FrancophonIA/ELRC3.0 huggingface dataset:
English: Although asymptomatic PML patients had generally similar baseline clinical characteristics compared with symptomatic patients, a higher proportion of asymptomatic patients presented with more localized disease (64% unilobar PML) on Magnetic Resonance Image (MRI) at the time of diagnosis compared to symptomatic PML patients (36%).
Estonian: Kuigi asümptomaatilise PML-iga patsientidel olid üldiselt samasugused algsed kliinilised tunnused kui sümptomaatilistel patsientidel, esines enamikul neist diagnoosimisel magnetresonantstomograafia abil rohkem lokaliseerunud haigus (64% unilobaarne PML), võrrelduna sümptomaatilise PML-iga patsientidega (36%).
English: In addition patients without prior immunosuppressant use and a low antibody index should also be tested every 6 months if they are treated beyond 2 years.
Estonian: Lisaks tuleb varem immunosupressante mittekasutanud ja väikese antikehade indeksiga patsiente samuti iga 6 kuu järel kontrollida, kui neid ravitakse kauem kui 2 aastat.
English: There seems to be consensus among experts that routine MRI screening for suspected PML lesions can be conducted without gadolinium-enhancement.
Estonian: Ekspertide hulgas näib valitsevat üksmeel, et rutiinseid magnetresonantstomograafia uuringuid PML-i kahjustuste kahtlusel võib läbi viia ilma gadoliiniumita.
English: The risk stratification algorithm in the educational material will be revised to include current estimates derived from a pooled study cohort (STRATIFY-2, TOP, TYGRIS and STRATA studies) of natalizumab-treated patients, and to incorporate anti-JCV antibody index.
Estonian: Õppematerjalis leiduv riski stratifitseerimise algoritm vaadatakse läbi, et lisada praegused hinnangud, mis on saadud natalizumabiga ravitud patsientide ühendatud uuringukohordist (uuringud STRATIFY-2, TOP, TYGRIS ja STRATA), ja JCV-vastaste antikehade indeks.
English: For patients without prior immunosuppressant use and with high anti-JCV antibody index, no further antibody testing is required, as more frequent MRI screening should be considered if natalizumab treatment is continued for more than 2 years.
Estonian: Varem immunosupressante mittekasutanud ja JVC-vastaste antikehade suure tiitriga patsientidel ei ole edasine antikehade kontrollimine vajalik, sest tuleb kaaluda magnetresonantstomograafia sõeluuringute sagedamat tegemist, kui ravi natalizumabiga jätkatakse kauem kui 2 aastat.
English: Available data to date suggest that anti-JCV antibody index is correlated with the risk of PML in anti-JCV antibody positive patients with no prior immunosuppressant use.
Estonian: Olemasolevad andmed viitavad sellele, et JVC-vastaste antikehade indeks korreleerub PML-i riskiga JVC-vastaste antikehade suhtes positiivsetel patsientidel, kes ei ole varem immunosupressante kasutanud.
English: Currently it is recommended that patients who are anti-JCV antibody negative should be tested for seroconversion twice yearly.
Estonian: Praegu soovitatakse JCV-vastaste antikehade suhtes negatiivseid patsiente kontrollida serokonversiooni suhtes kaks korda aastas.
English: MRI is considered to be a sensitive method to identify even small and asymptomatic PML lesions.
Estonian: Magnetresonantstomograafiat peetakse tundlikuks meetodiks, mille abil saab tuvastada isegi väikesed ja asümptomaatilised PML-i kahjustused.
English: Diffusion -weighted imaging is highly sensitive for depicting acute demyelinisation and can also aid differentiation of acute PML lesions from chronic and subacute demyelinating PML lesions.
Estonian: Difusioonirežiim on äärmiselt tundlik ägeda demüelinisatsiooni kirjeldamiseks ja võib samuti aidata diferentseerida ägeda PML-i kahjustusi kroonilistest ning alaägedatest demüeliniseeritud PML-i kahjustustest.
English: • The PRAC concluded that PML which is clinically asymptomatic at diagnosis represents more frequently localised disease in MRI, with a higher survival rate and better clinical outcome as compared to symptomatic PML.
Estonian: • Ravimiohutuse riskihindamise komitee järeldas, et PML, mis diagnoositakse kui kliiniliselt asümptomaatiline, on magnetresonantstomograafia uuringuis sagedamini lokaliseerunud haigus koos suurema elumusega ja paremate kliiniliste lõpptulemustega kui sümptomaatiline PML.
English: In patients treated for longer than 2 years, the risk of PML is low at index values of 0.9 or less, and increases substantially at values above 1.5.
Estonian: Üle 2 aasta ravitud patsientidel on PML-i risk väike, kui indeks on kuni 0,9, ja risk suureneb oluliselt, kui indeks on üle 1,5.
English: Published data suggest that patients considered as having a high risk for PML development and who continue natalizumab treatment beyond 2 years of treatment may benefit from more frequent MRI screening e.g. every 3 to 6 months.
Estonian: Avaldatud andmed viitavad, et patsiendid, kelle PML-i tekkeriski peetakse suureks ja kes jätkavad ravi natalizumabiga üle 2 aasta, võivad saada kasu sagedamatest nt iga 3 või 6 kuu järel toimuvatest magnetresonantstomograafia sõeluuringutest.
English: • The PRAC also concluded that, in patients who have not received prior immunosuppressant therapy and are anti-JCV antibody positive, the level of anti-JCV antibody response (index) is associated with risk of developing PML.
Estonian: • Ravimiohutuse riskihindamise komitee järeldas samuti, et patsientidel, kes varem ei ole saanud ravi immunosupressantidega ja kes on JCV-vastaste antikehade suhtes positiivsed, on JCV-vastaste antikehade vastuse (indeksi) tase seotud PML-i tekkimise riskiga.
English: Asymptomatic PML cases were identified via routine MRI.
Estonian: Asümptomaatilised PML-i juhud tuvastati rutiinse magnetresonantstomograafia abil.
English: • The PRAC recommended that patients with low anti-JCV antibody index who have not received prior immunosuppressant therapy should be retested every six months once they reach the 2-year treatment point.
Estonian: • Ravimiohutuse riskihindamise komitee soovitas, et väikese JCV-vastaste antikehade indeksiga patsiente, kes ei ole varem saanud immunosupressantide ravi, tuleb pärast 2aastast ravi uuesti iga kuue kuu järel kontrollida.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Tysabri.
Estonian: Seetõttu soovitab inimravimite komitee muuta Tysabri müügiloa tingimusi.
English: For natalizumab-treated patients with MS, who are at high risk of PML, brain MRI screening using a protocol that includes FLAIR (fluidattenuated inversion recovery), T2-weighted and diffusion -weighted imaging is recommended.
Estonian: Natalizumabi ravi saavatel hulgiskleroosiga patsientidel, kellel esineb suur PML-i risk, soovitatakse teha magnetresonantstomograafia sõeluuring, mis sisaldab FLAIR-i (fluid-attenuated inversion recovery), T2-kaalutud ja difusioonirežiime.
English: In patients with MRI lesions suggestive for PML, the MRI protocol should be extended to include contrast-enhanced T1-weighted imaging to detect inflammatory features and the possible coincidence of PML and PML-IRIS (Immune Reconstitution Inflammatory Syndrome), particularly during follow up.
Estonian: Patsientidel, kelle magnetresonantstomograafia uuringutes ilmnenud kahjustused viitavad PML-ile, tuleb magnetresonantstomograafia protokolli laiendada, nii et see sisaldaks kontrastainega T1-kaalutud režiimi põletikuliste omaduste ja PML-i ning PML-IRIS-sündroomi (immuunsüsteemi reaktivatsiooni sündroom) tuvastamiseks, eriti järelkontrolli ajal.
English: • As a consequence, the PRAC recommended that more frequent MRI screening for PML (e.g. every 3-6 months) using an abbreviated MRI protocol should be considered in patients at higher risk of development of PML.
Estonian: • Selle tulemusena soovitas ravimiohutuse riskihindamise komitee, et PML-i suurema riskiga patsientidel tuleb kaaluda PML-i sagedamaid magnetresonantstomograafia sõeluuringuid (nt iga 3-6 kuu järel), kasutades lühendatud magnetresonantstomograafia protokolli.
English: Anti-JCV antibody ELISA
Estonian: JVC-vastaste antikehade ELISA test
English: It is acknowledged that high expertise is necessary to identify small and asymptomatic PML lesions via MRI.
Estonian: Mööndakse, et väikeste ja asümptomaatiliste PML-i lesioonide tuvastamiseks magnetresonantstomograafia abil on vajalikud suured kogemused.
English: In view of all of the above, the PRAC concluded that the benefit-risk balance of Tysabri remains favourable subject to amendments to the product information and additional risk minimisation measures as described below.
Estonian: Kõige eeltoodu põhjal järeldas ravimiohutuse riskihindamise komitee, et Tysabri kasulikkuse ja riski tasakaal jääb positiivseks, kui ravimiteabesse tehakse muudatused ja lisatakse riski vähendamise meetmed, nagu kirjeldatud allpool.
English: In view of the above, the Committee considered that the benefit-risk balance of Tysabri remains favourable subject to the agreed amendments to the product information and additional risk minimisation measures.
Estonian: Eeltoodu põhjal järeldas ravimiohutuse riskihindamise komitee, et Tysabri kasulikkuse ja riski tasakaal jääb positiivseks, kui ravimiteabesse tehakse kavandatud muudatused ja lisatakse täiendavad riski vähendamise meetmed.
English: Considering the dire diagnosis of PML a high level of vigilance and a low threshold even for invasive diagnostic measures and interventions such as MRI is warranted for managing patients with high risk for PML development.
Estonian: Arvestades PMLi diagnoosi raskust, peab PMLi suure tekkeriskiga patsientide korral olema äärmiselt valvas ja tegutsema kiiresti, kasutades isegi invasiivseid diagnostilisi meetmeid ja sekkumisi, nagu nt magnetresonantstomograafia.
English: Anti-JCV antibody testing
Estonian: JVC-vastaste antikehade kontrollimine
English: The CHMP, as a consequence, considers that the benefit-risk balance of Tysabri remains favourable subject to the amendments to the product information described above.
Estonian: Inimravimite komitee leiab, et Tysabri kasulikkuse ja riski tasakaal jääb positiivseks, kui ravimiteabesse tehakse eelkirjeldatud muudatused.
English: A mock-up of the updated physician information and management guideline can be found annexed to the RMP.
Estonian: Arstiteabe ja ravijuhise uus versioon on riskijuhtimiskava lisas.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Estonian: Bioloogilise päritoluga toimeaine, mis on mõeldud aktiivse immuunsuse esile kutsumiseks ei kuulu määruse (EÜ) number 470/2009 reguleerimisalasse.
English: BATCH NUMBER Lot {number}
Estonian: PARTII NUMBER Lot{ number}
English: IMMUNOLOGICAL PROPERTIES To stimulate active immunity against Equine influenza ATC-vet code: QI05AA01
Estonian: IMMUNOLOOGILISED OMADUSED Hobuste gripi vastase aktiivse immuunsuse stimuleerimine ATC-vet kood: QI05AA01
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/056/001-004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/05/056/001-004
English: 2 weeks after the primary vaccination course Duration of immunity: 5 months after the primary vaccination course 12 months after the first revaccination
Estonian: 2 nädalat pärast esmast vaktsineerimist Immuunsuse kestvus: 5 kuud pärast esmast vaktsineerimist 12 kuud pärast esimest revaktsineerimist
English: Influenza Onset of immunity:
Estonian: Gripp Immuunsuse teke:
English: Poligono Ind. El Montalvo I C/Zeppelin 6, Parcela 38
Estonian: Merck Sharp & Dohme Animal Health, S. L. Poligono Ind. El Montalvo I C/Zeppelin 6, Parcela 38
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years 6.4 Special precautions for storage
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg: 2 aastat 6.4 Säilitamise eritingimused
English: METHODS AND ROUTE OF ADMINISTRATION i.m.
Estonian: MANUSTAMISVIIS JA -TEE(D) i.m.
English: Intervet International B.V. Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Estonian: Wim de Körverstraat 35 NL-5831 AN Boxmeer Holland
English: ADVICE ON CORRECT ADMINISTRATION Allow the vaccine to reach room temperature before use.
Estonian: SOOVITUSED ÕIGE MANUSTAMISE OSAS Enne kasutamist lasta vaktsiinil soojeneda toatemperatuurini.
English: Store at 2-8°C, protected from light.
Estonian: Hoida temperatuuril 2°C - 8°C, kaitstuna valguse eest.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Netherlands
Estonian: Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: A/equine-2/South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU).
Estonian: A/equine-2/ South Africa/4/03 (50 AÜ), A/equine-2/Newmarket/2/93 (50 AÜ).
English: Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection.
Estonian: 6 kuu vanuste ja vanemate hobuste aktiivseks immuniseerimiseks hobuste gripi vastu vähendamaks kliinilisi tunnuseid ja viiruse eritumist pärast nakatumist.
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).
Estonian: Suurenenud nakkusriski või ebapiisava kolostrumivõtu korral tehakse lisaks sissejuhatav manustamine 4 kuu vanuses, millele järgneb täielik vaktsineerimisprogramm (esmane vaktsineerimine 6 kuu vanuses ja 4 nädala pärast).
English: THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the sight and reach of children
Estonian: MÄRGE „HOIDA LASTE EEST VARJATUD JA KÄTTESAAMATUS KOHAS” Hoida laste eest varjatud ja kättesaamatus kohas.
English: INDICATION(S) Active immunisation of horses against equine influenza.
Estonian: NÄIDUSTUS(ED) Hobuste aktiivseks immuniseerimiseks hobuste gripi vastu.
English: 5 x 1 dose 10 x 1 dose
Estonian: 5 x 1 doos
English: Pain at the injection site can occur in rare cases, which may result in temporary functional discomfort (stiffness).
Estonian: Süstekohal võib harva esineda valulikkust, mis võib liikumisel põhjustada ajutist ebamugavustunnet (jäikust).
English: SPECIAL STORAGE CONDITIONS Store at 2-8 °C, protected from light.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida temperatuuril 2…8°C, valguse eest kaitstult.
English: The first revaccination (third dose) is given 5 months after the primary vaccination course.
Estonian: Esimene revaktsineerimine (kolmas doos) hobuste gripi vastu manustatakse 5 kuud pärast esmast vaktsineerimist.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza [a clear pictogram of a horse]
Estonian: VETERINAARRAVIMI NIMETUS Equilis Prequenza [selge hobuse piktogramm]
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza
Estonian: VETERINAARRAVIMI NIMETUS Equilis Prequenza
English: Name and address of the manufacturer of the biological active substance(s)
Estonian: Bioloogiliste toimeainete tootja nimi ja aadress
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose of vaccine, no side-effects other than those described under 4.6 have been observed except for some depression at the day of vaccination 4.11 Withdrawal period(s)
Estonian: Kahekordse doosi vaktsiini manustamisel ei ole teisi kõrvaltoimeid kui on kirjeldatud lõigus 4.6 välja arvatud mõningane depressioon vaktsineerimispäeval.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Estonian: B. HANKE- JA KASUTAMISTINGIMUSED VÕI PIIRANGUD Retseptiravim.
English: EXPIRY DATE EXP {number}
Estonian: KÕLBLIKKUSAEG EXP{kuu/aasta}
English: The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
Estonian: Tagamaks gripikomponendi vastast immuunsustaset on alternatiivseks kasutamiseks 12-kuulise intervalliga sobiv hobuste gripivastane vaktsiin, mis sisaldab tüvesid A/equine-2/South Africa/4/03 ja A/equine 2/Newmarket-2/93 (vt. skeemi).
English: In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, for up to 3 days in exceptional circumstances.
Estonian: Väga harva võib tekkida palavik kestvusega 1 päev, erandjuhtudel kuni 3 päeva, millega võivad kaasneda letargia ja isutus.
English: Phosphate buffer
Estonian: Fosfaatpuhver.
English: Read the package leaflet before use
Estonian: Enne kasutamist lugege pakendi infolehte.
English: PACKAGE SIZE 1 dose
Estonian: PAKENDI SUURUS(ED) 1 doos
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: A. BIOLOOGILIS(T)E TOIMEAINE(TE) TOOTJA JA RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV TOOTJA
English: SPECIAL WARNINGS Read the package leaflet before use
Estonian: ERIHOIATUS(ED), KUI VAJALIK Enne kasutamist lugege pakendi infolehte.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Per dose of 1 ml:
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Üks doos 1 ml sisaldab:
English: Equine influenza virus strains:
Estonian: Hobuste gripiviiruse tüved:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza, suspension for injection, for horses
Estonian: VETERINAARRAVIMI NIMETUS Equilis Prequenza, süstesuspensioon hobustele
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 08 July 2005 / 08 July 2010
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV
English: 1 Antigenic units Adjuvant Purified Saponin
Estonian: 1 Antigeeni ühikud Adjuvant:
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISVIIS(ID) JA -MEETOD 1 ml.
English: THE WORDS ‘FOR ANIMAL TREATMENT ONLY'
Estonian: MÄRGE „AINULT VETERINAARSEKS KASUTAMISEKS”
English: 4.8 Interaction with other medicinal products and other forms of interaction
Estonian: 4.8 Koostoimed teiste ravimitega ja muud koostoimed Puuduvad andmed antud vaktsiini ohutuse ja efektiivsuse kohta selle kasutamisel koos teiste veterinaarravimitega.
English: PACKAGE LEAFLET FOR: Equilis Prequenza suspension for injection for horses
Estonian: PAKENDI INFOLEHT Equilis Prequenza, süstesuspensioon hobustele
English: Administer one dose (1ml), by strict intramuscular injection, according to the following schedule: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Estonian: Manustada üks doos (1 ml) üksnes intramuskulaarselt süstides vastavalt järgmisele graafikule:
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND ANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Estonian: BIOLOOGILIS(T)E TOIMEAINE(TE) TOOTJA(D) JA RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV TOOTJA
English: 4.4 Special warnings
Estonian: 4.4 Erihoiatused iga loomaliigi kohta
English: It must also not be used together with certain medicines such as:
Estonian: Peale selle ei tohi seda kasutada koos teatud ravimitega, näiteks:
English: Maviret received a marketing authorisation valid throughout the EU on 26 July 2017.
Estonian: Maviret on saanud müügiloa, mis kehtib kogu ELis, 26. juulil 2017.
English: Other information about Maviret
Estonian: Muu teave Mavireti kohta
English: What measures are being taken to ensure the safe and effective use of Maviret?
Estonian: Mis meetmed võetakse, et tagada Mavireti ohutu ja efektiivne kasutamine?
English: Further information on Maviret can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Maviret.
Estonian: Lisateave Mavireti kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Maviret.
English: The recommended dose is three tablets once a day, with food, for 8, 12 or 16 weeks.
Estonian: Soovitatav annus on kolm tabletti üks kord ööpäevas koos toiduga 8, 12 või 16 nädala jooksul.
English: A negative test result means that the virus was not found.
Estonian: Analüüsi negatiivne vastus tähendab, et viirust ei tuvastatud.
English: The European Medicines Agency therefore decided that Maviret's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Mavireti kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: The medicine's effectiveness in clearing genotype 3 was slightly lower than for other genotypes (95%).
Estonian: Ravimi efektiivsus 3. genotüübi viiruse kõrvaldamisel oli veidi väiksem kui teiste genotüüpide korral (95%).
English: What is Maviret and what is it used for?
Estonian: Mis on Maviret ja milleks seda kasutatakse?
English: Based on data available in adults, it is expected that Maviret is also effective in children with genotypes 5 and 6.
Estonian: Täiskasvanute andmete põhjal eeldatakse, et Maviret on 5. ja 6. genotüübi korral efektiivne ka lastel.
English: As for all medicines, data on the use of Maviret are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Mavireti kasutamise kohta pidevat järelevalvet.
English: The duration of treatment depends on whether patients have liver cirrhosis (scarring of the liver) or whether they have received previous treatments with pegylated interferon and ribavirin, with or without sofosbuvir, or sofosbuvir and ribavirin.
Estonian: Ravi kestus sõltub sellest, kas patsiendil on maksatsirroos (maksa sidekoestumine) või kas ta on saanud varem ravi pegüleeritud interferooni ja ribaviriiniga (koos sofosbuviiriga või ilma) või sofosbuviiri ja ribaviriiniga.
English: In addition, results showed that the way the medicine was absorbed, modified and removed from the body was similar to that in adults.
Estonian: Peale selle ilmnes tulemustest, et ravimi organismis imendumine ja muundumine ning organismist eemaldamine toimus sarnaselt täiskasvanutega.
English: The most common side effects with Maviret (which may affect more than 1 in 10 people) are headache and tiredness.
Estonian: Mavireti kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu ja väsimus.
English: Results were similar for genotypes 2 and 4-6.
Estonian: 2. ja 4.-6. genotüübi korral olid tulemused sarnased.
English: For more information about using Maviret, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Mavireti kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Side effects reported with Maviret are carefully evaluated and any necessary action taken to protect patients.
Estonian: Mavireti kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Maviret have also been included in the summary of product characteristics and the package leaflet.
Estonian: Mavireti ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: • carbamazepine, phenobarbital, phenytoin, primidone (medicines for epilepsy);
Estonian: • karbamasepiin, fenobarbitaal, fenütoiin, primidoon (epilepsiaravimid);
English: Maviret is available as tablets that contain 100 mg glecaprevir and 40 mg pibrentasvir.
Estonian: Maviretit turustatakse tablettidena, mis sisaldavad 100 mg gletsapreviiri ja 40 mg pibrentasviiri.
English: This study is being carried out in light of data suggesting that patients treated with medicines belonging to the same class as Maviret and who have had liver cancer could be at risk of their cancer returning early.
Estonian: Uuring tehakse andmete põhjal, et patsientidel, kes on saanud ravi Maviretiga samasse klassi kuuluvate ravimitega ja kellel on varem olnud maksavähk, võib olla vähi varajase taastumise risk.
English: Maviret (glecaprevir / pibrentasvir)
Estonian: Maviret (gletsapreviir/pibrentasviir)
English: What are the risks associated with Maviret?
Estonian: Mis riskid Maviretiga kaasnevad?