FrancophonIA/ELRC3.0 huggingface dataset:
English: While the results are difficult to interpret due to the lack of a placebo control group to verify assay integrity, this randomised, double-blind actively controlled study provides supporting evidence of efficacy of tolperisone in terms of improvement of mobility in patients with spasticity caused by neurological disorders.
Estonian: Kuigi uuringu tulemusi on raske hinnata platseeborühma puudumise tõttu, pakub see randomiseeritud topeltpime aktiivse kontrollrühmaga uuring tolperisooni efektiivsust toetavaid andmeid liikuvuse paranemise kohta patsientidel, kelle spastilisuse põhjuseks on neuroloogilised häired.
English: The SAG was also of the opinion that it is not possible to derive any conclusion regarding the efficacy of tolperisone, nor was it possible to identify any specific patient subgroups that could benefit from treatment with tolperisone compared to other treatments.
Estonian: Samuti oli teadusnõuanderühm arvamusel, et analüüside alusel ei ole võimalik otsustada tolperisooni efektiivsust ega tuvastada ühtki patsientide alamrühma, kellele oleks tolperisoonravi muust ravist kasulikum.
English: • The Committee is of the opinion that the evidence for clinically significant efficacy of tolperisone in the currently approved indications is extremely limited, and therefore the potential benefit for patients in these indications is outweighed by the identified risk.
Estonian: • komitee on arvamusel, et tolperisooni kliiniliselt olulist efektiivsust tõendavad andmed praegu heakskiidetud näidustustel on äärmiselt piiratud, mille tõttu ületab tuvastatud risk nendel näidustustel võimalikku kasulikkust;
English: With regard to the safety of tolperisone, the CHMP reviewed the available safety data and retained its previous conclusions that there is a risk of hypersensitivity reactions associated with tolperisone, with data showing that 10% of all reported cases of hypersensitivity were considered to be life-threatening.
Estonian: Tolperisooni ohutuse osas vaatas inimravimite komitee läbi olemasolevad ohutusandmed ja jäi oma esialgsete järelduste juurde, et tolperisooni kasutamine on seotud ülitundlikkusreaktsioonide riskiga, millest olemasolevate andmete kohaselt võib 10% teatatud ülitundlikkusjuhtudest pidada eluohtlikeks.
English: Validation of new parameters needs to be done beforehand if proof of efficacy is to be derived from a study.
Estonian: Kui uuringust soovitakse saada efektiivsust kinnitavaid andmeid, tuleb uued parameetrid valideerida enne.
English: Based on the totality of the data made available on the safety and the efficacy of tolperisone, the CHMP considered that the risk of hypersensitivity is more significant than previously identified, and that as a consequence the demonstrated clinical benefits only outweigh the risks in the restricted indication symptomatic treatment of post-stroke spasticity in adults.
Estonian: Tuginedes kõigile olemasolevatele andmetele tolperisooni ohutuse ja efektiivsuse kohta, leidis inimravimite komitee, et ülitundlikkuse risk on palju suurem, kui oli tuvastatud varem, ja et seetõttu ületab kliiniline kasulikkus riske ainult piiratud näidustusel insuldijärgse spastilisuse sümptomaatiline ravi täiskasvanutel.
English: It possesses high affinity for nervous tissue, reaching the highest concentrations in the brain stem, spinal cord and peripheral nerve tissue.
Estonian: Tolperisoonil on suur afiinsus närvikoe suhtes ning suurimad kontsentratsioonid saavutatakse ajutüves, seljaajus ja perifeerses närvikoes.
English: In this randomised, double-blind, placebo controlled, multicentre study efficacy of tolperisone has been shown in the symptomatic treatment of patients with spasticity following cerebral stroke.
Estonian: See randomiseeritud, topeltpime, platseebokontrolliga mitmekeskuseline uuring tõestab tolperisooni efektiivsust ajuinsuldi järgse spastilisusega patsientide sümptomaatilises ravis.
English: Treatment of obliterative vascular diseases as well as syndromes due to impaired vascular innervation
Estonian: Obliteratiivsete vaskulaarsete haiguste ning vaskulaarse innervatsiooni häiretest tulenevate sündroomide ravi
English: • Little's disease (infantile diplegia spastica) and other encephalopaties accompanied by dystonia
Estonian: • Little'i tõbi (infantiilne spastiline dipleegia) ja muud düstooniaga kulgevate entsefalopaatiad.
English: The CHMP also noted the MAH proposal to conduct a clinical study to collect additional evidence of the efficacy of tolperisone in the proposed restricted low back pain indication, as a post-referral commitment, as well as the related draft study synopsis.
Estonian: Komitee kaalus ka müügiloa hoidja ettepanekut korraldada esildismenetluse järel kliiniline uuring, milles koguda täiendavaid andmeid tolperisooni efektiivsuse kohta väljapakutud piiratud alaseljavalu näidustusel, ja tutvus nimetatud uuringu kokkuvõtva kavaga.
English: In this respect, the CHMP took note of the fact that the marketing authorisation holder of the products for which these indications are approved concluded that the evidence of efficacy is insufficient to balance the risks associated to the product and proposed that the indications be deleted.
Estonian: Inimravimite komitee võtab arvesse ka seda, et nende ravimite müügiloa hoidja, mille korral need näidustused on heaks kiidetud, pidas efektiivsuse andmeid ravimi riskide tasakaalustamiseks ebapiisavaks ja tegi ettepaneku näidustused kustutada.
English: However, efficacy results of the subgroup treated with a daily tolperisone dose of up to 450 mg/day were consistent with the results of the whole ITT population.
Estonian: Selles patsientide alarühmas, kes said tolperisooni kuni 450 mg/d, vastasid efektiivsustulemused siiski kogu ravikavatsusliku populatsiooni tulemustele.
English: The CHMP endorsed a communication i.e. ‘Dear Healthcare Professional Communication (DHPC)' to communicate the outcome of the present review.
Estonian: Inimravimite komitee kinnitas tervishoiutöötajate teatise, milles edastatakse käesoleva läbivaatamise lõpptulemused.
English: • Acute or chronic treatment of pathologically elevated skeletal muscle tone in organic neurological disorders
Estonian: • patoloogiliselt suurenenud skeletilihastoonuse akuutne või krooniline ravi orgaaniliste neuroloogiliste häirete korral;
English: Treatment of pathologically elevated skeletal muscle tone in organic neurological disorders
Estonian: Patoloogiliselt suurenenud skeletilihastoonuse ravi orgaaniliste neuroloogiliste häirete korral
English: The Melka study can only be considered as providing supportive evidence of efficacy in the treatment of spasticity caused by neurological diseases.
Estonian: Melka uuring pakub vaid toetavaid andmeid toimeaine efektiivsuse kohta neuroloogiliste haiguste põhjustatud spastilisuse ravis.
English: Based on the totality of the data available on the safety and the efficacy of tolperisone and having noted the opinions of the BSWP and the SAG, the CHMP confirmed its initial conclusion that the risk of hypersensitivity is more significant than previously identified at the time of the initial marketing authorisation, and that as a consequence the benefits of tolperisone are outweighed by the risks in the indication “treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases” as well as in the proposed restricted indication “short-term treatment of muscle spasms in adult patients with acute non-specific low back pain”.
Estonian: Arvestades kõiki olemasolevaid andmeid tolperisooni ohutuse ja efektiivsuse kohta ning olles tutvunud biostatistika töörühma ja teadusnõuanderühma arvamustega, kinnitas inimravimite komitee oma esialgset järeldust, et ülitundlikkuse risk on suurem, kui oli tuvastatud esmase müügiloa väljaandmise ajal, mistõttu tolperisooni riskid näidustusel „lokomotoorsete haigustega seotud lihaste hüpertoonilisuse ja lihasspasmide ravi” ning ka väljapakutud piiratud näidustusel „lihasspasmide lühiaegne ravi ägedate mittespetsiifiliste alaseljavaludega täiskasvanutel” on suuremad kui selle kasulikkus.
English: However, as hypersensitivity is a characteristic of the active substance rather than of the formulation, the concerns identified with the oral formulations are also relevant for the parenteral formulation.
Estonian: Et aga ülitundlikkus on pigem toimeaine kui ravimvormi omadus, on suukaudsete ravimvormide tuvastatud probleemid asjakohased ka parenteraalsete ravimvormide korral.
English: Taken together, the existing dataset is indicative of a modest effect of tolperisone in the treatment of spasticity caused by neurological disorders.
Estonian: Kokkuvõttes viitab olemasolev andmestik tolperisooni mõõdukale toimele neuroloogiliste häirete põhjustatud spastilisuse ravis.
English: • The revocation of the marketing authorisation for the parenteral formulations of medicinal products referred to in annex I.
Estonian: • tühistada I lisas loetletud ravimite parenteraalsete ravimvormide müügiload.
English: There are a few studies where a parenteral formulation was used.
Estonian: Parenteraalset ravimvormi kasutati vähestes uuringutes.
English: As a result, the CHMP considered that none of the provided pooled analyses could be considered as supportive to demonstrate the efficacy of tolperisone in the “treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases” indication, nor in the proposed restricted indication.
Estonian: Inimravimite komitee järeldas seepärast, et mitte ükski esitatud koondanalüüsidest ei toeta tolperisooni efektiivsust ei näidustusel „lokomotoorsete haigustega seotud lihaste hüpertoonilisuse ja lihasspasmide ravi” ega ka väljapakutud piiratud näidustusel.
English: • Treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases (e.g. spondylosis, spondylarthrosis, cervical and lumbar syndromes, arthrosis of large joints)
Estonian: • lokomotoorsete haigustega (nt spondüloos, spondüloartroos, tservikaalsed ja lumbaarsed sündroomid, suurte liigeste artroosid) seotud lihaste hüpertoonilisuse ja lihasspasmide ravi;
English: Hypersensitivity reactions account for more than half of the spontaneous reports in the originators database, followed by adverse events (AEs) from the SOCs (System Organ Class) Gastrointestinal disorders, General disorders and administration site conditions and Nervous system disorders.
Estonian: Ülitundlikkusreaktsioonid moodustavad enamiku spontaansetest teadetest originaalravimi tootja andmebaasis, millele järgnevad kõrvaltoimed organsüsteemide kaupa: seedetrakti häired, üldised häired ja manustamiskoha reaktsioonid ning närvisüsteemi häired.
English: Little's disease and other encephalopaties accompanied by dystonia
Estonian: Little'i tõbi ja teised düstooniaga kulgevad entsefalopaatiad
English: Rehabilitation after orthopaedic and trauma surgery
Estonian: Ortopeediliste ja traumaoperatsioonide järgne taastusravi
English: • Rehabilitation after orthopaedic and trauma surgery
Estonian: • ortopeediliste ja traumaoperatsioonide järgne taastusravi;
English: The CHMP therefore carried out a new assessment of the available efficacy data in the concerned indication.
Estonian: Inimravimite komitee hindas seepärast näidustuse olemasolevaid ohutusandmeid uuesti.
English: Treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases
Estonian: Lokomotoorsete haigustega seotud lihaste hüpertoonilisuse ja lihasspasmide ravi
English: The Committee concluded that the benefit-risk balance of tolperisone-containing oral formulations is positive under normal conditions of use only in the symptomatic treatment of post-stroke spasticity in adults, subject to the changes to the product information agreed.
Estonian: Komitee järeldas, et tolperisooni sisaldavate suukaudsete ravimvormide kasulikkuse ja riski suhe on positiivne tavapärastes kasutustingimustes ainult insuldijärgse spastilisuse sümptomaatiliseks raviks täiskasvanutel vastavalt ravimiteabe kokkulepitud muudatustele.
English: The Committee, as a consequence, concluded that the benefit-risk balance of tolperisone-containing oral formulations is positive under normal conditions of use only in the symptomatic treatment of post-stroke spasticity in adults, taking into account the changes to the product information agreed.
Estonian: Eelöeldule tuginedes järeldas komitee, et tolperisooni sisaldavate suukaudsete ravimvormide kasulikkuse ja riski suhe on tavapärastes kasutustingimustes positiivne ainult insuldijärgse spastilisuse sümptomaatilises ravis täiskasvanutel, arvestades ravimiteabe kokkulepitud muudatusi.
English: The Committee therefore concluded that the benefit-risk balance of tolperisone-containing oral formulations is positive under normal conditions of use only in the symptomatic treatment of poststroke spasticity in adults, subject to the changes to the product information agreed.
Estonian: Inimravimite komitee järeldas seetõttu, et tolperisooni sisaldavate suukaudsete ravimite kasulikkuse ja riski suhe on tavatingimustel kasutamisel positiivne üksnes insuldijärgse spastilisuse sümptomaatilises ravis täiskasvanutel, kui ravimiteabesse tehakse kokkulepitud muudatused.
English: The SAG stated that it did not consider the results of the 4 pooled analyses to be supportive of the efficacy of tolperisone.
Estonian: Komitee otsustas seepärast, et metaanalüüs ei anna täiendavaid toetavaid andmeid tolperisooni efektiivsuse kohta.
English: EMA/785026/2012
Estonian: EMA/670858/2012 EMEA/H/C/001173
English: It is available as
Estonian: Seda turustatakse
English: The full EPAR for Clopidogrel ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Clopidogrel ratiopharmi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The standard dose of Clopidogrel ratiopharm is one 75 mg tablet once a day.
Estonian: Clopidogrel ratiopharmi tavaannus on üks 75 mg tablett üks kord ööpäevas.
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 Clopidogrel ratiopharm.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Clopidogrel ratiopharm can be started between seven days and six months after
Estonian: Clopidogrel ratiopharmi manustamist tohib alustada 7 päeva kuni 6 kuu jooksul pärast
English: The Committee recommended that Clopidogrel ratiopharm be given marketing authorisation.
Estonian: Komitee soovitas anda Clopidogrel ratiopharmi müügiloa.
English: Clopidogrel ratiopharm can be started between a few days and 35 days after the attack;
Estonian: Clopidogrel ratiopharmi manustamist tohib alustada mõne kuni 35 päeva jooksul pärast infarkti;
English: Because Clopidogrel ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Estonian: Et Clopidogrel ratiopharm on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel ratiopharm.
Estonian: See on ravimi Clopidogrel ratiopharm Euroopa avaliku hindamisaruande kokkuvõte.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel ratiopharm has been shown to have comparable quality and to be bioequivalent to Plavix.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel ratiopharmi võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
English: For more information about treatment with Clopidogrel ratiopharm, read the package leaflet (also part of the EPAR) or contact your
Estonian: Kui vajate Clopidogrel ratiopharmiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This means that Clopidogrel ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Estonian: See tähendab, et Clopidogrel ratiopharm on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
English: Other information about Clopidogrel ratiopharm
Estonian: Muu teave Clopidogrel ratiopharmi kohta
English: Clopidogrel ratiopharm is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Estonian: Clopidogrel ratiopharmi kasutatakse aterotrombootiliste nähtude (trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Plavixi korral, ületab Clopidogrel ratiopharmi kasulikkus sellega kaasnevad riskid.
English: Because Clopidogrel ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Estonian: Et Clopidogrel ratiopharm on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati Clopidogrel ratiopharmi bioekvivalentsust võrdlusravimiga Plavix.
English: Clopidogrel ratiopharm is a medicine that contains the active substance clopidogrel.
Estonian: Clopidogrel ratiopharm on ravim, mis sisaldab toimeainena klopidogreeli.
English: Clopidogrel ratiopharm can be given to the following groups
Estonian: Clopidogrel ratiopharmi tohib kasutada järgmistel patsiendirühmadel:
English: Clopidogrel ratiopharm is a ‘generic medicine'.
Estonian: Clopidogrel ratiopharm on geneeriline ravim.
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Estonian: Veri hüübib teatud vererakkude - trombotsüütide - agregatsiooni tõttu.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel
Estonian: Euroopa Komisjon andis Clopidogrel ratiopharmi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23. septembril 2009.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Estonian: Euroopa avaliku hindamisaruande täistekst võrdlusravimi kohta on samuti Euroopa Ravimiameti
English: Why has Clopidogrel ratiopharm been approved?
Estonian: Miks Clopidogrel ratiopharm heaks kiideti?
English: What is Clopidogrel ratiopharm used for?
Estonian: Milleks Clopidogrel ratiopharmi kasutatakse?
English: How is Clopidogrel ratiopharm used?
Estonian: Kuidas Clopidogrel ratiopharmi kasutatakse?
English: How has Clopidogrel ratiopharm been studied?
Estonian: Kuidas Clopidogrel ratiopharmi uuriti?
English: The active substance in Clopidogrel ratiopharm, clopidogrel, is an inhibitor of platelet aggregation.
Estonian: Clopidogrel ratiopharmi toimeaine klopidogreel on trombotsüütide agregatsiooni (vereliistakute kokkukleepumise) inhibiitor, mis aitab ennetada trombide (soonesiseste verehüüvete) tekkimist.
English: For more information on generic medicines, see the question-and-answer document here.
Estonian: Lisateave geneeriliste ravimite kohta
English: What are the benefits and risks of Clopidogrel ratiopharm?
Estonian: Milles seisneb Clopidogrel ratiopharmi kasulikkus ja mis riskid ravimiga
English: How does Clopidogrel ratiopharm work?
Estonian: Kuidas Clopidogrel ratiopharm toimib?
English: Trevaclyn with food, drink and alcohol
Estonian: Trevaclyn koos toidu, joogi ja alkoholiga
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/458/012
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/458/012
English: • It is important to follow the advice given in section 3 How to take Trevaclyn.
Estonian: • Tähtis on järgida lõigus 3 Kuidas Trevaclyn'i võtta toodud juhiseid.
English: • Take Trevaclyn once a day, in the evening or at bedtime.
Estonian: • Võtke Trevaclyn'i üks kord päevas, õhtul või enne magamaminekut.
English: Other medicines and Trevaclyn
Estonian: Muud ravimid ja Trevaclyn
English: It is not known if Trevaclyn will harm your unborn baby.
Estonian: Ei ole teada, kas Trevaclyn kahjustab veel sündimata last.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Trevaclyn to the woman.
Estonian: Otsuse tegemisel, kas jätkata/lõpetada rinnaga toitmine või jätkata/lõpetada ravi, tuleb arvesse võtta rinnaga toitmisest saadavat kasu lapsele ja ravist saadavat kasu naisele.
English: Your doctor will decide if Trevaclyn is right for you.
Estonian: Arst otsustab, kas Trevaclyn on teile sobiv ravim.
English: Trevaclyn is not recommended in pregnancy unless clearly necessary.
Estonian: Trevaclyn'i ei soovitata raseduse korral, välja arvatud kui see on selgelt vajalik.
English: Trevaclyn is used in addition to diet
Estonian: Trevaclyn'i kasutatakse lisaks dieedile,
English: This condition requires immediate medical attention.
Estonian: Selle seisundi tekkimisel on vajalik kohene arstiabi.
English: • Take Trevaclyn with food.
Estonian: • Võtke Trevaclyn'i koos toiduga.
English: What Trevaclyn is and what it is used for What you need to know before you take Trevaclyn How to take Trevaclyn
Estonian: Mis ravim on Trevaclyn ja milleks seda kasutatakse Mida on vaja teada enne Trevaclyn'i võtmist Kuidas Trevaclyn'i võtta
English: Aluminium/Aluminium blisters: 18 months.
Estonian: Alumiinium/alumiinium blistrid: 18 kuud
English: The name of your medicine is Trevaclyn.
Estonian: Teie ravimi nimetus on Trevaclyn.
English: • Taking aspirin before you take Trevaclyn does not reduce your flushing more than taking Trevaclyn alone.
Estonian: • Aspiriini võtmine enne Tradaptive'i võtmist ei vähenda õhetuse teket rohkem kui ainult Trevaclyn'i võtmine.
English: What Trevaclyn is and what it is used for
Estonian: Mis ravim on Trevaclyn ja milleks seda kasutatakse
English: Cases of overdose have been reported; the maximum dose of Trevaclyn taken was 5,000 mg/100 mg. All patients recovered without sequelae.
Estonian: Kirjeldatud on üleannustamise juhtusid; Trevaclyn'i maksimaalne manustatud annus oli 5000 mg/100 mg. Kõik patsiendid paranesid ilma järelnähtudeta.
English: Therefore, Trevaclyn should not be used in children and adolescents under 18 years of age.
Estonian: Seetõttu ei tohi Trevaclyn'i kasutada lastel ja alla 18-aastastel noorukitel.
English: If Trevaclyn is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Estonian: Kui Trevaclyn jääb manustamata vähem kui seitsmel järjestikusel päeval, võivad patsiendid ravi uuesti alustada viimati kasutatud annusega.
English: Therefore, Trevaclyn should not be used during pregnancy unless clearly necessary.
Estonian: Seetõttu ei tohi Trevaclyn'i kasutada raseduse ajal, kui see ei ole hädavajalik.
English: Patients receiving Trevaclyn concomitantly with acetylsalicylic acid and clopidogrel should be closely monitored as recommended in the Summary of Product Characteristics for those medicinal products and should be told that it might take longer than usual to stop bleeding and that they should report any unusual bleeding (site or duration) to their physician.
Estonian: Patsiente, kes saavad Trevaclyn'i samaaegselt atsetüülsalitsüülhappe ja klopidogreeliga, tuleb põhjalikult jälgida, nagu on soovitatud nende toodete ravimi omaduste kokkuvõtetes ja neid tuleb teavitada, et veritsuse peatamine võib tavalisest rohkem aega võtta ja nad peavad teatama igast ebatavalisest veritsusest (selle kohast või kestusest) oma arstile.
English: Trevaclyn should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease.
Estonian: Trevaclyn'i tuleb ettevaatusega kasutada patsientidel, kes kasutavad märkimisväärsetes kogustes alkoholi ja/või kellel on anamneesis põetud maksahaigus.