FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Harvoni can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Harvoni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Harvoni and what is it used for?
Estonian: Mis on Harvoni ja milleks seda kasutatakse?
English: The European Medicines Agency decided that Harvoni's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Euroopa Ravimiamet (EMA) otsustas, et Harvoni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: It must also not be used together with the following medicines which can reduce the effects of Harvoni:
Estonian: Harvonit ei tohi kasutada ka koos järgmiste ravimitega, sest need võivad vähendada Harvoni toimet:
English: Why is Harvoni approved?
Estonian: Miks Harvoni heaks kiideti?
English: Harvoni ledipasvir / sofosbuvir
Estonian: Harvoni ledipasviir/sofosbuviir
English: The addition of ribavirin was not needed for most patients.
Estonian: Enamik patsiente ei vajanud ribaviriini lisamist.
English: • rifampicin and rifabutin (antibiotics);
Estonian: • rifampitsiin, rifabutiin (antibiootikumid);
English: Harvoni must not be used together with the cholesterol medicine rosuvastatin.
Estonian: Harvonit ei tohi kasutada koos kolesteroolivastase ravimi rosuvastatiiniga.
English: The most common side effects with Harvoni (which may affect more than 1 in 10 people) are tiredness and headache.
Estonian: Harvoni kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on väsimus ja peavalu.
English: It is not intended to provide practical advice on how to use Harvoni.
Estonian: Hindamisaruandes ei anta Harvoni kasutamise praktilisi nõuandeid.
English: Sofosbuvir has been authorised as Sovaldi since January 2014.
Estonian: Sofosbuviiril on alates 2014. aasta jaanuarist müügiluba ravimina Sovaldi.
English: Harvoni is available as tablets which contain 90 mg ledipasvir and 400 mg sofosbuvir.
Estonian: Harvonit turustatakse tablettidena, mis sisaldavad 90 mg ledipasviiri ja 400 mg sofosbuviiri.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Harvoni have also been included in the summary of product characteristics and the package leaflet.
Estonian: Harvoni ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment.
Estonian: Kõigis kolmes uuringus oli efektiivsuse põhinäitaja nende patsientide arv, kellel ei leitud vereanalüüsiga 12 nädalat pärast ravi lõppu C-hepatiidi viirust.
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Estonian: Uuringus võetakse arvesse andmeid, mille kohaselt võib nende ravimitega ravitud patsientidel, kellel on varem olnud maksavähk, esineda vähi varase taastumise risk.
English: How does Harvoni work?
Estonian: Kuidas Harvoni toimib?
English: The company that markets Harvoni will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Harvoni.
Estonian: Harvoni turustaja korraldab uuringu patsientidel, kellel on varem olnud maksavähk, et hinnata maksavähi taastumise riski pärast ravi otsese toimega viirusvastaste ravimitega, näiteks Harvoniga.
English: Supportive data showed that Harvoni in combination with ribavirin would be of benefit for some patients with genotype 3 virus.
Estonian: Toetavate andmete järgi võib koos ribaviriiniga manustatav Harvoni olla kasulik osale 3. genotüübiga patsientidest.
English: In these studies, patients were given Harvoni, with or without ribavirin, for 8, 12 or 24 weeks, depending on the characteristics of the patients.
Estonian: Nendes uuringutes kasutasid eri uuringurühmade patsiendid Harvonit kas koos ribaviriiniga või ilma 8, 12 või 24 nädalat.
English: This is a summary of the European public assessment report (EPAR) for Harvoni.
Estonian: See on ravimi Harvoni Euroopa avaliku hindamisaruande kokkuvõte.
English: What are the risks associated with Harvoni?
Estonian: Mis riskid Harvoniga kaasnevad?
English: Other information about Harvoni
Estonian: Muu teave Harvoni kohta
English: By blocking these proteins, Harvoni stops the hepatitis C virus from multiplying and infecting new cells.
Estonian: Neid valke blokeerides peatab Harvoni C-hepatiidi viiruse paljunemise ja uute rakkude nakatumise.
English: • carbamazepine, phenobarbital and phenytoin (medicines for epilepsy);
Estonian: • karbamasepiin, fenobarbitaal, fenütoiin (epilepsiaravimid);
English: Sofosbuvir blocks the action of a protein called ‘NS5B RNA-dependent RNA polymerase', while ledipasvir targets a protein called ‘NS5A'.
Estonian: Sofosbuviir blokeerib valgu NS5B RNA-st sõltuva RNA polümeraasi toime ning ledipasviir blokeerib valgu NS5A.
English: Harvoni has been investigated in three main studies involving a total of around 2,000 adult patients infected with hepatitis C of genotype 1 whose liver function was normal.
Estonian: Harvonit uuriti kolmes põhiuuringus, milles osales kokku ligikaudu 2000 C-hepatiidi 1. genotüübi infektsiooniga (nakkusega) täiskasvanud patsienti, kelle maksatalitlus oli normaalne.
English: Harvoni can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Estonian: Harvoni on retseptiravim ning ravi sellega peab alustama ja jälgima kroonilise C-hepatiidi ravis kogenud arst.
English: For practical information about using Harvoni, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Harvoni kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Results of the studies also showed that patients who have compensated cirrhosis (scarring of the liver but the liver continues to work adequately) had a higher likelihood of clearing the virus when treatment was extended to 24 weeks.
Estonian: Samuti selgus uuringutes, et kompenseeritud maksatsirroosiga (maks sidekoestunud, kuid maksatalitlus oli normaalne) patsientidel kadus viirus organismist suurema tõenäosusega, kui ravi pikendati 24 nädalani.
English: The duration of treatment with Harvoni and whether it is used alone or in combination with another medicine called ribavirin depends on the genotype of the virus and the nature of the liver problems patients have, for example if they have liver cirrhosis (scarring) or their liver is not working properly.
Estonian: Harvoni-ravi kestus ja kasutamine ainuravimina või kombinatsioonis teise ravimiga (ribaviriiniga) sõltub viiruse genotüübist ja patsiendi maksaprobleemide olemusest, näiteks sellest, kas esineb maksatsirroos (maksa sidekoestumine) või muid maksaprobleeme.
English: For the full list of all side effects and restrictions with Harvoni, see the package leaflet.
Estonian: Harvoni kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The active substances in Harvoni, ledipasvir and sofosbuvir, block two proteins essential for the hepatitis C virus to multiply.
Estonian: Harvoni toimeained ledipasviir ja sofosbuviir blokeerivad C-hepatiidi viiruse paljunemiseks vajaliku kahe valgu toime.
English: What benefits of Harvoni have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Harvoni kasulikkus?
English: Harvoni contains the active substances ledipasvir and sofosbuvir.
Estonian: Harvoni sisaldab toimeainetena ledipasviiri ja sofosbuviiri.
English: Harvoni, with or without ribavirin, is highly beneficial for many patients with hepatitis C virus, including those who have had a liver transplant and/or who have compensated or decompensated cirrhosis.
Estonian: EMA leidis, et ravi Harvoniga, kas koos ribaviriiniga või ilma, on väga kasulik paljudele C-hepatiidi viirusega patsientidele, sealhulgas siiratud maksaga ja/või kompenseeritud või kompenseerimata maksatsirroosiga patsientidele.
English: For more information about treatment with Harvoni, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Harvoniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Benefit of Harvoni was also shown for patients with genotype 4, 5 and 6, for those with decompensated cirrhosis (when the liver does not work adequately) and for those who had received a liver transplant.
Estonian: Tõendati ka Harvoni kasulikkus patsientidele, kellel oli 4., 5. või 6. genotüübi viirus, kompenseerimata maksatsirroos (puudulik maksatalitlus) või kellele oli tehtud maksasiirdamine.
English: Harvoni is an antiviral medicine used to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Estonian: Harvoni on viirusvastane ravim, mida kasutatakse kroonilise (pikaajalise) C-hepatiidi (C-hepatiidi viiruse põhjustatud nakkuslik maksahaigus) raviks täiskasvanutel ja vähemalt 12-aastastel lastel.
English: • St John's wort (a herbal preparation used to treat depression and anxiety).
Estonian: • naistepuna (taimne depressiooni- ja ärevuseravim).
English: Patients whose infection was resistant to other antiviral medicines could also benefit from extending treatment to 24 weeks.
Estonian: Ravi pikendamine 24 nädalani oli kasulik ka patsientidele, kelle infektsioon oli muude viirusvastaste ravimite suhtes resistentne.
English: Harvoni is also being investigated in a study in children aged 3 to 18 years infected with hepatitis C. Results from 100 patients aged 12 to 18 years (all of whom had hepatitis C genotype 1) showed that 98% of them had no sign of the virus 12 weeks after the end of treatment.
Estonian: 100 patsiendist, kelle vanus oli 12-18 aastat ja kel kõigil oli 1. genotüübi C-hepatiit, oli 98% 12 nädalat pärast ravi lõppu viirusevaba.
English: There are several varieties (called genotypes) of hepatitis C virus and Harvoni is recommended for use in patients with virus of genotypes 1, 4, 5 and 6 and for some patients with genotype 3.
Estonian: Harvonit soovitatakse kasutada patsientidel, kellel on 1., 4., 5. või 6. genotüübi viirus, samuti teatud patsientidel, kellel on 3. genotüübi viirus.
English: Around 94% to up to 99% of patients given Harvoni alone had no sign of the virus 12 weeks after the end of treatment.
Estonian: Patsiente, kellel 12 nädalat pärast ravi lõppu analüüs viirust ei tuvastanud, oli ainuravimina manustatud Harvoni uuringurühmades 94-99%.
English: How is Harvoni used?
Estonian: Kuidas Harvonit kasutatakse?
English: 0.5 ml (20 mg/ml)
Estonian: Süstel (klaas) 0,5 ml (20 mg/ml) 1 süstel
English: 1 pre-filled syringe
Estonian: 10 süstlit
English: It was to be available as white tablets.
Estonian: Seda kavatseti turustada valgete tablettidena.
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Estonian: Seetõttu leidis inimravimite komitee, et nagu ka Bondronati puhul, ületab ravimi kasulikkus sellega kaasnevad riskid.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Estonian: Luukoe hävimise vähenemine muudab luud murdudele vastupidavamaks ning sel viisil saab ennetada luumurdude tekkimist rinnavähiga patsientidel, kellel on luumetastaasid.
English: On 21 July 2011, Hexal AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibandronic Acid Hexal, for the prevention of skeletal events in patients with breast cancer and bone metastases.
Estonian: 21. juulil 2011 teatas Hexal AG ametlikult inimravimite komiteele oma soovist võtta tagasi rinnavähi ja luumetastaasidega patsientide luukahjustuste ennetamisel kasutada kavatsetud ravimi Ibandronic Acid Hexal müügiloa taotlus.
English: Ibandronic Acid Hexal was to be used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Estonian: Ravimit Ibandronic Acid Hexal kavatseti kasutada luukahjustuste (luumurrud või ravi vajavad luutüsistused) ennetamiseks rinnavähi ja luumetastaasidega (kui vähk on levinud luudesse) patsientidel.
English: Because Ibandronic Acid Hexal was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is ‘bioequivalent' to the reference medicine.
Estonian: Et Ibandronic Acid Hexal töötati välja geneerilise ravimina, esitas ettevõte nende uuringute tulemused, milles uuriti ravimi bioekvivalentsust võrdlusravimiga.
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Hexal had been shown to have comparable quality and to be bioequivalent to Bondronat.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Ibandronic Acid Hexal võrdväärne kvaliteet ja bioekvivalentsus ravimiga Bondronat.
English: This means that Ibandronic Acid Hexal was intended to be similar to a ‘reference medicine' already authorised in the European Union called Bondronat.
Estonian: See tähendab, et Ibandronic Acid Hexal pidi olema sarnane võrdlusravimiga Bondronat, millel juba on Euroopa Liidus müügiluba.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Estonian: Toimeaine peatab osteoklastide ehk luukoe lagundamisel osalevate organismirakkude tegevuse.
English: What is Ibandronic Acid Hexal?
Estonian: Mis on Ibandronic Acid Hexal?
English: The Committee recommended that Ibandronic Acid Hexal be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi Ibandronic Acid Hexal müügiloa.
English: The active substance in Ibandronic Acid Hexal and Bondronat, ibandronic acid, is a bisphosphonate.
Estonian: Ravimite Ibandronic Acid Hexal ja Bondronat toimeaine ibandroonhape on bisfosfonaat.
English: Ibandronic Acid Hexal is a medicine that contains the active substance ibandronic acid.
Estonian: Ibandronic Acid Hexal on ravim, mis sisaldab toimeainena ibandroonhapet.
English: Ibandronic Acid Hexal was developed as a ‘generic medicine'.
Estonian: Ibandronic Acid Hexal töötati välja geneerilise ravimina.
English: Ibandronic Acid Hexal is expected to work in the same way as the reference medicine, Bondronat.
Estonian: Ravimi Ibandronic Acid Hexal eeldatav toime on samasugune nagu võrdlusravimil Bondronat.
English: EMA/685524/2011
Estonian: Müügiloa taotluse tagasivõtmise teave Ibandronic Acid Hexal (ibandroonhape) EMA/773581/2011
English: How is Ibandronic Acid Hexal expected to work?
Estonian: Milline on ravimi Ibandronic Acid Hexal eeldatav toime?
English: What was Ibandronic Acid Hexal expected to be used for?
Estonian: Milleks kavatseti ravimit Ibandronic Acid Hexal kasutada?
English: National Competent Authorities of Member States or reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Estonian: Liikmesriikide pädevad asutused või viiteliikmesriigid tagavad vajaduse korral, et müügiloa hoidjad täidavad järgmised tingimused.
English: As the maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use), the MAHs should provide a detailed plan including precise short timelines on the adaptation of the lower pack size (25g) and the withdrawal of the 35g and 50g pack sizes, in all EU member states where they are currently authorised.
Estonian: Kuna 0,01 massi% östradiooli sisaldavate paikseks kasutuseks mõeldud ravimite ravikuuri maksimaalne kestus on 4 nädalat (mitte korduv kasutus), peavad müügiloa hoidjad esitama üksikasjaliku plaani, mis hõlmab täpseid lühikesi tähtaegu väiksemate pakendite (25 g) kasutuselevõtmise kohta ning 35 g ja 50 g pakendite turult kõrvaldamist kõigis Euroopa Liidu liikmesriikides, kus ravimil on praegu müügiluba.
English: The maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use).
Estonian: 0,01 massi% östradiooli sisaldavate paikseks kasutuseks mõeldud ravimite ravikuuri maksimaalne kestus on 4 nädalat (mitte korduv kasutus).
English: Therefore pack sizes of 100g should be withdrawn from all EU member states where they are currently authorised.
Estonian: Seega tuleb kõigis Euroopa Liidu liikmesriikides, kus ravimil on praegu müügiluba, 100 g pakendid turult kõrvaldada.
English: Strength Pharmaceutical form
Estonian: EL number Nimetus Tugevus Ravimvorm Loomaliigid Manustamisviis Pakend
English: Oral use blister (PVC/alu)
Estonian: Blisterpakend (PVC/alumiinium)
English: 250 mg Capsule, hard
Estonian: 250 mg Kõvakapsel
English: EU/1/16/1110/001 Chenodeoxycholic acid Leadiant
Estonian: EU/1/16/1110/001
English: capsules
Estonian: Suukaudne
English: EU/1/04/289/001
Estonian: EU/1/04/289/001 Angiox
English: 250 mg Powder for concentrate for solution for
Estonian: 250 mg Pulber süste- või infusioonilahuse
English: Intravenous use Vial (glass)
Estonian: Viaal (klaas)
English: Angiox
Estonian: Intravenoosne
English: Route of administration Packaging Package size
Estonian: Pakendi suurus
English: • Try to take it at the same times each day.
Estonian: ● Proovige seda võtta iga päev samal ajal.
English: • The other ingredients are:
Estonian: ● Teised koostisosad on:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 April 2014
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 23 aprill 2014
English: More information is given below in "Other medicines and Vokanamet".
Estonian: Rohkem teavet saate allpool asuvast lõigust: „Muud ravimid ja Vokanamet”.
English: • The dose of Vokanamet is one tablet twice a day.
Estonian: ● Vokanameti annus on üks tablett kaks korda päevas.
English: • If you forget to take a dose, take it as soon as you remember.
Estonian: ● Kui te unustate annuse võtta, tehke seda niipea, kui see teile meenub.
English: This happens more often in people with kidney problems.
Estonian: See on sagedasem neeruprobleemidega inimestel.
English: • It is best to take your tablet with a meal.
Estonian: ● Parim on võtta tablett koos toiduga.
English: Common (may affect up to 1 in 10 people)
Estonian: Sage: (võivad esineda kuni 1 inimesel 10st)
English: • if you drink alcohol to excess (either every day or from time to time)
Estonian: ● kui te tarvitate liigselt alkoholi (kas igapäevaselt või aeg-ajalt);
English: • if you have type 1 diabetes (your body does not produce any insulin).
Estonian: ● kui teil on 1. tüüpi suhkurtõbi (teie keha ei tooda üldse insuliini).
English: • changes in urination (including urinating more frequently or in larger amounts, urgent need to urinate, need to urinate at night)
Estonian: ● muutunud urineerimine (sealhulgas sagedamini või suuremas koguses urineerimine, äkiline vajadus urineerida, vajadus urineerida öösel);
English: • Swallow the tablet whole with at least a half glass of water.
Estonian: ● Neelake tablett alla tervelt koos poole klaasi veega.
English: • medicines that contain alcohol.
Estonian: ● alkoholi sisaldavad ravimid.
English: • if you have a severe infection
Estonian: ● kui teil on raske infektsioon;
English: CrCl < 60 mL/min), (see sections 4.2 and 4.4);
Estonian: CrCl < 60 ml/min), (vt lõigud 4.2 ja 4.4);
English: • if you have or have recently had heart failure.
Estonian: ● kui teil on või on hiljuti olnud südamepuudulikkus.
English: Operations and X-rays Tell your doctor you are taking Vokanamet if you are going to have:
Estonian: Operatsioonid ja röntgenikiirgus Teavitage arsti, et te tarvitate Vokanameti, kui teile kavatsetakse teha:
English: See section “Look out for side effects” and section 4.
Estonian: Vt lõik „Olge tähelepanelik kõrvaltoimete suhtes” ja lõik 4.
English: If you take more Vokanamet than you should If you take more of this medicine than you should, talk to a doctor straight away.
Estonian: Kui te võtate Vokanameti rohkem kui ette nähtud Kui te võtate seda ravimit ettenähtust rohkem, rääkige sellest kohe arstile.
English: Diagnosis
Estonian: Diagnoosimine
English: You may need to stop taking Vokanamet for a couple of days before and after the operation.
Estonian: Võimalik, et te peate katkestama Vokanameti tarvitamise mõni päev enne ja pärast operatsiooni;
English: See section “Operations and X-rays”.
Estonian: „Operatsioonid ja röntgenikiirgus”;
English: Lactic acidosis may also be caused by excessive alcohol intake or prolonged fasting.
Estonian: Laktatsidoosi võib põhjustada ka liigne alkoholitarbimine või pikaajaline paastumine.
English: • if you are on medicines to lower your blood pressure (anti-hypertensives) or have ever had low blood pressure (hypotension).
Estonian: ● kui te saate vererõhku langetavaid (hüpertensioonivastaseid) ravimeid ja teil on kunagi esinenud madal vererõhk (hüpotensioon).
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing).
Estonian: ● raske allergiline reaktsioon (võib hõlmata näo, huulte, suu, keele või kurgu turset, mis võib põhjustada hingamis- või neelamisraskust).
English: • digoxin or digitoxin (medicines used for certain heart problems).
Estonian: ● digoksiin või digitoksiin (ravim, mida kasutatakse teatud südameprobleemide raviks).
English: Before taking Vokanamet again, your kidney function should be tested.
Estonian: Enne kui te alustate uuesti Vokanameti tarvitamist, peab uurima teie neerutalitlust.
English: The pack sizes are cartons of 20, 60, and 180 tablets (3 bottles containing 60 tablets each).
Estonian: Pakendi suurused: karbid, mis sisaldavad 20, 60 ja 180 tabletiga (3 pudelit, milles igas on 60 tabletti).
English: Avoid consumption of large amounts of alcohol, or medicines containing alcohol, when taking this medicine.
Estonian: Vältige antud ravimi kasutamise ajal suurte alkoholikoguste või alkoholi sisaldavate ravimite tarbimist.
English: • if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row
Estonian: ● kui te olete oma organismist kaotanud palju vedelikku (dehüdreeritud), nt pikaajalise või raske kõhulahtisuse tõttu või olete mitu korda järjest oksendanud;
English: If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient should be hospitalised immediately (see section 4.9).
Estonian: Metaboolse atsidoosi kahtluse korral peab kohe katkestama käimasoleva ravi ja patsiendi hospitaliseerima (vt lõik 4.9).
English: This is more likely if you are already fasting, have malnutrition, or liver problems.
Estonian: Risk on suurem, kui te olete juba paastunud, olete alatoitunud või kui teil on maksaprobleemid.
English: • Your doctor will prescribe the strength that is right for you.
Estonian: ● Arst kirjutab teile välja sobiva tugevusega ravimi.