FrancophonIA/ELRC3.0 huggingface dataset:
English: • dementia (loss of intellectual function).
Estonian: • Dementsus (vaimsete võimete nõrgenemine).
English: A scan is taken 3 to 6 hours after the injection.
Estonian: Uuring tehakse 3-6 tundi pärast süstet.
English: What measures are being taken to ensure the safe and effective use of Striascan?
Estonian: Mis meetmed võetakse, et tagada Striascani ohutu ja efektiivne kasutamine?
English: Striascan is a diagnostic medicine.
Estonian: Striascan on diagnostikaravim.
English: Other information about Striascan
Estonian: Muu teave Striascani kohta
English: I))
Estonian: Lk 2/2
English: Striascan is given by slow injection lasting at least 15 to 20 seconds into an arm vein.
Estonian: Striascani manustatakse patsiendile vähemalt 15-20 sekundit kestva aeglase süstega käsivarre veeni.
English: Because Striascan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Striascan on geneeriline ravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Between 1 to 4 hours before receiving Striascan, patients must also take another medicine, such as iodine tablets, to prevent the radioactive iodine in Striascan from getting into the thyroid gland.
Estonian: Patsiendid peavad 1-4 tundi enne Striascani manustamist võtma ka muud ravimit, näiteks jooditablette, et takistada Striascani radioaktiivse joodi sattumist kilpnäärmesse.
English: Side effects reported with Striascan are carefully evaluated and any necessary action taken to protect patients.
Estonian: Striascani kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Striascan has been shown to be comparable to DaTSCAN.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud Striascani sarnane toime ravimiga DaTSCAN.
English: As for every medicine, the company provided studies on the quality of Striascan.
Estonian: Nagu iga ravimi korral, esitas ettevõte Striascani kvaliteedi uuringud.
English: As for all medicines, data on the use of Striascan are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Striascani kasutamise kohta pidevat järelevalvet.
English: For more information about using Striascan, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Striascani 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 Striascan have been included in the summary of product characteristics and the package leaflet.
Estonian: Striascani ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: This build-up can be seen using an imaging technique called single-photon-emission computed tomography (SPECT), which detects the radioactive iodine-123.
Estonian: Seda kogunemist saab näha piltdiagnostikameetodi üksiku footoni emissiooni kompuutertomograafiaga (SPECT), mis tuvastab radioaktiivse isotoobi 123I.
English: Striascan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DaTSCAN.
Estonian: See tähendab, et Striascan sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim DaTSCAN, millel juba on ELis müügiluba.
English: Striascan can only be obtained with a prescription and should only be used in patients who have been referred by a doctor with experience in the management of movement disorders or dementia.
Estonian: Striascan on retseptiravim ja seda tohib kasutada ainult patsientidel, keda on ravile suunanud liikumishäirete või dementsuse ravis kogenud arst.
English: Therefore, the Agency's view was that, as for DaTSCAN, the benefit of Striascan outweighs the identified risk and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka DaTSCANi korral, ületab Striascani kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, DaTSCAN, and do not need to be repeated for Striascan.
Estonian: Võrdlusravimiga DaTSCAN on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ja neid ei ole vaja Striascaniga korrata.
English: What is Striascan and what is it used for?
Estonian: Mis on Striascan ja milleks seda kasutatakse?
English: In patients with Parkinson's disease and related diseases, and in patients with dementia with Lewy bodies, there is typically a loss of the dopamine-containing nerve cells in the striatum.
Estonian: Tüüpiliselt on Parkinsoni tõvega ja seonduvate haigustega patsientidel ning patsientidel, kellel on Lewy kehadega dementsus, juttkehas vähem dopamiini sisaldavaid närvirakke.
English: If this happens, the amount of Striascan attaching to these nerve cells is greatly reduced, which can be seen on the scan.
Estonian: Sellisel juhul seondub nende närvirakkudega oluliselt vähem Striascani, mis on uuringul näha.
English: This enables diseases related to Parkinson's disease to be distinguished from essential tremor, and for Lewy body dementia to be distinguished from Alzheimer's disease.
Estonian: See võimaldab eristada Parkinsoni tõvega seotud haigusi essentsiaalsest treemorist ja Lewy kehadega dementsust Alzheimeri tõvest.
English: Because tremor can also occur in ‘essential tremor' (tremor whose cause is unknown), Striascan can help distinguish between essential tremor and diseases related to Parkinson's disease;
Estonian: Värin võib esineda ka essentsiaalse treemorina (teadmata põhjusega värin) ning Striascaniga saab eristada seda Parkinsoni tõvega seotud haiguste tekitatud värinast.
English: Striascan is only handled and given by people who have experience in the safe handling of radioactive materials.
Estonian: Striascani tohivad käsitseda ja patsiendile manustada ainult radioaktiivsete ainete ohutu käsitsemise väljaõppega isikud.
English: • movement disorders such as those in Parkinson's disease and other related diseases, where a loss of nerve cells leads to tremor (shaking), gait disturbance (problems with the way the patient walks) and stiffness of the muscles.
Estonian: • Sellised liikumishäired, mis kaasnevad Parkinsoni tõve ja muude seotud haigustega, mille korral närvirakkude hävimine tekitab värinat, kõnnakuhäireid ja lihasejäikust.
English: Resuscitation equipment should be available before Striascan is given, in case the patient has an allergic reaction.
Estonian: Enne Striascani manustamist peavad patsiendi võimaliku allergilise reaktsiooni esinemiseks valmis olema elustamisvahendid.
English: There was no need for ‘bioequivalence' studies to investigate whether Striascan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Estonian: Bioekvivalentsust, st kas Striascan imendub organismis samamoodi kui võrdlusravim, et saavutada toimeaine sarnane sisaldus veres, ei olnud vaja uurida.
English: Striascan (ioflupane (
Estonian: Striascan (joflupaan (123I))
English: The medicine is used to help in the diagnosis of the following conditions in adults (aged 18 years or over):
Estonian: Striascani kasutatakse täiskasvanutel (vähemalt 18 a) järgmiste seisundite diagnoosimisel.
English: This is because Striascan is given by injection into a vein, so the active substance is delivered straight into the bloodstream.
Estonian: Seda ei olnud vaja, sest Striascan manustatakse veeni süstena, mille abil satub toimeaine otse vereringesse.
English: How is Striascan used?
Estonian: Kuidas Striascani kasutatakse?
English: An overview of Striascan and why it is authorised in the EU
Estonian: Ülevaade ravimist Striascan ja ELis müügiloa väljastamise põhjendus
English: It is used to detect the loss of nerve cells in an area of the brain called the striatum, specifically the cells that release dopamine, a chemical messenger.
Estonian: Seda kasutatakse närvirakkude hävimise tuvastamiseks peaaju osas juttkehas, eelkõige seoses virgatsainet dopamiini vabastavate rakkudega.
English: It contains a substance called ioflupane, which is labelled with 123I (iodine-123), a radioactive form of iodine.
Estonian: See sisaldab ainet joflupaani, mis on märgistatud joodi radioaktiivse isotoobiga 123I.
English: What are the benefits and risks of Striascan?
Estonian: Milles seisneb Striascani kasulikkus ja mis riskid ravimiga kaasnevad?
English: Striascan is used to help distinguish between a type of dementia known as ‘dementia with Lewy bodies' and Alzheimer's disease.
Estonian: Striascaniga saab eristada Lewy kehadega dementsust ja Alzheimeri tõbe.
English: Ioflupane attaches specifically to structures on nerve cell endings that are responsible for the transport of dopamine.
Estonian: Joflupaan seondub spetsiifiliselt närvilõpmetes olevate dopamiini transporteritega (dopamiini transportivate valkudega).
English: I) is distributed by the blood and builds up in the striatum, where it attaches to the structures that transport dopamine.
Estonian: Süstimisel levib joflupaan (123I) vereringe kaudu ja koguneb juhtkehas, kus seondub dopamiini transporteritega.
English: How has Striascan been studied?
Estonian: Kuidas Striascani uuriti?
English: Annex I Scientific conclusions
Estonian: I lisa Teaduslikud järeldused
English: It contains five live rotavirus strains, each carrying a different antigen (G1, G2, G3, G4 and P1[8]).
Estonian: See sisaldab viit rotaviiruse elustüve, millest igaüks sisaldab eri antigeeni (G1, G2, G3, G4 ja P1[8]).
English: The full EPAR for RotaTeq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst RotaTeqi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It must also not be used in babies whose immune system is weakened.
Estonian: Samuti ei tohi seda anda nõrgenenud immuunsüsteemiga imikutele.
English: A risk management plan has been developed to ensure that RotaTeq is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada RotaTeqi võimalikult ohutu kasutamine.
English: The first dose should be given six weeks after birth at the earliest.
Estonian: Esimene annus tuleb anda kõige varem 6 nädalat pärast sündi.
English: What measures are being taken to ensure the safe and effective use of RotaTeq?
Estonian: Mis meetmeid võetakse, et tagada RotaTeqi ohutu ja efektiivne kasutamine?
English: The European Commission granted a marketing authorisation valid throughout the European Union for RotaTeq on 27 June 2006.
Estonian: Euroopa Komisjon andis RotaTeqi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 27. juunil
English: Overall, the studies of RotaTeq involved over 72,000 babies, including about 2,000 premature babies.
Estonian: RotaTeqi uuringutes osales üle 72 000 imiku, sealhulgas ligikaudu 2000 enneaegset imikut.
English: It is available as a solution in a single-dose tube.
Estonian: Seda turustatakse lahusena üheannuselises tuubis.
English: RotaTeq is given according to official recommendations.
Estonian: RotaTeqi määratakse vastavalt ametlikele soovitustele.
English: RotaTeq contains viruses that carry the antigens for some of the most commonly occurring types of rotaviruses.
Estonian: RotaTeq sisaldab viirusi, mis sisaldavad mõningate kõige sagedamate rotaviirustüüpide antigeene.
English: The CHMP decided that RotaTeq's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et RotaTeqi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
English: The contents of the tube of RotaTeq are given directly into the baby's mouth.
Estonian: RotaTeqi tuubi sisu manustatakse vahetult imiku suhu.
English: About half of the babies received RotaTeq, and the others received placebo (a dummy vaccine).
Estonian: Imikutest ligikaudu pool sai RotaTeqi, ülejäänud said platseebot (näivat vaktsiini).
English: When a baby is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these antigens, which help prevent infections caused by rotaviruses that occur naturally and carry the same or very similar antigens.
Estonian: Kui imikule antakse vaktsiini, moodustab tema immuunsüsteem (organismi kaitsesüsteem) nende antigeenide vastaseid antikehi, mis aitavad ennetada looduslikult esinevate ja samu või väga sarnaseid antigeene sisaldavate rotaviiruste tekitatud nakkusi.
English: An antigen is a specific structure that the body can recognise as ‘foreign' and against which the body can make an antibody, a special protein that can neutralise or destroy the antigen.
Estonian: Antigeen on teatud ehitusega aine, mida organism peab võõraks ja moodustab selle vastu antikeha ehk erilise valgu, mis neutraliseerib või hävitab antigeeni.
English: Vaccination with RotaTeq should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.
Estonian: RotaTeqiga vaktsineerimist tuleb edasi lükata imikutel, kellel tekib äkki kõrge palavik, kõhulahtisus või oksendamine.
English: RotaTeq is used in babies from 6 to 32 weeks of age to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Estonian: RotaTeqi kasutatakse 6-32-nädalastel imikutel kaitseks rotaviirusinfektsioonist põhjustatud gastroenteriidi (kõhulahtisus ja oksendamine) eest.
English: RotaTeq can be given at the same time as other vaccinations (except the oral polio vaccine, when a two-week interval is needed between the two vaccines).
Estonian: RotaTeqi tohib anda samal ajal kui muid vaktsiine (v.a suukaudne poliovaktsiin, mille korral on vaja kummagi vaktsiini manustamise vahele jätta 2-nädalane vahe).
English: The main measure of effectiveness, which was studied in 6,000 babies, was the number of babies who developed rotavirus gastroenteritis during the following rotavirus season (the time of the year when rotaviruses are known to circulate and cause infection, generally during the cooler months in winter to early spring).
Estonian: Vaktsiini efektiivsust uuriti 6000 imikul ja efektiivsuse põhinäitaja oli nende imikute arv, kellel tekkis rotaviirusest põhjustatud gastroenteriit järgmisel rotaviiruse hooajal (ajal, mil rotaviirused teadaolevalt levivad ja põhjustavad infektsioone, tavaliselt talvel ja varakevadel).
English: The most common side effects with RotaTeq (seen in more than 1 patient in 10) are pyrexia (fever), diarrhoea and vomiting.
Estonian: RotaTeqi kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on püreksia (palavik), kõhulahtisus ja oksendamine.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for RotaTeq, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati RotaTeqi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The number of cases of rotavirus gastroenteritis due to viruses with the same antigens as in the vaccine decreased following vaccination with RotaTeq.
Estonian: Vaktsiiniga samu antigeene kandvast rotaviirusest põhjustatud gastroenteriidi juhtude arv vähenes pärast RotaTeqiga vaktsineerimist.
English: This document is a summary of the European public assessment report (EPAR) for RotaTeq.
Estonian: See on vaktsiini RotaTeq Euroopa avaliku hindamisaruande kokkuvõte.
English: The first dose is given when the baby is between 6 and 12 weeks of age.
Estonian: Esimene annus antakse 6-12-nädalasele imikule.
English: For more information about treatment with RotaTeq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate RotaTeqiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: RotaTeq should never be injected under any circumstances.
Estonian: RotaTeqi ei tohi mingil juhul süstida.
English: RotaTeq must not be used in babies who are hypersensitive (allergic) to the active substance or any of the other ingredients, or who showed signs of allergy after receiving a dose of RotaTeq or another vaccine against rotavirus in the past.
Estonian: RotaTeqi ei tohi kasutada imikutel, kes on toimeaine või vaktsiini mis tahes muu koostisaine suhtes ülitundlikud (allergilised) või kellel on tekkinud pärast RotaTeqi või muu rotaviirusvastase vaktsiini annuse saamist allergianähud.
English: It is recommended that the last dose be given to the child by the age of 20 to 22 weeks.
Estonian: Viimane annus on soovitatav anda enne lapse 20-22 nädala vanuseks saamist, aga vajaduse korral tohib selle manustada enne lapse 32 nädala vanuseks saamist.
English: RotaTeq can be given to premature babies, as long as the pregnancy lasted at least 25 weeks.
Estonian: RotaTeqi tohib manustada vähemalt 25 rasedusnädala järel sündinud enneaegsetele imikutele.
English: Among the almost 6,000 babies in whom the main measure of effectiveness was studied, 82 of the babies vaccinated with RotaTeq developed rotavirus gastroenteritis (one with severe gastroenteritis) compared with 315 of the babies who received placebo (51 severe cases).
Estonian: Ligikaudu 6000 imikust, kellel uuriti vaktsiini efektiivsust, tekkis rotaviirusest põhjustatud gastroenteriit RotaTeqiga vaktsineeritutest 82 imikul (1 imikul raske gastroenteriit) ning platseeborühmas 315 imikul (51 rasket juhtu).
English: For the full list of all side effects reported with RotaTeq, see the package leaflet.
Estonian: RotaTeqi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Other information about RotaTeq:
Estonian: Muu teave RotaTeqi kohta
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 RotaTeq.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: What is RotaTeq?
Estonian: Mis on RotaTeq?
English: RotaTeq is given as three doses, with at least four weeks between each dose.
Estonian: RotaTeqi antakse kolme annusena, jättes annuste vahele vähemalt neljanädalased intervallid.
English: RotaTeq must not be given to babies who have had intussusception in the past or who have problems with their bowel that could put them at risk of intussusception.
Estonian: RotaTeqi ei tohi anda imikutele, kellel on varem olnud sooletuppumus või kellel on soolehäireid, mis võivad soodustada sooletuppumuse tekkimist.
English: Why has RotaTeq been approved?
Estonian: Miks RotaTeq heaks kiideti?
English: What is the risk associated with RotaTeq?
Estonian: Mis riskid RotaTeqiga kaasnevad?
English: RotaTeq rotavirus vaccine, live
Estonian: RotaTeq rotaviiruse elusvaktsiin
English: There are various types of rotaviruses that cause gastroenteritis.
Estonian: Gastroenteriiti põhjustavad mitmesugused rotaviirused, mis võivad sisaldada eri antigeene.
English: RotaTeq is a vaccine that is taken by mouth.
Estonian: RotaTeq on suukaudne vaktsiin.
English: The study also showed that there were fewer hospital admissions or visits to emergency clinics for rotavirus gastroenteritis in babies vaccinated with RotaTeq.
Estonian: Uuring näitas ka, et RotaTeqiga vaktsineeritud imikud vajasid rotaviirusliku gastroenteriidi tõttu vähem statsionaarset või erakorralist haiglaravi.
English: How does RotaTeq work?
Estonian: Kuidas RotaTeq toimib?
English: What is RotaTeq used for?
Estonian: Milleks RotaTeqi kasutatakse?
English: What benefit has RotaTeq shown during the studies?
Estonian: Milles seisneb uuringute põhjal RotaTeqi kasulikkus?
English: How is RotaTeq used?
Estonian: Kuidas RotaTeqi kasutatakse?
English: How has RotaTeq been studied?
Estonian: Kuidas RotaTeqi uuriti?
English: What is DuoCover?
Estonian: Mis on DuoCover?
English: On 23 May 2008, Bristol Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for DuoCover for the prevention of atherothrombotic events.
Estonian: 23. mail 2008 teatas Bristol Myers Squibb Pharma EEIG ametlikult inimravimite komiteele oma soovist võtta tagasi müügiloa taotlus ravimile DuoCover, mis oli ette nähtud aterotromboosi nähtude ennetamiseks.
English: Ref. EMEA/270168/2008
Estonian: London, 30. mai 2008 Viitedokument EMEA/331175/2008
English: The CHMP was concerned that the bioequivalence studies that were carried out did not use the recommended methods and did not provide sufficient evidence that the combined tablet was absorbed in the body in the same way as the two medicines given separately.
Estonian: Inimravimite komitee ei olnud rahul asjaoluga, et bioekvivalentsuse uuringud ei olnud läbi viidud soovitatud meetodite kohaselt ega pakkunud piisavalt tõendeid selle kohta, et kombineeritud tablett absorbeerub organismis samal viisil kui need kaks ravimit eraldi manustatuna.
English: The active substances in DuoCover, clopidogrel and acetylsalicylic acid, are combined into one tablet in DuoCover to reduce the number of tablets the patients need to take every day.
Estonian: DuoCoveri toimeained klopidogreel ja atsetüülsalitsüülhape on koos ühes tabletis, et vähendada päevas võetavate tablettide arvu.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the company had not fully addressed their concerns and the benefit of the DuoCover combined tablet compared with the separate medicines had not been demonstrated.
Estonian: Seetõttu oli inimravimite komitee taotluse tagasivõtmise ajal arvamusel, et ettevõte ei olnud piisavalt käsitlenud probleemseid asjaolusid ja et kombineeritud DuoCoveri tabletist saadav kasu võrrelduna samade ravimite eraldi manustamisega ei olnud küllaldaselt tõendatud.
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.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks.
English: However the CHMP thought that the company could have addressed these concerns and was of the provisional opinion that DuoCover could have been approved for the prevention of atherothrombotic events.
Estonian: Komitee oli siiski arvamusel, et ettevõte suudab need probleemid lahendada, ning oli esialgsel seisukohal, et DuoCoverile võib anda aterotromboosi nähtude ennetamisravis kasutamiseks müügiloa.
English: Furthermore, the studies of Iscover and Plavix used with acetylsalicylic acid as separate tablets were used to support the use of DuoCover in the same indication.
Estonian: Lisaks kasutati Iscoveri ja Plavixi uuringutes atsetüülsalitsüülhapet eraldi tablettidena, et toetada DuoCoveri kasutamist samal näidustusel.
English: DuoCover was expected to be used in adult patients already taking clopidogrel and acetylsalicylic acid as separate tablets.
Estonian: DuoCoverit kavatseti kasutada täiskasvanud patsientidel, kes juba võtsid klopidogreeli ja atsetüülsalitsüülhapet, kuid eraldi tablettidena.
English: The company informed the CHMP that there are no consequences for patients who are planned to be included in clinical trials with DuoCover or patients currently included in clinical trials with clopidogrel and acetylsalicylic acid as separate medicines.
Estonian: Ettevõte teatas inimravimite komiteele, et patsientidele, keda plaaniti kaasata DuoCoveri kliinilistesse uuringutesse, ega patsientidele, kes praegu osalevad eraldi manustatud klopidogreeli ja atsetüülsalitsüülhappe kliinilistes uuringutes, tagasivõtmine mõju ei avalda.