FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kevzara have also been included in the summary of product characteristics and the package leaflet.
Estonian: Kevzara ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What are the risks associated with Kevzara?
Estonian: Mis riskid Kevzaraga kaasnevad?
English: Most side effects were mild to moderate in severity, and the more severe side effects were considered manageable with dose reduction or treatment interruption.
Estonian: Enamik kõrvalnähtusid olid kerge või mõõduka raskusastmega ning raskemaid kõrvalnähte peeti juhitavaiks annuse vähendamise või ravi katkestamisega.
English: It is not intended to provide practical advice on how to use Kevzara.
Estonian: Hindamisaruandes ei anta Kevzara kasutamise praktilisi nõuandeid.
English: The recommended dose is 200 mg given as an injection under the skin, once every 2 weeks.
Estonian: Soovitatav annus on 200 mg nahaaluse süstina kord iga kahe nädala järel.
English: The benefits seen in studies include reduced symptoms, improved physical function, and slower progression of joint damage.
Estonian: Uuringutes täheldati sümptomite ja füüsilise funktsiooni paranemist ning liigesekahjustuse progresseerumise aeglustumist.
English: Kevzara must not be used in patients with active, severe infections including infections localised to one area of the body.
Estonian: Kevzarat ei tohi kasutada aktiivsete raskete infektsioonidega (sh lokaliseerunud infektsioonidega) patsientidel.
English: The company that markets Kevzara will provide an alert card for patients, highlighting the risk of serious infections, neutropenia and intestinal perforation (a hole that develops in the wall of the gut), and listing the symptoms for which patients should seek immediate medical attention.
Estonian: Kevzara turustaja varustab patsiendid hoiatuskaartidega, juhtides tähelepanu raskete infektsioonide, neutropeenia ja seedetrakti perforatsiooni (auk sooleseinas) riskile ning loetledes sümptomid, mille korral patsiendid peavad viivitamata pöörduma tervishoiutöötaja poole.
English: Treatment should be interrupted in patients who develop serious infections until the infection is under control.
Estonian: Kui patsiendil tekib raske infektsioon, tuleb ravi katkestada, kuni infektsioon on kontrolli all.
English: A third study involving 369 patients compared Kevzara with adalimumab (another monoclonal antibody for the treatment of rheumatoid arthritis).
Estonian: Kolmandas uuringus, milles osales 369 patsienti, võrreldi Kevzarat adalimumabiga (teine reumatoidartriidi raviks kasutatav monoklonaalne antikeha).
English: This compared with 33% of the patients receiving placebo.
Estonian: Platseeborühmas oli sama tulemus 33%-l patsientidest.
English: Kevzara contains the active substance sarilumab.
Estonian: Kevzara sisaldab toimeainena sarilumabi.
English: Three studies involving over 2,100 adults with rheumatoid arthritis showed that Kevzara is effective at reducing joint pain and swelling, improving joint movement and slowing down joint damage after 24 weeks of treatment.
Estonian: Kolmes uuringus, milles osales enam kui 2100 reumatoidartriidiga täiskasvanut, oli Kevzara 24 ravinädala järel liigesevalu ja -turse vähendamisel, liigeste liikuvuse parandamisel ning liigesekahjustuse progresseerumise aeglustamisel efektiivne.
English: This is a summary of the European public assessment report (EPAR) for Kevzara.
Estonian: See on ravimi Kevzara Euroopa avaliku hindamisaruande kokkuvõte.
English: Kevzara is used when treatment with one or more medicines known as disease-modifying antirheumatic drugs (DMARDs) has not worked well enough or has led to troublesome side effects.
Estonian: Kevzarat kasutatakse juhul, kui ravi ühe või mitme haigust modifitseeriva antireumaatilise ravimiga (DMARD-ravimitega) ei ole andnud piisavat ravivastust või on põhjustanud raskeid kõrvalnähtusid.
English: The first study involved about 1,200 patients whose condition had not responded adequately to treatment with methotrexate; patients received Kevzara plus methotrexate or placebo plus methotrexate.
Estonian: Esimeses uuringus osales ligikaudu 1200 patsienti, kellel metotreksaat ei olnud andnud piisavat ravivastust; patsiendid said Kevzarat koos metotreksaadiga või platseebot koos metotreksaadiga.
English: 58% of patients given Kevzara 150 mg and 66% of patients given Kevzara 200 mg had a reduction in symptoms of 20% or more, based on a standard rating score (ACR 20).
Estonian: 58%-l Kevzarat annuses 150 mg saanud patsientidest ja 66%-l Kevzarat annuses 200 mg saanud patsientidest paranesid sümptomid standardse hindamisskoori (ACR 20) põhjal vähemalt 20% võrra.
English: By preventing interleukin-6 from attaching to its receptors, sarilumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
Estonian: Takistades IL-6 seondumist selle retseptoritega, vähendab sarilumab põletikku ja teisi reumatoidartriidiga seostatavaid sümptomeid.
English: For more information about treatment with Kevzara, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Kevzaraga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Patients treated with Kevzara had greater improvement in the function of their joints, compared with patients treated with adalimumab (based on a standard rating score called DAS28-ESR).
Estonian: Kevzaraga ravitud patsientide liigesefunktsioon paranes suuremal määral kui adalimumabi saanud patsientidel (lähtudes standardsest hindamisskoorist DAS28-ESR).
English: 56% of patients treated with Kevzara 150 mg and 61% of those treated with 200 mg had a reduction in symptoms of 20% or more, compared with 34% of patients on placebo.
Estonian: 56%-l Kevzarat annuses 150 mg saanud patsientidest ja 61%-l Kevzarat annuses 200 mg saanud patsientidest paranesid sümptomid vähemalt 20% võrra, platseeborühmas oli sama tulemus 34%-l patsientidest.
English: The active substance in Kevzara, sarilumab, is a monoclonal antibody, a type of protein which has been designed to attach to and block the receptor (target) for a molecule called interleukin-6.
Estonian: Kevzara toimeaine sarilumab on monoklonaalne antikeha (teatud valk), mis seondub IL-6 molekuli retseptoriga (sihtmärk) ja blokeerib selle.
English: How does Kevzara work?
Estonian: Kuidas Kevzara toimib?
English: For practical information about using Kevzara, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Kevzara kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How is Kevzara used?
Estonian: Kuidas Kevzarat kasutatakse?
English: The dose may have to be lowered in patients with abnormal blood tests.
Estonian: Normist kõrvalekalduvate verenäitajatega patsientidel võib olla vaja annust vähendada.
English: The most common side effect with Kevzara (which may affect more than 1 in 10 people) is neutropenia (low levels of neutrophils, a type of white blood cell that fights infection).
Estonian: Kevzara kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on neutropeenia (neutrofiilide ehk infektsioonivastaste valgeliblede vähesus).
English: A second study involved 546 patients whose condition had not responded adequately to, or who could not take, a TNF-α inhibitor (another type of medicine for rheumatoid arthritis); all patients received Kevzara or placebo in combination with a DMARD.
Estonian: Teises uuringus osales 546 patsienti, kellel ravi TNF-α inhibiitoriga (teine reumatoidartriidi ravim) ei olnud andnud piisavat ravivastust või kellele selline ravi ei sobinud; kõik patsiendid said Kevzarat või platseebot koos DMARD-ravimiga.
English: Interleukin-6 is involved in causing inflammation and is found at high levels in the joints of patients with rheumatoid arthritis.
Estonian: IL-6 osaleb põletiku tekitamises ja selle sisaldus liigestes on suur patsientidel, kellel on reumatoidartriit.
English: What benefits of Kevzara have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Kevzara kasulikkus?
English: Kevzara is a medicine for treating adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Estonian: Kevzara on ravim, mida kasutatakse mõõduka kuni raske reumatoidartriidiga (liigesepõletikku põhjustav haigus) täiskasvanute raviks.
English: Kevzara was shown to be of benefit to patients with moderate to severe rheumatoid arthritis whose condition did not improve adequately or who were intolerant to one or more DMARD medicines.
Estonian: Kevzara osutus efektiivseks mõõduka kuni raske reumatoidartriidiga patsientidel, kellel ravi ühe või mitme DMARD-ravimiga ei toiminud piisavalt hästi või ei olnud talutav.
English: Increased blood levels of a liver enzyme called ALT (a sign of liver problems), reddening of the skin at the site of injection, nose and throat infections, and infections of the structures that carry urine (such as the bladder) are also common side effects which may affect up to 1 in 10 people.
Estonian: Sagedad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on ka maksaensüümi alaniinaminotrasferaasi (ALATi) sisalduse suurenemine veres (viitab maksaprobleemidele), nahapunetus süstekohal, ülemiste hingamisteede infektsioonid ja kuseteede (nt põie-) infektsioonid.
English: Kevzara can only be obtained with a prescription, and treatment should be started and supervised by a specialist doctor experienced in treating rheumatoid arthritis.
Estonian: Ravi peab alustama ning jälgima reumatoidartriidi ravis kogenud eriarst.
English: Strength
Estonian: Nimetus Tugevus
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION
Estonian: TEADUSLIKU HINNANGU ÜLDKOKKUVÕTE
English: Whereas - The Committee considered the procedure under Article 20 of Regulation (EC) No 726/2004 for
Estonian: - inimtervishoius kasutatavate ravimite komitee kaalus vastavalt määruse (EÜ) nr 726/2004 artiklile 20 menetlust Protopy'i kohta;
English: • A statement that Protopy should not be used in children under 2 years.
Estonian: • märge selle kohta, et Protopy'it ei tohi kasutada alla 2-aastastel lastel.
English: Protopy is a dermatological medicinal product that contains the calcineurin inhibitor tacrolimus at a 0.1% and 0.03% concentration.
Estonian: Protopy on dermatoloogiline ravim, mis sisaldab kaltsineuriini inhibiitorit takroliimust kontsentratsioonis 0,1% ja 0,03%.
English: • Protopy should not be used in immunocompromised adults or children.
Estonian: • Protopy'it ei tohi kasutada immunosupressiooniga täiskasvanutel ega lastel;
English: The mode of action of tacrolimus is stated to be by inhibition of calcium dependent signal transduction pathways in T cells which results in prevention of transcription and synthesis of IL-2, IL3, IL-4, IL-5 and other cytokines.
Estonian: Takroliimuse toimemehhanismiks on kaltsiumsõltuvate signaaliradade pärssimine T-rakkudes, mille tulemuseks on IL-2, IL-3, IL-4, IL-5 ja teiste tsütokiinide transkriptsiooni ja sünteesi vältimine.
English: However there appeared to be an increase in numbers of patients with CTCL, relative to what would be expected.
Estonian: Siiski leiti, et CTCL-i põdevate patsientide arv oli oodatust suurem.
English: Therefore the CHMP requested that the MAH should take the appropriate measures in order to ensure that Protopy is not used in this age group.
Estonian: Seetõttu nõudis komitee, et müügiloa hoidja võtaks vajalikke meetmeid selle tagamiseks, et Protopy'it nimetatud vanuserühmas ei kasutataks.
English: The CHMP endorsed the ongoing registry study presented by the Marketing Authorisation Holder - APPLES study (paediatric registry).
Estonian: Komitee toetab käimasolevat registriuuringut APPLES (pediaatria register), mille esitas müügiloa hoidja.
English: The data presented did not show a definite association with lymphoma or any malignancy.
Estonian: Esitatud andmetest ei ilmnenud ravimi kindlat seost lümfoomi ega ühegi teise pahaloomulise protsessiga.
English: The CHMP also expressed concerns about the degree of use of Protopy in children under the age of 2 (not approved) when the immune system is still developing.
Estonian: Samas väljendas inimtervishoius kasutatavate ravimite komitee muret seoses Protopy'i kasutamise määraga kuni 2-aastastel lastel (ei ole heaks kiidetud), kelle immuunsüsteem alles areneb.
English: The CHMP has recommended the amendment to the terms of the Marketing Authorisation for Protopy for which the revised Summary of Product Characteristics and Package Leaflet are set out respectively in annexes I and IIIB.
Estonian: soovitab inimtervishoius kasutatavate ravimite komitee teha Protopy'i müügiloa tingimustesse muudatus, mille kohta läbivaadatud ravimi omaduste kokkuvõte ja pakendi infoleht on sätestatud vastavalt lisades I ja IIIB.
English: - The Committee acknowledged that cases of malignancy (including skin cancer and lymphoma) have been reported in patients treated with Protopy.
Estonian: - komitee nõustus, et on teateid pahaloomulistest protsessidest (sealhulgas nahavähk ja lümfoom) patsientidel, keda raviti Protopy'iga.
English: Systemic exposure is limited with the topical use of tacrolimus, however a local immunosuppressive effect in the skin cannot be excluded.
Estonian: Süsteemset kokkupuudet vähendab takroliimuse paikne kasutamine, kuid lokaalset immunosupressiivset toimet nahale ei saa välistada.
English: On 21 April 2005 the European Commission in view of the potential risk of malignancies requested the Opinion of the CHMP on the benefit/risk profile of Protopy.
Estonian: 21. aprillil 2005. aastal palus Euroopa Komisjon inimtervishoius kasutatavate ravimite komiteelt arvamust Protopy'i kasu-/riskiprofiili kohta seoses võimalike pahaloomuliste protsessidega.
English: This effect is thought to be mediated by the immunosuppression caused as a result of systemic treatment with the product.
Estonian: Arvatakse, et seda toimet vahendab ravimi süsteemse manustamise korral tekkiv immunosupressioon.
English: • The treatment with Protopy should only be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Estonian: • ravi Protopy'iga tohib alustada vaid arst, kellel on kogemus atoopilise dermatiidi
English: The CHMP also concluded that the potential role of tacrolimus in the pathogenesis of CTCL should be further investigated through mechanistic studies.
Estonian: Inimtervishoius kasutatavate ravimite komitee tegi ka järelduse, et takroliimuse võimalikku rolli CTCL-i patogeneesis tuleks edaspidi uurida mehhanistlikes uuringutes.
English: Following this request, the CHMP reviewed the available data on this safety issue, including post-marketing reports, data from nonclinical studies, clinical trials and epidemiological studies.
Estonian: Seetõttu vaatas inimtervishoius kasutatavate ravimite komitee üle olemasolevad ohutusandmed, sh müügiloa väljastamise järgsed aruanded, mittekliiniliste uuringute, kliiniliste katsete ning epidemioloogiliste uuringute andmed.
English: After reviewing the available data the CHMP concluded that the balance of risks and benefits for Protopy is considered favourable.
Estonian: Pärast olemasolevate andmete ülevaatamist järeldas inimtervishoius kasutatavate ravimite komitee, et Protopy'i riski ja kasu suhe on soodus.
English: Lymphoma is a recognised and listed adverse effect for systemically administered calcineurin inhibitor products.
Estonian: Lümfoom on süsteemselt manustatud kaltsineuriini inhibiitorite tuvastatud ja dokumenteeritud kõrvaltoime.
English: • A statement reflecting the cases of malignancies reported in the post-marketing
Estonian: • märge müügiloa saamise järgselt teatatud pahaloomuliste protsesside juhtudest;
English: • A warning to advise that any lymphadenopathy present prior to initiation of therapy should be investigated and kept under assessment.
Estonian: • hoiatus selle kohta, et kui patsiendil on enne ravi lümfadenopaatia, tuleb patsienti uurida ning jälgida;
English: With regard to the skin cancers, the CHMP concluded that treatment with tacrolimus was not likely to have caused these skin malignancies.
Estonian: Nahavähi osas tegi inimtervishoius kasutatavate ravimite komitee järelduse, et ravi takroliimusega ei olnud tõenäoliselt nende pahaloomuliste nahahaiguste põhjustaja.
English: The CHMP concluded as well that the risk of cutaneous malignancies should be assessed through case-control studies.
Estonian: Komitee järeldas ka seda, et pahaloomuliste nahaprotsesside riski tuleks hinnata juhupõhistes uuringute alusel.
English: In order to address the safety concerns in relation to the cases of malignancies the CHMP concluded that warnings reflecting the cases of malignancies and the need for monitoring of patients treated with Protopy should be included in the product information.
Estonian: Ohutusnõuete käsitlemiseks seoses pahaloomuliste haiguste tekkejuhtudega leidis inimtervishoius kasutatavate ravimite komitee, et ravimi infolehte tuleb lisada hoiatused pahaloomuliste haiguste tekke kohta ning rõhutada vajadust jälgida patsiente, kes saavad Protopy'i ravi.
English: However, having reviewed the available data, the CHMP concluded that not all cases could be considered to be cases of pre-existing malignancy disease, and an association with tacrolimus could not be excluded in some of the cases.
Estonian: Siiski leidis inimtervishoius kasutatavate ravimite komitee olemasolevate andmete põhjal, et mitte kõiki juhtumeid ei saa lugeda juba eelnevalt olemas olnud pahaloomulisteks haigusteks ning mõnel juhul ei saa välistada protsessi tekke seotust takroliimusega.
English: In addition, the CHMP concluded that further data are required to better elicit the long-term safety of Protopy in respect of its association with malignancies.
Estonian: Lisaks sellele leidis inimtervishoius kasutatavate ravimite komitee, et järelduste tegemiseks Protopy'i pikaajalise kasutamise ohutuse kohta eelkõige seoses pahaloomuliste protsessidega on vaja täiendavaid uuringuid.
English: In view of the available data (including pre clinical, clinical and epidemiological) the CHMP concluded that a potential association with the use of Protopy cannot be ruled out and therefore further data are needed to ensure an acceptable
Estonian: kliinilisi ja epdemioloogilisi), leidis inimtervishoius kasutatavate ravimite komitee, et nende juhtude võimalikku seost Protopy'iga ei saa välistada ning vastuvõetava pikaajalise ohutusprofiili tagamiseks on seetõttu vaja täiendavaid andmeid;
English: Protopy 0.1% is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults who are not adequately responsive to or are intolerant of conventional therapies and Protopy 0.03% is indicated for the treatment of moderate to severe AD in adults or children (2 years of age and above) who failed to respond adequately to conventional therapies.
Estonian: Protopy 0,03% on näidustatud mõõduka kuni raske AD raviks täiskasvanutel või lastel (alates teisest eluaastast), kes piisavalt ei allu ravile tavapäraste ravimitega.
English: The CHMP agreed that the diagnosis of these skin malignancies is difficult and may mimic AD.
Estonian: Inimtervishoius kasutatavate ravimite komitee otsustas, et pahaloomuliste nahahaiguste diagnoosimine on raske ning need võivad olla sarnased atoopilisele dermatiidile.
English: However, considering that tacrolimus is effective through its suppression of T cells which are involved in immune surveillance, it is possible that tacrolimus could have an effect on the behaviour of cutaneous lesions which were either pre-malignant or cases of early malignancy.
Estonian: Kuid arvestades asjaolu, et takroliimus toimib T-rakkude pärssimise kaudu ning need rakud on osa immuunsüsteemist, võis takroliimus mõjutada premaliigsete või vähemaliigsete nahakahjustuste arenguid.
English: As tacrolimus is an effective immunosuppressant that acts by suppressing T lymphocytes in the skin, the CHMP was of the opinion that an effect of tacrolimus on the development or progression of a variety of skin lesions could not be excluded.
Estonian: Kuna takroliimus on tugev immunosupressant, mis toimib T-lümfotsüütide pärssimise kaudu nahas, oli inimtervishoius kasutatavate ravimite komitee arvamusel, et takroliimuse seda toimet ei tohi tähelepanuta jätta.
English: The CHMP requested that the MAH should present 6 monthly updates on the status of recruitment of this study.
Estonian: Inimtervishoius kasutatavate ravimite komitee palus müügiloa hoidjal esitada kuus igakuist aruannet uutest andmetest katsetes osalejate kohta.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Estonian: EMEA POOLT ESITATUD TEADUSLIKUD JÄRELDUSED NING RAVIMI OMADUSTE
English: - The Committee, as a consequence, concluded that the following information should be included in the Summary of Product Characteristics and relevant sections of the Package Leaflet of
Estonian: - kokkuvõtteks leidis komitee, et Protopy'i ravimi omaduste kokkuvõttesse ja pakendi infolehele tuleb lisada järgmine teave:
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Estonian: ALUSED RAVIMI OMADUSTE KOKKUVÕTTE JA PAKENDI INFOLEHE MUUTMISEKS
English: Case reports of malignancies (including skin cancer, cutaneous T-Cell lymphoma (CTCL), NonHodking lymphoma (NHL) and systemic malignancies) have been received during the clinical development and post-marketing experience in association with the use of Protopy.
Estonian: Protopy'i kliinilise väljatöötamise ajal ja müügiloa väljastamise järel on esinenud teateid halvaloomulistest protsessidest seoses ravimi kasutamisega (sh nahavähk, naha T-rakuline lümfoom (CTCL), mitte-Hodgkini lümfoom (NHL) ja süsteemsed pahaloomulised protsessid).
English: In order to reduce the likelihood of mis-diagnosis and in order to better ensure the appropriate use of the medicinal product, the CHMP emphasised that the product information should reflect that the initial diagnosis and initial prescription should be undertaken by physicians with experience in the treatment of AD. Additionally, the CHMP concluded that Protopy should not be used in immunocompromised adults or children and that Protopy should not be applied to lesions that are considered to be potentially malignant or pre-malignant and that lymphadenopathy present at initiation of therapy should be investigated and kept under review.
Estonian: Lisaks järeldas inimtervishoius kasutatavate ravimite komitee, et Protopy'it ei tohi kasutada immunosupressiooniga täiskasvanutel ega lastel, samuti ei tohi Protopy'it kanda kahjustustele, mis võivad olla pahaloomulised või premaliigsed ning ravi alustamisel olemasolevat lümfadenopaatiat tuleb uurida ja jälgida.
English: • The treatment should be intermittent and not continuous.
Estonian: • ravi peab toimuma tsüklitena ning ei tohi olla pidev; • tuleb rõhutada seda, et takroliimust ei tohi kanda kahjustustele, mis võivad olla
English: This is normal, they will not harm you.
Estonian: See on tavapärane, need ei kahjusta teid.
English: Need help?
Estonian: Vajate abi?
English: Here are some reminders.
Estonian: Siin on mõned meeldetuletused.
English: The following is a general description.
Estonian: Järgnev on üldine kirjeldus.
English: Get medical help immediately.
Estonian: Vajate viivitamatult meditsiinilist abi.
English: These instructions are only for you.
Estonian: Need juhised on ainult teile.
English: Please follow the instructions carefully.
Estonian: Palun järgige hoolikalt neid juhiseid.
English: Wash your hands.
Estonian: Peske oma käed.
English: - Are you exercising more than usual?
Estonian: Kas treenite tavalisest enam?
English: • You may need to repeat this step up to 3 times before seeing insulin.
Estonian: • Teil võib olla vaja seda sammu korrata kuni 3 korda enne kui näete insuliini.
English: • Always carry sugar with you.
Estonian: • kandke alati kaasas suhkrut.