FrancophonIA/ELRC3.0 huggingface dataset:
English: For both intravenous and subcutaneuous administration,reconstitute the powder contained in the vial using the vial adapter and all solvent in the pre-filled syringe.
Estonian: Nii intravenoosse kui ka subkutaanse manustamise puhul tuleb viaalis olev pulber manustamiskõlblikuks muuta, kasutades viaaliadapterit ja süstlis olevat lahustit.
English: Your doctor will decide how you should be treated.
Estonian: • teie maksatalitlus oluliselt puudulik; teie arst otsustab, kuidas teid tuleb ravida;
English: If you miss a dose you should still take it if it is within 12 hours of the scheduled time.
Estonian: Kui teil jääb annus vahele, siis manustage see, kui ettenähtud ajast ei ole möödunud üle 12 tunni.
English: See section 4.4 for special considerations in patients with severe hepatic impairment.
Estonian: Erisusi raske maksakahjustusega patsientide puhul vt lõik 4.4.
English: The first injection of Cablivi into your vein must be given by a healthcare professional.
Estonian: Esimese süsti Cablivi'ga teie veeni peab tegema tervishoiutöötaja.
English: Subsequent doses are to be administered via subcutaneous injection in the abdomen.
Estonian: Edasised annused tuleb manustada subkutaanse süstina kõhupiirkonda.
English: METHOD AND ROUTE OF ADMINISTRATION For single use only
Estonian: MANUSTAMISVIIS JA -TEE(D) Ainult ühekordseks kasutamiseks.
English: • With the syringe still connected to the vial adapter, gently swirl the vial with connected syringe until the powder is dissolved.
Estonian: • Hoidke süstalt endiselt viaaliadapteri küljes ja keerutage viaali õrnalt koos süstlaga, kuni pulber on lahustunud.
English: In animal toxicology studies, no impact of caplacizumab on male and female fertility parameters was observed (see section 5.3).
Estonian: Toksikoloogia loomkatsetes ei täheldatud kaplatsizumabi mõju isaste ja emaste fertiilsusnäitajatele (vt lõik 5.3).
English: It also affects the disposition of von Willebrand factor, leading to transient reductions of total von Willebrand factor antigen levels and to concomitant reduction of factor VIII:C levels during treatment.
Estonian: Samuti mõjutab see von Willebrandi faktori vastuvõtlikkust, viies von Willebrandi faktori antigeeni üldtaseme mööduva vähenemiseni ning kaasuvalt FVIII:C taseme vähenemiseni ravi ajal.
English: • Gently lock the syringe onto the vial by turning it clockwise until resistance is felt.
Estonian: • Lukustage süstal õrnalt viaali külge, keerates seda päripäeva, kuni tunnete vastupanu.
English: Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.
Estonian: 10 mg kaplatsizumabi subkutaanselt üks kord ööpäevas pärast igat vereplasmavahetuse lõpetamist kogu igapäevase vereplasma vahetusravi kestel; millele järgnevad subkutaansed süstid 10 mg kaplatsizumabi üks kord ööpäevas 30 päeva vältel pärast igapäevase vereplasma vahetusravi lõppu.
English: • Multidose pack containing 7 vials with powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 hypodermic needles (30 gauge) and 14 alcohol swabs.
Estonian: • Mitmikpakk, mis sisaldab 7 viaali pulbriga, 7 süstlit lahustiga, 7 viaaliadapterit, 7 hüpodermilist nõela (30 G) ja 14 alkoholiga immutatud vatipatja.
English: Gingival bleeding* Haematemesis*, haematochezia*, melaena*, upper gastrointestinal haemorrhage*, haemorrhoidal haemorrhage*, rectal haemorrhage *, abdominal wall haematoma*
Estonian: Veritsus igemetest* Hematemees*, hematokeesia, meleena*, seedetrakti ülaosa verejooks*, hemorroidaalne verejooks*, pärasooleverejooks*, kõhuseina hematoom*
English: Epistaxis*
Estonian: Epistaksis*
English: The pharmacokinetics of caplacizumab depend on the expression of the target von Willebrand factor.
Estonian: Kaplatsizumabi farmakokineetika sõltub toime sihtkohaks oleva von Willebrandi faktori avaldumisest.
English: Leave the adapter attached to the vial, still in its outer packaging.
Estonian: Jätke adapter viaali külge, endiselt koos välispakendiga.
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Estonian: Neerukahjustusega patsientidel ei ole annuse kohandamine vajalik (vt lõik 5.2).
English: Subsequent doses
Estonian: Järgmised annused
English: Cablivi should only be restarted upon the advice of a physician experienced in the management of thrombotic microangiopathies.
Estonian: Ravi Cablivi'ga võib taasalustada üksnes trombootiliste mikroangiopaatiate ravikogemusega arsti soovitusel.
English: Haematoma*
Estonian: Hematoom*
English: Pharmacokinetics in patients with aTTP were investigated upon single intravenous and repeated subcutaneous injections.
Estonian: Farmakokineetikat omandatud trombootilise trombotsütopeenilise purpuriga patsientidel on uuritud pärast üht intravenoosset ja korduvat subkutaanset süsti.
English: • Put the vial and the attached adapter into the supplied disposal container.
Estonian: • Pange viaal ja selle küljes olev adapter käepärast olevasse jäätmemahutisse.
English: • subsequent doses: - 1 vial once daily as a subcutaneous injection (under the skin of the belly) - the subcutaneous injection will be given after each daily plasma exchange - after the daily plasma exchange finishes, your treatment with Cablivi will continue for at least 30 days with injection of 1 vial once daily.
Estonian: 1 viaal üks kord ööpäevas subkutaanse süstina (kõhunaha alla); subkutaanne süst tehakse pärast iga igapäevase vereplasmavahetuse lõpetamist; pärast igapäevaste vereplasmavahetuste lõppu jätkub teie ravi Cablivi'ga vähemalt 30 päeva ning teile süstitakse üks kord ööpäevas 1 viaal ravimit; teie arst võib paluda teil igapäevast ravi jätkata, kuni teie haiguse nähud on kadunud.
English: • Remove the plastic flip-off cap from the vial.
Estonian: • Eemaldage viaalilt plastkate.
English: • Single pack containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1
Estonian: • üksikpakina, mis sisaldab 1 viaali kaplatsizumabi pulbriga, 1 süstlit lahustiga, 1 viaaliadapterit,
English: Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses (see section 5.3).
Estonian: Katsed merisigadega näitasid, et kaplatsizumab ei mõjutanud tiineid emaseid ega looteid (vt lõik 5.3).
English: Number of days of Plasma Exchange (days)
Estonian: Aeg intensiivravi osakonnas (päevad)
English: In case of overdose, based on the pharmacological action of caplacizumab, there is the potential for an increased risk of bleeding.
Estonian: Üleannustamise korral on kaplatsizumabi farmakoloogilisest toimest lähtuvalt suurenenud veritsusrisk.
English: Slovenská republika sanofi-aventis Pharma Slovakia s.r.o.
Estonian: sanofi-aventis Pharma Slovakia s.r.o.
English: In the clinical studies of patients with TTP, those with renal impairment did not show additional risk of adverse events.
Estonian: Kliinilises uuringus trombootilise trombotsütopeenilise purpuriga patsientidega ei täheldatud kõrvaltoimete riski suurenemist neerukahjustusega patsientidel.
English: Target disposition
Estonian: Sihtmärgi vastuvõtlikkus
English: • Use the second alcohol pad to clean the injection site you have chosen.
Estonian: • Kasutage teist kaasasolevat alkoholiga immutatud vatipatja valitud süstekoha puhastamiseks.
English: • Do not touch the syringe tip or allow it to touch the surface.
Estonian: • Ärge puudutage süstla otsa ja ärge laske sel kokku puutuda ühegi pinnaga.
English: First dose Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.
Estonian: Esimene annus 10 mg kaplatsizumabi intravenoosse süstina enne vereplasmavahetust.
English: Tell your doctor if you are pregnant or plan to get pregnant.
Estonian: Kui te olete rase või kavatsete rasestuda, teavitage sellest oma arsti.
English: • muscle pain
Estonian: • Pulbri viaal
English: Place the syringe on the clean flat surface.
Estonian: Asetage süstal puhtale siledale pinnale.
English: The other ingredients are sucrose, citric acid anhydrous, trisodium citrate dihydrate and polysorbate 80.
Estonian: Muudeks koostisosadeks on sahharoos, veevaba sidrunhape, trinaatriumtsitraatdihüdraat ja polüsorbaat 80.
English: How to store Cablivi
Estonian: Kuidas Cablivi't säilitada
English: 7 vials with powder 7 syringes with solvent 7 sterile vial adapters 7 sterile needles 14 alcohol swabs
Estonian: 7 süstlit lahustiga 7 steriilset viaaliadapterit 7 steriilset nõela
English: Step 12 - Administration
Estonian: 12. samm.
English: No data on re-treatment with caplacizumab are available.
Estonian: Ravi kordamise kohta kaplatsizumabiga andmed puuduvad.
English: • Take the vial with the attached adapter.
Estonian: • Võtke viaal koos selle küljes oleva adapteriga.
English: • Without removing the needle cap, attach the needle to the syringe by turning clockwise until resistance is felt.
Estonian: • Ärge eemaldage nõelakatet ja kinnitage nõel süstla külge seda päripäeva keerates, kuni tunnete vastupanu.
English: A follow-up toxicokinetic study in pregnant guinea pigs assessed exposure of caplacizumab in the dams and foetuses.
Estonian: Toksikokineetiline jätkukatse tiinete merisigadega hindas kaplatsizumabiga kokkupuudet tiinetel emastel ja loodetel.
English: • Keep the vial standing vertically on the surface with the syringe pointing downwards.
Estonian: • Hoidke viaali pinnal püstiasendis, süstal suunaga allapoole.
English: • Do not touch the syringe tip or allow it to come into contact with any surfaces.
Estonian: • Ärge puudutage süstlaotsa ja ärge laske sel puutuda kokku ühegi pinnaga.
English: 1 vial with powder 1 syringe with solvent 1 sterile vial adapter 1 sterile needle 2 alcohol swabs
Estonian: 1 süstel lahustiga 1 steriilne viaaliadapter 1 steriilne nõel
English: The doctor will say when you can start your treatment again.
Estonian: • teil on ravi ajal rohkesti veritsusi; teie arst võib paluda teil ravi lõpetada; arst ütleb, millal te võite ravi uuesti alustada;
English: • Immediately after the injection, move the needle safety shield over the needle, until it clicks into place.
Estonian: • Kohe pärast süstimist pange kaitsekate nõela peale, kuni see kinnitub klõpsatusega.
English: Because von Willebrand factor acts as a carrier for factor VIII, reduced von Willebrand factor antigen levels resulted in a similar reduction in factor VIII:C levels.
Estonian: Von Willebrandi faktor toimib VIII faktori kandjana, mistõttu oli von Willebrandi faktori antigeenitaseme languse tulemuseks sarnane FVIII:C taseme langus.
English: Your doctor will decide if it can be postponed or if you should stop Cablivi before your surgery or dental treatment.
Estonian: • teil on planeeritud kirurgiline protseduur või hambaravi; teie arst otsustab, kas see tuleb edasi lükata või kas te peate ravi Cablivi'ga enne kirurgilist või hambaprotseduuri katkestama.
English: The pharmacologic effect of caplacizumab on target disposition was measured using von Willebrand factor antigen and factor VIII clotting activity (factor VIII:C) as biomarkers.
Estonian: Kaplatsizumabi farmakoloogilist toimet sihtmärgi vastuvõtlikkusele mõõdeti, kasutades biomarkeritena von Willebrandi faktori antigeeni ja VIII faktori hüübimisaktiivsust (FVIII:C).
English: Due to a potential increased risk of bleeding, use of Cablivi in patients with underlying coagulopathies (e.g. hemophilia, other coagulation factor deficiencies) is to be accompanied by close clinical monitoring.
Estonian: Kaasuva hüübimishäirega (nt hemofiilia, teiste hüübimisfaktorite vaegus) patsiente peab Cablivi'ga ravi ajal hoolikalt kliiniliselt jälgima.
English: Target-bound caplacizumab is assumed to be catabolised within the liver, whereas unbound caplacizumab is assumed to be renally cleared.
Estonian: Toime sihtkohaga seondunud kaplatsizumab kataboliseerub eeldatavalt maksas, seondumata kaplatsizumabi eritumine toimub eeldatavalt neerude kaudu.
English: An overdose is unlikely since one vial contains only a single dose.
Estonian: Kui te kasutate Cablivi't rohkem kui ette nähtud Üleannustamine on ebatõenäoline, sest viaal sisaldab vaid ühe annuse.
English: An embryo-foetal development study was conducted in guinea pigs, with no reported signs of toxicity.
Estonian: Embrüofetaalse arengu loomkatsetes merisigadega ei tuvastatud toksilisusilminguid.
English: • If the kit was not stored at room temperature, allow the vial and the syringe to reach room temperature (15°C - 25°C) by letting them stand at room temperature for a few minutes.
Estonian: (15...25 °C) soojeneda, lastes neil mõned minutid toatemperatuuril seista.
English: Vistor hf.
Estonian: Nõela kinnitamine.
English: Eye Haemorrhage*
Estonian: Subarahnoidaalne verejooks*
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1305/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/18/1305/001
English: White lyophilised powder.
Estonian: 1 viaal pulbriga
English: No formal study of the effect of hepatic or renal impairment on the pharmacokinetics of caplacizumab has been conducted.
Estonian: Maksa- või neerukahjustuse mõju kaplatsizumabi farmakokineetikale ei ole vormikohaselt uuritud.
English: Cablivi can be intravenously administered by connecting the prepared syringe to standard Luer locks of IV lines or using a suitable needle.
Estonian: Cablivi't võib intravenoosselt manustada, ühendades ettevalmistatud süstla i.v.
English: Target inhibition
Estonian: Sihtmärgi pärssimine
English: • Place the syringe on the clean flat surface.
Estonian: • Asetage süstal puhtale siledale pinnale.
English: Caplacizumab
Estonian: KG Dengelsberg
English: Step 2 - Before use
Estonian: Enne kasutamist.
English: Patients received a single intravenous bolus injection of 10 mg caplacizumab or placebo prior to the first plasma exchange on study.
Estonian: Enne uuringu esimest vereplasmavahetust said patsiendid ühe intravenoosse boolusinjektsioonina kas 10 mg kaplatsizumabi või platseebot.
English: There are no data on the use of caplacizumab in breastfeeding women.
Estonian: Kaplatsizumabi kasutamise kohta imetavatel naistel andmed puuduvad.
English: • Clean the exposed rubber stopper using one of the alcohol pads provided and allow it to dry for a few seconds.
Estonian: • Puhastage paljastatud kummikork, kasutades üht kaasasolevat alkoholiga immutatud vatipatja,
English: Pharmacokinetics of caplacizumab appear as non-dose proportional, as characterized by targetmediated disposition.
Estonian: Kaplatsizumabi farmakokineetika ei ole ilmselt annusest sõltuv, nagu näitab seondumine toime sihtkohaga.
English: • vomiting blood
Estonian: • veri väljaheites;
English: Contact your doctor immediately if any of the following serious side effects occur.
Estonian: Järgmiste raskete kõrvaltoimete tekkimisel võtke viivitamatult ühendust oma arstiga.
English: • are using anti-platelet agents such as aspirin, or low molecular weight heparin (which prevent blood clots).
Estonian: • te kasutate tromboosivastased aineid, nt aspiriini või madalmolekulaarset hepariini (mis ennetavad verehüübeid); teie arst otsustab, kuidas teid tuleb ravida;
English: Each vial contains 10 mg caplacizumab.
Estonian: Üks viaal sisaldab 10 mg kaplatsizumabi.
English: Step 5 - Prepare the syringe
Estonian: Valmistage süstal ette.
English: • pre-filled syringe The pre-filled syringe contains 1 mL water for injections.
Estonian: * Üks süstel lahustiga sisaldab 1 ml süstevett.
English: • Pull out the needle at the same angle you inserted it. Do not rub the injection site.
Estonian: • Tõmmake nõel välja sama nurga all, nagu sisestasite.
English: Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Estonian: Cablivi 10 mg süstelahuse pulber ja lahusti Kaplatsizumab (caplacizumabum)
English: STATEMENT OF ACTIVE SUBSTANCE Each vial of powder contains 10 mg caplacizumab.
Estonian: TOIMEAINE(TE) SISALDUS Üks pulbriga viaal sisaldab 10 mg kaplatsizumabi.
English: Cablivi contains the active substance caplacizumab.
Estonian: Cablivi sisaldab toimeainena kaplatsizumabi.
English: Place the tip of the syringe on the connector part of the vial adapter.
Estonian: Asetage süstla ots viaaliadapteri ühendusosale.
English: • water for injections in a pre-filled syringe to dissolve the powder After dissolving the powder in the solvent, the solution is clear, colourless or slightly yellowish.
Estonian: Pärast pulbri lahustamist lahustis on lahus läbipaistev, värvitu või kergelt kollakas.
English: MARKETING AUTHORISATION NUMBERS EU/1/18/1305/002
Estonian: MÜÜGILOA NUMBRID EU/1/18/1305/002
English: As such, caplacizumab prevents the ultralarge von Willebrand factor-mediated platelet adhesion, which is characteristic of aTTP.
Estonian: Kaplatsizumab ennetab seetõttu omandatud trombootilisele trombotsütopeenilisele purpurile iseloomulikku ülisuurt trombotsüütide adhesiooni, mida vahendab von Willebrandi faktor.
English: • If you have any further questions, ask your doctor or pharmacist.
Estonian: Kui teil on lisaküsimusi, pidage nõu oma arsti või apteekriga.
English: LIST OF EXCIPIENTS Excipients: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80.
Estonian: ABIAINED Abiained: sahharoos, veevaba sidrunhape, trinaatriumtsitraatdihüdraat, polüsorbaat 80.
English: Marketing Authorisation Holder and Manufacturer Ablynx NV
Estonian: Müügiloa hoidja ja tootja
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cablivi 10 mg powder for injection caplacizumab IV and SC
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Cablivi 10 mg süstelahuse pulber caplacizumabum i.v./s.c.
English: • to mitigate the risk of serious bleeding episode particularly in emergency situations (e.g. accident) to inform physicians about the medical blockage of the von Willebrand Factor.
Estonian: • teavitada arste tõsise verejooksu episoodi riski leevendamiseks, eriti erakorralistes olukordades
English: Haematuria*
Estonian: Hematuuria*
English: • multidose packs each containing 7 vials with caplacizumab powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 needles and 14 alcohol swabs.
Estonian: • mitmikpakina, mis sisaldab 7 viaali kaplatsizumabi pulbriga, 7 süstlit lahustiga, 7
English: • have severely reduced liver function.
Estonian: • väga tugev menstruatsiooniverejooks;
English: MARKETING AUTHORISATION NUMBERS EU/1/18/1305/001
Estonian: MÜÜGILOA NUMBRID EU/1/18/1305/001
English: NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection
Estonian: RAVIMPREPARAADI NIMETUS Cablivi 10 mg süstelahuse pulber ja lahusti
English: Each pre-filled syringe of solvent contains 1 mL of water for injections.
Estonian: Üks süstel lahustiga sisaldab 1 ml süstevett.
English: • single packs each containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 needle and 2 alcohol swabs
Estonian: • Üksikpakk, mis sisaldab 1 viaali pulbriga, 1 süstlit lahustiga, 1 viaaliadapterit, 1 hüpodermilist nõela (30 G) ja 2 alkoholiga immutatud vatipatja.
English: Step 13 - After administration
Estonian: 13. samm.
English: Close monitoring for signs and symptoms of bleeding is recommended.
Estonian: Soovitatav on hoolikas jälgimine veritsuse nähtude ja sümptomite osas (vt lõik 4.4.
English: It is unknown whether caplacizumab is excreted in human milk.
Estonian: Ei ole teada, kas kaplatsizumab eritub rinnapiima.
English: • tiredness
Estonian: • hingeldus;
English: Step 8 - Draw up solution
Estonian: 8. samm.
English: • black, tarry stools
Estonian: • must, tõrvavärvi väljaheide;
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Estonian: RAVIMVORM Süstelahuse pulber ja lahusti Valge lüofiliseeritud pulber.
English: • are using anticoagulants such as vitamin K antagonists , rivaroxaban, apixaban (which treat blood clots).
Estonian: K-vitamiini antagoniste, rivaroksabaani, apiksabaani; teie arst otsustab, kuidas teid tuleb ravida;
English: Willebrand factor antigen, and consequently factor VIII:C, were noted in cynomolgus monkeys and, to a lesser extent for factor VIII:C, in guinea pigs.
Estonian: Lisaks täheldati farmakoloogilist von Willebrandi faktori antigeeni ja FVIII:C taseme langust jaava makaakidel ning vähemal määral FVIII:C langust merisigadel.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous and subcutaneous use For single use only
Estonian: MANUSTAMISVIIS JA -TEE(D) Enne ravimi kasutamist lugege pakendi infolehte.
English: • bleeding gums
Estonian: • verejooks pärasoolest;
English: • bruise
Estonian: • Süstel
English: Step 4 - Attaching the adapter
Estonian: Adapteri paigaldamine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Estonian: RAVIMPREPARAADI NIMETUS Cablivi 10 mg süstelahuse pulber ja lahusti caplacizumabum
English: Citric acid anhydrous Trisodium citrate dihydrate Polysorbate 80
Estonian: Sahharoos, veevaba sidrunhape, trinaatriumtsitraatdihüdraat, polüsorbaat 80.
English: Step 7 - Prepare the solution
Estonian: 4.7 Toime reaktsioonikiirusele
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT SYRINGE LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Cablivi
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Cablivi lahusti
English: In the setting of concomitant use of anti-platelet agents and / or low molecular weight heparin (LMWH)
Estonian: Trombotsüütide agregatsiooni inhibiitorite ja/või madalmolekulaarse hepariini samaaegne manustamine
English: • stroke
Estonian: • veriköha;
English: Pyrexia, Fatigue
Estonian: Püreksia, kurnatus
English: • bleeding from eye
Estonian: • veritsus silmast;
English: Neuraceq florbetaben (
Estonian: Neuraceq florbetabeen (
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neuraceq on 20 February 2014.
Estonian: Euroopa Komisjon andis Neuraceqi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil 20. veebruaril 2014.
English: The full EPAR and risk management plan summary for Neuraceq 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 Neuraceqi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Neuraceq is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Neuraceqi võimalikult ohutu kasutamine.
English: Neuraceq has been investigated in one main study involving 216 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died; 41 volunteers (10 healthy young people and 31 patients) completed the study and were included in the results.
Estonian: Neuraceqi uuriti ühes põhiuuringus, milles osales 216 vabatahtlikku, kes jagati kahte rühma: tervete noorte rühm ja patsientide rühm, kelle elu hakkas lõppema ja kes nõustusid lahanguga pärast surma; uuringu lõpetas ka 41 vabatahtlikku (10 tervet noort inimest ja 31 patsienti), kes lisati tulemustesse.
English: Other information about Neuraceq
Estonian: Muu teave Neuraceqi kohta
English: What measures are being taken to ensure the safe and effective use of Neuraceq?
Estonian: Mis meetmed võetakse, et tagada Neuraceqi ohutu ja efektiivne kasutamine?
English: This means that the PET scans were able to correctly identify as positive 77.4% of the cases where patients had significant amounts of plaques, and that almost all patients without significant plaques were correctly rated as negative.
Estonian: See tähendab, et PET-uuringud suutsid õigesti tuvastada positiivsena 77,4% juhtudest, mille puhul patsiendil oli olulisel määral naaste, ja et peaaegu kõik patsiendid ilma olulise hulga naastudeta hinnati õigesti kui negatiivsed.