FrancophonIA/ELRC3.0 huggingface dataset:
English: Before administering a radioactive medicinal product to a breast-feeding mother, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of radioactivity in breast milk.
Estonian: Enne radioaktiivse ravimpreparaadi manustamist imetavale emale tuleks kaaluda, kas tuleb kõne alla uuringu edasilükkamine imetamisperioodi lõpuni.
English: Each 5 ml single dose vial contains 370 MBq ioflupane (
Estonian: Iga 5 ml ühekordse annusega viaal sisaldab 370 MBq ioflupaani (
English: Distribution Ioflupane (
Estonian: Jaotumine Ioflupaani (
English: Muscles
Estonian: Lihased
English: Clear colourless solution.
Estonian: Läbipaistev värvitu lahus
English: Each 2.5 ml single dose vial contains 185 MBq ioflupane (
Estonian: Iga 2,5 ml ühekordse annusega viaal sisaldab referentsmõõtmisel 185 MBq ioflupaani (
English: Gallbladder wall Gastrointestinal tract
Estonian: Rinnanäärmed Sapipõie sein Seedetrakt
English: Uncommon: Dizziness, formication (paraesthesia), dysgeusia
Estonian: Aeg-ajalt: pearinglus, "sipelgate jooksmise"-tunne (paresteesia), maitsehäire
English: Non-clinical data for ioflupane reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Estonian: Farmakoloogilise ohutuse, ühekordse ja kroonilise toksilisuse ja genotoksilisuse mittekliinilised uuringud ioflupaani kohta ei ole näidanud kahjulikku toimet inimesele.
English: I) at 1200 CET on DD/MM/YYYY
Estonian: I) kl 12.00 CET PP/KK/AAAA.
English: Salivary glands Skin
Estonian: Punane luuüdi Süljenäärmed Nahk
English: GE Healthcare B.V. Tel: +31 (0) 40 299 10 00
Estonian: Tel: +31 (0) 40 299 10 00
English: Kidneys
Estonian: Neerud
English: Small intestine wall
Estonian: Neerupealised Luu pealispind Aju
English: Ear and labyrinth disorders Uncommon: Vertigo
Estonian: Kõrva ja labürindi kahjustused Aeg-ajalt: vertiigo
English: Stomach wall
Estonian: Kusepõie sein Emakas
English: 2.5 ml presentation
Estonian: 2,5 ml esitusviis
English: • Instead use formula feed for your child. Express your breast milk regularly and throw away any breast milk you have expressed.
Estonian: • Toitke last sel ajal rinnapiima asendajaga.
English: GE Healthcare Buchler GmbH & Co. KG Tel: +49 (0) 5 307 93 00
Estonian: KG Tel: +49 (0) 5 307 93 00
English: Water for injections
Estonian: Organite kaudu omastamine
English: Handling and disposal - see package leaflet.
Estonian: Käsitsemise ja hävitamise kohta vt infoleht.
English: Pancreas
Estonian: Munandid
English: Tell your doctor if any of these apply to you.
Estonian: Kui teil on mõni neist seisunditest, rääkige sellest arstile.
English: The studies included data from 970 patients.
Estonian: Uuringud hõlmasid 970 patsiendi andmeid.
English: edotreotide
Estonian: edotreotiid
English: Ga) chloride.
Estonian: Ga)kloriidiga.
English: The substance that is used for radiolabelling SomaKit TOC is called gallium (
Estonian: Ravimit SomaKit TOC radiomärgistatakse gallium(
English: The tumours can then spread elsewhere in the body (metastasis).
Estonian: Seejärel võib kasvaja levida mujale organismi (metastaseeruda).
English: The PET scan images are then taken 40 to 90 minutes later.
Estonian: 40-90 minutit hiljem tehakse PETuuring.
English: A comparison using data from several of these studies (a meta-analysis) was also presented.
Estonian: Esitati ka eri uuringute andmete võrdlus (metaanalüüs).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the technical and diagnostic performance of the medicine had been demonstrated.
Estonian: Inimravimite komitee oli arvamusel, et ravimi tehniline ja diagnostiline toime on tõendatud.
English: Taken together, the studies were sufficient to show the effectiveness of SomaKit TOC for detection, although the exact results varied.
Estonian: Koos olid uuringud piisavad, et tõendada ravimi SomaKit TOC efektiivsus kasvaja tuvastamisel, kuigi täpsed tulemused varieerusid.
English: What measures are being taken to ensure the safe and effective use of SomaKit TOC?
Estonian: Mis meetmeid võetakse, et tagada ravimi SomaKit TOC ohutu ja efektiivne kasutamine?
English: Not all cells have these receptors but most welldifferentiated GEP-NET cells have high amounts on their surface.
Estonian: Neid retseptoreid ei ole kõigil rakkudel, kuid enamikul tugevalt diferentseerunud GEPNET-rakkude pinnal on neid retseptoreid palju.
English: Some studies looked at the sensitivity of the PET scans (how well the scans identified patients who had GEP-NETs or their metastases), some analysed specificity (how reliable scans were at identifying subjects who had no GEP-NETs) and some looked at lesion detection rate (how good scans were at identifying the tumours).
Estonian: Mõnes uuringus käsitleti PETuuringute tundlikkust (kui hästi uuring tuvastas GEP-NETi või selle metastaasidega patsiendid), mõnes analüüsiti spetsiifilisust (kui usaldusväärselt tuvastati uuringus GEP-NETita patsiendid) ja mõnes käsitleti tuvastatud kollete tuvastamise sagedust (kui efektiivne oli uuring kasvaja tuvastamisel).
English: The company therefore provided information from many, mostly small, studies in the published literature to show the effectiveness of SomaKit TOC at detection.
Estonian: Seetõttu esitas ettevõte teabe kirjanduses avaldatud paljudest, enamasti väikestest uuringutest, mis tõendasid ravimi SomaKit TOC efektiivsust kasvajate tuvastamisel.
English: In four other comparative studies it was seen that the active substance in SomaKit TOC detected more tumours than did indium (111In) pentetreotide in the same patients.
Estonian: Neljas muus võrdlusuuringus täheldati, et ravimi SomaKit TOC toimeainega tuvastati samadel patsientidel rohkem kasvajaid kui indium(111In)pentetreotiidiga.
English: It is given as a single injection into a vein immediately after being radiolabelled.
Estonian: Ravim manustatakse ühekordse süstena veeni kohe pärast ravimi radiomärgistamist.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for SomaKit TOC can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte ravimi SomaKit TOC kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: GEP-NETs are cancers which start in types of cells in the gut or pancreas that normally release hormones.
Estonian: GEP-NET on pahaloomuline kasvaja, mis algab soole või pankrease (kõhunäärme) rakkudest, milles normaalselt tekib hormoone.
English: What is SomaKit TOC and what is it used for?
Estonian: Mis on SomaKit TOC ja milleks seda kasutatakse?
English: Because the number of patients with GEP-NETs is low, the disease is considered ‘rare', and SomaKit TOC was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 March 2015.
Estonian: Et GEP-NETiga patsientide arv on väike ja see haigus esineb harva, nimetati SomaKit TOC 19. märtsil 2015 harvikravimiks.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of SomaKit TOC have been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi SomaKit TOC ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: This is a summary of the European public assessment report (EPAR) for SomaKit TOC.
Estonian: See on ravimi SomaKit TOC Euroopa avaliku hindamisaruande kokkuvõte.
English: The full EPAR for SomaKit TOC 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 ravimi SomaKit TOC kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: SomaKit TOC is a diagnostic medicine used in adult patients who are thought to have so-called welldifferentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Estonian: SomaKit TOC on diagnostiline ravim, mida kasutatakse täiskasvanutel, kellel kahtlustatakse tugevalt diferentseerunud gastroenteropankreaatilist neuroendokriinkasvajat (GEP-NET).
English: The medicine is not used directly, but must be ‘radiolabelled' before being injected, which means that it is tagged with a separate substance that emits small amounts of radiation.
Estonian: Ravimit ei kasutata vahetult, vaid seda radiomärgistatakse enne süstimist - ravim märgistatakse nõrgalt radioaktiivse teise ainega.
English: The risks of side effects seemed to be low and the CHMP therefore decided that SomaKit TOC's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Komitee otsustas, et ravimi SomaKit TOC kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: SomaKit TOC contains the active substance edotreotide.
Estonian: SomaKit TOC sisaldab toimeainena edotreotiidi.
English: It is not intended to provide practical advice on how to use SomaKit TOC.
Estonian: Hindamisaruandes ei anta ravimi SomaKit TOC kasutamise praktilisi nõuandeid.
English: After SomaKit TOC is radiolabelled it emits a small amount of radiation which poses a low risk of cancer or hereditary abnormalities.
Estonian: Pärast ravimi SomaKit TOC radiomärgistamist on ravim nõrgalt radioaktiivne, millel on väike pahaloomuliste kasvajate või pärilike häirete tekke risk.
English: Why is SomaKit TOC approved?
Estonian: Miks SomaKit TOC heaks kiideti?
English: For localising the primary GEP-NET, one study showed that the medicine had a sensitivity of 45% compared with 10% in patients given another approved diagnostic medicine, indium (111In) pentetreotide, and this was confirmed by another study that showed that the former had better sensitivity.
Estonian: Ühe uuringu järgi oli primaarse GEP-NETi tuvastamisel ravimi tundlikkus 45% ja teise heakskiidetud diagnostilise ravimi, indium(111In)pentetreotiidi kasutamisel 10%.
English: For practical information about using SomaKit TOC, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate ravimi SomaKit TOC kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Ga) chloride had a sensitivity and specificity of 100% and 89% respectively, and found a lesion detection rate of 75%.
Estonian: Muude uuringute järgi olid gallium(68Ga)kloriidiga märgistatud edotreotiidi tundlikkus 100% ja spetsiifilisus 89% ning tuvastatud kollete sagedus oli 75%.
English: Other information about SomaKit TOC
Estonian: Muu teave ravimi SomaKit TOC kohta
English: For more information about treatment with SomaKit TOC, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga SomaKit TOC toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The prepared medicine, radiolabelled with gallium (68Ga) chloride, attaches to these receptors on the GEP-NET cells.
Estonian: Ettevalmistatud ja gallium(68Ga)kloriidiga radiomärgistatud ravim seondub GEP-NET-rakkude somatostatiiniretseptoritega.
English: The active substance in SomaKit TOC, edotreotide radiolabelled with gallium (68Ga) chloride, has a well established use in detecting GEP-NETs.
Estonian: Ravimi SomaKit TOC toimeaine gallium(68Ga)kloriidiga märgistatud edotreotiidi kasutamine GEP-NETi tuvastamiseks on hästi tõestatud meditsiiniline kasutus.
English: What are the risks associated with SomaKit TOC?
Estonian: Mis riskid ravimiga SomaKit TOC kaasnevad?
English: How does SomaKit TOC work?
Estonian: Kuidas SomaKit TOC toimib?
English: The active substance in SomaKit TOC, edotreotide, attaches specifically to receptors called somatostatin receptors on the surface of cells.
Estonian: Ravimi SomaKit TOC toimeaine edotreotiid seondub spetsiifiliselt raku pinnal olevate somatostatiini retseptoritega.
English: For the full list of side effects or restrictions with SomaKit TOC, see the package leaflet.
Estonian: Ravimi SomaKit TOC kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: SomaKit TOC is available as a kit for preparing a solution for injection.
Estonian: Ravimit SomaKit TOC turustatakse süstelahuse valmistamise komplektina.
English: SomaKit TOC is used with a technique called positron emission tomography (PET scan) to obtain images that locate the cancers.
Estonian: Ravimit SomaKit TOC kasutatakse positronemissioon-tomograafiauuringus (PET) kasvaja asukohta tuvastavas piltdiagnostikas.
English: The resulting build-up of radiation can be detected by the special camera of the PET scan.
Estonian: Tekkivat kiirgusallikat saab tuvastada PET-uuringul erikaameraga, millega tuvastatakse kasvaja asukoht ja ulatus.
English: How is SomaKit TOC used?
Estonian: Kuidas ravimit SomaKit TOC kasutatakse?
English: What benefits of SomaKit TOC have been shown in studies?
Estonian: Milles seisneb uuringute põhjal ravimi SomaKit TOC kasulikkus?
English: SomaKit TOC can only be obtained with a prescription and the injection must only be prepared and given in a suitable facility by experts in handling radioactive medicines.
Estonian: Ravimit tohivad süstimiseks ette valmistada ja süstida radioaktiivsete ravimite käsitsemises kogenud spetsialistid asjakohastes ruumides.
English: Frequency ‘not known': aggression
Estonian: Esinemissagedus „teadmata”: agressiivsus.
English: Section 4: Possible side effects
Estonian: Lõik 4: võimalikud kõrvaltoimed
English: Having considered the available evidence in the literature and from individual case safety reports, the PRAC has agreed that the MAH(s) of aripiprazole-containing medicinal 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 kirjanduses ja üksikjuhtumite ohutusaruannetes olemasolevate andmete arutamist, et aripiprasooli sisaldavate ravimite müügiloa hoidjad peavad 2 kuu jooksul esitama muutuse, et viia ravimiteabesse järgmised muudatused (uus tekst on alla joonitud).
English: Adopted at the 9-12 March 2015 PRAC
Estonian: Vastu võetud ravimiohutuse riskihindamise komitee poolt 9.12. märtsil 2015.
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: Aggression
Estonian: Suukaudselt manustatava aripiprasooli turuletulekujärgselt on teatatud järgmistest kõrvaltoimetest, kuid esinemissagedus ei ole teada: agressiivsus.
English: Section 4.8 - Undesirable effects:
Estonian: Lõik 4.8 - kõrvaltoimed
English: PRAC recommendations on signals for update of the product information
Estonian: Ravimiohutuse riskihindamise komitee (PRAC) soovitused ravimiteabe ajakohastamise kohta ohusignaalide põhjal
English: The PRAC has further agreed that the MAH for Abilify and Abilify Maintena should submit in the next PSUR (data lock point 16/07/2015), a cumulative review of aripiprazole overdose and the risk of aggression and related events.
Estonian: Ravimiohutuse riskihindamise komitee leppis kokku, et Abilify ja Abilify Maintena müügiloa hoidja peab esitama järgmises perioodilises ohutusaruandes (andmete esitamise tähtpäev 16. juuli 2015) aripiprasooli üleannustamise ning agressiivsuse ja seotud kõrvalnähtude riski ülevaate.
English: Aripiprazole - Aggression and related events (EPITT no
Estonian: Aripiprasool - agressiivsus ja seotud kõrvalnähud (EPITT nr 18127)
English: Summary of Product Characteristics:
Estonian: Ravimi omaduste kokkuvõte
English: Tabulated list of adverse reactions
Estonian: Kõrvaltoimete tabel
English: 0.5 mg Capsule, hard
Estonian: 0,5 mg Kõvakapsel
English: Bottle (HDPE) 100 capsules
Estonian: Pudel (HDPE)
English: Invented name Strength Pharmaceutical Form Route of administration Packaging Package size
Estonian: Tugevus Ravimvorm
English: The full EPAR for Ifirmacombi can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ifirmacombi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ifirmacombi on 4 March 2011.
Estonian: Euroopa Komisjon andis Ifirmacombi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 4. märtsil
English: It is available as tablets (150 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide; 300 mg irbesartan and 12.5 mg hydrochlorothiazide).
Estonian: Seda turustatakse tablettidena (150 mg irbesartaani ja 12,5 mg hüdroklorotiasiidi; 300 mg irbesartaani ja 25 mg hüdroklorotiasiidi; 300 mg irbesartaani ja 12,5 mg hüdroklorotiasiidi).
English: Irbesartan/hydrochlorothiazide
Estonian: Ifirmacombi irbesartaan/hüdroklorotiasiid
English: Why has Ifirmacombi been approved?
Estonian: Miks Ifirmacombi heaks kiideti?
English: For more information about treatment with Ifirmacombi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ifirmacombiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Committee recommended that Ifirmacombi be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi Ifirmacombi müügiloa.
English: What is Ifirmacombi?
Estonian: Mis on Ifirmacombi?
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Estonian: Mõlema toimeaine kombinatsioonil on aditiivne toime: kombinatsioon alandab vererõhku rohkem kui kumbki ravim eraldi.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ifirmacombi.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This is a summary of the European public assessment report (EPAR) for Ifirmacombi.
Estonian: See on ravimi Ifirmacombi Euroopa avaliku hindamisaruande kokkuvõte.
English: This means that Ifirmacombi is similar to a ‘reference medicine' already authorised in the European Union (EU) called CoAprovel.
Estonian: See tähendab, et Ifirmacombi on sarnane võrdlusravimiga CoAprovel, millel juba on Euroopa Liidus müügiluba.
English: Other information about Ifirmacombi
Estonian: Muu teave Ifirmacombi kohta
English: Because Ifirmacombi 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: Et Ifirmacombi on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Therefore, the CHMP's view was that, as for CoAprovel, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka CoAproveli korral, ületab ravimi Ifirmacombi kasulikkus sellega kaasnevad riskid.
English: Ifirmacombi is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Estonian: Ifirmacombit kasutatakse essentsiaalse hüpertensiooniga (kõrgvererõhutõvega) täiskasvanutel, kellel ainult irbesartaani või hüdroklorotiasiidiga ei teki piisavat ravivastust.
English: Because Ifirmacombi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel.
Estonian: Et Ifirmacombi on geneeriline ravim, piirdusid uuringud katsetega, milles näidati Ifirmacombi bioekvivalentsust võrdlusravimiga CoAprovel.
English: What are the benefits and risks of Ifirmacombi?
Estonian: Milles seisneb Ifirmacombi kasulikkus ja mis riskid ravimiga kaasnevad?
English: The CHMP concluded that, in accordance with EU requirements, Ifirmacombi has been shown to have comparable quality and to be bioequivalent to CoAprovel.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Ifirmacombi võrreldav kvaliteet ja bioekvivalentsus ravimiga CoAprovel.
English: Ifirmacombi is a ‘generic medicine'.
Estonian: Ifirmacombi on geneeriline ravim.
English: Ifirmacombi is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Estonian: Ifirmacombi on ravim, mis sisaldab kaht toimeainet, irbesartaani ja hüdroklorotiasiidi.
English: Ifirmacombi contains two active substances, irbesartan and hydrochlorothiazide.
Estonian: Ifirmacombi sisaldab kaht toimeainet, irbesartaani ja hüdroklorotiasiidi.
English: What is Ifirmacombi used for?
Estonian: Milleks Ifirmacombit kasutatakse?
English: How has Ifirmacombi been studied?
Estonian: Kuidas Ifirmacombit uuriti?
English: How does Ifirmacombi work?
Estonian: Kuidas Ifirmacombi toimib?
English: Ifirmacombi may be added to other treatments for hypertension.
Estonian: Ifirmacombit tohib kasutada koos muude kõrgvererõhuravimitega.
English: How is Ifirmacombi used?
Estonian: Kuidas Ifirmacombit kasutatakse?
English: The dose of Ifirmacombi to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Estonian: Ifirmacombi annus sõltub patsiendi varasemast irbesartaani ja hüdroklorotiasiidi annusest.
English: The medicine can only be obtained with a prescription.
Estonian: Ifirmacombi on retseptiravim.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rienso on 15 June 2012.
Estonian: Euroopa Komisjon andis Rienso müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. juunil 2012.
English: The company will also carry out studies to further characterise this risk.
Estonian: Turustaja korraldab selle riski täpsemaks kirjeldamiseks täiendavad uuringud.
English: The full EPAR for Rienso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Rienso kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Depending on the severity of the anaemia and the patient's body weight, a second infusion may be given two to eight days after the first dose.
Estonian: Sõltuvalt aneemia raskusest ja patsiendi kehamassist tohib teise infusiooni manustada 2-8 päeva pärast esimest annust.
English: A risk management plan has been developed to ensure that Rienso is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Rienso võimalikult ohutu kasutamine.
English: The doctor should ensure that the patient is observed for adverse reactions for at least 30 minutes following the infusion.
Estonian: Arst peab tagama, et patsienti jälgitakse kõrvalnähtude suhtes vähemalt 30 minuti jooksul pärast infusiooni.
English: In all three studies, patients taking Rienso had higher average increases in haemoglobin: 1.2 g/dl versus 0.5 g/dl; 0.8 g/dl versus 0.2 g/dl; and 1.0 g/dl versus 0.5 g/dl.
Estonian: Kõigis kolmes uuringus oli Riensot saanud patsientidel hemoglobiini keskmine suurenemine suurem: vastavalt 1,2 g/dl ja 0,5 g/dl, 0,8 g/dl ja 0,2 g/dl ning 1,0 g/dl ja 0,5 g/dl.
English: What measures are being taken to ensure the safe and effective use of Rienso?
Estonian: Mis meetmed võetakse, et tagada Rienso ohutu ja efektiivne kasutamine?