 9 patsiendil 10st: kõhulahtisus ja iiveldus esines kumbki ligikaudu 7 patsiendil 10st, düspepsia (kõrvetised) ja oksendamine esines kumbki rohkem kui 3 patsiendil 10st ning kõhuvalu, ebamugavustunne kõhus, kõhu paisumine, kõhukinnisus ja kõhupuhitus esines igaüks vähemalt 2 patsiendil 10st.
English: The study will also provide data on pregnancies in women taking the medicine, and on healthcare professionals' compliance with the recommendations to screen and monitor patients before and during treatment.
Estonian: Uuringust saab andmeid ka ravimit võtvate rasedate ning selle kohta, kuidas tervishoiutöötajad täidavad soovitusi kontrollida ja jälgida patsiente enne ravi ja ravi ajal.
English: What is Lojuxta and what is it used for?
Estonian: Mis on Lojuxta ja milleks seda kasutatakse?
English: Lojuxta was not compared with any other treatment.
Estonian: Lojuxtat ei võrreldud ühegi teise ravimiga.
English: The Committee also noted that Lojuxta had side effects in the gut in most patients, which caused some patients to stop treatment, and that it led to increased liver enzyme levels whose long-term consequences are not known.
Estonian: Samuti märkis komitee, et Lojuxta tekitas enamikul patsientidel soolekõrvalnähte, mille tõttu mõni patsient lõpetas ravi, ja et see põhjustas maksaensüümide sisalduse suurenemist, mille pikaajalised tagajärjed ei ole teada.
English: It will also contain educational materials to be given to patients, including a brochure and an alert card.
Estonian: Materjalide hulgas on ka patsientide teabematerjalid, näiteks brošüür ja hoiatuskaart.
English: It must also not be used by patients with moderately or severely reduced liver function or with unexplained, abnormal liver test results, or by patients with significant or long-term bowel problems.
Estonian: Lojuxtat ei tohi kasutada ka mõõduka või raske maksatalitlushäirega patsiendid, seletamatute ebanormaalsete maksaanalüüsitulemustega patsiendid ega patsiendid, kellel on olulisi või pikaajalisi sooleprobleeme.
English: This is because it has not been possible to obtain complete information about Lojuxta to date due to the rarity of the disease.
Estonian: See tähendab, et harvaesineva haiguse tõttu ei olnud võimalik saada õigeks ajaks Lojuxta kohta täielikku teavet.
English: The benefits of Lojuxta in reducing blood cholesterol were assessed in a main study involving 29 patients with homozygous familial hypercholesterolaemia.
Estonian: Lojuxta kasulikkust vere kolesteroolisisalduse vähendamisel hinnati põhiuuringus, milles osales 29 homosügootse perekondliku hüperkolesteroleemiaga patsienti.
English: What are the risks associated with Lojuxta?
Estonian: Mis riskid Lojuxtaga kaasnevad?
English: Treatment should begin at a dose of 5 mg once per day, and if well tolerated may be steadily increased to a maximum dose of 60 mg per day.
Estonian: Kui patsient talub seda annust hästi, tohib annust järk-järgult suurendada kuni maksimaalse annuseni 60 mg ööpäevas.
English: Other information about Lojuxta
Estonian: Muu teave Lojuxta kohta
English: Patients taking certain other medicines may also need to take a reduced dose or take Lojuxta and their other medication at different times.
Estonian: Ka teatud muude ravimite tarvitamisel on vaja kasutada Lojuxta väiksemat annust või tuleb Lojuxtat ja muid ravimeid võtta eri ajal.
English: Lojuxta must not be used together with over 40 mg per day of simvastatin (another medicine used to lower blood cholesterol levels) or with certain other medicines that affect the way lomitapide is broken down in the body.
Estonian: Lojuxtat ei tohi kasutada koos simvastiini (samuti vere kolesteroolisisalduse vähendamise ravim) üle 40 mg ööpäevase annusega ega teatud teiste ravimitega, mis mõjutavad lomitapiidi lagunemist organismis.
English: This is a summary of the European public assessment report (EPAR) for Lojuxta.
Estonian: See on ravimi Lojuxta Euroopa avaliku hindamisaruande kokkuvõte.
English: Why is Lojuxta approved?
Estonian: Miks Lojuxta heaks kiideti?
English: It is not intended to provide practical advice on how to use Lojuxta.
Estonian: Hindamisaruandes ei anta Lojuxta kasutamise praktilisi nõuandeid.
English: It is used to treat adult patients with homozygous familial hypercholesterolaemia, an inherited disease causing high blood levels of cholesterol (a type of fat).
Estonian: Seda kasutatakse täiskasvanud patsientidel, kellel on homosügootne perekondlik hüperkolesteroleemia - vere suurt kolesteroolisisaldust (teatud rasvaliik) põhjustav pärilik haigus.
English: Lojuxta is a medicine that contains the active substance lomitapide.
Estonian: Lojuxta on ravim, mis sisaldab toimeainena lomitapiidi.
English: What information is still awaited for Lojuxta?
Estonian: Mis teavet Lojuxta kohta veel oodatakse?
English: Since Lojuxta has been approved under exceptional circumstances, the company that markets the medicine is carrying out a long-term study in patients taking Lojuxta to provide further data on its safety and effectiveness, including its side effects on the liver, stomach, gut, and cardiovascular system.
Estonian: Et Lojuxta kiideti heaks erandkorras, korraldab ravimit turustav ettevõte Lojuxtat võtvatel patsientidel pikaajalise uuringu, et saada rohkem andmeid ravimi ohutuse ja efektiivsuse, sealhulgas ravimi maksa-, mao-, soole- ja südame-veresoonkonna kõrvalnähtude kohta.
English: It is used together with a low fat diet and other medicines to reduce the level of fats in the blood.
Estonian: Ravimit kasutatakse koos vähese rasvasisaldusega dieedi ja teiste ravimitega, mis vähendavad vere rasvasisaldust.
English: In addition, the company that markets Lojuxta will provide educational materials to all doctors expected to prescribe Lojuxta, containing information on how to select suitable patients as well as key safety information, including side effects, interactions with other medicines and use in women who could potentially have children.
Estonian: Lisaks sellele annab Lojuxta turustaja kõigile Lojuxtat määravatele arstidele teabematerjali, mis sisaldavad teavet, kuidas valida sobivat patsienti, ning põhilist ohutusteavet, sealhulgas kõrvalnähtude, teiste ravimitega koosmõju ja fertiilses eas naistel kasutamise kohta.
English: Patients on kidney dialysis may need to take a reduced dose.
Estonian: Neerudialüüsiga patsiendid võivad vajada väiksemat annust.
English: For practical information about using Lojuxta, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Lojuxta kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The CHMP considered that the medicine's effect in reducing LDL cholesterol levels was a benefit for patients with homozygous familial hypercholesterolaemia, who have an unmet medical need.
Estonian: Inimravimite komitee leidis, et ravimi mõju LDL-kolesterooli sisalduse vähendamisel oli homosügootse perekondliku hüperkolesteroleemiaga ja täitmata ravivajadustega patsientidele soodne.
English: Lojuxta has been authorised under ‘exceptional circumstances'.
Estonian: Lojuxta kiideti heaks erandkorras.
English: Microsomal triglyceride transfer protein is involved in assembling fatty substances such as cholesterol and triglyceride into larger particles called lipoproteins, which are then released into the blood stream.
Estonian: MTTP osaleb rasvainetest, näiteks kolesteroolist ja triglütseriidist suuremate osakeste (lipoproteiinide) moodustamisel, mis liiguvad seejärel vereringesse.
English: For more information about treatment with Lojuxta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Lojuxtaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The main measure of effectiveness was the change in the patients' blood levels of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', after 26 weeks of treatment.
Estonian: Efektiivsuse põhinäitaja oli muutus väikese tihedusega lipoproteiinidega seotud LDLkolesterooli ehk nn halva kolesterooli sisalduses patsientide veres 26 ravinädala järel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lojuxta, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Lojuxta omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Lojuxta must not be used in women who are pregnant.
Estonian: Raseduse ajal Lojuxtat kasutada ei tohi.
English: By blocking this protein, Lojuxta decreases the level of fats released into the blood, thereby helping to reduce the level of cholesterol in hypercholesterolaemia.
Estonian: MTTP-d blokeerides vähendab Lojuxta verre sattuva rasva kogust, aidates seega vähendada hüperkolesteroleemiaga patsientide vere kolesteroolisisaldust.
English: The active substance in Lojuxta, lomitapide, blocks the action of a substance in the body called ‘microsomal triglyceride transfer protein', which is present in the cells of the liver and the gut.
Estonian: Lojuxta toimeaine lomitapiid blokeerib organismis mikrosomaalse triglütseriidide transportvalgu (MTTP), mida leidub maksa- ja soolerakkudes.
English: How is Lojuxta used?
Estonian: Kuidas Lojuxtat kasutatakse?
English: All patients were given Lojuxta together with other medicines for reducing the level of fats in the blood.
Estonian: Kõik patsiendid võtsid vere rasvasisalduse vähendamiseks Lojuxtat koos teiste ravimitega.
English: How does Lojuxta work?
Estonian: Kuidas Lojuxta toimib?
English: What benefits of Lojuxta have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Lojuxta kasulikkus?
English: The most serious side effect seen in some patients treated with Lojuxta is abnormally raised liver enzyme levels.
Estonian: Kõige raskem Lojuxtaga ravitud patsientidel esinenud kõrvalnäht on vere maksaensüümide sisalduse ebanormaalne suurenemine.
English: Patients should avoid drinking grapefruit juice while taking Lojuxta.
Estonian: Lojuxta võtmise ajal ei tohi juua greibimahla.
English: Patients with moderately or severely reduced liver function must not take Lojuxta.
Estonian: Lojuxtat ei tohi kasutada maksatalitluse mõõdukate või raskete häiretega patsiendid.
English: Treatment should be started and monitored by a doctor experienced in treating conditions involving high levels of fats in the blood.
Estonian: Ravi tohib alustada arst, kellel on kogemusi vere suure rasvasisaldusega seotud haiguste ravis, ja see peab toimuma tema järelevalve all.
English: Lojuxta can only be obtained with a prescription.
Estonian: Lojuxta on retseptiravim.
English: For the full list of side effects, see the package leaflet.
Estonian: Lojuxta kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: 1GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine
Estonian: 1GMNU = geomeetriliselt keskmine neutraliseeriv ühik, mis kutsutakse esile merisigadel pärast kahekordset immuniseerimist 0,5 ml selle vaktsiiniga.
English: * Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2)
Estonian: * Inaktiveeritud gripp A viiruse tüved /sigade Bakum/IDT1769/2003 (H3N2)
English: Packaging
Estonian: Pakend
English: EU/2/09/102/001 GRIPOVAC 3 strains of inactivated
Estonian: ≥ 10.22 log2 GMNU1 ≥ 12.34 log2 GMNU1
English: Bakum/1832/2000 (H1N2)
Estonian: ≥ 10.53 log2 GMNU1
English: EU Number Invented Name
Estonian: EL number
English: What measures are being taken to ensure the safe and effective use of Natpar?
Estonian: Mis meetmed võetakse, et tagada Natpari ohutu ja efektiivne kasutamine?
English: What is Natpar and what is it used for?
Estonian: Mis on Natpar ja milleks seda kasutatakse?
English: Why is Natpar approved?
Estonian: Miks Natpar heaks kiideti?
English: The maximum daily dose is 100 micrograms.
Estonian: Maksimaalne ööpäevane annus on 100 µg.
English: Other information about Natpar
Estonian: Muu teave Natpari kohta
English: In a main 24-week study involving 124 patients, 54.8% (46 out of 84) of the patients who received Natpar achieved and maintained acceptable blood calcium levels while reducing their doses of calcium and vitamin D supplements by at least 50%.
Estonian: 24-nädalases põhiuuringus, milles osales 124 patsienti, saavutas ja säilitas 54,8% Natparit saanud patsientidest (46 patsienti 84st) vere sobiva kaltsiumisisalduse, vähendades samal ajal kaltsiumi toidulisandite ja D-vitamiini annuseid vähemalt 50% võrra.
English: What are the risks associated with Natpar?
Estonian: Mis riskid Natpariga kaasnevad?
English: Because of the limited data available, Natpar has been given ‘conditional approval'.
Estonian: Piiratud andmete tõttu on Natpar saanud müügiloa tingimusliku heakskiidu alusel.
English: The proportion of patients taking placebo (a dummy treatment) who achieved the same was 2.5% (1 out of 40 patients).
Estonian: Platseebot (näiv ravim) saanud patsientidel oli see näitaja 2,5% (1 patsient 40st).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Natpar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Natpari kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What information is still awaited for Natpar?
Estonian: Mis teavet Natpari kohta veel oodatakse?
English: Regarding safety, the risk of calcium levels becoming too high or too low is considered important and further data are needed to better understand the consequences of wide fluctuations in blood calcium level after the medicine is given once a day.
Estonian: Ohutuse seisukohalt peetakse liiga suure või väikese kaltsiumisisalduse tekke riski oluliseks ja vaja on täiendavaid andmeid, et paremini mõista tagajärgi, mis kaasnevad vere kaltsiumisisalduse ulatusliku kõikumisega kord ööpäevas võetava annuse korral.
English: While the main study showed that Natpar helps control blood calcium levels while reducing the need for calcium and vitamin D supplements, the study was of short duration and there was no evidence of improvements in patients' quality of life or reductions in long-term problems such as kidney impairment.
Estonian: Kuigi põhiuuring näitas, et Natpar aitab reguleerida vere kaltsiumisisaldust, vähendades seejuures kaltsiumi toidulisandite ja Dvitamiini vajadust, oli uuringu kestus lühike ning puudusid tõendid patsientide elukvaliteedi paranemisest ja kasulikust toimest pikaajaliste probleemide, näiteks neerukahjustuste vastu.
English: The full EPAR for Natpar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Natpari kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company that markets Natpar will set-up a registry and collect long-term data on patients treated with Natpar, including its effects on bones, kidneys and patients' quality of life.
Estonian: Natpari turustaja loob registri ja hakkab koguma Natpariga ravitud patsientide kohta pikaajalisi andmeid, sealhulgas ravimi toime luustikule, neerudele ja patsientide elukvaliteedile.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Natpar have also been included in the summary of product characteristics and the package leaflet.
Estonian: Natpari ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The usual recommended starting dose is 50 micrograms once a day.
Estonian: Soovitatav algannus on 50 µg üks kord ööpäevas.
English: How does Natpar work?
Estonian: Kuidas Natpar toimib?
English: It is not intended to provide practical advice on how to use Natpar.
Estonian: Hindamisaruandes ei anta Natpari kasutamise praktilisi nõuandeid.
English: As a result, patients have low levels of calcium which can cause problems in bones, muscles, heart, kidneys and other parts of the body.
Estonian: Selle tagajärjel on patsientide vere kaltsiumisisaldus liiga väike, mis võib omakorda põhjustada probleeme luustikus, lihastes, südames, neerudes ja muudes kehaosades.
English: The most common side effects with Natpar (which may affect more than 1 in 10 people) are too high or too low blood calcium levels, which can lead to headache, diarrhoea, vomiting, paraesthesia (unusual sensations like pins and needles), hypoaesthesia (reduced sense of touch) and high calcium levels in the urine.
Estonian: Natpari kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on vere liiga suur või väike kaltsiumisisaldus, mis võib põhjustada peavalu, kõhulahtisust, oksendamist, paresteesiat ((vääraisting, näiteks torkiv valu), hüpoasteesiat (tundlikkuse vähenemine) ja hüperkaltsiuuriat (liigne kaltsiumisisaldus uriinis).
English: Natpar parathyroid hormone
Estonian: Natpar parathormoon
English: Therefore, Natpar should only be used in patients who are not adequately controlled with standard treatments alone, who do not have other treatment options.
Estonian: Seetõttu võivad Natpari kasutada üksnes patsiendid, kellel standardravi üksi ei toimi või kel ei ole muid ravivalikuid.
English: This is a summary of the European public assessment report (EPAR) for Natpar.
Estonian: See on ravimi Natpar Euroopa avaliku hindamisaruande kokkuvõte.
English: Because the number of patients with hypoparathyroidism is low, the disease is considered ‘rare', and Natpar was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2013.
Estonian: Et hüpoparatüreoosiga patsientide arv on väike ja see haigus esineb harva, nimetati Natpar 18. detsembril 2013 harvikravimiks.
English: For more information about treatment with Natpar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Natpariga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Since Natpar has been granted a conditional approval, the company that markets Natpar will conduct a further study to confirm the benefits and risks of the medicine and the appropriateness of the once-aday dosing schedule.
Estonian: Et Natpar on saanud müügiloa tingimusliku heakskiidu alusel, korraldab Natpari turustaja lisauuringu, et kinnitada ravimi kasulikkust ja riske ning kord ööpäevas manustamist ettenägeva annustamisskeemi sobivust.
English: For practical information about using Natpar, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Natpari kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Natpar must also not be used in patients who have unexplained increases in the levels of an enzyme called bone alkaline phosphatase and those who have pseudohypoparathyroidism, a rare disease where the body does not respond adequately to the parathyroid hormone produced by the body.
Estonian: Natparit ei tohi kasutada ka patsiendid, kellel on luuspetsiifilise aluselise fosfataasi (teatava ensüümi) sisaldus seletamatult suurenenud või kellel on pseudohüpoparatüreoos (harvikhaigus, mille korral organism ei reageeri adekvaatselt kehaomasele parathormoonile).
English: Natpar is used as an add-on to treatment with calcium and vitamin D supplements when these treatments have not worked well enough.
Estonian: Natpari kasutatakse täiendava ravina koos kaltsiumi toidulisanditega ja D-vitamiiniga, kui need ei ole andnud piisavat tulemust.
English: Natpar must not be used in patients who are having or have had radiation therapy to the bones, who have bone cancer or cancer that has spread to the bones and are at increased risk of developing a bone cancer called osteosarcoma.
Estonian: Natparit ei tohi kasutada patsiendid, kes saavad või on varem saanud luustiku kiiritusravi, kellel on luuvähk või luu metastaasid ja kellel on suurenenud osteosarkoomi (teatavat tüüpi luuvähi) tekke risk.
English: Natpar has been shown to help control blood calcium levels in patients with hypoparathyroidism who are receiving calcium and vitamin D supplements.
Estonian: Natpar on osutunud efektiivseks vere kaltsiumisisalduse reguleerimisel hüpoparatüreoosiga patsientidel, kes võtavad kaltsiumi toidulisandeid ja D-vitamiini.
English: In patients with this condition, the parathyroid glands in the neck do not produce enough parathyroid hormone which controls the level of calcium in the blood.
Estonian: Selle haigusega patsientidel ei tooda kaelapiirkonnas paiknevad kõrvalkilpnäärmed piisavalt parathormooni, mis reguleerib vere kaltsiumisisaldust.
English: The active substance in Natpar, parathyroid hormone, is a copy of the natural hormone produced by the parathyroid glands.
Estonian: Natpari toimeaine parathormoon ehk paratüriin on kõrvalkilpnäärmete toodetava loodusliku hormooni tehisteisend.
English: It replaces the missing hormone in patients with hypoparathyroidism, thus helping to restore calcium levels.
Estonian: See asendab hüpoparatüreoosiga patsientidel puuduvat hormooni, aidates taastada vere kaltsiumisisalduse.
English: What benefits of Natpar have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Natpari kasulikkus?
English: How is Natpar used?
Estonian: Kuidas Natpari kasutatakse?
English: For the full list of all side effects reported with Natpar, see the package leaflet.
Estonian: Natpari kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Natpar replaces the missing parathyroid hormone in patients with hypoparathyroidism.
Estonian: Natpar asendab hüpoparatüreoosiga patsientidel puuduvat parathormooni.
English: Patients can inject Natpar themselves once they have been trained.
Estonian: Pärast asjakohase väljaõppe saamist tohivad patsiendid süstida endale Natpari ise.
English: The medicine can only be obtained with a prescription and treatment should be supervised by a healthcare professional experienced in the management of patients with hypoparathyroidism.
Estonian: Ravi peab toimuma hüpoparatüreoosiga patsientide ravis kogenud tervishoiutöötaja järelevalve all.
English: Natpar contains the active substance parathyroid hormone.
Estonian: Natpar sisaldab toimeainena parathormooni ehk paratüriini.
English: Natpar is injected under the skin of the thigh using the Natpar pen.
Estonian: Natpari süstitakse reie piirkonda naha alla Natpari pen-süstlaga.