FrancophonIA/ELRC3.0 huggingface dataset:
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Estonian: HyQvia sisaldab immunoglobuliini G (IgG), mis on teatud tüüpi antikeha.
English: The possibility of patients or their carers giving the medicine themselves at home may also improve the convenience of the product.
Estonian: Patsientide või nende hooldajate võimalus ise kodus ravimit manustada võib samuti suurendada ravimi kasutusmugavust.
English: Why is HyQvia approved?
Estonian: Miks HyQvia heaks kiideti?
English: The main measure of effectiveness was the number of serious bacterial infections that developed over one year of treatment.
Estonian: Efektiivsuse põhinäitaja oli raskete bakteriaalsete infektsioonide arv üheaastase raviperioodi vältel.
English: In accordance with current guidelines for these medicines, HyQvia was investigated in one main study lasting over a year and involving 89 patients with PID who had already had treatment with human normal immunoglobulin for at least three months.
Estonian: Nende ravimite kasutamise kehtivate suunistega kooskõlas on HyQviat uuritud ühes põhiuuringus, mis kestis üle aasta ja milles osales 89 primaarse immuunpuudulikkuse sündroomiga patsienti, keda oli juba vähemalt kolm kuud ravitud inimese normaalimmunoglobuliiniga.
English: IgG has been used as a medicine since the 1950s and has a wide range of activity against organisms that can cause infection.
Estonian: IgG-d on meditsiinis kasutatud juba alates 1950. aastatest ja sel on mitmekülgne toime infektsioone põhjustavatele mikroorganismidele.
English: The Committee therefore decided that HyQvia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Seetõttu otsustas inimravimite komitee, et HyQvia kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: What are the risks associated with HyQvia?
Estonian: Mis riskid HyQviaga kaasnevad?
English: Other information about HyQvia
Estonian: Muu teave HyQvia kohta
English: HyQvia must not be given into a blood vessel or a muscle.
Estonian: HyQviat ei tohi manustada veresoonde ega lihasesse.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of HyQvia have been included in the summary of product characteristics and the package leaflet.
Estonian: HyQvia ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: HyQvia must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or hyaluronidase or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Estonian: HyQviat ei tohi kasutada patsiendid, kes on inimese normaalimmunoglobuliini või hüaluronidaasi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised), ega patsiendid, kes on allergilised teiste immunoglobuliinide tüüpide suhtes, eriti kui neil on immunoglobuliini A (IgA) puudulikkus (väga väike sisaldus) ja neil on IgA vastased antikehad.
English: Human normal immunoglobulin has been used to treat these diseases for many years.
Estonian: Inimese normaalimmunoglobuliini on nimetatud haiguste raviks kasutatud juba aastaid.
English: It is not intended to provide practical advice on how to use HyQvia.
Estonian: Hindamisaruandes ei anta HyQvia kasutamise praktilisi nõuandeid.
English: The most common side effects with HyQvia (which may affect more than 1 in 10 people) are local reactions such as swelling and discomfort at the site of the infusion.
Estonian: HyQvia kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on lokaalsed reaktsioonid, näiteks turse ja ebamugavustunne infusioonikohas.
English: This was below the predefined number needed to show effectiveness (which is one infection per year), and was similar to that seen with other licensed human normal immunoglobulin products.
Estonian: See oli vähem kui efektiivsuse tõendamiseks eelmääratletud arv (1 infektsioon aastas) ja sarnanes teiste müügiloaga inimese normaalimmunoglobuliinide kasutamisel täheldatuga.
English: • low levels of antibodies in the blood in patients who have chronic lymphocytic leukaemia or myeloma (two cancers affecting different types of white blood cell) and who have frequent infections.
Estonian: • vere väikese antikehade sisaldusega patsientidel, kellel on krooniline lümfoidne leukeemia või müeloom (kaks verevähki, mis mõjutavad vere valgeliblede eri tüüpe) ja sagedad infektsioonid.
English: HyQvia is used in patients with immunodeficiency syndromes.
Estonian: HyQviat kasutatakse immuunpuudulikkuse sündroomidega patsientide raviks.
English: Although there had been concerns that antibodies that develop against recombinant hyaluronidase could cause side effects by affecting the natural version of the enzyme, the results of studies were reassuring.
Estonian: Kuigi on avaldatud kahtlusi, et rekombinantse hüaluronidaasi vastu tekkivad antikehad võivad loodusliku ensüümi toimet mõjutades põhjustada kõrvalnähte, ei ole uuringud seda kinnitanud.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that HyQvia produces a similar reduction in the number of serious bacterial infections to that seen with other immunoglobulin products, and using recombinant hyaluronidase allows subcutaneous infusions to be given at much longer intervals, although local reactions are slightly more common.
Estonian: Inimravimite komitee märkis, et HyQvia kasutamisel saavutati raskete bakteriaalsete infektsioonide arvu samasugune vähenemine kui teiste müügiloaga inimese normaalimmunoglobuliinide kasutamisel ja et rekombinantse hüaluronidaasi kasutamine võimaldab manustada nahaaluseid infusioone palju pikemate ajavahemike tagant, ehkki lokaalseid reaktsioone esineb seejuures veidi sagedamini.
English: How is HyQvia used?
Estonian: Kuidas HyQviat kasutatakse?
English: The dose and frequency of infusions (how often it is given) depend on the individual patient and may need to be adjusted depending on their response.
Estonian: HyQvia annus ja infusioonide sagedus (st kui sageli HyQviat manustatakse) on igal patsiendil erinev ning neid võib ravivastuse alusel kohandada.
English: Detailed information about using HyQvia is provided in the package leaflet.
Estonian: HyQvia kasutamise üksikasjalik teave on pakendi infolehel.
English: This is a summary of the European public assessment report (EPAR) for HyQvia.
Estonian: See on ravimi HyQvia Euroopa avaliku hindamisaruande kokkuvõte.
English: HyQvia also contains recombinant human hyaluronidase.
Estonian: HyQvia sisaldab ka rekombinantset inimese hüaluronidaasi.
English: These are patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
Estonian: Need on patsiendid, kelle veres ei ole piisaval määral antikehi ehk immunoglobuliine (valgud, mis aitavad organismil võidelda infektsioonide ja teiste haigustega).
English: How does HyQvia work?
Estonian: Kuidas HyQvia toimib?
English: For more information about treatment with HyQvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate HyQviaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: A solution containing recombinant human hyaluronidase is given first and a solution containing human normal immunoglobulin (100 mg/ml) is then given by infusion in the same place.
Estonian: Kõigepealt manustatakse rekombinantset inimese hüaluronidaasi sisaldavat lahust ja seejärel manustatakse infusioonina samasse kehapiirkonda inimese normaalimmunoglobuliini lahust (100 mg/ml).
English: For practical information about using HyQvia, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate HyQvia kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: • primary immunodeficiency syndromes (PID, when patients are born with an inability to produce enough antibodies);
Estonian: • primaarsete immuunpuudulikkuse sündroomide korral (haigused, mille korral organismis ei teki piisavalt antikehi);
English: HyQvia works by restoring abnormally low IgG levels to their normal range in the blood.
Estonian: HyQvia suurendab vere ebanormaalselt väikese IgG-sisalduse normaalsele tasemele.
English: HyQvia is used as ‘replacement therapy' to treat:
Estonian: HyQviat kasutatakse asendusravina:
English: The active substance in HyQvia, human normal immunoglobulin, is a highly purified protein extracted from the blood.
Estonian: HyQvia toimeaine, inimese normaalimmunoglobuliin, on vereplasmast eraldatud ülipuhastatud valk.
English: What benefits of HyQvia have been shown in studies?
Estonian: Milles seisneb uuringute põhjal HyQvia kasulikkus?
English: For the full list of all side effects reported with HyQvia, see the package leaflet.
Estonian: HyQvia kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Patients or their carers may be able to give HyQvia themselves once they have been trained appropriately.
Estonian: Pärast vastava väljaõppe saamist võivad patsiendid või nende hooldajad HyQviat ise manustada.
English: HyQvia contains the active substance human normal immunoglobulin.
Estonian: HyQvia sisaldab toimeainena inimese normaalimmunoglobuliini.
English: HyQvia is available as two solutions for infusion (drip) under the skin.
Estonian: HyQviat turustatakse kahe nahaaluse infusiooni lahusena.
English: When given under the skin before the normal human immunoglobulin, it helps to deliver the active substance under the skin, and assists its absorption into the body.
Estonian: Hüaluronidaasi nahaalune manustamine enne inimese normaalimmunoglobuliini manustamist parandab HyQvia toimeaine jaotumist naha all ja selle imendumist organismis.
English: HyQvia can only be obtained with a prescription and treatment should be started and monitored by a doctor or nurse experienced in treating immunodeficiency syndromes.
Estonian: Ravi tohib alustada immuunpuudulikkuse sündroomidega patsientide ravis kogenud arst või meditsiiniõde ja see peab toimuma tema järelevalve all.
English: This is a form of the natural human enzyme, hyaluronidase, which breaks down a substance called hyaluronic acid that is present in the tissues in the tiny spaces between cells and so makes the area between cells temporarily more liquid.
Estonian: See loodusliku inimensüümi hüaluronidaasi erivorm lagundab hüaluroonhapet, mida leidub kudedes rakkude vahel.
English: Human normal immunoglobulin
Estonian: HyQvia inimese normaalimmunoglobuliin
English: The product also contains recombinant human hyaluronidase, which is an enzyme used to help deliver the human normal immunoglobulin under the skin and improve its absorption into the body.
Estonian: See ensüüm parandab inimese normaalimmunoglobuliini jaotumist naha all ja imendumist organismis.
English: Ref.: EMA/777733/2009 EMEA/H/C/253
Estonian: EMA/777733/2009 EMEA/H/C/253
English: These signs include:
Estonian: Nende nähtude hulka kuuluvad:
English: In addition, the baby must have a normal heart rate.
Estonian: Lisaks sellele peab lapsel olema normaalne südamelöögisagedus.
English: This summary was last updated in 12-2009.
Estonian: Kokkuvõtte viimane uuendus: 12-2009.
English: • regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
Estonian: • regulaarsed kontraktsioonid, mis kestavad vähemalt 30 sekundit ning mis korduvad iga 30 minuti järel vähemalt neli korda;
English: The marketing authorisation holder is Ferring Pharmaceuticals A/S.
Estonian: Müügiloa hoidja on Ferring Pharmaceuticals A/S.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tractocile on 20 January 2000.
Estonian: Euroopa Komisjon andis Tractocilele müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. jaanuaril 2000.
English: The main measure of effectiveness was whether the treatment had worked after a week.
Estonian: Efektiivsuse põhinäitaja oli ravi toime ühe nädala möödumisel.
English: Treatment should be started as soon as possible after diagnosis of pre-term labour.
Estonian: Ravi tuleb pärast enneaegse sünnituse diagnoosimist alustada nii kiiresti kui võimalik.
English: If contractions come back, treatment with Tractocile can be repeated up to three more times during the pregnancy.
Estonian: Kui kontraktsioonid tekivad taas, võib ravi Tractocilega korrata kuni kolm korda raseduse jooksul.
English: No side effects have been noted in the newborn baby.
Estonian: Vastsündinutel kõrvalnähte täheldatud ei ole.
English: Tractocile atosiban EPAR summary for the public
Estonian: Tractocile atosibaan Kokkuvõte üldsusele
English: Both contain the active substance atosiban (7.5 mg per millilitre).
Estonian: Nii süstelahus kui ka kontsentraat sisaldavad toimeainena atosibaani (7,5 mg/ml).
English: By blocking the action of oxytocin, Tractocile prevents contractions and causes the womb to relax, helping to delay birth.
Estonian: Blokeerides oksütotsiini toime, ennetab Tractocile kontraktsioone ja põhjustab emaka lõdvestumist, mis aitab sünnitust edasi lükata.
English: The Committee decided that Tractocile's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Komitee leidis, et Tractocile kasulikkus on suurem kui sellega seotud riskid ja soovitas anda ravimile müügiloa
English: Tractocile should not be used in people who may be hypersensitive (allergic) to atosiban or any of the other ingredients.
Estonian: Tractocilet ei tohi kasutada patsiendid, kes võivad olla atosibaani või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Tractocile is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours.
Estonian: Tractocilet manustatakse veeni kolmes järgus ja maksimaalselt 48 tunni jooksul: esimesele süstele (6,75 mg) järgneb suure ravimiannusega infusioon (300 µg/min) kolme tunni jooksul ning seejärel väiksema annusega infusioon (100 µg/min), mis kestab kuni 45 tundi.
English: It must not be used in women whose pregnancy is less than 24 weeks or more than 33 weeks, in women who have premature rupture of the membranes (when the waters break early) after 30 weeks of pregnancy, bleeding from the womb, eclampsia (a dangerous condition at the end of pregnancy caused by toxins in the blood), pre-eclampsia (a condition that can lead to eclampsia) or problems with the baby or placenta, or when continuing the pregnancy could be dangerous for the mother or baby.
Estonian: Ravimit ei tohi kasutada naised, kes on vähem kui 24 nädalat või rohkem kui 33 nädalat rasedad või kellel esineb enneaegne lootekestade purunemine pärast 30. rasedusnädalat, emakaverejooks, eklampsia (raseduse lõpus avalduv ohtlik seisund, mida põhjustavad veres olevad toksiinid) või preeklampsia (eklampsiani viiv seisund) või probleemid loote ja platsentaga või kui raseduse jätkumine ohustab last või ema.
English: The active substance in Tractocile, atosiban, is an antagonist of the natural hormone oxytocin.
Estonian: Tractocile toimeaine atosibaan on loodusliku hormooni oksütotsiini antagonist.
English: There were too few women with a pregnancy at less than 28 weeks for the effectiveness of Tractocile in comparison to beta-agonists to be established in this group.
Estonian: Vähem kui 28 nädalat kestnud rasedusega naisi oli liiga vähe, et tõestada selles rühmas Tractocile efektiivsust võrreldes beeta-agonistidega.
English: The better result with Tractocile over the beta-agonists might have been because it caused fewer side effects, thereby allowing the patients to receive a full course of treatment.
Estonian: Tractocile paremad tulemused võrreldes beeta-agonistidega võivad olla tingitud sellest, et Tractocile põhjustas vähem kõrvalnähte ja võimaldas patsientidel läbi teha täieliku ravikuuri.
English: The most common side effect with Tractocile (seen in more than 1 patient in 10) is nausea (feeling sick).
Estonian: Tractocile kõige sagedam kõrvalnäht (esinenud enam kui ühel patsiendil kümnest) on iiveldus.
English: • dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.
Estonian: • emakakaela avanemine 1-3 cm ja õhenemine 50% või rohkem.
English: Other information about Tractocile:
Estonian: Muu teave Tractocile kohta
English: This means that atosiban blocks the action of oxytocin.
Estonian: See tähendab, et atosibaan blokeerib oksütotsiini toime.
English: Oxytocin is the hormone involved in starting contractions of the womb.
Estonian: Oksütotsiin on hormoon, mis osaleb emakakontraktsioonide algatamises.
English: Tractocile is a solution for injection, and a concentrate that is made up into a solution for infusion (drip into a vein).
Estonian: Tractocile on süstelahus ja kontsentraat, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: Looking at the results of the three main studies together, 60% of the women treated with Tractocile were still pregnant one week after treatment (201 out of 337) compared with 48% of the women treated with the comparator medicines (163 out of 342).
Estonian: Kolmes uuringus kokku oli 60%-l Tractocilega ravitud naistest rasedus säilinud ka nädal pärast ravi lõppu (201 patsiendil 337-st).
English: The full EPAR for Tractocile is available here.
Estonian: Euroopa avalik hindamisaruanne Tractocile kohta on siin.
English: Treatment with Tractocile should be carried out by a doctor who has experience in the treatment of pre-term labour.
Estonian: Ravi Tractocilega peab teostama enneaegse sünnituse ravis kogenud arst.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Tractocile has shown an effectiveness in delaying pre-term birth that is the same as seen with beta-agonists, and that the better outcome with Tractocile was due to the medicine being better tolerated.
Estonian: Inimravimite komitee otsustas, et on tõendatud Tractocile beeta-agonistide toimega samalaadne efektiivsus enneaegse sünnituse edasilükkamisel.
English: What is Tractocile?
Estonian: Mis on Tractocile?
English: For the full list of all side effects reported with Tractocile, see the Package Leaflet.
Estonian: Tractocile kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What is the risk associated with Tractocile?
Estonian: Mis riskid Tractocilega kaasnevad?
English: Tractocile is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth pre-term (prematurely).
Estonian: Tractocilet kasutatakse sünnituse edasilükkamiseks naistel, kelle raseduse kestus on 24-33 nädalat ja kellel esinevad enneaegse sünnituse võimalusele viitavad nähud.
English: Why has Tractocile been approved?
Estonian: Miks Tractocile heaks kiideti?
English: What benefit has Tractocile shown during the studies?
Estonian: Milles seisneb uuringute põhjal Tractocile kasulikkus?
English: The ability of Tractocile to delay pre-term birth was studied in 742 women who were 23 to 33 weeks pregnant in three main studies.
Estonian: Tractocile efektiivsust enneaegse sünnituse edasilükkamiseks uuriti kolmes põhiuuringus742 naisel, kelle raseduse kestus oli 23-33 nädalat Tractocilet võrreldi ritodiini, terbutaliini ja salbutamooliga (beeta-agonistid, mida kasutatakse enneaegse sünnituse raviks).
English: How does Tractocile work?
Estonian: Kuidas Tractocile toimib?
English: How is Tractocile used?
Estonian: Kuidas Tractocilet kasutatakse?
English: How has Tractocile been studied?
Estonian: Kuidas Tractocilet uuriti?
English: What is Tractocile used for?
Estonian: Milleks Tractocilet kasutatakse?
English: Further information on Prasugrel Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave ravimi Prasugrel Mylan kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The materials will include information on how to prescribe the medicine safely and remind doctors that the medicine is not recommended for patients over the age of 75 years.
Estonian: Materjalide hulka kuulub ravimi ohutu määramise teave ja meeldetuletus, et ravimit ei soovitata kasutada üle 75-aastastel patsientidel.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Estonian: Ettevõte tegi ka uuringud, mis näitasid, et see on bioekvivalentne võrdlusravimiga.
English: What is Prasugrel Mylan and what is it used for?
Estonian: Mis on Prasugrel Mylan ja milleks seda kasutatakse?
English: What measures are being taken to ensure the safe and effective use of Prasugrel Mylan?
Estonian: Mis meetmed võetakse, et tagada ravimi Prasugrel Mylan ohutu ja efektiivne kasutamine?
English: It is recommended that treatment with Prasugrel Mylan and aspirin continue for up to a year.
Estonian: Ravi ravimiga Prasugrel Mylan ja aspiriiniga on soovitatav jätkata kuni üks aasta.
English: Prasugrel Mylan (prasugrel)
Estonian: Prasugrel Mylan (prasugreel)
English: The use of Prasugrel Mylan is not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Prasugrel Mylan as necessary.
Estonian: Ravimit Prasugrel Mylan ei soovitata kasutada üle 75-aastastel patsientidel, v.a kui arst on hoolikalt kaalutlenud ravi kasulikkust ja riske ning peab ravi ravimiga Prasugrel Mylan vajalikuks.
English: Prasugrel Mylan is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention.
Estonian: Ravimit Prasugrel Mylan kasutatakse koos aspiriiniga aterotrombootiliste nähtude (trombidest ja arterite lubjastumisest tingitud probleemid) ennetamiseks ägeda koronaarsündroomiga patsientidel, kellele tehakse perkutaanne koronaarinterventsioon.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Prasugrel Mylan has been shown to have comparable quality and to be bioequivalent to Efient.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud ravimi Prasugrel Mylan võrreldav kvaliteet ja bioekvivalentsus ravimiga Efient.
English: This means that Prasugrel Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Efient.
Estonian: See tähendab, et Prasugrel Mylan sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Efient, millel juba on ELis müügiluba.
English: For more information about using Prasugrel Mylan, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Prasugrel Mylan kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prasugrel Mylan have also been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Prasugrel Mylan ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Efient, and do not need to be repeated for Prasugrel Mylan.
Estonian: Võrdlusravimiga Efient on juba tehtud toimeaine heakskiidetud kasutamisviisi kasulikkuse ja riski uuringud ja neid ei ole vaja ravimiga Prasugrel Mylan korrata.