FrancophonIA/ELRC3.0 huggingface dataset:
English: For 84 days the woman takes the tablets containing levonorgestrel and ethinylestradiol and then for the remaining 7 days she takes tablets containing only ethinylestradiol.
Estonian: 84 päeva manustatakse levonorgestreeli ja etinüülöstradiooli sisaldavaid tablette ning ülejäänud 7 päeva ainult etinüülöstradiooli sisaldavaid tablette.
English: Teva Pharma submitted an application to the French medicines agency (ANSM) for Seasonique to be authorised in a decentralised procedure.
Estonian: Teva Pharma esitas Prantsusmaa ravimiametile (ANSM) ravimi Seasonique detsentraliseeritud menetluseha müügiloa taotluse.
English: On 26 June 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the oral contraceptive Seasonique.
Estonian: Euroopa Ravimiamet (EMA) lõpetas 26. juunil 2014 vahekohtumenetluse, mis käsitles Euroopa Liidu liikmesriikide erimeelsusi seoses suukaudse kontratseptiivi Seasonique müügiloa andmisega.
English: The Committee therefore concluded that the benefits of Seasonique outweigh its risks and recommended that marketing authorisation be granted in the reference and concerned Member States.
Estonian: Inimravimite komitee järeldas seega, et ravimi Seasonique kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda viiteliikmesriigis ja asjaomastes liikmesriikides ravimi müügiloa.
English: Combined hormonal contraceptives work by stopping the release of eggs from the ovaries and by causing changes in the cervix and the lining of the womb that make it harder for a sperm to reach an egg and for a fertilised egg to implant in the womb.
Estonian: Kombineeritud hormoonkontratseptiivid peatavad munarakkude vabanemise munasarjadest ning tekitavad emakakaela ja emaka limaskesta muutusi, mistõttu seemnerakul on raskem jõuda munarakuni ja viljastatud munarakul raskem emakasse kinnituda.
English: The grounds for the referral related to concerns raised by the German medicines agency about the effectiveness of Seasonique in preventing pregnancy and the irregular bleeding experienced by women taking the contraceptive.
Estonian: Esildise alus on seotud Saksamaa ravimiameti tõstatatud küsimustega, kas Seasonique on seda võtvatel naistel raseduse ja korrapäratu veritsuse ennetamisel efektiivne.
English: The Committee also noted that the irregular bleeding reported with Seasonique has not made women less likely to keep to their treatment and adequate information about the risk of irregular bleeding is included in the package leaflet.
Estonian: Samuti märkis komitee, et ravimi Seasonique kasutamisel teatatud korrapäratu veritsuse tõttu ei ole patsiendid ravi rohkem katkestanud ning korrapäratu veritsuse riski piisav teave on pakendi infolehel.
English: Women taking Seasonique will have longer intervals between withdrawal bleeding but may experience more irregular bleeding.
Estonian: Ravimit Seasonique võtvatel naistel on ärajätuveritsuse sagedus väiksem, kuid veritsus võib neil olla korrapäratum.
English: The full EPAR for Ribavirin Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Rebetol and do not need to be repeated for Ribavirin Teva Pharma B.V.
Estonian: Võrdlusravimiga Rebetol on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Ribavirin Teva Pharma B.V.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ribavirin Teva Pharma B.V. have been included in the summary of product characteristics and the package leaflet.
Estonian: ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The dose and duration of treatment is based on the patient's body weight and on the medicine used in combination with it.
Estonian: Annus ja ravi kestus sõltuvad patsiendi kehamassist ja samal ajal kasutatavast ravimist.
English: Ribavirin Teva Pharma B.V. must never be used on its own but only together with interferon alfa 2b (another medicine used in hepatitis).
Estonian: ei tohi kunagi kasutada ainsa ravimina, vaid ainult koos alfa-2b-interferooniga (samuti hepatiidiravim).
English: Ribavirin Teva Pharma B.V. can also be used in adults (aged 18 years and older) whose disease has come back after previous treatment.
Estonian: võib kasutada ka täiskasvanutel (vähemalt 18-aastastel), kelle haigus on pärast varasemat ravi taastunud.
English: Ribavirin Teva Pharma B.V. is taken with food each day in two divided doses (morning and evening).
Estonian: võetakse iga päev koos toiduga, jagades annuse kahte ossa (hommikune ja õhtune annus).
English: Because Ribavirin Teva Pharma B.V. 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: on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Ribavirin Teva Pharma B.V. available as tablets (200 and 400 mg).
Estonian: Ravimit turustatakse tablettidena (200 ja 400 mg).
English: Ribavirin Teva Pharma B.V. is a medicine used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Estonian: kasutatakse kroonilise (pikaajalise) C-hepatiidi (C-hepatiidi viiruse nakkusest põhjustatud maksahaigus) raviks vähemalt 3-aastastel patsientidel.
English: As for every medicine, the company provided studies on the quality of Ribavirin Teva Pharma B.V.
Estonian: Nagu iga ravimi korral, esitas ettevõte uuringud ravimi Ribavirin Teva Pharma B.V.
English: For more information about treatment with Ribavirin Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: ravi kohta lisateavet, lugege palun 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, Ribavirin Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Rebetol.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Ribavirin Teva Pharma B.V.
English: This means that Ribavirin Teva Pharma B.V. contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
Estonian: sisaldab sama toimeainet ja toimib samal viisil kui võrdlusravim Rebetol, millel juba on Euroopa Liidus müügiluba.
English: Ribavirin Teva Pharma B.V. is used in patients who have not been treated before for all types of hepatitis C except for genotype 1, as long as the liver is still working normally and hepatitis C virus can be found in the blood.
Estonian: Ravimit kasutatakse varem ravimata C-hepatiidiga (v.a 1. genotüübiga) patsientide raviks, kelle maks veel toimib ja kelle veres on C-hepatiidi viirust.
English: For practical information about using Ribavirin Teva Pharma B.V., patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: What measures are being taken to ensure the safe and effective use of Ribavirin Teva Pharma B.V.?
Estonian: Mis meetmed võetakse, et tagada Ribavirin Teva Pharma B.V.
English: Ribavirin Teva Pharma B.V.is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Estonian: häirib viiruste püsimiseks ja paljunemiseks vajaliku viiruse-DNA ja -RNA teket või toimet.
English: The active substance in Ribavirin Teva Pharma B.V., ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Estonian: toimeaine ribaviriin on nukleosiidianaloogide klassi kuuluv viiruseravim.
English: This is a summary of the European public assessment report (EPAR) for Ribavirin Teva Pharma B.V.
Estonian: Euroopa avaliku hindamisaruande täistekst Ribavirin Teva Pharma B.V.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva Pharma B.V. on 1 July 2009.
Estonian: müügiloa, mis kehtib kogu Euroopa Liidus, 1. juulil
English: Ribavirin Teva Pharma B.V. on its own has no effect on eliminating the hepatitis C virus from the body.
Estonian: ainsa ravimina ei kõrvalda C-hepatiidi viirust organismist.
English: Other information about Ribavirin Teva Pharma B.V.
Estonian: Muu teave Ribavirin Teva Pharma B.V.
English: Why is Ribavirin Teva Pharma B.V. approved?
Estonian: Miks Ribavirin Teva Pharma B.V.
English: Therefore, the CHMP's view was that, as for Rebetol, the benefits outweigh the identified risks.
Estonian: kasulikkus sellega kaasnevad riskid.
English: How does Ribavirin Teva Pharma B.V. work?
Estonian: Kuidas Ribavirin Teva Pharma B.V.
English: The Committee recommended that Ribavirin Teva Pharma B.V. be approved for use in the EU.
Estonian: Komitee soovitas Ribavirin Teva Pharma B.V.
English: How is Ribavirin Teva Pharma B.V. used?
Estonian: Mis on Ribavirin Teva Pharma B.V.
English: EU/1/15/1033/001 Kanuma
Estonian: EU/1/15/1033/001
English: Intravenous use vial (glass)
Estonian: Intravenoosne Viaal (klaasist)
English: It may also cause damage to your unborn baby.
Estonian: Samuti võib see kahjustada teie sündimata last.
English: County Cork Ireland
Estonian: County Cork Iirimaa
English: The following convention has been used for classification of frequency:
Estonian: Esinemissageduse klassifitseerimiseks on kasutatud järgmist konventsiooni:
English: Avda de la Industria, 30
Estonian: Avda de la Industria, 30 Alcobendas
English: The safety and efficacy of Cyramza in children and adolescents (<18 years) has not been established.
Estonian: Cyramza ohutus ja efektiivsus lastel ja noorukitel (<18 aastased) ei ole tõestatud.
English: - have high blood pressure.
Estonian: teil on kõrge vererõhk.
English: These and other factors investigated had < 20 % effect on ramucirumab disposition.
Estonian: Nendel ja teistel uuritud teguritel oli < 20% mõju ramutsirumabi dispositsioonile.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Estonian: TEISED ERIHOIATUSED (VAJADUSEL) Mitte loksutada.
English: Infection (sepsis) may be severe and could lead to death.
Estonian: Infektsioon (sepsis) võib olla raske ja lõppeda surmaga.
English: If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you can't use these medicines.
Estonian: Kui te ei ole milleski kindel, küsige palun oma arsti, apteekri või meditsiniiõe käest, kas on mingeid põhjusi, miks te neid ravimeid ei tohiks kasutada.
English: Alcobendas 28108 Madrid Spain
Estonian: 28108 Madriid Hispaania
English: A limited number of non-Caucasian, especially Black patients (2.6%) were included.
Estonian: Kaasati piiratud arv mitteheledanahalisi, eriti mustanahalisi patsiente (2,6%).
English: Lilly France Fegersheim 2 rue du Colonel Lilly 67640 Fegersheim France
Estonian: Lilly France Fegersheim 2 rue du Colonel Lilly 67640 Fegersheim Prantsusmaa
English: There are very limited efficacy and safety data available in these patients.
Estonian: Nendelt patsientidelt saadud efektiivsus- ja ohutusandmeid on väga piiratud hulgal.
English: ADRs are listed below by MedDRA body system organ class.
Estonian: Kõrvaltoimed on allpool loetletud MedDRA organsüsteemi klasside järgi.
English: Other medicines and Cyramza
Estonian: Muud ravimid ja Cyramza
English: It is recommended that treatment be continued until disease progression or until unacceptable toxicity has occurred.
Estonian: On soovitatav, et ravi jätkatakse kuni haigus progresseerub või kuni ilmneb vastuvõetamatu toksilisus.
English: The number of infusions you will receive depends on how you are responding to treatment.
Estonian: Manustatavate infusioonide arv sõltub sellest, kuidas te ravile reageerite.
English: This cancer treatment will be given to you by a doctor or nurse.
Estonian: Seda vähiravimit manustab teile arst või meditsiiniõde.
English: Date of first authorisation: 19 December 2014 Date of latest renewal: 26 September 2019
Estonian: Müügiloa viimase uuendamise kuupäev: 26. september 2019
English: Also tell your doctor if you are taking any medicines which may increase the risk of bleeding or which affect blood clotting ability.
Estonian: Samuti öelge oma arstile, kui te võtate mingeid ravimeid, mis võivad suurendada veritsusohtu või mis mõjutavad vere hüübimisvõimet.
English: No dose reductions are recommended.
Estonian: Annust ei soovitata vähendada.
English: Cyramza should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Estonian: Cyramza't ei tohi manustada alla 18-aastastele patsientidele, kuna puudub info, kuidas see ravim antud vanusegrupil toimib.
English: Proteinuriaa,f
Estonian: Proteinuuriaa,f
English: In such cases, your doctor will perform regular blood tests to monitor the risk of bleeding.
Estonian: Sellistel juhtudel teeb teie arst teile korrapäraselt vereanalüüse, et kontrollida veritsuse ohtu.
English: Overall survival, months
Estonian: Üldine elulemus, kuud
English: 5-FU bolus
Estonian: 5-FU boolus
English: To achieve the required infusion duration of approximately 60 minutes, the maximum infusion rate of 25 mg/minute should not be exceeded, instead the infusion duration should be increased.
Estonian: Vajaliku, ligikaudu 60-minutilise infusioonikiiruse tagamiseks, ei tohi ületada maksimaalset infusioonikiirust 25 mg/minutis, selle asemel võib infusiooni aega pikendada.
English: In most cases hypertension was managed using standard antihypertensive treatment.
Estonian: Enamusel juhtudel kontrolliti hüpertensiooni tavapärase kõrgvererõhuvastase raviga.
English: No dose reductions are recommended (see sections 4.4 and 5.1).
Estonian: Annust ei soovitata vähendada (vt lõigud 4.4 ja 5.1).
English: NCI CTCAE grade
Estonian: NCI CTCAE aste
English: <1.5 x upper limit of normal value (ULN)
Estonian: <1,5 x normi ülempiirist (ULN)
English: - have severe kidney problems.
Estonian: teil on tõsised probleemid neerudega.
English: Justification for not including Braille accepted
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Põhjendus Braille mitte lisamiseks aktsepteeritav
English: You should not receive Cyramza for at least 4 weeks before you undergo planned surgery and your doctor will decide when to re-start treatment.
Estonian: Te ei tohi saada Cyramza't vähemalt 4 nädalat enne plaanilisele operatsioonile minekut ja teie arst otsustab, millal ravi uuesti alustada.
English: The most frequent component of FOLFIRI to be discontinued was the 5-FU bolus.
Estonian: Kõige sagedamini ärajäetav FOLFIRI komponent oli 5-FU boolus.
English: Papendorpseweg 83 3528 BJ Utrecht
Estonian: Papendorpseweg 83 3528 BJ Utrecht Holland
English: - Elderly people with lung cancer: Your doctor will carefully evaluate the most appropriate treatment for you.
Estonian: - Eakad kopsuvähiga patsiendid: Teie arst hindab hoolega Teie jaoks kõige sobivamat ravi.
English: Median OS in patients who did not experience neutropenia was 10.7 months in both arms.
Estonian: Üldise elulemuse mediaan patsientidel, kel neutropeeniat ei esinenud, oli 10,7 kuud mõlemas ravigrupis.
English: - Fever or infection: You may develop a temperature of 38 ºC or greater during treatment (since you might have fewer white blood cells than normal which is very common).
Estonian: - Infektsioon või palavik: Ravi ajal võib teil tekkida palavik 38 °C või üle selle (sest teil võib olla vähem vere valgeliblesid kui normaalselt ja seda esineb väga sageli).
English: Progression free survival, months
Estonian: Progressioonivaba elulemus, kuud
English: For single use only.
Estonian: Ühekordseks manustamiseks.
English: - are going to have planned surgery, if you had recent surgery or if you have poor wound healing after surgery.
Estonian: te lähete plaanilisele operatsioonile, kui teil on hiljuti olnud operatsioon või kui teil on operatsioonijärgselt halvasti paranev haav.
English: Consider use of colonystimulating factor prior to next cycle.
Estonian: Kaaluge käärsoolt stimuleeriva faktori kasutamist enne järgmist tsüklit.
English: The majority of patients (76%) had experienced disease progression within 6 months from the start of first-line therapy.
Estonian: Enamusel patsientidest (76%) oli haigus progresseerunud 6 kuu jooksul alates esmavaliku ravi algusest.
English: From a microbiological point of view, the product should be used immediately.
Estonian: Mikrobioloogilise saastatuse lähtudes tuleb ravim kohe ära kasutada.
English: All medicinal products were administered intravenously.
Estonian: Kõiki ravimeid manustati intravenoosselt.
English: Each 10 ml vial contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Estonian: Iga 10 ml viaal sisaldab vähem kui 1 mmol (23 mg) naatriumi, see tähendab põhimõtteliselt „naatriumivaba“.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Estonian: Loomkatsed on reproduktiivtoksilisuse osas ebapiisavad (vt lõik 5.3).
English: To grow, cancer needs new blood vessels to develop.
Estonian: Kasvamiseks vajab vähk uusi veresooni.
English: In case of overdose, supportive therapy should be used.
Estonian: Üleannustamise korral tuleb rakendada toetavat ravi.
English: Samples were tested from 956 patients: 527 ramucirumab treated patients and 429 control treated patients.
Estonian: Analüüsiti 956-lt patsiendilt saadud proove: 527 ramutsirumabiga ravitud patsienti ja 429 kontrollravimit saanud patsienti.
English: REACH-2 efficacy results are shown in Table 12 and Figure 8.
Estonian: REACH-2 efektiivsustulemused on toodud tabelis 12 ja joonisel 8.
English: Baseline demographics and disease characteristics were balanced.
Estonian: Ravieelsed demograafilised ja haigust iseloomustavad näitajad olid tasakaalus.
English: As Cyramza inhibits the development of new blood vessels, it may decrease the likelihood of you becoming pregnant or maintaining a pregnancy.
Estonian: Kuna Cyramza takistab uute veresoonte arengut, võib see vähendada tõenäosust, et te võite rasestuda või rasedust säilitada.
English: Aspirin use at doses up to 325 mg/day was permitted (see section 5.1).
Estonian: Aspiriini kasutamine annustes 325 mg/ööpäevas oli lubatud (vt lõik 5.1).
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Estonian: Väga sage (≥1/10) Sage (≥1/100 kuni <1/10) Aeg-ajalt (≥1/1000 kuni <1/100) Harv (≥1/10000 kuni <1/1000)
English: The majority of events occurred during or following a first or second ramucirumab infusion.
Estonian: Enamus juhte ilmnes ramutsirumabi esimese või teise infusiooni ajal või selle järgselt.
English: For IV use after dilution.
Estonian: IV manustamiseks pärast lahjendamist
English: The correct amount of Cyramza needed to treat your disease will be calculated by your doctor or hospital pharmacist depending on your body weight.
Estonian: Teie haiguse raviks vajamineva Cyramza koguse arvutab teie arst või haigla apteeker sõltuvalt teie kehakaalust.
English: Store in a refrigerator (2 ºC - 8 ºC).
Estonian: Hoida külmkapis (2 ºC - 8 ºC).
English: The ECOG PS was 1 for 72% of patients.
Estonian: ECOG skaalal sooritusvõime 72% patsientidest 1.
English: *The 28 day time period begins on day 1 of the cycle subsequent to the ADR.
Estonian: *28-päevane periood algab kõrvaltoime ilmnemisele järgneva tsükli 1. päevast.
English: Hypertensiona,e
Estonian: Hüpertensioona,e
English: There have been no studies performed with other routes of administration.
Estonian: Teiste manustamisviisidega ei ole uuringuid läbi viidud.
English: It is not known if the medicine passes into breast milk and could affect a breastfed baby.
Estonian: Ei ole teada kas ravim eritub rinnapiima ja võib mõjutada rinnaga toidetavat last.
English: Cyramza should only be used if the potential benefit to the mother justifies the potential risk during pregnancy.
Estonian: Cyramza't tohib kasutada ainult juhul, kui võimalik kasu emale õigustab võimalikku riski raseduse kulule.
English: Time and dose dependency
Estonian: Aja ja annuse sõltuvus
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC21.
Estonian: Farmakoterapeutiline rühm: kasvajavastased ained, monoklonaalsed antikehad, ATC-kood: L01XC21.
English: Treatment cycles on both arms were repeated every 2 weeks.
Estonian: Mõlemas raviharus korrati ravitsükleid iga 2 nädala järel.
English: Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT)
Estonian: Aspartaadi aminotransferaas (ASAT)/alaniini aminotransferaas (ALAT)
English: In both treatment arms, patients who experienced neutropenia had a longer median OS compared to patients who did not experience neutropenia.
Estonian: Mõlemas ravigrupis oli patsientidel, kel esines neutropeeniat, kõrgem üldise elulemuse mediaan võrreldes nende patsientidega, kellel neutropeeniat ei esinenud.
English: What Cyramza looks like and contents of the pack
Estonian: Kuidas Cyramza välja näeb ja pakendi sisu
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Estonian: Enne ravimi võtmist, lugege hoolikalt infolehte, sest siin on teile vajalikku teavet.
English: h Includes cases of nephrotic syndrome.
Estonian: h Hõlmab nefrootilise sündroomi juhtusid.
English: Patients who discontinued one or more components of treatment because of an adverse event were permitted to continue therapy with the other treatment component(s) until disease progression or unacceptable toxicity.
Estonian: Patsientidel, kes katkestasid kõrvaltoimete tekke tõttu ühe või enama ravitsükli komponendi saamise, lubati ravi jätkata teis(t)e komponentidega (komponendiga) kuni haiguse progresseerumiseni või kuni ilmnes vastuvõetamatu toksilisus.
English: If you become pregnant during treatment with Cyramza, your doctor will discuss with you if the benefit of treatment for you is greater than any possible risk to you or your unborn baby.
Estonian: Kui te rasestute Cyramza-ravi ajal, arutab teie arst teiega, kas ravist saadav kasu teile kaaluks üles riski teile endale või teie sündimata lapsele.
English: - if there is X-ray evidence that the lung cancer has a cavity or hole in it or if the lung cancer is close to major blood vessels.
Estonian: - kui on olemas röntgenpildi tõestus, et kopsuvähis on kavitatsioon või auk või kui kopsuvähk on suurte veresoonte lähedal.
English: This is equivalent to approximately 4% of the recommended maximum daily dietary intake of sodium for an adult.
Estonian: See on võrdne ligikaudu 4 %-ga naatriumi maksimaalsest soovitatud ööpäevasest toiduga saadavast kogusest täiskasvanutel.
English: Prior to being given any paclitaxel infusion, you will have blood tests to check that your blood counts are high enough and that your liver is functioning well.
Estonian: Enne iga paklitakseeli infusiooni manustamist tehakse teile vereanalüüse, kontrollimaks kas teie vererakkude arv on piisav ja kas teie maks toimib korralikult.
English: Adverse reactions from other sources
Estonian: Muudest allikatest saadud kõrvaltoimed
English: In the pivotal studies there is limited evidence that patients 65 years of age or older are at increased risk of adverse events compared to patients younger than 65 years old.
Estonian: Olulistest uuringutest saadud piiratud andmed ei ole näidanud, et 65 -aastased ja vanemad patsiendid oleksid suurema kõrvaltoimete tekkeriskiga kui alla 65 -aastased patsiendid.
English: Includes: fatigue and asthenia.
Estonian: Hõlmab: väsimus ja asteenia.