FrancophonIA/ELRC3.0 huggingface dataset:
English: However, following a re-examination of this opinion, the Committee concluded that the medicine's modest effectiveness could also be of benefit to some of these patients.
Estonian: Pärast arvamuse taasläbivaatamist leidis komitee siiski, et mõnel patsiendil võib olla ravimi tagasihoidlikust efektiivsusest ka kasu.
English: What measures are being taken to ensure the safe use of Prometax?
Estonian: Mis meetmeid võetakse, et tagada Prometaxi kasutamise ohutus?
English: The capsules have been studied in 2,126 patients in three main studies, and the transdermal patches in one main study involving 1,195 patients.
Estonian: Kapslite kasutamist uuriti 2126 patsiendil kolmes põhiuuringus ja transdermaalsete plaastrite kasutamist ühes põhiuuringus, milles osales 1195 patsienti.
English: Prometax capsules or oral solution should be given twice a day, with morning and evening meals.
Estonian: Prometaxi kapsleid või suukaudset lahust manustatakse kaks korda ööpäevas, hommiku- ja õhtusöögi ajal.
English: The starting dose is 1.5 mg twice a day.
Estonian: Algannus on 1,5 mg kaks korda ööpäevas.
English: This is a summary of the European public assessment report (EPAR) for Prometax.
Estonian: See on ravimi Prometax Euroopa avaliku hindamisaruande kokkuvõte.
English: The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
Estonian: Et ravimist oleks võimalikult palju kasu, tuleb kasutada suurimat annust, mida patsient talub, kuid annus ei tohi ületada 6 mg kaks korda ööpäevas.
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Prometax's benefits did not outweigh its risks.
Estonian: Komitee jõudis algul järeldusele, et Parkinsoni tõvega kaasneva dementsuse ravis ei ületa Prometaxi kasulikkus sellega kaasnevaid riske.
English: Therefore, the Committee decided that Prometax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Komitee otsustas, et Prometaxi kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: Other information about Prometax
Estonian: Muu teave Prometaxi kohta
English: Prometax is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Estonian: Prometaxi kasutatakse kerge kuni mõõdukalt raskekujulise Alzheimeri dementsusega patsientide raviks; see on progresseeruv ajuhäire, mis kahjustab järk-järgult mälu, vaimseid võimeid ja käitumist.
English: Overall, the most common side effects (seen in more than 1 patient in 10) include nausea (feeling sick) and vomiting, particularly during the phase when the dose of Prometax is being increased.
Estonian: Kokkuvõttes on kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) iiveldus ja oksendamine, eelkõige Prometaxi annuse suurendamisel.
English: Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Prometax by the patient.
Estonian: Ravi tohib alustada vaid sel juhul, kui on olemas hooldaja, kes annab patsiendile regulaarselt Prometaxi ja jälgib, kuidas patsient seda kasutab.
English: Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.
Estonian: Ravi tuleb jätkata, kuni ravimist on kasu, kuid kõrvalnähtude tekkimisel võib patsiendi annust vähendada või ravi katkestada.
English: By blocking these enzymes, Prometax allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia associated with Parkinson's disease.
Estonian: Neid ensüüme blokeerides suurendab Prometax atsetüülkoliini sisaldust ajus, mis aitab vähendada Alzheimeri ja Parkinsoni tõvega seotud dementsuse sümptomeid.
English: For more information about treatment with Prometax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Prometaxiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Estonian: Alzheimeri dementsuse või Parkinsoni tõvega kaasneva dementsusega patsientidel hävivad ajus teatud närvirakud, mille tulemusena väheneb neurotransmitteri (keemiline aine, mis vahendab signaale närvirakkude vahel) atsetüülkoliini sisaldus.
English: The types of side effects seen with Prometax depend on the type of dementia it is being used to treat and whether the capsules, oral solution or transdermal patches are used.
Estonian: Prometaxi kasutamisel esinevad kõrvalnähud sõltuvad sellest, mis liiki dementsuse raviks seda kasutatakse ning kas kasutatakse kapsleid, suukaudset lahust või transdermaalseid plaastreid.
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 Prometax.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: All of the studies lasted six months and compared the effects of Prometax with those of placebo (a dummy treatment).
Estonian: Kõikide uuringute kestus oli kuus kuud ja neis võrreldi Prometaxi toimet platseebo (näiva ravimi) toimega.
English: It is available as capsules (1.5, 3, 4.5 and 6 mg), as an oral solution (2 mg/ml), and as transdermal patches, which release either 4.6 , 9.5 or 13.3 mg rivastigmine across the skin over 24 hours.
Estonian: Seda turustatakse kapslitena (1,5 mg, 3 mg, 4,5 mg ja 6 mg), suukaudse lahusena (2 mg/ml) ja transdermaalsete plaastritena, millest vabaneb 24 tunni jooksul naha kaudu 4,6 mg, 9,5 mg või 13,3 mg rivastigmiini.
English: Prometax is a medicine containing the active substance rivastigmine.
Estonian: Prometax on ravim, mis sisaldab toimeainena rivastigmiini.
English: The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Estonian: Plaaster kinnitatakse õlavarrele või rindkerele puhtale kuivale karvadeta ja tervele nahale ja plaastrit vahetatakse iga 24 tunni järel.
English: Why has Prometax been approved?
Estonian: Miks Prometax heaks kiideti?
English: The company that makes Prometax must ensure that all doctors who intend to prescribe Prometax transdermal patch receive an information pack containing instructions to be given to patients and caregivers on how to use the patch safely as well as a reminder card for patients and caregivers that contains key information on how to use the patch and allows them to record the application and removal of patches.
Estonian: Prometaxi tootja peab tagama, et kõikidele arstidele, kes kavatsevad määrata Prometaxi transdermaalse plaastri 13,3 mg/24 h, saadetakse teabepake plaastri ohutu kasutamise juhistega patsientide ja hooldajate jaoks, ning et patsientidele ja hooldajatele saadetakse hoiatuskaart, millel on plaastri kasutamise põhiteave ja mis võimaldab pidada arvestust plaastrite paigaldamise ja eemaldamise üle.
English: An additional study in 27 patients was used to show that Prometax capsules and oral solution produced similar levels of the active substance in the blood.
Estonian: Täiendava uuringuga, milles osales 27 patsienti, näidati, et Prometaxi kapslite ja suukaudse lahuse kasutamisel oli toimeaine sisaldus veres sarnane.
English: In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Estonian: Kui patsient seda annust talub, tohib annust 1,5 mg võrra suurendada mitte sagedamini kui kahenädalase intervalliga tavapärase annuseni 3-6 mg kaks korda ööpäevas.
English: Prometax capsules have also been studied in 541 patients with dementia due to Parkinson's disease.
Estonian: Prometaxi kapslite kasutamist uuriti ka 541 patsiendil, kellel oli Parkinsoni tõvega kaasnev dementsus.
English: What is Prometax?
Estonian: Mis on Prometax?
English: The CHMP concluded that Prometax has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Estonian: Inimravimite komitee järeldas, et Prometaxi efektiivsus Alzheimeri dementsuse sümptomite ravis on olnud tagasihoidlik, kuigi mõnel patsiendil on sellest olnud oluliselt kasu.
English: They should not be placed on irritated or red skin, on the thigh or abdomen (tummy), or in places where they will be rubbed by tight clothing.
Estonian: Plaastrit ei tohi panna ärritunud ega punetavale nahale, reiele, kõhule ega kohale, kus kitsad rõivad seda hõõruvad.
English: The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Estonian: Kapsleid ja suukaudset lahust tohib kasutada kerge kuni mõõdukalt raskekujulise dementsuse raviks ka Parkinsoni tõvega patsientidel.
English: Prometax must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Estonian: Prometaxi ei tohi kasutada patsiendid, kes on rivastigmiini, teiste karbamaadi derivaatide või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Prometax must also not be used in patients who are suspected to have had in the past a severe allergic reaction called ‘allergic contact dermatitis' to Prometax patch.
Estonian: Prometaxi ei tohi kasutada ka patsientidel, kellel võis varem olla Prometaxi plaastri suhtes raske allergiline reaktsioon: allergiline kontaktdermatiit.
English: In the three studies of Prometax capsules in patients with Alzheimer's dementia, patients taking doses of Prometax between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Estonian: Kolmes Prometaxi kapslite uuringus Alzheimeri dementsusega patsientidel suurenesid Prometaxi annuses 6-9 mg ööpäevas kasutanud patsientidel kognitiivsed sümptomid keskmiselt 0,2 punkti võrra, võrreldes 22,9 punktiga uuringu algul (väiksem punktiarv näitab paremat tulemust).
English: How does Prometax work?
Estonian: Kuidas Prometax toimib?
English: The Prometax transdermal patches were also more effective than placebo in preventing dementia from getting worse.
Estonian: Prometaxi transdermaalsed plaastrid ennetasid dementsuse süvenemist samuti efektiivsemalt kui platseebo.
English: What is the risk associated with Prometax?
Estonian: Mis riskid Prometaxiga kaasnevad?
English: For the full list of all side effects reported with Prometax, see the package leaflet.
Estonian: Prometaxi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: For the global score, patients taking Prometax capsules had in increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Estonian: Üldiste sümptomite punktiskaalal suurenesid Prometaxi kapsleid kasutanud patsientidel sümptomid 4,1 punkti võrra võrreldes 4,4 punktiga platseebot kasutanud patsientidel.
English: For the transdermal patch application site reactions are the most commonly seen side effects.
Estonian: Transdermaalse plaastri kõige sagedamad kõrvalnähud on manustuskoha reaktsioonid.
English: Prometax was more effective than placebo at controlling symptoms.
Estonian: Prometax oli sümptomite leevendamisel platseebost efektiivsem.
English: The 9.5 mg/24 h patch should be used for as long as the patient benefits from it. After six months of treatment with 9.5 mg/24 hours, the doctor may increase the dose to 13.3 mg/24 hours if the patient's condition has worsened.
Estonian: Pärast kuuekuulist ravi annusega 9,5 mg/24 h tohib arst suurendada annust koguseni 13,3 mg/24 h, kui patsiendi seisund on halvenenud.
English: See the summary of product characteristics (also part of the EPAR) for detailed information.
Estonian: Üksikasjalik teave on ravimi omaduste kokkuvõttes (samuti Euroopa avaliku hindamisaruande osa).
English: The patients with dementia due to Parkinson's disease taking Prometax capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Estonian: Parkinsoni tõvega kaasneva dementsusega patsientidel, kes kasutasid Prometaxi kapsleid, paranesid kognitiivsed sümptomid 2,1 punkti võrra, võrreldes halvenemisega 0,7 punkti võrra platseebot kasutanud patsientidel (uuringu alguses oli punktisumma ligikaudu 24).
English: The active substance in Prometax, rivastigmine, is an antidementia medicine.
Estonian: Prometaxis toimeaine rivastigmiin on dementsuse ravim.
English: Prometax has been studied in mild to moderately severe Alzheimer's disease.
Estonian: Prometaxi kasutamist uuriti kerge kuni mõõdukalt raskekujulise Alzheimeri tõve ravis.
English: If the transdermal patches are used, the 4.6 mg per 24 hours patch should be used first, with the dose increased to the 9.5 mg/24 h patch after at least four weeks if the lower dose is well tolerated.
Estonian: Transdermaalsete plaastrite korral tuleb algul kasutada plaastrit, mis vabastab toimeainet annuses 4,6 mg/24 h. Kui seda annust talutakse hästi, suurendatakse vähemalt nelja nädala pärast annus koguseni 9,5 mg/24 h. Plaastrit annusega 9,5 mg/24 h tuleb kasutada seni, kuni patsiendil on sellest kasu.
English: Treatment with Prometax should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Estonian: Ravi Prometaxiga tohib alustada üksnes Alzheimeri tõve või Parkinsoni tõvega kaasneva dementsuse diagnoosimises ja ravis kogenud arst ning see peab toimuma tema järelevalve all.
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Estonian: Rivastigmiini toime seisneb atsetüülkoliini lagundavate ensüümide atsetüülkoliinesteraasi ja butürüülkoliinesteraasi blokeerimises.
English: The global symptom score also improved more in the patients taking Prometax.
Estonian: Prometaxi kasutanud patsientidel paranes ka üldiste sümptomite punktisumma rohkem.
English: This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Estonian: Platseebot kasutanud patsientidel suurenes punktisumma algselt 22,5 punktilt 2,6 punkti võrra.
English: What benefit has Prometax shown during the studies?
Estonian: Milles seisneb uuringute põhjal Prometaxi kasulikkus?
English: Patients can be switched from the capsules or oral solution to the patches.
Estonian: Kapslitelt või suukaudselt lahuselt tohivad patsiendid üle minna plaastritele.
English: What is Prometax used for?
Estonian: Milleks Prometaxi kasutatakse?
English: How is Prometax used?
Estonian: Kuidas Prometaxi kasutatakse?
English: What measures are being taken to ensure the safe and effective use of Amgevita?
Estonian: Mis meetmed võetakse, et tagada Amgevita ohutu ja efektiivne kasutamine?
English: What is Amgevita and what is it used for?
Estonian: Mis on Amgevita ja milleks seda kasutatakse?
English: Amgevita adalimumab
Estonian: Amgevita adalimumaab
English: The full EPAR for Amgevita can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Amgevita kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After the starting dose, Amgevita is most often given every two weeks, but it may be given every week in certain situations.
Estonian: Pärast algannust manustatakse Amgevitat tavaliselt iga kahe nädala järel, kuid teatud olukordades tohib Amgevitat manustada iga nädal.
English: Why is Amgevita approved?
Estonian: Miks Amgevita heaks kiideti?
English: After training, patients or their carers may inject Amgevita if their doctor considers it appropriate.
Estonian: Patsiendid või nende hooldajad võivad pärast asjakohase väljaõppe saamist süstida Amgevitat ise, kui arst peab seda kohaseks.
English: This means that Amgevita is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Estonian: See tähendab, et Amgevita sarnaneb bioloogilise ravimiga (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba.
English: What are the risks associated with Amgevita?
Estonian: Mis riskid Amgevitaga kaasnevad?
English: Amgevita is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Estonian: Amgevitat kasutatakse enamasti raskes, mõõdukalt raskes või halvenevas seisundis täiskasvanutel või kui patsiendid ei saa muid ravimeid kasutada.
English: The Committee recommended that Amgevita be given marketing authorisation.
Estonian: Komitee soovitas anda ravimile Amgevita müügiloa.
English: Patients may be given other medicines during treatment with Amgevita, such as methotrexate or corticosteroids (other anti‑inflammatory medicines).
Estonian: Amgevita ravi ajal võib patsientidele manustada ka muid ravimeid, näiteks metotreksaati või kortikosteroide (samuti põletikuvastased ravimid).
English: Amgevita is a medicine that acts on the immune system and is used to treat the following conditions:
Estonian: Amgevita on immuunsüsteemi ravim ja seda kasutatakse järgmiste haiguste korral:
English: In addition, studies in rheumatoid arthritis and psoriasis have shown that the effects of the medicine are equivalent to those of Humira in these conditions.
Estonian: Peale selle on reumatoidartriidi ja psoriaasi uuringutes tõendatud, et Amgevita toime on kõnealuste seisundite korral võrreldav Humira toimega.
English: Because Amgevita is a biosimilar medicine, the studies on effectiveness and safety carried out for Humira do not all need to be repeated for Amgevita.
Estonian: Et Amgevita on bioloogiliselt sarnane ravim, ei pea kõiki Humiraga tehtud efektiivsus- ja ohutusuuringuid Amgevitaga kordama.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amgevita have also been included in the summary of product characteristics and the package leaflet.
Estonian: Amgevita ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: This is a summary of the European public assessment report (EPAR) for Amgevita.
Estonian: See on ravimi Amgevita Euroopa avaliku hindamisaruande kokkuvõte.
English: All these data were considered sufficient to conclude that Amgevita will behave in the same way as Humira in terms of effectiveness and safety in its approved indications.
Estonian: Nende piisavate andmete põhjal järeldati, et Amgevita efektiivsus ja ohutus on heakskiidetud näidustustel võrreldav Humira efektiivsuse ja ohutusega.
English: How is Amgevita used?
Estonian: Kuidas Amgevitat kasutatakse?
English: It is not intended to provide practical advice on how to use Amgevita.
Estonian: Hindamisaruandes ei anta Amgevita kasutamise praktilisi nõuandeid.
English: Amgevita must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Estonian: Amgevitat ei tohi kasutada aktiivse tuberkuloosi, muu raske infektsiooni ja mõõduka kuni raske südamepuudulikkusega patsiendid (kelle süda ei suuda pumbata organismi piisaval hulgal verd).
English: The medicine has been shown to have similar effects to Humira in one main study involving 526 patients with moderate to severe rheumatoid arthritis that had not responded adequately to methotrexate, and in another main study in 350 patients with moderate to severe psoriasis.
Estonian: Amgevita Humira toimega võrreldavat toimet tõendati ühes põhiuuringus 526-l mõõduka kuni raske reumatoidartriidiga patsiendil, kellel metotreksaadiga ei olnud tekkinud piisavat ravivastust, ning veel ühes põhiuuringus, milles osales 350 mõõduka kuni raske psoriaasiga patsienti.
English: These packs will include information on the safety of the medicine and an alert card to be given to patients.
Estonian: Teabematerjalis on ravimi ohutusteave ja patsiendi hoiatuskaart.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections in the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Estonian: Adalimumaabi kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on nina-neelu-, nina kõrvalurgete ja ülemiste hingamisteede infektsioonid, süstekoha reaktsioonid (punetus, sügelus, verejooks, valu või turse), peavalu ning lihase- ja luuvalu.
English: Therefore, the CHMP's view was that, as for Humira, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Humira korral, ületab ravimi kasulikkus sellega kaasnevad riskid.
English: Other rare serious side effects (seen in between 1 in 10,000 and 1 in 1,000 patients) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Estonian: Muud harvaesinevad rasked kõrvalnähud (esinenud 1-10 000 patsiendil ning 1 patsiendil 1000st) on muu hulgas luuüdi suutmatus toota vererakke, närvihäired, luupus ja luupuselaadne seisund (immuunsüsteem ründab patsiendi enda kudesid, mis põhjustab põletikku ja kahjustab organeid) ja Stevensi-Johnsoni sündroom (raske nahahaigus).
English: • hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses
Estonian: • hidradenitis suppurativa (acne inversa) - krooniline nahahaigus, mis põhjustab sõlmi, abstsesse
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Amgevita has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele bioloogiliselt sarnaste ravimite kohta on tõendatud, et Amgevita sarnaneb struktuuri, puhtuse ja bioloogilise toime poolest Humiraga ning et Amgevita jaotub organismis samamoodi kui Humira.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Estonian: Kasvaja nekroositeguriga seondudes blokeerib adalimumaab aine toime, vähendades seega põletikku ja muid haiguste sümptomeid.
English: In the rheumatoid arthritis study, response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 75% of those given Amgevita responded, compared with 72% of those given Humira.
Estonian: Reumatoidartriidi uuringus loeti ravivastuseks sümptomite skoori vähemalt 20%-list paranemist pärast 24 ravinädalat - Amgevitat saanud patsientidest saavutas ravivastuse 75% ja Humirat saanud patsientidest 72%.
English: For the full list of restrictions with Amgevita, see the package leaflet.
Estonian: Amgevita kohta teatatud piirangute täielik loetelu on pakendi infolehel.
English: The reference medicine for Amgevita is Humira.
Estonian: Amgevita võrdlusravim on Humira.