FrancophonIA/ELRC3.0 huggingface dataset:
English: The solution is clear to slightly opalescent and colourless to slightly yellow.
Estonian: Lahus on selge kuni kergelt opalestseeruv ja värvitu kuni kollakas.
English: The decision to stop using Ilumetri should be discussed with your doctor.
Estonian: Ravi lõpetamise otsust peaksite arutama arstiga.
English: reSURFACE 2
Estonian: Süstelahus 2 süstlit
English: • Choose an injection site with clear skin and easy access such as abdomen, thighs or upper arm. - DO NOT administer 5 cm around the navel or where the skin is tender, bruised, abnormally red, hardened or affected by psoriasis.
Estonian: • Valige puhta nahaga kergesti ligipääsetav süstekoht nagu alakõht, reied või õlavars.
English: The subcutaneous formulation of tildrakizumab showed an absolute bioavailability ranging from 73% (90% CI: 46% - 115%, 200 mg SC vs. 3 mg/kg IV) to 80% (90% CI: 62% - 103%, 50 mg SC vs. 0.5 mg/kg IV) in healthy subjects, as a result of cross study single dose comparison.
Estonian: Tildrakizumabi subkutaanse ravimvormi puhul oli absoluutne biosaadavus tervetel uuringus osalejatel ristuva uuringu ühekordse annuse võrdlemisel 73% (90% usaldusvahemik: 46...115%, 200 mg s.c. vs 3 mg/kg i.v.)
English: • Repeat the procedure with the second syringe in a different location of your skin if you are administering a dose of 200 mg.
Estonian: • Kui manustate 200 mg annust, korrake protseduuri teise süstliga valides erineva kohaoma nahal.
English: grade improvement from Baseline (%) PASI 90 (%)
Estonian: PGA “puhas” või “minimaalne” ≥2 astmelise paranemisega algtasemest (%) PASI 90 (%)
English: Common aIncluding nasopharyngitis.
Estonian: Sage a Sealhulgas nasofarüngiit.
English: Description of selected adverse reaction Immunogenicity
Estonian: Valitud kõrvaltoime kirjeldus
English: - Ilumetri is a clear to slightly opalescent and colourless to slightly yellow solution.
Estonian: - Ilumetri on selge kuni kergelt opalestseeruv ja värvitu kuni kollakas lahus.
English: • Insert the entire needle into the pinched skin between your fingers, straight up and down at a
Estonian: Pigistage nahk sõrmede vahele ja sisestage nõel
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Estonian: - Kui teil on lisaküsimusi, pidage nõu arsti, apteekri või meditsiiniõega.
English: Keep the pre-filled syringes in the outer carton in order to protect from light.
Estonian: Hoidke süstleid kuni kasutamiseni välispakendis, valguse eest kaitstult.
English: Maintenance of Response
Estonian: Ravivastuse püsivus
English: Ilumetri is a sterile solution for injection in pre-filled syringe.
Estonian: Ilumetri on steriilne süstelahus süstlis.
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Estonian: Hoida süstel välispakendis, valguse eest kaitstult.
English: The pre-filled syringes are for single use only.
Estonian: Süstel on mõeldud ainult ühekordseks kasutamiseks.
English: Clean injection site
Estonian: Infolehe sisukord
English: Nausea
Estonian: Seljavalu
English: • Hold the pre-filled syringe steady.
Estonian: • Hoidke süstlit kindlalt paigal.
English: In cynomolgus monkeys, there was negligible secretion of the product into breast milk.
Estonian: Jaava makaakidel esines toote vähene sekretsioon rinnapiima.
English: Ilumetri is a clear to slightly opalescent and colourless to slightly yellow solution.
Estonian: Ilumetri on selge kuni kergelt opalestseeruv ja värvitu kuni kollakas lahus.
English: Your doctor will decide for how long you need to take Ilumetri.
Estonian: Seda, kui pika aja jooksul peate Ilumetri't võtma, otsustab teie arst.
English: Ilumetri contains the active substance tildrakizumab.
Estonian: Ilumetri sisaldab toimeainena tildrakizumabi.
English: Ilumetri is used to treat a skin condition called plaque psoriasis, in adults with moderate to severe disease.
Estonian: Ilumetri'ga ravitakse täiskasvanutel mõõduka kuni raske kuluga nahahaigust, mis kannab nimetust naastuline psoriaas.
English: Ilumetri 100 mg solution for injection in pre-filled syringe tildrakizumab
Estonian: Ilumetri 100 mg süstelahus süstlis tildrakizumab
English: Ilumetri 100 mg solution for injection in pre-filled syringe.
Estonian: Ilumetri 100 mg süstelahus süstlis.
English: • Gently pinch your skin at the chosen injection site.
Estonian: • Pigistage valitud süstekohal nahk õrnalt sõrmede vahele.
English: Anti-TB therapy should be considered prior to initiating Ilumetri in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Estonian: Kui patsiendil on varem esinenud latentset või aktiivset tuberkuloosi ja ravikuuri piisavust ei saa kinnitada, tuleb enne Ilumetri'ga ravi alustamist kaaluda tuberkuloosiravi kasutamist.
English: Breast-feeding
Estonian: Immunogeensus
English: Inject
Estonian: Imendumine
English: Injection site pain
Estonian: Valu süstekohas
English: GENERAL CLASSIFICATION FOR SUPPLY
Estonian: ABIAINETE TÄIELIK LOETELU
English: METHOD OF ADMINISTRATION
Estonian: Toimemehhanism
English: The European Commission granted a marketing authorisation valid throughout the European Union for Luminity on 20 September 2006.
Estonian: Euroopa Komisjon andis Luminity müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. septembril 2006.
English: What measures are being taken to ensure the safe and effective use of Luminity?
Estonian: Mis meetmed võetakse, et tagada Luminity ohutu ja efektiivne kasutamine?
English: The full EPAR for Luminity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Luminity kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Luminity
Estonian: Muu teave Luminity kohta
English: There have been five main studies of Luminity, involving a total of 401 patients.
Estonian: Luminityt uuriti viies põhiuuringus, milles osales kokku 401 patsienti.
English: As all five original studies were carried out with a technique known as ‘fundamental' ultrasound imaging, the company also presented the results of some studies to show that the results seen using fundamental imaging could also be obtained when using the imaging techniques known as ‘harmonic' and ‘non linear'.
Estonian: Et kõik viis algset uuringut korraldati nn fundamentaalse ultraheliuuringutehnikaga, esitas ettevõte ka uuringutulemusi tõestamaks, et fundamentaalse uurimistehnikaga saadud tulemusi on võimalik saavutada ka siis, kui kasutatakse nn harmoonilist ja mittelineaarset uurimistehnikat.
English: The gas is then cleared through the lungs.
Estonian: Gaas väljub kopsude kaudu.
English: Luminity is for diagnostic use only.
Estonian: Luminity on ette nähtud kasutamiseks üksnes diagnostikas.
English: The most common side effects with Luminity (seen in between 1 and 10 patients in 100) are headache and flushing (reddening of the skin).
Estonian: Luminity kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on peavalu ja õhetus.
English: The CHMP decided that Luminity's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Luminity kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Before use, Luminity must be activated by shaking it using a mechanical device called Vialmix, which is supplied to doctors who need to prepare the medicine.
Estonian: Enne kasutamist tuleb Luminity aktiveerida mehhaanilise loksutusvahendi (Vialmix) abil, millega varustatakse kõik arstid, kes ravimit valmistavad.
English: This is a summary of the European public assessment report (EPAR) for Luminity.
Estonian: See on ravimi Luminity Euroopa avaliku hindamisaruande kokkuvõte.
English: In two of these studies, Luminity was compared with placebo (a dummy treatment).
Estonian: Neist uuringutest kahes võrreldi Luminityt platseeboga (näiv ravim).
English: These studies also looked at left ventricle image enhancement.
Estonian: Ka nendes uuringutes vaadeldi vasaku vatsakese kujutise paranemist.
English: Luminity perflutren-containing lipid microspheres
Estonian: Luminity perflutreeni sisaldavad mikrokuulid
English: This helps to obtain a better contrast between the area where the gas bubbles are (such as the heart chambers) and the surrounding tissue.
Estonian: See aitab saavutada gaasimullidega piirkonna (nt südameõõnte) ja ümbritseva koe vahel parema kontrasti.
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 Luminity.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: What is Luminity?
Estonian: Mis on Luminity?
English: When Luminity is injected, it travels in the veins to the heart.
Estonian: Pärast süstimist liigub Luminity veenide kaudu südamesse.
English: For more information about treatment with Luminity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist
Estonian: Kui vajate Luminityga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: During echocardiography, the perflutren microspheres in Luminity reflect ultrasound waves differently from the surrounding tissues.
Estonian: Perflutreeni mikrokuulid Luminitys peegeldavad ehhokardiograafia ajal ultraheli tunduvalt teistmoodi kui ümbritsevad koed.
English: What is the risk associated with Luminity?
Estonian: Mis riskid Luminityga kaasnevad?
English: Luminity should only be given by doctors trained in performing and reading images obtained with contrast echocardiography, in hospitals or clinics where appropriate resuscitation equipment is available in case of heart or lung problems or allergic reactions.
Estonian: Luminityt võib manustada üksnes arst, kes on saanud kontrastainega ehhokardiograafia tegemise ja selle kujutiste (ehhokardiogrammide) lugemise väljaõppe, ning ainult haiglates või polikliinikutes, kus on olemas võimalike südame- või kopsuprobleemide või allergiareaktsioonide järgse elustamise vahendid.
English: For the full list of all side effects and restrictions with Luminity, see the package leaflet.
Estonian: Luminity kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained without a contrast agent is not good enough.
Estonian: Luminityt kasutatakse kahtlustatava või diagnoositud südamepärgarteritõvega (südamelihast verega varustavate veresoonte ummistus) patsientidel, kui kontrastaineta saadud kujutis ei ole piisavalt hea.
English: This is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion after being diluted.
Estonian: See manustatakse veeni kas boolussüstina (kogu annus korraga) või infusioonina (pärast lahjendamist).
English: Three studies looked at its ability to enhance the image of the left ventricle, comparing the echocardiography scan before and after administration of Luminity.
Estonian: Kolmes uuringus vaadeldi ravimi võimet vasaku vatsakese kujutise parandamisel, võrreldes ehhokardiogrammi enne ja pärast Luminity manustamist.
English: This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion' of microspheres of perflutren gas of the right size to get a good quality image.
Estonian: See võimaldab ravimi korralikult läbi loksutada, mis tagab gaasilise perflutreeni mikrokuulide püsiva dispersiooni, mis on vajalik kvaliteetse kujutise saamiseks.
English: Luminity was effective in enhancing the image of the left ventricle, and it was more effective than placebo in the studies where Luminity and placebo were compared.
Estonian: Luminity oli vasaku vatsakese kujutise parandamisel efektiivne ning uuringutes, kus võrreldi Luminityt ja platseebot, oli Luminity platseebost efektiivsem.
English: Luminity is a solution for injection or infusion (drip) into a vein that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Estonian: Luminity on süste- või infusioonilahus (veeni tilgutatav lahus), mis sisaldab toimeainena gaasilise perflutreeni mikrokuule (väga väikesi mulle).
English: It is a contrast agent (a medicine that helps obtain better images of organs and tissues during a scan).
Estonian: See on kontrastaine ehk aine, mis aitab saada piltdiagnostikas paremaid pilte organitest ja kudedest.
English: Why has Luminity been approved?
Estonian: Miks Luminity heaks kiideti?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luminity have been included in the summary of product characteristics and the package leaflet.
Estonian: Luminity omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi ohutu ja tõhusa kasutamise teave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The way Luminity is given and the dose depend on the technique being used for the echocardiography.
Estonian: Luminity manustamisviis ja annus sõltuvad ehhokardiograafia tegemise viisist.
English: What benefit has Luminity shown during the studies?
Estonian: Milles seisneb uuringute põhjal Luminity kasulikkus?
English: Luminity is used in adults to obtain a clearer image of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound).
Estonian: Luminityt kasutatakse täiskasvanud patsientide ehhokardiograafias (diagnostiline uuring, kus südamest kujutise saamiseks kasutatakse ultraheli), et saada südameõõntest, eelkõige vasakust vatsakesest kontrastsem kujutis.
English: For full details, see the summary of product characteristics (also part of the EPAR).
Estonian: Üksikasjalik teave on ravimi omaduste kokkuvõttes, mis on samuti Euroopa avaliku hindamisaruande osa.
English: How has Luminity been studied?
Estonian: Kuidas Luminityt uuriti?
English: What is Luminity used for?
Estonian: Milleks Luminityt kasutatakse?
English: The last two studies were set up primarily to look at the ability of Luminity to improve the accuracy of the measurement of the ejection fraction (the percentage of the blood volume that is pumped out of the heart in one beat).
Estonian: Kahe ülejäänud uuringu põhieesmärk oli vaadelda, kuidas Luminity parandab südame löögimahu mõõtmise täpsust.
English: How is Luminity used?
Estonian: Kuidas Luminityt kasutatakse?
English: How does Luminity work?
Estonian: Kuidas Luminity toimib?
English: The medicine can only be obtained with a prescription.
Estonian: Luminity on retseptiravim.
English: 2 carton pack.
Estonian: Pakend kahe karbiga.
English: 40 mg/0.8 ml
Estonian: 40 mg Süstelahus Subkutaanne viaal (klaas) 0.8 ml (40mg/0.8ml)
English: Immediate Packaging
Estonian: Pakendi sisu Pakendi suurus
English: Each carton contains: 1 vial + 1 syringe + 1 needle + 1 sterile adapter + 2 alcohol pads
Estonian: 1 eeltäidetud süstal + 1 alkoholipadjake 1 pensüstel + 2 alkoholipadjakest blistris
English: Content (concentration)
Estonian: pensüstel (klaas)
English: 2 pre-filled syringes + 2
Estonian: 1 steriilne adapter + 2 alkoholipadjakest
English: 1 alcohol pad
Estonian: 1 nõel +
English: Solution for injection Subcutaneous use vial (glass)
Estonian: 1 nõelakaitsega eeltäidetud süstal + 1 alkoholipadjake eeltäidetud süstal (klaas)
English: This summary was last updated in 04-2011.
Estonian: Kokkuvõtte viimane uuendus: 04-2011.
English: The full EPAR for MabCampath can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst MabCampathi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was the overall response to treatment.
Estonian: Efektiivsuse põhinäitaja oli üldine ravivastus.
English: The European Commission granted a marketing authorisation valid throughout the European Union for MabCampath on 6 July 2001.
Estonian: Euroopa Komisjon andis MabCampathi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 6. juulil 2001.
English: It contains the active substance alemtuzumab (10 mg/ml or 30 mg/ml).
Estonian: Selle toimeaine on alemtusumab (10 mg/ml või 30 mg/ml).
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 04 July 2008.
Estonian: Et ettevõte esitas vajaliku lisateabe, tühistati müügiloa erandkorras väljastatus 4. juulil 2008.
English: The marketing authorisation holder is Genzyme Europa BV.
Estonian: Müügiloa hoidja on Genzyme Europe B.V.
English: The main measure of effectiveness was how long it took until the disease got worse or the patient died.
Estonian: Efektiivsuse põhinäitaja oli haiguse süvenemise või patsiendi surmani kulunud aeg.
English: MabCampath was originally authorised under ‘exceptional circumstances', because, for scientific reasons, it had not been possible to obtain complete information on the medicine.
Estonian: MabCampathi müügiluba anti algselt erandkorras, sest teaduslikel põhjustel ei ole olnud võimalik ravimi kohta saada täielikku teavet.
English: • who have an active infection that has spread throughout the body; • with HIV infection;
Estonian: • kellel on kogu organismis levinud aktiivne infektsioon,
English: During the first week of treatment, MabCampath should be given in increasing doses: 3 mg on day 1, 10 mg on day 2 and 30 mg on day 3, as long as each dose is well tolerated.
Estonian: Esimesel ravinädalal tuleb MabCampathit manustada suurenevates annustes: 1. päeval 3 mg, 2. päeval 10 mg ja 3. päeval 30 mg, kuni iga annust hästi talutakse.
English: What measures are being taken to ensure the safe use of MabCampath?
Estonian: Mis meetmeid võetakse, et tagada MabCampathi kasutamise ohutus?
English: In the patients receiving MabCampath, it took an average of 14.6 months for the disease to get worse or for the patient to die, compared with 11.7 months in those taking chlorambucil.
Estonian: MabCampathi saanud patsientidel kulus haiguse süvenemiseni või surmani keskmiselt 14,6 kuud, võrreldes 11,7 kuuga patsientidel, kes said kloorambutsiili.
English: In these studies, MabCampath was not compared with any other treatment.
Estonian: Nendes uuringutes ei võrreldud MabCampathit muude ravimitega.
English: The most frequent side effects with MabCampath are: infusion reactions (fever, chills, low blood pressure, itching, feeling sick, hives, increased heart rate, breathlessness), low counts of blood cells (white blood cells, platelets and red blood cells), infections (signs of cytomegalovirus in the blood, cytomegalovirus infection or other infections), gastrointestinal symptoms (feeling sick, vomiting, abdominal pain) and neurological symptoms (insomnia, anxiety).
Estonian: MabCampathi kõige sagedamad kõrvalnähud on infusioonireaktsioonid (palavik, külmavärinad, madal vererõhk, kihelus, iiveldus, lööve, südame löögisageduse suurenemine, õhupuudustunne), vererakkude (valgelibled, vereliistakud ja punalibled) vähesus, nakkused (tsütomegaloviiruse tunnused veres, tsütomegaloviirusinfektsioon vm nakkused), seedehäired (iiveldus, oksendamine, kõhuvalu) ja neuroloogilised nähud (unetus, ärevus).
English: MabCampath must not be used in patients:
Estonian: MabCampathit ei tohi kasutada järgmised patsiendid:
English: One study included 297 patients who had not received treatment before.
Estonian: Ühes uuringus osales 297 patsienti, keda varem ei olnud ravitud.
English: MabCampath has been looked at in four main studies involving a total of 446 patients with CLL.
Estonian: MabCampathit uuriti neljas põhiuuringus, milles osales kokku 446 kroonilise lümfotsüütleukeemiaga patsienti.
English: MabCampath is given as an infusion lasting about two hours.
Estonian: MabCampathi infusioon kestab ligikaudu kaks tundi.
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
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: After this, the recommended dose is 30 mg three times a week (every other day) for a maximum of 12 weeks.
Estonian: Pärast annuse järk-järgulist suurendamist on soovituslik annus 30 mg üks kord ööpäevas, mida antakse 3 korda nädalas (ülepäeviti) kuni 12 nädala jooksul.
English: They should also receive antibiotics and antiviral medicines during and after
Estonian: Ravi ajal ja pärast ravi tuleb neile anda ka antibiootikume ja viirusevastaseid ravimeid.
English: The most frequent serious adverse reactions are low counts of blood cells, infusion reactions, and infections or immunosuppression (reduced activity of the immune system).
Estonian: Kõige sagedamad rasked kõrvalnähud on vererakkude vähesus, infusioonireaktsioonid ja nakkused või immuunsüsteemi nõrgenemine.
English: In the study of patients who had been treated with fludarabine before, 33% responded partially or completely to treatment with MabCampath.
Estonian: Varem fludarabiiniga ravitud patsientide põhiuuringus tekkis MabCampathile osaline või täielik ravivastus 33% patsientidest.
English: In patients who had not received treatment before, MabCampath was more effective than chlorambucil.
Estonian: Varem ravimata patsientidel oli MabCampath efektiivsem kui kloorambutsiil.
English: • who have an active, second cancer; • who are pregnant.
Estonian: • kes on rasedad.
English: The CHMP noted that the effectiveness of MabCampath had been demonstrated, but that there is no information from studies directly comparing MabCampath with treatment combinations including fludarabine, which are widely used to treat patients with CLL.
Estonian: Inimravimite komitee märkis, et MabCampathi efektiivsus on tõendatud, aga puudub teave uuringute kohta, kus MabCampathit võrreldaks vahetult fludarabiini sisaldavate kombinatsioonravimitega, mida laialdaselt kasutatakse kroonilise lümfotsüütleukeemiaga patsientide ravimiseks.
English: For more information about treatment with MabCampath, read the package leaflet (also part of the EPAR) or contact your doctor or
Estonian: Kui vajate MabCampathiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The company that makes MabCampath will provide a brochure containing information on the medicine's safety to all doctors in all Member States who prescribe the medicine.
Estonian: MabCampathi tootja varustab kõik liikmesriigid ravimit määravatele arstidele suunatud ravimiohutuse teabepakmega.
English: This is a summary of the European public assessment report (EPAR) for MabCampath.
Estonian: Käesolev dokument on ravimi MabCampath Euroopa avaliku hindamisaruande kokkuvõte.
English: The other three studies looked at a total of 149 patients who had already received other treatments.
Estonian: Muus kolmes uuringus osales kokku 149 patsienti, keda varem oli ravitud muude ravimitega.
English: The Committee recommended that MabCampath be given marketing authorisation.
Estonian: Komitee soovitas anda MabCampathi müügiloa.
English: One of these studies included 93 patients in whom previous treatment with fludarabine had stopped working.
Estonian: Ühes uuringus osales 93 patsienti, kellel varasem ravi fludarabiiniga oli lakanud toimimast.
English: As a result, the lymphocytes die, and this helps to control the CLL.
Estonian: Selle tulemusel lümfotsüüdid hävivad, mis aitab ravida kroonilist lümfotsüütleukeemiat.
English: Why has MabCampath been approved?
Estonian: Miks MabCampath heaks kiideti?