FrancophonIA/ELRC3.0 huggingface dataset:
English: However, when these results were considered along with those of the three additional studies, it was noted that the effect of Ebixa was smaller in patients with mild disease.
Estonian: Kui neid tulemusi vaadeldi koos kolme täiendava uuringu tulemustega, täheldati, et kergema haigusega patsientidele mõjus Ebixa vähem.
English: In addition, overstimulation of the NMDA receptors may result in cell damage or death.
Estonian: NMDA-restseptorite liigne stimuleerimine võib rakke kahjustada või hävitada.
English: Ebixa should not be used in people who may be hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Estonian: Ebixat ei tohi kasutada patsiendid, kes võivad olla memantiinvesinikkloriidi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Ebixa was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Estonian: Ebixat uuriti ka kolmes täiendavas uuringus, milles osales kokku 1186 kerge kuni raske haigusega patsienti.
English: What is Ebixa?
Estonian: Mis on Ebixa?
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 Ebixa.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Ebixa has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.
Estonian: Ebixat uuriti kolmes põhiuuringus, milles osales kokku 1125 Alzheimeri tõvega patsienti, kellest mõne haigust oli varem ravitud teiste ravimitega.
English: To prevent side effects, the dose of Ebixa is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Estonian: Kõrvalnähtude ennetamiseks suurendatakse Ebixa annust esimese kolme ravinädala jooksul järk-järgult: esimesel nädalal on annus 5 mg, teisel 10 mg ja kolmandal 15 mg.
English: Ebixa is a medicine that contains the active substance memantine hydrochloride.
Estonian: Ebixa on ravim, mis sisaldab toimeainena memantiinvesinikkloriidi.
English: What is the risk associated with Ebixa?
Estonian: Mis riskid Ebixaga kaasnevad?
English: Ebixa is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.
Estonian: Ebixat turustatakse ka suukaudse lahusena koos pumbaga, mis annustab ühe vajutusega 5 mg memantiinvesinikkloriidi.
English: For the full list of all side effects reported with Ebixa, see the package leaflet.
Estonian: Ebixa kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Ebixa is used to treat patients with moderate to severe Alzheimer's disease.
Estonian: Ebixat kasutatakse mõõduka või raske Alzheimeri tõvega patsientide raviks.
English: Why has Ebixa been approved?
Estonian: Miks Ebixa heaks kiideti?
English: In the study of moderately severe to severe disease, patients taking Ebixa had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Estonian: Mõõdukalt raske kuni raske haigusega patsientide uuringus oli Ebixat kasutanud patsientidel 28 nädala pärast nii üldiste kui ka funktsionaalsete sümptomite punktiarvu järgi vähem sümptomeid kui platseebot kasutanud patsientidel.
English: Ebixa was more effective than placebo at controlling the symptoms of Alzheimer's disease.
Estonian: Ebixa parandas Alzheimeri tõve sümptomeid platseebost efektiivsemalt.
English: In the two studies of mild to moderate disease, patients on Ebixa had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Estonian: Kahes uuringus kerge või mõõduka raskusastmega haigusega olid Ebixat kasutanud patsientidel pärast 24-nädalast ravi üldiste ja funktsionaalsete sümptomite punktiarvu järgi sümptomid kergemad.
English: The active substance in Ebixa, memantine hydrochloride, is an antidementia medicine.
Estonian: Ebixa toimeaine memantiinvesinikkloriid on dementiaravim.
English: What benefit has Ebixa shown during the studies?
Estonian: Milles seisneb uuringute põhjal Ebixa kasulikkus?
English: How has Ebixa been studied?
Estonian: Kuidas Ebixat uuriti?
English: How is Ebixa used?
Estonian: Kuidas Ebixat kasutatakse?
English: The medicine can only be obtained with a prescription.
Estonian: Exiba on retseptiravim.
English: What is Ebixa used for?
Estonian: Milleks Ebixat kasutatakse?
English: How does Ebixa work?
Estonian: Kuidas Ebixa toimib?
English: This summary was last updated in 02-2017.
Estonian: Kokkuvõtte viimane uuendus: 02-2017.
English: What measures are being taken to ensure the safe and effective use of Synjardy?
Estonian: Mis meetmed võetakse, et tagada Synjardy ohutu ja efektiivne kasutamine?
English: Doses are adjusted as necessary.
Estonian: Annuseid kohandatakse vajaduse järgi.
English: Metformin has been available in the EU since the 1950s.
Estonian: Metformiini on Euroopa Liidus turustatud 1950. aastatest.
English: Supportive evidence was provided from several further studies.
Estonian: Esitati ka mitmest lisauuringust pärinevaid toetavaid tõendeid.
English: The full EPAR and risk management plan summary for Synjardy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Synjardy kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synjardy on 27 May 2015.
Estonian: Euroopa Komisjon andis Synjardy müügiloa, mis kehtib kogu Euroopa Liidus, 27. mail 2015.
English: Empagliflozin has been authorised in the EU under the trade name Jardiance since 2014.
Estonian: Empagliflosiin on alates 2014. aastast Euroopa Liidus heaks kiidetud kaubandusliku nimetusega Jardiance.
English: Other information about Synjardy
Estonian: Muu teave Synjardy kohta
English: What is Synjardy and what is it used for?
Estonian: Mis on Synjardy ja milleks seda kasutatakse?
English: Similar benefits were seen in the studies regardless of the other diabetes medicines being taken.
Estonian: Uuringutes täheldati sarnast kasulikkust olenemata muude diabeediravimite võtmisest.
English: Why is Synjardy approved?
Estonian: Miks Synjardy heaks kiideti?
English: Synjardy empagliflozin / metformin
Estonian: Synjardy empagliflosiin/metformiin
English: • in patients who are already taking metformin and empagliflozin as separate tablets.
Estonian: • patsiendid, kes juba võtavad metformiini ja empagliflosiini eraldi tablettidena.
English: Some of these were continuations of the main studies that suggested the benefits of the combination continued with longer therapy.
Estonian: Mõned neist olid põhiuuringute jätkuuuringud, mis tõendasid, et kombinatsioonravi oli jätkuvalt kasulik ka pikema ravi korral.
English: • liver impairment, or problems with alcoholism or alcohol intoxication.
Estonian: • maksatalitluse häire, alkoholism või alkoholimürgistus.
English: It is not intended to provide practical advice on how to use Synjardy.
Estonian: Hindamisaruandes ei anta Synjardy kasutamise praktilisi nõuandeid.
English: What are the risks associated with Synjardy?
Estonian: Mis riskid Synjardyga kaasnevad?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synjardy have been included in the summary of product characteristics and the package leaflet.
Estonian: Synjardy ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Synjardy must not be used in patients with:
Estonian: Synjardyt ei tohi kasutada patsiendid, kellel on
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Synjardy's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Synjardy kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: • in patients whose diabetes is not sufficiently controlled by metformin alone;
Estonian: • patsiendid, kelle diabeet ei ole ainult metformiiniga rahuldavalt reguleeritud;
English: Among these, in patients who were also taking metformin (the other active substance in Synjardy), the three major cardiovascular events occurred in 9.9% (344 out of 3,459) of patients receiving empagliflozin and in 10.9% (189 out of 1,734) of patients receiving placebo.
Estonian: Nendest oli patsiente, kes tarvitasid ka metformiini (Synjardy teine toimeaine) ning kellel esines üks kolmest põhilisest kardiovaskulaarsest juhust, empagliflosiini võtnutest 9,9% (344 patsienti 3459st) ja platseebot võtnutest 10,9% (189 patsienti 1734st).
English: The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such as pioglitazone or a type of diabetes medicine called a sulphonylurea).
Estonian: Empagliflosiini ja metformiini kombinatsiooni kasulikkust tõendati 3 põhiuuringus, milles osales 1679 II tüüpi diabeediga patsienti, kelle vere glükoosisisaldus ei olnud piisavalt reguleeritud ainult metformiiniga või metformiini ja teiste diabeediravimite, nt pioglitasooni või sulfonüüluurearavimi (samuti diabeediravim) kombinatsiooniga.
English: • a condition that could reduce the supply of oxygen to body tissues (such as in patients with worsening heart failure, recent heart attack, breathing difficulty or a steep fall in blood pressure);
Estonian: • seisund, mis võib vähendada kudede hapnikuvarustust (nt süveneva südamepuudulikkuse, hiljutise südameinfarkti, hingamisraskuste või vererõhu suure langusega patsientidel);
English: This leads to a high level of glucose in the blood.
Estonian: See põhjustab vere suure glükoosisisalduse.
English: Another main study showed that adding empagliflozin (one of the active substances of Synjardy) to usual treatment reduced adverse cardiovascular (heart and blood vessels) effects.
Estonian: Ühest põhiuuringust selgus, et empagliflosiini (üks Synjardy toimeainetest) lisamine tavapärasele ravile vähendab kardiovaskulaarseid (südant ja veresooni mõjutavaid) kõrvalnähte.
English: In those receiving empagliflozin, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo.
Estonian: Synjardy rühmas esines kardiovaskulaarseid juhte 10,5%-l (490 patsienti 4687st) ning platseeborühmas 12,1%-l (282 patsienti 2333st).
English: Synjardy is available as tablets containing 5 or 12.5 mg of empagliflozin with 850 or 1,000 mg of metformin, and can only be obtained with a prescription.
Estonian: Seda turustatakse tablettidena, mis sisaldavad 5 või 12,5 mg empagliflosiini ja 850 või 1000 mg metformiini.
English: Synjardy is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes.
Estonian: Synjardy on diabeediravim ning seda kasutatakse koos dieedi ja füüsilise treeninguga II tüüpi diabeediga (suhkurtõvega) täiskasvanutel.
English: The main measure of effectiveness was the reduction in the level of a substance in the blood called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
Estonian: Efektiivsuse põhinäitaja oli glükoseerunud hemoglobiini (HbA1c) sisalduse vähenemine veres 24 ravinädala järel.
English: The study involved patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack and stroke).
Estonian: Uuringus osalesid II tüüpi diabeediga patsiendid, kellel juba oli kardiovaskulaarne haigus (stenokardia, südameinfarkt või insult).
English: In type 2 diabetes the body does not make enough insulin to control the level of glucose (sugar) in the blood or the body is unable to use insulin effectively.
Estonian: II tüüpi diabeet on haigus, mille korral organismis ei teki vere glükoosisisalduse reguleerimiseks piisavalt insuliini või organism ei suuda insuliini efektiivselt kasutada.
English: Synjardy was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease.
Estonian: Synjardy vähendas ka kardiovaskulaarsete juhtude esinemissagedust II tüüpi diabeediga patsientidel, kellel juba oli kardiovaskulaarne haigus.
English: For practical information about using Synjardy, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Synjardy kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The CHMP concluded that the medicine could help produce a clinically meaningful reduction in blood glucose in patients with type 2 diabetes, and the benefits and risks were in line with those of the individual active substances.
Estonian: Inimravimite komitee järeldas, et ravim võib aidata II tüüpi diabeediga patsientidel vähendada vere glükoosisisaldust kliiniliselt olulisel määral ning et ravimi kasulikkus ja riskid on kooskõlas selle toimeainete kasulikkuse ja riskidega.
English: Studies also indicated Synjardy was as effective as empagliflozin and metformin taken separately, and that the combination helped reduce HbA1c when added to treatment including insulin.
Estonian: Uuringutest selgus ka, et Synjardy oli sama efektiivne kui eraldi võetavad empagliflosiin ja metformiin ning et insuliinravile lisatud kombinatsioonravi aitas vähendada HbA1c sisaldust.
English: In addition, the results indicated that the combination was associated with a beneficial decrease in body weight and blood pressure.
Estonian: Lisaks selgus, et kombinatsioonraviga kaasnevad kehakaalu ja vererõhu kasulik langus.
English: For more information about treatment with Synjardy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Synjardyga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The most common side effects with Synjardy are hypoglycaemia (low blood sugar levels) when the medicine is taken with a sulphonylurea or insulin, infections of the urinary tract and genitals, and increased urination.
Estonian: Synjardy kõige sagedamad kõrvalnähud on hüpoglükeemia (normaalsest väiksem glükoosisisaldus veres), kui ravimit võetakse koos sulfonüüluurearavimi või insuliiniga, kuseteede või suguelundite infektsioonid ja suurenenud kuseeritus.
English: If Synjardy is used in combination with insulin or a sulphonylurea (a medicine that increases the body's production of insulin), the doses of these medicines may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Estonian: Kui Synjardyt kasutatakse koos insuliini või sulfonüüluurearavimiga (organismis insuliini tekkimist soodustav ravim), võib olla vaja vähendada nende ravimite annust, et vähendada hüpoglükeemia (vere normaalsest väiksema glükoosisisalduse) riski.
English: • metabolic acidosis (when the body produces more acid than it gets rid of) or diabetic pre-coma (dangerous complications of diabetes);
Estonian: • metaboolne atsidoos (organismis tekib rohkem hapet kui eritub) või diabeetilise kooma eelseisund
English: This is a summary of the European public assessment report (EPAR) for Synjardy.
Estonian: See on ravimi Synjardy Euroopa avaliku hindamisaruande kokkuvõte.
English: The two active substances in Synjardy, empagliflozin and metformin, work in different ways to lower blood glucose, and thus to control symptoms of the disease.
Estonian: Mõlemad Synjardy toimeained, empagliflosiin ja metformiin, vähendavad vere glükoosisisaldust ja seega reguleerivad haiguse sümptomeid erineval viisil.
English: How is Synjardy used?
Estonian: Kuidas Synjardyt kasutatakse?
English: • in combination with other diabetes medicines in patients whose diabetes is not sufficiently controlled on these medicines plus metformin;
Estonian: • patsiendid, kes võtavad teisi diabeediravimeid, kuid kelle diabeet ei ole rahuldavalt reguleeritud nende ravimite ja metformiiniga;
English: What benefits of Synjardy have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Synjardy kasulikkus?
English: Because of concerns about the balance of benefit and risk in patients with reduced kidney function taking the fixed-dose combination, the CHMP recommended restricting its use in these patients.
Estonian: Inimravimite komitee nägi põhjust ettevaatlikkuseks seoses kasulikkuse ja riski tasakaaluga neerupuudulikkusega patsientidel, kes kasutavad fikseeritud annusega ravimikombinatsiooni, ning soovitas nendel patsientidel ravimi kasutamist piirata.
English: Overall, the additional reduction was 0.58 percentage points with a combination providing 5 mg of empagliflozin twice daily, and 0.62 percentage points with the 12.5 mg dose, and these reductions were considered clinically relevant.
Estonian: Kaks korda ööpäevas võetava 5 mg empagliflosiini kombinatsioonraviga vähenes HbA1c sisaldus kokkuvõttes 0,58% võrra rohkem ja 12,5 mg annusega 0,62% võrra rohkem.
English: By blocking the action of SGLT2, empagliflozin causes more glucose to be removed in the urine, thereby reducing the levels of glucose in the blood.
Estonian: SGLT2 toimet blokeerides suurendab empagliflosiin glükoosi eritumist uriiniga, mis vähendab vere glükoosisisaldust.
English: For the full list of all side effects reported with Synjardy, see the package leaflet.
Estonian: Synjardy kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: It contains the active substances empagliflozin and metformin.
Estonian: Synjardy sisaldab kahte toimeainet, empagliflosiini ja metformiini.
English: The recommended dose of Synjardy is one tablet twice a day with meals, and treatment is normally started with a tablet that supplies the dose of metformin the patient is already taking, together with the lowest dose (5 mg) of empagliflozin.
Estonian: Ravi alustatakse tavaliselt tabletiga, milles on sama annus metformiini, nagu patsient juba võtab, ja väikseim annus (5 mg) empagliflosiini.
English: Empagliflozin works by blocking a protein in the kidneys (called sodium-glucose co-transporter 2 or SGLT2).
Estonian: Empagliflosiin blokeerib neerudes valgu naatriumi-glükoosi kotransporteri 2 (SGLT2).
English: How does Synjardy work?
Estonian: Kuidas Synjardy toimib?
English: The studies showed a greater reduction in HbA1c when empagliflozin plus metformin was given, compared with placebo plus metformin.
Estonian: Uuringud tõendasid, et empagliflosiini ja metformiini kombinatsiooniga vähenes HbA1c sisaldus rohkem kui platseebo ja metformiini kombinatsiooniga.
English: Metformin works mainly by reducing the production of glucose in the body and reducing its absorption from the gut.
Estonian: Metformiin vähendab põhiliselt glükoosi teket ja selles imendumist sooles.
English: The studies compared the effect of empagliflozin plus metformin versus placebo (a dummy treatment) with metformin.
Estonian: Uuringutes võrreldi empagliflosiini ja metformiini kombinatsiooni toimet platseebo (näiva ravimi) ja metformiini kombinatsiooniga.
English: • severely reduced kidney function or conditions that could affect the kidneys such as dehydration, severe infection or a steep fall in blood pressure;
Estonian: • raske neerupuudulikkus või seisundid, mis võivad häirida neerutalitlust, näiteks dehüdratsioon,
English: Synjardy is used:
Estonian: Synjardyt kasutatakse järgmistes ravirühmades:
English: It is a ‘generic medicine'.
Estonian: See on geneeriline ravim.
English: Both active substances have been authorised in the EU since the early 2000s: emtricitabine was authorised as Emtriva in 2003, and tenofovir disoproxil was authorised as Viread in 2002.
Estonian: Mõlemat toimeainet on turustatud ELis alates 2000. aastate algusest: emtritsitabiini müügiluba (ravimina Emtriva) anti 2003. aastal ja tenofoviirdisoproksiili müügiluba (ravimina Viread) 2002. aastal.
English: In addition it may be used from the age of 12 years in adolescents with HIV that is resistant to first-line treatments or who cannot take them because of side effects.
Estonian: Seda tohib kasutada ka vähemalt 12-aastaste HIViga noorukite raviks, kes on esmavaliku ravimitele resistentsed või ei saa neid kasutada kõrvalnähtude tõttu.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Estonian: Tenofoviir on nukleotiidne pöördtranskriptaasiinhibiitor.
English: Further information on Emtricitabine/Tenofovir disoproxil Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
Estonian: Lisateave ravimi Emtricitabine/Tenofovir disoproxil Zentiva kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-zentiva.
English: Emtricitabine/Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Estonian: Emtricitabine/Tenofovir disoproxil Zentiva ei ravi HIV-nakkust ega AIDSi välja, kuid võib edasi lükata immuunsüsteemi kahjustumist ning AIDSiga kaasnevate infektsioonide ja haiguste tekkimist.
English: Emtricitabine/Tenofovir disoproxil Zentiva received a marketing authorisation valid throughout the EU on 9 November 2016.
Estonian: Emtricitabine/Tenofovir disoproxil Zentiva on saanud müügiloa, mis kehtib kogu ELis, 9. novembril
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Zentiva are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ravimi Emtricitabine/Tenofovir disoproxil Zentiva kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Zentiva has been shown to have comparable quality and to be bioequivalent to Truvada.
Estonian: Euroopa Ravimiamet otsustas, et vastavalt ELi nõuetele on tõendatud ravimi Emtricitabine/Tenofovir disoproxil Zentiva võrreldav kvaliteet ja bioekvivalentsus ravimiga Truvada.
English: Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Estonian: Emtricitabine/Tenofovir disoproxil Zentiva sisaldab kaht toimeainet: emtritsitabiini (200 mg) ja tenofoviirdisoproksiili (245 mg).
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Zentiva.
Estonian: Võrdlusravimiga Truvada on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Emtricitabine/Tenofovir disoproxil Zentiva korrata.
English: This means that Emtricitabine/Tenofovir disoproxil Zentiva contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
Estonian: See tähendab, et Emtricitabine/Tenofovir disoproxil Zentiva sisaldab sama toimeainet ja toimib samal viisil kui võrdlusravim Truvada, millel juba on Euroopa Liidus müügiluba.