FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro, besilesomab cross-reacts with CEA.
Estonian: In vitro tekib besilesomabil kartsinoembrüonaalse antigeeniga ristreaktsioon.
English: NAME OF THE MEDICINAL PRODUCT Scintimun 1 mg kit for radiopharmaceutical preparation besilesomab
Estonian: RAVIMPREPARAADI NIMETUS Scintimun 1 mg radiofarmatseutiline komplekt Besilesomab
English: Kit of one multidose vial of Scintimun and one vial of solvent.
Estonian: Komplekt, mis koosneb ühest mitmeannuselist Scintimuni viaalist ja ühest lahusti viaalist.
English: Take a vial of Solvent for Scintimun (yellow crimped aluminium capsule) from the kit.
Estonian: Võtke komplektist Scintimuni lahusti viaal (kollane gofreeritud alumiiniumist kork).Desinfitseerige membraan ja laske sellel kuivada.
English: What Scintimun looks like and contents of the pack Scintimun is a kit for radioactive preparation.
Estonian: Kuidas Scintimun välja näeb ja pakendi sisu
English: Thyroid
Estonian: Rind
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE
English: Bladder
Estonian: Munandid
English: Breast
Estonian: Emakas
English: Rf from strip cut of
Estonian: Rf radioaktii vsus riba
English: Total
Estonian: KÕLBLIKKUSAEG
English: Solvent for Scintimun
Estonian: Tc)- Scintimun
English: CLINICAL PARTICULARS 4.1 Therapeutic indications This medicinal product is for diagnostic use only.
Estonian: KLIINILISED ANDMED 4.1 Näidustused
English: Gallbladder
Estonian: Kilpnäärme
English: Liver
Estonian: Kopsud
English: Bone
Estonian: Maks
English: Neparvis tablets are taken twice a day.
Estonian: Neparvise tablette võetakse kaks korda ööpäevas.
English: What is Neparvis and what is it used for?
Estonian: Mis on Neparvis ja milleks seda kasutatakse?
English: Why is Neparvis approved?
Estonian: Miks Neparvis heaks kiideti?
English: Other information about Neparvis
Estonian: Muu teave Neparvise kohta
English: A risk management plan has been developed to ensure that Neparvis is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Neparvise võimalikult ohutu kasutamine.
English: The full EPAR for Neparvis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Neparvise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Neparvis?
Estonian: Mis meetmed võetakse, et tagada Neparvise ohutu ja efektiivne kasutamine?
English: The study was stopped early because there was compelling evidence that Neparvis was more effective than enalapril.
Estonian: Uuring katkestati varakult, sest esinesid vastuvaidlematud tõendid, et Neparvis oli enalapriilist efektiivsem.
English: Neparvis is available as tablets (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, and 97 mg sacubitril / 103 mg valsartan).
Estonian: Neparvist turustatakse tablettidena (24 mg sakubitriili / 26 mg valsartaani, 49 mg sakubitriili / 51 mg valsartaani ja 97 mg sakubitriili / 103 mg valsartaani).
English: In the group treated with Neparvis, 21.8% (914 of 4,187) patients either died as a result of heart and circulation problems or were admitted to hospital with heart failure compared to 26.5% (1,117 of 4,212) patients treated with enalapril.
Estonian: Neparvisega ravitud rühmas suri südame- ja vereringeprobleemide pärast või võeti südamepuudulikkuse tõttu haiglasse 21,8% patsientidest (914 patsienti 4187st) võrreldes 26,5%-ga enalapriiliga ravitud patsientidest (1117 patsienti 4212st).
English: The company that makes Entresto has agreed that its scientific data can be used for Neparvis (‘informed consent').
Estonian: Entresto tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka Neparvise toetuseks (teabel põhinev nõusolek).
English: The recommended starting dose is one tablet of Neparvis 49 mg / 51 mg twice a day and the dose is then doubled after 2 to 4 weeks to 97 mg / 103 mg twice a day.
Estonian: Soovitatav algannus on üks Neparvise 49 mg / 51 mg tablett kaks korda ööpäevas ja seejärel 2...4 nädala järel kahekordistatakse annus 97 mg / 103 mg-ni kaks korda ööpäevas.
English: What are the risks associated with Neparvis?
Estonian: Mis riskid Neparvisega kaasnevad?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Neparvis are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Neparvise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Neparvis sacubitril / valsartan
Estonian: Neparvis sakubitriil/valsartaan
English: This medicine is the same as Entresto, which is already authorised in the European Union (EU).
Estonian: See ravim on samane Entrestoga, millel juba on Euroopa Liidus müügiluba.
English: It is not intended to provide practical advice on how to use Neparvis.
Estonian: Hindamisaruandes ei anta Neparvise kasutamise praktilisi nõuandeid.
English: The serious side effects of Neparvis in the main study were similar to those of enalapril, which is already authorised for use in heart failure.
Estonian: Neparvise rasked kõrvalnähud olid põhiuuringus samasugused nagu enalapriilil, mis on juba heaks kiidetud kasutamiseks südamepuudulikkuse korral.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neparvis, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Neparvise omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The two active substances in Neparvis, sacubitril and valsartan, work in different ways.
Estonian: Neparvise kaks toimeainet sakubitriil ja valsartaan toimivad erineval moel.
English: This is a summary of the European public assessment report (EPAR) for Neparvis.
Estonian: See on ravimi Neparvis Euroopa avaliku hindamisaruande kokkuvõte.
English: The main study found that Neparvis reduced deaths from heart and circulation problems or hospital admissions for heart failure.
Estonian: Põhiuuringus leiti, et Neparvis vähendas nii südame- ja vereringeprobleemidest tulenevaid surmajuhte kui ka hospitaliseerimisi südamepuudulikkuse tõttu.
English: The most common side effects with Neparvis (which may affect more than 1 in 10 people) are high blood potassium levels, low blood pressure and the kidneys working less well.
Estonian: Neparvise kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on vere suur kaaliumisisaldus, madal vererõhk ja neerutalitluse halvenemine.
English: For practical information about using Neparvis, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Neparvise kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Neparvis is a heart medicine that contains the active substances sacubitril and valsartan.
Estonian: Neparvis on südameravim, mis sisaldab toimeainetena sakubitriili ja valsartaani.
English: Neparvis must not be taken with medicines known as ACE inhibitors (which are used to treat heart failure and high blood pressure).
Estonian: Neparvist ei tohi võtta koos ACE-inhibiitoritega (kasutatakse südamepuudulikkuse ja kõrge vererõhu raviks).
English: Natriuretic peptides also reduce blood pressure and protect the heart from developing fibrosis (scar tissue) that occurs in heart failure.
Estonian: Natriureetilised peptiidid langetavad samuti vererõhku ja kaitsevad südant südamepuudulikkuse korral tekkiva fibroosi (armkoe) eest.
English: For more information about treatment with Neparvis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Neparvisega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: How does Neparvis work?
Estonian: Kuidas Neparvis toimib?
English: Neparvis has been shown to be effective in treating heart failure in one main study.
Estonian: Neparvise efektiivsus südamepuudulikkuse ravis on tõendatud ühes põhiuuringus.
English: What benefits of Neparvis have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Neparvise kasulikkus?
English: For the full list of all side effects reported with Neparvis, see the package leaflet.
Estonian: Neparvise kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Neparvis can only be obtained with a prescription.
Estonian: Neparvis on retseptiravim.
English: How is Neparvis used?
Estonian: Kuidas Neparvist kasutatakse?
English: In the study, Neparvis was compared to enalapril, another medicine used for heart failure.
Estonian: Selles uuringus võrreldi Neparvist enalapriiliga, mis on samuti südamepuudulikkuse ravim.
English: Cutaneous use Multidose container with airless pump (PP/TPO/HDPE)
Estonian: Pakendi suurus õhukindla pumbaga mitmeannuseline konteiner (PP/TPO/HDPE)
English: Immediate Packaging Content (concentration)
Estonian: Tugevus Ravivorm Manustamistee Sisepakendi iseloomustus Pakendi sisu (kontsentratsioon)
English: Strength
Estonian: Tugevu
English: 3 inhalers with 60 actuations
Estonian: 3 inhalaatorit, igas inhalaatoris 60 annust
English: 17 December 2009 EMA/809491/2009 EMEA/H/C/471
Estonian: 17. detsember 2009 EMA/68779/2010
English: The full European Public Assessment Report for Abilify is available here.
Estonian: Euroopa avaliku hindamisaruande täistekst Abilify kohta on siin.
English: The study lasted up to a year and involved 1,076 patients, some of whom had completed one of the three short-term studies.
Estonian: Uuring kestis kuni ühe aasta ja selles osales 1076 patsienti, kellest mõni olid läbinud ka ühe kolmest lühiajalisest uuringust.
English: The company presented the results of three short-term and one long-term study to support its application.
Estonian: Ettevõte esitas oma taotluse toetuseks kolme lühiajalise ja ühe pikaajalise uuringu tulemused.
English: Abilify has been authorised since June 2004.
Estonian: Abilify sai müügiloa 2004. aasta juunis.
English: The main measure of effectiveness was the change in symptoms over the six weeks of dual treatment.
Estonian: Efektiivsuse põhinäitaja oli sümptomite muutus kahe ravimiga toimunud kuuenädalase ravikuuri jooksul.
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Estonian: See tähendab, et aripiprasool toimib nagu dopamiin ja 5-hüdroksütrüptamiin, aktiveerides neid retseptoreid, kuid vähem kui neurotransmitterid.
English: Abilify was not compared with any other treatments in this study and the patients knew which medicines they were taking.
Estonian: Selles uuringus ei võrreldud Abilifyt ühegi teise ravimiga ja patsiendid teadsid, mis ravimit nad kasutasid.
English: At the start of the study, the patients were put on an eight-week course of an antidepressant (escitalopram, sertraline, venlafaxine, fluoxetine or paroxetine).
Estonian: Uuringu alguses läbisid patsiendid kaheksanädalase ravikuuri, mille jooksul manustati neile antidepressanti (estsitalopraam, sertraliin, venlafaksiin, fluoksetiin või paroksetiin).
English: On 17 November 2009, Otsuka Pharmaceutical Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Abilify, in the treatment of resistant major depressive episodes.
Estonian: 17. novembril 2009 teatas ettevõte Otsuka Pharmaceutical Europe Ltd. ametlikult inimravimite komiteele, et soovib tagasi võtta ravimile Abilify uue näidustuse, ravile mittealluva raske depressiooni episoodide ravi lisamise taotluse.
English: Major depressive episodes are periods of depressed mood or loss of interest in everyday activities that last for at least two weeks in patients with major depression.
Estonian: Raske depressiooni episoodid on vähemalt kaks nädalat kestvad masendushood või huvipuudus igapäevaelu vastu raske depressiooniga patsientidel.
English: The Committee was also concerned that there was no long-term information from ‘double-blind' studies looking at the maintenance of Abilify's effects and its ability to prevent depression coming back.
Estonian: Komitee väljendas kahtlust ka selles osas, et puudus pikaajaline teave topeltpimedatest uuringutest, kus oleks uuritud Abilify toime säilimist ja omadust ennetada depressiooni taasteket.
English: The CHMP was concerned over the patients included in the studies, as it was not clear whether they all had resistant depression, defined as failure to respond to at least two previous antidepressants.
Estonian: Inimravimite komitee väljendas kahtlust seoses uuringus osalenud patsientidega, sest ei olnud kindel, kas neil kõigil oli ravile mittealluv depressioon, mida määratletakse kui vähemalt kahe eelnenud antidepressantravikuuri ebaõnnestumist.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Estonian: Inimravimite komitee oli hinnanud ettevõtte esitatud dokumente ja koostanud ettevõttele vastamiseks küsimused.
English: It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth), an oral solution and a solution for injection.
Estonian: Seda turustatakse tablettidena, suus dispergeeruvate (lagunevate) tablettidena, suukaudse lahusena ja süstelahusena.
English: The short-term studies were ‘double-blind', which means that neither the patients nor the investigators knew which patients were receiving Abilify and which were receiving placebo.
Estonian: Lühiajalised uuringud olid topeltpimedad, st ei patsiendid ega uuringu läbiviijad ei teadnud, kes patsientidest sai Abilifyt ja kes platseebot.
English: Each patient received an antidepressant that they had not previously taken for the current depressive episode.
Estonian: Iga patsient sai antidepressanti, mida ta ei olnud varem tookordse depressiooniepisoodi raviks võtnud.
English: Since dopamine and 5-hydroxytryptamine are involved in major depression, Abilify is expected to help to normalise the activity of the brain when it is added to antidepressants, reducing the symptoms of major depressive episodes.
Estonian: Et dopamiin ja 5-hüdroksütrüptamiin on seotud raske depressiooniga, peaks Abilify kombinatsioonis antidepressantidega aitama ajutalitlust normaliseerida, vähendades raske depressiooni episoodide sümptomeid.
English: There are no consequences on the use of Abilify in its authorised indications, for which the balance of benefits and risks remains unchanged.
Estonian: Tagasivõtmine ei avalda mõju Abilify kasutamisele nende näidustuste raviks, mille kohta on müügiluba juba antud ning mille korral jääb kasulikkuse ja riski suhe muutumatuks.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Abilify in the treatment of major depressive episodes did not outweigh its risks.
Estonian: Inimravimite komitee oli tagasivõtmise ajal seepärast arvamusel, et Abilify kasulikkus raske depressiooni episoodide ravis ei ole suurem kui sellega kaasnevad riskid.
English: How is Abilify expected to work?
Estonian: Milline on Abilify eeldatav toime?
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Estonian: Arvatakse, et aripiprasool toimib põhiliselt osalise agonistina neurotransmitterite dopamiini ja 5-hüdroksütrüptamiini (serotoniin) retseptoritele.
English: The long-term study looked at the maintenance of Abilify's effects when added to an antidepressant.
Estonian: Pikaajalises uuringus hinnati Abilify toime säilimist antidepressantravile lisamisel.
English: Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Abilify could not have been approved for the treatment of resistant major depressive episodes.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ning oli esialgsel seisukohal, et Abilify kasutamist ravile mittealluva raske depressiooni episoodide raviks ei ole võimalik heaks kiita.
English: The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Estonian: Abilify toimeaine aripiprasool on antipsühhootikum.
English: The short-term studies involved patients with major depressive episodes that had not responded to up to three previous antidepressant treatments.
Estonian: Lühiajalistes uuringutes osalesid raske depressiooni episoodidega patsiendid, kel ei olnud tekkinud ravivastust kuni kolmele varem antidepressantidega toimunud ravikuurile.
English: The 1,090 patients who did not respond to this antidepressant then added either Abilify or placebo (a dummy treatment).
Estonian: 1090 patsiendile, kes manustatavale antidepressandile ei reageerinud, lisati ravikuuri Abilifyt või platseebot (näiv ravim).
English: Abilify is a medicine that contains the active substance aripiprazole.
Estonian: Abilify sisaldab toimeainena aripiprasooli.
English: The company informed the CHMP that there are no consequences for patients currently in clinical trials or compassionate use programmes using Abilify.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu Abilify kliinilistes uuringutes või eriloaga kasutamise programmides osalevatele patsientidele tagasivõtmine mõju ei avalda.
English: It is already used to treat schizophrenia, and to treat and prevent manic episodes (periods of extremely high mood) in patients with bipolar I disorder.
Estonian: See on juba kasutusel skisofreenia ja maaniaepisoodide (meeleolu äärmuslik tõus) raviks ning ennetamiseks I tüüpi bipolaarse meeleoluhäirega patsientidel.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Abilify?
Estonian: Kuidas mõjutab tagasivõtmine praegu Abilify kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: What is happening with Abilify for the treatment of schizophrenia and the treatment and prevention of manic episodes in bipolar I disorder?
Estonian: Kuidas mõjutab tagasivõtmine Abilify kasutamist skisofreenia ning maaniaepisoodide ennetamises ja ravis I tüüpi bipolaarse meeleoluhäirega patsientidel?
English: Abilify was also expected to be used, in addition to antidepressants, to treat major depressive episodes in patients who had not responded adequately to previous antidepressant treatment.
Estonian: Abilifyt kavatseti kasutada kombinatsioonis teiste antidepressantidega raske depressiooni episoodide raviks patsientidel, kellele eelnev ravi antidepressantidega ei ole avaldanud piisavat toimet.
English: The evaluation was withdrawn after ‘day 90'.
Estonian: Taotluse menetlemine oli kestnud 90 päeva, kui ettevõte võttis taotluse tagasi.
English: What was Abilify expected to be used for?
Estonian: Milleks kavatseti Abilifyt kasutada?
English: The final agreed wording was:
Estonian: Lõplik heakskiidetud tekst on järgmine:
English: EMLA was first approved in Sweden in 1984 and is currently nationally approved in 22 countries of the European Economic Area (EEA): Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom and also in Iceland and Norway.
Estonian: EMLA kasutamine kiideti 1984. aastal heaks kõigepealt Rootsis ja praegu on see heaks kiidetud 22-s Euroopa Majanduspiirkonna (EMP) riigis: Austrias, Belgias, Hispaanias, Iirimaal, Itaalias, Kreekas, Küproses, Luksemburgis, Lätis, Madalmaades, Maltas, Poolas, Portugalis, Prantsusmaal, Rootsis, Saksamaal, Soomes, Taanis, Tšehhi Vabariigis ja Ühendkuningriigis ning Islandil ja Norras.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC
Estonian: • inimravimite komitee arutas direktiivi 2001/83/EÜ artikli 30 kohast esildist;
English: Overall summary of the scientific evaluation of EMLA cream and associated names (see Annex I)
Estonian: EMLA kreemi ja sarnaste nimetuste (vt I lisa) teadusliku hindamise üldkokkuvõte
English: In the majority of the countries the following age ranges are approved: neonates 0-2 months, infants 3-11 months and children 1-11 years.
Estonian: Enamikus riikides on heaks kiidetud järgmised vanusevahemikud: vastsündinud: 0-2 kuud; imikud: 311 kuud; lapsed: 1-11 aastat.
English: • Adults
Estonian: • Täiskasvanud
English: • Mechanical cleansing/debridement
Estonian: • Mehaaniline puhastamine/haavakorrastus
English: This information explains the time-course of the dynamic effects and how health care professionals can adapt to facilitate the procedures.
Estonian: Teave selgitab dünaamiliste toimete ajalist kulgu ja seda, kuidas tervishoiutöötajad saavad protseduure hõlbustada.
English: This dosage was previously approved and supported by the clinical study program.
Estonian: See annus oli varem heaks kiidetud ja seda toetas kliinilise uuringu programm.
English: The indication “topical anaesthesia of the skin” is approved in all countries where EMLA has a marketing authorisation.
Estonian: Näidustus „naha paikne anesteesia” on heaks kiidetud kõigis riikides, kus on antud EMLA müügiluba.
English: Labelling and Package Leaflet
Estonian: Pakendi märgistus ja infoleht
English: Available paediatric data do not demonstrate adequate efficacy for circumcision.”
Estonian: Olemasolevad pediaatrilised andmed ei tõenda piisavat efektiivsust ümberlõikamise korral.”
English: All these amendments were considered relevant by the CHMP and were endorsed.
Estonian: Inimravimite komitee pidas kõiki neid muudatusi asjakohaseks ja kiitis need heaks.
English: Section 4.6 - Fertility, pregnancy and lactation
Estonian: Lõik 4.6 - Fertiilsus, rasedus ja imetamine
English: Interactions are likely to be similar to the adult population” is preferred.
Estonian: Koostoime sarnaneb tõenäoliselt koostoimega täiskasvanute populatsioonis.”
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation
Estonian: II lisa Teaduslikud järeldused ja müügiloa tingimuste muutmise alused
English: The Committee also noted that data on efficacy in adults in this indication can be extrapolated to adolescents.
Estonian: Komitee märkis ka, et selle näidustuse efektiivsusandmed täiskasvanute kohta saab ekstrapoleerida noorukitele.
English: 1.5-2 g/10 cm2 for 2-5 hours” was previously approved and is in line with the CSP agreed in 2012.
Estonian: Annus „ligikaudu 1,5-2 g/10 cm2 2-5 tunniks” oli varem heaks kiidetud ja on kooskõlas 2012. aastal heaks kiidetud keskse ohutusprofiiliga.
English: The SmPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Estonian: Ravimi omaduste kokkuvõtte ühtlustamisel lähtuti kõigist ELis kehtivatest asjakohastest ravi- ja regulatiivsuunistest.
English: In addition it was recommended that this section should include a list of the most commonly concomitantly used medicines relevant to the population in which they are prescribed making also clear that this list is not exhaustive.
Estonian: Lisaks soovitati, et sellesse lõiku peaks kuuluma antud populatsioonis kõige sagedamini samaaegselt kasutatavate ravimite loetelu ja selge märge, et loetelu ei ole ammendav.
English: A reference for section 4.4 was also added in section 4.9 as follows: “Clinically significant methaemoglobinaemia should be treated with a slow intravenous injection of methylene blue (see also section 4.4)”.
Estonian: Ühtlasi lisati lõiku 4.9 järgmine viide lõigule 4.4 alljärgnevalt: „Kliiniliselt olulist methemoglobineemiat tuleb ravida metüleensinise aeglase intravenoosse süstimisega (vt ka lõik 4.4)”.