FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC agreed to ask for a scientific advisory group (SAG) advice regarding the risk factors and the monitoring (e.g. MRI, JCV status, CD4+/CD8+ ratio) of the patients treated with fingolimod, in order to advise on possibilities to improve the prognosis of the patients diagnosed early, and to identify patients at risk of developing PML.
Estonian: PRAC leppis kokku, et teadusnõuanderühmalt küsitakse nõu fingolimoodiga ravitud patsientide riskitegurite ja seire kohta (nt MRT, JC-viiruse seisund, CD4+/CD8+ suhe), et anda nõu varakult diagnoosi saanud patsientide ravivõimaluste kohta ja tuvastada PMLi riskiga patsiendid.
English: Latanoprost (Xalatan) - Increased reporting of eye disorders, in particular eye irritation, after change of formulation (EPITT no 18068)
Estonian: Latanoprost (Xalatan) - silma kahjustuste, eelkõige silmade ärrituse juhtudest teatamine on sagenenud pärast ravimvormi muutmist (EPITT nr 18068)
English: Summary of Product Characteristics (SmPC): Section 4.4 - Special warnings and precautions for use Infections
Estonian: Ravimi omaduste kokkuvõte Lõik 4.4 - Erihoiatused ja ettevaatusabinõud kasutamisel Infektsioonid
English: The symptoms of PML may be similar to an MS relapse.
Estonian: PMLi sümptomid võivad sarnaneda hulgiskleroosi taastekkega.
English: A targeted questionnaire should be implemented to maximise the information obtained from future cases.
Estonian: Uute juhtude maksimaalse teabe saamiseks tuleb kasutada ettenähtud küsimustikku.
English: Natalizumab - Anaemia (EPITT no 18137)
Estonian: Natalisumaab - aneemia (EPITT nr 18137)
English: Fingolimod - Progressive Multifocal Leukoencephalopathy (PML) (EPITT no 18241)
Estonian: Fingolimood - progresseeruv multifokaalne leukoentsefalopaatia (PML) (EPITT nr 18241)
English: Having considered the available evidence, including data submitted by the Marketing Authorisation Holder (MAH), and taking into account that Progressive Multifocal Leukoencephalopathy (PML) is a complex disease which may take a prolonged time before becoming clinically symptomatic, the PRAC has agreed that an update of the product information is warranted.
Estonian: Pärast kättesaadavate tõendite, sh ravimi müügiloa hoidja esitatud andmete arutamist ja arvestades, et progresseeruv multifokaalne leukoentsefalopaatia (PML) on keeruline haigus, mille kliiniliste sümptomite avaldumiseni võib kuluda pikem aeg, leppis PRAC kokku, et ravimiteavet on vaja ajakohastada.
English: The frequency may be calculated by considering the frequency of anaemia and haemolytic anaemia in studies.
Estonian: Esinemissagedus tuleb arvutada uuringute käigus tekkinud aneemia ja hemolüütilise aneemia esinemissageduse põhjal.
English: The prescriber's guide should be updated with this risk and PML should also be closely monitored in future PSURs.
Estonian: Nimetatud risk tuleb lisada ravimi määrajate juhistesse ja PMLi tuleb hoolikalt jälgida ka tulevaste perioodiliste ohutusaruannete jaoks.
English: Leflunomide - Colitis (EPITT no 18189)
Estonian: Leflunomiid - koliit (EPITT nr 18189)
English: Package Leaflet:
Estonian: Pakendi infoleht
English: Therefore, the MAH for fingolimod should submit a variation within 2 months, to amend the product information as described below (new text underlined) and to include PML in the RMP as an important identified risk (under the risk of infections).
Estonian: Seetõttu peab fingolimoodi sisaldava ravimi müügiloa hoidja esitama 2 kuu jooksul muutuse, et teha ravimiteabesse järgmised muudatused (uus tekst on alla joonitud) ning käsitleda PMLi riskijuhtimiskavas olulise tuvastatud riskina (infektsioonide riski all).
English: Frequency ‘common': colitis
Estonian: Esinemissagedus „sage”: koliit.
English: Having considered the data submitted by the MAH, as well as the evidence from EudraVigilance cases and the literature, the MAH of Tysabri should submit a variation within 60 days to add “anaemia” and “haemolytic anaemia” to section 4.8 of the SmPC and to update the Package Leaflet accordingly.
Estonian: Müügiloa hoidja esitatud andmete ning EudraVigilance andmebaasist ja kirjandusest saadud juhtude arutamist leiti, et Tysabri müügiloa hoidja peab 60 päeva jooksul esitama muutuse, et lisada ravimi omaduste kokkuvõtte lõiku 4.8 „aneemia” ja „hemolüütiline aneemia” ning ajakohastada sellele vastavalt pakendi infolehte.
English: Frequency ‘common': Colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis.
Estonian: Esinemissagedus „sage”: koliit, sh mikroskoopiline koliit, nt lümfotsütaarne koliit ja kollageenkoliit.
English: Having considered the available evidence from spontaneous reports, EudraVigilance and the literature, the PRAC considers that patients receiving Xalatan should be warned about the importance of seeking medical advice if they experience excessive eye irritation.
Estonian: Ravimiohutuse riskihindamise komitee leidis pärast spontaansete teatiste, EudraVigilance andmebaasist ja kirjandusest saadud andmete arutamist, et Xalatani saavaid patsiente tuleb hoiatada, et silmade liigse ärrituse korral on oluline pöörduda arsti poole.
English: Furthermore, the MAH should continue to monitor events of eye irritation and present updated data in the next PSUR.
Estonian: Müügiloa hoidja peab jätkama silmaärritusjuhtude seiret ja esitama ajakohastatud teabe järgmises perioodilises ohutusaruandes.
English: Frequency “not known”: Progressive multifocal leukoencephalopathy (PML) Package Leaflet:
Estonian: Esinemissagedus „teadmata”: progresseeruv multifokaalne leukoentsefalopaatia (PML).
English: During routine MRI, physicians should pay attention to PML suggestive lesions.
Estonian: Korralise magnetresonantstomograafia (MRT) uuringu ajal peavad arstid pöörama tähelepanu PMLile viitavatele kahjustustele.
English: Having considered the available evidence from clinical trials (colitis reported in 1% to <3% in treatment arm), from spontaneous cases including reported positive de-challenge and re-challenge cases as well as supporting reports in literature, the PRAC has agreed that the MAH(s) of leflunomidecontaining products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Estonian: Ravimiohutuse riskihindamise komitee leidis pärast kliinilistest uuringutest (ravirühmas teatati koliidist 1% ... < 3% juhtudel), spontaansetest juhtudest, sh teatatud reaktsiooni kadumise juhtudest ravi katkestamisel ja reaktsiooni taastekke juhtudest ravi taasalustamisel, ning kirjandusest saadud toetavate tõendite arutamist, et leflunomiidi sisaldavate ravimite müügiloa hoidjad peavad 2 kuu jooksul esitama muutuse, et teha ravimiteabesse järgmised muudatused (uus tekst on alla joonitud).
English: Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment since marketing authorization (see section 4.8).
Estonian: Müügiloa andmisest alates on teatatud fingolimoodravi käigus tekkinud progresseeruvast multifokaalsest leukoentsefalopaatiast (PML) (vt lõik 4.8).
English: Therefore the MAH for Xalatan (latanoprost) should submit a variation within 2 months to update the Package Leaflet as described below (new text underlined).
Estonian: Xalatani (latanoprost) müügiloa hoidja peab2 kuu jooksul esitama muutuse, et teha pakendi infolehel järgmised muudatused (uus tekst on alla joonitud).
English: You may need your treatment to be reviewed to ensure you keep receiving appropriate treatment for your condition.
Estonian: Et haiguse ravi oleks asjakohane, tuleb teie ravi läbi vaadata.
English: Gastrointestinal disorders
Estonian: Seedetrakti häired
English: Not known (frequency cannot be estimated from the available data) Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Estonian: Risk harvaesineva ajuinfektsiooniks, mida nimetatakse progresseeruvaks multifokaalseks leukoentsefalopaatiaks (PML).
English: Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Estonian: Lõik 4.4 - Erihoiatused ja ettevaatusabinõud kasutamisel Leflunomiidiga ravitud patsientidel on teatatud koliidi, sh mikroskoopilise koliidi juhtudest.
English: Symtuza received a marketing authorisation valid throughout the EU on 21 September 2017.
Estonian: Symtuza on saanud müügiloa, mis kehtib kogu ELis, 21. septembril 2017.
English: What measures are being taken to ensure the safe and effective use of Symtuza?
Estonian: Mis meetmed võetakse, et tagada Symtuza ohutu ja efektiivne kasutamine?
English: Other information about Symtuza
Estonian: Muu teave Symtuza kohta
English: Further information on Symtuza can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/symtuza.
Estonian: Lisateave Symtuza kohta on ameti veebilehel: ema.europa.eu/en/medicines/human/EPAR/symtuza.
English: Why is Symtuza authorised in the EU?
Estonian: Miks Symtuza ELis heaks kiideti?
English: The European Medicines Agency decided that Symtuza's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Symtuza kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: What is Symtuza and what is it used for?
Estonian: Mis on Symtuza ja milleks seda kasutatakse?
English: HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).
Estonian: HIV-1 on viirus, mis põhjustab omandatud immuunpuudulikkuse sündroomi (AIDS).
English: This overview was last updated in 07-2019.
Estonian: Kokkuvõtte viimane uuendus: 07.2019
English: It must also not be taken with certain medicines that can reduce the effectiveness of Symtuza, as well as medicines that can increase the risk of serious side effects.
Estonian: Seda ei tohi kasutada ka koos teatud ravimitega, mis võivad vähendada Symtuza efektiivsust, ega ravimitega, mis võivad suurendada raskete kõrvanähtude riski.
English: As for all medicines, data on the use of Symtuza are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Symtuza kasutamise kohta pidevat järelevalvet.
English: Side effects reported with Symtuza are carefully evaluated and any necessary action taken to protect patients.
Estonian: Symtuza kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Because the individual active substances of Symtuza have previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Symtuza produced similar levels of active substances in the blood as the active substances given separately.
Estonian: Et Symtuza toimeained eraldi on varasemates uuringutes osutunud efektiivseks ja on heaks kiidetud kasutamiseks HIV-infektsiooni ravis, oli uuringute eesmärk peamiselt tõendada, et Symtuza tekitab veres samasuguse toimeainesisalduse kui toimeained eraldi.
English: Symtuza does not cure HIV-1 infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Estonian: Symtuza ei ravi HIV-1 infektsiooni ega AIDS-i välja, kuid võib immuunsüsteemi kahjustumist ning AIDS-iga seotud infektsioonide ja haiguste tekkimist edasi lükata.
English: For more information about using Symtuza, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Symtuza kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symtuza have been included in the summary of product characteristics and the package leaflet.
Estonian: Symtuza ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Symtuza is an antiviral medicine used to treat human immunodeficiency virus type 1 (HIV-1) in adults and adolescents aged from 12 years (and weighing at least 40 kg).
Estonian: Symtuza on viirusvastane ravim, mida kasutatakse inimese immuunpuudulikkuse 1. tüüpi viiruse (HIV-1) raviks täiskasvanutel ja vähemalt 12-aastastel noorukitel (kehamassiga vähemalt 40 kg).
English: By blocking protease, Symtuza reduces the amount of HIV-1 in the blood and keeps it at a low level.
Estonian: Proteaasi blokeerimisega vähendab Symtuza HIV-1 kogust veres ja hoiab selle sisalduse väikese.
English: The most common side effects with Symtuza (which may affect more than 1 in 10 people) are diarrhoea, headache and rash.
Estonian: Symtuza kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on kõhulahtisus, peavalu ja lööve.
English: What are the risks associated with Symtuza?
Estonian: Mis riskid Symtuzaga kaasnevad?
English: Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was similar to the 74% (37 of 50) of patients who achieved it with the comparator.
Estonian: Kokku oli patsiente, kes pärast 24 ravinädalat saavutasid selle ravivastuse, Symtuza uuringurühmas 75% (77 patsienti 103st) ja võrdlusravimi rühmas 74% (37 patsienti 50st).
English: Symtuza is available as tablets, each containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Estonian: Symtuzat turustatakse tablettidena, mis sisaldavad 800 mg darunaviiri, 150 mg kobitsistaati, 200 mg emtritsitabiini ja 10 mg tenofoviiralafenamiidi.
English: • Emtricitabine is also a reverse transcriptase inhibitor and it works in the same way as tenofovir.
Estonian: • Emtritsitabiin on samuti pöördtranskriptaasi inhibiitor ning toimib samamoodi kui tenofoviir.
English: The active substances in Symtuza have already been shown to be effective when used individually, and combining them in a single tablet simplifies treatment.
Estonian: Symtuza toimeainete efektiivsus eraldi kasutamisel on juba tõendatud ning nende kombineerimine ühte tabletti lihtsustab ravi.
English: Symtuza must not be taken by patients with severely reduced liver function.
Estonian: Symtuzat ei tohi kasutada maksa raske talitlushäirega patsiendid.
English: Effectiveness was measured by a reduction in viral load (the amount of HIV-1 in the blood) to less than 50 copies/ml.
Estonian: Efektiivsuse põhinäitaja oli viiruskoormuse (veres sisalduva HIV-1 koguse) vähenemine alla taseme 50 koopiat/ml.
English: Symtuza contains four active substances which work in different ways against HIV:
Estonian: Symtuza sisaldab nelja toimeainet, millest igaühel on HIV vastu erinev toimemehhanism.
English: For more information on the medicines that should not be taken with Symtuza, see the package leaflet.
Estonian: Lisateave ravimite kohta, mida ei tohi võtta koos Symtuzaga, on pakendi infolehel.
English: Symtuza can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Estonian: Symtuza on retseptiravim ja ravi peab alustama HIV-infektsiooni ravis kogenud arst.
English: What benefits of Symtuza have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Symtuza kasulikkus?
English: Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide)
Estonian: Symtuza (darunaviir/kobitsistaat/emtritsitabiin/tenofoviiralafenamii d)
English: Tenofovir is a reverse transcriptase inhibitor, which means that it blocks the activity of the enzyme, reverse transcriptase, that the virus needs to reproduce itself.
Estonian: Tenofoviir on pöördtranskriptaasi inhibiitor, mis blokeerib ensüümi pöördtranskriptaasi, mida viirus samuti vajab paljunemiseks.
English: It blocks protease, an enzyme of the virus that allows it to reproduce itself in the cells it has infected.
Estonian: See blokeerib teatud proteaasi ehk viiruse ensüümi, mis võimaldab viirusel nakatunud rakkudes paljuneda.
English: Symtuza was also as effective as a similar combination medicine containing tenofovir disoproxil in place of tenofovir alafenamide.
Estonian: Symtuza on sama efektiivne kui teatud sarnane kombinatsioonravim, mis sisaldab tenofoviiralafenamiidi asemel tenofoviirdisoproksiili.
English: An overview of Symtuza and why it is authorised in the EU
Estonian: Ülevaade ravimist Symtuza ja ELis müügiloa väljastamise põhjendus
English: How is Symtuza used?
Estonian: Kuidas Symtuzat kasutatakse?
English: In addition, one main study compared Symtuza with another antiviral medicine containing darunavir, cobicistat, emtricitabine and tenofovir disoproxil in 153 adult patients with HIV who had not been previously treated.
Estonian: Peale selle võrreldi ühes põhiuuringus Symtuzat teise viirusvastase ravimiga (mis sisaldas darunaviiri, kobitsistaati, emtritsitabiini ja tenofoviirdisoproksiili) 153 varem ravimata täiskasvanud HIV-patsiendil.
English: • Cobicistat acts as a ‘booster' to increase the effects of darunavir, by slowing down the breakdown of darunavir and therefore prolonging its antiviral activity in the body.
Estonian: • Kobitsistaat võimendab darunaviiri toimet, aeglustades darunaviiri lagunemist ja pikendades selle viirusvastast toimeaega organismis.
English: For the full list of side effects reported with Symtuza, see the package leaflet.
Estonian: Symtuza kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: • Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Estonian: • Tenofoviiralafenamiid on tenofoviiri eelravim, mis muutub organismis toimeaineks tenofoviiriks.
English: Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.
Estonian: Symtuza sisaldab toimeainetena darunaviiri, kobitsistaati, emtritsitabiini ja tenofoviiralafenamiidi.
English: How does Symtuza work?
Estonian: Kuidas Symtuza toimib?
English: Because tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil, Symtuza offers the possibility of reduced side effects.
Estonian: Tenofoviiralafenamiid on efektiivne väiksemas annuses kui tenofoviirdisoproksiil ja seepärast on Symtuzal vähem kõrvalnähte.
English: • Darunavir is a type of antiviral agent called a ‘protease inhibitor'.
Estonian: • Darunaviir on proteaasiinhibiitorite hulka kuuluv viirusvastane aine.
English: EMA/551479/2018 EMEA/H/C/003855
Estonian: EMA/642277/2018 EMA/H/C/003855
English: What measures are being taken to ensure the safe and effective use of Coagadex?
Estonian: Mis meetmed võetakse, et tagada Coagadexi ohutu ja efektiivne kasutamine?
English: However, given the extreme rarity of the condition, the safety database is small and rare events are not expected to be captured during the clinical studies.
Estonian: Arvestades, et seisund esineb äärmiselt harva, on ohutusandmebaas väike ja harvaesinevaid sündmusi ei pruugi kliiniliste uuringute ajal tekkida.
English: Coagadex received a marketing authorisation valid throughout the EU on 16 March 2016.
Estonian: Coagadex on saanud müügiloa, mis kehtib kogu ELis, 16. märtsil 2016.
English: The European Medicines Agency decided that the benefits of Coagadex are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Coagadexi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: Further information on Coagadex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Coagadexi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was based on the doctor's and patient's assessment of how well the treatment worked in preventing and treating bleeding episodes.
Estonian: Efektiivsuse põhinäitaja oli arsti ja patsiendi hinnang, kui hästi ravi toimis verejooksuepisoodide ennetamisel ja ravis.
English: In total, 10 bleeds were reported in the study, of which 4 were treated with Coagadex.
Estonian: Kokku teatati uuringu jooksul 10 verejooksust, millest 4 raviti Coagadexiga.
English: In a study with 9 children aged less than 12 years (4 of whom were under4 years of age), a routine preventive treatment with Coagadex over 6 months was rated as excellent in reducing or preventing bleeding episodes.
Estonian: Uuringus, milles osales üheksa alla 12-aastast last (sh neli alla 4-aastast last) ja milles kasutati 6 kuu jooksul rutiinset ennetavat ravi Coagadexiga, hinnati ravimi toimet verejooksuepisoodide vähendamisel või ennetamisel väga heaks.
English: As for all medicines, data on the use of Coagadex are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Coagadexi kasutamise kohta pidevat järelevalvet.
English: For more information about using Coagadex, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Coagadexi kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Hypersensitivity (allergic) reactions can occur rarely in patients treated for bleeding disorders (in up to 1 patient in 1,000) and can be severe in some cases.
Estonian: Veritsushäirete tõttu ravi saavatel patsientidel võivad harva (kuni 1 patsiendil 1000st) tekkida ülitundlikkusreaktsioonid (allergilised reaktsioonid), mis võivad mõnel juhul olla rasked.
English: The dose and frequency of the injections depend on the severity of the patient's factor X deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Estonian: Süstide annus ja süstimissagedus sõltuvad patsiendi X hüübimisfaktori vaeguse raskusastmest, verejooksu ulatusest ja asukohast ning patsiendi seisundist ja kehamassist.
English: Coagadex has been investigated in one main study involving 16 patients with hereditary factor X deficiency aged 12 to 58 years.
Estonian: Coagadexi on uuritud ühes põhiuuringus, milles osales 16 X hüübimisfaktori vaegusega 12-58-aastast patsienti.
English: Other information about Coagadex
Estonian: Muu teave Coagadexi kohta
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Coagadex have been included in the summary of product characteristics and the package leaflet.
Estonian: Coagadexi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Coagadex (human coagulation factor X)
Estonian: Coagadex (inimese X hüübimisfaktor)
English: These reactions have not been reported during clinical studies with Coagadex.
Estonian: Nendest reaktsioonidest ei ole teatatud Coagadexi kliinilistes uuringutes.
English: For the treatment of bleeding, 187 bleeding episodes were recorded and assessed, and treatment with Coagadex was rated as ‘excellent' or ‘good' for 98.4% of bleeding episodes.
Estonian: Verejooksude raviks registreeriti ja hinnati uuringus 187 verejooksuepisoodi ning ravi Coagadexiga hinnati väga heaks või heaks 98,4%-l juhtudest.
English: Side effects reported with Coagadex are carefully evaluated and any necessary action taken to protect patients.
Estonian: Coagadexi kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Coagadex is a medicine used for the treatment and prevention of bleeding (including during and after an operation) in patients with hereditary factor X deficiency.
Estonian: Coagadex on ravim, mida kasutatakse verejooksu raviks ja ennetamiseks (sh kirurgilise operatsiooni ajal ja järel) X hüübimisfaktori päriliku vaegusega patsientidel.
English: The side effects of Coagadex were considered manageable and of mild or moderate intensity.
Estonian: Coagadexi kõrvalnähte peeti hallatavateks ja need hinnati kergeks või mõõdukaks.
English: A single infusion of Coagadex was sufficient to control each treated bleeding event.
Estonian: Coagadexi ühekordne infusioon oli piisav iga ravitava verejooksuepisoodi ohjamiseks.