FrancophonIA/ELRC3.0 huggingface dataset:
English: During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Estonian: Trombotsütopeeniast on teatatud ka Kinereti turustamisjärgsel kasutamisel, sh ka raskest trombotsütopeeniast (trombotsüütide sisaldus <10·109/l).
English: Blood and lymphatic system disorders Frequency ‘common': thrombocytopenia
Estonian: Ravimi omaduste kokkuvõte Lõik 4.8 - Kõrvaltoimed Vere ja lümfisüsteemi häired Esinemissagedus „sage”: trombotsütopeenia
English: EU Number Invented Name
Estonian: EL number Toote nimi Tugevus
English: Zero days
Estonian: 0 päeva
English: 1 dose 10 glass vials Zero days
Estonian: 1 doos 10 klaasviaali 0 päeva
English: Horses Intramuscular Vials (Type I glass) closed with a halogenobutyl rubber stopper and aluminium cap.
Estonian: Süstesuspensioon Hobune Intramuskulaarne Viaalid (tüüp I klaas) suletud halogeenbutüülkummist korgi ja alumiiniumkapsliga.
English: 1 dose 10 pre-filled syringes
Estonian: 1 doos 10 eeltäidetud süstalt
English: Horses Intramuscular Pre-filled syringes (Type I glass) with a plunger and cap tip of halogenobutyl rubber
Estonian: Süstesuspensioon Hobune Intramuskulaarne Eeltäidetud süstlad (tüüp I klaas) kolviga ja halogeenbutüülkummist korgi otsikuga
English: Content Package size Withdrawal period
Estonian: Sisu Pakendi suurus
English: Pharmaceutical Form
Estonian: Ravimvorm Loomaliik Manustamisviis Pakend
English: MA (EU) number
Estonian: MA (EL-i) number
English: 1 bag
Estonian: 1 kott
English: EU/1/16/1121/001 Zalmoxis
Estonian: EL/1/16/1121/001 Zalmoxis 5-20 x 106 rakku /ml Infusioonidispersio on
English: (Invented) name
Estonian: (Ravimi nimetus)
English: 5-20 x 106 cells/mL
Estonian: 10-100 ml
English: Immediate Packaging Content Pack size
Estonian: Toimeaine kogus Ravimvorm Manustamisviis Vahetu sisepakend Sisu
English: Intravenous use Ethylen-vinyl-acetate cryo bag (EVA)
Estonian: Intravenoosne Etüleenvinüülatsetaadi st krüokott
English: 1, Place Renault 92844 RUEIL-MALMAISON Cedex
Estonian: Prantsusmaa AstraZeneca 1, Place Renault 92844 RUEIL-MALMAISON Cedex
English: AstraZeneca S.p.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
Estonian: Palazzo Volta Via F. Sforza 20080 - Basiglio (Milano) Italy
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110
Estonian: Luksemburg NV AstraZeneca SA Egide Van Ophemstraat
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Estonian: I lisa Ravimi(te) nimetuste, ravimvormi(de), tugevus(t)e, manustamisviisi(de), müügiloa hoidja(te) loetelu liikmesriikides
English: Czech Republic AstraZeneca UK Limited 2 Kingdom Street
Estonian: Tšehhi Vabariik AstraZeneca UK Limited 2 Kingdom Street
English: United Kingdom AstraZeneca UK Limited 600 Capability Green
Estonian: Ühendkuningriik AstraZeneca UK Limited 600 Capability Green
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Estonian: NV AstraZeneca SA Egide Van Ophemstraat
English: SEROQUEL XR 200 mg 200mg
Estonian: SEROQUEL XR 200 mg
English: SEROQUEL XR 400 mg 400mg
Estonian: SEROQUEL XR 400 mg
English: SEROQUEL XR 150 mg 150mg
Estonian: SEROQUEL XR 150 mg
English: SEROQUEL XR 300 mg 300mg
Estonian: SEROQUEL XR 300 mg
English: Lithuania
Estonian: Slovakkia
English: Intravenous use vial (glass)
Estonian: Infusioonilahus Intravenoosne viaal (klaas)
English: Patients should not use more than one capsule in a day.
Estonian: Patsiendid ei tohi manustada üle ühe kapsli ööpäevas.
English: The recommended dose is one capsule once a day at the same time each day.
Estonian: Soovitatav annus on üks kapsel ööpäevas iga päev samal ajal.
English: The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment.
Estonian: Amet märkis ka, et ravimi kasutamine üks kord ööpäevas aitab patsientidel paremini järgida ravirežiimi.
English: Further information on Seebri Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave ravimi Seebri Breezhaler kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Seebri Breezhaler (glycopyrronium bromide) EMA/326863/2018
Estonian: Seebri Breezhaler (glükopürrooniumbromiid) EMA/326863/2018
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Estonian: Mõlemas uuringus oli efektiivsuse põhinäitaja see, kuidas paranes patsientide forsseeritud ekspiratoorne maht (FEV1, suurim õhukogus, mida inimene suudab 1 s jooksul välja hingata).
English: To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.
Estonian: Annuse manustamiseks asetab patsient kapsli inhalaatorisse ja hingab suu kaudu kapsli pulbrit sisse.
English: After 12 weeks of treatment, Seebri Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Estonian: 12-nädalase ravi järel suurendas Seebri Breezhaler patsientide forsseeritud ekspiratoorset mahtu esimeses uuringus 97 ml ja teises uuringus 108 ml võrra rohkem kui platseebo.
English: Seebri Breezhaler received a marketing authorisation valid throughout the EU for Seebri Breezhaler on 28 September 2012.
Estonian: Seebri Breezhaler on saanud müügiloa, mis kehtib kogu ELis, 28. septembril 2012.
English: The most common side effects with Seebri Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Estonian: Seebri Breezhaleri kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 100st) on suukuivus, nasofarüngiit (nina- ja kurgupõletik), unetus, lihase- ja luuvalu ning gastroenteriit (kõhulahtisus koos oksendamisega).
English: Side effects reported with Seebri Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Estonian: Seebri Breezhaleri kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Therefore, the Agency decided that Seebri Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Seebri Breezhaleri kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: What measures are being taken to ensure the safe use of Seebri Breezhaler?
Estonian: Mis meetmed võetakse, et tagada Seebri Breezhaleri ohutu kasutamine?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Seebri Breezhaler have been included in the summary of product characteristics and the package leaflet.
Estonian: Seebri Breezhaleri ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: What is Seebri Breezhaler and what is it used for?
Estonian: Mis on Seebri Breezhaler ja milleks seda kasutatakse?
English: Seebri Breezhaler capsules, which contain a powder for inhalation, are only used with the Seebri Breezhaler inhaler and must not be swallowed.
Estonian: Seebri Breezhaleri kapsleid, mis sisaldavad inhalatsioonipulbrit (sissehingatavat pulbrit), tohib kasutada üksnes Seebri Breezhaleri inhalaatoris ja neid ei tohi alla neelata.
English: Seebri Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Estonian: Seebri Breezhaler on ravim, mida kasutatakse kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamiseks täiskasvanutel.
English: Seebri Breezhaler (glycopyrronium bromide)
Estonian: Seebri Breezhaler (glükopürrooniumbromiid)
English: In addition, there were no major safety concerns with Seebri Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Estonian: Seebri Breezhaleriga ei ole ka suuri ohutusprobleeme ning kõrvalnähud on samalaadsed kui teistel muskariiniretseptorite antagonistidena toimivatel ravimitel.
English: Other information about Seebri Breezhaler
Estonian: Muu teave Seebri Breezhaleri kohta
English: As for all medicines, data on the use of Seebri Breezhaler are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse ravimi Seebri Breezhaleri kasutamise kohta pidevat järelevalvet.
English: For more information about using Seebri Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Seebri Breezhaler kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: For the full list of all side effects and restrictions with Seebri Breezhaler, see the package leaflet.
Estonian: Seebri Breezhaleri kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: For more information about treatment with Seebri Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Seebri Breezhaleriga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What are the risks associated with Seebri Breezhaler?
Estonian: Mis riskid Seebri Breezhaleriga kaasnevad?
English: Seebri Breezhaler is used for maintenance (regular) treatment.
Estonian: Seebri Breezhalerit kasutatakse säilitusraviks (tavaliseks raviks).
English: Seebri Breezhaler contains the active substance glycopyrronium bromide.
Estonian: Seebri Breezhaler sisaldab toimeainena glükopürrooniumbromiidi.
English: The European Medicines Agency noted that Seebri Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Estonian: Euroopa Ravimiamet märkis, et Seebri Breezhaleri kasulikkus patsientidele on väike, kuid oluline, sest ravim soodustab kopsutalitlust ja leevendab kroonilise obstruktiivse kopsuhaiguse sümptomeid.
English: An overview of Seebri Breezhaler and why it is authorised in the EU
Estonian: Ülevaade ravimist Seebri Breezhaler ja ELis müügiloa väljastamise põhjendus
English: How does Seebri Breezhaler work?
Estonian: Kuidas Seebri Breezhaler toimib?
English: How is Seebri Breezhaler used?
Estonian: Kuidas Seebri Breezhalerit kasutatakse?
English: Seebri Breezhaler can only be obtained with a prescription.
Estonian: Seebri Breezhaler on retseptiravim.
English: Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways.
Estonian: Muskariiniretseptorid reguleerivad lihaste kontraktsiooni: glükopürrooniumbromiidi sissehingamine lõdvestab bronhide lihaseid, mis hoiab bronhid avatuna ja võimaldab patsiendil kergemini hingata.
English: What benefits of Seebri Breezhaler have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Seebri Breezhaleri kasulikkus?
English: Seebri Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Estonian: Kahes põhiuuringus, milles osales kokku 1888 kroonilise obstruktiivse kopsuhaigusega patsienti, osutus Seebri Breezhaler platseebost (näiv ravim) efektiivsemaks.
English: Memantine LEK should be given once a day at the same time every day.
Estonian: Ravimit Memantine LEK peab võtma üks kord ööpäevas, iga päev samal kellaajal.
English: The full EPAR for Memantine LEK can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ravimi Memantine LEK kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Memantine LEK?
Estonian: Mis meetmed võetakse, et tagada ravimi Memantine LEK kasutamise efektiivsus ja ohutus?
English: To prevent side effects, the dose of Memantine LEK 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 ravimi Memantine LEK annust esimese kolme ravinädala jooksul järkjärgult: esimesel nädalal on annus 5 mg, teisel nädalal 10 mg ning kolmandal nädalal 15 mg.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine LEK on 22 April 2013.
Estonian: Euroopa Komisjon andis ravimi Memantine LEK müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 22. aprillil 2013.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Memantine LEK should be reassessed on a regular basis.
Estonian: Ravimi taluvust ja annust tuleb hinnata 3 kuu jooksul alates ravi algusest, seejärel tuleb ravimiga Memantine LEK ravi jätkamist regulaarselt uuesti hinnata.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine LEK by the patient.
Estonian: Ravi tohib alustada vaid sel juhul, kui on olemas hooldaja, kes jälgib regulaarselt, kuidas patsient ravimit Memantine LEK kasutab.
English: The Committee recommended that Memantine LEK be approved for use in the EU.
Estonian: Komitee soovitas ravimi Memantine LEK kasutamise Euroopa Liidus heaks kiita.
English: What is Memantine LEK and what is it used for?
Estonian: Mis on Memantine LEK ja milleks seda kasutatakse?
English: This means that Memantine LEK is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Estonian: See tähendab, et Memantine LEK on sarnane võrdlusravimiga Ebixa, millel juba on Euroopa Liidus müügiluba.
English: Memantine LEK is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Estonian: Memantine LEK on retseptiravim ja seda turustatakse 10 mg ja 20 mg tablettidena.
English: Memantine LEK is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Estonian: Alzheimeri tõbi on dementsuse (teatud ajuhäire) liik, mis kahjustab järk-järgult mälu, vaimseid võimeid ja käitumist.
English: Memantine LEK is a ‘generic medicine'.
Estonian: Memantine LEK on geneeriline ravim.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Memantine LEK, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi Memantine LEK ohutusteave koos vastavate ettevaatusabinõudega tervishoiuspetsialistidele ja patsientidele.
English: Because Memantine LEK is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Memantine LEK on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: It is not intended to provide practical advice on how to use Memantine LEK.
Estonian: Hindamisaruandes ei anta ravimi Memantine LEK kasutamise praktilisi nõuandeid.
English: For more information about treatment with Memantine LEK, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Memantine LEK toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine LEK has been shown to have comparable quality and to be bioequivalent to Axura.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Memantine LEK võrdväärne kvaliteet ja bioekvivalentsus ravimiga Axura.
English: Other information about Memantine LEK
Estonian: Muu teave ravimi Memantine LEK kohta
English: For practical information about using Memantine LEK, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate ravimi Memantine LEK kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Because Memantine LEK is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Axura.
Estonian: Et Memantine LEK on geneeriline ravim, piirdusid uuringud katsetega, milles näidati selle bioekvivalentsust võrdlusravimitega Axura.
English: This is a summary of the European public assessment report (EPAR) for Memantine LEK.
Estonian: See on ravimi Memantine LEK Euroopa avaliku hindamisaruande kokkuvõte.
English: The active substance in Memantine LEK, memantine, is an antidementia medicine.
Estonian: Ravimi Memantine LEK toimeaine memantiin on dementsuse ravim.
English: Why is Memantine LEK approved?
Estonian: Miks Memantine LEK heaks kiideti?
English: Therefore, the CHMP's view was that, as for Axura, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Axura korral, ületab ravimi Memantine LEK kasulikkus sellega kaasnevad riskid.
English: Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Estonian: Ravi tohib alustada üksnes Alzheimeri tõvega patsientide diagnoosimises ja ravis kogenud arst ning see peab toimuma tema järelevalve all.
English: How does Memantine LEK work?
Estonian: Kuidas Memantine LEK toimib?
English: How is Memantine LEK used?
Estonian: Kuidas ravimit Memantine LEK kasutatakse?
English: What are the benefits and risks of Memantine LEK?
Estonian: Milles seisneb ravimi Memantine LEK kasulikkus ja mis riskid ravimiga kaasnevad?
English: How has Memantine LEK been studied?
Estonian: Kuidas ravimit Memantine LEK uuriti?
English: 1 bottle + 1 adapter + 1 oral applicator
Estonian: 1 pudel + 1 adapter + 1 suukaudne aplikaator
English: Content (concentration) Package size
Estonian: Pakendi sisu (kontsentratsio on)
English: (Invented) name Strength Pharmaceutical Form
Estonian: (Väljamõel dud) nimetus
English: Oral solution bottle (HDPE) 230 ml
Estonian: Suukaudne lahus pudel (HDPE)
English: As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use (CHMP) on the basis of a recommendation of the Pharmacovigilance
Estonian: Et mõlemad algatatud menetluse taotlused põhinevad ravimiohutuse järelevalve tegevusest johtuval andmete hinnangul, palus Euroopa Komisjon võtta inimravimite komiteel vastu ravimiohutuse riskihindamise komitee (PRAC) soovitusel põhinev arvamus.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the
Estonian: • ravimiohutuse riskihindamise komitee arutas määruse (EÜ) nr 726/2004 artikli 20 kohast menetlust, mille aluseks olid kroonilise C-hepatiidi ravis näidustatud otsese toimega viirusevastaseid aineid sisaldavate ravimite ravimiohutuse järelevalve andmed;
English: The RMP of the relevant medicinal products will be updated accordingly.
Estonian: Asjaomaste ravimite riskijuhtimiskavad ajakohastatakse
English: Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested
Estonian: Pärast selle läbivaatamise alustamist tuvastati 2014. aasta oktoobrist kuni 2015. aasta detsembrini kestnud uuringus (Reig et al. 2016) mis tehti nelja Hispaania ülikooli haigla hepatoloogia osakonnas kroonilist C-hepatiiti põdevate ja hepatotsellulaarse kartsinoomi anamneesiga patsientidel, keda raviti otsese toimega viirusevastaste ainetega, ootamatult varajane hepatotsellulaarse kartsinoomi
English: The product information will include a warning to inform about the risk of hepatitis B reactivation and
Estonian: Tooteinfo peab sisaldama hoiatust B-hepatiidi reaktivatsiooni riski kohta ja kajastama neid soovitusi;
English: The current referral procedure was triggered by the European Commission (EC) to allow further investigation of the risk of hepatitis B virus replication after starting treatment with DAAs and recommend any appropriate measure to
Estonian: Euroopa Komisjon algatas käesoleva esildismenetluse, et teha lisauuringuid B-hepatiidi viiruse replikatsiooniriski kohta pärast otsese toimega viirusevastaste ainetega ravi alustamist ja soovitada sobivaid meetmeid riski vähendamiseks.
English: • The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral
Estonian: • ravimiohutuse riskihindamise komitee vaatas läbi kõik müügiloa hoidjate kirjalikult esitatud andmed ja suuliselt antud selgitused B-hepatiidi reaktivatsiooni riski kohta ning otsese toimega viirusevastaseid aineid kasutavatel patsientidel hepatotsellulaarse kartsinoomi esinemist käsitlevates aruannetes tõstatatud küsimused, samuti HIV/viirushaiguste teadusliku nõuanderühma kohtumise tulemused;
English: Generally, the reactivation occurred shortly after the initiation of treatment in a pattern that implies a correlation with the rapid decrease in HCV viral load which characterises the viral load dynamics with DAAs.
Estonian: Tavaliselt tekkis üsna pea pärast raviskeemi alustamist reaktivatsioon ja see viitab korrelatsioonile HCV viiruskoormuse kiire vähenemisega, mis iseloomustab viiruskoormuse muutumist otsese toimega
English: Some of the cases identified with DAAs had serious outcomes, with worsening of hepatic status and at least one case where the patient
Estonian: Mõne juhtumi puhul, kus kasutati otsese toimega viirusevastaseid aineid, esines raske tagajärjena maksa seisundi halvenemist, ja ühel juhul vajas patsient maksasiirdamist.
English: Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk
Estonian: Üldiselt oli ravimiohutuse riskihindamise komitee arvamusel, et leidub tõendeid HBV reaktivatsiooni kohta HBV/HCV liitnakkusega patsientidel, keda ravitakse otsese toimega viirusevastaste ainetega, ja seepärast tuleb HBV reaktivatsiooni pidada liitnakkusega patsientide puhul oluliseks tuvastatud riskiks, mida tuleb hoolega jälgida korrapäraste riski vähendamise meetmete võtmise kaudu.
English: In view of the above, the PRAC considers that the benefit-risk balance of direct-acting antivirals remains favourable subject to the amendments to the terms of the marketing authorisations.
Estonian: Kokkuvõttes leidis ravimiohutuse riskihindamise komitee, et otsese toimega viirusevastaseid aineid sisaldavate ravimite kasulikkuse ja riski tasakaal jääb positiivseks, kui müügilubade tingimustesse tehakse kavandatud muudatused.